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Press Release Communiqué de presse - September 20, 2006 20 September, 2006
Diabetic Product Development Leads to Name Change: Sernova Corp.
Kelowna, B.C. - Pheromone Sciences Corp.
is
pleased to announce it has changed its name to
Sernova
Corp. ("Sernova"). The company's new stock
symbol is
SVA.
"The new name fits better with projects such as
our
current development of a potential breakthrough
treatment
for diabetes," said Chairman Dr. William
Cochrane. "We
wanted a new name to help make it clear to
investors that
our focus is no longer centred around
pheromones, but
can include all kinds of biotechnology
developments."
Shareholders approved the name change at the
Company's annual general meeting held on
August 18th
2006 and elected 5 directors to the Board: Dr.
William
Cochrane (Chair), Charles Allard, Justin
Leushner,
Devinder Randhawa and Dr. Eldon Smith.
The Company's officers are: Chief Executive
Officer-
Devinder Randhawa, President-Justin Leushner,
and Chief
Financial Officer and Corporate Secretary-Patrick
Groening.
Sernova Corp. is a biotechnology research and
development company focused on
commercializing
medical technologies.
This news release may contain forward-looking
statements. Forward-looking statements address
future
events and conditions and therefore involve
inherent risks
and uncertainties. Actual results may differ
materially from
those currently anticipated in such statements.
ON BEHALF OF THE BOARD
"Dev Randhawa"
Dev Randhawa, CEO
For further information contact:
TEL: (888) 318-7062 Mr. Phil Morehouse
FAX: (250) 868-8493 Sernova Corp.
Press Release Communiqué de presse - April 28, 2009 28 April, 2009
New Strategic Plan
APPOINTMENT OF DR. PHILIP TOLEIKIS AS
PRESIDENT
AND CEO
*
PRIVATE PLACEMENT FINANCING
*
GRANT OF STOCK OPTIONS
London, Ontario - April 28, 2009 - Sernova Corp.
(TSX-V:
SVA)
At the Annual General Meeting of Shareholders
held
today, the Sernova Board of Directors issued its
report on
the internal review of the Corporation's research
and
development, financing and partnering activities
and
strategies that had been conducted over the last
three
months by Mr. Jeffrey Bacha, an independent
Director of
the Corporation. Based on the analysis of the
Corporation's scientific progress to date,
regulatory
requirements, and financial and human
resources, the
Board of Directors has approved Mr. Bacha's
recommended strategic plan.
Sernova's immediate priority will be to seek
scientific
collaborations with key international transplant
centres
that currently offer islet transplantation (known
as the
Edmonton Protocol) to patients suffering from
Type 1
diabetes. Sernova strongly believes that its
proprietary
Sertolin(tm) technology, which utilizes co-
transplantation of
porcine islets and Sertoli cells in a unique
transplantation
device, offers a quantum leap forward over the
Edmonton
Protocol, the current standard of care. The
limitations of
the Edmonton Protocol are well understood: very
small
source of donated human islets, potential
damage to the
patient's liver, significant loss of islets following
transplantation, severe immune and
inflammatory
responses to the transplanted islets, and the
permanent
need for the patient to take toxic and expensive
anti-
rejection drugs. The Sertolin(tm) treatment would
potentially overcome all of the Edmonton
Protocol
limitations in a simpler, less invasive, safer and
less
expensive way, since it is based on the
availability of a
large supply of porcine islets and sertoli cells
from
controlled herds, reduced loss of islets following
transplantation, no minimal immune or
inflammatory
responses, and no need for any antirejection
drugs.
Sernova has already initiated discussions with
several key
transplantation centres in the United States with
a view to
establishing scientific collaborations to
demonstrate proof
of concept and commercialize Sertolin(tm). Mr.
Bacha
stated: "By working together with leading
transplant
centres, we can achieve far more in a shorter
period of
time, and ensure the highest quality studies that
will meet
the standards of the FDA and the international
scientific
community."
Sernova is also aggressively seeking
government and
private grants to fund key projects within the
overall
Sertolin(tm) development plan. Until further
funding and/or
scientific collaborations are secured, the
Corporation has
significantly reduced its overhead and operating
expenses.
The Board of Directors also announces the
appointment of
Dr. Philip Toleikis as the President and CEO of
the
Corporation. Dr. Toleikis is a seasoned and
experienced
biotechnology executive, with over 20 years of
research,
intellectual property, management and business
experience in the pharmacology and
biotechnology
sectors. His most recent position was as Vice
President,
R&D Pharmacology and Drug Screening, for
Angiotech
Pharmaceuticals, Inc. of Vancouver, British
Columbia,
where he built a major scientific and information
technology team that included senior scientists,
research
scientists and technicians. Dr. Toleikis' major
achievements at Angiotech included successful
completion of Phase II European Clinical Trials,
chairing
the Joint Research Committee, in-licensing and
out-
licensing of technologies, and management of
key patents
and patent applications. Dr. Toleikis is the author
of
multiple issued patents and over 110 patent
applications.
His research training and experience includes
biochemical
pharmacology, diabetes, oncology, inflammatory
diseases
(psoriasis, multiple sclerosis, surgical adhesions,
Alzheimer's disease and rheumatoid arthritis),
osteoarthritis, neurological diseases and
cardiovascular
conditions including ischemic heart disease,
cardiomyopathy, hypertension and aneurysms.
Dr.
Toleikis will be presenting on the Corporation's
behalf at
the BioFinance Conference in Toronto on
Wednesday,
April 29, 2009.
Dr. George Adams, Chairman of the Board of
Directors,
welcomed Dr. Toleikis, stating "Sernova is
privileged to
now be led by such a distinguished scientist and
executive. We are fully confident that Dr. Toleikis
will drive
our technology through the worldwide regulatory
process
and into commercialization. The treatment of
insulin-
dependent diabetes will be just the first
commercial
application of our platform technology. On behalf
of the
Board of Directors and our shareholders, I
welcome Dr.
Toleikis to the Sernova family."
Sernova also announces that it will be seeking
the
approval of the TSX Venture Exchange for a
private
placement of up to 14 million shares at a price of
$0.03
per common share, for aggregate consideration
of
$420,000. A commission of 10%, along with a
10% agents
warrant to purchase common shares at $0.05
per
common share, will be paid.
The Corporation also announces the granting of
incentive
stock options to an officer to purchase up to
700,000
common shares at $0.10 per share for a period
of 5 years
expiring April 28, 2014.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using its patented Sertolin cell
technology.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every 8 dollars spent
on health
care in the United States is spent on treating
diabetes and
its complications. Worldwide expenditures on
insulin alone
are estimated to be $15 billion annually and
growing.
This news release may contain forward-looking
statements. Forward-looking statements address
future
events and conditions and therefore involve
inherent risks
and uncertainties. Actual results may differ
materially from
those currently anticipated in such statements.
For further information contact:
Craig Gauld, Executive Vice President
Tel: (888) 318-7062; (519) 858-5126
info@sernova.com
www.sernova.com
THE TSX VENTURE EXCHANGE HAS NOT
REVIEWED
AND DOES NOT ACCEPT RESPONSIBILITY
FOR THE
Press Release Communiqué de presse - July 12, 2010 12 July, 2010
Sernova Announces Positive Results of its Proprietary Cell Pouch System(tm) in Preclinical Diabetes Model
Source: Sernova Corp
July 12, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire -- July 12,
2010) -
Sernova Corp. (TSX VENTURE:SVA) is pleased
to report
positive results from a long-term study
evaluating the
safety and efficacy of the Cell Pouch System(TM)
in a pre-
clinical model of diabetes.
Detailed data will be presented at the 23rd
International
Conference of the Transplant Society,
Vancouver, British
Columbia, Canada, August 15th-19th in a
presentation
entitled, "A novel Cell Pouch(TM), an alternative
to
intrahepatic islet transplantation."
Dr. Philip Toleikis, Sernova's President & CEO,
noted "Our
Cell Pouch System(TM) is a proprietary medical
device
implanted under the skin rapidly forming into a
tissue-
engineered, organ-like structure that provides a
natural
environment for the survival and function of
therapeutic
cells. These long-term results represent a
significant
achievement as a possible alternative to the
current
practice of injecting islets directly into the portal
vein of the
liver."
"Our data are profound because they suggest
the
potential to reduce side-effects associated with
the current
standard of care and achieve glucose control
with
significantly fewer islets than normally required,"
said
Toleikis.
On March 16, 2010, Sernova reported initial
results
demonstrating that the Cell Pouch System(TM)
becomes
rapidly vascularised and achieved initial glucose
control in
subject animals.
The following summarizes important new
findings reported
today:
Long-term insulin independence was
successfully
achieved with significantly fewer islets than the
current
standard of care, requiring only about 10% of
insulin-
producing islets normally used for the Edmonton
Protocol.
Animals in the study achieved long-term glucose
normalization throughout the course of the study.
Standard laboratory tests demonstrated
transplanted islets
produced insulin and responded similarly to non-
diabetic
animals to provide control of glucose.
No adverse events related to the Cell Pouch
System(TM)
occurred during the study.
About the Study
The Cell Pouch System(TM) was implanted in
pigs which
were then made diabetic through removing the
pancreas
and chemical induction. The animal's own islets
(Autograft)
isolated from the pancreas were transplanted
into the
device. Standard measures of efficacy including
fasting
and non-fasting glucose levels, glucose
tolerance tests
(IVGTT), and C-peptide were taken up to 72 days
post-
transplant. At the end of the study period, the
device
containing the islets was removed and the
animals
returned to a diabetic state.
Following transplantation, a substantial number
of study
animals maintained glucose levels within the
normal
range, showed glucose tolerance tests (IVGTT)
similar to
non-diabetic animals and were C-peptide
positive, an
important confirmation of insulin-producing islet
function.
Microscopic fluorescence analysis of the device
revealed
both microvessels and insulin associated with
islets.
Upon removal of the Cell Pouch System(TM)
containing
islets, fasting glucose levels returned to the
diabetic range
and animals required daily insulin injections to
maintain
normal glucose levels. The animals return to the
diabetic
state was further confirmed by IVGTT and C-
peptide
analysis.
From a safety perspective, no adverse events
occurred
related to the Cell Pouch(TM) throughout the
study
following implantation of over 40 devices for up
to 5
months. The devices were well-incorporated with
collagen
at all time points and yet were not visible under
the skin,
an important consideration for patients.
Dr. David White, Chair of Sernova's Scientific
Advisory
Board stated, "I am particularly enthusiastic
about these
results and the potential clinical relevance to
patients
suffering from diabetes. These new data suggest
that the
Cell Pouch System(TM) represent a possible
clinically
relevant alternative to injection of islets into the
portal vein
of the liver and may reduce the side effects of
transplantation including the instant blood-
mediated
reaction (IBMR). The indication that our device
achieves
glucose control with a reduction in the number of
islets
normally required is also of profound clinical
importance
as it may increase the availability of life-changing
islet
transplantation to many diabetic patients."
Sernova believes that the Cell Pouch
System(TM) has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, and
other chronic
debilitating diseases. Based on these
encouraging results,
the Company is taking steps towards clinical
evaluation of
its Cell Pouch System(TM).
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every eight dollars
spent on
health care in the United States is spent on
treating
diabetes and its complications. Worldwide
expenditures on
insulin alone are estimated to be $15 billion
annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - March 03, 2011 3 March, 2011
Sernova To Present Cell Pouch System™ Research Results At Transplantation Conference
Source: Sernova Corp
FOR RELEASE
March 3, 2011, 6:00 a.m. EST
LONDON, ONTARIO--(Marketwire - March 3,
2011) -
Sernova Corp. (TSX VENTURE:SVA) is pleased
to
announce the Company will present results of
preclinical
studies with its Cell Pouch System(TM), at the
Canadian
Society of Transplantation 2011 Annual Scientific
Conference at Mt-Tremblant, Quebec, Canada
held March
2-5.
The conference brings together eminent
scientists and
clinicians in the cell and organ transplantation
field from
across Canada and around the world. Sernova
will be
making three poster presentations entitled:
"The establishment of a stringent large animal
model of
insulin-dependent diabetes"
"A subcutaneous Cell Pouch(TM) as an
alternative to
intraportal infusion of islets of Langerhans to
restore
carbohydrate control in the diabetic recipient,"
and
"Islets transplanted into a subcutaneous Cell
Pouch(TM)
demonstrate long-term efficacy measured by C-
peptide."
"The conference provides a venue to discuss the
attributes of Sernova's novel Cell Pouch
System(TM) as
an alternate site for insulin-producing islet
transplantation
and its potential for additional cellular therapies
with
leaders from the medical transplantation
community,"
stated Delfina Siroen, Sernova's Research and
Development Head.
The Cell Pouch System(TM) is a proprietary
medical
device which may offer a revolutionary
improvement over
the current practice of injecting therapeutic cells
into blood
vessels. Based on previous pre-clinical research,
the Cell
Pouch System(TM) becomes a vascularised
organ-like
endocrine structure when placed in the body,
providing
the microcirculation thought to be essential to
early
function and long-term survival of therapeutic
cells.
Sernova has conducted efficacy studies in small
and large
animal models of diabetes and shown the device
with
insulin-producing islets to control blood glucose
levels
long-term without the need for daily insulin
injections.
Sernova believes the Cell Pouch System(TM)
has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, spinal
cord injury,
Parkinson's disease and other chronic
debilitating
diseases.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every 8 dollars spent
on health
care in the United States is spent on treating
diabetes and
its complications. Worldwide expenditures on
insulin alone
are estimated to be $15 billion annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - October 25, 2011 25 October, 2011
Sernova Enters Into Collaboration With Edmonton's Clinical Islet Transplant Program To Expand Cell Pouch(tm) Applications For Diabetes Treatment
Source: Sernova Corp
LONDON, ONTARIO - (Marketwire - October 25,
2011) -
Sernova Corp. (TSX-V: SVA), is pleased to
announce it
has entered into a collaboration with The Clinical
Islet
Transplant Program at the University of Alberta
Hospital.
The Program is headed by Dr. James Shapiro,
MD, Ph.D.
FRCS (Eng) FRCSC, the leader of the team that
developed
the Edmonton Protocol, the current standard of
care for
islet transplantation. In September 2010,
following review
of Sernova's preclinical data, Dr. Shapiro joined
the
Corporation's Scientific Advisory Board.
"Dr. Shapiro's contributions to date position us to
enter
into this important collaboration which is targeted
to
expand access to islet transplantation for the
treatment of
diabetes to a much wider base of patients using
Sernova's
Cell Pouch(tm)," said Dr. Philip Toleikis, Ph.D.,
President
and CEO of Sernova.
The current procedure for islet transplantation to
treat
diabetes, commonly known as the "Edmonton
Protocol"
involves transplanting islets directly into a blood
vessel
(portal vein) of the liver. The Cell Pouch(tm) is
expected to
solve a number of issues arising from portal vein
delivery.
For example, the Cell Pouch(tm) provides a
natural setting
where blood vessels grow adjacent to the islets
rather
than being bathed in blood which can result in
the death of
up to 75% of the islets through an instant blood
mediated
inflammatory response (IBMIR). Use of the Cell
Pouch(tm)
would eliminate portal vein hypertension and
thrombosis
associated with portal vein islet delivery and
potentially
reduce the cost of the procedure as the
catheterization
laboratory is not required for implantation of the
Cell
Pouch(tm) or islet transplantation. Importantly,
preclinical
studies of the Cell Pouch(tm) have consistently
shown
excellent safety and efficacy profiles with
significantly
fewer islets than for portal vein delivery, which
could
increase the number of recipients treated with
the current
donor pool. Furthermore, implantation of the Cell
Pouch(tm) just under the skin allows for imaging
of the
islets and microvessels and for local
immunoprotection of
therapeutic cells.
Sernova's Cell Pouch(tm) is a scalable medical
device
providing a natural "organ-like" environment for
therapeutic cells. Once implanted under the skin,
the Cell
Pouch(tm) develops pancreas-like function when
infused
with islets, controlling blood sugar levels as
shown by
published preclinical data which also suggests
that the
natural environment promotes cell survival
reducing the
number of islets required for therapy.
Sernova is currently pursuing upcoming human
testing of
the Cell Pouch(tm) based on the strong
preclinical safety
and efficacy data generated to date.
This collaboration will further seek to position the
Cell
Pouch(tm) through next generation
improvements to the
Edmonton Protocol to expand access to cell
transplant to a
much wider patient population. The collaboration
will
include work related to:
Assessment of islet protective agents that could
further
reduce the islet mass required for each
transplant using
the Cell Pouch(tm)
Assessment of locally administered anti-rejection
strategies within the Cell Pouch(tm) with the goal
of
reducing or eliminating systemic antirejection
regimens
Assessment of a proprietary, ethically derived
insulin-
producing stem cell technology within the Cell
Pouch(tm)
as an enabling technology which could
significantly
expand the number of patients treated
Development of high resolution imaging systems
to enable
physicians to better assess and optimize long-
term islet
function
A video describing the Edmonton Protocol and
the
collaboration of Sernova with Dr. Shapiro may
be viewed
on Sernova's website at www.sernova.com
"The safety and efficacy of the Cell Pouch(tm) in
preclinical
studies is impressive. We are excited to be
working with
Sernova in both preparing for its upcoming
clinical trial and
in this collaboration. We are hopeful that
Sernova's Cell
Pouch(tm) will significantly increase the number
of diabetic
patients that can be treated with islet
transplantation," said
Dr. Shapiro, Director of the Clinical Islet
Transplant
Program, at the University of Alberta and
member of
Sernova's Scientific Advisory Board.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - May 02, 2012 2 May, 2012
Sernova Receives Health Canada Approval to Initiate Human Clinical Trials of its Cell Pouch ™
-Patients with insulin-dependent diabetes to be
treated
with Sernova's subcutaneous Cell Pouch (TM)
and insulin-
producing islets-
Source: Sernova Corp
LONDON, ONTARIO--(Marketwire - May 2,
2012) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE: SVA - News) today announced it
received
Health Canada Approval to conduct a human
clinical trial
assessing both the safety and efficacy of
Sernova's Cell
Pouch(TM) with transplanted insulin-producing
islets in
patients with insulin-dependent diabetes. The
study will be
conducted in collaboration with Dr. James
Shapiro at the
University of Alberta Health Science Centre in
Edmonton.
"Sernova's compelling pre-clinical results
provide
optimism that the Cell Pouch(TM) has the
potential to
change the standard of care of patients with
diabetes
receiving islet transplantation," said Dr. James
Shapiro,
principal investigator of the study. "I am excited
to begin
enrolment of patients in this ground breaking
clinical study
to evaluate the Cell Pouch(TM) in humans."
The study, entitled "A Phase I/II Study of the
Safety and
Efficacy of Sernova's Cell Pouch(TM) for
Therapeutic Islet
Transplantation," is an open label, non-
randomized,
single-arm, Phase I/II safety and efficacy study
of up to 20
patients with insulin-dependent diabetes
undergoing
allograft pancreatic islet transplantation.
In this study, patients who have met the
enrolment criteria
and provided informed consent will be implanted
with the
Cell Pouch(TM) approximately 2-12 weeks prior
to
transplantation of donor human islets. To prevent
islet
graft rejection, patients will be treated with the
standard
immunosuppressive regimen.
The primary endpoint of the study is to assess
the safety
of the Sernova Cell Pouch(TM) in adult
participants with
Type-1 diabetes receiving islet transplantation
for the first
time. This endpoint will be assessed just prior to
islet
transplantation and one month thereafter.
The secondary endpoint of the study is to
determine the
proportion of subjects implanted with the Cell
Pouch(TM)
and transplanted with islets who achieve and
maintain
insulin independence as measured three months
post-final
islet transplantation.
In addition, the study will provide preliminary
data on the
efficacy of the Cell Pouch(TM) to maintain
adequate
immunological protection against both allo- and
autoimmunity of islet transplant recipients.
Following assessment of primary and secondary
endpoints, patients will be followed for a
minimum of three
years to assess long-term safety and efficacy of
the Cell
Pouch(TM). It should also be noted that the study
allows
for interim analysis of the data at various study
time
points.
"The initiation of this study marks a significant
milestone
for Sernova, and is the result of years of hard
work and
dedication from our company's staff and
collaborators,"
said Dr. Philip Toleikis, President and CEO of
Sernova
Corp. "We have developed the subcutaneous
Cell
Pouch(TM) for Sernova's first clinical application,
insulin-
dependent diabetes, as an alternative site for
islet
transplantation that may allow for safer, more
efficient
engraftment of islets and potential improved
long-term
insulin independence using a marginal islet
mass. We are
pleased to have Dr. Shapiro and his team
conduct this
study at this world class institute for islet
transplantation."
The Cell Pouch(TM) is a proprietary medical
device that,
once implanted subcutaneously, incorporates
with tissue
and microvessels. It has been shown in multiple
preclinical
studies to provide a safe environment for
transplantation,
as well as long-term survival and efficacy of
therapeutic
cells. Sernova's goals for the diabetes indication
include
making the Cell Pouch(TM) available to a wider
group of
patients than currently possible with intraportal
delivery of
islets. Sernova also plans to make the Cell
Pouch(TM)
available as a natural, improved site for non-
primary-
derived, insulin-secreting cells for long-term
function to
enable large numbers of patients with insulin-
dependent
diabetes to be treated without limitation to
availability of
cells.
About Sernova
Sernova Corp. is a clinical stage health-sciences
company
focused on commercializing medical
technologies.
Sernova is currently developing a platform
technology for
a number of serious disease indications, starting
with a
novel treatment for insulin-dependent diabetes,
using the
novel Cell Pouch System(TM) for transplantation
and long-
term survival of therapeutic cells and its patented
Sertolin(TM) cell technology which can provide
an
immune-protected local environment for
therapeutic cells.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Forward Looking Information This release may
contain
forward-looking statements. Forward-looking
statements
are statements that are not historical facts and
are
generally, but not always, identified by the words
"expects", "plans", "anticipates", "believes",
"intends",
"estimates", "projects", "potential" and similar
expressions, or that events or conditions "will",
"would",
"may", "could" or "should" occur. Although
Sernova
believes the expectations expressed in such
forward-
looking statements are based on reasonable
assumptions,
such statements are not guarantees of future
performance
and actual results may differ materially from
those in
forward looking statements. Forward-looking
statements
are based on the beliefs, estimates and opinions
of
Sernova's management on the date such
statements
were made. Sernova expressly disclaims any
intention or
obligation to update or revise any forward-
looking
statements whether as a result of new
information, future
events or otherwise.
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
Press Release Communiqué de presse - August 15, 2012 15 August, 2012
World First - Islet Transplant Into Man Using Sernova's Cell Pouch™ For Treatment Of Diabetes
-Company to Host Conference Call at 9 a.m.
EDT,
Today, Aug. 16, to Discuss Clinical and Business
Developments-
Source: Sernova Corp
LONDON, ONTARIO and EDMONTON,
ALBERTA
(Marketwire -- August 16, 2012) -- Sernova
Corp.
("Sernova" or the "Company") (TSX VENTURE:
SVA -
News) and the University of Alberta today
announced the
treatment of the first patient with insulin-
producing islets
transplanted into Sernova's Cell Pouch(TM) in a
Phase I/II
clinical study to treat Type-1 diabetes led by Dr.
James
Shapiro, Professor of Surgery and Medicine,
University of
Alberta and Director, Clinical Islet Transplant
Program.
Sernova will host a conference call at 9 a.m.
EDT, today,
Aug. 16, 2012, to discuss the company's clinical
and
business developments.
"The Sernova Cell Pouch(TM) implantation and
transplantation processes are simple, rapid
minimally
invasive procedures, conducted on an outpatient
basis
under local anesthesia," said Dr. Shapiro. "This
offers
substantial potential benefit over the Edmonton
protocol
and the ease of use provides an opportunity for
the Cell
Pouch(TM) to become the standard of care for
people with
diabetes if it proves to be effective in these initial
trials."
The objectives of the human clinical trial are to
assess the
safety and efficacy of the Cell Pouch(TM) with
transplanted islets in up to 20 patients with Type-
1
diabetes. The study is sponsored by Sernova
Corp and
the University of Alberta. In the study, patients
who have
met the enrolment criteria and provided informed
consent
are implanted with the Cell Pouch(TM) prior to
transplantation of donor human islets. To prevent
islet
graft rejection, patients in this study are treated
with the
best in class standard of care
immunosuppression
protocol. Interim analysis of the data from this
clinical
study is expected during H1, 2013. Further
information on
the trial may be found at www.clinicaltrials.gov
(Identifier:
NCT01652911).
"The Cell Pouch(TM) is a breakthrough
technology which
has the potential to significantly improve the lives
of
people living with chronic diseases such as
diabetes," said
Philip Toleikis, Ph.D., President and CEO of
Sernova Corp.
"Supported by Sernova's strong preclinical
results, the
treatment of patients in this clinical trial of the Cell
Pouch(TM) further advances our vision for the
future of
providing millions of diabetic patients with the
Cell
Pouch(TM), and an unlimited source of insulin-
producing
cells protected with a local anti-rejection
technology."
Conference Call
The conference call to discuss Sernova's clinical
and
business developments may be accessed by
dialing 866-
532-1852 for domestic callers and +443-842-
7644 for
international callers. Please specify to the
operator that
you would like to join the "Sernova conference
call" or
"conference ID: 21155379."
About The Cell Pouch(TM)
The Cell Pouch(TM) is a proprietary medical
device that,
following subcutaneous implantation,
incorporates with
tissue and microvessels forming a natural
environment for
transplantation of therapeutic cells. Multiple
preclinical
studies demonstrated the Cell Pouch(TM) to
provide a safe
environment for transplantation, as well as long-
term
efficacy of therapeutic cells. Sernova's goals for
the Cell
Pouch(TM) for diabetes include providing a safe
and
natural site for islets to significantly increase the
number of
patients currently treated with intraportal delivery
of donor
islets and to provide a safe environment for
virtually
unlimited available sources of insulin-secreting
cells such
as insulin-producing stem cells and xenogeneic
cells. This
vision combined with local anti-rejection
protection of the
cells could enable millions of patients with
insulin-
dependent diabetes to be treated without
limitation to
availability of cells.
About Sernova
Sernova Corp. is a clinical stage health-sciences
company
focused on commercializing medical
technologies.
Sernova is currently developing a platform
technology for
a number of serious disease indications, starting
with a
novel treatment for insulin-dependent diabetes,
using the
novel Cell Pouch System(TM) for transplantation
and long-
term survival of therapeutic cells and its patented
Sertolin(TM) cell technology which can provide
an
immune-protected local environment for
therapeutic cells.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Dr. James Shapiro MD PhD FRCS
Professor of Surgery and Medicine, University of
Alberta
Director, Clinical Islet Transplant Program
Tel: (780) 407-7330
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Forward Looking Information This release may
contain
forward-looking statements. Forward-looking
statements
are statements that are not historical facts and
are
generally, but not always, identified by the words
"expects", "plans", "anticipates", "believes",
"intends",
"estimates", "projects", "potential" and similar
expressions, or that events or conditions "will",
"would",
"may", "could" or "should" occur. Although
Sernova
believes the expectations expressed in such
forward-
looking statements are based on reasonable
assumptions,
such statements are not guarantees of future
performance
and actual results may differ materially from
those in
forward looking statements. Forward-looking
statements
are based on the beliefs, estimates and opinions
of
Sernova's management on the date such
statements
were made. Sernova expressly disclaims any
intention or
obligation to update or revise any forward-
looking
statements whether as a result of new
information, future
events or otherwise.
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
Press Release Communiqué de presse - February 28, 2013 28 February, 2013
Sernova and Centre for Commercialization of Regenerative Medicine Partner To Treat Chronic Diseases
February 28, 2013 (TORONTO and LONDON,
ON) -- The
Centre for Commercialization of Regenerative
Medicine
(CCRM) is pleased to announce the addition of
Sernova
Corp. ("Sernova" or the "Company") (TSX
VENTURE: SVA
- News) to its member-based industry
consortium.
Sernova's combination of immuno-protective
technology
and therapeutic cells for the treatment of chronic
diseases
advances CCRM's goal of developing innovative
cell-
based product.
"Sernova's technology for transplanting
therapeutic cells
into an implanted medical device for the
treatment of
diabetes and other chronic diseases goes hand-
in-hand
with our strategy of translating cell-based
medical
discoveries into commercial products and
therapies," says
Dr. Michael May, CEO of CCRM. "Sernova's
expertise in
the area of cell therapy will bring great value to
CCRM's
core development platforms and to other
consortium
members."
CCRM is working with its industry consortium to
address
real-life bottlenecks in cell-based product
pipelines. Its
industry consortium now numbers over 20
members.
These companies represent the key sectors of
the
industry: therapeutics, devices, reagents, and
cells as
tools.
"Becoming a member of CCRM offers the
opportunity for
further validation for our technology and
demonstrates our
company's commitment to the advancement of
our Cell
Pouch System(tm) as an effective, safe, long-
term and
convenient therapeutic option for the treatment
of chronic
diseases," says Dr. Philip Toleikis, President and
CEO of
Sernova Corp. "We will work together with the
other
consortium members to achieve CCRM's
objectives in
treating and managing devastating diseases
such as
diabetes."
CCRM has built three core development
platforms: cell
reprogramming and engineering; cell
manufacturing; and,
biomaterials and devices to carry out projects
commissioned by academia and industry. CCRM
has a
fully resourced, 6,000 square foot development
facility
where all development work takes place.
Please visit www.ccrm.ca/industry-consortium to
see a
complete list of CCRM's members.
About the Centre for Commercialization of
Regenerative
Medicine (CCRM)
CCRM, a Canadian not-for-profit organization
funded by
the Government of Canada's Networks of
Centres of
Excellence program and six academic partners,
supports
the development of technologies that accelerate
the
commercialization of stem cell- and biomaterials-
based
technologies and therapies. A network of
academics,
industry and entrepreneurs, CCRM aims to
translate
scientific discoveries into marketable products for
patients.
CCRM launched in Toronto's Discovery District
on June
14, 2011.
About Sernova
Sernova Corp. is a clinical stage health-sciences
company
focused on commercializing medical
technologies.
Sernova is currently developing a platform
technology for
a number of serious disease indications, starting
with a
novel treatment for insulin-dependent diabetes,
using the
novel Cell Pouch System(TM) for transplantation
and long-
term survival of therapeutic cells and its patented
Sertolin(TM) cell technology, which can provide
an
immune-protected local environment for
therapeutic cells.
For more information on CCRM, please contact:
Stacey Johnson
Manager, Communications
Centre for Commercialization of Regenerative
Medicine
647-309-1830
stacey.johnson@ccrm.ca
www.ccrm.ca
For further information on Sernova, please
contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Press Release Communiqué de presse - September 09, 2013 9 September, 2013
Sernova And Medicyte To Collaborate On Cell-Based Therapy To Treat Haemophilia
* Novel Approach to Address Unmet Need for an
Effective Therapy *
LONDON, ONTARIO and HEIDELBERG, GERMANY--
(Marketwire -- September 10, 2013) - Sernova Corp. (TSX-
V: SVA) and Medicyte GmbH, today announced that the
companies have entered into a Material Transfer
Agreement (MTA) to jointly evaluate the use of Medicyte's
upcyte® cells in Sernova's Cell Pouch(TM) for the
treatment of patients with haemophilia A.
The two companies have also entered into a nonbinding
term sheet outlining the general terms of a collaboration
for the pre-clinical and clinical development of the novel
Cell Pouch(TM)/upcyte® combination product for the
treatment of haemophilia A. The parties intend to complete
negotiations of a definitive agreement while initial research
is being carried out under the terms of the MTA.
"The joint development program with Medicyte is further
indication that our Cell Pouch(TM) technology is versatile
and has high potential to be employed for the treatment of
a range of chronic diseases," said Dr. Philip Toleikis,
President and CEO Sernova Corp. "We are in line with our
strategy to expand the testing of the Cell Pouch(TM) in
various indications by collaborating with leading cell-based
therapy companies, such as Medicyte."
Dr. Joris Braspenning, CEO of Medicyte, added, "There is
a great unmet medical need for the treatment of severe
haemophilia A. We believe that Medicyte's upcyte® cells
being sheltered in Sernova's Cell Pouch(TM) represent a
promising combination of technologies to produce
effective levels of Factor VIII, and to prevent excessive
bleeding episodes of patients suffering haemophilia A.
Together with Sernova, we are looking forward to
evaluating the potential of a combined product."
Haemophilia A is the most common form of haemophilia
and results from a deficiency of clotting Factor VIII to a
level of less than 1% of the normal blood concentration.
Haemophiliacs have prolonged bleeding which in areas
such as the brain can be fatal or inside joints can be
permanently debilitating. Approximately 20,000 people in
the United States have the moderate or severe form of
haemophilia A, as well as approximately 2,500 in Canada
and 10,000 in Europe. Though there is no cure for
haemophilia A, it is currently controlled with regular
injections of recombinant clotting Factor VIII. Annual costs
for the treatment of the disease may range from $60,000
to $260,000 per patient for a total cost of between $2-4B
per year in North America and Europe.
Development of a product capable of producing an
effective level of Factor VIII within the Cell Pouch(TM)
environment has the potential to provide haemophilia A
patients with better protection against dangerous episodes
of excessive bleeding and greatly reduce annual therapy
costs.
Continuation of the parties' joint studies beyond the MTA
is subject to negotiation and execution of a definitive
collaboration agreement.
About Medicyte
Medicyte is specialised in the controlled generation and
standardisation of human primary cell products in virtually
unlimited quantities and of highest quality for cell therapy
and cell-based R&D. Medicyte's proprietary technologies
upcyte® and vericyte® enable researchers to expand
human cells from different donors and from multiple
tissues in a standardized procedure, thereby making these
cells for the first time commercially available in high
numbers and consistent quality. Beside their therapeutic
applications, pharmaceutical companies are using
upcyte® and vericyte® products for in vitro assays and
ADMET testing.
For further information contact:
Joris Braspenning, Ph.D., CEO
Tel: +49 (6221) 72925-30
j.braspenning@medicyte.com
www.medicyte.com
About Sernova
Sernova Corp. is a clinical stage health-sciences company
focused on commercializing medical technologies.
Sernova is developing a platform technology based on the
Cell Pouch(TM), Sertolin(TM) and therapeutic cells, for a
number of chronic diseases, including insulin-dependent
diabetes as a first indication and other cell therapies for
diseases such as parathyroid disease, haemophilia, and
Parkinson's disease. Sernova's goals for the Cell
Pouch(TM) for diabetes include increasing the number of
patients currently treated with intraportal delivery of donor
islets and to provide a safe environment for sources of
unlimited insulin-secreting cells such as insulin-producing
stem cells and xenogeneic cells. This vision combined with
local anti-rejection protection of the cells could enable
millions of patients with insulin-dependent diabetes to be
treated without limitation to availability of cells.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Tony Russo, Ph.D.
Russo Partners, LLC
Tel: (212) 845-4251
tony.russo@russopartnersllc.com
Neither the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking information,
which involves known and unknown risks, uncertainties
and other factors that may cause actual events to differ
materially from current expectation. Important factors -
including availability of funds, the results of financing
efforts, the results of research and product development
activities -- that could cause actual results to differ
materially from Sernova's expectations are disclosed in
Sernova's documents filed from time to time on SEDAR
(see www.sedar.com). Readers are cautioned not to place
undue reliance on these forward-looking statements,
which speak only as of the date of this press release. The
company disclaims any intention or obligation, except to
the extent required by law, to update or revise any
forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - April 21, 2014 21 April, 2014
Sernova’s Cell Pouch™ Diabetes Clinical Trial Demonstrates Interim Safety and Biocompatibility
Sernova’s Cell Pouch with insulin-producing islets is safe and
biocompatible in patients with unstable diabetes
Source: Sernova Corp
FOR RELEASE
April 22nd, 2014, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire – April 22nd, 2014) - Sernova Corp. (TSX-V: SVA), a clinical stage company
developing medical technologies for the long-term treatment of chronic metabolic diseases including diabetes,
blood disorders such as haemophilia and other diseases, today announced interim results in an ongoing type 1
diabetes human clinical trial with the Company’s Cell Pouch(TM).
Sernova’s human clinical trial is designed to assess the safety and efficacy of the Cell Pouch in subjects with
unstable diabetes receiving an islet transplant. Interim study results in the first group of patients support that
the implanted Cell Pouch, transplanted with insulin-producing islets is showing longer-term safety and
biocompatibility with one of the patients beyond the 180 day time point.
Encouraging early results up to 30 days post-islet transplant were presented at the International Pancreas and
Islet Transplantation Congress in September, 2013. These results showed after implantation under the skin, the
Cell Pouch is safe and biocompatible. Following islet transplantation, the islets living within a natural tissue
matrix were supported with a rich supply of blood vessels, similar to the pancreas. Of further importance, the
islets were shown to make insulin, somatostatin and glucagon – key hormones in the control of blood sugar
levels. The ongoing study is being conducted with Dr. James Shapiro as principal investigator at the University
of Alberta Health Sciences Centre in Edmonton, Alberta.
"The fact that the Cell Pouch continues to exhibit both safety and biocompatibility in longer term follow-up is
an important milestone in the early clinical testing of this device, and provides encouragement that human
islets transplanted within the device may provide the opportunity to change the standard of care of patients
with diabetes," said Dr. James Shapiro. “I look forward to the ongoing results of the investigation as the study
progresses."
The study, entitled “A Phase I/II Study of the Safety and Efficacy of Sernova's Cell Pouch for Therapeutic Islet
Transplantation,” is an open label, non- randomized, Phase I/II safety and efficacy study of up to 20 patients
with type 1 diabetes undergoing allograft pancreatic islet transplantation. Patients who have met the enrolment
criteria and provided informed consent are implanted with the Cell Pouch approximately 2-24 weeks prior to
transplantation of donor human islets. To prevent islet graft rejection, the standard of care immunosuppressive
regimen is provided.
The primary endpoint of the study is to assess the safety of the Sernova Cell Pouch in these patients just prior
to islet transplantation, following islet transplantation and at various points during follow up. The secondary
endpoint of the study, efficacy, is to determine the proportion of subjects implanted with the Cell Pouch and
transplanted with islets who achieve and maintain insulin independence. Patient follow up occurs for a
minimum of three years to assess long-term safety and efficacy.
“In the second half of 2014, we expect to provide further preliminary safety and efficacy data”, remarked Dr.
James Shapiro.
"This interim update by Dr. Shapiro suggests we are making positive strides forward. The Cell Pouch could
potentially be a game changer for patients suffering from this debilitating disease. Indeed, this is the result of
years of hard work and dedication from our company's staff and collaborators," said Dr. Philip Toleikis,
President and CEO of Sernova Corp. "We have developed the subcutaneous Cell Pouch for Sernova's first
clinical application, insulin- dependent diabetes, as an alternative site for islet transplantation that may allow
for safer, more efficient engraftment of islets and potential improved long-term insulin independence using a
marginal islet mass. What adds further credence to the Cell Pouch’s mechanism of action is the application of
the Cell Pouch for other clinical indications which Sernova is undertaking”, added Dr. Toleikis."
About the Cell Pouch
The Cell Pouch is a proprietary, scalable, biocompatible medical device, that once implanted subcutaneously,
incorporates with the patient’s tissue and microvessels. The Cell Pouch is contract manufactured (ISO13485) to
meet international regulatory standards. Sernova’s research has demonstrated that when the Cell Pouch is
inserted under the skin, it forms an ideal environment, rich in microvessels and tissue matrix for the placement
and function of therapeutic cells. The Cell Pouch is currently being evaluated in clinical trials at the University
of Alberta with Dr. James Shapiro as principal investigator in patients with type 1 diabetes receiving an islet
transplant.
It has been shown in multiple preclinical studies to provide a safe environment for transplantation, as well as
for the long-term survival and efficacy of therapeutic cells. Sernova's goals for the diabetes indication include
making the Cell Pouch available to a wider group of patients than currently possible with intraportal delivery of
islets. Sernova also plans to make the Cell Pouch available as a natural, improved site for non-primary-derived,
insulin-secreting cells. This may enable long-term treatment in large numbers of patients with insulin-
dependent diabetes without limitation to availability of donor-derived cells.
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the
treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including haemophilia
and other diseases treated through replacement of proteins or hormones missing or in short supply within the
body. Sernova is developing the Cell Pouch, an implantable medical device for therapeutic cells (donor,
xenogeneic or stem cells) which then release proteins and/or hormones as required.
About Clinical Islet Transplantation Program
Please view www.islet@ca for more information on the Clinical Islet Transplantation Program at the University
of Alberta.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance and actual results may differ materially from those in forward looking statements.
Forward-looking statements are based on the beliefs, estimates and opinions of Sernova’s management on the
date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 11, 2015 11 February, 2015
Sernova is Awarded Patents in Multiple Countries for Cell Pouch™ and Therapeutic Cell Transplantation Technologies
Source: Sernova Corp
February 12, 2015, 6:00 a.m. EDT
LONDON, ONTARIO (Marketwire – February 12, 2015) - Sernova Corp. (TSX-V: SVA), today announced that the
Patent Offices in China, Israel, Singapore and New Zealand have issued Notices of Allowance and issued
patents to Sernova for its patent application entitled "Methods and Devices for Cellular Transplantation.”
These patents help protect Sernova’s entire Cell Pouch(TM) system, including the Cell Pouch(TM) itself, as well
as the Cell Pouch(TM) combined with therapeutic cells and surgical tools for cell transplantation. These issued
patents, in addition to patent rights already granted or actively being pursued in other countries, will provide
Sernova with patent protection through 2030.
“Patent applications on Sernova’s technologies are being pursued in multiple countries around the world and we
are confident that additional patents will be granted on an international basis,” stated Dr. Philip Toleikis,
Sernova’s President and CEO.
"Potential strategic partners, including major pharmaceutical companies place significant value in issued
patents,” stated Dr. Philip Toleikis, Sernova’s President and CEO. He continued, “Since 2009, we have been
relentless at carrying out our strategy to secure exclusive patent rights on our core technologies, to develop an
international footprint for our products.”
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the
treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia
and other diseases treated through replacement of proteins or hormones missing or in short supply within the
body. Sernova is developing the Cell Pouch(TM), an implantable medical device for therapeutic cells (donor,
xenogeneic or stem cells) which then release proteins and/or hormones as required. The therapeutic cells are
protected from immune attack by Sernova’s proprietary local immune protection technology.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance and actual results may differ materially from those in forward looking statements.
Forward-looking statements are based on the beliefs, estimates and opinions of Sernova’s management on the
date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - April 22, 2015 22 April, 2015
Sernova Receives Issued Patent in the United States for its Cell Pouch™ and Therapeutic Cell Transplantation Technologies
Sernova Receives Issued Patent in the United States for its Cell Pouch(TM) and Therapeutic Cell
Transplantation Technologies
Sernova’s cell transplantation and local immune protection patent families are secured and protected to
maximize stakeholder value
Source: Sernova Corp
April 23, 2015, 6:00 a.m. EDT
LONDON, ONTARIO (Marketwire – April 23, 2015) - Sernova Corp. (TSX-V: SVA), is pleased to announce that
the U.S. Patent and Trademark
Office (USPTO) has issued Sernova a patent that helps protect Sernova’s entire Cell Pouch System (TM).
This patent entitled "Methods and Devices for Cellular Transplantation” includes claims covering implantable
polymer devices such as the Cell
Pouch(TM) itself, as well as methods using the same combined with therapeutic cells such as self‐cells, donor
cells, stem cells and genetically
modified cells as well as surgical tools for cell transplantation. This new patent provides Sernova with patent
protection through 2030. Sernova
currently has over 55 issued patents and patent pending applications worldwide covering its therapeutic cell
transplantation and local immune
protection technologies.
The USPTO grants a patent after a vigorous search of the existing technology and a determination that a
claimed invention is novel and
nonobvious over that technology. Gaining such patent protection is commercially important because the United
States represents one of the
world’s largest markets for Sernova’s various therapeutic products in development.
“Since 2009, we have pursued patent rights around the world for our cell transplantation and local immune
protection technologies and we will
continue our rigorous strategy to secure and protect our proprietary technologies,” stated Dr. Philip Toleikis,
Sernova’s President and CEO.
Within its patented technological armamentarium, Sernova uses biocompatible polymers to develop unique,
highly vascularized subcutaneous
tissue chambers for the placement, survival and long term function of therapeutic cells. Over the past six years,
Sernova has demonstrated an
excellent safety profile and efficacy benefit for its technologies in small and large animal models of disease and,
more importantly, in humans
with severe diabetes where transplanted therapeutic cells become highly vascularized and able to produce their
therapeutic product.
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the
treatment of chronic debilitating
metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through
replacement of proteins or
hormones missing or in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable
medical device for therapeutic
cells (donor, xenogeneic or stem cells) which then release proteins and/or hormones as required. The
therapeutic cells are protected from
immune attack by Sernova’s proprietary local immune protection technology.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are
generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”,
“estimates”, “projects”, “potential” and
similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although
Sernova believes the expectations
expressed in such forward-looking statements are based on reasonable assumptions, such statements are not
guarantees of future
performance and actual results may differ materially from those in forward looking statements. Forward-
looking statements are based on the
beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova
expressly disclaims any intention
or obligation to update or revise any forward-looking statements whether as a result of new information, future
events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of
the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - September 09, 2015 9 September, 2015
Sernova Secures Commercial Rights to Proprietary Stem Cell Derived Technologies
– UHN (University Health Network) agreement transitions Sernova to an integrated therapeutic cell regenerative
medicine Company –
Source: Sernova Corp
September 10, 2015, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – September 10, 2015) – Sernova Corp.
(TSX-V: SVA) (FSE: PSH), a clinical stage company developing medical technologies for the long-term treatment
of chronic metabolic diseases including diabetes, blood disorders such as haemophilia and other diseases,
announced today it has signed a license agreement with the University Health Network (UHN) of Toronto,
Canada to gain exclusive worldwide rights to certain patent-pending technologies developed by distinguished
UHN researchers, Dr. Cristina Nostro and Dr. Gordon Keller. These technologies relate to the development of
stem cells into glucose-responsive therapeutic cells for the treatment of patients with insulin-dependent
diabetes.
”This agreement provides us with a proprietary source of stem cell derived glucose responsive therapeutic
cells. When placed within Sernova’s prevascularized Cell Pouch(TM), and protected locally from immune
system attack, we believe that Sernova has the potential to provide a significant break-through in the quality of
treatment for the millions of people suffering from insulin-dependent diabetes, said Dr. Philip Toleikis,
Sernova’s President and CEO”. “Such individuals could essentially be liberated from their current onerous daily
regime of multiple blood glucose testing and insulin administration delivered through injections or electronic
means which is expected to materially improve their quality of life, prevent or reduce abnormal glucose
complications, and reduce short term and longer term health care costs.”
The current standard of care for islet transplantation is limited to diabetic patients with severe hypoglycemia
unawareness due to both a lack of cadaveric donor islets and a requirement for life-long use of toxic anti-
rejection drugs.
“We believe that a virtually unlimited supply of glucose responsive therapeutic cells could be generated from
ethically derived stem cells which, if shown to have positive safety and efficacy in clinical trials, could be used
to treat millions of patients,” commented Delfina Siroen, Sernova’s head of Research and Development. “The
addition of the UHN stem cell technologies moves Sernova one step further toward being able to provide a full
solution (device, unlimited cell supply and local immune protection) for cell therapy applications.”
About Diabetes
The worldwide incidence of diabetes is approximately 370 million. Sernova’s potential addressable market
which includes Type-1 patients and those Type-2 patients requiring insulin is over 30 million people. Although
there is currently no cure for diabetes, blood glucose levels are being controlled with frequent blood glucose
testing combined with regular injections of insulin via syringe or insulin pump; however, blood glucose control
using this treatment approach can be poor, leading to side effects such as heart, kidney and eye diseases as
well as ischemia-induced amputations. According to the Juvenile Diabetes Research Foundation, annual health
care costs for the treatment of diabetes and its debilitating side effects are estimated to be over US $245 billion
per year in North America (http://jdrf.org/).
About Sernova
Sernova Corp is a clinical stage regenerative medicine company developing medical technologies for the
treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia
and other diseases treated through replacement of proteins or hormones missing or in short supply within the
body. Sernova is developing the Cell Pouch(TM), an implantable medical device for therapeutic cells (donor,
xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance and actual results may differ materially from those in forward looking statements.
Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch and our
expectations of the potential benefits of the license agreement, are based on the beliefs, estimates and
opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any
intention or obligation to update or revise any forward-looking statements whether as a result of new
information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - December 20, 2015 20 December, 2015
Sernova Awarded Europe’s Prestigious Horizon 2020 Grant to Fund Development of Cell-based Hemophilia Therapeutic Product into the Clinic
Distinguished European consortium awarded approximately $8.5 Million CAD by the European Commission via
its Horizon 2020 Program to partner advanced cell based Factor VIII therapy in collaboration with Sernova and
its Cell Pouch(TM) device technologies
Source: Sernova Corp
December 21, 2015, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – December 21, 2015) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE:
PSH), a clinical stage regenerative medicine company, announced today that the European Commission’s
Horizon 2020 program has awarded a Euro 5.6M ($8.5M CAD) grant to a consortium consisting of Sernova
Corp and five European academic and private partners to advance development of a GMP clinical grade Factor
VIII releasing therapeutic cell product in combination with Sernova’s Cell Pouch(TM) for the treatment of severe
hemophilia A, a serious genetic bleeding disorder caused by missing or defective factor VIII in the blood
stream.
The current market for factor VIII is US$5.0B/year, with a cost of up to US$260,000 per patient each year.
Current standard of care involves regular infusions of factor VIII, which achieves normal factor VIII blood levels
for only a few hours at a time. The product being developed by the HemAcure consortium will seek to provide
constant delivery of Factor VIII to normalize blood levels in an effort to significantly improve the quality of life
of patients suffering from hemophilia A.
The product being developed by the HemAcure consortium is expected to be highly disruptive to the current
standard of care treatments for hemophilia A. The therapeutic goal of the product is to use the patient’s own
cells corrected for the factor VIII gene. These cells placed in the implanted Cell Pouch will release factor VIII on
a continual basis at a rate that would be expected to significantly reduce disease-associated hemorrhaging and
joint damage. The constant delivery of factor VIII is also expected to reduce or eliminate the need for multiple
weekly infusions which is the current standard of care using plasma-derived or recombinant, genetically
engineered factor VIII for the prophylactic treatment of hemophilia A.
“The therapeutic potential to have a constant release of factor VIII from a hemophilia A patient’s own
genetically corrected cells placed within the implanted Cell Pouch would be a very significant advance in the
treatment of hemophilia A,” remarked Dr. David Lillicrap, MD, FRCPC Professor Department of Pathology and
Molecular Medicine Queens University, Canada Research Chair in Molecular Hemostasis and member of the
HemAcure Scientific Advisory Board. “Sernova’s Cell Pouch with its vascularized tissue lined chambers for
therapeutic cells, which has already been proven for islet safety and survival in human clinical assessment of
diabetes, is an ideal, fully scalable first-in-class medical device suitable for the potential treatment of
hemophilia,” added Dr. Lillicrap.
“It has been exciting working together with the highly skilled team of experts in the HemAcure consortium in
hemophilia and cell therapy. The scientific strength of this consortium was evident from the inception of the
idea through the development and awarding of the grant to the stimulating kick off meeting,” said Delfina
Siroen, Sr. Director of Sernova’s Research and Development team. “In a very short time, Sernova’s hemophilia
program has achieved great strides and the addition of this European grant and team will ensure the best
possible outcome for this program to the clinic,” continued Ms. Siroen.
The preliminary preclinical proof of concept data used as a basis to support the foundation of the grant was
generated in a collaborative agreement between Medicyte GmbH under the FP7 ReLiver project, grant
agreement 304961 and Sernova Corp where cryopreserved cells with the ex vivo inserted corrected gene for
factor VIII were successfully shipped and assessed in Sernova’s Cell Pouch at its headquarters in Canada.
Regarding Sernova’s participation in the consortium, the review of the HemAcure grant proposal stated the
following, “Participation of the third country partner (Sernova Corp) is essential for carrying out the (program).
This is justified by the fact that the partner in question is the one who possesses the technology that will be the
basis of the whole proposal, and which will perform all the in vivo studies. Sernova uses a scalable, contract
manufactured, proprietary patented worldwide implantable medical device (Cell Pouch) transplanted with
therapeutic cells. (It) has been in development for more than six years and has shown success in multiple small
and large animal preclinical models and is now in a clinical trial for another therapeutic indication. This Cell
Pouch device is the only such device that when implanted under the skin is proven to become incorporated with
blood vessel enriched tissue-forming chambers for the placement of therapeutic cells. This implies that the
Canadian partner (Sernova) is an essential partner for the success of this project.”
About Hemophilia A
People with Hemophilia have prolonged abnormal bleeding as a result of trauma. Hemophilia A, also called
factor VIII (FVIII) deficiency is the most common form of Hemophilia and is a genetic disorder caused by
missing or defective factor VIII, a blood clotting protein. Severe hemophilia occurs in about 60% of cases where
the deficiency of Factor VIII is less than 1% of normal blood concentration. While it is passed down from
parents to children, about 1/3 of cases are caused by a spontaneous change in the gene. According to the US
Centers for Disease Control and Prevention hemophilia occurs in about 1 in 5,000 births. If the prolonged
bleeding occurs in the brain of a person with hemophilia, it can be fatal. Prolonged bleeding in joints can cause
inflammatory responses and permanent joint damage. Approximately 20,000 people in the United States and
10,000 in Europe have the moderate or severe form of hemophilia A, as well as approximately 2,500 in Canada.
All races and ethnic groups are equally affected by hemophilia A. Though there is no cure for the disease, it can
be controlled with regular infusions of recombinant clotting Factor VIII. Annual costs for the treatment of the
disease for each patient may range from $60,000 to $260,000 US for a total cost of between $2-5B per year in
North America and Europe.
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly Euro 80 billion of funding
available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by
taking great ideas from the lab to the market. The project is funded as part of societal challenges “personalizing
health and care” in a specific call about innovative treatments and technologies. New therapies, such as gene or
cell therapies, often require technological innovation in the form of development of specific component tools
and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the
therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving
therapeutic scale production and GMP standards at reasonable cost is often underestimated. The European
Union aims to improve the development of advanced methods and devices for targeted and controlled delivery,
and to bring these innovative treatments to the patient.
About HemAcure
HemAcure is the name of the consortium developing a product for hemophilia A. This project has received
funding from the European Union's Horizon 2020 research and innovation program under grant agreement No
667421. The consortium members include the University Hospital Wurzburg (Coordinating Institute), Integrierte
Management Systeme IMS e.K., Universita del Piemonte Orientale “Amedeo Avogadro,” Loughborough
University, GABO:mi Gesellschaft für Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main
objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo
prepared cell based therapy within Sernova’s prevascularized Cell Pouch to treat this bleeding disorder that
should ultimately lead to improved quality of life of the patients.
About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing medical technologies for the
treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia
and other diseases treated through replacement of proteins or hormones missing or in short supply within the
body. Sernova is developing the Cell Pouch(TM), an implantable medical device and therapeutic cells (donor,
xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance and actual results may differ materially from those in forward looking statements.
Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch and our
expectations of the potential benefits of the consortium and the Horizon 2020 hemophilia project, are based on
the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova
expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a
result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - January 26, 2016 26 January, 2016
Sernova Announces Agreement with CCRM to Produce Specialized Cells for the Treatment of Diabetes
CCRM to establish, optimize and validate methods for producing Sernova’s transformative cell-based therapies for Type-1 diabetes
Source: Sernova Corp
January 26, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – January 26, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing medical technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, announced today it has entered into a service agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) to establish, optimize and validate Sernova’s licensed technology for creating stem cell derived therapeutic cells that produce insulin and are glucose responsive.
“Sernova’s Cell Pouch System(TM) is a novel, preclinically validated and clinically tested platform for multiple types of therapeutic cells, including human islets,” said Dr. Philip Toleikis, President and CEO Sernova Corp. “Sernova’s CCRM partnership with CCRM’s expertise in developing production processes for cellular therapies is an important step in Sernova’s plan to commercialize an unlimited supply of glucose responsive, insulin producing cells for the Cell Pouch System. Sernova continues to seek out and evaluate optimal unlimited cell sources both internally developed and through corporate partnerships involving stem cell derived, and xenogeneic cell sources. Our manufacturing partnership with CCRM will provide the ability for the scale up production required to ensure successful commercialization of Sernova’s cellular therapies for diabetes,” added Dr. Philip Toleikis.
CCRM is a unique not-for-profit group that is solely focused on developing and commercializing cell therapy and regenerative medicine technologies. Sernova is a member of CCRM’s industry consortium, a group of nearly 50 companies formed to address bottlenecks in cell therapy and regenerative medicine product pipelines by enabling industry to engage with CCRM’s broad network of researchers and institutions. Industry consortium members represent key sectors in regenerative medicine – therapeutics, devices, reagents and cells as tools – and tremendous industry experience.
"As a member of CCRM’s industry consortium, Sernova is a valued partner in our quest to develop global breakthroughs in regenerative medicine,” remarked Michael May, President and CEO of CCRM. “Commercializing a regenerative medicine therapy for diabetes – the goal for Sernova and CCRM – has the potential to disrupt and transform current standard of treatment. We are excited about the timing of this partnership,” added Dr. May, “as it is our expectation that projects like this become candidates for the new advanced manufacturing initiative that we announced during a visit by Prime Minister Trudeau in mid-January.”
About Sernova
Sernova Corp. is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch System and our cell technologies, and manufacturing capabilities of CCRM are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - February 05, 2016 5 February, 2016
Sernova Honoured as Member of the “2016 TSX Venture 50” and Ranked #4 in Life Sciences and Clean Technologies
Sernova resides in the top 3% of TSX Venture Exchange Companies in market performance
Source: Sernova Corp
February 5, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – February 5, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing medical technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, announced today it has received the ranking of fourth in the category of Life Sciences and Clean Technologies and has been selected as member of the “2016 TSX Venture 50” Companies. This is a prestigious group of top market performers from among the 1,791 companies listed on the Toronto Venture Exchange as of December 31, 2015.
"We are honoured to be distinguished by the TSX from amongst all TSX Venture Companies and are appreciative of our investors who have rewarded our progress as acknowledged through the TSX Venture Exchange,” remarked Dr. Philip Toleikis, President and CEO. “We congratulate our peer companies in this category who have shown superior results in key metrics of market performance such as market capitalization growth, share price appreciation and trading volume – with Sernova providing a return of 118% in market cap appreciation in 2015. The shares of these companies also enjoyed a liquid market, with a total of 3.0 billion shares traded over the course of 2015,” added Dr. Toleikis.
“Sernova’s ongoing development of its platform technologies for cell therapy, the advancement of it programs in diabetes and hemophilia, and its focus on forging mutually beneficial pharmaceutical collaborations will, we believe, make 2016 another rewarding year for our shareholders and investors,” stated Frank Holler, Sernova Chairman. “This TSX Venture recognition adds to our growing profile in the public markets and we are most appreciative of receiving this distinction," added Mr. Holler.
About Sernova
Sernova Corp. is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, which include our beliefs about the functionality of the Cell Pouch System and our cell technologies, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Press Release Communiqué de presse - July 12, 2016 12 July, 2016
Sernova and JDRF Announce Funding of Joint Research Collaboration to Advance Human Clinical Trials for the Treatment of Hypoglycemic Unawareness Patients with Severe Type 1 Diabetes
$2.45 million USD awarded to advance Sernova’s Cell Pouch System(TM) (CPS) technologies in a US FDA Clinical Trial with Initiation Scheduled for the Second Half of 2016
Source: Sernova Corp
July 12, 2016, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – July 12, 2016) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, is pleased to announce today it has entered into a research funding agreement with JDRF, the leading global organization funding and advocating for type 1 diabetes (T1D) research. The purpose of the funding is to advance human clinical trials of Sernova’s CPS technologies for treatment of hypoglycemia unawareness patients with severe type 1 diabetes. T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose.
JDRF will provide Sernova up to $2.45 million USD to support a clinical trial at a major transplantation center in the United States. The goal of the study is to provide patients with hypoglycemia unawareness a novel cell therapy treatment utilizing Sernova’s proprietary, highly vascularized, cell macroencapsulated implantable and scalable device to reduce or eliminate the need for injections of exogenous insulin.
“JDRF has previously provided funding to advance the development of Sernova’s technologies through a preclinical collaboration with Massachusetts General Hospital, and we are proud to continue our support as Sernova’s technologies progress into new safety and efficacy clinical trials,” said Derek Rapp, JDRF President and CEO. “JDRF is excited about this collaboration, which advances research in encapsulated cell therapies, and will continue to drive progress toward our mission to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications.”
“Sernova and JDRF are tightly aligned in our vision to see cell-based therapies developed to reduce disease burden and significantly increase the quality of life for people living with T1D,” remarked Dr. Philip Toleikis, Sernova’s President and CEO. “We see our work with JDRF on this important clinical trial as an exciting opportunity to more rapidly advance Sernova’s therapies to treat people with diabetes and address many of the shortcomings and challenges of current insulin therapy.”
“Sernova’s progression to human clinical trials is an incredible accomplishment in the global diabetes research agenda,” said Dave Prowten, President and CEO of JDRF Canada. “I am particularly proud of this trial being a part of the JDRF portfolio because it supports advancements of the best and brightest research minds in Canada at Sernova. Also, this is a shining example of the international collaboration fostered by projects funded by JDRF. Working together with our global partners, we can accelerate this type of transformative research and ensure it becomes available for the T1D community.”
To date, there is no cure for T1D, and people living with the disease are dependent on insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing highly disruptive medical technologies to improve the treatment and quality of life of people with chronic debilitating metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch System, an implantable medical device which forms highly vascularized chambers, ideal for therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required to treat disease. For more information, please visit Sernova.com or follow us on Twitter: @SernovaCorp
About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
info@sernova.com
www.sernova.com
Ray Matthews & Associates
Suite 601-128 West Cordova Street, Vancouver, BC V6B 0E6
Tel: (604) 818-7778
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which include our belief that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - December 11, 2017 11 December, 2017
Sernova Receives US FDA IND Allowance to Initiate a US Clinical Trial of its Cell Pouch for the Treatment of Type 1 Diabetes
Source: Sernova Corp
December 11, 2017, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – Monday December 11, 2017) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing regenerative medicine technologies for the long-term treatment of diseases including diabetes and hemophilia, is pleased to announce it has received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (TM) (CPS) in the United States. The Company will host a conference call for shareholders with Dr. Philip Toleikis, President and CEO on Monday, December 11th at 10:00am Eastern Standard Time to discuss the trial.
Sernova plans to initiate the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.
JDRF has previously committed to provide Sernova up to $2.45 million USD to support the clinical trial.
“Hypoglycemia unawareness is a serious consequence of type 1 diabetes,” said Derek Rapp, President & CEO, JDRF International. “We are excited to see progress in this and other potentially life-saving JDRF-funded research, which could help prevent people with hypoglycemia unawareness from experiencing dangerous lows, as we strive to achieve our vision of a world without T1D.”
“We are extremely enthusiastic about the promise of Sernova’s regenerative medicine platform to provide a new therapeutic option for diabetes patients with hypoglycemia unawareness. We believe Sernova’s multiple advancing cell based therapies have the potential to deliver significant improvement in the quality of life of patients suffering from diabetes and other debilitating diseases,” said Dr. Philip Toleikis, Sernova’s president & CEO.
About the Trial
The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development, a dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year.
“Sernova’s FDA clearance to commence human clinical trials in the United States is an exciting step forward in diabetes research, initially focused to reduce the risk of hypoglycemia unawareness, a complication in which a patient is unaware of a deep drop in blood sugar that can have life threatening consequences,” said Dave Prowten, President and CEO of JDRF Canada. “This is also an example of the international collaboration fostered by JDRF-funded projects to accelerate transformative research to benefit the T1D community,” added Mr. Prowten.
About Sernova’s Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells (donor, stem cell derived cells and xenogeneic cells) which then release proteins and/or hormones as required to treat disease. The device is designed upon implantation to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells. The device with therapeutic cells has been shown to provide long term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin producing cells in humans.
About Diabetes
T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, and people living with the disease are dependent on exogenous insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
Conference Call Details
To participate in this live conference call, please dial + 1-877-858-5743 prior to the scheduled conference call time. International callers should dial +1-858-609-8959. The conference participant pass code is 355 040. Following the conference call a recording will be available at www.sernova.com
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778\
www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which include our belief about the conduct and outcome of clinical trials and that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 22, 2018 22 February, 2018
Sernova’s Cell Pouch Regenerative Medicine Clinical Trial for Patients with Type 1 Diabetes Supported with Continuous Glucose Monitoring Systems
Continuous Glucose Monitoring System (CGM) to provide sensitive tracking of key efficacy measures in patients at important time points throughout the study
Source: Sernova Corp
February 22, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – February 22, 2018) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage company developing regenerative medicine technologies for the treatment of chronic diseases including diabetes and hemophilia, is pleased to announce continuous glucose monitoring systems (CGM (Medtronic Minimed, Northridge, CA)) will be provided to patients in Sernova’s US regenerative medicine clinical trial of its Cell Pouch(TM). CGM will be used to track the function of the transplanted cells in the measurement of key efficacy measures at multiple time points following transplantation of the therapeutic cells into the Cell Pouch.
Glucose variability and hypoglycemia duration can be determined using CGM. CGM involves the subcutaneous placement of a glucose sensor connected to a pager-sized monitoring device that stores glucose data over a 6-day period. Data from each period will be analyzed for mean glucose concentration, mean glucose variability, number and duration of hyper- and hypo- glycemic episodes, and total duration of hypoglycemia.
“We believe continuous glucose monitoring of patients may be an important and sensitive method to closely track the function of the transplanted therapeutic cells within the Cell Pouch,” said Dr. Philip Toleikis, Sernova’s President and CEO. “We are pleased with our collaborators in this study who have shown the foresight to support Type 1 diabetes patients seeking treatment via next-generation regenerative medicine technologies.”
Sernova has recently received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (CPS) in the United States. Sernova is taking final steps to begin enrollment of patients in the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.
About the Trial
The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the study under informed consent. Patients will then be implanted with the Cell Pouch including sentinel devices. Following vascularized tissue development, a dose of purified islets under strict release criteria will be transplanted into the Cell Pouch and patients followed for safety and efficacy measures for approximately six months. At this point a decision will be made whether to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. CGM is planned to provide a sensitive and accurate tracking method to follow important efficacy measures at various time points throughout the study.
About Sernova’s Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term survival and function of therapeutic cells (donor, stem cell derived cells and xenogeneic cells) which then release proteins and/or hormones as required to treat disease. The device is designed upon implantation to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells. The device with therapeutic cells has been shown to provide long term safety and efficacy in small and large animal models with diabetes and has been proven to provide a biologically compatible environment for insulin producing cells in humans.
About Diabetes
T1D is a life-threatening disease in which the body's immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, and people living with the disease are dependent on exogenous insulin therapy to help keep their blood-sugar levels from spiking too high, which can lead to long-term complications such as kidney and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, however, an imperfect treatment method that requires people with T1D to carefully monitor their blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve their long-term blood glucose targets, placing them at risk for T1D-related health complications.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device and immune protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778\
www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements, are based on the beliefs, estimates and opinions of Sernova’s management on the date such statements were made, which include our belief about the conduct and outcome of clinical trials and that Sernova will be able to raise additional capital to fund its clinical programs including its planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - May 08, 2018 8 May, 2018
Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator
Leading Surgeon and Researcher in Islet Transplantation at the University of Chicago to
act as Clinical Trial Principal Investigator. Study to focus on severely diabetic patients
with hypoglycemia unawareness
Source: Sernova Corp
May 8, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire May 8, 2018) – Sernova Corp. (TSX-V: SVA)
(OTCQB: SEOVF) (FSE: PSH), announces Dr. Piotr Witkowski, M.D., Ph.D., a leading
expert in type 1 diabetes (T1D) and islet transplantation, as the Clinical Trial Principal
Investigator for Sernova’s new clinical study. Dr Witkowski, at the University of Chicago
site, will work closely with Sernova’s team to conduct the clinical and regulatory aspects
of the Cell Pouch trial.
Dr. Witkowski is a widely published diabetes researcher and respected surgeon with a
longstanding record of success in both basic science and clinical research pertaining to
islet cell and abdominal organ transplantation. Among other accomplishments, he was
instrumental in developing an optimized islet isolation technique that greatly improved
success in clinical transplants. Under Dr. Witkowski's leadership, multidisciplinary
research teams at the University of Chicago are currently conducting several studies
designed to improve the quality and outcomes of islet cell transplantation in patients with
T1D.
“Sernova’s achievement to commence US human clinical trials is a key step to
improving the therapeutic treatment for people living with diabetes. This Cell Pouch
safety and efficacy trial aims to reduce the risk of hypoglycemia unawareness, a
complication in which a patient is unable to recognize and control impending
hypoglycemia resulting in a drop in blood sugar that can have life threatening
consequences,” said Dr. Witkowski. “Our experienced diabetes treatment team at the
University of Chicago sees the potential of this transformative therapy to benefit and
substantially improve the care of T1D.”
“Improving the quality of life and outcomes of people with diabetes are Sernova’s main
priorities, and we are grateful to have the opportunity to work with Dr. Witkowski and his
expert team at the University of Chicago, a team known for outstanding diabetes
research and patient care,” stated Dr. Philip Toleikis, Sernova’s President & CEO.
The study is a Phase I/II, non-randomized, unblinded, single-arm, company sponsored
trial. Under the clinical leadership of Dr. Witkowski, University of Chicago Medicine,
patients with hypoglycemia unawareness will be enrolled in the study under informed
consent. Patients then will be implanted with the Cell Pouch including sentinel devices.
Following vascularized tissue development in the Cell Pouch, an initial dose of purified
islets under strict release criteria will be transplanted into the Cell Pouch and patients
followed for safety and efficacy measures for approximately six months. At this point a
decision will be made with regards to the transplant of a second islet dose with
subsequent safety and efficacy follow up. Patients will then be further followed for one
year, with interim patient results released at periodic intervals consistent with an open
label study.
About Dr. Witkowski
Piotr Witkowski M.D. Ph.D. is an Associate Professor of Surgery and a transplant
surgeon at the University of Chicago Medicine. He has been involved in islet
transplantation research for the past 17 years, initially at Columbia University in New
York City and then as a Director of the Pancreatic Islet Transplantation Program at the
University of Chicago Medicine. For the last nine years, Dr. Witkowski has been
conducting multiple clinical studies in intraportal islet allotransplantation in patients with
brittle type diabetes as well as islet autotransplantation in patients with chronic
pancreatitis. Recently, he accomplished a phase 3 clinical trial and is currently preparing
application to the FDA for islet graft as a biological product, which is pivotal to enable
islet transplantation to become available to patients as a standard of care procedure.
Being aware of shortcomings of intrahepatic islet transplantation, Dr Witkowski has been
working on optimization of the subcutaneous location for improved islet engraftment. He
has proven the concept that this pre-vascularized site enhances islet survival in a
preclinical diabetes model.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a
medical device (Cell Pouch) and immune protected therapeutic cells to improve the
treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated
through replacement of proteins or hormones missing or in short supply within the body.
For more information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939;
philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778; www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are
statements that are not historical facts and are generally, but not always, identified by
the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”,
“potential” and similar expressions, or that events or conditions “will”, “would”, “may”,
“could” or “should” occur. Although Sernova believes the expectations expressed in such
forward-looking statements are based on reasonable assumptions, such statements are
not guarantees of future performance and actual results may differ materially from those
in forward looking statements. Forward-looking statements, are based on the beliefs,
estimates and opinions of Sernova’s management on the date such statements were
made, which include our belief about the conduct and outcome of clinical trials and that
Sernova will be able to raise additional capital to fund its clinical programs including its
US FDA clinical trial. Sernova expressly disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - May 14, 2018 14 May, 2018
Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study
IRB Approval Signals ‘Green Light‘ for Sernova’s Clinical Protocol to Proceed
Source: Sernova Corp
May 14, 2018 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – Monday May 14, 2018 ) – Sernova Corp.
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), announces today it has received University
of Chicago Institutional Review Board (IRB) approval to begin a new clinical protocol for
the FDA-cleared human clinical trial to investigate the Cell Pouch™ for treatment of type
1 diabetes (T1D) in individuals with hypoglycemia unawareness.
The University of Chicago Institutional Review Board (IRB) is a committee established to
review and approve research involving human subjects. The purpose of the IRB is to
ensure that all human subject research is conducted in accordance with all federal,
institutional, and ethical guidelines. The primary goal of an IRB is to safeguard the rights,
safety and welfare of participants in research studies.
"The approval of our clinical protocol by the University of Chicago IRB represents a
significant milestone enabling the company to expand the clinical testing of our Cell
Pouch System to the US. Patient selection and enrollment can now proceed," said Dr.
Philip Toleikis, Sernova President and CEO.
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-
sponsored trial, where diabetic subjects with hypoglycemia unawareness will be enrolled
into the study under informed consent. Subjects will then be implanted with Cell Pouches.
Following development of vascularized tissue chambers within the Cell Pouch, subjects
will then be stabilized on immunosuppression and a dose of purified islets under strict
release criteria will be transplanted into the Cell Pouch.
A sentinel pouch, also transplanted with islets, will be removed for an early assessment
of the islet transplant. Subjects will be followed for safety and efficacy measures for
approximately six months. At this point, a decision will be made with regards to the
transplant of a second islet dose with subsequent safety and efficacy follow up. Patients
will then be further followed for one year. The primary objective of the study is to
demonstrate safety and tolerability of islet transplantation into the Cell Pouch™. The
secondary objective is to assess efficacy through a series of defined measures.
About Sernova’s Cell Pouch™ Technologies
The Cell Pouch™ is a novel, proprietary, scalable, implantable macroencapsulation
device designed to prevent device fibrosis for the long-term survival and function of
therapeutic cells (donor, stem cell-derived cells and xenogeneic cells) which then release
proteins and/or hormones as required to treat disease. The device is designed upon
implantation to incorporate with tissue, forming highly vascularized tissue chambers for
the transplantation and function of therapeutic cells. The device with therapeutic cells has
been shown to provide long-term safety and efficacy in small and large animal models of
diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans
About Diabetes
T1D is a life-threatening disease, affecting more than 3.3 million individuals in Canada
and US, in which the body's immune system mistakenly attacks and kills the pancreatic
cells that produce insulin a hormone that is essential for life because of its role to help the
body use glucose. The existing standard of care for patients with TID is suboptimal. To
date, there is no cure for T1D, and people living with the disease are dependent on
exogenous insulin therapy to help keep their blood-sugar levels from spiking too high,
which can lead to long-term complications such as kidney and heart diseases or an
acute, potentially deadly health crisis. Present-day insulin therapy is, however, an
imperfect treatment method that requires people with T1D to carefully monitor their
blood sugar throughout the day and take multiple, calculated doses of insulin based on
food intake, exercise, stress, illness and other factors. A miscalculation or unexpected
variable leading to high or low blood sugar episodes are daily threats, and only a third of
people with T1D achieve their long-term blood glucose targets, placing them at risk for
T1D-related health complications.
About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a
medical device and immune protected therapeutic cells to improve the treatment and
quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases. For more
information, please visit www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939;
philip.toleikis@sernova.com www.sernova.com
Ray Matthews & Associates Tel: (604) 818-7778; www.raymatthews.ca
ray@raymatthews.ca
Forward Looking Information
This release may contain forward-looking statements. Forward-looking statements are
statements that are not historical facts and are generally, but not always, identified by
the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”,
“potential” and similar expressions, or that events or conditions “will”, “would”, “may”,
“could” or “should” occur. Although Sernova believes the expectations expressed in such
forward-looking statements are based on reasonable assumptions, such statements are
not guarantees of future performance and actual results may differ materially from those
in forward looking statements. Forward-looking statements, are based on the beliefs,
estimates and opinions of Sernova’s management on the date such statements were
made, which include our belief about the conduct and outcome of clinical trials and that
Sernova will be able to raise additional capital to fund its clinical programs including its
planned US FDA clinical trial. Sernova expressly disclaims any intention or obligation to
update or revise any forward-looking statements whether as a result of new information,
future events or otherwise.
Press Release Communiqué de presse - July 05, 2018 5 July, 2018
Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes
Source: Sernova Corp
July 5, 2018, 6:00 a.m. EDT
LONDON, ONTARIO –July 5, 2018 – Sernova Corp.
(“Sernova” or the “Company”)
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH)
announces that patient screening and
recruitment has begun in its regenerative medicine
US clinical trial for diabetic patients
with hypoglycemia unawareness.
Sernova’s initial clinical evaluation of the
prevascularized Cell Pouch (TM) demonstrated
biocompatibility and safety of the Cell Pouch as well
as viability and vascularization of its
transplanted insulin-producing islets, a first in world
achievement in a prevascularized
implantable medical device.
“This first-in-human work helped frame the design
of Sernova’s new Phase I/II clinical
protocol. Our clinical team at the University of
Chicago is excited to initiate this trial of
Sernova’s transformative technology,” said
principal investigator, Dr. Piotr Witkowski,
M.D., Ph.D.
“To support the clinical study’s timely execution
under the highest quality standards,
Sernova and CTI (Clinical Trial and Consulting), a
well-respected clinical research
organization with deep experience in the
regenerative medicine field, are working
closely with Dr. Witkowski’s team,” said Dr. Philip
Toleikis, Sernova’s President and
CEO.
The study is a Phase I/II, non-randomized, open
label, single-arm, company-sponsored
trial. Under the clinical leadership of Dr. Witkowski,
University of Chicago Medicine,
subjects with hypoglycemia unawareness enrolled
in the study under informed consent
will be implanted with the Cell Pouch. Following
vascularized tissue development in the
Cell Pouch, an initial dose of purified islets under
strict release criteria will be
transplanted into the Cell Pouch.
A sentinel pouch, also transplanted with islets, will
be removed for an early assessment
of the islet transplant. Subjects will be followed for
safety and efficacy measures for
approximately six months. At this point, a decision
will be made with regards to the
transplant of a second islet dose with subsequent
safety and efficacy follow up. Subjects
will then be further followed for one year, with
interim participants results released at
periodic intervals consistent with an open-label
study.
About Sernova’s Cell Pouch Technologies
The Cell Pouch is a novel, proprietary, scalable,
implantable prevascularized
macroencapsulation device for the long-term
survival and function of therapeutic cells
(donor, stem cell derived cells and xenogeneic cells)
which then release proteins and/or
hormones as required to treat disease. The device
is designed to eliminate concerns of
fibrosis upon implantation by incorporating with
tissue, forming highly vascularized
tissue chambers for the transplantation and function
of therapeutic cells. The device with
therapeutic cells has been shown to provide long-
term safety and efficacy in small and
large animal models of diabetes and has been
proven to provide a biologically
compatible environment for insulin-producing cells
in humans.
About Diabetes
Type1 Diabetes (T1D) is a life-threatening disease
in which the body's immune system
mistakenly attacks and kills the pancreatic cells that
produce insulin—a hormone that is
essential for life because of its role to help the body
use glucose. The existing standard of
care for patients with TID is suboptimal. To date,
there is no cure for T1D, and people
living with the disease are dependent on exogenous
insulin therapy to help keep their
blood-sugar levels from spiking too high, which can
lead to long-term complications such
as kidney and heart diseases or an acute,
potentially deadly health crisis. Present-day
insulin therapy is, however, an imperfect treatment
method that requires people with
T1D to carefully monitor their blood sugar
throughout the day and take multiple,
calculated doses of insulin based on food intake,
exercise, stress, illness and other
factors. A miscalculation or unexpected variable
leading to high or low blood sugar
episodes are daily threats, and only a third of
people with T1D achieve their long-term
blood glucose targets, placing them at risk for T1D-
related health complications.
About Sernova Corp
Sernova Corp is developing regenerative medicine
therapeutic technologies using an
implantable medical device and immune protected
therapeutic cells to improve the
treatment and quality of life of people with chronic
metabolic diseases such as insulin-
dependent diabetes, blood disorders including
hemophilia, and other diseases treated
through replacement of proteins or hormones
missing or in short supply within the body.
For more information, please visit
www.sernova.com
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
Philip.toleikis@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward Looking Information
This release may contain forward-looking
statements. Forward-looking statements are
statements that are not historical facts and are
generally, but not always, identified by
the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”,
“potential” and similar expressions, or that events
or conditions “will”, “would”, “may”,
“could” or “should” occur. Although Sernova
believes the expectations expressed in such
forward-looking statements are based on
reasonable assumptions, such statements are
not guarantees of future performance and actual
results may differ materially from those
in forward looking statements. Forward-looking
statements, are based on the beliefs,
estimates and opinions of Sernova’s management
on the date such statements were
made, which include our belief about the conduct
and outcome of clinical trials and that
Sernova will be able to raise additional capital to
fund its clinical programs including its
planned US clinical trial. Sernova expressly
disclaims any intention or obligation to
update or revise any forward-looking statements
whether as a result of new information,
future events or otherwise.
Press Release Communiqué de presse - November 20, 2018 20 November, 2018
Sernova Highlights Achievements from the HemAcure Consortium in Developing a Novel Cell-Based Therapy for Hemophilia A
Source: Sernova Corp
November 20, 2018, 8:30 a.m. EST
LONDON, ONTARIO –November 20, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) a
clinical-stage regenerative medicine company, highlights the achievements in developing a novel cell-based
therapy in combination with Sernova’s Cell Pouch™ for treatment of Hemophilia A.
The therapeutic significance of this work supports the HemAcure Consortium’s concept that Factor VIII
genetically corrected human cells from a blood sample of patients with Hemophilia A transplanted into the Cell
Pouch can improve blood clotting.
“I am impressed with the achievements of this International Consortium within the limited time allowed. The
technical teams worked closely together to complete this work in developing a first-in-world ex vivo gene
therapy approach in an implanted vascularized medical device for the treatment of Hemophilia A.” said Dr.
David Lillicrap, Professor in the Department of Pathology and Molecular Medicine at Queen’s University,
member of the Medical Advisory Board of the World Federation of Hemophilia, and HemAcure Scientific
Advisory Board member.
A summary of the Consortium’s achievements are as follows:
• In blood donated from patients with Hemophilia A, endothelial outgrowth cells to be corrected for the
Factor VIII gene were isolated and grown successfully in a specialized Good Manufacturing Process (cGMP)
compliant medium developed by the Consortium.
• Using a human Factor VIII gene insertion technique, the cells were corrected and confirmed to produce
Factor VIII.
• A preliminary experiment showed these cells could release Factor VIII in the blood over time and improve
blood clotting in an animal model of Hemophilia A, in preparation for transplant into the Cell Pouch.
• The corrected cells were proven to be successfully replicated through a production scale-up process.
Following amplification, these cells maintained their normal healthy behavior in producing Factor VIII.
Additional safety metrics were achieved using established tests.
• The cells were then cryopreserved and shipped from the European partners to Sernova in North America
where they were shown to remain healthy through quality control testing in preparation for transplantation.
• The Cell Pouch, manufactured under cGMP, and following implantation in the Hemophilia A animal model
showed development of vascularized chambers suitable to receive the corrected cells.
• Following transplantation into the Cell Pouch in a Hemophilia A animal model, the patient’s Factor VIII
corrected cells survived at three months (the duration of the study).
• Initial results showed Factor VIII released from the cells in the Cell Pouch was detected in blood and
notably, showed improved clotting when compared to the Hemophilia A animal control which did not receive
human corrected cells.
• The steps of the cell production process were documented towards development of the cGMP
manufacturing process for the corrected cells for future clinical use. An Instructions-for-Use document was
also developed for implantation of the cGMP Cell Pouch and transplantation of patient corrected Factor VIII
producing cells applicable for future human testing in patients with Hemophilia A.
Sernova’s President & CEO, Dr. Philip Toleikis added, “These series of breakthroughs demonstrate success in
correcting a Hemophilia A patient’s own cells to produce the missing Factor VIII protein and to improve blood
clotting in an animal model of Hemophilia A in preparation for future human clinical trials.”
Technical results will continue to be presented by HemAcure Consortium members at scientific conferences and
disseminated in scientific publications. Furthermore, steps are to complete cGMP manufacturing of the cells
using the tools and methods developed by the Consortium, optimize dosing of cells in the Cell Pouch to achieve
optimal therapeutic blood levels of Factor VIII, and conduct final formal studies in preparation for a first-in-
human clinical study.
HemAcure’s webinar in which the consortium expert leaders present an overview of the findings is now available
both on Sernova’s website at www.sernova.com and the HemAcure project website at www.hemacure.eu
About HemAcure
The overall objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex
vivo prepared cell-based therapy to treat the bleeding disease, Hemophilia A (caused by a genetic deficiency in
clotting Factor VIII (FVIII)) that should ultimately lead to improved quality of life of the patients. The European
Union's Horizon 2020 research and innovation program has awarded approximately €5.5 million (CDN$8.5) to
support the project. International consortium members include the University Hospital Wuerzburg
(Coordinating Institute), Germany, IMS - Integrierte Management, Heppenheim, Germany, Università del
Piemonte Orientale “Amedeo Avogadro,” Novara, Italy, Loughborough University, Loughborough, United
Kingdom, ARTTIC International Management Services, Munich, Germany and Sernova Corp., London, Ontario,
Canada. This project has received funding from the European Union’s Horizon 2020 Research and Innovation
Programme under grant agreement No 667421. The Consortium has been working together to provide sets of
design and manufacturing protocols, based on current European GMP regulations to prepare an Investigational
Medicinal Product Dossier (IMPD) for an Investigational Medicinal Product (IMP), composed of therapeutic cells
and an implantable medical device (Sernova’s Cell Pouch). For more information, visit www.hemacure.eu
About Hemophilia A
People with Hemophilia A have prolonged abnormal bleeding as a result of trauma. Hemophilia A is the most
common form of Hemophilia and is a genetic disorder caused by missing or defective FVIII, a blood clotting
protein. Severe Hemophilia A occurs in about 60% of cases where the deficiency of FVIII is less than 1% of
normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused
by a spontaneous change in the gene. According to the US Centers for Disease Control and Prevention,
Hemophilia A occurs in about 1 in 5,000 births. Prolonged bleeding, in areas such as the brain, of a person with
Hemophilia A, can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint
damage. Approximately 20,000 people in the United States, 2,500 in Canada and 10,000 in Europe have
moderate to severe forms of Hemophilia A. Though there is no cure for the disease, Hemophilia A can be
controlled with regular infusions of recombinant clotting FVIII. Annual worldwide costs for the treatment of the
disease for each patient may range from $60,000 to $260,000 US for a total cost of approximately $15B per
year.
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly €80 billion of funding
available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by
taking great ideas from the lab to the market. The project is funded as part of societal challenges “personalizing
health and care” in a specific call about innovative treatments and technologies. New therapies, such as gene or
cell therapies, often require technological innovation in the form of development of specific component tools
and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the
therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving
therapeutic scale production and cGMP standards at reasonable cost is often underestimated. The European
Union aims to improve the development of advanced methods and devices for targeted and controlled delivery,
and to bring these innovative treatments to the patient.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells to improve the treatment and quality of life of people with chronic metabolic
diseases such as insulin-dependent diabetes, blood disorders including Hemophilia A, and other diseases
treated through replacement of proteins or hormones missing or in short supply within the body. For more
information, please visit www.sernova.com
For further information contact:
Danny Matthews,
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
Dominic Gray,
Corporate Communications
Tel: (519) 858-5126
Dominic.Gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of the Hemophilia
A program. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking
statements whether as a result of new information, future events or otherwise.
HemAcure Webinar: https://youtu.be/ihyHefvJ8cQ
Press Release Communiqué de presse - December 20, 2018 20 December, 2018
Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes
Initiating Treatment Phase of the Study at the University of Chicago
December 20, 2018 9:00 a.m. EST
LONDON, ONTARIO – December 20, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a
clinical-stage regenerative medicine company announces the enrollment of the first patient in its Phase I/II
trial of Sernova’s Cell Pouch for Clinical Islet Transplantation in type 1 diabetes.
“There is a real need for new treatment options in the field of type 1 diabetes,” said Dr. Piotr Witkowski,
principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago
School of Medicine. “Due to Sernova’s novel approach to demonstrate vascularization of the Cell Pouch and
remarkable preclinical and first-in-human data, we are hopeful this study will provide a new functional
therapeutic option in the treatment of patients with diabetes.” Dr. Witkowski added, “We expect completion
of enrollment of the first patient cohort to be January 2019 and full enrollment to be completed by mid-
2019 as we continue to screen patients for the Sernova study.”
“The initiation of this Phase I/II trial is an important milestone for Sernova as our team looks to showcase
our research and development efforts in diabetes on a clinical level at the University of Chicago, a world
leader in regenerative medicine,” added Dr. Philip Toleikis, President and CEO of Sernova. “In our pilot first-
in-human study, Sernova’s regenerative medicine approach, involving therapeutic cells within Sernova’s Cell
Pouch, showed surviving vascularized islets able to produce all the hormones necessary to control blood
glucose levels. Based on these positive initial results, we expect our therapeutic approach will demonstrate
continued safety and therapeutic benefit to people suffering from type 1 diabetes.”
The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of
2019 and preliminary efficacy data in the second half of 2019.
About the Study
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial,
where diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent.
Participants are then implanted with Cell Pouches. Following the development of vascularized tissue
chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified
islets, under strict release criteria, is transplanted into the Cell Pouch.
A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed
for additional safety and efficacy measures for approximately six months. At this point, a decision will be
made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up.
Patients will then be further followed for one year. The primary objective of the study is to demonstrate
safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess
efficacy through a series of defined measures.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939 . For
more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact
(773) 702-2504.
About Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune
system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body
use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent
on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along
with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or
unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people
with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-
related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals
experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1
diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue,
forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which
then release proteins and hormones as required to treat disease. The device along with therapeutic cells has
been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has
been proven to provide a biologically compatible environment for insulin-producing cells in humans.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement
of proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
For further information contact:
United States:
Danny Matthews
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
For investor inquiries and media inquiries in Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”,
“anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that
events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the
expectations expressed in such forward-looking statements are based on reasonable assumptions, such
statements are not guarantees of future performance, and actual results may differ materially from those in
forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions
of Sernova’s management on the date such statements were made, which include our beliefs about the
conduct and outcome of clinical trials. Sernova expressly disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - April 11, 2019 11 April, 2019
Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes
April 11, 2019, 9:00 a.m. EDT
LONDON, ONTARIO – April 11, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage
regenerative medicine company today announced the first Cell Pouch™ transplant of insulin-producing cells in
its U.S. Phase I/II clinical trial evaluating the safety and efficacy of the Cell Pouch for Clinical Islet
Transplantation in type 1 diabetes.
“Sernova’s Cell Pouch technologies are positioned to provide the most severe patients with improved, long
term options to manage their diabetes,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and
Director of the Pancreatic Islet Transplant Program at the University of Chicago. “The current standard of care,
involves islet transplants into the portal vein which has significant limitations including the development of an
immediate blood-mediated inflammatory reaction (IBMIR), limited supply of donor organs and the challenges in
isolating and obtaining a consistent quality of islet preparations.”
In accordance with the study protocol, the Cell Pouch was implanted prior to transplant of purified islets. This
procedure enables the development of vascularized tissue chambers and provides an interval for patient
stabilization on standard immune protection medications. Prior to transplantation, the Cell Pouch was
assessed for safety. A Sentinel Pouch, a small monitoring device, was also transplanted with islets. In
accordance with the protocol the Sentinel Pouch will be removed approximately 90 days post-transplant to
assess islet survival as an interim indicator of efficacy.
“Sernova’s Cell Pouch provides a non-fibrosing, vascularized environment for the transplantation of therapeutic
cells, to enhance the curative potential of islet transplantation and other cell therapies,” said Dr. Philip Toleikis,
President and CEO of Sernova. “We are thrilled with Dr. Witkowski’s progress as well as his decision to move
forward with transplantation based on his analysis of the safety and vascularization of the Cell Pouch.”
“This important clinical milestone advances our Cell Pouch technologies as a valuable enabling foundation for
cell therapies across a range of indications including type 1 diabetes, hemophilia and thyroid disease,” added
Dr. Toleikis.
The Company is expecting to report preliminary safety data from Sernova’s clinical study in the first half of
2019 and preliminary efficacy data in the second half of 2019.
About the Study
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where
diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. Participants
are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the
Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict
release criteria, is transplanted into the Cell Pouch.
A sentinel pouch will be removed for an early assessment of the islet transplant. Subjects will be followed for
additional safety and efficacy measures for approximately six months. At this point, a decision will be made
with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will
then be further followed for one year. The primary objective of the study is to demonstrate the safety and
tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a
series of defined measures.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
About Hypoglycemia Unawareness and Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune
system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body
use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on
insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with
multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected
variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1
diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health
complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop
in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming
highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release
proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to
provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to
provide a biologically compatible environment for insulin-producing cells in humans.
About Sernova Corp
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
United States:
Danny Matthews
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
Forward-Looking Information
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - July 03, 2019 3 July, 2019
Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes
Sernova’s Cell Pouch (TM) with transplanted islet cells reached primary safety measurements and clinically
significant efficacy outcomes including glucose-stimulated C-peptide and the release of insulin in the first
patient transplanted
July 3, 2019 5:30 a.m. EDT
LONDON, ONTARIO – July 3, 2019 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF), a clinical-stage regenerative
medicine company today announced that in an interim analysis of its human Phase I/II clinical trial, Sernova’s
Cell Pouch transplanted with islet cells showed initial safety, as well as key efficacy measures, including glucose
stimulated C-peptide, insulin production and additional clinically significant measures of glucose control in the
first study patient with type-1 diabetes and severe hypoglycemia unawareness.
Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study
principal investigator presented on Sernova’s Cell Pouch technology and preliminary data from Sernova’s
current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet
Transplantation today at the 17th World Congress of the International Pancreas and Islet Transplantation
Association (IPITA) in Lyon, France.
Highlights of the presentation of the data from the first patient who received islet transplanted into Sernova
Cell Pouch included:
• No incidences of adverse events determined to be related to the Cell Pouch implant.
• The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the
purified islets
• A weight reduction of 6.35kg (12% total body weight)
• Stabilizing improvements in all glycemic control parameters as indicated by Continuous Glucose
Monitoring (CGM) as assessed by Medtronic
• 87.5% reduction in hypoglycemic events from baseline collected over a two-week monitoring period
• Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point
as indicated in a mixed meal tolerance test
“I am quite pleased with these interim results in the first implanted patient,” said Dr. Witkowski. “The first of
two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy.
Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is
definitive proof of islet survival and function in the Cell Pouch. These results are an important first step towards
a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-
term results in enrolled patients as the trial progresses,” said Dr. Witkowski, principal study investigator.
ABOUT IPITA
The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant
scientific community in providing a forum for the open exchange of knowledge and expertise in order to
facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of
human diabetes.( https://www.tts.org/ipita/home)
ABOUT THE STUDY
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where
diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are then implanted with
Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are
then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is
transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects will be followed for
additional safety and efficacy measures for approximately six months. At this point, a decision will be made
with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will
then be further followed for one year. The primary objective of the study is to demonstrate safety and
tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a
series of defined measures.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
United States:
Danny Matthews
Solebury Trout
Tel: (646) 378-2928
dmatthews@soleburytrout.com
www.soleburytrout.com
For investor inquiries and media inquiries in Canada:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Ray Matthews & Associates
Tel: (604) 818-7778
ray@raymatthews.ca
www.raymatthews.ca
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - October 16, 2019 16 October, 2019
Sernova Confirms Enduring Levels of Fasting C-Peptide in Bloodstream of First Patient in its Phase I/II Clinical Trial for Type-1 Diabetes
Findings further validate Cell Pouch and therapeutic cell performance in Type-1 diabetes
October 16, 2019 9:00 a.m. EDT
LONDON, ONTARIO – October 16, 2019 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage regenerative medicine company, is pleased to announce the detection of enduring levels of C-peptide
(measured up to 30 days and ongoing), a biomarker of transplanted beta cell insulin production, in the
bloodstream of a fasting patient in its ongoing Phase I/II Cell Pouch(TM) US clinical study of type-1 diabetes.
The detection of fasting C-peptide in the bloodstream of our first patient, in addition to Sernova’s recent
announcement of glucose-stimulated C-peptide and other early efficacy indicators, demonstrate a normalizing
response of the Cell Pouch therapeutic cells to the body’s varied need for insulin production. This is an
important step forward and evidence of ongoing islet engraftment within the Cell Pouch.
“Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide
levels in the patient’s bloodstream after recent transplant, not only following stimulation with a meal but also
when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring
islet survival and function within Sernova’s Cell Pouch,” said Dr. Piotr Witkowski, Director of Pancreatic, and
Islet Transplant Program at the University of Chicago and study principal investigator. “We look forward to
reporting ongoing results in additional patients as the trial progresses.”
The entry criteria of Sernova’s clinical study require patients to be C-peptide negative upon enrolment. C-
peptide measured in the bloodstream is a biomarker of insulin and is widely used as a measure of insulin
production by islet cells. C-peptide is typically measured following overnight fasting (fasting C-peptide) and
during a glucose tolerance test (glucose-stimulated C-peptide). Together these measures provide an index of
the patient’s ability to control blood glucose through their production of insulin.
With the goal of improved blood glucose control and stabilization of fluctuating blood sugar levels commonly
experienced in people with type-1 diabetes, a normalizing response can also decrease the likelihood of life
threatening hypoglycemic unaware events, a key efficacy measure in the Sernova trial.
Sernova’s clinical trial is continuing active recruitment and enrollment of study participants and further results
will continue to be reported as the study progresses.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, to assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in participants with
diabetes and hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of
defined measures. Importantly, patients enrolled in Sernova’s clinical trial are incapable of producing C-
peptide prior to implantation of Sernova’s Cell Pouch and therapeutic cells.
Eligible subjects are implanted with Cell Pouches. Following development of vascularized tissue chambers
within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under
strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional
safety and efficacy measures for approximately six months. At this point, a decision is made with regards to the
transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then further
followed for one year to assess longer-term safety and efficacy.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For
more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the
long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming
highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release
proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to
provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to
provide a biologically compatible environment for insulin-producing cells in humans.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials. The information disclosed represents results from one patient and may not be representative of all study
patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 10, 2020 10 February, 2020
Sernova Announces Positive DSMB Review and Recommendation for Continuation of Phase I/II Diabetes Clinical Trial of Cell Pouch
Ongoing Safety of Sernova’s Clinical Trial Confirmed
February 10, 2020 9:00 a.m. EDT
LONDON, ONTARIO – February 10, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage company and leader in regenerative medicine therapeutics is pleased to announce that the independent
Data Safety Monitoring Board (“DSMB”) completed its first interim analysis of the ongoing Safety, Tolerability
and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation Phase I/II clinical trial in patients
with severe hypoglycemia unawareness.
The DSMB did not raise any concerns regarding safety and recommended the continuation of the study.
“We are very pleased with the recommendation of the DSMB. In light of this positive assessment, Sernova
continues the trial as we carry on compiling safety and efficacy results from our treated patients along with
advancing further patient enrollment at the University of Chicago,” said Dr. Philip Toleikis, President and CEO
of Sernova. “We thank the DSMB for its diligence, guidance, and support as we continue moving forward with
our mission to provide people suffering from diabetes and other chronic diseases improved treatment options
and a better quality of life.”
The DSMB is an independent group of clinical research experts who review the accumulated safety data
throughout the clinical trial to safeguard the safety and interests of participating patients while ensuring the
scientific validity and integrity of the trial. This interim analysis was the first of three planned DSMB reviews of
this clinical trial.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial to assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in diabetic subjects
with hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined
measures. Patients enrolled in Sernova’s clinical trial are incapable of producing c-peptide, a biomarker for
insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue chambers
within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under
strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional
safety and efficacy measures for approximately six months. At this point, a decision will be made with regards
to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then
further followed for one year to assess longer-term safety and efficacy.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long- term survival and function of therapeutic cells. The device
is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and
function of therapeutic cells which then release proteins and hormones as required to treat disease. The Cell
Pouch along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large
animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-
producing cells in humans. In early assessments of its ongoing Phase I/II clinical trial, Sernova has shown
presence of blood levels of c-peptide both during glucose tolerance tests as well as under fasting conditions.
Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 13, 2020 13 February, 2020
Sernova Achieves Positive Efficacy Endpoint in Phase I/II Clinical Trial for Type 1 Diabetes
Most advanced subject in the clinical trial continues to show positive indicators of islet function following
islet
transplant into the Cell Pouch
February 13, 2020 9:00 a.m. EDT
LONDON, ONTARIO – February 13, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a
clinical-
stage company and regenerative medicine therapeutics leader, is pleased to announce that Sernova’s first
treated patient in its Phase I/II clinical trial of its Cell Pouch with therapeutic cells for type 1 diabetes at the
University of Chicago, has demonstrated survival of endocrine tissue (insulin-producing islets) in the sentinel
Cell Pouch following 90 days transplant.
This efficacy outcome, namely, survival of endocrine tissue (insulin-producing islets) in the sentinel Cell
Pouch
following 90 days transplant, is measured by positive staining of islets during histological analysis. According
to
the independent pathologist who conducted the analysis, “The explanted sentinel pouch shows abundant
viable, organized islet cells intimately associated with blood vessels within a collagen matrix after 90 days of
transplantation. These surviving islet cells strongly express insulin.”
A representative histological image from the islet-transplanted mini-sentinel Cell Pouch explanted from a
patient at 90 days post-transplant. Islets with positive insulin staining (red), and new blood vessels (green)
are
detected. (A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet
Transplantation.)
This achievement is important because it is an indicator of transplanted islet health in the therapeutic Cell
Pouches remaining in the subject, including the islets ability to produce insulin into the bloodstream. This
has
been demonstrated by our previous reported findings of blood levels of both glucose-stimulated and fasting
C-
peptide as well as other efficacy indicators in this patient who had no measurable levels of this biomarker of
insulin prior to the Cell Pouch islet transplant.
“We believe these accumulating positive results continue to validate our Cell Pouch technologies as a viable
regenerative medicine therapeutic platform for humans in insulin-dependent diabetes and other chronic
diseases,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “With these encouraging results and
the
positive review and recommendation from the Data Safety and Monitoring Board (DSMB), we are excited to
continue the clinical trial and carry on compiling safety and efficacy data from our current and future treated
patients.”
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, Company-sponsored trial to
assess
the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in diabetic
subjects
with hypoglycemia unawareness. The primary objective of the study is to assess the safety of the Cell Pouch
following implantation and transplantation. The secondary objective is to assess efficacy through a series of
defined measures. Patients enrolled in Sernova’s clinical trial are incapable of producing C-peptide, a
biomarker for insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue
chambers
within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets,
under
strict release criteria, is transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for
additional
safety and efficacy measures for approximately six months. At this point, a decision will be made with
regards
to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then
further followed for one year to assess longer-term safety and efficacy.
For more information on the clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For
more
information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch System including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long- term survival and function of therapeutic cells. The
device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for
the
transplantation and function of therapeutic cells which then release proteins and hormones as required to
treat
disease. The Cell Pouch along with therapeutic cells has been shown to provide long-term safety and
efficacy in
small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans. In early assessments of its ongoing Phase I/II clinical
trial,
Sernova has shown in its first treated patient presence of blood levels of C-peptide both during glucose
tolerance tests as well as under fasting conditions. Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins
or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements within the meaning of applicable Canadian securities
laws. Forward-looking statements in this press release are statements that are not historical facts and are
generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”,
“estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”,
“may”,
“could” or “should” occur. Forward-looking statements include statements about subsequent clinical
activity,
including enrolment of patients and continuing results therefrom, and the potential benefits, safety, and
efficacy
of the Cell Pouch for various indications, including type 1 diabetes.
While Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to
significant scientific, business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors that could cause Sernova’s actual results,
performance
or achievements to be materially different from any future results, performance or achievements expressed
or
implied by the forward-looking statements contained in this press release. Results in early-stage clinical
trials
may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure
regulatory approval. Readers should not place undue reliance on these statements or the scientific data
presented and should refer to the risk factors identified in the company’s continuous disclosure filed on
SEDAR.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - June 08, 2020 8 June, 2020
Sernova to Acquire Cellular Local Immune Protection Technology Accelerating Expansion of its Regenerative Medicine Therapeutics Platform
June 8, 2020 8:00 a.m. EDT
LONDON, ONTARIO – June 8, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage
regenerative medicine therapeutics company, announced today its acquisition of an innovative cellular immune
protection technology. This acquisition represents a strategic accelerator for expansion of Sernova’s total
regenerative medicine cell therapy therapeutics platform.
Said Dr. Philip Toleikis, President and CEO Sernova Corp., “This is a game-changer for Sernova. We have
strategically focused on adding local immune protection technologies to our portfolio as they represent the last
essential pillar for our cell therapy therapeutics platform. This technology acquisition, in addition to our
recently announced collaboration with AgeX Therapeutics, Inc. to use their UniverCyte™ gene-editing
technology to protect cells, positions Sernova with multiple potential approaches to guard therapeutic cells
within our Cell Pouch against host immune-response across multiple clinical applications.”
Pursuant to an asset purchase agreement with Converge Biotech, Inc. (“Converge”), Sernova is acquiring all
intellectual property associated with Converge’s conformal coating cell encapsulation technology (“Conformal
Coating Technology”), including issued patents, patent applications, and know-how. The transaction is
expected to close by June 11, 2020.
“Conformal coating technology could be very synergistic with the Sernova Cell Pouch, as it could confer
protection from the immune attack, decreasing or eliminating the need for immunosuppressive drugs. The
minimal volume of the conformal capsules makes it possible to include immuno-protected insulin-producing
cells in the Sernova Cell Pouch. If the combination of these technologies proves successful, it will represent an
important step towards elimination of the need for immunosuppressive medications, bringing a functional cure
closer to reality for patients suffering from this debilitating disease,” said Dr. Camillo Ricordi, Stacy Joy
Goodman Professor of Surgery and Chief, Division of Cellular Transplantation, Distinguished Professor of
Medicine, Professor of Biomedical Engineering, Microbiology and Immunology and Director, Diabetes Research
Institute and Cell Transplant Center. The Diabetes Research Institute (DRI) is a designated Center of Excellence
at the University of Miami Miller School of Medicine.
Why is the Conformal Coating Technology Important?
The Conformal Coating Technology consists of a thin proprietary coating layer that effectively cloaks coated
therapeutic cells to protect them from an auto-response attack by one’s own immune system post cell
transplantation into the body.
The advantages and potential benefits of this cell encapsulating technology are as follows:
• provides protection of the therapeutic cells from immune system attack locally within the Cell Pouch
chambers potentially avoiding the need for life-long immunosuppression medications, that are typically
required after cell transplantation;
• enables close contact of the transplanted therapeutic cells with the vascularized tissue matrix within the
Cell Pouch to enable closer interactions unlike standard microencapsulation technologies in which the capsules
are significantly larger than the cells limiting required tissue interactions;
• improves the diffusion of small molecules and biomolecules (i.e., glucose, insulin, and other proteins or
hormones), providing a physiological glucose-stimulated insulin response without delay that occurs with other
encapsulation technologies; and
• due to the improved diffusion of biomolecules, it may require a smaller load of therapeutic cells to achieve
the desired therapeutic effect in comparison to standard microcapsules.
Local immune protection technologies to cloak cells, such as the Conformal Coating Technology and the
UniverCyte™ gene technology, have the potential to protect cells from immune system attack within Sernova’s
Cell Pouch through different and independent mechanisms.
“The potential to eliminate antirejection medications with these complementary technologies to our proprietary
Cell Pouch, both for human donor and stem cell-derived cells, will enable us to increase patient safety and
quality of life, and significantly expand the number of treatable patients suffering from chronic diseases. With
extensive preclinical studies already conducted at DRI, we look forward to the possibility of advancing this local
immune protection technology into human trials following successful preclinical proof-of-concept testing. We
believe that this could accelerate Sernova’s opportunity to be first-to-market to provide a functional cure to the
many diabetic patients worldwide. Our vision is to bring a new standard of care approach for chronic
debilitating diseases to the healthcare landscape,” said Dr. Philip Toleikis.
Acquisition Funding
To fund the Conformal Coating Technology acquisition, Sernova will issue to a strategic investor a $1,000,000
convertible debenture that is unsecured, repayable in 30 months (unless earlier converted or redeemed), and
carries an 8% interest rate (the “Debenture”). The Company will also issue 3,000,000 non-transferable share
purchase warrants (the “Warrants”) to the strategic investor, each Warrant being exercisable into one common
share at a price of $0.20 per share for 30 months. The Debenture holder will have the right to convert the
principal amount of the Debenture into common shares of Sernova at a conversion price of $0.25 per share.
“Securing the debenture financing commitment on these favorable terms when Sernova’s Covid-19 impacted
shares were trading in the range of $0.13-0.15 was strategic to reduce our cost of capital and minimize both
dilution and any impact on existing cash resources,” said David Swetlow, Sernova’s CFO.
Neither the Debenture or Warrants have been or will be registered under the United States Securities Act of
1933, as amended (the “U.S. Securities Act”), or any state securities laws and such securities may therefore not
be offered or sold in the United States or to or for the account or benefit of a person in the United States or a
U.S. Person (as defined in Regulation S of the U.S. Securities Act) absent registration or an applicable exemption
from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This
press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale
of the debenture units in any jurisdiction in which such offer, solicitation or sale would be unlawful.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat
disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy
in small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of
the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FORWARD-LOOKING INFORMATION
This news release contains forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur, and include statements about the closing of the Conformal
Coating Technology acquisition and the Debenture issuance and funding. Although Sernova believes the
expectations expressed in such forward-looking statements are based on reasonable assumptions, such
statements are not guarantees of future performance, and actual results may differ materially from those in
forward-looking statements. While Sernova considers these assumptions to be reasonable, these assumptions
are inherently subject to significant scientific, business, economic, competitive, market and social uncertainties
and contingencies. Additionally, there are known and unknown risk factors that could cause Sernova’s actual
results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements contained in this press release.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the effect on company operations and capital
markets of events related to the COVID-19 pandemic, the conduct and outcome of discussions with strategic
partners, and expected progress in preclinical programs and clinical trials. Sernova expressly disclaims any
intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - June 15, 2020 15 June, 2020
Sernova Completes Acquisition of Cellular Local Immune Protection Technology
June 15, 2020 9:00 a.m. EDT
LONDON, ONTARIO – June 15, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage regenerative medicine therapeutics company, is pleased to announce it has completed the acquisition of
cellular local immune protection technology from Converge Biotech, Inc. (“Converge”).
“This acquisition is a strategic accelerator for expansion of Sernova’s total regenerative medicine cell
therapy therapeutics platform,” stated Dr. Philip Toleikis, Sernova’s President and Chief Executive Officer.
“Local immune protection technologies to cloak therapeutic cells have the potential to protect cells from
immune system attack within Sernova’s Cell Pouch™ through different and independent mechanisms to
eliminate the need for life-long immunosuppression medications.”
Pursuant to the asset acquisition, Sernova acquired all intellectual property associated with Converge’s
conformal coating cell encapsulation technology (“Conformal Coating Technology”), including issued
patents, patent applications, and know-how.
ABOUT SERNOVA’S CONFORMAL COATING TECHNOLOGY
The Conformal Coating Technology consists of a thin proprietary coating layer that effectively cloaks coated
therapeutic cells to protect them from an auto-response attack by one’s own immune system post cell
transplantation into the body.
The advantages and potential benefits of this novel cell encapsulating technology are as follows:
• provides protection of therapeutic cells from immune system attack locally within Sernova’s Cell Pouch,
potentially avoiding the need for life-long immunosuppression medications, that are currently required after
cell transplantation;
• enables intimate contact of therapeutic cells with the vascularized tissue matrix of the Cell Pouch
improving essential physiological interactions of the cells for survival and function, unlike other micro and
macro-encapsulation technologies;
• improves the diffusion of small molecules and biomolecules (i.e., glucose, insulin, and other proteins or
hormones), providing a physiological glucose-stimulated insulin response without delay that occurs with
other encapsulation technologies; and
• with improved diffusion of biomolecules, may require a smaller load of therapeutic cells to achieve the
desired therapeutic effect in comparison to standard microcapsules.
Sernova has also completed its announced $1,000,000 unsecured convertible debenture financing, with the
proceeds used to fund the Conformal Coating Technology acquisition. The debenture is repayable on
December 9, 2022, unless earlier converted or redeemed, and carries an 8% interest rate. The Company
also issued 3,000,000 non-transferable share purchase warrants, each warrant being exercisable into one
common share at a price of $0.20 per share up to December 9, 2022. The debenture holder will have the right
to convert the principal amount of the debenture into common shares of Sernova at a conversion price of
$0.25
per share. The debenture and warrants are subject to a four-month hold period under securities regulations.
Neither the debenture or warrants have been or will be registered under the United States Securities Act of
1933, as amended (the “U.S. Securities Act”), or any state securities laws and such securities may therefore
not be offered or sold in the United States or to or for the account or benefit of a person in the United States
or
a U.S. Person (as defined in Regulation S of the U.S. Securities Act) absent registration or an applicable
exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities
laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there
be any sale of the debenture units in any jurisdiction in which such offer, solicitation or sale would be unlawful.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The
device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers
for the transplantation and function of therapeutic cells, which then release proteins and hormones as
required
to treat disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and
efficacy in small and large animal models of diabetes and has been proven to provide a biologically
compatible environment for insulin-producing cells in humans.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell-derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies
of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FORWARD-LOOKING INFORMATION
This news release contains forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”,
“anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or
conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees
of
future performance, and actual results may differ materially from those in forward-looking statements.
While
Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to
significant
scientific, business, economic, competitive, market and social uncertainties and contingencies. Additionally,
there are known and unknown risk factors that could cause Sernova’s actual results, performance or
achievements to be materially different from any future results, performance or achievements expressed or
implied by the forward-looking statements contained in this press release.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the
date such statements were made, which include our beliefs about the effect on company operations and
capital markets of events related to the COVID-19 pandemic, the conduct and outcome of discussions with
strategic partners, and expected progress in preclinical programs, clinical trials and technology
development.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - August 04, 2020 4 August, 2020
Sernova Enters into Exclusive Worldwide License Agreement with University of Miami for Therapeutic Cell Immune Protection Technologies
Sernova expands its intellectual property portfolio and capabilities to develop first-in-class cell therapy
solutions for type 1 diabetes and other chronic diseases that eliminate the need for life-long
immunosuppression drugs
August 4, 2020 7:00 a.m. EDT
LONDON, ONTARIO – August 4, 2020 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage
regenerative medicine company developing a ‘functional cure’ for type 1 diabetes and other chronic diseases,
announced today it has entered into an exclusive, worldwide license with the University of Miami at Coral
Gables, Florida, for the commercial rights to novel conformal coating immune protection technologies. The
technologies were developed by Dr. Alice Tomei, Dr. Jeffrey Hubbell, and Aaron Stock (Graduate Student). Dr.
Tomei is a leading international expert in immunoprotection and diabetes immunoengineering, of the renowned
Diabetes Research Institute (DRI), a designated Center of Excellence at the University of Miami Miller School of
Medicine. Dr. Hubbell is the Eugene Bell Professor of Tissue Engineering at the University of Chicago and
leading international researcher in immunoengineering.
This exclusive worldwide license agreement is important to Sernova because it broadens the technology scope
of Sernova’s immune protection conformal coating technologies and related intellectual property. Furthermore,
it adds to a series of recent strategic acquisitions and collaborations for the Company and builds on our goal of
protecting Sernova’s therapeutic cells or tissues transplanted into Sernova’s Cell Pouch™ from a detrimental
auto-immune system response while eliminating the need for immunosuppressive drugs in treated patients.
“Sernova is further advancing development of its novel Cell Pouch System™ as a therapeutic platform to
provide cell therapy solutions to patients with chronic diseases, such as type 1 diabetes, without the current
need for life-long immunosuppressive drugs. We believe, with the addition of local immune protection, our
breakthrough technologies will have the potential to significantly expand access to and the availability of
therapeutic solutions to millions of people as a ‘functional cure’ for the chronic diseases from which they are
suffering,” said Dr. Philip Toleikis, President and CEO of Sernova Corp.
Dr. Toleikis continued, “As we continue to advance our first-in-class technologies, we have diligently selected
complementary technologies developed by recognized experts in the field such as those by Dr. Tomei and
colleagues to add to our Cell Pouch™ platform. With the continued expansion of our regenerative medicine
therapeutics platform, we are positioning the Company at the forefront in the development of safe, functional
regenerative medicine therapeutics.”
Dr. Alice Tomei, the Director of the Islet Immunoengineering Laboratory at DRI stated, “Following my
postdoctoral training in Dr. Hubbell’s laboratory at École Polytechnique Fédérale de Lausanne, Switzerland, I
joined the University of Miami where I have focussed my academic career in the pursuit and development of
novel cellular immune protection technologies to advance the field of cell therapy. With Sernova’s goal of a
‘functional cure’ for diabetes, supported by its positive preclinical and more recent, emerging clinical safety
and efficacy data from the University Chicago clinical trial, I am excited to contribute to the addition of local
immune protection technologies provided by conformal coatings as the next important step towards this
ultimate goal.”
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch™)
and immune protected therapeutic cells/tissues (i.e., human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH™ SYSTEM
The Cell Pouch™, as part of the Cell Pouch™ System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease. The Cell Pouch™, along with therapeutic cells, has been shown to provide long-term safety and
efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently
conducting a Phase I/II study at the University of Chicago.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp.
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the Company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the Company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the Company’s Cell Pouch System and/or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the Company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - February 18, 2021 18 February, 2021
Sernova Announces Second Annual Data Safety Monitoring Board Review of its Diabetes Cell Pouch System™ Clinical Trial and Recommendation for Protocol Continuation
Ongoing Safety of Sernova's Clinical Trial Confirmed
February 18, 2021 9:00 a.m. EST
LONDON, ONTARIO – February 18, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage company and leader in regenerative medicine therapeutics, is pleased to announce that the clinical trial
independent Data Safety Monitoring Board ("DSMB") has completed the second planned annual review of the
ongoing Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation Phase
I/II clinical trial in patients with severe hypoglycemia unawareness and inability to produce their own insulin.
The DSMB recommended that the Phase I/II clinical study should continue according to the study protocol and
any related amendments. In their assessment, the DSMB did not raise any concerns regarding patient safety.
"We are pleased with the second annual independent DSMB review of our Phase I/II clinical trial," said Dr.
Philip Toleikis, President & CEO Sernova Corp. "We thank the DSMB for its diligence, guidance and support as
Sernova continues progressing the clinical trial."
The DSMB is an independent group of clinical research experts who review the accumulated data to permit a
thorough evaluation of patient safety and to ensure the integrity of the study's data and progress towards
completion.
ABOUT SERNOVA'S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial to assess
the safety and tolerability of islet transplantation into the company's patented Cell Pouch in diabetic subjects
with hypoglycemia unawareness and an inability to produce their own insulin. The secondary objective is to
assess efficacy through a series of defined measures. Eligible subjects are implanted with Cell Pouches.
Following development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on
immunosuppression and a dose of purified islets, under strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional
safety and efficacy measures for approximately six months. At this point, a decision will be made with regards
to the transplant of a second islet dose with subsequent safety and efficacy follow-up. Following this period,
eligible patients may be administered a single dose of islets through the portal vein. Patients will be then further
followed for one year to assess longer-term safety and efficacy. This study is supported in part by funding from
JDRF, the leading global organization funding type 1 diabetes (T1D) research.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more
information on enrollment and recruitment details, please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA'S CELL POUCH SYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long- term survival and function of therapeutic cells. The device
is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and
function of therapeutic cells which then release proteins and hormones as required to treat disease. The Cell
Pouch along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large
animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-
producing cells in humans. In early assessments of its ongoing Phase I/II clinical trial, Sernova has shown
presence of blood levels of c-peptide both during glucose tolerance tests as well as under fasting conditions.
Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates",
"believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions
"will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova's management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - February 25, 2021 25 February, 2021
Sernova Corp. Selected for the TSX Venture Stock Exchange’s 2021 Venture 50 List of Top Performing Listed Companies
February 25, 2021 9:00 a.m. EST
LONDON, ONTARIO - February 25, 2021 - Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF)
(Frankfurt/Xetra:PSH), a clinical-stage company and leader in regenerative medicine therapeutics is pleased
to announce that the TSX Venture Stock Exchange (TSX Venture) has recognized Sernova as a 2021 Venture
50 company, showcasing the top 50 performing listed companies.
“We are honoured to be chosen for the 2021 Venture 50 list and to be included amongst this distinguished
group of industry leaders. We share this honour with our institutional and retail investors who are supporting
our continued success and growth,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “This
recognition is another validation of Sernova’s ongoing therapeutic advancements and builds upon what will
be another very strong year as we continue to grow the company and build further shareholder value.”
The Venture 50 are the top ten companies listed on TSX Venture Exchange in each of five major industry
sectors – mining, energy & energy services, clean technology & life sciences, diversified industries and
technology – based on a ranking formula with equal weighting given to market cap growth, trading volume
amount and share price appreciation. All data was as of December 31, 2020.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The
device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells which then release proteins and hormones as required to
treat disease. The Cell Pouch along with therapeutic cells has been shown to provide long-term safety and
efficacy in small and large animal models of diabetes and has been proven to provide a biologically
compatible environment for insulin-producing cells in humans. In early assessments of its ongoing Phase I/II
clinical trial, Sernova has shown presence of blood levels of c-peptide both during glucose tolerance tests as
well as under fasting conditions. Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement
of proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words “expects”, “plans”,
“anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that
events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the
expectations expressed in such forward-looking statements are based on reasonable assumptions, such
statements are not guarantees of future performance, and actual results may differ materially from those in
forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions
of Sernova’s management on the date such statements were made, which include our beliefs about the
conduct and outcome of clinical trials. Sernova expressly disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - March 01, 2021 1 March, 2021
SERNOVA ANNOUNCES CLOSING OF C$23 MILLION BOUGHT DEAL FINANCING INCLUDING FULL EXERCISE OF OVER-ALLOTMENT OPTION
LONDON, ONTARIO – March 1, 2021 – Sernova Corp. (“Sernova” or the “Company”) (TSX-V: SVA) (OTCQB:
SEOVF) (Frankfurt/Xetra: PSH), a leading clinical-stage regenerative medicine therapeutics company, is
pleased to announce that it has closed its previously announced bought deal financing of 16,700,000 units of
the Company (the “Units”) at a price of C$1.20 per Unit (the “Issue Price”), and the exercise in full of the
Over-Allotment Option of 2,505,000 Units at the Issue Price, for aggregate gross proceeds to the Company
of approximately C$23,046,000 (the “Offering”).
Each Unit is comprised of one common share of the Company (a “Common Share”) and one Common Share
purchase warrant (a “Warrant”). Each Warrant entitles the holder thereof to purchase one Common Share
(as “Warrant Share”) at an exercise price of C$1.70 (the “Exercise Price”) until March 1, 2023. The expiry
date of the Warrants may be accelerated by the Company if the daily volume weighted average trading price
of the Common Shares on the TSX Venture Exchange (the “Exchange”) is greater than C$3.05 for the
preceding ten (10) consecutive trading days, at which time the Company may accelerate the expiry date of
the Warrants by providing notice to the holders of Warrants or issuing a news release announcing such
acceleration, whereupon the Warrants will expire not less than 30 days after the date of such notice or news
release.
The Offering was conducted on a “bought deal” basis, led by Canaccord Genuity Corp. and Leede Jones
Gable Inc. as co-lead underwriters (together, the “Underwriters). As consideration for their services in
connection with the Offering, the Company paid to the Underwriters: (i) a cash commission of $1,452,981;
(ii) a corporate finance fee of 384,100 Units; and (iii) 1,210,818 compensation options (the “Compensation
Options”), where each Compensation Option entitles the holder thereof to purchase one Unit (a
“Compensation Unit”) at the Issue Price until March 1, 2023. Each Compensation Unit is comprised of one
Share and one Warrant exercisable into a Warrant Share at the Exercise Price.
The net proceeds of the Offering will be used to advance the Company’s clinical development programs,
including its US Phase I/II Cell Pouch clinical trial in insulin-dependent diabetes, expand the Company’s
research and development programs, including its local immune protection technologies for the Cell Pouch,
as well as for working capital and general corporate purposes.
The Offering was completed (i) by way of a short form prospectus filed in each of the provinces of Canada,
other than Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions, (ii) on a
private placement basis in the United States pursuant to exemptions from the registration requirements of
the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and applicable U.S. state
securities laws, and (iii) outside Canada and the United States on a basis which does not require the
qualification or registration of any of the Company’s securities under domestic or foreign securities laws.
The securities referred to in this press release have not been, nor will they be, registered under the U.S.
Securities Act or any U.S. state securities laws, and may not be offered or sold within the United States or to,
or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the
U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a
solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such
offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be
made by means of a prospectus containing detailed information about the company and management, as
well as financial statements.
About Sernova Corp.
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells, and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement
of proteins or hormones missing or in short supply within the body. For more information, please visit
www.sernova.com.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp
T: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Cautionary Statement Regarding Forward-Looking Information
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian
securities legislation. These statements relate to future events or future performance. The use of any of the
words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and
statements relating to matters that are not historical facts are intended to identify forward-looking
information and are based on Sernova’s current belief or assumptions as to the outcome and timing of such
future events. Forward looking information in this press release includes information with respect to the
intended use of proceeds by the Company. Forward-looking information is based on reasonable
assumptions that have been made by Sernova at the date of the information and is subject to known and
unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially
from those anticipated in the forward-looking information. Examples of such risk factors include: credit;
market (including equity, foreign exchange and interest rate); liquidity; operational (including technology and
infrastructure); reputational; insurance; strategic; regulatory; legal; environmental; capital adequacy; the
general business and economic conditions in the regions in which the Company operates; the ability of the
Company to execute on key priorities, including the successful development of its product candidates, and
strategic plans and to attract, develop and retain key executives; the ability to implement business strategies
and pursue business opportunities; disruptions in or attacks (including cyber-attacks) on the Company's
information technology; the failure of third parties to comply with their obligations to the Company or its
affiliates; the impact of new and changes to, or application of, current laws and regulations governing the
Company’s business; dependence on key suppliers; granting of permits and licenses; increased competition;
changes in foreign currency rates; increased funding costs and market volatility due to market illiquidity and
competition for funding; the availability of funds and resources to pursue operations; critical accounting
estimates and changes to accounting standards, policies, and methods used by the Company; the
occurrence of natural and unnatural catastrophic events and claims resulting from such events; risks related
to COVID-19 including various recommendations, orders and measures of governmental authorities to try to
limit the pandemic, including travel restrictions, border closures, nonessential business closures,
quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic
activity, financing, supply chains and sales channels, and a deterioration of general economic conditions
including a possible national or global recession; as well as those risk factors disclosed under the heading
“Risk Factors” in the Company’s Annual Information Form (dated February 8, 2021) for the year ended
October 31, 2020, which has been filed on SEDAR and is available under the Company’s profile at
www.sedar.com. Given these risks, uncertainties and assumptions, you should not unduly rely on these
forward-looking statements. The forward-looking information contained in this press release is made as of
the date hereof, and Sernova is not obligated to update or revise any forward-looking information, whether
as a result of new information, future events or otherwise, except as required by applicable securities laws.
The foregoing statements expressly qualify any forward-looking information contained herein.
Press Release Communiqué de presse - March 15, 2021 15 March, 2021
Sernova Provides Positive Outlook Regarding the Development of Its Innovative Therapeutics Platform Technology for Chronic Diseases
Sernova is the first and only regenerative medicine therapeutics platform company to demonstrate a well-
vascularized subcutaneous islet transplant technology achieving persistent islet graft function in diabetic
patients
Sernova CEO hosting an investor conference call on March 18, 2021 at 11:00 am (EDT)
March 15, 2021 9:00 a.m. EDT
LONDON, ONTARIO – March 15, 2021 – Sernova Corp. (TSX-V:SVA) (FSE/XETRA:PSH) (OTCQB:SEOVF), a
clinical-stage regenerative medicine company, today provides a Corporate Update and highlights recent key
achievements in its pipeline, including its diabetes clinical program as well as other leading development
programs.
“I am pleased that our clinical study based on our unique technology platform continues to contribute
significant advancements to the field of regenerative medicine therapeutics. This is demonstrated by ongoing
positive patient outcomes in safety, tolerability, and efficacy measures as we actively approach completion of
full study enrolment. These advancements are occurring despite ongoing global uncertainty related to the
COVID-19 pandemic. In this restrictive environment, Sernova also achieved significant advancements in our
other therapeutic programs and in the development of technologies that we believe are building significant
shareholder value and justified optimism for patients suffering from chronic diseases. As validation of our
strategic approach, we are pleased with the recently completed institutional led bought deal financing of $23M.
We are aggressively moving forward with all of our programs,” said Dr. Philip Toleikis, President and CEO of
Sernova.
DIABETES : SERNOVA’S LEAD CLINICAL INDICATION
Sernova’s principal investigator in its US Phase I/II diabetes clinical trial, Dr. Piotr Witkowski, presented an
update at the recent 2021 21st Winter Symposium of the American Society of Transplant Surgeons based on
data from its current clinical trial: A Safety, Tolerability and Efficacy -Study of Sernova's Cell Pouch for Clinical
Islet Transplantation.
Five of the 7 planned patients have been enrolled, implanted with the Cell Pouch, and are advancing through
the transplantation phases of the study.
The following key findings to date have been noted in our trial patients:
• The Primary Safety Endpoint of the study continues to be met:
o the Cell Pouch, following implantation under the skin, shows consistent incorporation with vascularized
tissue in multiple patients providing a suitable environment for the survival and function of insulin producing
cells; and
o the implanted Cell Pouch and therapeutic cells continue to demonstrate a positive safety profile with no
serious adverse events related to the Cell Pouch.
• The Secondary Efficacy measures continue to show clinical benefit in the most advanced treated patients
including:
o absence of life-threatening hypoglycemic episodes;
o enduring presence of insulin produced by the Cell Pouch transplanted cells (measured by the biomarker C-
peptide) in the bloodstream;
o reduction or elimination in the daily amount of insulin injected; and
o a reduction in HbA1c, a measure of long-term blood sugar control, which can lead to reduced diabetic
complications.
Pre-screening of the final two patients is actively underway to complete study enrollment.
HEMOPHILIA A
Sernova as a member of the Horizon 2020 HemAcure Consortium (HemAcure Consortium) presented results of
the Consortium’s research at the American Society of Gene and Cell Therapy. Importantly, the following
highlights were presented:
• hemophilia A patients unable to express the required clotting factor VIII (FVIII) blood cells were isolated;
• the human FVIII gene responsible for the production of the missing required clotting factor was
successfully inserted to achieve a therapeutic effect;
• the safety of these newly corrected cells and their ability to produce sufficient human clotting factor both
in laboratory and in an initial preclinical animal model was confirmed.
o human FVIII blood levels reached up to 10%, which is considered sufficient to enable patients to regain
their clotting ability;
o these corrected therapeutic cells in the Cell Pouch were successfully assessed in a preclinical model of
hemophilia A showing long-term survival of cells;
o human FVIII was also detected in the bloodstream long-term (measured up to four months, the length of
the study, following treatment); and
• data further confirmed functional clotting improvement in the blood at the four months time point where
human FVIII corrected cells transplanted into the hemophilia A preclinical model restored the animals clotting
activity to a therapeutic level within the Cell Pouch.
“These results demonstrate the success in developing a novel approach for the treatment of hemophilia A.
These results continue to showcase Sernova’s Cell Pouch platform technologies for the treatment of multiple
indications including rare diseases where a gene can be inserted into cells to produce any protein or factor
required to treat disease,” added Toleikis. “We look forward to completing work to bring this and other novel
therapies to human clinical testing as soon as practicable.”
HYPOTHYROID DISEASE
Sernova is developing a treatment for hypothyroid disease following complete or partial removal of the thyroid
gland (thyroidectomy). To advance this platform technology, in collaboration with Dr. Sam Wiseman and in part
funded by a Transplant Venture Grant awarded by the Transplant Research Foundation (TRF) of British
Columbia, we are assessing healthy human thyroid tissue in preparation of a clinical program.
This new treatment approach allows patients to preserve their thyroid function following a thyroidectomy by
transplanting healthy thyroid cells into Sernova’s Cell Pouch. Currently completed pre-clinical work is setting
the stage for a regulatory submission for this second clinical program.
PLATFORM EXPANDING TECHNOLOGIES AND CORPORATE COLLABORATIONS
Sernova is acquiring and developing state of the art technologies. These involve both unique cell encapsulating
technologies and gene editing technologies to reduce or eliminate the need for immunosuppression
medications targeted to our specific cell therapy clinical applications within the Cell Pouch platform.
• Sernova has acquired all the patented technology and knowhow for a cellular local immune protection
technology (Conformal Coating Technology)
o an exclusive worldwide license agreement with the University of Miami was signed, broadening this
technology scope.
o Sernova intends on bringing the Cell Pouch platform technologies, which includes conformally coated
therapeutic cell technology, to the clinic first for our diabetes donor and stem cell programs with the goal to
improve current cell therapy treatment options.
• Sernova also entered into a collaboration agreement with AgeX Therapeutics to utilize their UniverCyte™
technology. The objective is to generate transplantable genetically engineered stem cells that are immune
protected to treat diseases for use in Sernova’s Cell Pouch.
Sernova is in active collaborations with leading global pharmaceutical companies for multiple cell therapy
clinical applications in combination with Sernova’s cell therapy therapeutic platform and technologies. The goal
of these collaborations is to initiate co-development and/or licensing agreements, as well as the potential
ability to market and distribute our regenerative medicine therapeutics worldwide.
Dr. Toleikis will participate in the first of a series of conference calls for shareholders to provide corporate
updates and answer questions at 11:00 am (EDT) on March 18, 2021. A presentation will be made available on
Sernova’s website before the call. All questions to Dr. Toleikis can be submitted to info@sernova.com prior to
the call. To participate in this live conference call, please visit:
Meeting link:
https://sernovacorp.my.webex.com/sernovacorp.my/j.php?MTID=md016888548d385cd4fea3878b73a9b5d
Meeting number: 182 490 4245
Password: SVAMarch2021 (78262724 from phones and video systems)
Join by phone
+1-416-915-6528 CANADA TOLL
+1-415-655-0001 US TOLL
Access code: 182 490 4245
(Global call-in numbers available upon request)
Following the conference call a recording will be available at www.sernova.com
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information, please contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the
date such statements were made, which include our beliefs about the conduct and outcome of clinical trials.
Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - April 28, 2021 28 April, 2021
Sernova KOL Event Highlights Novel Cell Therapy Approach for the Potential Treatment of Thyroid Disease
April 28, 2021 9:00 AM ET
LONDON, ONTARIO – April 28, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a
leading clinical-stage regenerative medicine therapeutics company, announced today the highlights of its
first virtual Key Opinion Leader (KOL) event on thyroid disease.
The KOL event featured a presentation by Dr. Sam Wiseman, a leading surgeon and internationally
recognized expert in the management of thyroid and parathyroid disease. In his presentation, Dr. Wiseman
discussed current treatment options and the potential for a novel cell therapy approach for the treatment of
postoperative hypothyroidism using Sernova’s Cell Pouch™. The presentation was followed by a Q&A session
with attendees.
“I’m very excited about this program because as surgeons, we will be able to offer our patients a treatment
option that could allow for avoidance of postoperative hypothyroidism requiring life-long dependence on
thyroid medication,” said Dr. Sam Wiseman. “Our preclinical study evaluating transplantation of human
thyroid tissue into Sernova’s Cell Pouch has shown promising results. I believe this very exciting new
approach represents a critical step towards an entirely new treatment option for post-thyroidectomy
hypothyroidism."
Dr. Wiseman's presentation and the subsequent Q&A session are now available on Sernova's website at
www.sernova.com and on Sernova’s social media channels.
ABOUT SERNOVA'S THYROID PROGRAM
Sernova's approach for treating postoperative hypothyroidism is to transplant a portion of the thyroid gland
being removed into a pre-implanted vascularized Cell Pouch™ to recover thyroid function. In collaboration
with Dr. Wiseman, preclinical proof of concept study conducted under a grant from the British Columbia
Transplant Foundation is contributing to advancing Sernova's plans to conduct clinical assessment of this
novel approach. Sernova's overall treatment goal is to preserve thyroid function, and improve patient
quality of life, relative to current treatments.
Thyroidectomy is commonly performed for management of cancer, and for treatment of benign (non-
cancerous) disease that includes nodules, goitre and hyperthyroidism. It is estimated that about 150,000
thyroidectomies are performed in the US annually, with most individuals undergoing thyroid surgery
eventually being diagnosed with benign conditions. Patients undergoing total thyroidectomy, and many
patients undergoing partial thyroidectomy, require life-long oral postoperative thyroid hormone
replacement.
Post-surgical thyroid hormone replacement therapy, if monitored carefully, can be effective; however, some
patients may suffer from deleterious side-effects including body weight gain, fatigue, and depression, with a
resultant negative impact on quality of life, and significant costs to the healthcare system. We believe
Sernova's development of new therapeutic strategies to treat post-surgical hypothyroidism has the potential
of addressing an important unmet medical need.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells, stem cell-derived cells and
tissues) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through
replacement of proteins or hormones missing or in short supply within the body. For more information,
please visit www.sernova.com.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dominic Gray
Sernova Corp.
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are
not historical facts and are generally, but not always, identified by the words "expects", "plans",
"anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that
events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the
expectations expressed in such forward-looking statements are based on reasonable assumptions, such
statements are not guarantees of future performance, and actual results may differ materially from those in
forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions
of Sernova's management on the date such statements were made, which include our beliefs about the
conduct and outcome of clinical trials. Sernova expressly disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - June 07, 2021 7 June, 2021
Sernova's Principal Investigator Presents Positive New Data from Ongoing Type 1 Diabetes (T1D) Clinical Trial at ATC 2021 Virtual Connect Conference
Multiple patients with sustained clinical benefit, including positive fasting serum C-peptide (a biomarker of
insulin produced by Sernova’s Cell Pouch islets) detected in their bloodstream
June 7, 2021 6:00 a.m. EDT
LONDON, ONTARIO – June 7, 2021 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
leading clinical-stage regenerative medicine therapeutics company today announced that its principal
investigator, Dr. Piotr Witkowski, presented new preliminary data from Sernova’s ongoing U.S. Phase I/II T1D
clinical trial at the University of Chicago. Dr. Witkowski’s presented the data at the American Transplant
Congress (ATC) 2021 Virtual Connect conference on Saturday June 5, 2021.
The overall objective of the clinical trial is to assess the safety, tolerability, and efficacy of the Cell Pouch with
insulin-producing islets. In addition to other criteria, prior to entry into the study, the patients must
demonstrate long-standing T1D with severe hypoglycemic unawareness episodes and no glucose-stimulated C-
peptide circulating in their bloodstream.
Dr. Witkowski’s presentation entitled “Islet Allotransplantation Into The Pre-Vascularized Sernova Cell
PouchTM Device - Preliminary Results Of The Phase I/II Prospective, Open-Label, Single-Arm Study At
University of Chicago” highlighted the following key points:
• 6 patients are implanted with Cell Pouches and continue to meet the study’s primary safety endpoint;
• 5 patients have now been transplanted with at least one dose of therapeutic cells (insulin producing islets)
and are in different stages of the clinical trial; and
• most significantly, positive fasting serum C-peptide has been detected in the bloodstream of 4 patients so
far. C-peptide is a biomarker for insulin produced by the islets in the Cell Pouch.
In addition to the continued confirmation of ongoing safety and tolerability in all currently enrolled patients, Dr.
Witkowski provided further updates on the longest treated study patients. These patients continue to show
defined clinical benefit associated with ongoing efficacy indicators including:
• reduction/elimination in the need for daily injectable insulin
• continued improvement, i.e. reduction/elimination, in Severe Hypoglycemic Events (SHE);
• persistent detection of fasting and stimulated C-peptide in patients’ bloodstream;
• reduction in HbA1c; and
• continued improvement of glucose control determined through patient blinded Continuous Glucose
Monitoring (CGM) and measured by reduction of Time Above Range (TAR) and increase of Time in Range (TIR).
As previously reported, the most advanced patient in the study, who had achieved a ‘functional cure’ (requiring
no injectable insulin) and had been insulin independent for 9 months, has now been insulin independent for 14
months with optimal glucose control.
“I believe Sernova is the first company in the world to demonstrate a subcutaneous vascularized device with
therapeutic cells able to produce insulin in the bloodstream across multiple patients with the most severe
diabetes. This is a remarkable feat. As the study progresses and our patient dataset continues to build, I am
more confident than ever of the potential of Sernova’s regenerative medicine therapeutic platform,” said Dr.
Philip Toleikis, President and CEO of Sernova. “Our vision of improving the lives of people suffering from
diabetes with a ‘functional cure’ is another step closer to becoming a reality.”
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune
protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to
improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent
diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or
hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investor Relations
Sernova Corp.
Tel: (519) 858-5126
investorrelations@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events, including results of clinical trials, and are based on information currently available to
management on the date such statements were made. Many factors could cause Sernova’s actual results,
performances or achievements to not be as anticipated, estimated or intended or to differ materially from
those expressed or implied by the forward-looking statements contained in this news release. Many of the
factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus
pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for
additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly
disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Press Release Communiqué de presse - September 16, 2021 16 September, 2021
Sernova Signs Collaboration Agreement to Advance Conformal Coated Immune Protected Therapeutic Cells for Diabetes with the University of Miami
Collaboration to build on positive Cell Pouch T1D Clinical Outcomes and preclinical success in Global
Pharmaceutical Collaborations to develop regenerative medicine therapeutic cures without life-long
immunosuppression medications across multiple diseases
An information session featuring Dr. Alice Tomei, a leading international expert in immunoprotection and
diabetes immunoengineering at the University of Miami, will take place on September 20th, 2021, at 1:00 PM
EDT
September 16, 2021 6:00 a.m. EDT
LONDON, ONTARIO – September 16, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a
clinical-stage regenerative medicine company developing a ‘functional cure’ for type 1 diabetes (T1D) and
other chronic diseases, announced today it has entered into a research agreement with the University of Miami
to advance the development of our Cell Pouch™ cell therapy platform combined with the novel conformal
coating cellular immune protection technology.
Dr. Alice Tomei, of the renowned Diabetes Research Institute (DRI) at the University of Miami Miller School of
Medicine, is an associate professor and international expert in immunoprotection and diabetes
immunoengineering. As part of this important collaboration, Dr. Tomei and her team is working closely with
Sernova’s R&D team. The expert teams have developed a series of key preclinical and polymer
characterization studies. In addition, work is being conducted to scale-up the conformal coating technology
process. The ultimate goal of this work is to support and accelerate the anticipated clinical evaluation of the
Cell Pouch platform without the need for immunosuppression in patients with brittle T1D.
While the studies will focus on immune protection of insulin producing cells in the Cell Pouch, these technology
advances are expected to be directly relevant and applicable to an array of cell technologies for treatment of
multiple cell therapy applications.
Dr. Tomei stated, “We have developed and optimized the conformal coating technologies over approximately
twelve years with the goal of ensuring local immune protection of therapeutic cells without the need for life-
long immunosuppression medications. Our hope is that Sernova’s Cell Pouch technologies, which have already
shown initial clinical benefit in patients with brittle T1D, when combined with conformally coated local immune
protected islets, have the potential to provide a significant advancement in the treatment of people suffering
from T1D.”
Dr. Toleikis, President & CEO of Sernova stated, “In our development of a therapeutic cell therapy approach
for all people with T1D, we have used a systematic and stepwise strategy, first by combining our Cell Pouch in
the clinic for patients with brittle T1D with human donor islets protected with immunosuppression. Given the
proven safety and efficacy of our Cell Pouch technologies, we are now thrilled to take this next step in our
strategic approach by collaborating with Dr. Tomei’s team to advance the conformal coating as a cellular local
immune protection strategy for islet technologies.”
“An information session will take place on September 20th, 2021, at 1:00 PM EDT. The information session will
feature Dr. Alice Tomei, associate professor at the University of Miami. During this information session, Dr.
Tomei will discuss the conformal coating technology approach for local cellular immune protection and
Sernova will also provide a management update during this session," said Dr. Philip Toleikis, "Session
attendees will be able to ask questions during a following Q&A period with Dr. Tomei and Sernova
management.”
The presentation will be made available on Sernova's website before the call. Questions can be submitted to
info@sernova.com prior to the call.
To register and access the Zoom link for this event, please click:
https://us02web.zoom.us/webinar/register/WN_iDuWzqW4R3COgQ_toI376A
Following the event, a recording will be available at www.sernova.com.
ABOUT SERNOVA
Sernova Corp is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch™)
and immune protected therapeutic cells/tissues (i.e., human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease. The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and
efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible
environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently
conducting a Phase I/II study at the University of Chicago. Positive initial results have been presented at several
international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investor Relations Sernova Corp.
Tel: (519) 858-5126
investorrelations@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - October 01, 2021 1 October, 2021
Sernova: The Ultimate Combination of Two Proven Technologies as Potential Functional Cure for Type1 Diabetes and Other Chronic Diseases
Information Session Webinar on Sernova’s Conformal Coating Immune Protection Technology with Dr. Toleikis
and International Expert, Dr. Tomei Now Available on Sernova’s Website
October 1, 2021 6:00 a.m. EDT
LONDON, ONTARIO – October 1, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF) (FSE/XETRA:PSH), a
leading clinical-stage regenerative medicine company developing a ‘functional cure’ for type 1 diabetes (T1D)
and other chronic diseases, recently hosted an information session webinar. The webinar announced Sernova’s
collaboration with the University of Miami (UMiami) and associate professor and international expert in
immunoprotection and diabetes engineering, Dr. Alice Tomei of the UMiami’s Diabetes Research Institute.
During this webinar Drs. Toleikis and Tomei discussed the Conformal Coating Immunoprotection Technology
and its pivotal role within Sernova’s Cell Pouch Technology platform. A Q&A session followed the presentation
by Drs. Toleikis and Tomei. The responses to key questions asked by attendees are summarized below.
For those investors and other interest parties who were unable to attend the information session, a recording is
available at www.sernova.com
At what stage of development is the Conformal Coating Immunoprotection Technology?
This technology is backed by over 12 years of scientific research. Scientific research has included extensive
preclinical testing followed by optimization to arrive at the final formulation which is being tested in Sernova’s
Cell Pouch.
Have islets with Conformal Coating been shown to be safe in preclinical models?
Yes. A positive safety profile has been demonstrated in small and large animal preclinical models.
Does the Conformal Coating affect the release of insulin from islets tested in the lab?
Insulin release in conformal coated islets is comparable to uncoated islets. Conformal coated islets have shown
uptake of glucose and the release of insulin remains normal.
When tested in preclinical models of diabetes, is the release of insulin into the bloodstream from islets with
Conformal Coating similar to uncoated islets?
Preclinical diabetes studies completed have shown a normal insulin response to a glucose challenge (glucose
tolerance test).
Have conformal coated islets been shown to provide a ‘functional cure’ for diabetes in preclinical models?
Yes. In two preclinical diabetes animal model studies completed, long-term insulin independence without the
need for immunosuppressive drugs has been demonstrated which is considered to be a ‘functional cure’.
Have stem cell derived islets with Conformal Coating been shown to provide a ‘functional cure’ for diabetes in
preclinical models?
Yes. Long-term insulin independence has been demonstrated.
It seems the Conformal Coating and Cell Pouch technologies have both been tested and optimized. Do you
expect that the combination of these two technologies will enable more rapid entry into the clinic than if
developing new technologies?
Yes. We are combining these two well tested technologies in our studies with the goal of entering clinical trials
for both donor islets and diabetes stem cell technologies as soon as practicable.
Why is the Conformal Coating approach for immune protection ideally suited for the Sernova’s Cell Pouch
technologies?
We believe the Cell Pouch design provides the ideal organ-like environment for therapeutic cells. Our ability to
provide Conformal Coating immunoprotection of cells within the Cell Pouches vascularized, organ-like
environment could avoid the detrimental issues associated with other immune protected macro devices, while
providing a protected and retrievable site for the therapeutic cells. This combination is expected to form a
platform for multiple therapeutic cell technologies.
From an investor viewpoint, why is this collaboration important?
The opportunity to provide patients with a locally immune protected cell therapy treatment approach without
the need to take life-long immunosuppression medications is expected to dramatically increase the available
patient populations for multiple diseases who could benefit from these therapies. In addition, locally immune
protected cells within the Cell Pouch is of great interest to our pharmaceutical collaborators. The ultimate
combination of two proven technologies as a potential ‘functional cure’ for T1D and other chronic diseases
would be expected to add tremendous shareholder value from the expansion of addressable markets across
multiple indications, and in turn, potential long term revenues.
Dr. Toleikis, President & CEO of Sernova, stated, “In the development of a novel therapeutic cell therapy
approach for all people with T1D, Sernova’s systematic approach has provided encouraging initial safety and
clinical benefit in patients with brittle T1D. We continue to take a leadership role with our unique local cellular
immunoprotection strategies for islet technologies and look forward to the day when patients can enjoy a
‘functional cure’ without the need for life-long immunosuppression drugs.”
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch™) and
immune protected therapeutic cells/tissues (i.e., human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investors:
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
212-915-2577
Corporate:
Investor Relations Sernova Corp.
Tel: (519) 858-5126
investorrelations@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - January 05, 2022 5 January, 2022
Sernova to Announce New Interim Results of its Type 1 Diabetes Clinical Trial During the 40th Annual J.P. Morgan Healthcare Conference
LONDON, ONTARIO – January 5, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company focused on developing a potential
‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce that new interim
results from the ongoing safety, tolerability and efficacy Phase I/II clinical trial of Sernova’s Cell Pouch™ will be
released on January 10, 2022.
Originally, it was planned that Dr. Piotr Witkowski, principal investigator of Sernova’s Phase I/II clinical trial
would present an update in a poster session at the American Society of Transplant Surgeons (ASTS) 22nd
Annual “State of the Art” Winter Symposium on January 13, 2022, but the conference was postponed
yesterday until the end of July 2022 because of the ongoing COVID-19 pandemic.
“We are pleased to be announcing these new interim data earlier than anticipated in conjunction with the J.P.
Morgan conference which is one of the premier international healthcare conferences,” said Dr. Philip Toleikis,
President & CEO of Sernova.
ABOUT THE J.P. MORGAN HEALTHCARE CONFERENCE
The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment
symposium in the industry which connects global industry leaders, emerging fast growth companies, innovative
technology creators and members of the investment community. The J.P. Morgan 40th Annual Healthcare
Conference (JPM 2022) will take place virtually, January 10-13, 2022.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - January 10, 2022 10 January, 2022
The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Independent
LONDON, ONTARIO – January 10, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE / XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to provide a progress update on its Phase
1/2 T1D clinical trial in conjunction with Dr. Piotr Witkowski, the clinical trial’s Principal Investigator at the
University of Chicago. Dr. Witkowski was originally scheduled to provide a clinical trial update at the 2022
American Society of Transplant Surgeons (ASTS) Winter Symposium; however, the conference is now
postponed until August 2022 as a result of the ongoing COVID-19 pandemic.
The objective of Sernova’s Phase 1/2 clinical trial is to assess the safety, tolerability and efficacy of its
proprietary Cell Pouch™ transplanted with insulin-producing islets in patients with T1D complicated by
hypoglycemia unawareness and a history of severe hypoglycemic events. Study patients must meet stringent
eligibility criteria including, but not limited to, long-standing T1D, recent episodes of hypoglycemic
unawareness and an absence of glucose-stimulated C-peptide detectable in their bloodstream. Study patients
are eligible to receive up to three islet cell transplants throughout the study, including two marginal dose
transplants into the Cell Pouch and a single, marginal islet supplement transplanted via the portal vein.
Sernova would like to highlight some updated study findings and key points from the ongoing trial:
• the ongoing safety and tolerability of Cell Pouch has been maintained in all study patients;
• Islet transplantation to the Cell Pouch resulted in the establishment of new, measurable islet function
documented by detectable levels of stimulated C-peptide in the first three patients, who completed the
protocol-defined course of transplants.
• a supplemental, single intraportal islet transplant was sufficient for the first two patients to achieve and
maintain sustained ongoing insulin independence and freedom from severe hypoglycemic events for over
21 and 2 months, respectively.
• the third transplanted patient recently completed their course of Cell Pouch transplants and a
supplemental intraportal islet infusion, with favorable improvements in glucose control, near-normal
levels of C-peptide, an absence of severe hypoglycemic events and reductions in daily insulin use;
• the other three enrolled study patients are progressing through the study protocol, as planned. All have
received Cell Pouch implants and are at various stages of protocol-defined islet transplants and follow-up;
and
• a 7th study patient has been identified.
“We are very encouraged by finding detectable serum C-peptide levels after islet transplantation into the
Sernova Cell Pouch in the three most advanced study patients. Additionally, we are very excited about the first
two patients becoming insulin independent and free from severe hypoglycemic events after a single
supplemental intraportal islet infusion,” said Dr. Witkowski. “I look forward to continuing this trial with
Sernova as we further optimize our use of the Cell Pouch System and validate its therapeutic potential.”
Dr. Philip Toleikis, President & CEO of Sernova Corp further remarked, “We believe Sernova is the first
company to report that its first two transplanted T1D cell therapy study patients achieved sustained insulin
independence. We are further reassured that our Cell Pouch System is performing as expected by creating a
safe, vascularized, and natural tissue environment inside the human body, allowing the islet cells to thrive and
function efficiently following transplantation. As we progress through the trial, under the expert guidance of Dr.
Witkowski, we have had several scientific breakthroughs and advancements related to insulin producing cell
dynamics and efficacy related to our Cell Pouch technologies. These findings have led to several technical
optimizations, including the upcoming introduction of a higher capacity Cell Pouch configuration designed to
accommodate the total quantity and distribution of islets that are achieving insulin independence for patients
in our clinical trial. This configuration of Cell Pouch has already received regulatory authorization to be used
for the remaining trial implants. Sernova is grateful to Dr. Witkowski’s leadership in this trial as we further
enhance our therapeutic cell transplantation approach with our goal to achieve a ‘functional cure’ for the
patients with complicated T1D.”
Sernova has developed its cell therapy platform, the Cell Pouch System, with the vision of treating the millions
of patients with T1D and other chronic diseases using immune-protected therapeutic cells, including stem cell-
derived technologies. Sernova’s approach is to provide a minimally invasive, retrievable, safe, organ like
environment for rapid engraftment and long-term survival of therapeutic cells as well as to avoid blood
mediated inflammatory reactions and permit cell retrievability that cannot be achieved with the traditional
portal vein transplantation.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939.
For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT HYPOGLYCEMIA UNAWARENESS
Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they
become severe or even fatal. It typically occurs when blood glucose levels are below 3.0 mmol/L and is
estimated to affect approximately 15% of people with T1D.
Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and
personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care
and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure,
coma or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. After
implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the
transplantation and function of therapeutic cells, that release proteins and hormones as required to treat
disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several
international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - January 20, 2022 20 January, 2022
Sernova Announces Peer Reviewed Publication Demonstrating Safety and Efficacy of a Novel Cell Pouch Cell Therapy Approach for Treatment of Severe Hemophilia A
LONDON, ONTARIO – January 20, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for chronic diseases is pleased to announce a peer reviewed published scientific journal article
highlighting successful development of a novel cell therapy approach for treatment of severe hemophilia A , a
serious genetic bleeding disorder caused by missing factor VIII (FVIII) activity in the blood stream.
The journal article entitled “Efficient and Safe Correction of Hemophilia A by Lentiviral Vector-Transduced
BOECs in an Implantable device (Sernova’s Cell Pouch™),” was published in the prestigious scientific journal,
Molecular Therapy: Methods & Clinical Development, Volume 23, December 2021.
The therapeutic approach includes use of the patient’s own cells obtained from a blood sample, which are then
modified using a lentiviral vector-mediated gene transfer procedure using the B-domain deleted form of FVIII
under the control of an endothelial-specific promoter and subsequently transplanted within Sernova’s
vascularized Cell Pouch into a mouse model of hemophilia A. These cells then provide a continuous therapeutic
release of factor VIII into the bloodstream. The publication highlights that the HemAcure Consortium has now
successfully demonstrated safety and long-term improvement in blood clotting in a hemophilia A mouse
model.
It is estimated that 115,000 people live with hemophilia A in North America and Europe with a significant
proportion who rely on regular infusions of FVIII. Treatment costs per patient are as high as US $200,000 each
year, with an aggregate therapeutic cost of over US$ 10 billion per year.
“This novel ex vivo gene therapy approach is the first demonstration showing the safety and feasibility of
transplantation of lentiviral-corrected blood outgrowth endothelial cells (BOECs) within an implantable
medical device using GMP-like procedures for the long-term treatment of hemophilia A,” said the lead author
Dr. Antonia Follenzi, MD, PhD, Professor, Department of Health Sciences, School of Medicine, Università del
Piemonte Orientale. “If this therapy is successful in future clinical trials, it could become an important new
therapeutic approach to improve the quality of life for people suffering with severe hemophilia A.”
Dr. Philip Toleikis, President and CEO Sernova Corp stated, “This publication represents approximately four
years of dedicated work by the HemAcure consortium, from conceptualizing this novel treatment approach,
through to validating its potential as a safe and long-term treatment option for people with hemophilia A. The
Sernova Cell Pouch provides the required environment for transplanted cells to survive and function in the
body, as demonstrated by the production of FVIII to improve blood clotting as reported by Dr. Follenzi and
colleagues.” He continued, “We recognizes ex vivo gene therapy as a potential therapeutic option for people
suffering from multiple rare diseases and we are proud that our technologies may contribute to the
development and future delivery of functional cures for these ailments.”
The HemAcure consortium research was supported by funding from the European Commission’s Horizon 2020.
ABOUT HEMOPHILIA A
Hemophilia A is the most common form of hemophilia and is a genetic disorder caused by the reduced or
absence of FVIII, a blood clotting protein. People with hemophilia A have prolonged abnormal bleeding as a
result of trauma or surgery. While it is passed down from parents to children, about 1/3 of cases are caused by
a spontaneous change in the gene responsible for FVIII production. According to the US Centers for Disease
Control and Prevention, hemophilia A occurs in about 1 in 5,000 male births. Prolonged bleeding in high-risk
areas such as the brain can be catastrophic, while persistent bleeding in joints results in permanent damage
making joint replacement surgery common and risky procedures among these patients. Approximately 115,000
people in North America and Europe have hemophilia A. Although there is no cure for the disease, hemophilia
A can be controlled with medications to supplement or replace the missing FVIII. Annual worldwide costs for
the treatment of the disease for each patient may range from $60,000 to $260,000 US for an aggregate
therapeutic cost of approximately $15B per year.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
ABOUT HORIZON 2020 PROGRAM AND HEMACURE
Horizon 2020 was the biggest EU Research and Innovation program ever with nearly €80 billion of funding
available over seven years (2014 to 2020). It promised more breakthroughs, discoveries and world-firsts by
taking great ideas from the lab to the market. The project was funded as part of societal challenges
“personalizing health and care” in a specific call about innovative treatments and technologies. The overall
objective of the HemAcure project was to develop and refine the tools and technologies for a novel ex vivo
prepared cell-based therapy to treat the bleeding disease, hemophilia A (caused by a genetic deficiency in
clotting Factor VIII (FVIII)) that should ultimately lead to improved quality of life of the patients. The European
Union's Horizon 2020 research and innovation program awarded approximately €5.5 million (CDN$8.5) to
support the project. International consortium members included the University Hospital Würzburg
(Coordinating Institute), Germany; IMS - Integrierte Management, Heppenheim, Germany; Università del
Piemonte Orientale “Amedeo Avogadro,” Novara, Italy; Loughborough University, Loughborough, United
Kingdom; ARTTIC International Management Services, Munich, Germany and Sernova Corp., London, Ontario,
Canada. This project received funding from the European Union’s Horizon 2020 Research and Innovation
Programme under grant agreement No 667421. The Consortium worked together to provide sets of design and
manufacturing protocols, based on current European GMP regulations to prepare an Investigational Medicinal
Product Dossier (IMPD) for an Investigational Medicinal Product (IMP), composed of therapeutic cells and an
implantable medical device (Sernova’s Cell Pouch).
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - January 27, 2022 27 January, 2022
Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System™ Therapeutic Approach for Treatment of Thyroid Disease
Sernova prepares for clinical trial of new treatment for post-operative hypothyroidism
LONDON, ONTARIO – January 27, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for chronic diseases including type 1 diabetes (T1D) is pleased to announce publication of a peer
reviewed preclinical study demonstrating positive results of a novel Cell Pouch System™ cell therapy approach
to treat hypothyroidism and potentially avoid lifelong dependence on thyroid medication following surgical
removal of the thyroid gland.
The journal article entitled “Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell
Pouch™ device in a Mus musculus model: Evidence of viability and function for thyroid transplantation,” by
lead author, Dr. Sam M. Wiseman was published in the prestigious scientific journal, PLOS ONE, January 20,
2022. In this study, thyroid tissue from patients undergoing surgery for treatment of benign disease was
transplanted into Sernova Cell Pouches that had been previously implanted into laboratory mice. The aim of
the study was to investigate the long-term survival of human thyroid tissue in the Cell Pouch and evaluate the
ability of these thyroid transplants to release thyroid hormones into the bloodstream. The study confirmed that
the human thyroid tissue transplanted into the Cell Pouch survived and released human thyroglobulin into the
bloodstream, with no adverse effects for the three-months duration of the study. Thyroglobulin was used as a
biomarker efficacy measure in this study as it is the precursor of thyroid hormones.
“I’m very excited about this study because it represents a critical first step towards a future where we can offer
our patients a treatment option that allows for preservation of their thyroid function with avoidance of
postoperative hypothyroidism, its many associated morbidities and life-long dependence on thyroid
medication,” commented Sam M. Wiseman BSc, MD, FRCSC, FACS.
Dr. Philip Toleikis, President and CEO Sernova Corp stated, “For hypothyroid disease, these data support the
potential of our Cell Pouch to allow for a recovery of the natural thyroid hormone feedback system following
thyroidectomy, restoring thyroid hormone levels without the risks and side effects associated with hormone
replacement drugs. This could provide life-changing options for the more than 150,000 patients who undergo
a thyroidectomy in the US, alone, each year. These preclinical data are consistent with our findings utilizing the
Cell Pouch in the treatment of T1D and Hemophilia A. We believe the Sernova Cell Pouch System therapeutic
approach could provide a ‘functional cure’ for millions of patients who suffer from afflictions caused by the
absence of systemic proteins or hormones.”
Sernova Corp., with Dr. Wiseman as clinical investigator, is preparing regulatory documents to proceed with a
Phase 1/2 human clinical trial in subjects undergoing thyroid surgery. In this study, the subjects will be
implanted with the Cell Pouch to create the vascularized tissue environment several weeks prior to transplant
of their healthy thyroid tissue. The objective of the study is to assess the safety and efficacy of the Cell Pouch
transplanted tissue, with efficacy measured as recovery of thyroid hormone in the bloodstream. The Company
expects to submit a clinical trial application within 2022.
The thyroid gland produces hormones that regulate metabolism within a narrow functional range. Thyroid
hormone replacement drugs are frequently used to treat insufficient or absent thyroid activity. Optimization of
thyroid hormone replacement medications can be difficult with dose adjustments requiring frequent lab tests
to reach appropriate levels. Thyroid hormone replacement therapy is associated with several side-effects
including impaired cognition, lethargy, and weight gain, leading to diminished quality of life, and incurring
significant ongoing costs to the patient and healthcare system.
ABOUT THYROID DISEASE
Surgical removal of the thyroid gland, or thyroidectomy, is commonly performed for management of thyroid
cancers, and for treatment of benign (non-cancerous) diseases that include nodules, goitre, and
hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the U.S. annually, with
most individuals undergoing thyroid surgery eventually being diagnosed with benign conditions. Some patients
undergoing partial thyroidectomy and all patients undergoing total thyroidectomy require life-long oral
postoperative thyroid hormone replacement treatment.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, thyroid disease and other diseases treated
through cellular production of proteins or hormones missing or in short supply within the body. For more
information, please visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans. Sernova is currently conducting a Phase 1/2 study at the University of
Chicago. Positive initial results have been presented at several international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - February 24, 2022 24 February, 2022
Sernova Corp Ranks Among Top 50 Performing Companies on the 2022 TSX Venture List
Sernova awarded top performer status for two years standing
February 24, 2022 7:30 a.m. EST
LONDON, ONTARIO – February 24, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company focused on developing a potential
‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce that that it has
been named as one of the top 50 performers on the TSX Venture Exchange.
The 2022 TSX Venture Top 50 is a ranking of top performers on the TSX Venture Exchange over the last year
based on three equally weighted criteria: share price appreciation, average trading volume and market
capitalization growth.
“We are honored by the TSX Venture Exchange recognition of Sernova as a 2022 Top 50 recipient company.
Being awarded this title two years in a row is strong validation of our persistent dedication to increasing
shareholder value as we continue to deliver on our strategic plan to build a leadership position in the
regenerative medicine cell therapy therapeutics field. In 2022, we look forward to driving continued success
through, evolving our clinical programs, further developing our pharmaceutical partnerships and by advancing
our capital market initiatives,” said Dr. Philip Toleikis, Chief Executive Officer of Sernova.
As part of the award, the TSX Venture Exchange sponsored a Q&A highlight interview with Dr. Toleikis. To view
the video, please https://share.vidyard.com/watch/dsfSgoQyYi87x8pj8oUEz6
and for the complete list of 2022 TSX Venture 50 companies.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device
upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the
transplantation and function of therapeutic cells, which then release proteins and hormones as required to
treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
I/II study at the University of Chicago. Positive initial results have been presented at several international
scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - March 17, 2022 17 March, 2022
Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova’s Cell Pouch System™ in Patients with Type-1 Diabetes
Confirms Ongoing Safety and Tolerability of Sernova’s Cell Pouch
March 17, 2022 10:00 a.m. EDT
LONDON, ONTARIO – March 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that the Data
Safety Monitoring Board ("DSMB") has completed the third annual review of Sernova’s ongoing Phase 1/2
clinical study “Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch for Clinical Islet Transplantation”
in patients with Type-1 Diabetes (T1D) who suffer from hypoglycemia unawareness and severe hypoglycemic
events.
In their assessment, the DSMB recommended that the clinical study should continue according to the study
plan.
The DSMB is an independent committee of clinical experts who review the accumulated trial data to evaluate
patient safety and ensure the integrity of the study data.
“This recommendation from the DSMB affirms our understanding of the safety of Cell Pouch in this patient
population transplanted with human donor islets. We look forward to sharing updates from the study through
upcoming conference presentations by Dr. Piotr Witkowski, the trial Principal Investigator.” said Dr. Philip
Toleikis, President & CEO of Sernova Corp.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For
more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.
ABOUT HYPOGLYCEMIA UNAWARENESS
Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they
become severe enough to be incapacitating or even fatal, which may occur when blood glucose levels are
below 3.0 mmol/L. It is estimated that approximately 15% of people with T1D, or approximately 240,000
people, are affected by hypoglycemia unawareness in the US alone.
Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and
personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care
and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure,
coma, or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.
ABOUT SERNOVA
Sernova is developing regenerative medicine cell therapeutic solutions using a medical device (Cell Pouch) and
immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-
derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as
insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular
production of proteins or hormones missing or in short supply within the body. For more information, please
visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro-
encapsulation device solution designed for the long-term survival and function of therapeutic cells. After
implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the
transplantation and function of therapeutic cells, that release proteins and hormones as required to treat
disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several
international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeScience Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - May 17, 2022 17 May, 2022
Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a 'Functional Cure' for Diabetes
• Partnership Leverages Sernova’s Proprietary Cell Pouch System™ with Evotec’s iPSC-Based Insulin-
Producing Beta Cells
• Partners to Develop and Commercialize an Off-The-Shelf Cell Replacement Therapy for Treatment of
Patients with Insulin-Dependent Diabetes
• Evotec to Make Strategic Equity Investment of CAD $27 M / €20 M in Sernova
• Sernova / Evotec Joint Conference Call and Webcast at 8:30 am EDT May 17, 2022
LONDON, ONTARIO – May 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a
clinical-stage company and leader in regenerative medicine cell therapeutics, and Evotec SE (FSE: EVT;
NASDAQ: EVO), a global pharmaceutical and life science company, and leading developer of iPSC cell
technologies for therapeutic applications, are pleased to announce an exclusive global strategic partnership to
develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes. The two
Companies will combine and leverage their respective technologies and scientific expertise to develop an
implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited
insulin-producing cell source to treat patients with insulin-dependent diabetes.
The collaboration agreement is a transformative partnership that combines Sernova’s Cell Pouch System
technologies, which has demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with
Evotec’s iPSC-based beta cells. Incorporating Evotec’s insulin-producing, ethically-derived beta cells within
Sernova’s Cell Pouch platform creates the potential to provide a ‘functional cure’ for millions of people
suffering from diabetes using a cGMP controlled and scalable off-the-shelf product.
With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably
produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary
process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like
clusters have now been proven to be functionally equivalent to primary human islets in their ability to
normalize blood glucose using in vivo models of type 1 diabetes (T1D).
The partnership provides Sernova a global exclusive option to license Evotec’s iPSC-based beta cells for use in
treating both type 1 and type 2 diabetes. In addition to entering into the collaboration agreement, Evotec has
made a strategic equity investment of €15M and will make a further investment of €5M. Specifically,
concurrently with the entering into the collaboration agreement, Evotec acquired a total of 12,944,904
common shares at a price of CAD $1.57 per share for gross proceeds to Sernova of $20,323,500. In addition,
pursuant to an unconditional purchase warrant, Evotec will acquire, on or before August 31, 2022, a further
2,709,800 common shares at a price of CAD$2.50 per share for gross proceeds of $6,774,500. All of the
securities issued to Evotec are subject to a four month hold period.
Further to the collaboration and Evotec’s strategic equity investment, Dr. Cord Dohrmann, Chief Scientific
Officer of Evotec will join Sernova’s Board of Directors.
Dr. Philip Toleikis, President, and Chief Executive Officer of Sernova, commented, “In tandem with our current
clinical islet cell program, Sernova entered into multiple pharmaceutical research collaborations to identify the
highest quality and most compatible iPSC cell technology, and validate the cells preclinically within our Cell
Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to
developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense,
both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and Dr.
Dohrmann’s appointment to Sernova’s Board adds significant regenerative medicine depth and cell therapy
expertise. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our
diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired
conformal coating immune protection technology, this now establishes a total regenerative medicine cell
therapy solution for insulin-dependent diabetes.”
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “We searched long and hard for the right
partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch™ technology, which fits
perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta
cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-
dependent diabetic patients. The synergies of Evotec’s and Sernova’s technologies puts Sernova in position to
become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic
interest in this collaboration with Sernova. I am very much looking forward to collaborating with Sernova on
the project as well as contributing to their Board of Directors.”
Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell
(iPSC)-based Beta cells to treat patients with insulin-dependent diabetes. From an operational perspective,
the preclinical development program(s) will be jointly funded by Sernova and Evotec until IND acceptance.
Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will
contribute its cell manufacturing capabilities through research, development and product commercialization
and will decide in the future on the joint funding of clinical development. Upon commercialization, there will
be a profit-sharing arrangement between the two companies, with the split being dependent on Evotec’s
participation in funding the clinical development program.
Joint Sernova / Evotec Conference Call and Webcast Details:
Date: Tuesday, May 17, 2022
Time: 8:30 am EDT
US Toll Free: 1-877-704-4453
International: 1-201-389-0920
Conference ID: 13730121
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d
A simultaneous slide presentation will be available via the above webcast link.
ABOUT SERNOVA CORP AND THE CELL POUCH SYSTEM CELL THERAPY PLATFORM
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body.
The Cell Pouch, as part of the Cell Pouch System, is a proprietary, scalable, implantable macro- encapsulation
device solution designed for the long-term survival and function of therapeutic cells. After implantation, the
device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation
and function of therapeutic cells, that release proteins and hormones as required to treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
For more information, please visit www.sernova.com
ABOUT EVOTEC AND iPSC
Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be
generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto,
Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could
convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John
Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem
cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well
as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they
represent a single source of cells that could be used to replace those lost to damage or disease.
Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated
iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to
industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the
highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s
proprietary EVOcells platform.
For further information contact:
Corporate and Investors:
Sernova Corp
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, MD
LifeSci Communications
emiller@lifescicomms.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees
of future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials, and the development of new technologies, cell therapy solutions and or products. The information
disclosed represents results from one patient and may not be representative of all study patients or of the final
study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking
statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - May 24, 2022 24 May, 2022
Sernova Receives Conditional Approval to Up-list to the Toronto Stock Exchange
London, Ontario – May 24, 2022 – Sernova Corp. (TSX-V:SVA; OTCQB:SEOVF; FSE/XETRA:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that it has
received conditional approval to list its common shares on the Toronto Stock Exchange (the "TSX") and move
off of the TSX Venture Exchange ("TSXV").
Final approval of the listing is subject to the Company meeting certain customary conditions required by the
TSX. The company will issue a press release once the TSX confirms the date when trading of Sernova’s
common shares is expected to commence on the TSX. Upon completion of the final listing requirements,
Sernova’s common shares will be delisted from the TSXV.
Dr. Philip Toleikis, President and CEO of Sernova Corp commented, “Moving onto the Toronto Stock Exchange
represents a milestone achievement in our evolution as an emerging regenerative medicine company. Up-
listing will provide enhanced liquidity and bring new visibility and investors into the company as we advance
our therapeutic cell therapy platform with the goal to provide ‘functional cures’ for multiple diseases including
type one diabetes, hemophilia and thyroid disease.”
Shareholders are not required to exchange their share certificates or take any other action in connection with
the TSX listing, as there will be no change in the trading symbol or CUSIP for the common shares. The
Company will continue to trade its common shares on the OTCQB market in the United States under the
symbol "SEOVF", and the Frankfurt exchange under the symbol "PSH".
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY
Sernova Corp. is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body.
The Cell Pouch™ is a proprietary, scalable, implantable macro- encapsulation device solution designed for the
long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue,
forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells,
that release proteins and hormones as required to treat disease.
The Cell Pouch along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
For more information, please visit www.sernova.com
For further information contact:
Corporate and Investors:
Sernova Corp.
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, MD
LifeSci Communications
emiller@lifescicomms.com
Neither the TSXV nor the TSX accepts responsibility for the adequacy or accuracy of this news release.
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials, and the development of new technologies, cell therapy solutions and or products. The information
disclosed represents results from one patient and may not be representative of all study patients or of the final
study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking
statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - June 01, 2022 1 June, 2022
SERNOVA SHARES TO COMMENCE TRADING ON TSX ON JUNE 2, 2022
June 1, 2022 6:00 a.m. EDT
London, Ontario – June 1, 2022 – Sernova Corp. (TSX-V:SVA; OTCQB:SEOVF; FSE/XETRA:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that its common
shares have been approved for listing on the Toronto Stock Exchange (the "TSX") and will commence trading
on the TSX at the opening of market on June 2, 2022. Concurrent with the TSX listing, the common shares of
the Company will be delisted from the TSX Venture Exchange.
Shareholders are not required to exchange their share certificates or take any other action in connection with
the TSX listing, as there will be no change in the trading symbol or CUSIP for the common shares. The
Company will continue to trade its common shares on the OTCQB market in the United States under the
symbol "SEOVF", and the Frankfurt exchange under the symbol "PSH".
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY
Sernova Corp. is developing regenerative medicine therapeutic technologies using a medical device and
immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived
cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-
dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of
proteins or hormones missing or in short supply within the body.
The Cell Pouch™ is a proprietary, scalable, implantable macro- encapsulation device solution designed for the
long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue,
forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells,
that release proteins and hormones as required to treat disease.
The Cell Pouch along with therapeutic cells, has been shown to provide long-term safety and efficacy in small
and large animal models of diabetes and has been proven to provide a biologically compatible environment for
insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase
1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several
international scientific conferences.
For more information, please visit www.sernova.com
For further information contact:
Corporate and Investors:
Sernova Corp.
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, MD
LifeSci Communications
emiller@lifescicomms.com
Neither the TSXV nor the TSX accepts responsibility for the adequacy or accuracy of this news release.
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not
historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”,
“believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions
“will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in
such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of
future performance, and actual results may differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on
the date such statements were made, which include our beliefs about the conduct and outcome of clinical
trials, and the development of new technologies, cell therapy solutions and or products. The information
disclosed represents results from one patient and may not be representative of all study patients or of the final
study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking
statements whether as a result of new information, future events or otherwise.
Press Release Communiqué de presse - June 06, 2022 6 June, 2022
Sernova Announces Positive Updated Phase 1/2 Clinical Data on Cell Pouch System™ at American Diabetes Association 82nd Scientific Sessions 2022
• Researchers from the Dr. Piotr Witkowski Laboratory at the University of Chicago presented updated data
on six patients with type 1 diabetes and hypoglycemia unawareness
• The first three patients have been insulin independent for over 2 years, 6 months, and 3 months,
respectively
• Those first three patients with islets transplanted into the Cell Pouch™ subsequently presented positive
serum C-peptide values confirming active insulin production by the Cell Pouch islet grafts
• The Cell Pouch was well tolerated with implant durations exceeding 35 months
LONDON, Ontario – June 6, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, today announced the presentation of
clinical data from its Phase 1/2 clinical trial supporting the potential of its proprietary Cell Pouch System to
provide a ‘functional cure’ for insulin-dependent diabetes. The updated data from the ongoing study being
conducted by Piotr Witkowski, M.D., Ph.D. at the University of Chicago, were presented as an oral podium
presentation at the American Diabetes Association (ADA) 82nd Scientific Sessions, held from June 3-7, 2022, at
the Ernest N. Morial Convention Center in New Orleans, LA.
The presented data, from the Dr. Piotr Witkowski Laboratory at the University of Chicago, reviewed the six
patients who lived with long-standing insulin-dependent type 1 diabetes (T1D) and hypoglycemia unawareness
prior to study treatment who underwent both Cell Pouch implantation and islet transplantation. Graft function
was measured by blood glucose, patient insulin usage, and C-peptide, a widely used measure of islet function.
The first three patients achieved complete and sustained insulin independence. Three additional patients on
study did not maintain optimal immunosuppression, which has now been resolved enabling those patients to
receive further protocol-defined islet transplants.
Key findings from interim clinical update:
• Surgical implantation of the Cell Pouch was found to be generally well tolerated with a favorable safety
profile
• All patients who had favorable immunosuppression achieved complete insulin independence
o The first three transplanted patients presented positive serum C-peptide values confirming active
insulin production after islet transplantation into the Sernova Cell Pouch
o Supplemental marginal dose islet transplantation via the portal vein was sufficient to allow those
three patients to achieve and maintain insulin independence for over 2 years, 6 months, and 3
months, respectively
o Insulin independent patients have HbA1c in the normal range: 5.0, 5.2, and 5.2%, respectively
• Dr. Witkowski further optimized outcomes in the ongoing clinical trial:
o Replacing patients’ own plasma with serum as the islet suspension medium
o Decreasing the concentration of islet suspensions transplanted to Cell Pouch resulted in greater
stimulated C-peptide
o The Cell Pouch implantation procedure was optimized with two shorter incisions to minimize
infection risk and enhance healing
o Implementing a higher capacity Cell Pouch System, that has been developed by Sernova, will
provide approximately 50% more volume to accommodate more islets at the optimal
concentration for use in future implantation procedures
“Despite some advances in the diabetes space, insulin-dependent diabetes patients continue to require
numerous injections daily, and for those with hypoglycemia unawareness, it can be increasingly life threatening.
We are committed to developing a ‘functional cure’ to potentially free patients from the life-limiting burdens of
this disease,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “We are encouraged by
the data demonstrating our Cell Pouch System has been well tolerated and multiple patients remain insulin
independent. We remain on track to further dose the three aforementioned subjects and to implement the
higher capacity Cell Pouch System in the next implanted patients.”
The incidence of T1D in the U.S. (in ages 0 to 64 years) is estimated to be 64,000 cases annually, with a
predicted prevalence of 5 million people by 2050 (1,2). The annual direct cost of healthcare expenditures and
lost income from T1D has been estimated as $16 billion (3). Sernova’s Cell Pouch System is designed to
address this vastly expanding need by providing a ‘functional cure’ for the millions of people afflicted by
insulin-dependent diabetes worldwide. Sernova is also addressing the life-threatening complication of
hypoglycemia unawareness (HU) in patients with T1D. HU is a person’s inability to recognize the symptoms of
low blood sugar before it becomes severe enough to be incapacitating or even fatal. About 1 in 5 people with
T1D report experiencing hypoglycemia unawareness (4).
Dr. Piotr Witkowski, Director of Pancreatic Islet Transplantation Program at University of Chicago and study
Principal Investigator added, “The data coming out of the Cell Pouch and islet transplantation trial show
incredible promise for insulin-dependent diabetes patients. I am excited about the potential impact on the field
and look forward to seeing continued progression of the data from this trial.”
Sernova recently entered into a global strategic partnership with Evotec A.G., a Nasdaq listed biotechnology
company, to develop an implantable off-the-shelf induced pluripotent stem cell (iPSC) -based beta cell
replacement therapy, which will provide Sernova with an unlimited supply of insulin-producing cells,
circumventing any potential future islet supply issues. Sernova is also working to eliminate the need for chronic
immunosuppression with cell transplants by incorporating technology developed by Dr. Alice Tomei’s
laboratory at the University of Miami, to protect cells from immune system recognition.
For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).
1. Rogers MAM, Kim C, Banerjee T, Lee JM. Fluctuations in the incidence of type 1 diabetes in the United
States from 2001 to 2015: a longitudinal study. BMC Med. 2017;15(1):199. Published 2017 Nov 8.
doi:10.1186/s12916-017-0958-6
2. Dabelea D, Mayer-Davis EJ, Saydah S, et al. Prevalence of type 1 and type 2 diabetes among children and
adolescents from 2001 to 2009. JAMA. 2014;311(17):1778-1786. doi:10.1001/jama.2014.3201
3. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care.
2018;41(5):917-928. doi:10.2337/dci18-0007
4. Reno CM, Litvin M, Clark AL, Fisher SJ. Defective counterregulation and hypoglycemia unawareness in
diabetes: mechanisms and emerging treatments. Endocrinol Metab Clin North Am. 2013;42(1):15-38.
doi:10.1016/j.ecl.2012.11.005
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic
technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders
like hemophilia A. Sernova is currently focused on finding a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell-Pouch SystemTM, a novel implantable and scalable medical device which forms a
natural environment in the body for long-term survival and function of therapeutic cells that release necessary
proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already
shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase I/II study
at the University of Chicago. Sernova is also working on technology with the University of Miami to cloak the
implant from the immune system, to eliminate the need for immunosuppressives to protect the cells from
immune system attack. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop
an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This
partnership provides Sernova an unlimited supply of insulin-producing cells to treat millions of patients with
insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two programs
that utilize its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid
gland removal and an ex-vivo lentiviral factor 8 gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - September 01, 2022 1 September, 2022
Sernova Receives Second Tranche Equity Investment from Evotec of $6.8 Million at a Price of $2.50 Per Share
LONDON, Ontario – September 1, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/ XETRA:PSH), a
clinical-stage company and leader in regenerative medicine cell therapeutics, today announced that it has
completed the second and final tranche of its previously announced private placement with Evotec SE
(FSE:EVT) (NASDAQ: EVO) of 2,709,800 common shares of the Company (“Common Shares”) at a price of
$2.50 per share for total proceeds of $6,774,500. Upon completion of the second tranche, Evotec’s strategic
investment in Sernova totals $27,098,000.
“Evotec’s investment at $2.50 per share, significantly more than double yesterday’s closing price, reflects the
value our strategic partner places on Sernova relative to the current trading price on the TSX,” commented Dr.
Philip Toleikis, President and CEO of Sernova Corp. “The dedication and synergy of our mutual teams to
advance the iPSC diabetes program expeditiously has been impressive. We remain confident that our
combined product strategy could dramatically impact the day to day lives of millions of people and their
families worldwide with diabetes. With $50 million on our balance sheet, including Evotec’s additional
investment and recent significant exercises of outstanding warrants, Sernova is well positioned to expedite the
advancement of our iPSC diabetes stem cell initiative with Evotec and other regenerative cell therapy programs
which we envision having a significant valuation impact.”
Sernova will use the net proceeds from the Common Shares for general working capital purposes and to
continue pursuing ‘functional cures’ for diabetes, hypothyroidism and hemophilia A. The Common Shares are
subject to a statutory four month hold period.
Warrants Update
In addition to the Evotec private placement share issuances, 14,814,535 common shares have been issued for
the exercise of warrants for proceeds totaling $4,493,587 since the end of the Company’s last filed fiscal
quarter (April 30, 2022). All warrants with expiry dates of August 16, August 30, and September 9, 2022 have
been fully exercised by the warrant holders. Of the warrants previously issued expiring September 22, 2022, to
date a total of 2,382,954 have been exercised by the warrant holders. If the remaining outstanding warrants
are fully exercised by September 22, 2022, additional proceeds of approximately $3.5 million will be received
and further bolster the Company’s cash reserves.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic
technologies for chronic diseases, including diabetes, thyroid disease, and blood disorders including
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for diabetes with its regenerative
cell therapy platform technologies, including its proprietary Cell Pouch™. On implantation, the Cell Pouch
forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic
cells that release necessary proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell
Pouch System has already shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in
an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing its proprietary
conformal coating technology in collaboration with the University of Miami to cloak the therapeutic cells from
the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022,
Sernova and Evotec entered into a global strategic collaboration to develop an implantable off-the-shelf iPSC-
based (induced pluripotent stem cells) beta cell replacement therapy. This collaboration potentially provides
Sernova an unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent
diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two additional programs that utilize
its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid gland
removal and an ex-vivo lentiviral factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - November 03, 2022 3 November, 2022
Sernova Receives Authorization to Enroll Second Patient Cohort of Phase 1/2 Trial with Cell Pouch System™ for Type 1 Diabetes
Sernova plans to begin enrollment of second cohort in the coming weeks and implant multiple patients with the
enhanced capacity 10-channel Cell Pouch before the end of 2022
Positive interim results from patients in the first cohort informed the islet dose and density threshold
optimizations for the second cohort
Expedited enrollment is anticipated with Sernova’s engagement of an experienced clinical trial patient
recruitment agency and the Company expects to report interim data in 2023
Results from the combined cohorts will help guide the design of Sernova’s pivotal study, which would support
an anticipated BLA submission to the US FDA and accelerate our iPSC stem cells into the clinic
LONDON, Ontario – November 3, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, is pleased to announce, in conjunction with the
advancement of its ongoing Phase 1/2 clinical trial of the Sernova Cell Pouch System™ for patients with type 1
diabetes (T1D) who suffer from hypoglycemia unawareness (the “T1D Study”), the approval of a protocol
amendment by the University of Chicago Institutional Review Board (IRB) and no objections from FDA, allowing
the Company to proceed with a strategically optimized protocol reducing the time required for patient
treatment while accelerating potential secondary endpoint efficacy achievement with more optimal dosing.
Following promising interim results from the first six patients of Sernova’s active T1D Study, the protocol
amendment enables the testing of a small second cohort of up to seven patients, to evaluate the Company’s
optimized 10-channel Cell Pouch™, which provides 50% more islet capacity compared to the 8-channel Cell
Pouch used to date for the T1D Study. Study data from the first six patients formed the basis for the amended
optimized treatment plan for the additional new cohort of patients. Results from the combined cohorts will
help guide the design of Sernova’s pivotal study, supporting an anticipated BLA submission to the US FDA.
With the protocol amendment, enrollment of the first cohort of patients has concluded and patient enrollment
for the new second cohort will begin. The first three patients of the first cohort with completed islet transplants
have achieved insulin independence and the remaining three are progressing towards completion of the
treatment regimen. Data from these first patients has enabled Sernova to determine dose thresholds and islet
concentrations intended to optimize endogenous insulin production in treated patients. Furthermore, safety
observations to date support reducing the time between Cell Pouch islet transplants from 180 to 90 days,
which substantially reduces the overall treatment period in the amended protocol update. To expedite rapid
enrollment of the second cohort, Sernova has engaged a clinical trial patient recruitment partner with extensive
experience and success in accelerating T1D clinical trial patient enrollment.
“Sernova is committed to developing a potential ‘functional cure’ with the goal of freeing patients from the life-
limiting burdens of T1D and dramatically enhancing their quality of life,” said Dr. Philip Toleikis, President and
Chief Executive Officer. “We are pleased with the positive interim results demonstrating that the Cell Pouch
System is well tolerated, reduces or eliminates the frequency of severe hypoglycemic events and continues to
contribute to durable insulin independence among patients. Based on our now expanded recruitment activities
and efforts, we anticipate implanting multiple patients before the end of 2022. The results from these
additional patients will directly contribute to our pivotal T1D trial design and help accelerate entry into the
clinic with our iPSC stem cell derived islet technology in conjunction with our Evotec partnership that is
progressing ahead of our expectations.”
ABOUT PHASE 1/2 STUDY SECOND COHORT
The Phase 1/2 study (NCT03513939) is an open-label single-arm trial to assess the safety, tolerability, and
efficacy of Sernova’s Cell Pouch System for clinical transplantation of human donor islets in patients with T1D.
Six patients were transplanted in the first cohort utilizing the 8-channel Cell Pouch System and interim data
have been previously reported by Dr. Piotr Witkowski and his colleagues. With the expansion into the second
cohort utilizing the 10-channel Cell Pouch System, patient eligibility criteria remain unchanged and includes
those aged 18-65 with T1D who suffer from both hypoglycemic unawareness and severe hypoglycemic
episodes, and who are eligible for donor islet transplantation. Eligible trial patients have had at least one
episode of severe hypoglycemia in the previous 12 months and an absence of stimulated C-peptide (a marker
of insulin production by the body) in response to a mixed meal tolerance test.
Islets are transplanted into the Cell Pouch approximately six weeks after Cell Pouch implantation to allow
development of fully vascularized native tissue chambers and achieve a stable immunosuppressant regimen. At
90 days post-islet transplant, safety and efficacy are assessed prior to initiating a second transplant of islets.
At 90 days following each patient’s second islet transplant to Cell Pouch, safety and efficacy endpoints are
evaluated again. Trial patients who remain dependent on insulin for at least 6 months following the second islet
transplant to Cell Pouch may be eligible for a third supplemental islet transplant via the portal vein.
Patients who elect to retain their implants will be followed for up to 3 years after the final islet transplant to
Cell Pouch. Multiple transplanted patients from the first cohort have implant durations of more than 3 years
and none have elected to have their Cell Pouch implants removed.
The primary objective of the Phase 1/2 study is safety and tolerability. Secondary objectives include the
following efficacy endpoints: production of C-peptide, insulin use, HbA1c, and frequency of hypoglycemic
events.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative therapeutic cell
technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders
that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent
diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with
immune protected therapeutic cells. On implantation, The Cell Pouch™ forms a natural vascularized tissue
environment in the body for long-term survival and function of therapeutic cells that release essential factors
that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System
has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical
study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: An implantable cell therapy
for benign thyroid disease resulting from thyroid gland removal; and an ex-vivo lentiviral Factor VIII gene
therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and/or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - November 17, 2022 17 November, 2022
Sernova Announces First Two Patients Implanted with Cell Pouch™ in the Second Cohort of its US Phase 1/2 Clinical Trial for Type 1 Diabetes
- Company’s recent recruitment strategy change has resulted in an unprecedented level of inquiries
regarding potential study participation
- Transplantation of islets into the enhanced 10-channel Cell Pouch is anticipated in early 2023
- Company continues to anticipate first interim safety/efficacy data from second cohort in 2023
LONDON, Ontario – November 17, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the
second cohort of its active U.S. Phase 1/2 type 1 diabetes (T1D) clinical trial have been implanted with its 10-
channel Cell Pouch, which provides >50% more capacity relative to the Cell Pouches used for the first cohort.
The transition to this new 10-channel Cell Pouch under the revised protocol enables optimized dosing and
shorter efficacy evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints
include survival of transplanted islet cells, reduction of severe hypoglycemic episodes, changes in HbA1c,
increased C-peptide production, and reduction in insulin requirements.
Sernova has engaged a clinical trial recruitment partner with extensive experience and success in accelerating
T1D clinical trial patient enrollment. The second cohort of the study is intended to enroll up to seven patients
with insulin dependent T1D who also suffer from severe hypoglycemic episodes and hypoglycemia
unawareness. The Company anticipates reporting interim data in 2023. Results from the combined cohorts
will inform the design of Sernova’s anticipated Phase 3 T1D pivotal study.
“Our drive to liberate individuals suffering with type 1 diabetes from the burden of daily insulin injections has
been strengthened by the safety and efficacy observations in the first cohort of patients in our Phase 1/2 study,
and we are pleased to have commenced the treatment phase for the second cohort,” said Dr. Philip Toleikis,
President and Chief Executive Officer of Sernova. “We believe the new 10-channel Cell Pouch configuration
provides for optimal dosing of islets towards achievement of a potential ‘functional cure’. We look forward to
reporting interim data from the second cohort in 2023. Planning and preparations are underway for the pivotal
trial program, while we advance our iPSC-derived islet program into the clinic in collaboration with Evotec.”
ABOUT THE US PHASE 1/2 SECOND STUDY COHORT
The US Phase 1/2 study (NCT03513939) is an open-label single-arm trial to assess the safety, tolerability, and
efficacy of Sernova’s Cell Pouch System™ for clinical transplantation of human donor islets in patients with
T1D. Six patients were transplanted in the first cohort utilizing the 8-channel Cell Pouch System and interim
data have been previously reported by Dr. Piotr Witkowski and his colleagues. With the expansion into the
second cohort utilizing the 10-channel Cell Pouch System, patient eligibility criteria remain unchanged and
includes those aged 18-65 with T1D who suffer from both hypoglycemic unawareness and severe
hypoglycemic episodes, and who are eligible for donor islet transplantation. Eligible trial patients have had at
least one episode of severe hypoglycemia in the previous 12 months and an absence of stimulated C-peptide
(a marker of insulin production by the body) in response to a mixed meal tolerance test.
Islets are transplanted into the Cell Pouch approximately six weeks after Cell Pouch implantation to allow
development of fully vascularized native tissue chambers and achieve a stable immunosuppressant regimen.
At 90 days post-islet transplant, safety and efficacy are assessed prior to initiating a second transplant of
islets. At 90 days following each patient’s second islet transplant to Cell Pouch, safety and efficacy endpoints
are evaluated again. Trial patients who remain dependent on insulin for at least 6 months following the second
islet transplant to Cell Pouch may be eligible for a third supplemental islet transplant via the portal vein.
Patients who elect to retain their implants will be followed for up to 3 years after the final islet transplant into
the Cell Pouch. Multiple transplanted patients from the first cohort have implant durations of more than 3
years and none have elected to have their Cell Pouch implants removed.
The primary objective of the Phase 1/2 study is safety and tolerability. Secondary objectives include the
following efficacy endpoints: production of C-peptide, insulin use, HbA1c and frequency of hypoglycemic
events.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are
absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for
hypothyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for
hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - January 10, 2023 10 January, 2023
Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diabetes
- First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards
regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D)
and severe hypoglycemia
- iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation
for first human clinical evaluation
- T1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now
demonstrated consistent long-term insulin independence de-risking the combined technologies for both
companies
LONDON, Ontario – January 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, announced today that significant progress has been
achieved in its collaboration with Evotec SE (FSE: EVT; NASDAQ: EVO). This progress includes advancement
of Evotec’s iPSC derived islet-like clusters in combination with Sernova’s implantable Cell Pouch™ device
toward a first-in-human Phase 1/2 clinical trial for the treatment of patients with T1D and severe
hypoglycemia slated for regulatory filing in 2024. The objective of the collaboration is to produce an off the-
shelf, commercially viable, ethically derived cell therapy treatment for people suffering from T1D. The
treatment would include Sernova’s Cell Pouch System™ incorporating Evotec’s iPSC-derived islet-like
clusters. The combination product is anticipated to be the first treatment of its kind to reach clinical testing
for T1D.
The Evotec and Sernova collaboration has to date resulted in the following significant achievements:
- Development of a robust, cost-efficient, scalable, highly controlled iPSC differentiation protocol with the
ability to cryopreserve and store batches of differentiated islet-cell clusters
- Demonstration of excellent islet-like cluster survival under standard shipping conditions and following
transplantation
- Demonstration of consistent long-term insulin independence with no hypoglycemic events and consistent
safety profiles in a gold standard T1D preclinical model with Evotec’s iPSC-derived islet-like clusters
transplanted in Sernova’s Cell Pouch
- iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotec’s iPSC GMP facility
are well under way in preparation for manufacture of clinical and commercial iPSC islet-like clusters supply
- Interactions with experts in support of design of the first Phase 1/2 clinical trial
Based on these achievements the following activities will be continuing throughout 2023 in preparation for
regulatory filings anticipated in 2024:
- Completion of standard formal safety/toxicology studies and other required preclinical studies
- Identification and securing of potential clinical study sites to enable efficient patient enrollment following
initiation of the Phase 1/2 clinical study
- Preparation of regulatory submissions for planned trial geographies, combining both the established library
of regulatory documentation for Sernova’s Cell Pouch and that developed by Evotec for their iPSC islet-like
clusters
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, commented, “Together Sernova and
Evotec maintain a shared, singular focus on developing the first combination product involving ethically
sourced iPSC-derived islet-like clusters within Sernova’s Cell Pouch for a type 1 diabetes functional cure
that could, conceivably, eliminate the need for daily insulin injections in patients with diabetes and
significantly reduce the burden on healthcare systems worldwide. Furthermore, we believe that Evotec’s
strategic design of its islet-like clusters to closely match human islets and the cost-efficient manufacturing
process combined with our collective approach to efficiently deliver the islet-like clusters to patients for
transplant into our Cell Pouch represents a disruptive and commercially attractive treatment, that could
one day treat people with insulin-dependent diabetes worldwide.”
Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “Evotec’s iPSC-derived human beta
cells in combination with Sernova’s implantable Cell Pouch device represent a unique cell therapy product
opportunity aiming to provide a potential functional cure to insulin-dependent diabetic patients. The
combination product is highly differentiated through the quality of the cells and the device but also the
scalability of the manufacturing process of the iPSC-derived cells and therefore clearly positioned to
become the best-in-class cell therapy in the field.”
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative therapeutic cell
technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood
disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for
insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable
medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural
vascularized tissue environment in the body for long-term survival and function of therapeutic cells that
release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases.
Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D
in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary
technology in collaboration with the University of Miami to shield therapeutic cells from immune system
attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022,
Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf
iPSC-based (induced pluripotent stem cells) islet replacement therapy. This partnership provides Sernova
a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent
diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize
its Cell Pouch System: an implantable cell therapy for benign thyroid disease resulting from thyroid gland
removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate Investors Media
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may
constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions,
including, without limitation, statements regarding the prospects, plans, and objectives of the company.
Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends",
"estimates", "projects", "potential for" and similar expressions, or that events or conditions "will",
"would", "may", "could" or "should" occur are used to identify forward-looking statements. These
statements reflect management’s beliefs with respect to future events and are based on information
currently available to management on the date such statements were made. Many factors could cause
Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended
or to differ materially from those expressed or implied by the forward-looking statements contained in
this news release. Such factors could include, but are not limited to, the company’s ability to secure
additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all
required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies,
including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on
a timely basis; ability to in-license additional complementary technologies; ability to execute its business
strategy and successfully compete in the market; and the inherent risks associated with the development
of biotechnology combination products generally. Many of the factors are beyond our control, including
those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the
company’s quarterly and annual filings available on www.sedar.com for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention
or obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
Press Release Communiqué de presse - January 30, 2023 30 January, 2023
Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy
- Preclinical proof of concept study demonstrates that thyroid auto-transplantation into the Cell Pouch can
restore thyroid hormone production following removal of the thyroid gland
- Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective
therapy for hypothyroidism
LONDON, Ontario – January 30, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, today announced advancements in its thyroid cell
therapy program – one of three cell therapy development programs utilizing the Company’s proprietary Cell
Pouch System™. In a preclinical proof of concept study, the Company demonstrated that auto-transplantation
of thyroid tissue into the Cell Pouch can compensate for removal of the thyroid gland (total thyroidectomy),
restoring normal thyroid hormone levels in an animal model.
The thyroid is a vital hormone-producing gland that is critical for metabolism and regulation of body
functions.1 Loss of thyroid function occurs following surgical removal of the gland and is associated with
memory impairment, depression, intolerance to cold, chronic fatigue, constipation, weight gain and lethargy.2
It is estimated that more than 150,000 patients in the US undergo thyroidectomies annually3, and subsequently
require lifelong thyroid hormone replacement therapy.
Despite some benefits, patients on thyroid replacement medications often experience significant impairment in
psychological well-being.4 The primary goal of Sernova’s thyroid program is to restore normal thyroid function
without life-long medication, and avoid the burden of repeated laboratory testing in patients who have
undergone thyroid surgery.
Data from Sernova’s preclinical program demonstrates that total thyroidectomy with auto-transplantation into
the Cell Pouch allows for reestablishment of production of triiodothyronine (T3) and thyroxine (T4).
The study was conducted in a pre-clinical animal model whereby the Cell Pouch was pre-implanted for several
weeks prior to each subject undergoing total thyroidectomy. The thyroid gland of each Treatment Group
subject was removed, prepared with minimal manipulation, and transplanted into the pre-implanted Cell
Pouch. Thyroid hormones were monitored over several months with weekly measurements of circulating
thyroid hormones (T3, T4). Following thyroidectomy in the Treatment Group, the T3 and T4 levels fell initially
but subsequently recovered to normal or near-normal levels following thyroid transplant into the Cell Pouch.
Control Group subjects received the Cell Pouch implant and underwent total thyroidectomy but did not receive
a thyroid transplant. In the Control Group, post-thyroidectomy T3 and T4 rapidly decreased and remained
below baseline concentrations throughout the experiment.
“Along with previously published preclinical data that reported survival and function of human thyroid tissue
transplanted into the Cell Pouch5, this preclinical study also supports the viability of Sernova’s Cell Pouch
System approach and represents an important step towards establishing an entirely new treatment option for
post-thyroidectomy hypothyroidism,” commented Dr. Sam Wiseman, BSc, MD, FRCSC, FACS.
“These findings demonstrate a further therapeutic application of Sernova’s Cell Pouch System,” said Dr. Philip
Toleikis, President and Chief Executive Officer of Sernova. “In addition to type 1 diabetes [and hemophilia],
this study shows the potential to treat the significant number of patients undergoing removal of their thyroid
glands each year. We have already begun to interact with regulatory authorities towards initiating clinical trials
with this novel therapy.”
Sernova intends to present data from the Company’s thyroid development program at a scientific conference
later this year.
References
1. InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care; How does the
thyroid gland work? 2010 Nov 17 [Updated 2018 Apr 19]. https://www.ncbi.nlm.nih.gov/books/NBK279388/
2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017; 390: 1550–1562.
https://doi.org/10.1016/S0140-6736(17)30703-1 PMID: 28336049
3. Al-Qurayshi Z, Robins R, Hauch A, Randolph GW, Kandil E. Association of Surgeon Volume With
Outcomes and Cost Savings Following Thyroidectomy: A National Forecast. JAMA Otolaryngol Head Neck
Surg. 2016;142(1):32–39. doi:10.1001/jamaoto.2015.2503
4. Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in
patients on 'adequate' doses of l-thyroxine: results of a large, controlled community-based questionnaire
study. Clin Endocrinol (Oxf). 2002 Nov;57(5):577-85. doi: 10.1046/j.1365-2265.2002.01654.x. PMID:
12390330.
5. Wiseman SM, Memarnejadian A, Boyce GK, Nguyen A, Walker BA, Holmes DT, Welch ID, Mazzuca DM,
Toleikis PM. Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch™ device
in a Mus musculus model: Evidence of viability and function for thyroid transplantation. PLoS One. 2022;
17(1): e0262345. https://doi.org/10.1371/journal.pone.0262345
ABOUT SERNOVA’S CELL THERAPY THYROID DISEASE PROGRAM
Sernova is utilizing its Cell Pouch System platform as a potential treatment for hypothyroid disease. Our
approach is to transplant a patient’s own healthy thyroid tissue following thyroidectomy into the pre-implanted
vascularized Cell Pouch to preserve the normal thyroid function and reduce or eliminate the need for lifelong
daily thyroid replacement therapy. Sernova plans to conduct clinical assessments of the Cell Pouch with
transplanted thyroid tissue in patients suffering from post-surgical hypothyroidism with the aim of preserving
thyroid function and improving patient quality of life.
Thyroidectomy is commonly performed for cancer diagnosis or treatment and for treatment of benign (non-
cancerous) disease that includes goiter and hyperthyroidism. It is estimated that about 150,000
thyroidectomies are performed in the US yearly. Patients undergoing total thyroidectomy, and many patients
undergoing partial thyroidectomy, require life-long thyroid hormone medication. Post-surgical thyroid hormone
replacement therapy, if monitored carefully, can be effective; however, patients often suffer from deleterious
side-effects including weight gain, depression, headaches, and cardiovascular disease, with resultant negative
impact on quality of life, and significant costs to the healthcare system. The development of new therapeutic
strategies to overcome hypothyroidism remains an important unmet medical need.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress a third development program that utilizes its Cell Pouch System with an ex vivo lentiviral Factor VIII
gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - March 08, 2023 8 March, 2023
Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes
- Third patient now implanted with higher capacity, 10-chamber Cell Pouch
- Company anticipates first interim data from second cohort in Q4 2023
LONDON, Ontario – March 8, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort
of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia
unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell
Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of
islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient
has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.
In November 2022, the Company announced the addition of a second cohort and protocol amendment for its
T1D Study. The amended protocol includes a second cohort of up to seven patients for the transplant of islets
into Sernova’s higher-capacity Cell Pouch. Enrollment for the new second cohort has occurred rapidly with
approximately half of the patients already completed.
The amended protocol to use the 10-channel Cell Pouch enables optimized dosing and shorter efficacy
evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of
transplanted islet cells, reduction of severe hypoglycemic episodes, and changes in HbA1c, serum C-peptide
production, and insulin requirements. The higher capacity 10-channel Cell Pouch provides greater than 50%
more capacity relative to the Cell Pouches used for the T1D Study’s first cohort.
“I am excited to apply the learnings from the first patient cohort, including implementation of the higher
capacity Cell Pouch, which enables us to optimize the dose and concentration of islets to achieve our clinical
objectives with these patients,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the
Pancreatic Islet Transplant Program at the University of Chicago. “I look forward to reporting the first interim
results of the second patient cohort.”
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, added, “With the first two patients
transplanted and a third patient now implanted with the higher capacity Cell Pouch, we are pleased to see the
successful results of our patient enrollment acceleration strategy and are driving to complete full enrollment as
expeditiously as possible. We look forward to presenting our next readout of interim results.”
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec SE entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for
hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for
hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or
"should" occur are used to identify forward-looking statements. These statements reflect management’s
beliefs with respect to future events and are based on information currently available to management on the
date such statements were made. Many factors could cause Sernova’s actual results, performances or
achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or
implied by the forward-looking statements contained in this news release. Such factors could include, but are
not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable
terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch
System and or related technologies, including the timing and results of those trials; ability to obtain all
necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary
technologies; ability to execute its business strategy and successfully compete in the market; and the inherent
risks associated with the development of biotechnology combination products generally. Many of the factors
are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic.
Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional
information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims
any intention or obligation to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Press Release Communiqué de presse - March 22, 2023 22 March, 2023
Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for Oral Podium Presentation at American Diabetes Association 83rd Scientific Sessions 2023
LONDON, Ontario – March 22, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, is pleased to announce that an abstract has been selected for
an oral podium presentation at the upcoming American Diabetes Association (ADA) 83rd Scientific Sessions, to
be held from June 23-26, 2023, in San Diego, CA. It will also be published on the journal Diabetes® website.
Abstract: #240-OR
Title: Islet Allotransplantation into Pre-vascularized Sernova Cell Pouch—Early Results from the University of
Chicago
Abstract Session: Clinical Islet-Cell Transplantation
Date/Time: Saturday June 24, 2023 at 5:15 PM PT
Authors: Mateusz Ogledzinski, Sarah Gondek, William Lin, Kamila Milejczyk, Braden Juengel, Lisa Potter, Piotr
K. Bachul, Lindsay Basto, Laurencia Perea, Lingjia Wang, Martin Tibudan, Rolf Barth, John Fung, Piotr
Witkowski
Sernova will disclose additional information about the presentation at the time of the conference in alignment
with the American Diabetes Association’s abstract embargo policies, which lift at the conclusion of the
presentation on June 24, 2023. All abstracts are preliminary until the time of presentation.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid
disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - April 24, 2023 24 April, 2023
Successful Results Using Sernova's Cell Pouch System™ with Evotec's iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit
- Evotec’s scalable GMP manufacturing process has been designed to produce induced pluripotent stem cell
(iPSC)-derived islet-like clusters (ILCs) with high insulin-producing beta cell content as well as glucagon and
somatostatin (produced by alpha cells and delta cells, respectively), similar to human islets
- The ILCs are cryopreserved during manufacturing, enabling storage of mass volumes and cost efficient on-
demand worldwide delivery as required
- Results from a type 1 diabetes (T1D) preclinical model with Evotec’s ILCs implanted into Sernova’s Cell
Pouch™ demonstrated robust and durable insulin independence with blood C-peptide levels and glucose
tolerance test results equivalent to a test group with human islets
- An additional T1D study with Evotec’s ILCs demonstrated sustained normalization of blood sugar levels in
diabetic mice throughout the 320 day term of the study
- IND filing and Phase 1/2 clinical program with Sernova’s Cell Pouch and Evotec’s iPSC ILCs on track for 2024
LONDON, Ontario – April 24, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced the presentation of preclinical data supporting
the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s (FSE: EVT; NASDAQ:
EVO) iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of
patients with T1D. The objective of the partnership is to produce an off-the-shelf, commercially scalable cell
therapy treatment, with human testing anticipated to begin in 2024.
The data were presented by Matthias Austen, PhD, SVP Cell Therapy at Evotec SE (Evotec), as an oral podium
presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell
Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge,
Massachusetts. The presentation included an introduction to Evotec’s proprietary GMP process for
manufacturing iPSC-derived ILCs for use in Sernova’s Cell Pouch, as well as encouraging results from multiple
studies using a standard mouse model of T1D.
Key findings:
- Evotec has developed a scalable GMP manufacturing workflow, starting from GMP-grade iPSCs to the final
product of ILCs, yielding a high beta cell fraction with no post-implantation variability of cell composition.
- Evotec ILCs are cryopreserved at a late-intermediate stage of differentiation allowing for a cost-effective
large-scale manufacturing process to optimize both pre- and post-implantation durability, offering a major
advantage over competing cell therapies in development.
- ILCs implanted to mouse kidney capsule demonstrated complete and durable normalization of glucose levels
in a standard diabetic mouse model out to the pre-planned termination date at 320 days.
- ILCs implanted into Sernova’s Cell Pouch demonstrated rapid normalization of glycemic control in the
streptozotocin (STZ)-induced diabetic NSG (NOD.SCID.IL-2Rgammanull) mouse model.
- Circulating C-peptide levels (a biomarker for insulin production) in mice implanted with the Cell Pouch and
ILCs were equivalent after 6 weeks to those in mice that received 4000 IEQ human islets under the kidney
capsule.
- Efficient glucose clearance and no hypoglycemia was demonstrated in an oral glucose tolerance test
administered at 8 weeks post-implantation. Animals implanted with Cell Pouch and ILCs showed an identical
glucose clearance time course compared to animals transplanted with 4000 IEQ human islets.
- Upon explantation of the Cell Pouch with ILCs after the 32-week survival period, histological graft analyses
showed the presence of all relevant islet cell types including insulin-producing beta cells, glucagon-producing
alpha cells, and somatostatin-producing delta cells, indicating a favorable cell composition of the implanted
ILCs.
- Histological graft analyses also revealed extensive intra-graft vascularization, likely contributing to the
excellent endocrine cell survival with a high beta cell fraction, and consistent with the observed functional
outcomes.
“Our ongoing productive partnership with Evotec continues to progress towards human clinical trials in 2024
with an impressive cell therapy paired with our Cell Pouch to create a potential ‘functional cure’ for T1D,” said
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “These results demonstrate that Evotec’s
ILCs in the Cell Pouch can become fully functional endocrine islets following implantation, with potency
equivalent to human islets. Our goal is to advance beyond decades-old insulin injections to provide a potential
one-time treatment to restore normal pancreatic glycemic control for individuals with T1D. We look forward to
providing an update at the American Diabetes Association conference in June on our ongoing Phase 1/2 study
in T1D patients with our Cell Pouch containing human donor islet cells and to progressing our next generation
product utilizing Evotec cells into the clinic in 2024.”
Dr. Cord Dohrmann, Chief Scientific Officer of Evotec commented, “We are thrilled to show these results with
Evotec’s ILCs that we have spent years perfecting with a scalable cost-effective GMP workflow to create a
cryopreserved product with excellent survival under standard shipping conditions and optimized for
implantation into Sernova’s Cell Pouch. These new data demonstrating rapid, complete, and durable
normalization of glucose control that is equi-potent comparable in potency to human islets is one of the final
steps prior to our anticipated human testing in 2024.”
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent or
deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated
its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University
of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to
shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic
immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop
an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This
partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of
patients with insulin-dependent diabetes (type 1 and type 2). Sernova has secured an exclusive option for an
exclusive global license for Evotec’s ethically derived iPSC insulin producing islet clusters for use with Sernova’s
Cell Pouch System or alone with other technologies. Sernova continues to progress two additional
development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from
thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - May 03, 2023 3 May, 2023
Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications
LONDON, Ontario – May 3, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced it has entered into a preclinical research
collaboration with AstraZeneca (LSE/STO/Nasdaq:AZN) to evaluate the use of Sernova’s Cell Pouch System™ in
combination with AstraZeneca’s novel therapeutic cells.
“Sernova has developed a novel cell therapy approach for the potential treatment of insulin-dependent
diabetes, hypothyroidism and hemophilia A,” said Dr. Philip Toleikis, President and Chief Executive Officer of
Sernova. “By engrafting functional therapeutic cells within an implanted Cell Pouch, which naturally
vascularizes with surrounding tissues, we create an environment for the production and release of absent or
under-expressed hormones and proteins. We are pleased to be working with AstraZeneca in the preclinical
assessment of its various proprietary therapeutic cells in combination with our Cell Pouch.”
AstraZeneca is exploring the use of Sernova’s Cell Pouch System as a potential platform for integration with its
development of the next wave of innovative cell therapies for various indications. Under the terms of the
collaboration, AstraZeneca will lead and completely fund the development of the cell technologies and pre-
clinical activities in conjunction with Sernova. The discovery work is being funded and conducted at
AstraZeneca. The preclinical research outcomes will determine the feasibility of potential therapeutic
applications and subsequent product development activities between the two companies.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid
disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - June 26, 2023 26 June, 2023
Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessions
• In the first cohort of the ongoing Phase 1/2 clinical trial, the first 5 patients to complete protocol-defined
islet transplants achieved insulin-independence for ongoing periods of 6 to 38 months.
• Following islet transplants to the 8-channel Cell Pouches, patients in the first cohort required only modest
islet top-up via portal vein to achieve insulin independence, supporting the contribution to blood glucose
control from islet grafts in the Cell Pouch™.
• Five of the 7 planned patients have been enrolled in the second cohort and implanted with higher capacity
10-channel Cell Pouches. Three patients in the second cohort have received their first pancreatic islet
transplant to Cell Pouch.
• Persistent fasting and stimulated serum C-peptide confirms stable islet graft function in the first evaluable
patient to receive islet transplants to the higher capacity Cell Pouch.
LONDON, Ontario – June 26, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-
stage company and leader in cell therapeutics, today announced updated positive interim data from its ongoing
Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia
unawareness. The new data from the study, which is being conducted by Piotr Witkowski, M.D., Ph.D., at The
University of Chicago, were presented during an oral podium presentation at the American Diabetes
Association (ADA) 83rd Scientific Sessions, on June 24th, 2023 in San Diego, California.
The presentation discussed the first eleven patients enrolled across two cohorts in the clinical trial evaluating
Cell Pouch in combination with pancreatic islets and reconfirmed the safety of Cell Pouch up to more than 4
years following implant. During the trial, the function of the transplanted islets are measured by blood glucose
levels, patient insulin usage, and serum C-peptide - a measure of islet insulin secretion.
To date, 5 patients in the first cohort of 6 subjects who have completed Cell Pouch implantation, islet
transplant to Cell Pouch, and supplemental portal vein islet infusion, continue to experience insulin
independence for periods ranging from 6 months to greater than 3 years. The sixth patient in the first cohort
has only recently completed the protocol-defined islet transplants and awaits assessment of their islet graft
function.
In addition, updates were provided for the second cohort with the recently implemented 10-channel Cell Pouch
with more than 50% greater transplant capacity than the previous 8-channel system. Five of 7 patients meeting
the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher capacity Cell
Pouch. Three of the 5 patients enrolled in the second cohort have each received a first islet transplant to their
implanted Cell Pouches. The first evaluable patient in the second cohort has demonstrated persistent fasting
and stimulated serum C-peptide levels following a single islet transplant into the pre-vascularized 10-channel
Cell Pouch.
KEY POINTS FROM THE INTERIM CLINICAL UPDATE
• Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favorable safety
profile in patients receiving either 8 or 10-channel Cell Pouches.
• Five of 6 patients in the first cohort achieved insulin independence following supplemental islet transplants
via the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the 8-
channel Cell Pouch is supporting ongoing glucose control.
• Histological assessment of sentinel Cell Pouches excised at ≥90 days post-transplant revealed surviving
functional islets in 5 of 6 patients in the first cohort.
• The 5 patients in the first cohort that have achieved insulin independence have each remained free of
endogenous insulin therapy ranging from 6 months to greater than 3 years. The sixth patient in the first cohort
has recently completed the protocol-defined islet transplants and is awaiting their next islet graft assessment.
• In the second cohort, 5 of 7 planned patients are now enrolled and implanted with the higher capacity Cell
Pouches. Three of the 5 patients have received their first dose of pancreatic islets transplanted to Cell Pouch.
• One patient in the second cohort has demonstrated persistent serum C-peptide levels after only a single
islet transplant into 10-channel Cell Pouch. The first patient in the second cohort developed persistent
neutropenia requiring cessation of immunotherapy. The third patient awaits their first islet graft assessment.
Further data from the second cohort of the clinical trial is expected in the second half of 2023.
“We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-
channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D,” said Dr. Philip
Toleikis, President and Chief Executive Officer of Sernova. “These additional data continue to confirm our
understanding and provide verification of our estimates of islet dose thresholds and density required for
optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll
the study’s second cohort, while setting the stage for Cell Pouch in combination with Evotec’s iPSC derived
islet-like clusters in our upcoming clinical trial.”
Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago, and
principal investigator of the clinical trial added, “I continue to be encouraged by the results achieved in this
trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell
Pouch. I look forward to reporting further data later this year.”
For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).
To add to the ongoing Phase 1/2 clinical trial of the Cell Pouch System in T1D, Sernova also continues to
advance its global strategic partnership with Evotec SE (Evotec). Together the companies remain on track to
advance Sernova’s Cell Pouch in combination with Evotec’s induced pluripotent stem cell (iPSC) derived islet-
like clusters into the clinic. Furthermore, Sernova is advancing its conformal coating cellular immune
protection technologies in collaboration with the University of Miami with the goal to reduce or eliminate the
need for immunosuppression agents.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a novel therapy for
hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for
hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances, or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - September 05, 2023 5 September, 2023
Sernova Corporation Announces the Appointment of Cynthia Pussinen as CEO
Industry veteran with deep commercial experience joins to lead the next stage of growth and development
Dr. Philip Toleikis will serve as Chief Technology Officer
Sernova to host investor calls
LONDON, Ontario; Windham County, CT – September 5, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF)
(FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced that its Board of
Directors has appointed Cynthia Pussinen as Chief Executive Officer and a member of the Board of Directors.
Dr. Philip Toleikis, who has led the company since 2009 as President and CEO will serve as Chief Technology
Officer.
Ms. Pussinen’s expertise spans the drug development continuum from research through commercialization. She
has led the development, licensure, commercialization and/or subsequent delivery to patients, of more than
fifteen new medical therapies for patients globally, including Obizur® (Antihemophilic Factor (Recombinant),
Porcine Sequence), Eraxis® (anidulafungin), Zmax® (azithromycin extended-release) and LUXTURNA®
(voretigene neparvovec-rzyl), the first gene therapy approved in both the United States and the European
Union.
Most recently, Ms. Pussinen was the Chief Technical Officer for Spark Therapeutics, Inc., a fully integrated,
commercial gene therapy company, and a member of the Roche Group. Prior to joining Spark in 2021, Ms.
Pussinen’s leadership roles include 6 years with Ipsen Biomeasure and Ipsen Biosciences, U.S. R&D focused
subsidiaries of Ipsen, where she served as President and CEO. She was instrumental in leading and executing
the divestiture of Obizur® and its associated manufacturing physical infrastructure to Baxter. Ms. Pussinen was
also the Executive Vice President, Technical Development, Operations & Supply Chain for Actinium
Pharmaceuticals, Inc. and the Global Vice President and General Manager, Life Sciences and Specialty
Chemicals for Honeywell International. Early in her career Ms. Pussinen spent more than 18 years at Pfizer in a
variety of increasingly responsible leadership roles across various functional areas.
Ms. Pussinen also served on the Drexel University Solutions Advisory Board, as a Board Director for Spark
Therapeutics UK Ltd. and Spark Therapeutics Ireland Ltd. and is a member of an early-stage biotech
company’s scientific and technical advisory board.
Ms. Pussinen earned a Master of Science in R&D management from Rensselaer Polytechnic Institute and a
Bachelor of Science in chemistry, with a minor in engineering from the University of Connecticut. She is lean six
sigma certified, is recognized as a mentor through the Healthcare Businesswomen’s Association (HBA) and was
honored by WEST (Women in the Enterprise of Science and Technology) as a recipient of their Giving Back
award.
“Sernova has demonstrated tremendous growth over the past several years as it has transitioned from a
research company to one that is moving towards commercialization of a product for the treatment of multiple
chronic diseases including our flagship program for Type 1 Diabetes (T1D). As a united Board, we feel now is
the time to bring in an industry leader with extensive experience with large pharmaceutical companies as well
as entrepreneurial biotech and advanced therapeutics focused companies,” commented Brett Whalen, Chair of
the Board of Directors of Sernova. “The skills that Ms. Pussinen brings to our company include over 25 years
of global experience shepherding new therapies from development through commercialization across multiple
conditions with sales measured in the billions.”
Mr. Whalen continued, “the Board would like to thank Dr. Toleikis for his significant contributions to Sernova
and his passionate commitment to our mission, and for continuing in his new role as Chief Technology Officer.
Under his leadership, Sernova has solidified the strong scientific and technical foundations for future success
and created significant market value driven by the strong positive clinical data outcomes in T1D. The Board is
convinced that Ms. Pussinen and Dr. Toleikis bring the right combination of experience and talent to optimize
this unique opportunity for all stakeholders.”
Ms. Pussinen added, “It is an honor and a privilege to join Sernova at this pivotal stage in the company’s
evolution. Sernova has developed novel technology, and I am very excited by the positive pre-clinical and
clinical results thus far. The company is a pioneer in creating new ways to address some of the most
challenging chronic diseases, providing the possibility of a life-changing ‘functional cure’ for conditions
including Type 1 Diabetes. I am inspired by the mission to improve human health and look forward to working
with the passionate Sernova team to boldly advance the company’s mission for the benefit of all patients,
stakeholders and investors.”
Dr. Toleikis said, “I am grateful to have led Sernova’s dedicated team over the past years. I am proud of all that
we have accomplished together over the past years, including establishing a strong technology and scientific
foundation along with introducing new treatments options to patients with chronic conditions. I am very
pleased to welcome Ms. Pussinen to the Sernova team as the new CEO and look forward to working together. I
look forward to my continued involvement with the Company to see through the realization of Sernova’s
mission to bring a functional cure to patients around the world suffering from chronic diseases.
Sernova’s management will host investor calls, firstly to introduce Ms. Pussinen, and later, in approximately 30
days, to provide an overview of Sernova as well as a question-and-answer session. Investors will be informed
of the details once finalized.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment
in the body for long-term survival and function of therapeutic cells that release essential factors that are absent
or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has
demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study
at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the
University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need
for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic
partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet
replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing
cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to
progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid
disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and
uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Press Release Communiqué de presse - September 29, 2023 29 September, 2023
Sernova Presents Compelling New Data on the Cell Pouch System™ as a Promising Treatment for Post-Operative Hypothyroidism at the 2023 American Thyroid Association Annual Meeting
Proof-of-concept data supports the clinical evaluation of the Cell Pouch System as a potential treatment for
post-operative hypothyroidism
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 29, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced
new preclinical data for its novel cell therapy platform, the Cell Pouch System, as a potential treatment for
post-operative hypothyroidism at the 2023 American Thyroid Association (ATA) Annual Meeting being held in
Washington, D.C., from September 27 to October 1, 2023.
Key insights from the poster:
• After total thyroidectomy, re-implantation of thyroid tissue into the pre-vascularized Cell Pouch™ resulted
in the restoration of the two main thyroid hormones, i.e., free thyroxine (FT4) and triiodothyronine (T3), to the
baseline levels.
• Thyroid stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a
gradual decline observed starting five weeks after the re-implantation of thyroid glands. This pattern
underscores the re-establishment of the intrinsic thyroid feedback loop's impact.
• Newly reported radio-isotope uptake imaging and histology assessments confirmed the presence of
healthy and functional thyroid tissues within the Cell Pouch six months following re-implantation.
“Currently, thyroidectomy patients are bound to life-long thyroid hormone replacement therapy. A significant
subset of those patients grapple with persistent symptoms of thyroid dysfunction including weight gain, fatigue,
depression, memory and cognitive impairment, negatively impacting their quality of life,” said Cynthia
Pussinen, Chief Executive Officer at Sernova. “With Sernova’s Cell Pouch System, we aim to improve quality of
life with a treatment for post-operative hypothyroidism. These new data replicate a human clinical scenario in
which thyroid tissue is reimplanted into the patient, via the Cell Pouch, leading to the restoration of normal
thyroid function. Sernova is assessing the commercial opportunity and pathways for accelerated development
of the thyroid program.”
Approximately 150,000 thyroidectomies are performed annually in the U.S. alone, representing a significant
market opportunity*. Sernova’s potential first-generation product would utilize healthy tissue from the patient’s
own gland removed during thyroidectomy for benign disease. This therapeutic approach would negate the need
for immune suppression medication. A second-generation stem cell-derived technology could potentially be
used to treat the broader population with hypothyroid disease.
(*Sun, G. H., DeMonner, S., & Davis, M. M. (2013). Epidemiological and economic trends in inpatient and
outpatient thyroidectomy in the United States, 1996–2006. Thyroid, 23(6), 727-733.)
Poster details:
Title: Auto-Transplantation of Rat Thyroid into a Pre-Vascularized Retrievable Cell Pouch™ Device
for the Treatment of Post-Operative Hypothyroidism
Presenter: Dr. Arash Memarnejadian, Senior Research Scientist, Sernova Corp.
Date and Time: September 29 from 9:50 a.m. to 12:40 p.m. Eastern Time
Poster #: 323
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for
chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include
hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune
protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in
the body for long-term survival and function of therapeutic cells that release essential factors that are absent or
deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated
its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University
of Chicago, with Cell Pouches implanted for periods of more than four years and counting.
Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield
therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic
immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop
an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This
partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of
patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional
development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from
thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extent they are not recitations of historical facts, may constitute
“forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without
limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but
not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects",
"potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should"
occur are used to identify forward-looking statements. These statements reflect management’s beliefs with
respect to future events and are based on information currently available to management on the date such
statements were made. Many factors could cause Sernova’s actual results, performances or achievements to
not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the
forward-looking statements contained in this news release. Such factors could include, but are not limited to,
the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all;
ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or
related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory
approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute
its business strategy and successfully compete in the market; and the inherent risks associated with the
development of biotechnology combination products generally. Many of the factors are beyond our control,
including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult
the company’s quarterly and annual filings available on www.sedarplus.ca for additional information on risks
and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Modestus Obochi
Chief Business Officer Directeur commercial
Accomplished executive with global diverse industry-leading experiences across pharmaceutical and biotechnology industries, including operational leadership and advisory roles. Demonstrated successes growing revenues, shareholder value and managing global P&L in start-up, medium and large companies. Proven fund-raising, business development, M&A and general management skills, building fruitful partnerships with many companies and delivering multimillion-dollar bottom-line growth.
Dr. Obochi joins Sernova from Phlow Corp., where he served as Executive Vice President of Strategy and Business Development. In that role, he led the design, development, and execution of corporate strategy and business development plans. He also managed the due diligence, structuring, and negotiations of all transactions, including licensing deals, product acquisitions, partnerships, M&A, and strategic investments. Prior to his role at Phlow Corp., Dr. Obochi held several executive-level commercial and business development roles at leading pharmaceutical companies including Pfizer, Hospira, and Baxter, as well as at innovative biotech companies including QLT and Pfenex and has previously consulted for several biotechnology companies. Most notably, in these roles, Dr. Obochi has helped corporations raise significant capital and has successfully structured and closed multiple strategic transactions worth over $7 billion.
Dr. Obochi holds a Ph.D. in Immunology from the University of British Columbia, Vancouver, and an MBA from the Beedie School of Business at Simon Fraser University, Vancouver. He has published over 30 manuscripts, including journal articles and symposia abstracts, and is an inventor on several patents, including one on cell transplantation.
Cadre accompli avec des expériences mondiales diversifiées de pointe dans les secteurs pharmaceutique et pharmaceutique. industries de la biotechnologie, y compris des rôles de leadership opérationnel et de conseil. Succès démontrés croissance des revenus, de la valeur actionnariale et gestion du P&L mondial dans les start-ups, moyennes et grandes entreprises. Compétences avérées en matière de collecte de fonds, de développement commercial, de fusions et acquisitions et de gestion générale, établissant des partenariats fructueux avec de nombreuses entreprises et générant une croissance de plusieurs millions de dollars.
Le Dr Obochi rejoint Sernova après avoir travaillé chez Phlow Corp., où il occupait le poste de vice-président exécutif de la stratégie et du développement commercial. À ce poste, il a dirigé la conception, le développement et l’exécution de la stratégie d’entreprise et des plans de développement commercial. Il a également géré la diligence raisonnable, la structuration et les négociations de toutes les transactions, y compris les accords de licence, les acquisitions de produits, les partenariats, les fusions et acquisitions et les investissements stratégiques. Avant de rejoindre Phlow Corp., le Dr Obochi a occupé plusieurs postes de direction commerciale et de développement commercial au sein de sociétés pharmaceutiques de premier plan, notamment Pfizer, Hospira et Baxter, ainsi que dans des sociétés de biotechnologie innovantes, notamment QLT et Pfenex. plusieurs sociétés de biotechnologie. Plus particulièrement, dans ces fonctions, le Dr Obochi a aidé des entreprises à lever des capitaux importants et a structuré et conclu avec succès plusieurs transactions stratégiques d'une valeur de plus de 7 milliards de dollars.
Le Dr Obochi est titulaire d'un doctorat. en immunologie de l'Université de la Colombie-Britannique à Vancouver et un MBA de la Beedie School of Business de l'Université Simon Fraser à Vancouver. Il a publié plus de 30 manuscrits, dont des articles de revues et des résumés de colloques, et est l'inventeur de plusieurs brevets, dont un sur la transplantation cellulaire.
Frank Shannon
Vice President, Clinical Development and Regulatory Affairs Vice-président, Développement clinique et affaires réglementaires
Mr. Shannon has a track record of more than 25 years of proven experience in clinical development and regulatory affairs. He has served in senior level positions within the international medical device, pharmaceutical, and biologic industries where he achieved commercial goals through innovative risk management and execution strategies, to obtain marketing approval of products. M. Shannon a plus de 25 ans d'expérience avérée dans le développement clinique et les affaires réglementaires. Il a occupé des postes de direction au sein des industries internationales des dispositifs médicaux, pharmaceutiques et biologiques où il a atteint des objectifs commerciaux grâce à des stratégies innovantes de gestion des risques et d'exécution, afin d'obtenir l'approbation de commercialisation des produits.
Mr. Shannon most recently served as VP Clinical Development, Regulatory Affairs and Quality at Ripple Therapeutics, a spin-out of Interface Biologics where he served in the same capacity since 2016. Prior to these appointments, he held various senior clinical/regulatory positions at Baxter International, St. Jude Medical, Boehringer-Ingelheim, Hoffmann-La Roche/Roche Laboratories, Inc., Genentech Canada, Inc., and Ciba-Geigy Canada, Ltd. M. Shannon a récemment occupé le poste de vice-président du développement clinique, des affaires réglementaires et de la qualité chez Ripple Therapeutics, une entreprise dérivée d'Interface Biologics où il occupait le même poste depuis 2016. Avant ces nominations, il a occupé divers postes cliniques/réglementaires supérieurs chez Baxter International, St. Jude Medical, Boehringer-Ingelheim, Hoffmann-La Roche/Roche Laboratories, Inc., Genentech Canada, Inc. et Ciba-Geigy Canada, Ltd.
Chris Barnes
Vice President, Investor Relations Vice-président, Relations avec les investisseurs
Chris has worked in financial services for 23 years, first as an investor relations consultant, then as the investor relations officer for Extendicare Inc., a large North American nursing home company listed on both the TSX and NYSE. Subsequently Chris moved directly into capital markets as an IIROC registered institutional sales person with three Toronto based investment boutiques, including Fraser Mackenzie, Octagon Capital and Pace Securities covering accounts in Canada, the United States and Europe. Chris holds a bachelor’s degree in English and Political Science from Laurentian University plus he completed the Richard Ivey School of Business at University of Western Ontario, Strategic Investor Relations diploma. Chris a travaillé dans les services financiers pendant 23 ans, d'abord en tant que consultant en relations avec les investisseurs, puis en tant que responsable des relations avec les investisseurs pour Extendicare Inc., une grande société nord-américaine de maisons de soins infirmiers cotée à la fois à la Bourse de Toronto et à la Bourse de New York. Par la suite, Chris est passé directement aux marchés des capitaux en tant que vendeur institutionnel inscrit auprès de l'OCRCVM auprès de trois boutiques d'investissement basées à Toronto, dont Fraser Mackenzie, Octagon Capital et Pace Securities couvrant des comptes au Canada, aux États-Unis et en Europe. Chris détient un baccalauréat en anglais et en sciences politiques de l'Université Laurentienne et il a complété le diplôme en relations stratégiques avec les investisseurs de la Richard Ivey School of Business de l'Université de Western Ontario.
Chris enjoys golf, competitive swimming, baseball and hockey. Chris aime le golf, la natation de compétition, le baseball et le hockey.
James Parsons
Director - Board of Directors Directeur - Conseil d'administration
James T. Parsons is a life sciences industry consultant and director. He previously served as the Chief Financial Officer of Trillium Therapeutics Inc. from 2011 to its acquisition by Pfizer in November 2021 for US$2.2 billion. Mr. Parsons has a broad background in the life sciences industry across therapeutics, diagnostics and device companies. Mr. Parsons has extensive experience in strategic planning, financing, contract negotiation, investor relations, risk management, corporate governance and public company management. Mr. Parsons also serves on the board of directors of DiaMedica Therapeutics (NASDAQ:DMAC) and is chair of their audit committee and serves on the board of Oncolytics Biotech Inc (NASDAQ:ONCY). He has a Master of Accounting degree from the University of Waterloo and is a Chartered Professional Accountant, Chartered Accountant (CPA, CA).
James T. Parsons est consultant et directeur de l'industrie des sciences de la vie. Il a précédemment occupé le poste de directeur financier de Trillium Therapeutics Inc. de 2011 jusqu'à son acquisition par Pfizer en novembre 2021 pour 2,2 milliards de dollars américains. M. Parsons possède une vaste expérience dans l'industrie des sciences de la vie dans des entreprises de produits thérapeutiques, de diagnostic et d'appareils. M. Parsons possède une vaste expérience en planification stratégique, en financement, en négociation de contrats, en relations avec les investisseurs, en gestion des risques, en gouvernance d'entreprise et en gestion de sociétés ouvertes. M. Parsons siège également au conseil d'administration de DiaMedica Therapeutics (NASDAQ:DMAC) et est président de leur comité d'audit et siège au conseil d'Oncolytics Biotech Inc (NASDAQ:ONCY). Il est titulaire d'une maîtrise en comptabilité de l'Université de Waterloo et est comptable professionnel agréé, comptable agréé (CPA, CA).
Jonathan Rigby
Chairman and Chief Executive Officer Président-directeur général
Mr. Rigby has a breadth of industry knowledge and productive experience having served as President and CEO of Revolo Biotherapeutics where he took the company through multiple financings and two Phase 2 clinical trials, as well as serving as Chairman and Chief Business Officer of BIOS Acquisition Corporation (NASDAQ: BIOS), with an oversold IPO. Mr. Rigby served as the CEO for SteadyMed Therapeutics (NASDAQ: STDY), which he listed on Nasdaq prior to its acquisition by United Therapeutics (NASDAQ: UTHR), and was co-founder of Zogenix (NASDQ:ZGNX), which was also acquired by UCB pharma after completing a NASDAQ listing.
In addition, Mr. Rigby currently serves on the Board of Directors of cancer therapy company Oncolytics Biotech Inc. (NASDAQ: ONCY) and IM Therapeutics which is developing therapies for Type 1 diabetes (T1D). He is a past Board Member of Thermalin Inc., which engineered new forms of insulin to improve patient lives and outcomes for the treatment of T1D and was formerly on the board of Xeris Pharmaceuticals (NASDAQ: XERS) which developed and commercialised a therapy to treat T1D severe hypoglycemia. Mr. Rigby holds a degree in Biological Sciences from the University of Sheffield, UK, and has a Master of Business Administration degree from the University of Portsmouth, UK.
M. Rigby possède une vaste connaissance de l'industrie et une expérience productive ayant servi en tant que président et chef de la direction de Revolo Biotherapeutics où il a dirigé l'entreprise à travers de multiples financements et deux essais cliniques de phase 2, ainsi qu'en tant que président et directeur commercial de BIOS Acquisition Corporation. (NASDAQ : BIOS), avec une introduction en bourse survendue. M. Rigby a été PDG de SteadyMed Therapeutics (NASDAQ : STDY), qu'il a coté au Nasdaq avant son acquisition par United Therapeutics (NASDAQ : UTHR), et a été co-fondateur de Zogenix (NASDQ : ZGNX), qui a également été acquise par UCB Pharma après avoir été cotée au NASDAQ.
De plus, M. Rigby siège actuellement au conseil d'administration de la société de thérapie contre le cancer Oncolytics Biotech Inc. (NASDAQ : ONCY) et d'IM Therapeutics, qui développe des thérapies pour le diabète de type 1 (DT1). Il est un ancien membre du conseil d'administration de Thermalin Inc., qui a conçu de nouvelles formes d'insuline pour améliorer la vie des patients et les résultats du traitement du DT1 et était auparavant membre du conseil d'administration de Xeris Pharmaceuticals (NASDAQ : XERS) qui a développé et commercialisé une thérapie pour traiter Hypoglycémie sévère du DT1. M. Rigby est titulaire d'un diplôme en sciences biologiques de l'Université de Sheffield, au Royaume-Uni, et d'une maîtrise en administration des affaires de l'Université de Portsmouth, au Royaume-Uni.
Dr. Steven Sangha
Director - Board of Directors Directeur - Conseil d'administration
Dr. Steven Sangha has over 25 years of experience in investment banking, business development, and asset management. Dr. Sangha’s extensive experience with Public Company Governance & Compliance, and finance has led him to successfully run a Private Fund Family Office. Dr. Sangha’s interest in the biotechnology and mining industries has allowed positive growth for early-stage companies with his consummate efforts in assessment, development, and financial support. Dr. Sangha holds a Doctorate of Dental Surgery (DDS) from the University of Western Ontario in London, Ontario, and a Bachelor of Pharmaceutical Science (BscPharm) from the University of British Columbia in Vancouver, British Columbia.
Le Dr Steven Sangha a plus de 25 ans d'expérience dans les services bancaires d'investissement, le développement des affaires et la gestion d'actifs. La vaste expérience du Dr Sangha dans le domaine de la gouvernance et de la conformité des entreprises publiques et de la finance l'a amené à diriger avec succès un Family Office de fonds privés. L'intérêt du Dr Sangha pour les industries de la biotechnologie et de l'exploitation minière a permis une croissance positive pour les entreprises en démarrage grâce à ses efforts considérables en matière d'évaluation, de développement et de soutien financier. Le Dr Sangha est titulaire d'un doctorat en chirurgie dentaire (DDS) de l'Université de Western Ontario à London, en Ontario, et d'un baccalauréat en sciences pharmaceutiques (BscPharm) de l'Université de la Colombie-Britannique à Vancouver, en Colombie-Britannique.
David Paterson
Director - Board of Directors Directeur - Conseil d'administration
Mr. Paterson is currently employed at Colorado State University as Assistant Vice President for Research Translation and Commercialization where he manages strategic industry relationships. In addition, he brings broad biopharma industry knowledge having worked for Impax Laboratories (IPXL: NASDAQ) in both Europe and North America where he provided leadership and Board support to the business development team for ten years until its acquisition by Amneal Pharmaceuticals (AMRX: NASDAQ). Prior to Impax, Mr. Paterson held senior roles with Sepracor (Sunovion), GlaxoSmithKline and Skyepharma. Mr. Paterson is also a co-founder of Neurogastrx, Inc helping to bring in early-stage capital. Mr. Paterson has a Batchelor of Science from the University of Glasgow, a Ph.D. from the University of Illinois and was a Post-Doctoral Fellow in Molecular Genetics and Cellular Biology at the University of Chicago.
M. Paterson est actuellement employé à la Colorado State University en tant que vice-président adjoint pour l'application et la commercialisation de la recherche, où il gère les relations stratégiques avec l'industrie. En outre, il apporte une vaste connaissance de l'industrie biopharmaceutique après avoir travaillé pour Impax Laboratories (IPXL : NASDAQ) en Europe et en Amérique du Nord, où il a assuré la direction et le soutien du conseil d'administration de l'équipe de développement commercial pendant dix ans jusqu'à son acquisition par Amneal Pharmaceuticals (AMRX : NASDAQ). ). Avant Impax, M. Paterson a occupé des postes de direction chez Sepracor (Sunovion), GlaxoSmithKline et Skyepharma. M. Paterson est également co-fondateur de Neurogastrx, Inc, qui contribue à attirer des capitaux de démarrage. M. Paterson est titulaire d'un baccalauréat ès sciences de l'Université de Glasgow et d'un doctorat. de l'Université de l'Illinois et a été chercheur postdoctoral en génétique moléculaire et biologie cellulaire à l'Université de Chicago.
Dr. Bernd Muehlenweg
Director - Board of Directors Directeur - Conseil d'administration
Bernd Muehlenweg has more than two decades of experience in senior positions focusing on business and corporate development along with alliance management in the pharma and biotechnology industries. He has been involved in establishing a broad bandwidth of collaborations to develop and commercialize assets from early research stage up to late-stage clinical development. He also founded Panoptes Pharma GmbH, a biotech start-up that was acquired by a NASDAQ listed company. Dr. Muehlenweg currently serves as Senior Vice President of Global Business Development at Evotec. Before this he held the position of Chief Business Officer, Member of the Executive Board at Nanobiotix, a French clinical stage oncology company. Building sustainable and durable partnership to advance innovative approaches into approved medications has been driving him throughout his career.
Bernd Muehlenweg possède plus de deux décennies d'expérience dans des postes de direction axés sur le développement commercial et d'entreprise ainsi que sur la gestion d'alliances dans les secteurs pharmaceutique et biotechnologique. Il a participé à l'établissement d'un large éventail de collaborations pour développer et commercialiser des actifs depuis les premiers stades de recherche jusqu'aux stades avancés du développement clinique. Il a également fondé Panoptes Pharma GmbH, une start-up biotechnologique rachetée par une société cotée au NASDAQ. Le Dr Muehlenweg est actuellement vice-président principal du développement commercial mondial chez Evotec. Avant cela, il a occupé le poste de Chief Business Officer, membre du Directoire de Nanobiotix, société française d'oncologie au stade clinique. Construire un partenariat durable pour faire progresser des approches innovantes en matière de médicaments approuvés l'a motivé tout au long de sa carrière.
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Updated July 6, 2018
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Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8
Mis à jour le 6 juillet 2018
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London, ON Canada N6G 4X8