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Press Release Communiqué de presse - November 27, 2023 27 November, 2023
Sernova Receives Orphan Drug and Rare Pediatric Disease Designations for its Hemophilia A Program from FDA
Sernova announces research collaboration with Professor Antonia Follenzi, expert in hemophilia A at the
University of Piemonte Orientale
LONDON, Ontario; WINDHAM COUNTY, Connecticut – November 27, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today
announced the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and
Rare Pediatric Disease Designation (RPDD) for the company’s Hemophilia A program.
The FDA grants orphan designation, also referred to as orphan status, to therapies intended for the treatment
of rare diseases that affect fewer than 200,000 people in the US. This designation provides certain benefits,
including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven
years of market exclusivity, if approved. Separately, rare pediatric disease designations are granted for rare
diseases that primarily affect children under 18 years old with recipients of this designation being awarded a
priority review voucher, upon approval. The priority review voucher may be redeemed, transferred, or sold.
“We are pleased with the FDA’s decision to grant these designations for our novel treatment for Hemophilia A,
which uses the Cell Pouch™ in combination with cells corrected for the production of Factor VIII,” commented
Cynthia Pussinen, Chief Executive Officer of Sernova. “Hemophilia A is a serious, life limiting condition and we
are committed to advancing development of the program, with a hope to positively impact patients around the
world who are waiting for improved treatments.”
About Sernova’s Hemophilia A Cell Pouch System Program
Sernova’s Hemophilia A program combines the Sernova Cell Pouch™ with a patient’s own cells and will not
require the use of immunosuppression medications. This therapy is intended to replace Factor VIII (FVIII) - an
essential blood-clotting protein that is deficient or absent in patients with hemophilia A; this is accomplished by
correcting the patient’s own Blood Outgrowth Endothelial Cells (BOECs) and subsequently returning them to
the patient via the Cell Pouch™. These modified cells function to release FVIII into the bloodstream, restoring
the patient’s ability for clotting during periods of bleeding.
Sernova and research partners, through a Horizon 2020 grant which is part of the EU's research and innovation
funding program in proof-of-concept work, successfully corrected human blood cells from patients with
hemophilia A to produce Factor VIII using a novel first-in-class gene and cell therapy approach where the
corrected cells were transplanted into the pre-implanted, vascularized Cell Pouch in a preclinical model of
Hemophilia A. The work demonstrated an improvement in blood clotting using the combined technologies
(Efficient and safe correction of hemophilia A by lentiviral vector-transduced BOECs in an implantable device;
Molecular Therapy: Methods & Clinical Development Vol.23, Dec 2021).
Collaboration with the University of Piemonte Orientale
The company is pleased to announce a collaboration with the University of Piemonte Orientale, Italy under the
direction of Antonia Follenzi MD, Ph.D. Professor of Histology and Cell and Gene therapy. Dr. Follenzi is a
pioneer of cell and gene therapy approaches to cure Hemophilia A. Her laboratory has expertise in the
generation of BOECs from Hemophilic patients and correcting the FVIII gene using Lentiviral vectors.
The purpose of the new collaboration is to optimize the technology using lentiviral vectors to drive the
expression of FVIII transgene under the control of novel promoters into BOECs of hemophilia patients to
achieve optimal sustained production of FVIII using an optimized cell dose within the Cell Pouch in an animal
model of Hemophilia A. The overall goal of the collaboration is to develop a product combination along with
pre-clinical results that support advancing into clinical trials in patients with Hemophilia A.
Professor Follenzi stated, “I am pleased to be working with the Sernova team on these advanced technologies
for a new and safe treatment of patients with Hemophilia A using a gene and cell therapy approach within the
Cell Pouch. Our goal is to advance these new technologies to further maximize the release of FVIII into the
bloodstream and to extend the duration of that release for a sufficient duration of time to eliminate the need
for weekly infusions of FVIII and to significantly improve the lives of people with Hemophilia A.”
BENEFITS OF ODD AND RPDD
Combined benefits of these designations include exclusive marketing rights for a seven-year period, after
marketing approval, a 25% federal tax credit for clinical research expenses incurred in the US which is
applicable for up to 20 years, waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs
(currently worth >US$3 million), ability to qualify to compete for research grants from the Office of Orphan
Products Development (OOPD) to support clinical studies for the orphan indication, and eligibility to receive
regulatory assistance and guidance from FDA to design the development plan.
Furthermore, once the therapy is approved for marketing, it cannot be copied and sold in the US for 7 years
regardless of patent life and the sponsor will be granted a Priority Voucher which can be used to receive
approximately 4 months reduction time of the standard FDA review period or sold.
ABOUT HEMOPHILIA A
Hemophilia encompasses a group of inherited disorders that alter blood coagulation. Classical hemophilia,
also known as hemophilia A, is a hereditary hemorrhagic disorder resulting from a congenital deficit of FVIII
that manifests as protracted and excessive bleeding either spontaneously or secondary to trauma. 1
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. Treatment costs per patient are as high as US $200,000 or more each year, with an
aggregate therapeutic cost of over US$ 10 billion per year.
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.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.
Press Release Communiqué de presse - October 30, 2023 30 October, 2023
Sernova Announces New Advancements of Conformal Coating Technology in Combination with the Cell Pouch System™ at the 2023 IPITA-IXA-CTRMS Joint Congress
LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 30, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today
announced an update on its conformal coating immune protection technology program, that is used in
combination with the Cell Pouch™.
The goal of the program is to eliminate the need for chronic immunosuppression medications, currently used in
islet cell transplantation for type 1 diabetes (T1D) treatment.
The update was presented by Dr. Alice Tomei, of the University of Miami, at the International Pancreas and
Islet Transplant Association (IPITA)-International Xenotransplantation Association (IXA)-Cell Transplant and
Regenerative Medicine Society (CTRMS) Joint Congress, taking place from October 26-29 in San Diego,
California.
The presentation showcased positive advancement in the refinement of the coating composition and process,
outcomes of preclinical studies with the Cell Pouch as well as rationale and historical development of the
technology.
The following summarizes key advancements presented:
• The final conformal coating composition exhibits significantly improved cell compatibility and overall
biocompatibility, representing evolution across years of process development work and preclinical testing.
• Coating process enhancements resulted in a 500% increase in conformal coating production capacity
(number of starting islets to be coated) and an 89% overall islet encapsulation yield (ratio of conformal
coated islets to initial islets). These enhancements have a direct positive impact on the in vitro and in vivo
efficacy of the coated islets.
• The final conformal coated product was purified using a process to contain 98% conformal coated islets
and only 2% empty capsules. This enables an increase in the number of functional coated islets that are
transplanted within the Cell Pouch chambers and minimization of graft volume.
• Using these composition and process development improvements, the coated islets were tested, in
combination with the Cell Pouch, in a syngeneic gold standard animal model of T1D to assess the safety
and efficacy of the combined product.
o Biocompatibility of the coated islets within the Cell Pouch was confirmed histologically demonstrating
healthy islets within the vascularized tissue matrix;
o Importantly, normal physiological transfer of glucose-stimulated insulin from the conformal coated islets
within the Cell Pouch was confirmed;
o Diabetic animals that received conformal coated islets within the Cell Pouch exhibited controlled blood
glucose to non-diabetic levels - which reversed upon removal of the Cell Pouch - proving function of the
conformal coated islets.
• A series of pilot studies using conformal coated islets, in combination with the Cell Pouch, in an allogeneic
rat model of T1D established the optimal conditions to achieve diabetes reversal. These conditions, which
are being used in confirmatory allogeneic studies in additional upcoming preclinical work, included:
o Drug kinetic studies which identified the optimal dose and frequency of a single selective immune
response agent to be used in combination with conformal coated islets;
o Islet dose-dependent glucose control was demonstrated using conformal coated islets in the Cell Pouch
with the selective immune response agent.
• The release criteria essential for clinical manufacturing have been developed, including coating
conformality, completeness, stiffness, thickness, and selective permeability. Using these criteria, the
conformal coating material showed long term mechanical stability, durability and selective permeability to
insulin and glucose molecules but not to antibodies or inflammatory cells. These are key requirements for
long-term function of the conformal coating technology in vivo.
• Significant progress was achieved in manufacturing of the coating scale up equipment. Prototype devices
are manufactured, and testing is in progress. Final system design will provide fully automated, GMP-
compliant coating applied to transplantable coated islets. The system function will involve conformal
coating, washing, counting and production monitoring.
“We have made significant advancements in the evolution of the conformal coating technology in our
collaboration with Sernova and are confident we have the final formulation. I look forward to our continuing
studies and presenting more results,” said Dr. Alice Tomei, Miami Engineering Career Development Associate
Professor of Biomedical Engineering at the University of Miami and director of the Islet Immunoengineering Lab
at the Miller School of Medicine Diabetes Research Institute.
“We understand that eliminating the standard immune suppression regimen is key to Sernova delivering a
‘functional cure’ for all T1D patients,” said Cynthia Pussinen, Chief Executive Officer at Sernova. “Our goal is to
continue to drive this technology ahead and ultimately bring a local immune-protected cell product into the
clinic combined with the Sernova Cell Pouch and iPSC islet-like clusters.”
RELEVANT PRESENTATION DETAILS
Title: Transplantation of Conformal Coated Islets in a Pre-Vascularized Cell Pouch™ Device for Beta Cell
Replacement in Diabetic Rats
Session: Islet Transplantation: Engineering the Islet Site Session
Date: Friday, October 27, 2023
ABOUT THE CONFORMAL COATING TECHNOLOGY
The conformal coating technology is a proprietary, mechanically stable, thin, biocompatible, and cross-linked
polymer hydrogel that coats the outside of each individual islet housed within the Cell Pouch. The conformal
coating technology offers selective permeability, with immuno-protective capability, while not interfering with
the kinetics of insulin and glucose release. Importantly, the conformal coating configuration also allows for the
physiological transfer of oxygen and nutrients needed for islet survival and long-term function within the pre-
vascularized Cell Pouch.
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.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.
Press Release Communiqué de presse - October 27, 2023 27 October, 2023
Sernova Announces Positive Ongoing Interim Phase 1/2 Clinical Data for the Cell Pouch System™ for Type 1 Diabetes Trial at the 2023 IPITA, IXA, and CTRMS Joint Congress
• All six patients in the first cohort (Cohort A) were successfully implanted with the 8-channel Cell Pouch
System with post-transplant follow-up periods ranging from 6 months to 3.5 years;
• 5 of 6 patients in Cohort A discontinued insulin therapy (insulin independent) following islet
transplantation into the Cell Pouch and modest islet top-up via portal vein. All 6 patients achieved HbA1c
values in the non-diabetic range (<6.5%);
• In Cohort B, the first 6 of 7 planned patients have received the higher capacity 10-channel Cell Pouch and
5 patients have received a first islet transplant;
• Stable fasting and stimulated serum C-peptide levels were observed following a single islet transplant into
the 10-channel Cell Pouch in the first assessable Cohort B patient who subsequently achieved insulin
independence with a modest portal vein top up.
LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 27, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today presented
interim positive results from its ongoing Phase 1/2 clinical trial investigating islet allotransplantation into pre-
vascularized Sernova Cell Pouch™ during an oral presentation at the 2023 IPITA, IXA, and CTRMS Joint
Congress in San Diego, California.
Enrollment in Cohort A, which utilizes the 8-channel Cell Pouch, is complete with post-transplant data
available for periods of follow-up ranging from 6 months to 3.5 years. Enrollment in Cohort B, which utilizes
the higher capacity Cell Pouch and a revised and better-tolerated immunosuppressive regimen, began in
November 2022 and 6 of the 7 planned patients have now been successfully implanted.
The primary objective of the study is to investigate the safety and tolerability of islet transplantation into Cell
Pouch in patients with T1D, impaired hypoglycemia awareness, and a history of severe hypoglycemic episodes.
Secondary study objectives include establishment of islet release criteria predictive of outcomes from islet
transplant into the Cell Pouch and optimal dose and concentration ranges for purified islets transplanted into
the Cell Pouch.
Interim results from Cohort A demonstrated successful implantations of the 8-channel Cell Pouch in the 6
treated patients that were well tolerated with no seromas and no unexpected AEs (adverse events), chronic
pain or discomfort. Data showed histological evidence of surviving and functional islets and positive fasting
and stimulated serum C-peptide (a measure of islet insulin secretion) in patients who maintained optimal
immunosuppression. All 6 patients eventually received supplemental, marginal-dose islet infusions via the
portal vein with the first 5 having achieved sustained insulin independence. All 6 Cohort A patients achieved
HbA1c values in the non-diabetic range (<6.5%) with persistent serum fasting and stimulated C-peptide levels
for current durations out to 3.5 years.
In Cohort B, 6 of the planned 7 patients have been implanted with the higher capacity 10-channel Cell Pouch,
without complications. Among the 6 patients that have been implanted, 5 have completed at least one of the
two protocol-defined islet transplants to Cell Pouch.
The first assessable patient in Cohort B following the first Cell Pouch islet transplant showed persistent fasting
and stimulated serum C-peptide, with stable BETA-2 scores (a measure of islet graft function) that continued
at Day 180 following their first islet transplant to Cell Pouch. The same patient showed modest but favorable
improvements in HbA1c from 7.5% at baseline to 6.9% also at Day 180.
The day following the second islet transplant to Cell Pouch, results from a sample of the islets taken from the
donor pancreas on the day of transplant came back positive for the yeast, Candida albicans. Out of an
abundance of caution, Cell Pouches containing the contaminated islets were immediately removed. The Cell
Pouches that were previously transplanted with the first dose of uncontaminated, healthy islets were not
removed and remained in place, continuing to function. Explantation of the Cell Pouches containing
contaminated islets was completed without complications and the patient fully recovered without any wound
or systemic blood infection, demonstrating the designed retrievability of the transplanted Cell Pouch.
Following recovery, this patient received a modest intraportal islet transplant and remains insulin independent.
The revised immunosuppression protocol, used in Cohort B, continues to demonstrate favorable protection for
the islet grafts with no donor islet rejection or donor specific antibodies observed under the new regimen.
“I am pleased with the overall patient outcomes and learnings from the first trial cohort. We have applied those
learnings to the second patient cohort along with the introduction of the higher capacity 10-channel Cell
Pouch.” commented Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The
University of Chicago, and principal investigator for the Sernova trial. “I am encouraged by the positive safety
profile observed with Cell Pouch implants longer than 4 years, and early patient outcomes with the enhanced
10-channel device that we are using in the second cohort. Enrollment of the second cohort is nearly complete,
and I look forward to reporting further results.”
“We are very encouraged by the results and our learnings from our trial to date.” said Cynthia Pussinen, Chief
Executive Officer at Sernova. “Having recently advanced the trial into Cohort B, using our higher capacity 10-
channel Cell Pouch, we are already seeing positive signals for both safety and efficacy. We look forward to
sharing the next trial update, in the coming months.”
These results were presented by Piotr Witkowski, Professor of Surgery at the University of Chicago at the
International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation
Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress, taking
place from October 26 – 29 in San Diego, CA as an oral presentation entitled “Islet allotransplantation into pre-
vascularized Sernova Cell Pouch - Lessons learned from the first patient cohort” (Abstract #105, Session: “Islet
Transplantation: Engineering the Islet Site Session,” Thursday, October 26, 2023 2:45 p.m. to 3:45 p.m. PT)
For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).
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.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.
Press Release Communiqué de presse - October 11, 2023 11 October, 2023
Sernova to Provide Two Program Updates in Podium Presentations at 2023 IPITA Congress
Dr. Piotr Witkowski presenting new data from ongoing Phase 1/2 clinical trial of the Cell Pouch System™ in patients with type 1 diabetes (T1D)
Dr. Alice Tomei presenting preclinical data on transplantation of conformal coated islet cells in pre- vascularized Cell Pouch
LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced two oral presentations at the upcoming International Pancreas and Islet Transplant Association (IPITA), International Xenotransplantation Association (IXA) Cell Transplant & Regenerative Medicine Association (CTRMA) joint congress taking October 26-29, 2023 in San Diego, CA.
More details about the conference, including accepted abstracts, are available on the IPITA website HERE. In alignment with the embargo policy, Sernova plans to share details from both speakers lectures following completion of their presentations.
Presenation details:
Abstract #: 105.1 Title: Islet allotransplantation into pre-vascularized Sernova Cell Pouch™ - Lessons learned from the first patient cohort Presenter: Piotr Witkowski, United States, Associate Professor of Surgery, University of Chicago Session: Islet Transplantation: Engineering the Islet Site Session Date and Time: Thursday, October 26, 2023 from 2:45 p.m. to 3:45 p.m. PT
Abstract #: 205.1 Title: Transplantation of conformal coated islets in a pre-vascularized Cell Pouch™ device for beta cell replacement in diabetic rats Presenter: Alice Tomei, United States, Associate Professor - Biomedical Engineering and Diabetes Research Institute, University of Miami Session: Engineering the site (Joint) Session Date and Time: Friday, October 27, 2023 from 8:30 a.m. to 9:30 a.m. PT
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 insulindependent 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 insulinproducing 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:
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 Communicaons 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.
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.
Press Release Communiqué de presse - September 14, 2023 14 September, 2023
Sernova Investor Conference Call Previously Scheduled for September 15 Now Rescheduled for September 22
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 14, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced
it has rescheduled the investor and analyst conference call previously scheduled for September 15 at 10 a.m.
Eastern Time. The call will now occur on September 22 at 10 a.m. Eastern Time. The business strategy and
update call remains as scheduled for October 5, 2023.
This call will introduce the newly appointed CEO, Cynthia Pussinen, as well as the recently appointed Chief
Business Officer, Dr. Modestus Obochi, Ph.D., MBA, and will discuss the overall vision of both executives to
deliver novel medical therapies to patients.
CEO Introduction:
Date: Friday, September 22, 2023
Time: 10:00 a.m. Eastern Time
Dial-In: 1-877-704-4453
Conference ID: 13741199
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1634340&tp_key=29a41cab17
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 13, 2023 13 September, 2023
Sernova to Host Investor Calls to Introduce Newly Appointed CEO and Provide Business Update
- Introduction of New CEO Cynthia Pussinen and Recently Appointed Chief Business Officer, Dr. Modestus
Obochi, on September 15, 2023 -
- Business Update, Strategy & Outlook Call on October 5, 2023 -
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 13, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced
it will host two investor and analyst conference calls, with corresponding live webcasts.
The first of these two events will introduce the newly appointed CEO, Cynthia Pussinen, as well as the recently
appointed Chief Business Officer, Dr. Modestus Obochi, Ph.D., MBA, and will discuss the overall vision of both
executives to deliver novel medical therapies to patients. The second in this series of calls is intended to
provide an overall business update and discuss the strategy and operating plans going forward. Details of each
event are as follows:
CEO Introduction:
Date: Friday, September 15, 2023
Time: 10:00 a.m. Eastern Time.
Dial-In: 1-877-704-4453
Conference ID: 13741199
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1634340&tp_key=29a41cab17
Business Update:
Date: Thursday, October 5, 2023
Time: 10:00 a.m. Eastern Time.
Dial-In: 1-877-704-4453
Conference ID: 13741177
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1634043&tp_key=195a900d23
The October 5 event will conclude with a question-and-answer component, and investors can also email
questions in advance to info@sernova.com. The company will answer as many questions as allowable within
the given time constraints. Subsequently, replays of each event will be available on the events section of the
Company’s website at www.sernova.com.
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 07, 2023 7 September, 2023
Sernova Provides Development Update on Proprietary Cellular Conformal Coating Technology in Combination with Cell Pouch Device
Dr. Alice Tomei of the University of Miami, Miller School of Medicine, to present updates in podium
presentation at the 2023 IPITA-IXA-CTRMS Joint Congress being held in San Diego from October 26-29
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 7, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today provided a
development update on its exclusively licensed, proprietary conformal coating immune protection technology,
being advanced in combination with the Cell Pouch™ through a collaboration with Dr. Alice Tomei at the
University of Miami, Miller School of Medicine. The goal of the technology is to eliminate the need for long-
term use of conventional immunosuppressive medications currently required to prevent graft rejection with
Sernova’s flagship cell therapy program for treatment of type 1 diabetes (T1D).
“One of the biggest challenges in bringing a ‘functional cure’ to people living with T1D is preventing therapeutic
cell transplantation from eliciting an immune response without the need for conventional life-long
immunosuppressive agents,” said Dr. Philip Toleikis, Chief Technology Officer of Sernova Corp. “Our conformal
coating technology closely surrounds insulin-producing islets without altering the genetic makeup or function,
offering potential protection from the human immune system while maintaining normal cell function. We are
encouraged by both our ongoing preclinical results, and our continued progress with manufacturing scale-up of
conformally coated islets, which is a key hurdle prior to initiation of clinical studies.”
The conformal coating technology has been developed in partnership with Dr. Alice Tomei, Miami Engineering
Career Development Associate Professor of Biomedical Engineering at the University of Miami and director of
the Islet Immunoengineering Lab at the Miller School of Medicine Diabetes Research Institute. Dr. Tomei will
provide a detailed update of the technology in a podium presentation at the 2023 IPITA-IXA-CTRMS Joint
Congress being held in San Diego from October 26-29. Presentation details will be shared in October 2023.
Dr. Tomei added, “I am pleased with the technical advancements we have made in collaboration with the
Sernova scientific team. We have achieved success in pre-clinical safety and efficacy studies demonstrating the
optimal conditions for conformally coated islets within the Cell Pouch. We have also made significant progress
in developing release criteria which are essential for the clinical manufacturing process. Furthermore, along
with Sernova, we have optimized the manufacturing process and are currently scaling up the GMP production
of the conformally coated islets. These elements are critical to advancing the conformal coating technology
into the clinic for the potential treatment of all patients with T1D. I look forward to sharing more on our
progress at the 2023 IPITA-IXA-CTRMS Joint Congress in San Diego.”
Pre-clinical studies conducted at the University of Miami in collaboration with Sernova demonstrated that
conformally coated islets transplanted into the pre-vascularized Cell Pouch achieved normal blood glucose
control and reversed the effects of T1D in a syngeneic rat model of T1D. Conformally coated islets show
normal responsiveness to glucose and fully regulated insulin production when transplanted in the Cell Pouch.
Treated animals ultimately achieved full insulin independence (return to normal glucose levels).
In optimization studies in T1D animal models transplanted with conformally coated allogeneic islets in an
implanted Cell Pouch, subjects treated with a single selective immune response agent achieved sustained,
normalized blood glucose levels during the study period. These findings support our approach and the
potential to eliminate the need for the immunosuppressive cocktails that are typically used for islet transplant
patients and are frequently associated with toxic side effects.
As prerequisites for clinical testing in humans, characterization assays have been identified to develop and
validate product release criteria for conformal coating. Long-term in vitro stability and durability studies have
been successfully completed and release testing is routinely conducted for the finished coated islet product to
ensure quality, safety, and efficacy potential, prior to the transplantation of conformally coated islets into Cell
Pouch. Sernova is also undertaking a standard array of biocompatibility studies and is completing an allogeneic
optimization study using conformally coated islets in the Cell Pouch with the addition of a selective immune
response agent which has proven effective in the ongoing Phase 1/2 clinical trial of the Cell Pouch System™ in
T1D at the University of Chicago. A single agent provided intermittently with the conformal coating technology
would be a significant advancement in the field of cellular immune protection.
Additionally, through a design and manufacturing partner, Sernova is developing a bench-top, scalable, fully
automated, and GMP-compatible cell coating system. The clinical-scaled system is designed for installation in
GMP cell manufacturing facilities that produce coated islets for clinical trials.
ABOUT THE CONFORMAL COATING TECHNOLOGY
The conformal coating technology is a proprietary, mechanically stable, thin, biocompatible, and cross-linked
polymer hydrogel that coats the outside of each individual islet housed within the Cell Pouch. The conformal
coating technology offers selective permeability, with immuno-protective capability, while not interfering with
the kinetics of insulin and glucose release. Importantly, the conformal coating configuration also allows for the
physiological transfer of oxygen and nutrients needed for islet survival and long-term function within the pre-
vascularized Cell Pouch.
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.
Disclaimer Avis de non-responsabilite
Sernova maintains the investor relations section of this internet site as an informational service and for the readers. Sernova maintient la section des relations investisseurs de ce site Internet en tant que service afin d’informer les lecteurs.
This site is not intended to supplement or substitute for the legal disclosure for the Corporation or the prospectus disclosure related to the public offering of any of its securities. Please read the legal notice on the site before you proceed. Ce site n'a pas pour objet de compléter ou de remplacer la divulgation légale de la Société ou les informations du prospectus relatives à l’offre au public de ses titres. Veuillez lire l'avis juridique sur le site avant de poursuivre.
Privacy PolicyPolitique de confidentialité
Updated July 6, 2018
Please read this Policy carefully along with our Legal Notice that describes our Terms of Use for the Website.
By accessing www.sernova.com (the “Website”) you hereby agree with the practices described in this Privacy Policy (the “Policy”)
This Policy applies to all information gathered through the Website and/or any related marketing technique or events.
Information Collection
The information collected is limited to the information that you decide to share with us through the News Dispatch Service, when participating at event or activities or in the general course of business by expressing an interest in obtaining information about Sernova Corp. and our products, such as name, email, phone number, and similar contact information. This information is stored through MailChimp (please refer to MailChimp Privacy Policy at https://mailchimp.com/legal/privacy/).
Information Sharing
Sernova Corp. is the sole owner of any information collected on the Website. We do not sell, share or rent this information to others.
Traffic and Automatic Information Collection
Sernova Corp. maintains log files of the traffic on www.sernova.com. This information is not linked to any personal information that you have provided us. Logs are used to manage traffic, identify content accessed, and IT requirements. Information logged and automatically collected includes without being limited to IP addresses and browser types. This information does not reveal your specific identity.
Cookies
Cookies can be used to provide you with a more personalized experience. The Website may use cookies to make that experience more companionable when you return to the Website. You have the option at all time to decline the use of cookies. If you choose to do so, you may not be able to fully use all features of the Website. You can also delete cookie files at all time from your computer. Those cookies may include first-party cookies (such as the Google Analytics cookies).
Updates
This Policy is a living document and may be amended or updated from time to time without further notice. We encourage you to review the Policy periodically.
Contact
If you have any questions or comments about our policy, you can email us at info@sernova.com or by phone at 1(877) 299-4603 or by mail at
Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8
Mis à jour le 6 juillet 2018
Veuillez lire attentivement cette politique ainsi que notre avis juridique qui décrit nos conditions d'utilisation du site Web.
En accédant à www.sernova.com (le «site Web»), vous acceptez les pratiques décrites dans la présente politique de confidentialité (la «politique»).
Cette politique s'applique à toutes les informations collectées via le site Web et / ou toute technique ou événement marketing associé.
Collecte d'informations
Les informations collectées se limitent aux informations que vous décidez de partager avec nous par le biais du service d’expédition de nouvelles, lorsque vous participez à un événement ou à des activités ou que vous vous intéressez à obtenir des informations sur Sernova Corp. comme nom, email, numéro de téléphone et informations de contact similaires. Ces informations sont stockées via MailChimp (veuillez vous reporter aux règles de confidentialité de MailChimp sur https://mailchimp.com/legal/privacy/).
Partage d'information
Sernova Corp. est l'unique propriétaire de toute information collectée sur le site Web. Nous ne vendons pas, ne partageons pas ou ne louons pas ces informations à des tiers.
Collecte d'informations routières et automatiques
Sernova Corp. gère les fichiers journaux du trafic sur www.sernova.com. Ces informations ne sont liées à aucune information personnelle que vous nous avez fournie. Les journaux sont utilisés pour gérer le trafic, identifier le contenu accédé et les besoins informatiques. Les informations consignées et collectées automatiquement ne sont pas limitées aux adresses IP et aux types de navigateur. Cette information ne révèle pas votre identité spécifique.
Cookies
Les cookies peuvent être utilisés pour vous offrir une expérience plus personnalisée. Le site Web peut utiliser des cookies pour rendre cette expérience plus conviviale lorsque vous revenez sur le site Web. Vous avez la possibilité à tout moment de refuser l'utilisation de cookies. Si vous choisissez de le faire, vous ne pourrez peut-être pas utiliser toutes les fonctionnalités du site Web. Vous pouvez également supprimer des fichiers de cookies à tout moment depuis votre ordinateur. Ces cookies peuvent inclure des cookies de première partie (tels que les cookies de Google Analytics).
Mises à jour
Cette politique est un document évolutif et peut être modifié ou mis à jour de temps à autre sans préavis. Nous vous encourageons à consulter la politique périodiquement.
Contact
Si vous avez des questions ou des commentaires sur notre politique, vous pouvez nous envoyer un courriel à info@sernova.com ou par téléphone au 1 (877) 299-4603 ou par courrier à
Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8