Stock Info (+) Info bourse (+)

TSX: SVA  |  OTCQB: SEOVF

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

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

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

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

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

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

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

Indications: Les indications:


Diabetes Diabète

Haemophilia A Hémophilie A

Thyroid disease Maladie thyroïdienne

Clinical studies: Etudes cliniques:


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

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

Cell Pouch System™


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


Immune Protection Protection immunitaire


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

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

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

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


Featured News Nouvelles en vedette

February 25, 2022 25 Février, 2022

Loading... Chargement...

Sernova Made the 2022 TSX Venture 50 List!

November 18, 2021 18 Novembre, 2021

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

September 30, 2021 30 Septembre, 2021

Loading... Chargement...

Dr. Tomei Conformal Coating Immunoprotection Webinar with Sernova

July 6, 2021 6 Juillet, 2021

Sernova 2021 AGM Recording

April 28, 2021 28 Avril, 2021

Loading... Chargement...

Sernova KOL Event on Thyroid Disease with Dr. Sam Wiseman

December 22, 2020 22 Décembre, 2020

Global News Radio - London, Ont. company makes big leap forward in the fight to cure Type 1 diabetes


News Releases Communiqués de presse

May 24, 2022 24 Mai, 2022

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

May 17, 2022 17 Mai, 2022

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

May 9, 2022 9 Mai, 2022

Sernova Announces Abstract on Phase 1/2 Trial with Cell Pouch Selected for Oral Podium Presentation at American Diabetes Association 82nd Scientific

May 5, 2022 5 Mai, 2022

Sernova to Participate in Multiple U.S. Healthcare Investor Conferences

Invest with Sernova Investir dans Sernova

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

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

 

Diabetes patients Patients diabétiques

 

Hemophilia Orphan Indication Indication orpheline de l'hémophilie

 

Sernova is traded on: Sernova est échangé sur:

Subscribe to our Newsletter Abonnez-vous à notre newsletter

*indicates required* requis

By subscribing to our Newsletter you will receive Sernova’s press releases and news as they develop by email. We do not send direct mail, customized online advertising, and we do not share your personal information. We respect your privacy. En vous abonnant à notre newsletter, vous recevrez par e-mail les communiqués de presse et les actualités de Sernova au fur et à mesure de leur développement. Nous n'envoyons pas de publipostage, de publicité en ligne personnalisée et nous ne partageons pas vos informations personnelles. Nous respectons votre vie privée.

Please read our Pour plus d’informations, veuillez lire notre Privacy policypolitique de confidentialité.

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

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

 

Privacy PolicyPolitique de confidentialité

Updated July 6, 2018

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

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

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



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

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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

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


London, Ontario – May 24, 2022 – Sernova Corp. (TSX-V:SVA; OTCQB:SEOVF; FSE/XETRA:PSH), a clinical- stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that it has received conditional approval to list its common shares on the Toronto Stock Exchange (the "TSX") and move off of the TSX Venture Exchange ("TSXV").

Final approval of the listing is subject to the Company meeting certain customary conditions required by the TSX. The company will issue a press release once the TSX confirms the date when trading of Sernova’s common shares is expected to commence on the TSX. Upon completion of the final listing requirements, Sernova’s common shares will be delisted from the TSXV.

Dr. Philip Toleikis, President and CEO of Sernova Corp commented, “Moving onto the Toronto Stock Exchange represents a milestone achievement in our evolution as an emerging regenerative medicine company. Up- listing will provide enhanced liquidity and bring new visibility and investors into the company as we advance our therapeutic cell therapy platform with the goal to provide ‘functional cures’ for multiple diseases including type one diabetes, hemophilia and thyroid disease.”

Shareholders are not required to exchange their share certificates or take any other action in connection with the TSX listing, as there will be no change in the trading symbol or CUSIP for the common shares. The Company will continue to trade its common shares on the OTCQB market in the United States under the symbol "SEOVF", and the Frankfurt exchange under the symbol "PSH".

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

Sernova Corp. is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (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 replacement of proteins or hormones missing or in short supply within the body.

The Cell Pouch™ is a 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. Encouraging interim results have been presented at several international scientific conferences.

For more information, please visit www.sernova.com

For further information contact:

Corporate and Investors: Sernova Corp. Christopher Barnes Tel: (519) 858-5126 christopher.barnes@sernova.com www.sernova.com

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

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

Neither the TSXV nor the TSX accepts responsibility for the adequacy or accuracy of this news release.

FORWARD-LOOKING INFORMATION This release may contain 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 Sernova 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 forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials, and the development of new technologies, cell therapy solutions and or products. The information disclosed represents results from one patient and may not be representative of all study patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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

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


• Partnership Leverages Sernova’s Proprietary Cell Pouch System™ with Evotec’s iPSC-Based Insulin- Producing Beta Cells • Partners to Develop and Commercialize an Off-The-Shelf Cell Replacement Therapy for Treatment of Patients with Insulin-Dependent Diabetes • Evotec to Make Strategic Equity Investment of CAD $27 M / €20 M in Sernova • Sernova / Evotec Joint Conference Call and Webcast at 8:30 am EDT May 17, 2022

LONDON, ONTARIO – May 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics, and Evotec SE (FSE: EVT; NASDAQ: EVO), a global pharmaceutical and life science company, and leading developer of iPSC cell technologies for therapeutic applications, are pleased to announce an exclusive global strategic partnership to develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes. The two Companies will combine and leverage their respective technologies and scientific expertise to develop an implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited insulin-producing cell source to treat patients with insulin-dependent diabetes.

The collaboration agreement is a transformative partnership that combines Sernova’s Cell Pouch System technologies, which has demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with Evotec’s iPSC-based beta cells. Incorporating Evotec’s insulin-producing, ethically-derived beta cells within Sernova’s Cell Pouch platform creates the potential to provide a ‘functional cure’ for millions of people suffering from diabetes using a cGMP controlled and scalable off-the-shelf product.

With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like clusters have now been proven to be functionally equivalent to primary human islets in their ability to normalize blood glucose using in vivo models of type 1 diabetes (T1D).

The partnership provides Sernova a global exclusive option to license Evotec’s iPSC-based beta cells for use in treating both type 1 and type 2 diabetes. In addition to entering into the collaboration agreement, Evotec has made a strategic equity investment of €15M and will make a further investment of €5M. Specifically, concurrently with the entering into the collaboration agreement, Evotec acquired a total of 12,944,904 common shares at a price of CAD $1.57 per share for gross proceeds to Sernova of $20,323,500. In addition, pursuant to an unconditional purchase warrant, Evotec will acquire, on or before August 31, 2022, a further 2,709,800 common shares at a price of CAD$2.50 per share for gross proceeds of $6,774,500. All of the securities issued to Evotec are subject to a four month hold period.

Further to the collaboration and Evotec’s strategic equity investment, Dr. Cord Dohrmann, Chief Scientific Officer of Evotec will join Sernova’s Board of Directors.

Dr. Philip Toleikis, President, and Chief Executive Officer of Sernova, commented, “In tandem with our current clinical islet cell program, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells preclinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and Dr. Dohrmann’s appointment to Sernova’s Board adds significant regenerative medicine depth and cell therapy expertise. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes.”

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch™ technology, which fits perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin- dependent diabetic patients. The synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. I am very much looking forward to collaborating with Sernova on the project as well as contributing to their Board of Directors.”

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells to treat patients with insulin-dependent diabetes. From an operational perspective, the preclinical development program(s) will be jointly funded by Sernova and Evotec until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute its cell manufacturing capabilities through research, development and product commercialization and will decide in the future on the joint funding of clinical development. Upon commercialization, there will be a profit-sharing arrangement between the two companies, with the split being dependent on Evotec’s participation in funding the clinical development program.

Joint Sernova / Evotec Conference Call and Webcast Details:

Date: Tuesday, May 17, 2022 Time: 8:30 am EDT US Toll Free: 1-877-704-4453 International: 1-201-389-0920 Conference ID: 13730121 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d

A simultaneous slide presentation will be available via the above webcast link.

ABOUT SERNOVA CORP AND THE CELL POUCH SYSTEM CELL THERAPY PLATFORM

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (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 replacement of proteins or hormones missing or in short supply within the body.

The Cell Pouch, as part of the Cell Pouch System, is a 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. Encouraging interim results have been presented at several international scientific conferences. For more information, please visit www.sernova.com

ABOUT EVOTEC AND iPSC

Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s proprietary EVOcells platform.

For further information contact:

Corporate and Investors:

Sernova Corp Christopher Barnes Tel: (519) 858-5126 christopher.barnes@sernova.com www.sernova.com

Investors:

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

Media:

Elizabeth Miller, MD LifeSci Communications emiller@lifescicomms.com

FORWARD-LOOKING INFORMATION This release may contain 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 Sernova 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 forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials, and the development of new technologies, cell therapy solutions and or products. The information disclosed represents results from one patient and may not be representative of all study patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - Mai 09, 2022 9 Mai, 2022

Sernova Announces Abstract on Phase 1/2 Trial with Cell Pouch Selected for Oral Podium Presentation at American Diabetes Association 82nd Scientific Sessions 2022


LONDON, ONTARIO – May 9, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage 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 that an abstract has been selected for an oral podium presentation at the upcoming American Diabetes Association (ADA) 82nd Scientific Sessions, to be held from June 3-7, 2022, at the Ernest N. Morial Convention Center in New Orleans, LA.

Abstract 306-OR: Modified Approach for Improved Islet Allotransplantation into Prevascularized Sernova Cell PouchTM Device: Preliminary Results of the Phase I/II Clinical Trial at University of Chicago

Abstract Session: Islet Transplantation —Basic Science Session Date/Time: Monday, June 6, 2022 at 2:15 PM – 4:15 PM CT Presentation Time: 3:15-3:30 PM CT Authors: Bachul PJ, Perez-Guetierrez A, Ling-jia Wang, Golab K, Basto L, Perea L, Tibudan M, Braden J, Thomas C, Philipson L, Barth R, Fung JJ, Witkowski P

Sernova will disclose additional information about the presentation at the time of the conference in alignment with the American Diabetes Association’s abstract embargo policies.

ABOUT SERNOVA

Sernova is developing regenerative medicine cell 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. Encouraging interim results have been presented at several international scientific conferences.

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

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

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



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

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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

Sernova to Participate in Multiple U.S. Healthcare Investor Conferences


Sernova Engages Leading U.S.-Based Healthcare Communications Firm to Broaden Awareness of Potential ‘Functional Cure’ Technology for Type 1 Diabetes

LONDON, ONTARIO – May 5, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical stage regenerative medicine company focused on developing a potential ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases including hemophilia A and thyroid disease, today announced that the company will be participating in several upcoming U.S. healthcare industry and investor conferences. Conference details are provided below.

The Company is also pleased to announce it has engaged New York-based LifeSci Communications, a global life science and medical technologies-focused communications and marketing agency. LifeSci Communications will assist Sernova to expand and elevate its profile through strategic communications and public relations. Sernova is also working with affiliate LifeSci Advisors LLC, a leading investor relations consultancy firm serving life science companies, providing institutional investor communications and capital markets outreach services in support of the Company’s U.S. capital markets objectives.

“With multiple collaborations advancing across our pipeline and growing interest in our best-in-class cell therapy therapeutic solution platform - consisting of immune protected therapeutic cells and our proprietary Cell Pouch™ medical device - as a potential ‘functional cure’ for multiple patient populations, the timing is right to drive awareness of our unique cell therapy proposition and unprecedented clinical results including the demonstration of continuous insulin independence for over two years now in our most advanced Phase 1/2 T1D study patient, in contrast to the clinical setbacks of several of our peer companies,” commented Dr. Philip Toleikis, President & CEO of Sernova.

UPCOMING U.S. HEALTHCARE INDUSTRY AND INSTITUTIONAL INVESTOR PRESENTATIONS

Event: Roth Capital’s Canada Corporate Access Day Date: May 17, 2022 Format: Corporate presentation and 1x1 meetings with institutional investors Location: New York, NY Event: H.C. Wainwright Global Life Sciences Conference Date: May 24-25, 2022 Format: Corporate presentation and 1x1 meetings with institutional investors Location: Miami Beach, FL Event: Truist Securities Cell Therapy Symposium Date: June 28, 2022 Format: Panel expert and discussions Location: New York, NY

ABOUT SERNOVA Sernova is developing regenerative medicine cell 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. Encouraging interim results have been presented at several international scientific conferences. FOR FURTHER INFORMATION, PLEASE CONTACT: Investors and Analysts Christopher Barnes Corey Davis, Ph.D. VP, Investor Relations Managing Director Sernova Corp. LifeSci Advisors, LLC christopher.barnes@sernova.com cdavis@lifesciadvisors.com Tel: 519-902-7923 Tel: 212-915-2577 www.sernova.com Media Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.com FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to complete collaboration activities; ability to secure collaboration arrangements from its collaboration activities; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - Avril 29, 2022 29 Avril, 2022

Sernova Announces 2022 Annual General Meeting Results


LONDON, ONTARIO – April 29, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical stage regenerative medicine company focused on developing a potential ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to announce results from its Annual General Meeting of Shareholders (the “AGM”) held virtually via live audio webcast, on April 28, 2022. Shareholders voted overwhelmingly in favour of all management resolutions proposed in the Company’s Information Circular.

The following resolutions were proposed and approved at the AGM: • The re-election of the following directors for the ensuing year: Frank Holler, James Parsons, Jeffrey Bacha, Deborah Brown, Dr. Mohammad Azab and Dr. Philip Toleikis. • The appointment of Davidson & Company LLP, as auditors of the Company until the next annual meeting and the authorization of the directors of the Company to fix the remuneration to be paid to the auditors.

“I sincerely appreciate our shareholders ongoing support for Sernova. The Board and management are very excited about the immediate and long-term prospects of the Company as we expand our therapeutic applications, broaden our capital markets following and execute on a number of strategic initiatives,” said Dr. Philip Toleikis, President & CEO of Sernova Corp.

Management’s corporate update to shareholders will be available on Sernova’s website next week at www.sernova.com.

For further information contact:

Sernova Corp Christopher Barnes Tel: (519) 858-5126 christopher.barnes@sernova.com www.sernova.com

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

ABOUT SERNOVA

Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (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 replacement 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

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device 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 device 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.

FORWARD-LOOKING INFORMATION This release may contain 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 Sernova 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 forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials. The information disclosed represents results from one patient and may not be representative of all study patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.



Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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

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


Confirms Ongoing Safety and Tolerability of Sernova’s Cell Pouch

March 17, 2022 10:00 a.m. EDT

LONDON, ONTARIO – March 17, 2022 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical- stage company and leader in regenerative medicine cell therapeutics, is pleased to announce that the Data Safety Monitoring Board ("DSMB") has completed the third annual review of Sernova’s ongoing Phase 1/2 clinical study “Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch for Clinical Islet Transplantation” in patients with Type-1 Diabetes (T1D) who suffer from hypoglycemia unawareness and severe hypoglycemic events.

In their assessment, the DSMB recommended that the clinical study should continue according to the study plan.

The DSMB is an independent committee of clinical experts who review the accumulated trial data to evaluate patient safety and ensure the integrity of the study data.

“This recommendation from the DSMB affirms our understanding of the safety of Cell Pouch in this patient population transplanted with human donor islets. We look forward to sharing updates from the study through upcoming conference presentations by Dr. Piotr Witkowski, the trial Principal Investigator.” said Dr. Philip Toleikis, President & CEO of Sernova Corp.

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 enough to be incapacitating or even fatal, which may occur when blood glucose levels are below 3.0 mmol/L. It is estimated that approximately 15% of people with T1D, or approximately 240,000 people, are affected by hypoglycemia unawareness in the US alone. 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 cell 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

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

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


Sernova awarded top performer status for two years standing

February 24, 2022 7:30 a.m. EST

LONDON, ONTARIO – February 24, 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 that it has been named as one of the top 50 performers on the TSX Venture Exchange.

The 2022 TSX Venture Top 50 is a ranking of top performers on the TSX Venture Exchange over the last year based on three equally weighted criteria: share price appreciation, average trading volume and market capitalization growth.

“We are honored by the TSX Venture Exchange recognition of Sernova as a 2022 Top 50 recipient company. Being awarded this title two years in a row is strong validation of our persistent dedication to increasing shareholder value as we continue to deliver on our strategic plan to build a leadership position in the regenerative medicine cell therapy therapeutics field. In 2022, we look forward to driving continued success through, evolving our clinical programs, further developing our pharmaceutical partnerships and by advancing our capital market initiatives,” said Dr. Philip Toleikis, Chief Executive Officer of Sernova.

As part of the award, the TSX Venture Exchange sponsored a Q&A highlight interview with Dr. Toleikis. To view the video, please https://share.vidyard.com/watch/dsfSgoQyYi87x8pj8oUEz6 and for the complete list of 2022 TSX Venture 50 companies.

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. LifeSci 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - Janvier 27, 2022 27 Janvier, 2022

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


Sernova prepares for clinical trial of new treatment for post-operative hypothyroidism

LONDON, ONTARIO – January 27, 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 including type 1 diabetes (T1D) is pleased to announce publication of a peer reviewed preclinical study demonstrating positive results of a novel Cell Pouch System™ cell therapy approach to treat hypothyroidism and potentially avoid lifelong dependence on thyroid medication following surgical removal of the thyroid gland.

The journal article entitled “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,” by lead author, Dr. Sam M. Wiseman was published in the prestigious scientific journal, PLOS ONE, January 20, 2022. In this study, thyroid tissue from patients undergoing surgery for treatment of benign disease was transplanted into Sernova Cell Pouches that had been previously implanted into laboratory mice. The aim of the study was to investigate the long-term survival of human thyroid tissue in the Cell Pouch and evaluate the ability of these thyroid transplants to release thyroid hormones into the bloodstream. The study confirmed that the human thyroid tissue transplanted into the Cell Pouch survived and released human thyroglobulin into the bloodstream, with no adverse effects for the three-months duration of the study. Thyroglobulin was used as a biomarker efficacy measure in this study as it is the precursor of thyroid hormones.

“I’m very excited about this study because it represents a critical first step towards a future where we can offer our patients a treatment option that allows for preservation of their thyroid function with avoidance of postoperative hypothyroidism, its many associated morbidities and life-long dependence on thyroid medication,” commented Sam M. Wiseman BSc, MD, FRCSC, FACS.

Dr. Philip Toleikis, President and CEO Sernova Corp stated, “For hypothyroid disease, these data support the potential of our Cell Pouch to allow for a recovery of the natural thyroid hormone feedback system following thyroidectomy, restoring thyroid hormone levels without the risks and side effects associated with hormone replacement drugs. This could provide life-changing options for the more than 150,000 patients who undergo a thyroidectomy in the US, alone, each year. These preclinical data are consistent with our findings utilizing the Cell Pouch in the treatment of T1D and Hemophilia A. We believe the Sernova Cell Pouch System therapeutic approach could provide a ‘functional cure’ for millions of patients who suffer from afflictions caused by the absence of systemic proteins or hormones.”

Sernova Corp., with Dr. Wiseman as clinical investigator, is preparing regulatory documents to proceed with a Phase 1/2 human clinical trial in subjects undergoing thyroid surgery. In this study, the subjects will be implanted with the Cell Pouch to create the vascularized tissue environment several weeks prior to transplant of their healthy thyroid tissue. The objective of the study is to assess the safety and efficacy of the Cell Pouch transplanted tissue, with efficacy measured as recovery of thyroid hormone in the bloodstream. The Company expects to submit a clinical trial application within 2022.

The thyroid gland produces hormones that regulate metabolism within a narrow functional range. Thyroid hormone replacement drugs are frequently used to treat insufficient or absent thyroid activity. Optimization of thyroid hormone replacement medications can be difficult with dose adjustments requiring frequent lab tests to reach appropriate levels. Thyroid hormone replacement therapy is associated with several side-effects including impaired cognition, lethargy, and weight gain, leading to diminished quality of life, and incurring significant ongoing costs to the patient and healthcare system.

ABOUT THYROID DISEASE

Surgical removal of the thyroid gland, or thyroidectomy, is commonly performed for management of thyroid cancers, and for treatment of benign (non-cancerous) diseases that include nodules, goitre, and hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the U.S. annually, with most individuals undergoing thyroid surgery eventually being diagnosed with benign conditions. Some patients undergoing partial thyroidectomy and all patients undergoing total thyroidectomy require life-long oral postoperative thyroid hormone replacement treatment.

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, thyroid disease 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 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. 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. Sernova is currently conducting a Phase 1/2 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - Janvier 20, 2022 20 Janvier, 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.

Share the news     Partagez les nouvelles

Email Facebook LinkedIn Twitter See direct link

Press Release Communiqué de presse - Janvier 10, 2022 10 Janvier, 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.