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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.

Read about Financial Reports, Events, Analyst Coverage and Stock Price. Consultez nos rapports financiers, nos événements, la couverture des analystes et le cours des actions.

 

Investor Presentation Présentation investisseurs

Les documents suivants ne sont présentement disponibles qu’en anglais

NEW Sernova Investor Presentation - January 2023

December 23, 2022 23 December, 2022

NEW Stifel Healthcare Conference - Sernova Presentation

November 15, 2022 15 November, 2022

LifeSci Partners - HealthTech Symposium Presents: Dr. Philip Toleikis, Fireside Chat

September 21, 2022 21 September, 2022

H.C. Wainwright 24th Annual Global Investor Conference

September 15, 2022 15 September, 2022

Sernova's Fireside Chat with Doug Loe, Healthcare & Biotechnology Analyst at Leede Jones Gable

September 8, 2022 8 September, 2022

Sernova & Evotec: Partnership and Licensing Option Agreement

May 17, 2022 17 May, 2022

Sernova & Evotec: Partnering and Licensing Option Agreement Live Presentation

May 17, 2022 17 May, 2022
 

News Releases Communiqués de presse

Latest News Releases Derniers communiqués de presse

January 30, 2023 30 January, 2023

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

January 10, 2023 10 January, 2023

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

December 6, 2022 6 December, 2022

Sernova Corp. Announces CEO Succession Plan and Expanded Management Team

November 17, 2022 17 November, 2022

Sernova Announces First Two Patients Implanted with Cell Pouch™ in the Second Cohort of its US Phase 1/2 Clinical Trial for Type 1 Diabetes

November 4, 2022 4 November, 2022

Sernova to Participate in the Stifel Healthcare Conference

November 3, 2022 3 November, 2022

Sernova Receives Authorization to Enroll Second Patient Cohort of Phase 1/2 Trial with Cell Pouch System™ for Type 1 Diabetes

October 24, 2022 24 October, 2022

Sernova Corp. Announces Change of Auditor

September 28, 2022 28 September, 2022

Sernova to Participate in the Roth Inaugural Healthcare Opportunities Conference

 

Latest Updates Dernières mises à jour

June 2, 2022 2 June, 2022

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Sernova Opens the Market Thursday, June 2, 2022

February 25, 2022 25 February, 2022

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Sernova Made the 2022 TSX Venture 50 List!

November 18, 2021 18 November, 2021

Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum

September 30, 2021 30 September, 2021

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Dr. Tomei Conformal Coating Immunoprotection Webinar with Sernova

April 28, 2021 28 April, 2021

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Sernova KOL Event on Thyroid Disease with Dr. Sam Wiseman

June 29, 2020 29 June, 2020

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Watch our latest commercial!

June 18, 2020 18 June, 2020

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ADA Scientific Sesssions

December 4, 2019 4 December, 2019

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Whiteboard: Sernova's Cell Pouch for Type 1 Diabetes (T1D)

April 23, 2019 23 April, 2019

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CTV London: Hope for diabetes cure

December 28, 2018 28 December, 2018

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New device from Ont. firm could revolutionize diabetes care

June 7, 2018 7 June, 2018

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Watch Dr Philip Toleikis, Ph.D. on CTV News

 

Financial Report and Other Filings Rapport financier et autres dépôts

 

Events Événements

Upcoming Events Évènements à venir

Event un événement - March 12, 2023

35th Annual Roth Conference

Event un événement - April 12, 2023

Cell & Gene Meeting on the Med

Event un événement - June 05, 2023

BIO International Convention


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Analyst Coverage Couverture des analystes

Please Note Notez s'il vous plaît

Sernova and its securities are covered by the following investment firms. This list of investment firms is being provided solely for your information and convenience and does not constitute an endorsement of or concurrence with any information, opinions, estimates, forecasts or recommendations provided by any of the investment firms listed below by Sernova. Furthermore, Sernova does not distribute information or reports prepared by analysts. The following list includes analysts currently known by Sernova Corp. to follow the company but may not be complete or up to date and may change without notice. Sernova undertakes no obligation to update and maintain this list. Please refer to the Legal Notice on this website for further information. Sernova et ses titres font l’objet d’analyse de la part des sociétés d'investissement suivantes. Cette liste de sociétés d'investissement est fournie uniquement à titre informatif et pour votre commodité et ne constitue en aucun cas une approbation ou un accord par Sernova ou ses dirigeants avec les informations, opinions, estimations, prévisions ou recommandations fournies par les sociétés d'investissement énumérées ci-dessous. En outre, Sernova ne distribue pas d'informations ou de rapports préparés par des analystes. La liste suivante inclut les analystes actuellement connus pour suivre la société, mais elle peut ne pas être complete ou à jour et peut changer sans préavis. Sernova n’assume aucune obligation quant à la mise à jour et au maintien de cette liste. Veuillez-vous reporter à l'avis légal sur ce site pour plus d'informations.



Analyst Analyste

Firm Société d’investissement

Phone Téléphone

Chelsea Stellick

iA Capital Markets

587.920.5682

Doug Loe

Leede Jones Gable

416.365.9924

Joseph Pantginis, Ph.D

H.C. Wainwright Research

646.975.6968

Stefan Quenneville

Echelon Capital Markets

416.662.6134

Tony Butler, PH.D

Roth Capital Partners

646.616.2789

 

Stock Price Prix de l'action

Please Note Notez s'il vous plaît

All information is provided "as is" for informational purposes only and is not intended for trading purposes or advice. Neither Sernova nor any independent providers are liable for any errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. Toutes les informations sont fournies "telles quelles" à des fins d'information uniquement, et ne sont pas destinées à des fins transactionnelles ou à titre de conseils ou recommandations. Ni Sernova ni aucun fournisseur indépendant ne peuvent être tenus responsables des erreurs d'information, des données incomplètes, des retards ou des actions prises en fonction des informations contenues dans les presentes.

 

Company Milestones Jalons de l'entreprise

2016

January January

Sernova Announces Agreement with CCRM to Produce Specialized Cells for the Treatment of Diabetes



February February

Sernova Honoured as Member of the “2016 TSX Venture 50” and Ranked #4 in Life Sciences and Clean Technologies



July July

Sernova and JDRF Announce Funding of Joint Research Collaboration to Advance Human Clinical Trials for the Treatment of Hypoglycemic Unawareness Patients with Severe Type 1 Diabetes



2017

December December

Sernova Receives US FDA IND Allowance to Initiate a US Clinical Trial of its Cell Pouch for the Treatment of Type 1 Diabetes



2018

February February

Sernova’s Cell Pouch Regenerative Medicine Clinical Trial for Patients with Type 1 Diabetes Supported with Continuous Glucose Monitoring Systems



May May

Sernova Announces U.S. Phase I/II Cell Pouch Clinical Trial with Prominent Diabetes Clinical Investigator



May May

Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study



July July

Sernova Initiates Patient Screening and Recruitment for its US Clinical Trial for Diabetes



November November

Sernova Highlights Achievements from the HemAcure Consortium in Developing a Novel Cell-Based Therapy for Hemophilia A



December December

Sernova Announces Enrollment of First Patient in U.S. Phase I/II Study of Cell Pouch for Treatment in Type 1 Diabetes



2019

April April

Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company Phase I/II U.S. Clinical Study for Diabetes



July July

Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes



October October

Sernova Confirms Enduring Levels of Fasting C-Peptide in Bloodstream of First Patient in its Phase I/II Clinical Trial for Type-1 Diabetes



2020

February February

Sernova Announces Positive DSMB Review and Recommendation for Continuation of Phase I/II Diabetes Clinical Trial of Cell Pouch



February February

Sernova Achieves Positive Efficacy Endpoint in Phase I/II Clinical Trial for Type 1 Diabetes



June June

Sernova to Acquire Cellular Local Immune Protection Technology Accelerating Expansion of its Regenerative Medicine Therapeutics Platform



June June

Sernova Completes Acquisition of Cellular Local Immune Protection Technology



August August

Sernova Enters into Exclusive Worldwide License Agreement with University of Miami for Therapeutic Cell Immune Protection Technologies



2021

February February

Sernova Announces Second Annual Data Safety Monitoring Board Review of its Diabetes Cell Pouch System™ Clinical Trial and Recommendation for Protocol Continuation



February February

Sernova Corp. Selected for the TSX Venture Stock Exchange’s 2021 Venture 50 List of Top Performing Listed Companies



March March

SERNOVA ANNOUNCES CLOSING OF C$23 MILLION BOUGHT DEAL FINANCING INCLUDING FULL EXERCISE OF OVER-ALLOTMENT OPTION



March March

Sernova Provides Positive Outlook Regarding the Development of Its Innovative Therapeutics Platform Technology for Chronic Diseases



April April

Sernova KOL Event Highlights Novel Cell Therapy Approach for the Potential Treatment of Thyroid Disease



June June

Sernova's Principal Investigator Presents Positive New Data from Ongoing Type 1 Diabetes (T1D) Clinical Trial at ATC 2021 Virtual Connect Conference



September September

Sernova Signs Collaboration Agreement to Advance Conformal Coated Immune Protected Therapeutic Cells for Diabetes with the University of Miami



October October

Sernova: The Ultimate Combination of Two Proven Technologies as Potential Functional Cure for Type1 Diabetes and Other Chronic Diseases



2022

January January

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



January January

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



January January

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



January January

Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System™ Therapeutic Approach for Treatment of Thyroid Disease



February February

Sernova Corp Ranks Among Top 50 Performing Companies on the 2022 TSX Venture List



March March

Data Safety Monitoring Board Recommends Continuation of Phase 1/2 Clinical Trial with Sernova’s Cell Pouch System™ in Patients with Type-1 Diabetes



May May

Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a 'Functional Cure' for Diabetes



May May

Sernova Receives Conditional Approval to Up-list to the Toronto Stock Exchange



June June

SERNOVA SHARES TO COMMENCE TRADING ON TSX ON JUNE 2, 2022



June June

Sernova Announces Positive Updated Phase 1/2 Clinical Data on Cell Pouch System™ at American Diabetes Association 82nd Scientific Sessions 2022



 

Corporate Governance Gouvernance d'entreprise

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Insider Trading Compliance Policy Politique de conformité des opérations d'initiés

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Whistleblower Policy Politique de dénonciation

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

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


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

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

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

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

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

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

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

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

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

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

ABOUT SERNOVA’S CELL THERAPY THYROID DISEASE PROGRAM

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

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

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

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

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

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

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

FORWARD-LOOKING INFORMATION

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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Press Release Communiqué de presse - December 06, 2022 6 December, 2022

Sernova Corp. Announces CEO Succession Plan and Expanded Management Team


The Company is recruiting a new CEO for its next stage of growth - Dr. Toleikis, President and CEO, to transition to Chief Technology Officer upon new appointment

LONDON, Ontario -- December 6, 2022 -- Sernova Corp. (Sernova) (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that, as part of a planned leadership succession process, and after a successful 13-year tenure leading the Company through the development of its pioneering Cell Pouch SystemTM and ensuing growth, Dr. Philip Toleikis, President and Chief Executive Officer will be appointed Sernova’s Chief Technology Officer (CTO). To achieve a seamless transition and continue progress on all Company activities, Dr. Toleikis will remain in the CEO role during the search period and continue to work closely with Executive Chair, Frank Holler. Mr. Holler will, in particular, take a leadership role and work closely with Dr. Toleikis in advancing Sernova’s business development and corporate finance activities during the search period.

“On behalf of the board, I am very grateful for the substantial contributions made by Dr. Toleikis to the Company’s growth and success over the years,” said Frank Holler, Executive Chair. “Philip has played a pivotal role in strategically advancing Sernova’s CPS platform to become one of the world’s most prominent cell therapy platforms and a leader in the development of cell therapy treatments for insulin- dependent diabetes. With the Company’s anticipated next phase of growth in US capital markets, it is a natural time to recruit a new CEO. Dr. Toleikis has endorsed this transition plan as it will enable him to focus on accelerating the further development of the Cell Pouch System.”

Dr. Philip Toleikis joined Sernova in 2009. Under his leadership, the Company has achieved remarkable interim results in its ongoing Phase 1/2 type 1 diabetes (T1D) clinical trial, expanded the capabilities of its CPS platform via technology acquisitions, and significantly bolstered its balance sheet.

“It has been an absolute privilege to lead Sernova from the initial concept of cell therapy as a means of achieving a potential functional cure for chronic diseases, to the development and refinement of our Cell Pouch System, and now the reality of long-term diabetic patients achieving insulin independence in our current US Phase 1/2 clinical study,” said, Dr. Toleikis “Furthermore, our recent global strategic partnership with Evotec is transformative because it provides the potential for Sernova to treat millions of insulin-dependent diabetic patients with scalable, best-in-class, iPSC-derived islet cells. I am very proud of the Company’s achievements to date, and I look forward to working closely with the new CEO. I am delighted to continue working with our extraordinary team, and the best-in-class leadership within, to advance Sernova to the next level of growth as well as the continued development of Sernova’s cell therapy platform on the world stage.” The Company has engaged Slone Partners, an executive search firm with offices in Boston, San Francisco and Washington, D.C., to assist the Board of Directors in the hiring of the new CEO.

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

Sernova Corp. is a clinical-stage biotechnology company that is developing its Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells, for the treatment of chronic diseases such as insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for the long-term survival and function of therapeutic cells that release essential factors absent or deficient in patients with certain chronic diseases. Sernova is also advancing a proprietary technology to shield therapeutic cells from immune system attacks with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, the Company announced a global strategic partnership with Evotec, providing Sernova with a potentially unlimited supply of insulin-producing islet cells to treat patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress additional development programs utilizing its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT: Corporate:

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

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

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

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - November 17, 2022 17 November, 2022

Sernova Announces First Two Patients Implanted with Cell Pouch™ in the Second Cohort of its US Phase 1/2 Clinical Trial for Type 1 Diabetes


- Company’s recent recruitment strategy change has resulted in an unprecedented level of inquiries regarding potential study participation - Transplantation of islets into the enhanced 10-channel Cell Pouch is anticipated in early 2023 - Company continues to anticipate first interim safety/efficacy data from second cohort in 2023

LONDON, Ontario – November 17, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 type 1 diabetes (T1D) clinical trial have been implanted with its 10- channel Cell Pouch, which provides >50% more capacity relative to the Cell Pouches used for the first cohort. The transition to this new 10-channel Cell Pouch under the revised protocol enables optimized dosing and shorter efficacy evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of transplanted islet cells, reduction of severe hypoglycemic episodes, changes in HbA1c, increased C-peptide production, and reduction in insulin requirements.

Sernova has engaged a clinical trial recruitment partner with extensive experience and success in accelerating T1D clinical trial patient enrollment. The second cohort of the study is intended to enroll up to seven patients with insulin dependent T1D who also suffer from severe hypoglycemic episodes and hypoglycemia unawareness. The Company anticipates reporting interim data in 2023. Results from the combined cohorts will inform the design of Sernova’s anticipated Phase 3 T1D pivotal study.

“Our drive to liberate individuals suffering with type 1 diabetes from the burden of daily insulin injections has been strengthened by the safety and efficacy observations in the first cohort of patients in our Phase 1/2 study, and we are pleased to have commenced the treatment phase for the second cohort,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “We believe the new 10-channel Cell Pouch configuration provides for optimal dosing of islets towards achievement of a potential ‘functional cure’. We look forward to reporting interim data from the second cohort in 2023. Planning and preparations are underway for the pivotal trial program, while we advance our iPSC-derived islet program into the clinic in collaboration with Evotec.”

ABOUT THE US PHASE 1/2 SECOND STUDY COHORT

The US Phase 1/2 study (NCT03513939) is an open-label single-arm trial to assess the safety, tolerability, and efficacy of Sernova’s Cell Pouch System™ for clinical transplantation of human donor islets in patients with T1D. Six patients were transplanted in the first cohort utilizing the 8-channel Cell Pouch System and interim data have been previously reported by Dr. Piotr Witkowski and his colleagues. With the expansion into the second cohort utilizing the 10-channel Cell Pouch System, patient eligibility criteria remain unchanged and includes those aged 18-65 with T1D who suffer from both hypoglycemic unawareness and severe hypoglycemic episodes, and who are eligible for donor islet transplantation. Eligible trial patients have had at least one episode of severe hypoglycemia in the previous 12 months and an absence of stimulated C-peptide (a marker of insulin production by the body) in response to a mixed meal tolerance test.

Islets are transplanted into the Cell Pouch approximately six weeks after Cell Pouch implantation to allow development of fully vascularized native tissue chambers and achieve a stable immunosuppressant regimen. At 90 days post-islet transplant, safety and efficacy are assessed prior to initiating a second transplant of islets. At 90 days following each patient’s second islet transplant to Cell Pouch, safety and efficacy endpoints are evaluated again. Trial patients who remain dependent on insulin for at least 6 months following the second islet transplant to Cell Pouch may be eligible for a third supplemental islet transplant via the portal vein.

Patients who elect to retain their implants will be followed for up to 3 years after the final islet transplant into the Cell Pouch. Multiple transplanted patients from the first cohort have implant durations of more than 3 years and none have elected to have their Cell Pouch implants removed. The primary objective of the Phase 1/2 study is safety and tolerability. Secondary objectives include the following efficacy endpoints: production of C-peptide, insulin use, HbA1c and frequency of hypoglycemic events.

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

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

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

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

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

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - November 04, 2022 4 November, 2022

Sernova to Participate in the Stifel Healthcare Conference


LONDON, Ontario – November 4, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced it will be presenting at the upcoming Stifel Healthcare Conference being held in-person in New York, NY on November 15-16, 2022. Company management will also be participating in one-on-one investor meetings at the conference.

Stifel Healthcare Conference Date: 9:45AM, November 15, 2022 Presenter: Dr. Philip Toleikis, President & CEO, Sernova Corp Location: Lotte New York Palace, New York, NY

Please contact your Stifel representative to schedule one-on-one meetings with the management team during the conference.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM™ PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative cell therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders including hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. 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 necessary proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also in development of two additional programs that utilize its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.

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

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

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

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - November 03, 2022 3 November, 2022

Sernova Receives Authorization to Enroll Second Patient Cohort of Phase 1/2 Trial with Cell Pouch System™ for Type 1 Diabetes


Sernova plans to begin enrollment of second cohort in the coming weeks and implant multiple patients with the enhanced capacity 10-channel Cell Pouch before the end of 2022

Positive interim results from patients in the first cohort informed the islet dose and density threshold optimizations for the second cohort

Expedited enrollment is anticipated with Sernova’s engagement of an experienced clinical trial patient recruitment agency and the Company expects to report interim data in 2023

Results from the combined cohorts will help guide the design of Sernova’s pivotal study, which would support an anticipated BLA submission to the US FDA and accelerate our iPSC stem cells into the clinic

LONDON, Ontario – November 3, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce, in conjunction with the advancement of its ongoing Phase 1/2 clinical trial of the Sernova Cell Pouch System™ for patients with type 1 diabetes (T1D) who suffer from hypoglycemia unawareness (the “T1D Study”), the approval of a protocol amendment by the University of Chicago Institutional Review Board (IRB) and no objections from FDA, allowing the Company to proceed with a strategically optimized protocol reducing the time required for patient treatment while accelerating potential secondary endpoint efficacy achievement with more optimal dosing.

Following promising interim results from the first six patients of Sernova’s active T1D Study, the protocol amendment enables the testing of a small second cohort of up to seven patients, to evaluate the Company’s optimized 10-channel Cell Pouch™, which provides 50% more islet capacity compared to the 8-channel Cell Pouch used to date for the T1D Study. Study data from the first six patients formed the basis for the amended optimized treatment plan for the additional new cohort of patients. Results from the combined cohorts will help guide the design of Sernova’s pivotal study, supporting an anticipated BLA submission to the US FDA.

With the protocol amendment, enrollment of the first cohort of patients has concluded and patient enrollment for the new second cohort will begin. The first three patients of the first cohort with completed islet transplants have achieved insulin independence and the remaining three are progressing towards completion of the treatment regimen. Data from these first patients has enabled Sernova to determine dose thresholds and islet concentrations intended to optimize endogenous insulin production in treated patients. Furthermore, safety observations to date support reducing the time between Cell Pouch islet transplants from 180 to 90 days, which substantially reduces the overall treatment period in the amended protocol update. To expedite rapid enrollment of the second cohort, Sernova has engaged a clinical trial patient recruitment partner with extensive experience and success in accelerating T1D clinical trial patient enrollment.

“Sernova is committed to developing a potential ‘functional cure’ with the goal of freeing patients from the life- limiting burdens of T1D and dramatically enhancing their quality of life,” said Dr. Philip Toleikis, President and Chief Executive Officer. “We are pleased with the positive interim results demonstrating that the Cell Pouch System is well tolerated, reduces or eliminates the frequency of severe hypoglycemic events and continues to contribute to durable insulin independence among patients. Based on our now expanded recruitment activities and efforts, we anticipate implanting multiple patients before the end of 2022. The results from these additional patients will directly contribute to our pivotal T1D trial design and help accelerate entry into the clinic with our iPSC stem cell derived islet technology in conjunction with our Evotec partnership that is progressing ahead of our expectations.”

ABOUT PHASE 1/2 STUDY SECOND COHORT

The Phase 1/2 study (NCT03513939) is an open-label single-arm trial to assess the safety, tolerability, and efficacy of Sernova’s Cell Pouch System for clinical transplantation of human donor islets in patients with T1D. Six patients were transplanted in the first cohort utilizing the 8-channel Cell Pouch System and interim data have been previously reported by Dr. Piotr Witkowski and his colleagues. With the expansion into the second cohort utilizing the 10-channel Cell Pouch System, patient eligibility criteria remain unchanged and includes those aged 18-65 with T1D who suffer from both hypoglycemic unawareness and severe hypoglycemic episodes, and who are eligible for donor islet transplantation. Eligible trial patients have had at least one episode of severe hypoglycemia in the previous 12 months and an absence of stimulated C-peptide (a marker of insulin production by the body) in response to a mixed meal tolerance test.

Islets are transplanted into the Cell Pouch approximately six weeks after Cell Pouch implantation to allow development of fully vascularized native tissue chambers and achieve a stable immunosuppressant regimen. At 90 days post-islet transplant, safety and efficacy are assessed prior to initiating a second transplant of islets. At 90 days following each patient’s second islet transplant to Cell Pouch, safety and efficacy endpoints are evaluated again. Trial patients who remain dependent on insulin for at least 6 months following the second islet transplant to Cell Pouch may be eligible for a third supplemental islet transplant via the portal vein.

Patients who elect to retain their implants will be followed for up to 3 years after the final islet transplant to Cell Pouch. Multiple transplanted patients from the first cohort have implant durations of more than 3 years and none have elected to have their Cell Pouch implants removed.

The primary objective of the Phase 1/2 study is safety and tolerability. Secondary objectives include the following efficacy endpoints: production of C-peptide, insulin use, HbA1c, and frequency of hypoglycemic events.

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

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

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

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

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

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - October 24, 2022 24 October, 2022

Sernova Corp. Announces Change of Auditor


London, Ontario October 24, 2022. Sernova Corp. (“Sernova” or the “Corporation”) (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH) announces that it has changed its auditor to KPMG LLP, Chartered Professional Accountants (the “Successor Auditor”) effective October 14, 2022.

Sernova’s board of directors appointed the Successor Auditor to hold office as the new auditor of the Corporation until the close of the Corporation’s next annual general meeting of shareholders. The Corporation’s former auditor, Davidson & Company, Chartered Professional Accountants (the “Former Auditor”), resigned effective October 14, 2022, at the request of Sernova.

There were no reservations in the Former Auditor's audit reports for any financial period during which the Former Auditor was the Corporation's auditor. Also, there are no "reportable events" (as the term is defined in National Instrument 51-102 - Continuous Disclosure Obligations) between the Corporation and the Former Auditor.

In accordance with National Instrument 51-102, the Notice of Change of Auditor, together with the required letters from the Former Auditor and the Successor Auditor, have been reviewed by the Corporation's audit committee and board of directors and will be filed on SEDAR accordingly.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing cell therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders including hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. 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 necessary proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also in development of two additional programs that utilize its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.

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

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

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

FORWARD LOOKING STATEMENTS: This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

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Press Release Communiqué de presse - September 28, 2022 28 September, 2022

Sernova to Participate in the Roth Inaugural Healthcare Opportunities Conference


LONDON, Ontario – September 28, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in regenerative cell therapeutics, today announced it will be presenting at the upcoming Roth Inaugural Healthcare Opportunities Conference being held in-person in New York, NY on October 6, 2022. Company management will also be participating in one-on-one investor meetings at the conference.

Roth Inaugural Healthcare Opportunities Conference Date: Thursday, October 6, 2022 Presenter: Dr. Philip Toleikis, President & CEO, Sernova Corp Location: The Yale Club, New York, NY

Please contact your Roth representative to schedule one-on-one meetings with the management team during the conference.

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

Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative cell therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders including hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. 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 necessary proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also in development of two additional programs that utilize its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

Investors:

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

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

FORWARD-LOOKING INFORMATION

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

Disclaimer Avis de non-responsabilite

Sernova maintains the investor relations section of this internet site as an informational service and for the readers. Sernova maintient la section des relations investisseurs de ce site Internet en tant que service afin d’informer les lecteurs.

This site is not intended to supplement or substitute for the legal disclosure for the Corporation or the prospectus disclosure related to the public offering of any of its securities. Please read the legal notice on the site before you proceed. Ce site n'a pas pour objet de compléter ou de remplacer la divulgation légale de la Société ou les informations du prospectus relatives à l’offre au public de ses titres. Veuillez lire l'avis juridique sur le site avant de poursuivre.


Privacy PolicyPolitique de confidentialité

Updated July 6, 2018

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

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

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



Information Collection

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



Information Sharing

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



Traffic and Automatic Information Collection

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



Cookies

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



Updates

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



Contact

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

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

Mis à jour le 6 juillet 2018

Veuillez lire attentivement cette politique ainsi que notre avis juridique qui décrit nos conditions d'utilisation du site Web.

En accédant à www.sernova.com (le «site Web»), vous acceptez les pratiques décrites dans la présente politique de confidentialité (la «politique»).

Cette politique s'applique à toutes les informations collectées via le site Web et / ou toute technique ou événement marketing associé.



Collecte d'informations

Les informations collectées se limitent aux informations que vous décidez de partager avec nous par le biais du service d’expédition de nouvelles, lorsque vous participez à un événement ou à des activités ou que vous vous intéressez à obtenir des informations sur Sernova Corp. comme nom, email, numéro de téléphone et informations de contact similaires. Ces informations sont stockées via MailChimp (veuillez vous reporter aux règles de confidentialité de MailChimp sur https://mailchimp.com/legal/privacy/).



Partage d'information

Sernova Corp. est l'unique propriétaire de toute information collectée sur le site Web. Nous ne vendons pas, ne partageons pas ou ne louons pas ces informations à des tiers.



Collecte d'informations routières et automatiques

Sernova Corp. gère les fichiers journaux du trafic sur www.sernova.com. Ces informations ne sont liées à aucune information personnelle que vous nous avez fournie. Les journaux sont utilisés pour gérer le trafic, identifier le contenu accédé et les besoins informatiques. Les informations consignées et collectées automatiquement ne sont pas limitées aux adresses IP et aux types de navigateur. Cette information ne révèle pas votre identité spécifique.



Cookies

Les cookies peuvent être utilisés pour vous offrir une expérience plus personnalisée. Le site Web peut utiliser des cookies pour rendre cette expérience plus conviviale lorsque vous revenez sur le site Web. Vous avez la possibilité à tout moment de refuser l'utilisation de cookies. Si vous choisissez de le faire, vous ne pourrez peut-être pas utiliser toutes les fonctionnalités du site Web. Vous pouvez également supprimer des fichiers de cookies à tout moment depuis votre ordinateur. Ces cookies peuvent inclure des cookies de première partie (tels que les cookies de Google Analytics).



Mises à jour

Cette politique est un document évolutif et peut être modifié ou mis à jour de temps à autre sans préavis. Nous vous encourageons à consulter la politique périodiquement.



Contact

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

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