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The Path to a Regenerative Cure Le chemin vers un traitement régénérateur

The Path to a Regenerative Cure Le chemin vers un traitement régénérateur

Sernova is a regenerative medicine therapeutics company Sernova est une société de traitement en médecine régénérative

Developing therapeutics platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is the development of technologies for the treatment of patients with insulin-dependent (T1) diabetes, hemophilia A and thyroid disease. Développer des technologies de plate-forme thérapeutique pour traiter les maladies chroniques grâce à une approche de médecine régénérative. L’objectif principal de Sernova est la mise au point de technologies de traitement du diabète insulino-dépendant (T1), de l’hémophilie A et de la thyroïde.

About Sernova, Corp. À propos de Sernova, Corp.

Sernova is committed to the development and clinical advancement of its products for metabolic, hematological and other chronic diseases using therapeutic cells transplanted into a patented implanted medical device, which forms an organ-like environment promoting long-term function and survival of the therapeutic cells. Sernova s'engage dans le développement et l'avancement clinique de ses produits contre les maladies métaboliques, hématologiques et autres maladies chroniques utilisant des cellules thérapeutiques transplantées dans un dispositif médical implanté breveté, qui forme un environnement semblable à un organe favorisant la fonction et la survie à long terme des cellules thérapeutiques.

The company’s management believes in building strong and long-lasting collaborations and partnerships that would lead to the rapid advancement of Sernova’s portfolio of products into the market, improving global health and bringing value to patients and society, in concert with our clinical development programs. La direction de la société croit à la mise en place de collaborations et de partenariats solides et durables qui permettraient au portefeuille de produits de Sernova de progresser rapidement sur le marché, d’améliorer la santé mondiale et d’apporter une valeur ajoutée aux patients et à la société, de concert avec nos programmes de développement clinique.

Indications: Les indications:


Diabetes Diabète

Haemophilia A Hémophilie A

Thyroid disease Maladie thyroïdienne

Clinical studies: Etudes cliniques:


Diabetes US phase I/II clinical study cleared by the FDA Etude clinique de phase I / II sur le diabète, approuvée par la FDA

First-in-human study in Diabetic subjects with hypoglycemia unawareness Première étude chez l'homme chez des sujets diabétiques peu conscients de l'hypoglycémie

Cell Pouch System™


Sernova’s Cell Pouch System™ is a novel implantable and scalable medical device which forms a highly vascularized organ-like environment in the body for the housing, function and long-term survival of therapeutic cells. These therapeutic cells release necessary proteins or hormones missing from the body to treat chronic diseases as an alternative to daily administration of drugs. Le Cell Pouch System™ est un nouveau dispositif médical préalablement implanté et formant un environnement naturel hautement vascularisé afin d’y loger des cellules thérapeutiques, favorisant leur bon fonctionnement et leur survie dans le corps. Ces cellules thérapeutiques libèrent les protéines ou les hormones nécessaires pour traiter les maladies chroniques comme alternative a l’administration quotidienne de médicaments.


Immune Protection Protection immunitaire


We have shown that cells can be protected using medications that prevent immune system attack within the Cell Pouch™. Nous avons montré que les cellules peuvent être protégées en utilisant des médicaments qui empêchent les attaques du système immunitaire dans la Cell Pouch™.

Microencapsulation technologies house cells within the Cell Pouch chambers and protect the cells from immune system attack. Les technologies de microencapsulation hébergent les cellules dans les chambres à cellules et les protègent des attaques du système immunitaire.

Technologies are in development to make transplanted cells unrecognizable to the immune system. Des technologies sont en cours de développement pour rendre les cellules greffées méconnaissables du système immunitaire.

Sernova’s Cell Pouch™, combined with immune protected therapeutic cells, offers protection from immune system attack creating an effective, safe, long-term and convenient therapeutic option for patients with chronic diseases who seek to improve their quality of life. Le Cell Pouch™ de Sernova, associé à des cellules immunitaires protégées, offre une protection contre le système immunitaire avec une option thérapeutique efficace, sûre, à long terme et pratique pour les patients atteints de maladies chroniques qui cherchent à améliorer leur qualité de vie.


Featured News Nouvelles en vedette

October 5, 2023 5 Octobre, 2023

Sernova Business Update

June 30, 2023 30 Juin, 2023

Marek Sutherland of CTV News London - Cure for type one diabetes getting closer, London company says

June 30, 2023 30 Juin, 2023

Noah Stansfield of CGT Live - Patients With T1D Achieve Insulin Independence Following Implantation of Cell Pouch System and Islet Transplant

June 28, 2023 28 Juin, 2023

Sean Whooley and Danielle Kirsh of Fast Five- Teleflex has a Class I recall, Boston Scientific appoints two new board directors (Sernova discussed in the podcast recording from 1:00-2:58 time marks)

June 26, 2023 26 Juin, 2023

Lei Lei Wu of EndPoints News - Sernova says five diabetes patients have now been taken off insulin after 'cell pouch' therapy

June 26, 2023 26 Juin, 2023

Shane Whooley of MassDevice - Sernova reports positive interim data for Cell Pouch System


News Releases Communiqués de presse

January 29, 2024 29 Janvier, 2024

Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones

November 27, 2023 27 Novembre, 2023

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

October 30, 2023 30 Octobre, 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 Octobre, 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

Invest with Sernova Investir dans Sernova

If you are a shareholder, investor, broker, analyst, journalist, investment advisor, or looking to develop business opportunities, please feel free to contact us by email or telephone. Si vous êtes actionnaire, investisseur, courtier, analyste, journaliste, conseiller en placement ou souhaitez développer des opportunités d’affaires, n'hésitez pas à nous contacter par email ou par téléphone.

Sernova is a regenerative medicine company developing therapeutic technologies with multibillion-dollar market potential for each of its clinical indications. Sernova est une société de médecine régénérative développant des technologies thérapeutiques offrant un potentiel de marché de plusieurs milliards de dollars pour chacune de ses indications cliniques.

 

Diabetes patients Patients diabétiques

 

Hemophilia Orphan Indication Indication orpheline de l'hémophilie

 

Sernova is traded on: Sernova est échangé sur:

Sernova is a Collaborative Team Sernova, c’est aussi les collaborations

We believe in advancing our clinical programs and building strong and long-lasting collaborations and partnerships that will lead to the rapid advancement of Sernova’s portfolio of products into the market, improving global health and bringing value to patients and society. Nous croyons en la promotion de nos programmes cliniques et en la mise en place de collaborations et de partenariats solides et durables qui permettront au portefeuille de produits de Sernova de progresser rapidement sur le marché, d'améliorer la santé mondiale et d'apporter de la valeur aux patients et à la société.

 

Privacy PolicyPolitique de confidentialité

Updated July 6, 2018

Please read this Policy carefully along with our Legal Notice that describes our Terms of Use for the Website.

By accessing www.sernova.com (the “Website”) you hereby agree with the practices described in this Privacy Policy (the “Policy”)

This Policy applies to all information gathered through the Website and/or any related marketing technique or events.



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The information collected is limited to the information that you decide to share with us through the News Dispatch Service, when participating at event or activities or in the general course of business by expressing an interest in obtaining information about Sernova Corp. and our products, such as name, email, phone number, and similar contact information. This information is stored through MailChimp (please refer to MailChimp Privacy Policy at https://mailchimp.com/legal/privacy/).



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Sernova Corp. is the sole owner of any information collected on the Website. We do not sell, share or rent this information to others.



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Sernova Corp. maintains log files of the traffic on www.sernova.com. This information is not linked to any personal information that you have provided us. Logs are used to manage traffic, identify content accessed, and IT requirements. Information logged and automatically collected includes without being limited to IP addresses and browser types. This information does not reveal your specific identity.



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Cookies can be used to provide you with a more personalized experience. The Website may use cookies to make that experience more companionable when you return to the Website. You have the option at all time to decline the use of cookies. If you choose to do so, you may not be able to fully use all features of the Website. You can also delete cookie files at all time from your computer. Those cookies may include first-party cookies (such as the Google Analytics cookies).



Updates

This Policy is a living document and may be amended or updated from time to time without further notice. We encourage you to review the Policy periodically.



Contact

If you have any questions or comments about our policy, you can email us at info@sernova.com or by phone at 1(877) 299-4603 or by mail at

Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8

Mis à jour le 6 juillet 2018

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Si vous avez des questions ou des commentaires sur notre politique, vous pouvez nous envoyer un courriel à info@sernova.com ou par téléphone au 1 (877) 299-4603 ou par courrier à

Sernova Corp.
700 Collip Circle, Suite 114
London, ON Canada N6G 4X8

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Press Release Communiqué de presse - Janvier 29, 2024 29 Janvier, 2024

Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones


- Recently completed recruitment of all 7 patients in Cohort 2

- Anticipates additional data from Cohort 2 of Phase 1/2 clinical trial evaluating its enhanced 10-channel Cell Pouch in patients with type 1 diabetes (T1D) in Q1/24

- Expects to report preclinical data supporting an IND application to evaluate the use of therapeutic cells in combination with Cell Pouch in patients with post-operative hypothyroidism

LONDON, Ontario; Boston, Massachusetts – January 29, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today provided a business update, including a recap of 2023 accomplishments and a preview of certain milestones anticipated in 2024.

“In 2023, we added to the compelling and expanding set of data demonstrating the safety and efficacy of our novel cell therapy platform for chronic diseases, including our higher capacity 10-channel Cell Pouch that is being evaluated in our ongoing Phase 1/2 human donor islet clinical trial in T1D,” said Cynthia Pussinen, Chief Executive Officer of Sernova. “We also made significant progress with our hemophilia A program, including receipt of both Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA). Lastly, we announced an exciting preclinical research collaboration with AstraZeneca that has the potential to significantly expand the use of the Cell Pouch in additional high-value indications.”

“Looking ahead to 2024, we anticipate additional patient data from Cohort 2 of our T1D human donor islet trial, as well as important data from our thyroid disease program as we work to further our preclinical pipeline. We continue to advance plans for our next T1D Phase 1/2 clinical study utilizing Evotec’s iPSC-derived islet like clusters (ILCs) in our Cell Pouch. Use of iPSCs provides significant advantages over human donor islets, including the ability to scale this promising treatment to commercially viable levels enabling the treatment of millions of patients. Throughout 2024 our strategic partner, Evotec, will continue to optimize and advance the development of iPSC derived ILCs for use in additional IND enabling studies and clinical trials. Given the complexity around scaling-up of iPSCs and therapeutic cell manufacturing, as well as the relative nascency of the entire advanced therapeutics field, timelines have extended, and we now anticipate initiating a clinical trial evaluating our Cell Pouch with iPSC-derived ILCs in the fourth quarter of 2025.” Ms. Pussinen added.

“I am encouraged with our progress and believe we have built a solid foundation consisting of a portfolio of fundamentally transformational medical treatments for patients living with chronic conditions that will result in multiple potentially value-creating milestones this year and next,” Ms. Pussinen concluded. 2023 Achievements:

• Announced senior leadership additions, including Cynthia Pussinen as new Chief Executive Officer, and Dr. Modestus Obochi, Ph.D., MBA, as Chief Business Officer

• Received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for the Company’s hemophilia A program

• Announced positive interim data from Cohorts 1 and 2 of the ongoing Phase 1/2 human donor islet clinical trial of its Cell Pouch System™ in patients with T1D at the 2023 IPITA-IXA-CTRMS Joint Congress. Notably, five of the six patients in Cohort 1 were able to discontinue insulin therapy following islet transplantation, and all six patients achieved HbA1c values in the non-diabetic range (<6.5%). In Cohort 2, the first six of seven planned patients received the higher capacity 10-channel Cell Pouch and five patients 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 2 patient who subsequently achieved insulin independence with a modest portal vein top-up.

• Announced positive results from its conformal coating immune protection technology program that is used in combination with the Cell Pouch System™ and is intended to eliminate the need for chronic immunosuppression medications.

• Presented preclinical data supporting the planned Phase 1/2 clinical trial of Evotec’s “off-the-shelf” iPSC- derived ILCs in combination with Sernova’s Cell Pouch System for the treatment of patients with T1D. Specifically, data demonstrated that Evotec’s iPSC-derived ILCs generated robust and durable insulin independence with blood C-peptide levels and glucose tolerance test results equivalent to a test group with human islets. A separate study showed sustained normalization of blood sugar levels in diabetic mice throughout the 320-day term of the study. Human testing is anticipated to begin in late 2025.

• Announced a research collaboration with AstraZeneca to evaluate the use of Sernova’s Cell Pouch System in combination with AstraZeneca’s novel therapeutic cells for various indications. The discovery work is being funded and conducted by AstraZeneca.

• Completed recruitment of all 7 patients in Cohort 2 of the ongoing Phase 1/2 trial using the 10-channel Cell Pouch.

Anticipated Select 2024 Milestones:

• Additional data from Cohort 2 of the ongoing U.S. Phase 1/2 clinical trial, which is evaluating its enhanced 10-channel Cell Pouch in patients with T1D, are expected beginning in Q1.

• Additional preclinical data to support an IND application to evaluate the Company’s autograft thyroid cells in patients suffering from thyroid disease, with no immunosuppressive regimen required.

• Completion of thyroid disease market study validating the current market size and detailing the unmet medical need.

• Potential engagement with additional life sciences focused companies, academic institutions and external parties through partnership and collaboration opportunities, which could be announced over the course of 2024.

• Additional funding to support growth through strategic alliances, credit facilities and/or institutional equity financings with the goal of maximizing shareholder value.

Fiscal Year 2023 Financials

Today, Sernova filed its financial results on SEDAR for the fiscal year 2023.

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

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. Forward looking statements in this news release include, without limitation, statements relating to the timing of clinical trials, the timing with respect to the receipt of data from on-going clinical trials, timing with respect to preclinical data, the completion of thyroid disease market study, statements with respect to the potential future engagement with additional universities, life sciences focus companies and external parties and the timing thereof.

These statements reflect the current expectations, assumptions and beliefs of management currently available to it on the date such statements were made, including Sernova’s ability to secure additional financing and licensing arrangements; the timing with respect to the engineering and scaling-up of Sernova’s technologies; the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies; the timing and results of preclinical and clinical trials; the ability to obtain all necessary regulatory approvals on a timely basis; the ability to in-license additional complementary technologies; and the ability of Sernova to execute its business strategy, attract additional partners and successfully compete in the market.

Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, forward-looking statements are not a guarantee of future performance and accordingly undue reliance should not be placed on such statements. Forward-looking statements are subject to a number of risks and uncertainties, some that are similar to biotechnology companies and some that are unique to Sernova. The actual results may differ materially from those expressed or implied by the forward-looking information, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, Sernova. Sernova’s annual information form dated January 29, 2024, its annual management's discussion and analysis for the year ended October 31, 2023, and other documents it files from time to time with securities regulatory authorities describe the risks, uncertainties, material assumptions and other factors that could influence actual results and such factors are incorporated herein by reference. Copies of these documents are available without charge by referring to the company's profile on SEDAR+ at www.sedarplus.ca. All forward-looking statements speak only as of the date on which they were made and, except as may be required by applicable securities laws, the Company disclaims any intent or obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise.

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Press Release Communiqué de presse - Novembre 27, 2023 27 Novembre, 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.

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Press Release Communiqué de presse - Octobre 30, 2023 30 Octobre, 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.



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Press Release Communiqué de presse - Octobre 27, 2023 27 Octobre, 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.

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Press Release Communiqué de presse - Octobre 11, 2023 11 Octobre, 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.

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Press Release Communiqué de presse - Septembre 29, 2023 29 Septembre, 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.

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Press Release Communiqué de presse - Septembre 14, 2023 14 Septembre, 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.

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Press Release Communiqué de presse - Septembre 13, 2023 13 Septembre, 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.

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Press Release Communiqué de presse - Septembre 07, 2023 7 Septembre, 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.

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Press Release Communiqué de presse - Septembre 05, 2023 5 Septembre, 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.

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