2018 Press Releases Communiqués de presse
Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes
Sernova Highlights Achievements from the HemAcure Consortium in Developing a Novel Cell-Based Therapy for Hemophilia A
Sernova Retains FronTier Flex for Canadian Investor Relations and Marketing
Sernova Establishes Comprehensive North American Investor Relations and Communications Strategy
Sernova-HemAcure Consortium to Present Achievements in Development of a Regenerative Medicine Approach to Treat Hemophilia A
Sernova Completes Oversubscribed Private Placement of $2,754,000
Sernova Announces $2,000,000 First Closing of Private Placement
Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes
Sernova Announces $2 Million Private Placement Financing
Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study
Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator
Sernova Announces Results of 2018 Annual General Meeting of Shareholders and New Chief Financial Officer
Sernova’s Cell Pouch Regenerative Medicine Clinical Trial for Patients with Type 1 Diabetes Supported with Continuous Glucose Monitoring Systems
Sernova to Participate at the Biotech Showcase 2018 Healthcare Partnering Conference
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 - 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 - November 09, 2018 9 November, 2018
Sernova Retains FronTier Flex for Canadian Investor Relations and Marketing
Source: Sernova Corp.
November 9, 2018 6:00 a.m. EST
LONDON, ONTARIO – November 9, 2018– Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical-
stage regenerative medicine company, announces that it has engaged FronTier Flex, an investor relations (IR)
and marketing group based in Toronto, Ontario Canada to provide Canadian IR and strategic marketing
services.
Sernova President and CEO Dr. Philip Toleikis commented, "FronTier’s engagement falls within the expanded
communications strategy Sernova is implementing to help investors and shareholders stay well-informed as we
advance our new US diabetes Phase I/II clinical study and other programs. FronTier’s media experience will
increase Sernova’s visibility and reach into the investment community through strategic messaging and investor
outreach.”
Through their established network of financial industry professionals and marketing service providers, FronTier
will assist the corporation by increasing market awareness for the corporation using a number of financial
market communications initiatives, including facilitating in-person introductions for the corporation with
institutional and retail brokers in Toronto and other financial capitals, and through media distribution on
national television, radio and multiple online channels.
Under the terms of the engagement, FronTier has been retained for a 12-month period for aggregate
remuneration of $87,000 plus expenses.
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:
Dominic Gray, Corporate Communications
Tel: (519) 858-5126
Dominic.Gray@sernova.com
www.sernova.com
Philip Toleikis, Ph.D., President and CEO
Tel: (519) 858-5184
info@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 06, 2018 6 November, 2018
Sernova Establishes Comprehensive North American Investor Relations and Communications Strategy
US Program to Focus on Raising Company’s Visibility Through Engagement of Solebury Trout
Source: Sernova Corp
November 6, 2018 6:00 a.m. EST
LONDON, ONTARIO, November 6, 2018 – Sernova Corp (TSXV: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical-
stage regenerative medicine company, today announced it has engaged Solebury Trout ("Trout"), a New York-
based investor relations and strategic advisory consultant serving life science companies.
Solebury Trout will develop and implement a comprehensive investor outreach program tailored to and in
collaboration with Sernova that will include analyst and institutional and retail investor targeting/outreach, non-
deal roadshows, corporate communications, and Key Opinion Leader (KOL) events in the chronic disease
space.
“We have made significant progress in our diabetes program this year by advancing our US Phase I/II human
clinical study of Sernova’s Cell Pouch™ with insulin-producing cells and by announcing the HemAcure
Consortium’s achievements in developing a novel cell-based therapy for Hemophilia A. At this important
juncture in the Company’s history, the engagement of Solebury Trout advances our strategic initiative to expand
awareness of Sernova in the investment community, particularly among US institutional investors,” said Dr.
Philip Toleikis, Chief Executive Officer of Sernova. “The team at Trout, with its capital market and institutional
experience, brings capabilities that will enable us to present Sernova’s compelling story to a wide audience of
investors, both in the U.S. and internationally.”
“Sernova has the potential to transform the diabetes, hemophilia and other chronic diseases treatment
landscape with their disruptive regenerative medicine technologies and Solebury Trout will provide Sernova
with its biotechnology and life sciences industry experience.” Stated Danny Matthews, Senior Associate at
Solebury Trout.
Under the terms of the engagements, Solebury Trout has been retained for an extendable 12-month period for
a monthly remuneration of US$16,500 plus direct expenses. Solebury Trout does not currently have any
interest, either directly or indirectly, in the company. The agreement is subject to approval by the TSX Venture
Exchange.
About Solebury Trout
Solebury Trout provides clients with senior counsel and execution on investor relations and corporate
communications strategies. The firm's global reach extends through a network of offices in New York, Boston,
Stamford and San Francisco, as well as consultants in the U.K., connecting clients with the right investors and
media in all the major financial centers. A highly-experienced team of 60 senior professionals has expertise in
investor relations, equity research, portfolio management, private equity, investment banking, journalism and
corporate communications. Solebury Trout is affiliated with Solebury Capital, the leading equity capital
markets advisory firm, and is a subsidiary of The PNC Financial Services Group, Inc.
About Sernova’s Cell Pouch Technologies
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term
survival and function of therapeutic cells (donor, proprietary stem cell- derived cells and xenogeneic cells)
which then release proteins and/or hormones as required to treat disease. The device, designed to eliminate
concerns of fibrosis upon implantation incorporates 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 survival of insulin-producing cells in humans. Sernova is
undertaking a Phase I/II clinical trial of the Cell Pouch with therapeutic cells for diabetes 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 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:
Danny Matthews, Solebury Trout Tel: (646) 378-2928 dmatthews@soleburytrout.com www.soleburytrout.com
Dominic Gray 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 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 - October 23, 2018 23 October, 2018
Sernova-HemAcure Consortium to Present Achievements in Development of a Regenerative Medicine Approach to Treat Hemophilia A
Source: Sernova Corp
October 23, 2018 6:00 a.m. EDT
LONDON, ONTARIO –October 23, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) a
regenerative medicine company, announces that Dr. Philip Toleikis, Sernova’s President and CEO, along with
the additional Horizon 2020 HemAcure Consortium Leaders, will present an overview of key achievements in
developing a novel cell-based therapy for the treatment of Hemophilia A, in a publicly accessible webinar.
The webinar will include an introduction to the consortium, an overview of bleeding disorders with a focus on
Hemophilia A, the innovative therapeutic approach HemAcure is developing as well as results and achievements
to date. Participants are welcome to submit their questions during the webinar through the Q&A section.
Questions that are left unanswered due to time constraint will be collected and answered in a written follow-up
published on the HemAcure website.
“Sernova is proud to be amongst the innovators participating in this product development program involving
Sernova’s platform technologies with the goal to treat hemophilia A patients. HemAcure is another great
opportunity for Sernova to collaborate with international experts to advance next-generation regenerative
medicine therapies,” stated Dr. Philip Toleikis, President and CEO of Sernova.
Webinar: Results in Fighting Haemophilia A Date/Time: Thursday October 25, 2018, 4:00 pm CEST (10:00 am
ET) Speakers: Dr. Joris Braspenning (University Hospital Würzburg, Germany), Coordinator Prof. Dr. Antonia
Follenzi (Università del Piemonte Orientale "Amedeo Avogadro,” Italy) Prof. Dr. Alexandra Stolzing
(Loughborough University, UK) Dr. Philip Toleikis (Sernova Corp, Canada) Dipl.-Ing. Martin Zierau (Grünewald
GmbH & Co. KG, Germany)
Host: Dr. Gabriele Wagner (ARTTIC, Germany)
To sign up for the Webinar, please visit bit.ly/2J63NYO or follow the instruction provided under Project News at
www.hemacure.eu
The webinar will be made available on ARTTIC's YouTube channel, HemAcure’s website and Sernova’s website
shortly after the event.
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. 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 Sernova’s Cell Pouch™ Technologies
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for the long-term
survival and function of therapeutic cells (donor, proprietary stem cell- derived cells and xenogeneic cells)
which then release proteins and/or hormones as required to treat disease. The device, designed to eliminate
concerns of fibrosis upon implantation, incorporates 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 the survival of 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 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,
Corporate Communications
Tel: (519) 858-5126
Dominic.Gray@sernova.com
www.sernova.com
Philip Toleikis, Ph.D.,
President and CEO
Tel: (519) 858-5184
info@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 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 23, 2018 23 July, 2018
Sernova Completes Oversubscribed Private Placement of $2,754,000
Source: Sernova Corp
July 23, 2018 6:00 a.m. EDT
LONDON, ONTARIO –July 23, 2018 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) announces it
has completed a non-brokered private placement of $2.754 million,
pursuant to which Sernova issued a total of 11,016,000 special warrants in two closing (July
13, 2018, and July 20, 2018).
“This oversubscribed placement was supported by retail and institutional investors who see
Sernova rapidly advancing its regenerative medicine technologies on the world stage,” said
Dr. Philip Toleikis, President and CEO of Sernova Corp.
Net proceeds from the private placement will be used to support funding of Sernova's FDA
cleared US Phase I/II regenerative medicine clinical trial, “Safety, Tolerability and Efficacy
Study of Sernova’s Cell Pouch™ for Clinical Islet Transplantation” and to advance
corporate/academic collaborations utilizing the Company’s platform technology to treat
diabetes, hemophilia and other serious disease conditions, as well as for general corporate
purposes.
“With advancement of our programs, including our diabetes Phase I/II clinical trial,
Sernova’s clinical development group has integrated the CTI and University of Chicago
teams to advance a substantial regulatory package that has made the initiation of our first
US clinical trial possible as we now advance patient enrollment and treatment with the
resolute goal to improve the lives of people with diabetes,” said Toleikis.
Each Special Warrant will convert, for no additional consideration, into one Unit (Unit) on the
earlier of the third business day after a receipt of a final prospectus qualifying the
conversion is issued and the day after the expiry of the four-month statutory hold period.
Each Unit will consist of one common share and one common share purchase warrant, with
each warrant exercisable into one share at a price of $0.35 per share for a 24 month
exercise period, subject to abridgement of the exercise period (after the expiry of the 4
month hold period) on 30 days notice to holders in the event that the twenty-day volume
weighted price of the shares exceeds $0.50 per share.
The private placement has received approval of the TSX Venture Exchange. Pursuant to
applicable Canadian securities laws, the securities issued under the Private Placement are
subject to a four-month hold period from the time of closing of the Private Placement. The
hold periods for this Private Placement expire on November 14, 2018 and November 21,
2018.
The Company compensated finders by way of cash fees of $75,425 and 301,700 non-
transferable finder warrants, each such finder warrant having the same terms as the Unit
warrants.
About Sernova’s Cell Pouch™ Technologies
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device for
the long-term survival and function of therapeutic cells (donor, proprietary stem cell-derived
cells and xenogeneic cells) which then release proteins and/or hormones as required to treat
disease. The device, designed to eliminate concerns of fibrosis upon implantation
incorporates 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 survival of 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 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 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 16, 2018 16 July, 2018
Sernova Announces $2,000,000 First Closing of Private Placement
Due to Oversubscription, Offering Increased to $2,700,000
THIS NEWS RELEASE IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES
NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES.
Source: Sernova Corp
July 16, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – July 16, 2018 – Sernova Corp. (“Sernova” or the “Company”)
(TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH) is pleased to announce that it closed
$2,000,000 of its non-brokered private placement announced on June 26, 2018. In
addition, as the Company has received over-subscriptions of $404,000, it is increasing
the total amount of the non-brokered private placement offering of up to $2,700,000 for
a total offering of 10,800,000 Special Warrants at $0.25 per Special Warrant. The
Company plans to close the balance of the placement on July 20, 2018.
“We are pleased with the strong support from our longstanding as well as new investors
including one of Canada’s most prestigious institutional funds who enthusiastically led
this placement,” said Dr. Philip Toleikis, President and CEO of Sernova Corp. “We
believe Sernova is the first in world to demonstrate survival and vascularization of
human islets in a patented, implantable prevascularized device in our first assessment in
humans and we are thrilled with our outstanding next-step clinical development program
initiated at the University of Chicago for which this funding is primarily focussed.”
Net proceeds from the private placement will be used to support funding of Sernova's
FDA cleared US Phase I/II regenerative medicine clinical trial and to advance
corporate/academic collaborations utilizing the Company’s platform technology to treat
diabetes, hemophilia and other serious disease conditions, as well as for general
corporate purposes.
In the first closing on July 13, 2018, Sernova issued 8,000,000 Special Warrants at $0.25
per Special Warrant for gross proceeds of $2,000,000. Each Special Warrant will
convert, for no additional consideration, into one Unit (“Unit”) on the earlier of the third
business day after a receipt of a final prospectus qualifying the conversion is issued and
the day after the expiry of the four-month statutory hold period. Each Unit will consist of
one common share and one common share purchase warrant, with each warrant
exercisable into one share at a price of $0.35 per share for a 24 month exercise period,
subject to abridgement of the exercise period (after the expiry of the 4 month hold
period) on 30 days notice to holders in the event that the twenty-day volume weighted
price of the shares exceeds $0.50 per share.
Also, in respect of the first closing, the Company compensated finders by way of cash
fees of $35,875 and 143,000 non-transferable finder warrants, each such finder Warrant
will be exercisable into one share at $0.35 per share for a period of 24 months. The
Company may also compensate finders on a portion of the increased private placement
consisting of 7% in cash and 7% in finder warrants, or a combination thereof.
Completion of the private placement is subject the approval of the TSX Venture
Exchange. All securities issued in connection with the private placement will be subject to
a statutory hold period of four months.
This news release does not constitute an offer to sell or the solicitation of an offer to buy
any of the securities in the United States. The securities have not been and will not be
registered under the U.S. Securities Act of 1933 or any state securities laws, and may
not be offered or sold in the United States without registration under the U.S. Securities
Act of 1933 and all applicable state securities laws, or an applicable exemption from
registration requirements.
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 - 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 - June 26, 2018 26 June, 2018
Sernova Announces $2 Million Private Placement Financing
THIS NEWS RELEASE IS NOT INTENDED FOR
DISTRIBUTION TO UNITED STATES
NEWSWIRE SERVICES OR DISSEMINATION IN
THE UNITED STATES.
Source: Sernova Corp
June 26, 2018 6:00 a.m. EDT
LONDON, ONTARIO – June 26, 2018 – Sernova
Corp. (TSX-V: SVA) (OTCQB: SEOVF)
(FSE: PSH) is pleased to announce that the
Company has secured a $1 million
institutional lead order in connection with a
proposed private placement (the “Offering”)
of up to $2 million special warrants (“Special
Warrants”) of the Company at a price of
$0.25 per Special Warrant.
Each Special Warrant will convert, for no additional
consideration, into one Unit (“Unit”)
of the Company. Each Unit will consist of one
common share and one common share
purchase warrant (“Warrant”) of the Company.
Each Warrant will be exercisable into
one share at $0.35 per share for a period of 24
months, subject to abridgement of the
exercise period if the 20 day volume weighted price
of the Company’s shares exceeds
$0.50 per share.
Net proceeds from the private placement will be
used to fund Sernova's US-based
Phase I/II diabetes clinical trial as well as potential
collaborations utilizing our Cell Pouch
System platform technologies and for general
corporate purposes.
All securities issued in connection with the private
placement will be subject to a
statutory hold period of four months. The Company
will compensate finders on a portion
of the private placement, such compensation
consisting of 7% in cash or 7% in finder
warrants, or a combination thereof. Completion of
the private placement is subject to the
receipt of all necessary corporate and regulatory
approvals, including approval of the
TSX Venture Exchange.
The Company has agreed to file a final short form
prospectus to qualify the distribution of
the Units upon deemed conversion of the Special
Warrants (the "Qualification") following
the receipt of a final prospectus. If the Qualification
does not occur within 4 months of
closing, the Special Warrants will automatically
convert into Units immediately following
the expiry of the 4-month hold period.
This news release does not constitute an offer to
sell or a solicitation of an offer to buy
any of the securities in the United States. The
securities have not been and will not be
registered under the United States Securities Act of
1933, as amended (the “U.S.
Securities Act”) or any state securities laws and
may not be offered or sold within the
United States unless registered under the U.S.
Securities Act and applicable state
securities laws or an exemption from such
registration is available.
About Sernova’s Cell Pouch technologies
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, designed to eliminate concerns
of fibrosis upon implantation
incorporates 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
survival of 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 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 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 - 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 04, 2018 4 May, 2018
Sernova Announces Results of 2018 Annual General Meeting of Shareholders and New Chief Financial Officer
Shareholder approval of all management resolutions at AGM; CEO announces new
Biotech CFO with strong North America capital market experience
Source: Sernova Corp
May 4, 2018, 6:00 a.m. EDT
LONDON, ONTARIO – (Globe Newswire – May 4, 2018) – Sernova Corp. (TSX-V: SVA)
(OTCQB: SEOVF) (FSE: PSH), announced shareholder approval of all management
resolutions brought forward at the 2018 Annual General Meeting held in Vancouver,
April 25th. In addition, we are pleased to announce Mr. Sean Hodgins, CA, CPA, CPA
(Illinois) has joined Sernova as Chief Financial Officer, effective immediately. Mr.
Hodgins will work in conjunction with Sernova’s CEO in the execution of the company’s
financial, business development and capital markets strategies as well as future planned
tracking to a US exchange.
“Mr. Hodgins is an experienced biotech executive with both US and Canada corporate
background. He is joining Sernova at an important juncture as we embark on our US
clinical study and further develop our international business relationships,” said Dr. Philip
Toleikis, President and CEO, Sernova Corp.
A veteran of the biotechnology industry for over 20 years, Mr. Hodgins is a CA-CPA
having earned a Bachelor of Commerce degree (economics) from the University of
British Columbia. He has gained US and Canada experience having tenured at Deloitte
LLP in Vancouver and PricewaterhouseCoopers LLP in San Jose, California. While in the
US he managed two NASDAQ IPO’s, and on returning to Canada, several Canadian
IPOs as well as serving as CFO for three TSX listed public companies and supporting a
number of successful Canadian biotech companies.
Sernova thanks Mr. Scott Langille for his contribution as previous CFO and wishes him
well in his future endeavours.
Management resolutions at the AGM which were approved by an overwhelming
majority of shareholders who voted including election of the directors, Frank Holler
(chair), James Parsons, Bruce Weber, Jeffrey Bacha and Dr. Philip Toleikis; approval of
the stock option plan and amendments and approval of Davidson and Co. LLP as
Sernova’s auditor for 2019.
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
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 - January 05, 2018 5 January, 2018
Sernova to Participate at the Biotech Showcase 2018 Healthcare Partnering Conference
Source: Sernova Corp
January 5, 2018, 6:00 a.m. EDT
LONDON, Ontario – (Globe Newswire Friday, January 5, 2018) – Sernova Corp (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage regenerative medicine company, today announced that Dr. Philip Toleikis, Sernova’s President and CEO, will be participating at the10th annual Biotech Showcase Conference in San Francisco, CA. Sernova’s focus will be on meeting with potential partners for its developing technologies.
“We see this gathering of international pharmaceutical executives as an excellent opportunity to have new and ongoing discussions with potential industry partners, especially given the recent clearance by FDA to initiate Sernova’s US clinical study of our novel implantable Cell Pouch device with therapeutic cells as a next step regenerative medicine treatment for diabetes. We will be discussing Sernova’s regenerative medicine platform including our clinical trial for patients with type 1 diabetes and our product development advancements,” remarked Dr. Philip Toleikis, President and CEO.
About Biotech Showcase(TM)
Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.
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, an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required. Sernova’s Cell Pouch and therapeutic cell technologies have shown therapeutic cell survival and efficacy in a vascularized tissue environment without the issue of fibrosis, a particular problem for many implantable medical devices.
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 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.