2022 Press Releases Communiqués de presse

January 20, 2022 20 January, 2022

Sernova Announces Peer Reviewed Publication Demonstrating Safety and Efficacy of a Novel Cell Pouch Cell Therapy Approach for Treatment of Severe Hemo

January 10, 2022 10 January, 2022

The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Ind

January 5, 2022 5 January, 2022

Sernova to Announce New Interim Results of its Type 1 Diabetes Clinical Trial During the 40th Annual J.P. Morgan Healthcare Conference

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Press Release Communiqué de presse - January 20, 2022 20 January, 2022

Sernova Announces Peer Reviewed Publication Demonstrating Safety and Efficacy of a Novel Cell Pouch Cell Therapy Approach for Treatment of Severe Hemophilia A


LONDON, ONTARIO – January 20, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional cure’ for chronic diseases is pleased to announce a peer reviewed published scientific journal article highlighting successful development of a novel cell therapy approach for treatment of severe hemophilia A , a serious genetic bleeding disorder caused by missing factor VIII (FVIII) activity in the blood stream.

The journal article entitled “Efficient and Safe Correction of Hemophilia A by Lentiviral Vector-Transduced BOECs in an Implantable device (Sernova’s Cell Pouch™),” was published in the prestigious scientific journal, Molecular Therapy: Methods & Clinical Development, Volume 23, December 2021.

The therapeutic approach includes use of the patient’s own cells obtained from a blood sample, which are then modified using a lentiviral vector-mediated gene transfer procedure using the B-domain deleted form of FVIII under the control of an endothelial-specific promoter and subsequently transplanted within Sernova’s vascularized Cell Pouch into a mouse model of hemophilia A. These cells then provide a continuous therapeutic release of factor VIII into the bloodstream. The publication highlights that the HemAcure Consortium has now successfully demonstrated safety and long-term improvement in blood clotting in a hemophilia A mouse model.

It is estimated that 115,000 people live with hemophilia A in North America and Europe with a significant proportion who rely on regular infusions of FVIII. Treatment costs per patient are as high as US $200,000 each year, with an aggregate therapeutic cost of over US$ 10 billion per year.

“This novel ex vivo gene therapy approach is the first demonstration showing the safety and feasibility of transplantation of lentiviral-corrected blood outgrowth endothelial cells (BOECs) within an implantable medical device using GMP-like procedures for the long-term treatment of hemophilia A,” said the lead author Dr. Antonia Follenzi, MD, PhD, Professor, Department of Health Sciences, School of Medicine, Università del Piemonte Orientale. “If this therapy is successful in future clinical trials, it could become an important new therapeutic approach to improve the quality of life for people suffering with severe hemophilia A.”

Dr. Philip Toleikis, President and CEO Sernova Corp stated, “This publication represents approximately four years of dedicated work by the HemAcure consortium, from conceptualizing this novel treatment approach, through to validating its potential as a safe and long-term treatment option for people with hemophilia A. The Sernova Cell Pouch provides the required environment for transplanted cells to survive and function in the body, as demonstrated by the production of FVIII to improve blood clotting as reported by Dr. Follenzi and colleagues.” He continued, “We recognizes ex vivo gene therapy as a potential therapeutic option for people suffering from multiple rare diseases and we are proud that our technologies may contribute to the development and future delivery of functional cures for these ailments.”

The HemAcure consortium research was supported by funding from the European Commission’s Horizon 2020.

ABOUT HEMOPHILIA A

Hemophilia A is the most common form of hemophilia and is a genetic disorder caused by the reduced or absence of FVIII, a blood clotting protein. People with hemophilia A have prolonged abnormal bleeding as a result of trauma or surgery. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene responsible for FVIII production. According to the US Centers for Disease Control and Prevention, hemophilia A occurs in about 1 in 5,000 male births. Prolonged bleeding in high-risk areas such as the brain can be catastrophic, while persistent bleeding in joints results in permanent damage making joint replacement surgery common and risky procedures among these patients. Approximately 115,000 people in North America and Europe have hemophilia A. Although there is no cure for the disease, hemophilia A can be controlled with medications to supplement or replace the missing FVIII. Annual worldwide costs for the treatment of the disease for each patient may range from $60,000 to $260,000 US for an aggregate therapeutic cost of approximately $15B per year.

ABOUT SERNOVA Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell- derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.

ABOUT SERNOVA’S CELL POUCH SYSTEM

The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.

ABOUT HORIZON 2020 PROGRAM AND HEMACURE

Horizon 2020 was the biggest EU Research and Innovation program ever with nearly €80 billion of funding available over seven years (2014 to 2020). It promised more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project was funded as part of societal challenges “personalizing health and care” in a specific call about innovative treatments and technologies. The overall objective of the HemAcure project was to develop and refine the tools and technologies for a novel ex vivo prepared cell-based therapy to treat the bleeding disease, hemophilia A (caused by a genetic deficiency in clotting Factor VIII (FVIII)) that should ultimately lead to improved quality of life of the patients. The European Union's Horizon 2020 research and innovation program awarded approximately €5.5 million (CDN$8.5) to support the project. International consortium members included the University Hospital Würzburg (Coordinating Institute), Germany; IMS - Integrierte Management, Heppenheim, Germany; Università del Piemonte Orientale “Amedeo Avogadro,” Novara, Italy; Loughborough University, Loughborough, United Kingdom; ARTTIC International Management Services, Munich, Germany and Sernova Corp., London, Ontario, Canada. This project received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 667421. The Consortium worked together to provide sets of design and manufacturing protocols, based on current European GMP regulations to prepare an Investigational Medicinal Product Dossier (IMPD) for an Investigational Medicinal Product (IMP), composed of therapeutic cells and an implantable medical device (Sernova’s Cell Pouch).

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

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

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

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Press Release Communiqué de presse - January 10, 2022 10 January, 2022

The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Independent


LONDON, ONTARIO – January 10, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE / XETRA:PSH), a clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to provide a progress update on its Phase 1/2 T1D clinical trial in conjunction with Dr. Piotr Witkowski, the clinical trial’s Principal Investigator at the University of Chicago. Dr. Witkowski was originally scheduled to provide a clinical trial update at the 2022 American Society of Transplant Surgeons (ASTS) Winter Symposium; however, the conference is now postponed until August 2022 as a result of the ongoing COVID-19 pandemic.

The objective of Sernova’s Phase 1/2 clinical trial is to assess the safety, tolerability and efficacy of its proprietary Cell Pouch™ transplanted with insulin-producing islets in patients with T1D complicated by hypoglycemia unawareness and a history of severe hypoglycemic events. Study patients must meet stringent eligibility criteria including, but not limited to, long-standing T1D, recent episodes of hypoglycemic unawareness and an absence of glucose-stimulated C-peptide detectable in their bloodstream. Study patients are eligible to receive up to three islet cell transplants throughout the study, including two marginal dose transplants into the Cell Pouch and a single, marginal islet supplement transplanted via the portal vein.

Sernova would like to highlight some updated study findings and key points from the ongoing trial:

• the ongoing safety and tolerability of Cell Pouch has been maintained in all study patients; • Islet transplantation to the Cell Pouch resulted in the establishment of new, measurable islet function documented by detectable levels of stimulated C-peptide in the first three patients, who completed the protocol-defined course of transplants. • a supplemental, single intraportal islet transplant was sufficient for the first two patients to achieve and maintain sustained ongoing insulin independence and freedom from severe hypoglycemic events for over 21 and 2 months, respectively. • the third transplanted patient recently completed their course of Cell Pouch transplants and a supplemental intraportal islet infusion, with favorable improvements in glucose control, near-normal levels of C-peptide, an absence of severe hypoglycemic events and reductions in daily insulin use; • the other three enrolled study patients are progressing through the study protocol, as planned. All have received Cell Pouch implants and are at various stages of protocol-defined islet transplants and follow-up; and • a 7th study patient has been identified.

“We are very encouraged by finding detectable serum C-peptide levels after islet transplantation into the Sernova Cell Pouch in the three most advanced study patients. Additionally, we are very excited about the first two patients becoming insulin independent and free from severe hypoglycemic events after a single supplemental intraportal islet infusion,” said Dr. Witkowski. “I look forward to continuing this trial with Sernova as we further optimize our use of the Cell Pouch System and validate its therapeutic potential.”

Dr. Philip Toleikis, President & CEO of Sernova Corp further remarked, “We believe Sernova is the first company to report that its first two transplanted T1D cell therapy study patients achieved sustained insulin independence. We are further reassured that our Cell Pouch System is performing as expected by creating a safe, vascularized, and natural tissue environment inside the human body, allowing the islet cells to thrive and function efficiently following transplantation. As we progress through the trial, under the expert guidance of Dr. Witkowski, we have had several scientific breakthroughs and advancements related to insulin producing cell dynamics and efficacy related to our Cell Pouch technologies. These findings have led to several technical optimizations, including the upcoming introduction of a higher capacity Cell Pouch configuration designed to accommodate the total quantity and distribution of islets that are achieving insulin independence for patients in our clinical trial. This configuration of Cell Pouch has already received regulatory authorization to be used for the remaining trial implants. Sernova is grateful to Dr. Witkowski’s leadership in this trial as we further enhance our therapeutic cell transplantation approach with our goal to achieve a ‘functional cure’ for the patients with complicated T1D.” Sernova has developed its cell therapy platform, the Cell Pouch System, with the vision of treating the millions of patients with T1D and other chronic diseases using immune-protected therapeutic cells, including stem cell- derived technologies. Sernova’s approach is to provide a minimally invasive, retrievable, safe, organ like environment for rapid engraftment and long-term survival of therapeutic cells as well as to avoid blood mediated inflammatory reactions and permit cell retrievability that cannot be achieved with the traditional portal vein transplantation.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.

ABOUT HYPOGLYCEMIA UNAWARENESS

Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they become severe or even fatal. It typically occurs when blood glucose levels are below 3.0 mmol/L and is estimated to affect approximately 15% of people with T1D.

Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure, coma or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.

ABOUT SERNOVA Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell- derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.

ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM

The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells, that release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase 1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

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

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - January 05, 2022 5 January, 2022

Sernova to Announce New Interim Results of its Type 1 Diabetes Clinical Trial During the 40th Annual J.P. Morgan Healthcare Conference


LONDON, ONTARIO – January 5, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicine and cell therapy therapeutics company focused on developing a potential ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce that new interim results from the ongoing safety, tolerability and efficacy Phase I/II clinical trial of Sernova’s Cell Pouch™ will be released on January 10, 2022.

Originally, it was planned that Dr. Piotr Witkowski, principal investigator of Sernova’s Phase I/II clinical trial would present an update in a poster session at the American Society of Transplant Surgeons (ASTS) 22nd Annual “State of the Art” Winter Symposium on January 13, 2022, but the conference was postponed yesterday until the end of July 2022 because of the ongoing COVID-19 pandemic.

“We are pleased to be announcing these new interim data earlier than anticipated in conjunction with the J.P. Morgan conference which is one of the premier international healthcare conferences,” said Dr. Philip Toleikis, President & CEO of Sernova.

ABOUT THE J.P. MORGAN HEALTHCARE CONFERENCE

The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry which connects global industry leaders, emerging fast growth companies, innovative technology creators and members of the investment community. The J.P. Morgan 40th Annual Healthcare Conference (JPM 2022) will take place virtually, January 10-13, 2022.

ABOUT SERNOVA Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell- derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.

ABOUT SERNOVA’S CELL POUCH SYSTEM

The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

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

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