News Nouvelles

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.

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Press Releases Communiqués de Nouvelles

Latest News Releases Derniers communiqués de presse

June 11, 2024 11 June, 2024

Sernova Announces Marketed Public Offering of Units

May 28, 2024 28 May, 2024

Sernova Appoints Jonathan Rigby to its Board of Directors

May 1, 2024 1 May, 2024

Sernova Announces AGM Voting Results

April 25, 2024 25 April, 2024

Sernova Provides Organizational Update

April 22, 2024 22 April, 2024

Sernova Welcomes Dr. Bernd Muehlenweg as Evotec’s Nominee for its Board of Directors

April 2, 2024 2 April, 2024

Sernova Provides Positive Clinical and Platform Portfolio Update

March 11, 2024 11 March, 2024

Sernova Announces Management Developments

January 29, 2024 29 January, 2024

Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones

 
October 5, 2023 5 October, 2023

Sernova Business Update

June 30, 2023 30 June, 2023

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

June 30, 2023 30 June, 2023

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

June 28, 2023 28 June, 2023

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

June 26, 2023 26 June, 2023

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

June 26, 2023 26 June, 2023

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

June 26, 2023 26 June, 2023

Madeleine Armstrong of Evaluate Vantage talks about Sernova - ADA 2023 – Vertex raises hopes of type 1 diabetes cure But it still has a long way to go with its islet cell therapies.

June 26, 2023 26 June, 2023

Shane Whooley of Drug Delivery Business News: A MassDevice Resource - Sernova reports positive interim data for Cell Pouch System

May 5, 2023 5 May, 2023

Marisa Wexler of Hemophilia News Today - AstraZeneca, Sernova join forces on cell therapy research

May 4, 2023 4 May, 2023

Medical Device Network - Sernova and AstraZeneca team to study novel therapeutic cell applications

May 3, 2023 3 May, 2023

Manshi Mamtora of Seeking Alpha - Sernova joins hands with AstraZeneca for potential therapeutic cell applications

May 3, 2023 3 May, 2023

Shane Whooley of Drug Delivery Business - Sernova, AstraZeneca collaborate to deliver therapeutic cells with Sernova Cell Pouch

May 3, 2023 3 May, 2023

Noah Stansfield of CGTLive features Sernova in Around the Helix: Cell and Gene Therapy Company Updates – May 3, 2023

March 17, 2023 17 March, 2023

Dr. Philip Toleikis recently spoke with proto.life (formerly NEO.LIFE) on the advancements of our Cell Pouch System™ to develop a potential ‘functional cure’ to improve the quality of life for patients with T1D

February 8, 2023 8 February, 2023

Dr. Philip Toleikis sat down with PharmaShots to discuss our global strategic partnership with Evotec and how it will contribute to the advancement of our Cell Pouch System as a "functional cure" for insulin-dependent diabetes

January 31, 2023 31 January, 2023

Scrip Asks…What Does 2023 Hold For Biopharma? Part 5: Technological Advances

January 9, 2023 9 January, 2023

Sernova Featured at PBA's Year in Review Event

December 20, 2022 20 December, 2022

Jim Cornell of Labiotech.eu - Sernova's Cell Pouch System Tackles Diabetes

November 23, 2022 23 November, 2022

The London Free Press - "London Company Working on Diabetes Cure Ramps Up Hiring as Trials Show Promise"

November 22, 2022 22 November, 2022

Shane Whooley of Mass Device - "How Sernova seeks to treat insulin-dependent diabetes with its Cell Pouch System"

November 16, 2022 16 November, 2022

Sernova's Fireside Chat from the 2022 Stifel Healthcare Conference

November 7, 2022 7 November, 2022

Shane Whooley of Mass Device - "Sernova to enroll second cohort in trial of Cell Pouch System for type 1 diabetes"

October 12, 2022 12 October, 2022

Collaborator, Dr. Alice Tomei from the University of Miami, discussed the advancements in conformal coating to overcome challenges associated with transplanting insulin-producing cells in the body.

October 6, 2022 6 October, 2022

Dr. Philip Toleikis' Fireside Chat with LifeSci Partners at the Virtual HealthTech Symposium

August 18, 2022 18 August, 2022

Dr. Philip Toleikis sat with Erin Harris, Cell & Gene Podcast to discuss the development of the Cell Pouch as a "functional cure" for chronic diseases such as T1D

July 28, 2022 28 July, 2022

Dr. Philip Toleikis sat with Ayesha Rashid on the Xtalks Life Science Podcast to explain how our Cell Pouch System works and the clinical advances we are making to develop a "functional cure" for patients with diabetes

June 27, 2022 27 June, 2022

Dr. Philip Toleikis, shared his thoughts on the next treatment innovations being a "functional cure" for chronic diseases in a recent pharma's almanac roundtable

June 24, 2022 24 June, 2022

Miriam E. Tucker from Medscape highlights the recent presentation of our interim data at the 2022 ADA as well as how our innovative Cell Pouch differs from other developments in the diabetes space

June 21, 2022 21 June, 2022

Sernova featured in Evaluate Vantage: "Sernova gets under the skin"

June 16, 2022 16 June, 2022

Dr. Philip Toleikis joined Stacey Simms on Diabetes Cxns to discuss our Cell Pouch System, a potential "functional cure" for insulin-dependent diabetes.

June 14, 2022 14 June, 2022

Dr. Philip Toleikis was recently interviewed by Joachim Brunner of SmallCap Investor TV

June 9, 2022 9 June, 2022

Dr. Philip Toleikis spoke with Alex Keown from BioSpace about the updated positive interim data from the Phase 1/2 diabetes clinical trial of our Cell Pouch System, presented at the 2022 ADA by our collaborators at the University of Chicago

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

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Press Release Communiqué de presse - June 11, 2024 11 June, 2024

Sernova Announces Marketed Public Offering of Units


NEWS RELEASE Sernova Announces Marketed Public Offering of Units

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

LONDON, Ontario; BOSTON, Massachusetts – June 6, 2024, Sernova Corp. (“Sernova” or the “Company”) (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH) is pleased to announce that it has filed a preliminary short form prospectus in connection with a best efforts marketed public offering (the “Offering”) of units of the Company (the “Units”). The Offering is being led by Stifel Nicolaus Canada Inc., as lead agent (the “Lead Agent”) and joint bookrunner with Leede Jones Gable Inc., on behalf of a syndicate of agents that includes Ventum Financial Corp., Raymond James, Research Capital Corporation and Roth Canada, Inc. (together with the Lead Agent, the “Agents”) and is for minimum gross proceeds of $6,500,000 and up to maximum gross proceeds of $10,000,000. Each Unit will be offered at a price of $0.33 per Unit (the “Offering Price”), and shall consist of one (1) common share of the Company (each, a “Common Share”) and one (1) Common Share purchase warrant (a “Warrant”). Each Warrant will entitle the holder to purchase one Common Share (each, a “Warrant Share”) at an exercise price of $0.40 per Warrant Share for 36 months. It is expected that a definitive agency agreement will be entered into between the Company and the Agents following the successful marketing of the Offering.

The Company has agreed to grant the Agents an option (the “Over-Allotment Option”) to sell up to an additional number of Units at the Offering Price as is equal to 15% of the number of Units issued pursuant to the Offering, exercisable in whole or in part, at any time and from time to time on or prior to the date that is 30 days following the Closing Date (as defined below) to cover over-allotments, if any, and for market stabilization purposes. The Over-Allotment Option shall be exercisable for any number of Units, Common Shares, Warrants, or any combination thereof at a price equal to the Offering Price for a Unit and a price to be agreed upon for the Common Shares and Warrants.

The Company plans to use the net proceeds from the offering to expand enrollment in the Company’s phase I/II Human Donor Islet clinical study, to support the Company’s R&D activities and for general corporate purposes. In addition Sernova would like to announce that Evotec SE, its largest shareholder and collaboration partner, will participate in the offering.

The Offering is scheduled to close on or about June 20, 2024 (the “Closing Date”), and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the Toronto Stock Exchange (the “Exchange”).

A preliminary short form prospectus containing important information relating to the Offering has been filed with the securities regulatory authorities in each of the provinces in Canada, other than the Province of Québec, and is still subject to completion or amendment. The preliminary short form prospectus is available via SEDAR+ at www.sedarplus.ca. Alternatively, the Company, any Agent or any dealer participating in the Offering will arrange to send you the preliminary short form prospectus upon request from the Lead Agent at ecmcanada@stifel.com.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any U.S. state securities laws and may not be offered or sold to or for the account or benefit of persons in the “United States” or “U.S. persons” (as such terms are defined in Regulation S under the U.S. Securities Act) unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin- producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

For further information, please contact:

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

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Press Release Communiqué de presse - May 28, 2024 28 May, 2024

Sernova Appoints Jonathan Rigby to its Board of Directors


Sernova Appoints Jonathan Rigby to its Board of Directors

LONDON, Ontario; BOSTON, Massachusetts – May 28, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, announces today that Jonathan Rigby will join Sernova’s Board of Directors effective immediately.

“We are excited to welcome Jonathan to Sernova’s Board of Directors. With more than 30 years of diverse experience across the biopharmaceutical landscape, Jonathan brings a track record of substantial contributions across our sector as a biotech CEO and Board member. He will both complement and augment the expertise and composition of our current Board,” said Cynthia Pussinen, Chief Executive Officer of Sernova. “We welcome Jonathan’s passion for improving the lives of patients and his guidance on accelerating delivery of our development programs.”

Mr. Rigby has a breadth of industry knowledge and productive experience having served as President and CEO of Revolo Biotherapeutics where he took the company through multiple financings and two Phase 2 clinical trials, as well as serving as Chairman and Chief Business Officer of BIOS Acquisition Corporation (NASDAQ: BIOS), with an oversold IPO. Mr. Rigby served as the CEO for SteadyMed Therapeutics (NASDAQ: STDY), which he listed on Nasdaq prior to its acquisition by United Therapeutics (NASDAQ: UTHR), and was co-founder of Zogenix (NASDAQ:ZGNX), which was also acquired by UCB (Euronext: UCB) after completing a NASDAQ listing.

In addition, Mr. Rigby currently serves on the Board of Directors of cancer therapy company Oncolytics Biotech Inc. (NASDAQ: ONCY) and IM Therapeutics which is developing therapies for Type 1 diabetes (T1D). He is a past Board Member of Thermalin Inc., which engineered new forms of insulin to improve patient lives and outcomes for the treatment of T1D and was formerly on the board of Xeris Pharmaceuticals (NASDAQ: XERS) which developed and commercialised a therapy to treat T1D severe hypoglycemia. Mr. Rigby holds a degree in Biological Sciences from the University of Sheffield, UK, and has a Master of Business Administration degree from the University of Portsmouth, UK.

“As an individual with T1D, I am acutely aware of the challenges of living with this life changing condition and the need to effectively cure the disease. Given Sernova’s vision of a future where chronic conditions are no longer insurmountable obstacles, and their foundational work on delivering a ‘functional cure’ for T1D, I am especially excited to join the Board and work hard to progress the company forward. Sernova represents a new era of development for cell therapy treatments and I look forward to working with the Board and the leadership team in advancing Sernova’s groundbreaking technology and therapies,” said Mr. Rigby.

ABOUT SERNOVA AND ITS 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 technology, 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 partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT: Christopher Barnes VP, Investor Relations Sernova Corp. Tel: +1 519-902-7923 Email: christopher.barnes@sernova.com Website: www.sernova.com

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - May 01, 2024 1 May, 2024

Sernova Announces AGM Voting Results


SERNOVA ANNOUNCES AGM VOTING RESULTS

LONDON, Ontario; BOSTON, Massachusetts – May 1, 2024, Sernova Corp. (“Sernova” or the “Corporation”) (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH) a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, is pleased to announce results from its Annual General Meeting of Shareholders (the “AGM”) held virtually via live audio webcast, on April 30, 2024. At the Meeting, a total of 88,316,160 common shares were voted, representing 29.11% of the votes attached to all outstanding common shares as of the record date. The voting results were as follows:

Director% of Votes For% of Votes Against
Cynthia Pussinen95.62%4.38%
James T. Parsons98.63%1.37%
Dr. Steven Sangha96.43%3.57%
Brett A. Whalen73.91%26.09%




Accordingly, Cynthia Pussinen, James T. Parsons, Dr. Steven Sangha and Brett A. Whalen were elected to the board of directors for the ensuing year. In addition, Bernd Muehlenweg was appointed to the board of directors following the AGM. Bertram von Plettenberg resigned from the board of directors prior to the AGM and did not stand for election at the AGM.

Shareholders also approved (with 99.79% of the votes approving) the re-appointment of KPMG LLP, Chartered Professional Accountants as the Company’s auditor for the ensuing year, and approved (with 82.57% of the votes approving) the amendments to the Option Plan and DSU Plan and the increase in the maximum number of Common Shares reserved for issuance.

ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with Evotec to develop an implantable o􀆯-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’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

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

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - April 25, 2024 25 April, 2024

Sernova Provides Organizational Update


Sernova Provides Organizational Update

• Dr. Philip Toleikis to retire as of April 30, 2024

• Cost savings from restructuring and strategic transformation anticipated to extend runway

• Board rebuild underway

LONDON, Ontario; BOSTON, Massachusetts – April 25, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, today announced the retirement of Chief Technology Officer (CTO), Dr. Philip Toleikis along with progress on strategic transformation efforts including a restructuring of operations and a workforce reduction of approximately 35%.

Commenting on his retirement, Dr. Toleikis said, “It has been a tremendous honor and privilege to serve Sernova since 2009, initially as the President, CEO and director, and more recently as its CTO. Significant progress has been made and there is exciting work ahead that I am confident will be realized by the team, under the guidance of our CEO, Ms. Pussinen.” Dr. Toleikis further states, “I am pleased to provide continued support to Sernova as a consultant. I am proud of the Company’s advancements towards redefining the way chronic diseases will be treated using a cell therapy-based approach while importantly contributing to improving the lives of those living with chronic diseases.”

“Philip’s contributions to Sernova’s research and development, and fund-raising efforts have been foundational to the Company’s evolution into a next-generation regenerative medicine company,” said Brett Whalen, Chairman of the Sernova Board. “He will leave a company which is well-positioned to foster the next wave of innovations in stem cell therapies. On behalf of the Board of Directors and the entire company, I would like to thank Dr. Philip Toleikis for his contributions and unwavering dedication to the Company. We wish him all the best for his future.”

As communicated in early April, following a review of the company’s therapeutic pipeline and emerging opportunities for its Cell Pouch system platform technologies, Sernova confirmed key priorities including its lighthouse program in insulin dependent Type 1 Diabetes plus its intention to advance an IND filing for its post- operative hypothyroidism program. “The pipeline and platform review and associated strategy refresh highlighted several ways by which to optimize financial resources, extending the Company’s cash runway. We continue to seek ways to raise additional capital to strengthen our financial foundation,” said Cynthia Pussinen, Chief Executive Officer of Sernova. “In connection with the strategic transformation, we will pause on any new investments into the conformal coating program to reallocate funds. In parallel, we continue to evaluate alternative approaches to obviate the need for immunosuppressive regimens for our allogeneic therapies.”

Sernova has implemented a plan to fortify the balance sheet and cash position, including a workforce restructuring, representing a key step towards streamlining the organization while ensuring the ability to secure core competencies needed to drive further progress in key clinical and pre-clinical assets. “Decisions to scale back or to rebalance headcount are extremely difficult. I want to express my heartfelt appreciation and gratitude to those impacted for their invaluable contributions, dedication to helping patients and impact to furthering the Company’s vision of a future where chronic conditions are no longer insurmountable obstacles”, said Ms. Pussinen.

The Company confirms the completion and closure of all internal investigation efforts, previously announced with respect to its former CFO and potentially a second employee of the Company. No new findings were revealed and there will be no further action on the matter. The investigation confirmed that there have been no securities violations and that findings bore no material impact to financial statements and operations.

Lastly, Sernova Director Mr. Bertram von Plettenberg has retired from the Company’s Board, effective April 23rd. “The Board and Management sincerely thank Mr. von Plettenberg for his past year of service to the Company, and wish him well in future endeavors,” said Ms. Pussinen. “The evolution and composition of the Board will continue, as we look to enhance our life sciences industry specific strength, to better serve our patients and shareholders.”

ABOUT SERNOVA’S ANNUAL GENERAL MEETING

Sernova’s Annual General Meeting will be held on Tuesday April 30, 2024 starting at 1:00 PM ET. The meeting will be conducted virtually, via live webcast and accessible online at https://virtualmeetings.tsxtrust.com/1571.

Please note that this site may not be fully accessible on all internet browsers, and it is advisable to use a browser other than Internet Explorer for optimal experience. If you are unable to join the meeting through your usual web browser, we suggest trying an alternate browser.

For investors who wish to submit questions via the TSX Trust portal voting control numbers will be needed. For attendees who would simply like to listen to the meeting conduct, you can register as a guest.

ABOUT SERNOVA AND ITS 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 technology, 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 allowing 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 partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin- producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. FOR FURTHER INFORMATION, PLEASE CONTACT: Christopher Barnes VP, Investor Relations Sernova Corp. Tel: +1 519-902-7923 Email: christopher.barnes@sernova.com Website: www.sernova.com

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

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Press Release Communiqué de presse - April 22, 2024 22 April, 2024

Sernova Welcomes Dr. Bernd Muehlenweg as Evotec’s Nominee for its Board of Directors


Dr. Daniel Mahony to step down to pursue new commitment

LONDON, Ontario; BOSTON, Massachusetts – April 22, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, announces today that Dr. Bernd Muehlenweg, Senior Vice President of Global Business Development at Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO), has been appointed to its Board of Directors. Evotec recently shared that due to the impending departure of Dr. Daniel Mahony, its current Sernova Board delegate, who is leaving to pursue a new professional undertaking, they would be nominating a new Board representative. With heartfelt gratitude, we wish Dan all the very best in his future endeavors.

Dr. Muehlenweg will join Sernova’s Board of Directors effective immediately. Sernova expects the brief period of overlap with Dr. Daniel Mahony will assist in the transition bringing Dr. Muehlenweg rapidly up to speed on Sernova’s operational and strategic matters.

Bernd Muehlenweg's work experience includes various senior leadership positions in the biotech and pharmaceutical industry with a concentration on business development and alliance management roles. At Evotec, he leads the company's partnering and out-licensing efforts in their focus areas including iPSC-based Cell Therapy, Panomics-driven drug discovery, Oncology, Immunology & Inflammation, Infectious Diseases, Predictive Safety and Enabling Technologies.

Prior to joining Evotec, he held the position of Chief Business Officer and served on the Executive Board of Nanobiotix, a French clinical stage oncology company. Bernd co-founded Panoptes Pharma GmbH, an Austrian biotech company focused on developing therapies for eye diseases, which was later acquired by Eyegate Pharmaceuticals. Additionally, at Wilex AG, he played a key role in the company's growth and expansion. He began his career as a Group Leader at the Technical University of Munich, Germany.

Bernd Muehlenweg graduated with a Ph.D. from the oncology research group at the Department of Gynecology at the Technical University of Munich in 2000. He further attended management classes at the Switzerland based St. Galler Business School in 2006. “Sernova’s Cell Pouch and Evotec’s iPSC derived islet like clusters are a powerful combination, offering a potential functional cure for type 1 diabetes (T1D) in the not-too-distant future. My personal goal is to foster sustainable, fruitful and durable partnerships to advance scientific innovations into approved treatments. I have tremendous confidence that the strategic collaboration between Evotec and Sernova will provide a strong foundation to potentially achieve this objective” said Bernd Muehlenweg, Sernova’s new Board Director. “At Sernova, we will continue to pursue opportunities to improve the lives of patients with unmet needs while building long-term value for shareholders in multiple ways. I cannot stress enough the importance of the Cell Pouch System as the anchor for our ongoing T1D trial. In addition to its longterm payload survival, containment and retrievability characteristics, we believe that the Cell Pouch is a key differentiator in delivering clinically meaningful outcomes, including insulin independence and normalized HbA1c counts amongst others, to several patients in our ongoing Phase 1/2 trial. We are pleased to welcome Bernd as he joins us on our mission to build a future where chronic conditions are no longer insurmountable obstacles.” said Cynthia Pussinen, CEO of Sernova.

ABOUT SERNOVA AND ITS 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 technology, 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 partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Christopher Barnes VP, Investor Relations Sernova Corp. Tel: +1 519-902-7923 Email: christopher.barnes@sernova.com Website: www.sernova.com

FORWARD-LOOKING INFORMATION

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

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Press Release Communiqué de presse - April 02, 2024 2 April, 2024

Sernova Provides Positive Clinical and Platform Portfolio Update


Sernova Provides Positive Clinical and Platform Portfolio Update

  • Type 1 diabetes (T1D) Cohort 2 patient data demonstrates favorable islet engraftment and long-term survival of human donor islets in the Cell Pouch
  • First treated Cohort 1 patient in the T1D clinical trial to celebrate four years of insulin independence and normalized HbA1c
  • With recent positive findings in post-surgical hypothyroidism large animal study, Sernova anticipates filing an Investigational New Drug (IND) application in 2024
  • Additional chronic disease indications identified for further pipeline expansion with a focus on endocrine disorders


  • LONDON, Ontario; BOSTON, Massachusetts – April 2, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, today provided a business update. Following a review of the company’s therapeutic pipeline and emerging opportunities for its Cell Pouch system platform technologies, Sernova confirms key priorities including its lighthouse program in insulin dependent Type 1 Diabetes plus its intention to advance an IND filing for its post-operative hypothyroidism program.



    Data from a patient in Cohort 2 of the company’s lead clinical program for insulin dependent Type 1 diabetes (T1D) confirms histologic evidence of long-term (one year) robust survival of abundant human donor islets throughout the Cell Pouch. Additional Cohort 2 findings are specific to an advanced immunosuppression regimen planned for use in its upcoming Phase I/II trial with stem cell-derived islets under co-development with Evotec.



    Cohort 2 patients treated with an advanced immunosuppression protocol avoided graft rejection and experienced minimal side e􀆯ects in comparison to those patients observed in Cohort 1. None of the six patients in Cohort 2 treated with the advanced regimen have tested positive for donor specific antibodies (DSAs), a marker of graft rejection, in comparison to three of six patients who developed DSAs under the conventional immunosuppression regimen in Cohort 1. Ancillary medication, used in some Cohort 2 patients, demonstrated highly favorable graft survival and function for islets transplanted to the Cell Pouch and has been integrated into the updated regimen and implemented for all subsequent patient trial enrollments. The company anticipates reporting additional data from Cohort 2 of its ongoing Phase 1/2 clinical trial of its expanded 10-channel Cell Pouch during the second half of the year at major medical conferences. Sernova is pleased to report that this month marks the four-year anniversary of the first patient in Cohort 1 of this Phase 1/2 study who will celebrate insulin independence and normalized blood sugar levels, based on two transplants of human donor islets to the Cell Pouch plus a marginal portal vein top up.



    “Based on the favorable results we are observing in ongoing pre-clinical studies, we have concluded that our hypothyroidism program represents another compelling opportunity by which to improve patients’ lives. We look forward to completing our pre-clinical work, engaging with regulatory agencies, and preparing for an IND filing later this year, with the goal of advancing a second indication into the clinic, further demonstrating the Cell Pouch as a drug delivery vehicle platform technology. Also of note, in addition to allowing for long term payload survival, our Cell Pouch has powerful containment and retrievability capabilities that we expect will have tremendous value for pharmaceutical companies looking to treat patients with cell therapies,” said Cynthia Pussinen, Chief Executive O􀆯icer of Sernova.



    “In parallel with these activities, and our ongoing hemophilia A work, we have identified several high value indications with unmet medical needs that could potentially benefit from our platform Cell Pouch technology, with an initial focus on endocrine disorders. In the coming months, we will be conducting commercial assessments to prioritize those areas where we can best extend our reach to more patients while creating enduring value for our shareholders. I am excited for what we are poised to achieve this year and look forward to providing further updates in the future,” Ms. Pussinen concluded.



    ABOUT SERNOVA AND ITS 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 technology, 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 partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.



    FOR FURTHER INFORMATION, PLEASE CONTACT:

    • Christopher Barnes
    • VP, Investor Relations
    • Sernova Corp.
    • Tel: +1 519-902-7923
    • Email: christopher.barnes@sernova.com
    • Website: www.sernova.com



    FORWARD-LOOKING INFORMATION



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

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    Press Release Communiqué de presse - March 11, 2024 11 March, 2024

    Sernova Announces Management Developments


    LONDON, Ontario; BOSTON, Massachusetts – March 11, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company focused on providing regenerative medicine therapeutics to patients with chronic conditions, today announced that Nicholas J. Rossettos, CPA has joined Sernova on a consulting basis as interim Chief Financial Officer (CFO).

    With a wealth of experience in financial leadership within the biotech industry, Nick brings a fresh perspective and a strong track record of success to the Sernova team during this transition period. The company has initiated a formal search for a permanent CFO and is also actively recruiting additional talent to fill key leadership roles and strengthen its senior executive team, which started with the additions of Cynthia Pussinen as the Chief Executive Officer and Modestus Obochi as Chief Business Officer. The goal is to ensure that Sernova has the expertise to execute its strategic vision and drive the company forward by delivering life- changing therapies to patients worldwide.

    David Swetlow, Chief Financial Officer, is no longer with the company. Mr. Swetlow’s employment was terminated for cause after the Board received and considered findings made by independent legal counsel in connection with an ongoing investigation into alleged misconduct. Another senior officer of the company has been placed on administrative leave pending the final outcome of the investigation. None of the allegations, if substantiated, are expected to materially change or impact the Company's financial statements or its reporting obligations. The Sernova mission remains unchanged: to improve the lives of patients through groundbreaking innovation and compassionate care. The board and the senior leadership team are deeply grateful for the dedication and hard work of the Company’s employees, partners, and stakeholders, and remains steadfast in its commitment to maintaining the highest standards of integrity, transparency, and accountability in all aspects of our operations.

    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. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

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

    FORWARD-LOOKING INFORMATION

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

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

    Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones


    - Recently completed recruitment of all 7 patients in Cohort 2

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

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

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

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

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

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

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

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

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

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

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

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

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

    Anticipated Select 2024 Milestones:

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

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

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

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

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

    Fiscal Year 2023 Financials

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

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

    Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. FOR FURTHER INFORMATION, PLEASE CONTACT: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com

    FORWARD-LOOKING INFORMATION

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

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

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

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    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