2023 Press Releases Communiqués de presse

November 27, 2023 27 November, 2023

Sernova Receives Orphan Drug and Rare Pediatric Disease Designations for its Hemophilia A Program from FDA

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 Cong

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

October 11, 2023 11 October, 2023

Sernova to Provide Two Program Updates in Podium Presentations at 2023 IPITA Congress

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 Thyro

September 14, 2023 14 September, 2023

Sernova Investor Conference Call Previously Scheduled for September 15 Now Rescheduled for September 22

September 13, 2023 13 September, 2023

Sernova to Host Investor Calls to Introduce Newly Appointed CEO and Provide Business Update

September 7, 2023 7 September, 2023

Sernova Provides Development Update on Proprietary Cellular Conformal Coating Technology in Combination with Cell Pouch Device

September 5, 2023 5 September, 2023

Sernova Corporation Announces the Appointment of Cynthia Pussinen as CEO

July 26, 2023 26 July, 2023

Sernova Expands Leadership Team with Appointment of Modestus Obochi, Ph.D., MBA, as Chief Business Officer

June 26, 2023 26 June, 2023

Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessi

June 22, 2023 22 June, 2023

Sernova to Present Updated Interim Phase 1/2 Clinical Data on Cell Pouch System™ During Oral Presentation at American Diabetes Association 83rd Scie

June 16, 2023 16 June, 2023

Sernova to Participate in Upcoming Truist Securities Cell Therapy Symposium

May 31, 2023 31 May, 2023

Sernova Announces Executive Alignment and Appoints New Board Chair

May 3, 2023 3 May, 2023

Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications

April 28, 2023 28 April, 2023

SERNOVA CORP. ANNOUNCES VOTING RESULTS OF THE 2023 ANNUAL GENERAL MEETING OF SHAREHOLDERS

April 24, 2023 24 April, 2023

Successful Results Using Sernova's Cell Pouch System™ with Evotec's iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA

April 21, 2023 21 April, 2023

Sernova Reminds Shareholders to Vote FOR the Eight Management Director Nominees Using ONLY the WHITE Management Proxy

April 18, 2023 18 April, 2023

Two Independent Proxy Advisory Firms, Including Glass Lewis & Co. LLC. Recommend Sernova's Shareholders Vote FOR all Management Nominees on Management

April 14, 2023 14 April, 2023

Institutional Shareholder Services Inc. Recommends Sernova's Shareholders Vote FOR all Management Nominees on Management's White Proxy

April 10, 2023 10 April, 2023

Sernova to Present at 2023 Alliance for Regenerative Medicine Cell & Gene Meeting on the Med

April 6, 2023 6 April, 2023

Sernova Responds to Dissident Shareholders' Misleading Statements and Provides Corporate Updates

March 22, 2023 22 March, 2023

Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for

March 14, 2023 14 March, 2023

Sernova Announces Upcoming Podium Presentation of iPSC and Cell Pouch™ Combination Treatment for Type One Diabetes at the 4th IPITA / HSCI / JDRF Su

March 8, 2023 8 March, 2023

Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of

March 2, 2023 2 March, 2023

Sernova to Participate in Upcoming Roth and Oppenheimer Investor Conferences

January 30, 2023 30 January, 2023

Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy

January 10, 2023 10 January, 2023

Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diab

Press Releases from: Communiqués de presse de:

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.



Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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 Communica􀆟ons 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - September 05, 2023 5 September, 2023

Sernova Corporation Announces the Appointment of Cynthia Pussinen as CEO


Industry veteran with deep commercial experience joins to lead the next stage of growth and development

Dr. Philip Toleikis will serve as Chief Technology Officer

Sernova to host investor calls

LONDON, Ontario; Windham County, CT – September 5, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced that its Board of Directors has appointed Cynthia Pussinen as Chief Executive Officer and a member of the Board of Directors. Dr. Philip Toleikis, who has led the company since 2009 as President and CEO will serve as Chief Technology Officer.

Ms. Pussinen’s expertise spans the drug development continuum from research through commercialization. She has led the development, licensure, commercialization and/or subsequent delivery to patients, of more than fifteen new medical therapies for patients globally, including Obizur® (Antihemophilic Factor (Recombinant), Porcine Sequence), Eraxis® (anidulafungin), Zmax® (azithromycin extended-release) and LUXTURNA® (voretigene neparvovec-rzyl), the first gene therapy approved in both the United States and the European Union.

Most recently, Ms. Pussinen was the Chief Technical Officer for Spark Therapeutics, Inc., a fully integrated, commercial gene therapy company, and a member of the Roche Group. Prior to joining Spark in 2021, Ms. Pussinen’s leadership roles include 6 years with Ipsen Biomeasure and Ipsen Biosciences, U.S. R&D focused subsidiaries of Ipsen, where she served as President and CEO. She was instrumental in leading and executing the divestiture of Obizur® and its associated manufacturing physical infrastructure to Baxter. Ms. Pussinen was also the Executive Vice President, Technical Development, Operations & Supply Chain for Actinium Pharmaceuticals, Inc. and the Global Vice President and General Manager, Life Sciences and Specialty Chemicals for Honeywell International. Early in her career Ms. Pussinen spent more than 18 years at Pfizer in a variety of increasingly responsible leadership roles across various functional areas.

Ms. Pussinen also served on the Drexel University Solutions Advisory Board, as a Board Director for Spark Therapeutics UK Ltd. and Spark Therapeutics Ireland Ltd. and is a member of an early-stage biotech company’s scientific and technical advisory board.

Ms. Pussinen earned a Master of Science in R&D management from Rensselaer Polytechnic Institute and a Bachelor of Science in chemistry, with a minor in engineering from the University of Connecticut. She is lean six sigma certified, is recognized as a mentor through the Healthcare Businesswomen’s Association (HBA) and was honored by WEST (Women in the Enterprise of Science and Technology) as a recipient of their Giving Back award.

“Sernova has demonstrated tremendous growth over the past several years as it has transitioned from a research company to one that is moving towards commercialization of a product for the treatment of multiple chronic diseases including our flagship program for Type 1 Diabetes (T1D). As a united Board, we feel now is the time to bring in an industry leader with extensive experience with large pharmaceutical companies as well as entrepreneurial biotech and advanced therapeutics focused companies,” commented Brett Whalen, Chair of the Board of Directors of Sernova. “The skills that Ms. Pussinen brings to our company include over 25 years of global experience shepherding new therapies from development through commercialization across multiple conditions with sales measured in the billions.”

Mr. Whalen continued, “the Board would like to thank Dr. Toleikis for his significant contributions to Sernova and his passionate commitment to our mission, and for continuing in his new role as Chief Technology Officer. Under his leadership, Sernova has solidified the strong scientific and technical foundations for future success and created significant market value driven by the strong positive clinical data outcomes in T1D. The Board is convinced that Ms. Pussinen and Dr. Toleikis bring the right combination of experience and talent to optimize this unique opportunity for all stakeholders.”

Ms. Pussinen added, “It is an honor and a privilege to join Sernova at this pivotal stage in the company’s evolution. Sernova has developed novel technology, and I am very excited by the positive pre-clinical and clinical results thus far. The company is a pioneer in creating new ways to address some of the most challenging chronic diseases, providing the possibility of a life-changing ‘functional cure’ for conditions including Type 1 Diabetes. I am inspired by the mission to improve human health and look forward to working with the passionate Sernova team to boldly advance the company’s mission for the benefit of all patients, stakeholders and investors.”

Dr. Toleikis said, “I am grateful to have led Sernova’s dedicated team over the past years. I am proud of all that we have accomplished together over the past years, including establishing a strong technology and scientific foundation along with introducing new treatments options to patients with chronic conditions. I am very pleased to welcome Ms. Pussinen to the Sernova team as the new CEO and look forward to working together. I look forward to my continued involvement with the Company to see through the realization of Sernova’s mission to bring a functional cure to patients around the world suffering from chronic diseases.

Sernova’s management will host investor calls, firstly to introduce Ms. Pussinen, and later, in approximately 30 days, to provide an overview of Sernova as well as a question-and-answer session. Investors will be informed of the details once finalized.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577 Media: Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - July 26, 2023 26 July, 2023

Sernova Expands Leadership Team with Appointment of Modestus Obochi, Ph.D., MBA, as Chief Business Officer


LONDON, Ontario – July 26, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical- stage company and leader in cell therapeutics, today announced the appointment of Modestus Obochi, Ph.D., MBA, a veteran dealmaker and strategic leader with 25+ years of biotech and pharmaceutical industry experience, as Chief Business Officer effective September 8, 2023.

“Dr. Obochi brings additional invaluable industry acumen to our expanding leadership team,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “His proven expertise in strategy, business development, product lifecycle management, and operational excellence will be vital to our team as we continue to strategically advance our proprietary therapeutic cell therapy technologies including our Cell Pouch System™, both independently and with industry partners, as a potential ‘functional cure’ for multiple chronic diseases.”

Dr. Obochi added, “I am very excited by the significant commercial potential and the immense clinical potential that Sernova’s proprietary cell therapy platform has shown in the ongoing Phase 1/2 study in people living with type 1 diabetes. As an immunologist and someone whose family has been impacted by the devastating effects of T1D, the Sernova opportunity is very personal to me. I look forward to working with Sernova’s management and board of directors, its partners, and research collaborators as we aim to develop Sernova’s proprietary cell therapy platform into a commercially viable ‘functional cure’ modality for multiple chronic diseases, including insulin-dependent diabetes, hemophilia A, and hypothyroidism.”

Based in the Chicago, Illinois area, where he has resided for the last 16 years, Dr. Obochi joins Sernova from Phlow Corp., where he served as Executive Vice President of Strategy and Business Development. In that role, he led the design, development, and execution of corporate strategy and business development plans. He also managed the due diligence, structuring, and negotiations of all transactions, including licensing deals, product acquisitions, partnerships, M&A, and strategic investments. Prior to his role at Phlow Corp., Dr. Obochi held several executive-level commercial and business development roles at leading pharmaceutical companies including Pfizer, Hospira, and Baxter International, and has previously consulted for several biotechnology companies. Most notably, in these roles, Dr. Obochi has helped corporations raise significant capital and has successfully structured and closed multiple strategic transactions worth over $5 billion. Dr. Obochi holds a Ph.D. in Immunology from the University of British Columbia, Vancouver, and an MBA from the Beedie School of Business of Simon Fraser University, Vancouver. He has published over 30 manuscripts, including journal articles and symposia abstracts, and is an inventor on several patents, including one on cell transplantation.

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 therapeutic cell technology 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - June 26, 2023 26 June, 2023

Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessions


• In the first cohort of the ongoing Phase 1/2 clinical trial, the first 5 patients to complete protocol-defined islet transplants achieved insulin-independence for ongoing periods of 6 to 38 months. • Following islet transplants to the 8-channel Cell Pouches, patients in the first cohort required only modest islet top-up via portal vein to achieve insulin independence, supporting the contribution to blood glucose control from islet grafts in the Cell Pouch™. • Five of the 7 planned patients have been enrolled in the second cohort and implanted with higher capacity 10-channel Cell Pouches. Three patients in the second cohort have received their first pancreatic islet transplant to Cell Pouch. • Persistent fasting and stimulated serum C-peptide confirms stable islet graft function in the first evaluable patient to receive islet transplants to the higher capacity Cell Pouch.

LONDON, Ontario – June 26, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical- stage company and leader in cell therapeutics, today announced updated positive interim data from its ongoing Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia unawareness. The new data from the study, which is being conducted by Piotr Witkowski, M.D., Ph.D., at The University of Chicago, were presented during an oral podium presentation at the American Diabetes Association (ADA) 83rd Scientific Sessions, on June 24th, 2023 in San Diego, California.

The presentation discussed the first eleven patients enrolled across two cohorts in the clinical trial evaluating Cell Pouch in combination with pancreatic islets and reconfirmed the safety of Cell Pouch up to more than 4 years following implant. During the trial, the function of the transplanted islets are measured by blood glucose levels, patient insulin usage, and serum C-peptide - a measure of islet insulin secretion.

To date, 5 patients in the first cohort of 6 subjects who have completed Cell Pouch implantation, islet transplant to Cell Pouch, and supplemental portal vein islet infusion, continue to experience insulin independence for periods ranging from 6 months to greater than 3 years. The sixth patient in the first cohort has only recently completed the protocol-defined islet transplants and awaits assessment of their islet graft function.

In addition, updates were provided for the second cohort with the recently implemented 10-channel Cell Pouch with more than 50% greater transplant capacity than the previous 8-channel system. Five of 7 patients meeting the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher capacity Cell Pouch. Three of the 5 patients enrolled in the second cohort have each received a first islet transplant to their implanted Cell Pouches. The first evaluable patient in the second cohort has demonstrated persistent fasting and stimulated serum C-peptide levels following a single islet transplant into the pre-vascularized 10-channel Cell Pouch.

KEY POINTS FROM THE INTERIM CLINICAL UPDATE

• Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favorable safety profile in patients receiving either 8 or 10-channel Cell Pouches. • Five of 6 patients in the first cohort achieved insulin independence following supplemental islet transplants via the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the 8- channel Cell Pouch is supporting ongoing glucose control. • Histological assessment of sentinel Cell Pouches excised at ≥90 days post-transplant revealed surviving functional islets in 5 of 6 patients in the first cohort. • The 5 patients in the first cohort that have achieved insulin independence have each remained free of endogenous insulin therapy ranging from 6 months to greater than 3 years. The sixth patient in the first cohort has recently completed the protocol-defined islet transplants and is awaiting their next islet graft assessment. • In the second cohort, 5 of 7 planned patients are now enrolled and implanted with the higher capacity Cell Pouches. Three of the 5 patients have received their first dose of pancreatic islets transplanted to Cell Pouch. • One patient in the second cohort has demonstrated persistent serum C-peptide levels after only a single islet transplant into 10-channel Cell Pouch. The first patient in the second cohort developed persistent neutropenia requiring cessation of immunotherapy. The third patient awaits their first islet graft assessment. Further data from the second cohort of the clinical trial is expected in the second half of 2023.

“We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10- channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “These additional data continue to confirm our understanding and provide verification of our estimates of islet dose thresholds and density required for optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll the study’s second cohort, while setting the stage for Cell Pouch in combination with Evotec’s iPSC derived islet-like clusters in our upcoming clinical trial.”

Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago, and principal investigator of the clinical trial added, “I continue to be encouraged by the results achieved in this trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell Pouch. I look forward to reporting further data later this year.”

For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).

To add to the ongoing Phase 1/2 clinical trial of the Cell Pouch System in T1D, Sernova also continues to advance its global strategic partnership with Evotec SE (Evotec). Together the companies remain on track to advance Sernova’s Cell Pouch in combination with Evotec’s induced pluripotent stem cell (iPSC) derived islet- like clusters into the clinic. Furthermore, Sernova is advancing its conformal coating cellular immune protection technologies in collaboration with the University of Miami with the goal to reduce or eliminate the need for immunosuppression agents.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a novel therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances, or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - June 22, 2023 22 June, 2023

Sernova to Present Updated Interim Phase 1/2 Clinical Data on Cell Pouch System™ During Oral Presentation at American Diabetes Association 83rd Scientific Sessions


Company to host in-person only analyst and investor event at an offsite location following the presentation on Saturday, June 24 at the ADA Scientific Sessions

LONDON, Ontario – June 22, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical- stage company and leader in cell therapeutics, will be presenting updated interim data from its ongoing Phase 1/2 clinical trial of the Cell Pouch System™ in patients with type 1 diabetes (T1D) and hypoglycemia unawareness at the American Diabetes Association (ADA) 83rd Scientific Sessions, to be held June 23-26, 2023, in San Diego.

The abstract, which was submitted several months ago, written by Dr. Piotr Witkowski, M.D., Ph.D. and his team at The University of Chicago Pritzker School of Medicine, was released by the ADA and shows that five of the six patients receiving the Sernova Cell Pouch remain insulin independent (>2.5 years, >1 year, 10 months, 2 months, and 1 month). With the 6th patient awaiting a final protocol-mandated islet transplant. The oral podium presentation will contain additional updated information and will take place on Saturday, June 24. In alignment with the ADA embargo policy, the additional data updates will be shared by Sernova following the completion of the presentation. The abstract for the oral presentation can be accessed here. Presentation details:

• Abstract: #240-OR • Title: Islet Allotransplantation into Pre-vascularized Sernova Cell Pouch—Early Results from the University of Chicago • Abstract Session: Clinical Islet-Cell Transplantation • Date: Saturday, June 24, 2023 • Time: 5:15 PM PT • Location: Room 30 • Authors: Mateusz Ogledzinski, Sarah Gondek, William Lin, Kamila Milejczyk, Braden Juengel, Lisa Potter, Piotr K. Bachul, Lindsay Basto, Laurencia Perea, Lingjia Wang, Martin Tibudan, Rolf Barth, John Fung, Piotr Witkowski

Sernova will host an in-person analyst and investor event following the presentation at ADA: • Date: Saturday, June 24, 2023 • Time: 6:30 PM PT • Location: The Hilton San Diego Bayfront • Room: Aqua 310B

Register for the event here: https://events.r20.constantcontact.com/register/eventReg? oeidk=a07ejsjhyfz2e580299&oseq=&c=&ch=

Abstracts for the ADA 83rd Scientific Sessions can be accessed here: https://eppro02.ativ.me/src/EventPilot/php/express/web/planner.php?id=ADA23

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - June 16, 2023 16 June, 2023

Sernova to Participate in Upcoming Truist Securities Cell Therapy Symposium


LONDON, Ontario – June 16, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, today announced it will be participating in the upcoming symposia-cel Truist Securities Cell Therapy Symposium being held June 27, 2023 in New York City. Company management will also be participating in one-on-one investor meetings at the conference.

symposia-cel - A Truist Securities Cell Therapy Symposium

Format: Fireside Chat Date: June 27, 2023, 2:15pm Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp Location: Lotte New York Palace

Please contact your representative at Truist to schedule a one-on-one meeting with the management team during the conference.

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 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - May 31, 2023 31 May, 2023

Sernova Announces Executive Alignment and Appoints New Board Chair


LONDON, Ontario – May 31, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical- stage company and leader in cell therapeutics, today announced the outcomes from a strategic and executive leadership review conducted by its Board of Directors (the “Board”).

Following the recent 2023 Annual General Meeting of Shareholders (the “AGM”), the Sernova Board welcomed Mr. Brett Whalen, Dr. Steven Sangha and Mr. Bertram von Plettenberg as newly elected Directors. The newly constituted Board has appointed Mr. Brett Whalen as its new Chair, Mr. Bertram von Plettenberg to serve on its Audit and Compensation Committees, and Dr. Steven Sangha to serve on its Nomination and Corporate Governance Committee. In addition, the new Board has determined that it is in the best interest of the Company that Dr. Philip Toleikis remain as President and Chief Executive Officer and continue leading the Company’s Management Team and executing Sernova’s vision.

“As newly appointed Chair, I would like to welcome Dr. Sangha and Mr. von Plettenberg,” said Mr. Whalen. “As a long-standing shareholder and newly elected Board member, I am excited to take on the role as Chair. I look forward to helping guide the company through its next critical phase of development.”

Sernova’s new Board and Management Team are fully aligned to position the Company in the biotech sector as a leading player developing cell-based ‘functional cures’ for type one diabetes (“T1D”), hypothyroid disease and rare diseases, such as hemophilia A, and are committed to unlocking the value inside of Sernova by ensuring the market recognizes the full potential of the Company and its extendible cell therapy platform and technologies.

The Board recognizes the contributions of the Concerned Shareholders Group that engaged in the democratic process for the recent AGM, and therefore the Company intends, as an act of good faith, and in the interest of fully aligning Sernova shareholders with Management and the Board, to reimburse the Concerned Shareholders Group for their reasonable AGM related expenses. In addition, the Company has re-priced the recently issued options granted to the Board members to $1.20 per share from $0.84, reflecting the unanimous belief from the Board that the market is undervaluing the Company at this time. In a statement from the Concerned Shareholders Group, “The newly constituted Board seems aligned with shareholder interests as evidenced by the above actions. We are pleased to note a change in tone and energy resulting from the new Board composition. We are confident they will bring about the necessary changes to unlock value for the short, medium, and longer-term horizons.”

Dr. Toleikis added, “The most promising days for Sernova from a program and business development perspective are ahead. We look forward to sharing the updated results from our ongoing T1D Phase 1/2 trial with our Cell Pouch System™ at the upcoming American Diabetes Association 83rd Scientific Sessions meeting on June 24th and advancing our second patient cohort towards full enrolment followed by anticipated initial interim results by the end of 2023. Furthermore, we are thrilled to be advancing on schedule the first human clinical studies with iPSC-based insulin-producing islet-like clusters in 2024 under our partnership with Evotec SE that is catching the eye of the investment and pharmaceutical business communities.”

Lastly, Sernova Directors Ms. Deborah Brown and Dr. Mohammad Azab have retired from the Company’s Board, effective May 30th. “The Board and Management wish to recognize and thank Ms. Brown and Dr. Azab for their years of service and contributions in providing guidance to the Company, particularly relating to corporate governance and clinical development, respectively, during their tenure,” said Mr. Whalen.

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - May 03, 2023 3 May, 2023

Sernova Announces Research Collaboration with AstraZeneca to Evaluate Novel Potential Therapeutic Cell Applications


LONDON, Ontario – May 3, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, today announced it has entered into a preclinical research collaboration with AstraZeneca (LSE/STO/Nasdaq:AZN) to evaluate the use of Sernova’s Cell Pouch System™ in combination with AstraZeneca’s novel therapeutic cells.

“Sernova has developed a novel cell therapy approach for the potential treatment of insulin-dependent diabetes, hypothyroidism and hemophilia A,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “By engrafting functional therapeutic cells within an implanted Cell Pouch, which naturally vascularizes with surrounding tissues, we create an environment for the production and release of absent or under-expressed hormones and proteins. We are pleased to be working with AstraZeneca in the preclinical assessment of its various proprietary therapeutic cells in combination with our Cell Pouch.”

AstraZeneca is exploring the use of Sernova’s Cell Pouch System as a potential platform for integration with its development of the next wave of innovative cell therapies for various indications. Under the terms of the collaboration, AstraZeneca will lead and completely fund the development of the cell technologies and pre- clinical activities in conjunction with Sernova. The discovery work is being funded and conducted at AstraZeneca. The preclinical research outcomes will determine the feasibility of potential therapeutic applications and subsequent product development activities between the two companies.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 28, 2023 28 April, 2023

SERNOVA CORP. ANNOUNCES VOTING RESULTS OF THE 2023 ANNUAL GENERAL MEETING OF SHAREHOLDERS


LONDON, Ontario - April 28, 2023 - Sernova Corp. (“Sernova” or the “Corporation”) (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicine company and leader in cell therapeutics focused on developing a potential ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce results from its Annual General Meeting of Shareholders (the “AGM”), held virtually via live audio webcast on April 27, 2023.

The following resolutions were proposed and approved at the AGM: - Dr. Philip M. Toleikis, James T. Parsons, Deborah M. Brown, Dr. Mohammad Azab, Dr. Daniel Mahony, Brett Whalen, Dr. Steven Sangha and Bertram von Plettenberg were elected as directors of the Corporation for the ensuing year. - Appointment of KPMG LLP, as auditors of the Company until the next annual meeting and the authorization of the directors of the Company to fix the remuneration to be paid to the auditors.

The resolution to ratify and confirm amendments to the Option Plan and DSU Plan and to increase the maximum number of Common Shares reserved for issuance was not tabled at the AGM and as such the current incentive plan without the amendments continues in effect.

“As they transition out of their director roles, I would like to acknowledge Frank Holler and Jeffrey Bacha’s many years of contributions to Sernova’s Board of Directors,” said Dr. Philip Toleikis, President & CEO of Sernova Corp. “With today’s results, I would also like to welcome our two new directors, Dr. Steven Sangha and Bertram von Plettenberg to the company. We look forward to working with them as we strive to advance the Cell Pouch™ and work to create other therapeutic options for patients with chronic diseases.

“We are honored to be given the opportunity to represent the voice of all shareholders. As directors on the Board of Sernova, we will work hard to ensure the best interests of the company, shareholders and all other stakeholders are addressed in a timely manner,” said Dr. Steven Sangha and Bertram von Plettenberg.

ABOUT SERNOVA CORP.

Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders including 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. The Cell Pouch on implantation forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release necessary proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase I/II clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova an unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two additional programs that utilize its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral factor 8 gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 24, 2023 24 April, 2023

Successful Results Using Sernova's Cell Pouch System™ with Evotec's iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit


- Evotec’s scalable GMP manufacturing process has been designed to produce induced pluripotent stem cell (iPSC)-derived islet-like clusters (ILCs) with high insulin-producing beta cell content as well as glucagon and somatostatin (produced by alpha cells and delta cells, respectively), similar to human islets - The ILCs are cryopreserved during manufacturing, enabling storage of mass volumes and cost efficient on- demand worldwide delivery as required - Results from a type 1 diabetes (T1D) preclinical model with Evotec’s ILCs implanted into Sernova’s Cell Pouch™ demonstrated robust and durable insulin independence with blood C-peptide levels and glucose tolerance test results equivalent to a test group with human islets - An additional T1D study with Evotec’s ILCs demonstrated sustained normalization of blood sugar levels in diabetic mice throughout the 320 day term of the study - IND filing and Phase 1/2 clinical program with Sernova’s Cell Pouch and Evotec’s iPSC ILCs on track for 2024

LONDON, Ontario – April 24, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, today announced the presentation of preclinical data supporting the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s (FSE: EVT; NASDAQ: EVO) iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of patients with T1D. The objective of the partnership is to produce an off-the-shelf, commercially scalable cell therapy treatment, with human testing anticipated to begin in 2024.

The data were presented by Matthias Austen, PhD, SVP Cell Therapy at Evotec SE (Evotec), as an oral podium presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge, Massachusetts. The presentation included an introduction to Evotec’s proprietary GMP process for manufacturing iPSC-derived ILCs for use in Sernova’s Cell Pouch, as well as encouraging results from multiple studies using a standard mouse model of T1D.

Key findings: - Evotec has developed a scalable GMP manufacturing workflow, starting from GMP-grade iPSCs to the final product of ILCs, yielding a high beta cell fraction with no post-implantation variability of cell composition. - Evotec ILCs are cryopreserved at a late-intermediate stage of differentiation allowing for a cost-effective large-scale manufacturing process to optimize both pre- and post-implantation durability, offering a major advantage over competing cell therapies in development. - ILCs implanted to mouse kidney capsule demonstrated complete and durable normalization of glucose levels in a standard diabetic mouse model out to the pre-planned termination date at 320 days. - ILCs implanted into Sernova’s Cell Pouch demonstrated rapid normalization of glycemic control in the streptozotocin (STZ)-induced diabetic NSG (NOD.SCID.IL-2Rgammanull) mouse model. - Circulating C-peptide levels (a biomarker for insulin production) in mice implanted with the Cell Pouch and ILCs were equivalent after 6 weeks to those in mice that received 4000 IEQ human islets under the kidney capsule. - Efficient glucose clearance and no hypoglycemia was demonstrated in an oral glucose tolerance test administered at 8 weeks post-implantation. Animals implanted with Cell Pouch and ILCs showed an identical glucose clearance time course compared to animals transplanted with 4000 IEQ human islets. - Upon explantation of the Cell Pouch with ILCs after the 32-week survival period, histological graft analyses showed the presence of all relevant islet cell types including insulin-producing beta cells, glucagon-producing alpha cells, and somatostatin-producing delta cells, indicating a favorable cell composition of the implanted ILCs. - Histological graft analyses also revealed extensive intra-graft vascularization, likely contributing to the excellent endocrine cell survival with a high beta cell fraction, and consistent with the observed functional outcomes.

“Our ongoing productive partnership with Evotec continues to progress towards human clinical trials in 2024 with an impressive cell therapy paired with our Cell Pouch to create a potential ‘functional cure’ for T1D,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “These results demonstrate that Evotec’s ILCs in the Cell Pouch can become fully functional endocrine islets following implantation, with potency equivalent to human islets. Our goal is to advance beyond decades-old insulin injections to provide a potential one-time treatment to restore normal pancreatic glycemic control for individuals with T1D. We look forward to providing an update at the American Diabetes Association conference in June on our ongoing Phase 1/2 study in T1D patients with our Cell Pouch containing human donor islet cells and to progressing our next generation product utilizing Evotec cells into the clinic in 2024.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec commented, “We are thrilled to show these results with Evotec’s ILCs that we have spent years perfecting with a scalable cost-effective GMP workflow to create a cryopreserved product with excellent survival under standard shipping conditions and optimized for implantation into Sernova’s Cell Pouch. These new data demonstrating rapid, complete, and durable normalization of glucose control that is equi-potent comparable in potency to human islets is one of the final steps prior to our anticipated human testing in 2024.”

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova has secured an exclusive option for an exclusive global license for Evotec’s ethically derived iPSC insulin producing islet clusters for use with Sernova’s Cell Pouch System or alone with other technologies. Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 21, 2023 21 April, 2023

Sernova Reminds Shareholders to Vote FOR the Eight Management Director Nominees Using ONLY the WHITE Management Proxy


- Protect your investment in Sernova by voting FOR all of Sernova Management’s director nominees. - ISS and Glass Lewis, independent third-party proxy advisory firms, both recommend that shareholders vote FOR Sernova’s eight management nominees and not to vote for the dissident nominees. - The deadline to submit WHITE management proxies is Tuesday April 25, 2023 at 10:00 a.m. (Pacific time) - Shareholders who have questions or need assistance with voting their shares voting should contact Sernova Corp.’s strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452- 7184 or by email at assistance@laurelhill.com.

LONDON, Ontario – April 21, 2023 – Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), reminds shareholders to vote the WHITE management proxy in advance of the proxy voting deadline on Tuesday April 25, 2023 at 10:00 a.m. (Pacific Time) FOR all of the Sernova management director nominees. We thank the many shareholders who have already voted FOR Sernova’s management nominees using the WHITE proxy and urge those who have not voted yet to cast their vote using the WHITE proxy —every shareholder and every share counts.

Shareholders are encouraged to read Sernova’s management information circular, the letter to shareholders the Corporation recently mailed to all shareholders and press releases by visiting Sernova - AGM Annual General Meeting, for details about how a group of dissident shareholders is trying to impose two unqualified nominees on Sernova’s board of directors.

Sernova’s Board Nominees – The Right Team with the Right Experience Sernova’s nominees, Frank Holler, Dr. Mohammad Azab, Jeffery Bacha, Deborah Brown, Dr. Daniel Mahony, James Parsons, Dr. Philip Toleikis and Brett Whalen possess the skills Sernova needs to continue the successful execution the Corporation’s plan to progress Sernova to its next stage of development:

- Significant expertise and experience in leading biotech companies. Sernova’s nominees all have significant breadth and depth of expertise and experience in directing public biotech, pharmaceutical, and healthcare sector companies in Canada and elsewhere. - Director Qualifications. Sernova’s nominees each have deep biotechnology industry experience encompassing relevant capabilities in finance, product and corporate development. The board has been developed and refreshed over time against a specific skills matrix with currently 50% of the board having served for less than 4 years. - Strong Financial and Cash Position. Sernova ended Q1 2023 with a strong balance sheet including cash resources of $45.6 million. Since the April 2022 annual meeting of shareholders, proceeds of $8 million were raised from the full exercise of the remaining outstanding 2019 and 2020 private placement common share purchase warrants. Additionally, the Company completed a private placement with strategic partner Evotec resulting in a total equity investment of $27 million.

In addition, within the last year, Sernova’s Board and management team have made significant progress with a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System (“CPS”), a novel implantable medical device with immune protected therapeutic cells. With a strong management and Board of Directors in the last 12 months the Company has:

- In May, 2022 - Entered into a global strategic partnership with Evotec SE (“Evotec”) 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 islet clusters to treat millions of patients with insulin-dependent diabetes (both type 1 and type 2). - In June, 2022 - Transitioned the Company from the TSX Venture Exchange to the TSX as part of the Company’s capital markets strategy to access a broader base of investors and position the Company more favourably for institutional investment. - In January 2023 - The Company announced the confirmation of its hypothyroid program proof-of concept, demonstrating that thyroid auto-transplantation in the Cell Pouch can compensate for removal of the thyroid gland and restore normal thyroid hormone production – potentially a lifechanging treatment for patients who have gone through the thyroid gland removal procedure.

Vote FOR your Management Nominees using ONLY Management’s WHITE Proxy Voting is easy. We encourage you to vote online or by telephone using the information on your WHITE proxy. Shareholders who have voted using the dissident’s GOLD proxy and wish to support Sernova’s management nominees still have the right to change their vote by simply voting FOR Sernova’s management nominees using the WHITE proxy. A later dated WHITE proxy will replace a previously submitted vote.

YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S MANAGEMENT NOMINEES AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN

Shareholders are encouraged to vote your shares as soon as possible. The deadline for voting your shares is at 10:00 a.m. (Pacific Time) on Tuesday April 25, 2023.

Sernova’s board of directors recommends that shareholders vote FOR all of the management director nominees and meeting resolutions using only the WHITE proxy.

Shareholder Questions Shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation agent and shareholder communications advisor:

Laurel Hill Advisory Group Toll Free: 1-877-452-7184 (for shareholders in North America) International: +1 416-304-0211 (for shareholders outside Canada and the US) By Email: assistance@laurelhill.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 Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 18, 2023 18 April, 2023

Two Independent Proxy Advisory Firms, Including Glass Lewis & Co. LLC. Recommend Sernova's Shareholders Vote FOR all Management Nominees on Management's White Proxy


- Following Institutional Shareholder Services’ positive recommendations, Glass Lewis is the second independent, third-party proxy advisory firm to recommend Sernova’s shareholders vote FOR all management’s director nominees using ONLY management’s WHITE proxy. - Glass Lewis does not believe Sernova’s dissident shareholders have compiled a sufficiently compelling case to warrant investor support and refers to their arguments as “incomplete”. - Shareholders who have questions or need assistance with voting their shares should contact Sernova Corp.’s strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452-7184 or by email at assistance@laurelhill.com.

LONDON, Ontario – April 18, 2023 – Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce that a second independent, third-party proxy advisory firm, Glass Lewis & Co. LLC (“Glass Lewis”), has recommended Sernova’s shareholders vote FOR all of Sernova’s management nominees using only management’s WHITE proxy.

Glass Lewis also recommended that shareholders vote FOR the appointment of KPMG LLP as Sernova’s auditors and FOR the resolution to amend the Corporation’s stock option plan and DSU Plan.

Glass Lewis is a leading independent, third-party proxy advisory firm which provides proxy voting recommendations to pension funds, investment managers, mutual funds, and other institutional shareholders.

Reasons for Glass Lewis’ Support of Sernova’s Management Nominees Glass Lewis’ recommendation that shareholders vote FOR all of Sernova’s management nominees using only management’s WHITE proxy, is based on a number of factors. Glass Lewis’ report states: “In this case… we do not believe the Dissidents have compiled a sufficiently compelling case to warrant investor support at this time. Our view in this regard hinges on three principal factors: (i) the Dissidents overall case against incumbent management and the board is fairly broad and arguably incomplete, with core analyses (e.g. share price performance) lacking context and certain strategic commentary failing to offer much depth relative to the board's much more copious rebuttal; (ii) the need to pursue the Dissidents' promulgated alternatives for the Company (i.e. positioning Sernova to secure additional financing within the next 18 months, investing in a go-to-market strategy, solidifying succession planning) is not especially well established, in our view, particularly given the Company's stable capital position and relationship with Evotec; and (iii) the Dissident nominees — which include a dentist with unspecified experience investing in early stage companies and a business consultant with a prior relationship with Sernova — do not appear to represent a clear, incremental improvement over the incumbent board members.

We also consider the board has, with due reference to Sernova's development stage and size, offered a reasonably well-rounded corporate update, touching both on the Company's prior milestones and anticipated near-term developments. The board also draws attention to Sernova's currently adequate capital position, which, though certainly not intended to serve as an indefinite bulwark against future funding requirements, appears to offer Sernova sufficient near-term liquidity and structural flexibility.

Under these conditions, we do not see that the Dissidents have provided Sernova investors with sufficient cause to support their agenda at this time.”

Glass Lewis Recommends Support of Sernova’s Proposed Securities Authorized for Issuance Under its Equity Compensation Plans Glass Lewis recommended that shareholders vote FOR the resolution to amend the Corporation’s stock option plan and DSU Plan, as the proxy advisory firm believes the terms of the plan are in line with the majority of similar equity-based plans of TSX issuers. Glass Lewis’ view is that the plan will serve to strengthen the alignment of company and shareholder interests. The Corporation believes that encouraging its executive officers, senior management and employees to become shareholders is the best way of aligning their interests with those of its long-term shareholders. As a result, executive officers management and employees are provided with the opportunity to participate in the appreciation of the Corporation’s share price, through Sernova’s equity compensation incentive plan.

Vote FOR your Management Nominees using ONLY Management’s WHITE Proxy It is up to you to protect the value of your investment in Sernova by voting FOR the eight management nominees. We encourage you to read Sernova’s management information circular and visit our website at www.sernova.com for more information. It is important that you ACT TODAY to protect your investment by voting FOR Sernova’s management nominees.

Sernova’s management nominees, Frank Holler, Dr. Mohammad Azab, Jeffery Bacha, Deborah Brown, Dr. Daniel Mahony, James Parsons, Dr. Philip Toleikis and Brett Whalen are committed to creating value for the Company’s shareholders through delivering results from clinical trials, expanding the Sernova’s Cell Pouch System™ technology platform for additional indications, and building on the relationships with the Corporation’s business partners to create long term shareholder value.

YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S MANAGEMENT NOMINEES AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN

Shareholders are encouraged to read Sernova’s management information circular and vote your shares as soon as possible. The deadline for voting your shares is at 10:00 a.m. (Pacific Time) on Tuesday, April 25, 2023.

Sernova’s board of directors recommends that shareholders vote FOR all of the management director nominees and meeting resolutions using only the WHITE proxy.

Shareholder Questions Shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation agent and shareholder communications advisor:

Laurel Hill Advisory Group Toll Free: 1-877-452-7184 (for shareholders in North America) International: +1 416-304-0211 (for shareholders outside Canada and the US) By Email: assistance@laurelhill.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 Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends",

"estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 14, 2023 14 April, 2023

Institutional Shareholder Services Inc. Recommends Sernova's Shareholders Vote FOR all Management Nominees on Management's White Proxy


- ISS, an independent, third-party proxy advisory firm, recommends Sernova’s shareholders vote FOR all management’s director nominees using ONLY management’s WHITE proxy. - ISS notes the dissidents failed to present a detailed explanation of their case and there does not seem to be a compelling case that change at Sernova is warranted at this time. - Shareholders who have questions or need assistance with voting their shares voting should contact Sernova Corp.’s strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452- 7184 or by email at assistance@laurelhill.com.

LONDON, Ontario – April 14, 2023 – Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce that Institutional Shareholders Services Inc. (“ISS”) has recommended Sernova’s shareholders vote FOR all of Sernova’s management nominees using only management’s WHITE proxy.

ISS is a leading independent, third-party proxy advisory firm which provides proxy voting recommendations to pension funds, investment managers, mutual funds, and other institutional shareholders.

Reasons for ISS’ Support of Sernova’s Management Nominees In reaching its conclusion to recommend that Sernova’s shareholders vote FOR the Corporation’s management nominees and reject the attempt of a group of dissident shareholders to impose their director nominees on Sernova, ISS provided a number of reasons including the following:

“As the dissident has failed to present a detailed explanation of its case, there does not seem to be a compelling case that change is warranted at this time. The case for change is further impaired by the fact that the dissident has targeted two of the more tenured and experienced board members…. As such, the election of the dissidents to the board carries risk to cause an additional near-term impact at the management level which diverges from a status quo that does not seem unreasonable. Shareholders are therefore recommended to vote on the management proxy card for the eight management nominees.”

ISS’ review of dissident shareholders reasons for proposing change on Sernova’s board shows that a number of claims the dissidents made in their communications with Sernova’s shareholders are unsubstantiated:

“The dissident's arguments do not provide context in support of its claims, and the proposed solution does not include a reasoned basis for how it could lead to a superior outcome. As the dissident has not made a compelling case that board change is necessary at this time, votes on the management proxy card for the eight management nominees are warranted…. Moreover, the company's ability to secure relevant industry partnerships, as evidenced by its agreement secured with Evotec during 2022, seems difficult to call into question. The board has overseen the successful up-listing of the company to the TSX and there are members of the incumbent board which have sat on NASDAQ-listed biotech boards. In addition, the company seems to communicate interim data or study progress updates to shareholders multiple times annually and continues to provide this information at investor conferences, making broad-based allegations with respect to company communication look dubious.”

Vote FOR your Management Nominees using ONLY Management’s WHITE Proxy It is up to you to protect the value of your investment in Sernova by voting FOR the eight management nominees. We encourage you to read Sernova’s management information circular and visit our website at www.sernova.com for more information. It is important that you ACT TODAY to protect your investment by voting FOR Sernova’s management nominees.

Sernova’s management nominees, Frank Holler, Dr. Mohammad Azab, Jeffery Bacha, Deborah Brown, Dr. Daniel Mahony, James Parsons, Dr. Philip Toleikis and Brett Whalen have reputational credibility in capital markets to finance the growth of the Company. Sernova’s board and management team are committed to creating value for the Corporation’s shareholders through delivering results from clinical trials, driving preclinical programs, expanding the application of Sernova’s Cell Pouch System technology.

YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S MANAGEMENT NOMINEES AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN

Shareholders are encouraged to read Sernova’s management information circular and vote your shares as soon as possible. The deadline for voting your shares is at 10:00 a.m. (Pacific Time) on Tuesday April 25, 2023.

Sernova’s board of directors recommends that shareholders vote FOR all of the management director nominees and meeting resolutions using only the WHITE proxy.

Shareholder Questions Shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation agent and shareholder communications advisor:

Laurel Hill Advisory Group Toll Free: 1-877-452-7184 (for shareholders in North America) International: +1 416-304-0211 (for shareholders outside Canada and the US) By Email: assistance@laurelhill.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

Investor Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 10, 2023 10 April, 2023

Sernova to Present at 2023 Alliance for Regenerative Medicine Cell & Gene Meeting on the Med


LONDON, Ontario – April 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, today announced that President and Chief Executive Officer, Dr. Philip Toleikis, will present at the upcoming annual Cell & Gene Meeting on the Med to be held April 12-14, 2023 at the Hotel Arts Barcelona in Barcelona, Spain and livestreamed globally.

Panel: Navigating CGTx Development in 2023 Date: Wednesday, April 12, 2023 Time: 4:45 – 5:30 PM CET Location: BioCentriq Ballroom | Hotel Arts Barcelona, Spain

Virtual attendance is available which includes a livestream of Sernova’s presentation and the ability to view all conference sessions on-demand. Please visit https://meetingonthemed.com/ for full information including registration.

Complimentary attendance at this event is available for credentialed investors. Investors should contact Laura Stringham at lstringham@alliancerm.org.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com

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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - April 06, 2023 6 April, 2023

Sernova Responds to Dissident Shareholders' Misleading Statements and Provides Corporate Updates


- The dissident director nominees declined to follow proper protocol to participate in Sernova’s board renewal process and instead are imposing themselves on the Company through a costly and disruptive proxy battle - Management and the Board have placed Sernova in a position to bring value to shareholders and in a challenging time for companies in the biotech sector, Sernova’s share price is up 17% year-to-date compared to an 8% decline in the benchmark Nasdaq XBI biotech index over the same period - Shareholders who have questions or need assistance with voting their shares should contact Sernova’s proxy solicitation agent, Laurel Hill Advisory Group by telephone at 1-877-452-7184 or by email at assistance@laurelhill.com

LONDON, Ontario – April 6, 2023 – Sernova Corp. (“Sernova” or the “Company”) (TSX:SVA) (OTCQB: SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today responds to misleading statements made in a press release from a group of dissident shareholders. Additionally, Sernova is pleased to highlight select upcoming milestones for the remainder of 2023 and into 2024 and provides an update on key achievements and events since the Company’s last annual general meeting (AGM) in 2022.

BACKGROUND TO DISSIDENT ACTIONS AND BOARD RENEWAL PROCESS

Leading up to the Company’s 2023 annual meeting of shareholders and pursuant to Sernova’s Advance Notice By-law, the Company received two nominations for the position of director to Sernova’s board of directors (the “Board”) from the dissident shareholders. A third candidate also expressed interest in joining Sernova’s board of directors. With three candidates to consider for a single board seat, the board’s Nominating and Governance Committee (the “NGC”) invited all three candidates to participate in a formal review and rigorous evaluation process, including presentation of their respective credentials and expertise to the board. Following good corporate governance practices, Sernova’s NGC evaluates candidates against formalized criteria and a skills matrix that align with the Company’s current, and more importantly, future needs to ensure the best candidates are selected as nominees for election to the board.

The Dissident Shareholders’ claim that the board did not meaningfully engage is simply untrue

- Only one candidate, Mr. Brett Whalen, chose to participate in the formal process. After rigorous evaluation, vetting and determination that his background and experience would be beneficial to the future direction of the Company, Mr. Brett Whalen was selected for nomination for election to the board at Sernova’s 2023 annual meeting of shareholders. - The two individuals nominated by the dissident shareholder group elected not to participate in the interview process nor did they meet with Sernova’s board. Instead, they have chosen to go the route of a costly and distracting proxy battle.

The Dissident Shareholders are opposing the revised / amended compensation plan based on their claim that management unilaterally decreased their price from $1.30 to $0.91, which is simply untrue

- No outstanding stock options have been repriced by the Company nor is there any intention. - The pricing of any future stock options granted by the Company would be in compliance with the policies of the TSX.

The current board members are well positioned to build on the progress the Company has made to date and take Sernova to its next stage of development as outlined under the Corporate Updates below.

CORPORATE UPDATES

Sernova’s board and management team are committed to creating value for the Company’s shareholders through delivering results from clinical trials, driving preclinical programs, expanding the Company’s Cell Pouch System technology platform to additional indications, and evolving industry relationships for potential future partnership opportunities to create long term shareholder value. The Company is providing the following updates to keep shareholders abreast of developments and work that will create value for shareholders.

BIOTECH INDUSTRY PERFORMANCE AND SERNOVA SHARE PRICE

After a record-breaking year in 2021, 2022 was one of the most challenging years for the general healthcare and biotech industries in capital markets history. Similar to that experienced by peer companies and healthcare related industries as a whole, Sernova’s share price was negatively impacted with investors reallocating capital to other market sectors. Despite the ongoing difficult markets, Sernova has made encouraging progress in 2023 as reflected in its share performance being up 17% year-to-date (as of April 3, 2023) compared to an 8% decline in the Nasdaq XBI biotech index over the same period. The 25% relative advance of Sernova’s share price compared to this benchmark index recognizes the sound fundamentals and progress as the Company continues to deliver results from the clinic and evolve preclinical programs and key technologies to create long term shareholder value.

UPCOMING EVENTS AND PROGRAM MILESTONES

- On April 24, 2023, the Company’s global iPSC strategic partner, Evotec SE (Evotec), will showcase the first data on the use of its iPSC pancreatic islet-like clusters in Sernova’s Cell Pouch™ in a podium presentation at the IPITA / HSCI / JDRF Summit. The peer reviewed abstract is entitled: “Manufacturing of Optimized Human Islet-like Clusters (ILCs) from iPSCs and Functional Testing of an ILC + Cell Pouch Combination In Vivo.” - On June 24, 2023, the research team of Dr. Piotr Witkowski, primary investigator for the Company’s ongoing Phase 1/2 clinical trial for type-1 diabetes (T1D), will deliver an oral presentation at the American Diabetes Association (ADA) 83rd Scientific Sessions, providing an update on interim results from patients enrolled and treated in the ongoing study. The peer reviewed abstract is entitled: “Islet Allotransplantation into Prevascularized Sernova Cell Pouch – Early Results from the University of Chicago.” - During 2023 H2, Sernova anticipates providing the first interim data for the recently initiated second cohort of patients for its ongoing Phase 1/2 T1D clinical trial using the dose-optimized higher capacity 10-channel Cell Pouch. - In 2024, Sernova plans to initiate a Phase 1/2 clinical trial for T1D with Evotec’s iPSC islet-like cluster technology in Sernova’s Cell Pouch. - In 2024, Sernova plans on initiating a Phase 1/2 clinical trial for treatment of hypothyroid disease following complete thyroidectomy and transplanting a patient’s own healthy thyroid tissue into the Sernova Cell Pouch.

SELECT HIGHLIGHTS SINCE SERNOVA’S 2022 AGM

Advances in Sernova’s U.S. Phase 1/2 clinical trial for the treatment of T1D and hypoglycemia unawareness (the “Phase 1/2 T1D Study”) - November 2022 – Completion of enrollment for the first cohort of patients. - November 2022 – Regulatory clearance received to proceed to enroll a second patient cohort (of up to seven patients) with the dose optimized higher capacity 10-channel Cell Pouch. - January 2023 – The first two patients in the second cohort were enrolled and implanted with the dose optimized 10-channel Cell Pouch. - March 2023 – The second cohort’s third patient was enrolled and implanted with the dose optimized 10- channel Cell Pouch and initial islet transplantation completed for the first two patients.

May 2022 – Sernova signed a landmark iPSC stem cell technology deal with Evotec - Sernova and Evotec entered an exclusive global strategic partnership to develop a best-in-class iPSC stem cell-derived technology to provide a commercially viable supply of islet clusters for patients living with insulin- dependent diabetes. - Sernova has option exercise rights for an exclusive global license up to and upon filing of an IND. - Evotec will contribute its cell manufacturing capabilities through research, development and product commercialization and may also jointly fund future clinical development. Upon commercialization, royalties will be payable by Sernova to Evotec with the royalty rate dependent on Evotec’s participation in funding of the clinical development program. - Evotec made a strategic investment into Sernova with an initial 6% equity stake.

June 2022 - Sernova common shares up-listed to the Toronto Stock Exchange (TSX) - Transition from the TSX Venture Exchange to the TSX was part of the Company’s capital markets strategy to pursue more senior exchange listings, at the appropriate time, to access a broader base of investors and position the Company more favourably for institutional investment. - This transition also further favourably readies the Company to leverage the unique advantages of the Multijurisdictional Disclosure System (“MJDS”) available to qualifying Canadian companies for a potential future senior U.S. exchange listing. A senior U.S. exchange listing would be contingent on further improvement to the challenging capital markets for healthcare companies.

June 2022 – Dr. Piotr Witkowski presented positive interim Phase 1/2 clinical data in an oral podium presentation at the American Diabetes Association 82nd Scientific Sessions - The first three transplanted patients presented positive serum C-peptide values confirming active insulin production after islet transplantation into the Cell Pouch System. - All patients who had favorable immunosuppression achieved complete insulin independence with normal HbA1c measurements of 5.0, 5.2 and 5.2%.

January 2023 – Hypothyroid program proof-of-concept confirmed and advancements announced - A pre-clinical study confirmed proof-of-concept for the thyroid indication – the third indication for the Company’s Cell Pouch System™ - demonstrating that thyroid auto-transplantation in the Cell Pouch can compensate for removal of the thyroid gland (total thyroidectomy), restoring normal thyroid hormone production. - Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective therapy for hypothyroidism.

FINANCIAL AND CASH RESOURCES UPDATE

- Sernova ended Q1 2023 with a strong balance sheet including cash resources of $45.6 million. - Since the April 2022 AGM: - Proceeds of $8 million were raised from the full exercise of the remaining outstanding 2019 and 2020 private placement common share purchase warrants. - The Company completed a private placement with strategic partner Evotec resulting in a total equity investment of $27 million.

VOTE TODAY USING ONLY MANAGEMENT’S PROXY

Shareholders are encouraged to read Sernova’s 2023 AGM Management Information Circular available on the Company’s website at www.sernova.com/investor/agm. The best path forward is for shareholders to vote for management’s slate of directors and the resolutions contained within.

YOUR VOTE HAS NEVER BEEN MORE IMPORTANT. VOTE YOUR SHARES FOR SERNOVA’S NOMINEES USING ONLY MANAGEMENT’S PROXY AS SOON AS POSSIBLE, REGARDLESS OF THE NUMBER OF SHARES YOU OWN

The deadline for voting your shares is at 10:00 a.m. Pacific Time on Tuesday April 25, 2023.

SHAREHOLDER QUESTIONS

Sernova shareholders who have any questions or require assistance with voting may contact Sernova’s proxy solicitation agent and shareholder communications advisor:

Laurel Hill Advisory Group Toll Free: 1-877-452-7184 (for shareholders in North America) International: +1 416-304-0211 (for shareholders outside Canada and the US) By email: assistance@laurelhill.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 Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - March 22, 2023 22 March, 2023

Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for Oral Podium Presentation at American Diabetes Association 83rd Scientific Sessions 2023


LONDON, Ontario – March 22, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, is pleased to announce that an abstract has been selected for an oral podium presentation at the upcoming American Diabetes Association (ADA) 83rd Scientific Sessions, to be held from June 23-26, 2023, in San Diego, CA. It will also be published on the journal Diabetes® website.

Abstract: #240-OR Title: Islet Allotransplantation into Pre-vascularized Sernova Cell Pouch—Early Results from the University of Chicago Abstract Session: Clinical Islet-Cell Transplantation Date/Time: Saturday June 24, 2023 at 5:15 PM PT Authors: Mateusz Ogledzinski, Sarah Gondek, William Lin, Kamila Milejczyk, Braden Juengel, Lisa Potter, Piotr K. Bachul, Lindsay Basto, Laurencia Perea, Lingjia Wang, Martin Tibudan, Rolf Barth, John Fung, Piotr Witkowski

Sernova will disclose additional information about the presentation at the time of the conference in alignment with the American Diabetes Association’s abstract embargo policies, which lift at the conclusion of the presentation on June 24, 2023. All abstracts are preliminary until the time of presentation.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705



FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - March 14, 2023 14 March, 2023

Sernova Announces Upcoming Podium Presentation of iPSC and Cell Pouch™ Combination Treatment for Type One Diabetes at the 4th IPITA / HSCI / JDRF Summit


- First pre-clinical data presentation of Sernova’s Cell Pouch with Evotec’s iPSC derived islet-like cluster technology for type 1 diabetes (T1D)

LONDON, Ontario – March 14, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, announced today that an abstract has been selected for an oral presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, to be held from April 24-25, 2023 in Cambridge, Massachusetts. The presentation will be given by Matthias Austen, PhD, SVP Cell Therapy at Evotec SE (FSE:EVT; NASDAQ:EVO).

Abstract Title: Manufacturing of optimized human islet-like clusters (ILCs) from iPSCs and functional testing of an ILC + Cell Pouch™ combination in vivo

Authors: Audrey Holtzinger, Simone Strauch, Thomas Reinbothe, Claudia Wrzos, Andreas Scheel, Cord Dohrmann, Arash Memarnejadian, Pardis Pakshir, Philip M. Toleikis, Matthias Austen

Date / Time: Monday, April 24, 2023 from 2:45pm-4:25pm ET

Evotec has developed a scalable and comprehensive process for GMP manufacturing of ILCs from a human GMP-grade induced pluripotent stem cell (iPSC) line for cell therapy treatment of insulin-dependent diabetes. In 2022, Evotec entered into a collaboration with Sernova Corp., which has developed the proprietary Cell Pouch System™. Following implantation, the Cell Pouch develops a vascularized environment to support engraftment and long-term function of therapeutic cells.

Sernova will disclose additional information about the presentation at the time of the conference.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705



FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - March 08, 2023 8 March, 2023

Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes


- Third patient now implanted with higher capacity, 10-chamber Cell Pouch - Company anticipates first interim data from second cohort in Q4 2023

LONDON, Ontario – March 8, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.

In November 2022, the Company announced the addition of a second cohort and protocol amendment for its T1D Study. The amended protocol includes a second cohort of up to seven patients for the transplant of islets into Sernova’s higher-capacity Cell Pouch. Enrollment for the new second cohort has occurred rapidly with approximately half of the patients already completed.

The amended protocol to use the 10-channel Cell Pouch enables optimized dosing and shorter efficacy evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of transplanted islet cells, reduction of severe hypoglycemic episodes, and changes in HbA1c, serum C-peptide production, and insulin requirements. The higher capacity 10-channel Cell Pouch provides greater than 50% more capacity relative to the Cell Pouches used for the T1D Study’s first cohort.

“I am excited to apply the learnings from the first patient cohort, including implementation of the higher capacity Cell Pouch, which enables us to optimize the dose and concentration of islets to achieve our clinical objectives with these patients,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the Pancreatic Islet Transplant Program at the University of Chicago. “I look forward to reporting the first interim results of the second patient cohort.”

Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, added, “With the first two patients transplanted and a third patient now implanted with the higher capacity Cell Pouch, we are pleased to see the successful results of our patient enrollment acceleration strategy and are driving to complete full enrollment as expeditiously as possible. We look forward to presenting our next readout of interim results.”

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec SE entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT: Corporate Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705



FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - March 02, 2023 2 March, 2023

Sernova to Participate in Upcoming Roth and Oppenheimer Investor Conferences


-Sernova provides warrant update

LONDON, Ontario – March 2, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical- stage company and leader in cell therapeutics, today announced it will be participating in the upcoming 35th Annual Roth Conference being held March 12-14, 2023 and the Oppenheimer 33rd Annual Healthcare Conference, taking place March 13-15, 2023. Company management will also be participating in one-on-one investor meetings at the conferences.

35th Annual Roth Conference – March 12-14, 2023

Format: Fireside Chat Date: 4:00PM PT, March 13, 2023 Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp Location: The Ritz Carlton, Laguna Niguel in Dana Point, California Webcast Link: https://wsw.com/webcast/roth46/sva/1689510

Oppenheimer Virtual 33rd Annual Healthcare Conference – March 13-15, 2023

Format: Corporate Presentation Date & Time: 2:00PM ET, March 14, 2023 Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp Location: Virtual Webcast Link: https://wsw.com/webcast/oppenheimer27/sva/2565906*

*A replay will be available on the Investors section of Sernova’s website for 90 days.

Please contact your representative at either Roth or Oppenheimer to schedule a one-on-one meeting with the management team during the conference.

Sernova also announced that 20,136,918 warrants, issued at the time of its previous financing in March 2021, expired unexercised on March 1, 2023. Total shares outstanding in the Company stands at 303,332,686. There are no outstanding warrants remaining in Sernova’s capital structure.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress a third development program that utilizes its Cell Pouch System with an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - January 30, 2023 30 January, 2023

Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy


- Preclinical proof of concept study demonstrates that thyroid auto-transplantation into the Cell Pouch can restore thyroid hormone production following removal of the thyroid gland - Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective therapy for hypothyroidism

LONDON, Ontario – January 30, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced advancements in its thyroid cell therapy program – one of three cell therapy development programs utilizing the Company’s proprietary Cell Pouch System™. In a preclinical proof of concept study, the Company demonstrated that auto-transplantation of thyroid tissue into the Cell Pouch can compensate for removal of the thyroid gland (total thyroidectomy), restoring normal thyroid hormone levels in an animal model.

The thyroid is a vital hormone-producing gland that is critical for metabolism and regulation of body functions.1 Loss of thyroid function occurs following surgical removal of the gland and is associated with memory impairment, depression, intolerance to cold, chronic fatigue, constipation, weight gain and lethargy.2 It is estimated that more than 150,000 patients in the US undergo thyroidectomies annually3, and subsequently require lifelong thyroid hormone replacement therapy.

Despite some benefits, patients on thyroid replacement medications often experience significant impairment in psychological well-being.4 The primary goal of Sernova’s thyroid program is to restore normal thyroid function without life-long medication, and avoid the burden of repeated laboratory testing in patients who have undergone thyroid surgery.

Data from Sernova’s preclinical program demonstrates that total thyroidectomy with auto-transplantation into the Cell Pouch allows for reestablishment of production of triiodothyronine (T3) and thyroxine (T4).

The study was conducted in a pre-clinical animal model whereby the Cell Pouch was pre-implanted for several weeks prior to each subject undergoing total thyroidectomy. The thyroid gland of each Treatment Group subject was removed, prepared with minimal manipulation, and transplanted into the pre-implanted Cell Pouch. Thyroid hormones were monitored over several months with weekly measurements of circulating thyroid hormones (T3, T4). Following thyroidectomy in the Treatment Group, the T3 and T4 levels fell initially but subsequently recovered to normal or near-normal levels following thyroid transplant into the Cell Pouch. Control Group subjects received the Cell Pouch implant and underwent total thyroidectomy but did not receive a thyroid transplant. In the Control Group, post-thyroidectomy T3 and T4 rapidly decreased and remained below baseline concentrations throughout the experiment.

“Along with previously published preclinical data that reported survival and function of human thyroid tissue transplanted into the Cell Pouch5, this preclinical study also supports the viability of Sernova’s Cell Pouch System approach and represents an important step towards establishing an entirely new treatment option for post-thyroidectomy hypothyroidism,” commented Dr. Sam Wiseman, BSc, MD, FRCSC, FACS.

“These findings demonstrate a further therapeutic application of Sernova’s Cell Pouch System,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “In addition to type 1 diabetes [and hemophilia], this study shows the potential to treat the significant number of patients undergoing removal of their thyroid glands each year. We have already begun to interact with regulatory authorities towards initiating clinical trials with this novel therapy.”

Sernova intends to present data from the Company’s thyroid development program at a scientific conference later this year.

References 1. InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care; How does the thyroid gland work? 2010 Nov 17 [Updated 2018 Apr 19]. https://www.ncbi.nlm.nih.gov/books/NBK279388/ 2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017; 390: 1550–1562. https://doi.org/10.1016/S0140-6736(17)30703-1 PMID: 28336049 3. Al-Qurayshi Z, Robins R, Hauch A, Randolph GW, Kandil E. Association of Surgeon Volume With Outcomes and Cost Savings Following Thyroidectomy: A National Forecast. JAMA Otolaryngol Head Neck Surg. 2016;142(1):32–39. doi:10.1001/jamaoto.2015.2503 4. Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in patients on 'adequate' doses of l-thyroxine: results of a large, controlled community-based questionnaire study. Clin Endocrinol (Oxf). 2002 Nov;57(5):577-85. doi: 10.1046/j.1365-2265.2002.01654.x. PMID: 12390330. 5. Wiseman SM, Memarnejadian A, Boyce GK, Nguyen A, Walker BA, Holmes DT, Welch ID, Mazzuca DM, Toleikis PM. Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch™ device in a Mus musculus model: Evidence of viability and function for thyroid transplantation. PLoS One. 2022; 17(1): e0262345. https://doi.org/10.1371/journal.pone.0262345

ABOUT SERNOVA’S CELL THERAPY THYROID DISEASE PROGRAM

Sernova is utilizing its Cell Pouch System platform as a potential treatment for hypothyroid disease. Our approach is to transplant a patient’s own healthy thyroid tissue following thyroidectomy into the pre-implanted vascularized Cell Pouch to preserve the normal thyroid function and reduce or eliminate the need for lifelong daily thyroid replacement therapy. Sernova plans to conduct clinical assessments of the Cell Pouch with transplanted thyroid tissue in patients suffering from post-surgical hypothyroidism with the aim of preserving thyroid function and improving patient quality of life.

Thyroidectomy is commonly performed for cancer diagnosis or treatment and for treatment of benign (non- cancerous) disease that includes goiter and hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the US yearly. Patients undergoing total thyroidectomy, and many patients undergoing partial thyroidectomy, require life-long thyroid hormone medication. Post-surgical thyroid hormone replacement therapy, if monitored carefully, can be effective; however, patients often suffer from deleterious side-effects including weight gain, depression, headaches, and cardiovascular disease, with resultant negative impact on quality of life, and significant costs to the healthcare system. The development of new therapeutic strategies to overcome hypothyroidism remains an important unmet medical need.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress a third development program that utilizes its Cell Pouch System with an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - January 10, 2023 10 January, 2023

Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diabetes


- First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D) and severe hypoglycemia - iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation for first human clinical evaluation - T1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now demonstrated consistent long-term insulin independence de-risking the combined technologies for both companies

LONDON, Ontario – January 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that significant progress has been achieved in its collaboration with Evotec SE (FSE: EVT; NASDAQ: EVO). This progress includes advancement of Evotec’s iPSC derived islet-like clusters in combination with Sernova’s implantable Cell Pouch™ device toward a first-in-human Phase 1/2 clinical trial for the treatment of patients with T1D and severe hypoglycemia slated for regulatory filing in 2024. The objective of the collaboration is to produce an off the- shelf, commercially viable, ethically derived cell therapy treatment for people suffering from T1D. The treatment would include Sernova’s Cell Pouch System™ incorporating Evotec’s iPSC-derived islet-like clusters. The combination product is anticipated to be the first treatment of its kind to reach clinical testing for T1D.

The Evotec and Sernova collaboration has to date resulted in the following significant achievements: - Development of a robust, cost-efficient, scalable, highly controlled iPSC differentiation protocol with the ability to cryopreserve and store batches of differentiated islet-cell clusters - Demonstration of excellent islet-like cluster survival under standard shipping conditions and following transplantation - Demonstration of consistent long-term insulin independence with no hypoglycemic events and consistent safety profiles in a gold standard T1D preclinical model with Evotec’s iPSC-derived islet-like clusters transplanted in Sernova’s Cell Pouch - iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotec’s iPSC GMP facility are well under way in preparation for manufacture of clinical and commercial iPSC islet-like clusters supply - Interactions with experts in support of design of the first Phase 1/2 clinical trial

Based on these achievements the following activities will be continuing throughout 2023 in preparation for regulatory filings anticipated in 2024: - Completion of standard formal safety/toxicology studies and other required preclinical studies - Identification and securing of potential clinical study sites to enable efficient patient enrollment following initiation of the Phase 1/2 clinical study - Preparation of regulatory submissions for planned trial geographies, combining both the established library of regulatory documentation for Sernova’s Cell Pouch and that developed by Evotec for their iPSC islet-like clusters

Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, commented, “Together Sernova and Evotec maintain a shared, singular focus on developing the first combination product involving ethically sourced iPSC-derived islet-like clusters within Sernova’s Cell Pouch for a type 1 diabetes functional cure that could, conceivably, eliminate the need for daily insulin injections in patients with diabetes and significantly reduce the burden on healthcare systems worldwide. Furthermore, we believe that Evotec’s strategic design of its islet-like clusters to closely match human islets and the cost-efficient manufacturing process combined with our collective approach to efficiently deliver the islet-like clusters to patients for transplant into our Cell Pouch represents a disruptive and commercially attractive treatment, that could one day treat people with insulin-dependent diabetes worldwide.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “Evotec’s iPSC-derived human beta cells in combination with Sernova’s implantable Cell Pouch device represent a unique cell therapy product opportunity aiming to provide a potential functional cure to insulin-dependent diabetic patients. The combination product is highly differentiated through the quality of the cells and the device but also the scalability of the manufacturing process of the iPSC-derived cells and therefore clearly positioned to become the best-in-class cell therapy in the field.”

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT: Corporate Investors Media Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com Tel: 646-791-9705

FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.