• Merger unites Sernova's Cell Pouch Bio-hybrid Organ with Seraxis' stem cell-derived pancreatic islet cells and in-house cGMP manufacturing
  • The combined entity will operate under the name BetaNova Biotherapeutics, Inc.
  • SR-02 allogeneic islet cell therapy Phase 1/2 clinical trial in T1D expected to dose patients Q1 2027 under an FDA-cleared IND (NCT07581197) with data anticipated by mid-year
  • SR-03 next-generation gene-edited islet cell therapy targeting immune evasion; IND submission expected H2 2027
  • US$10 million non-brokered financing secured to fund initial development plans to key milestones
  • Merger expected to close in November 2026, subject to shareholder approval
  • Upon completion of the Merger, BetaNova intends to seek listing on NASDAQ in Q1 2027, subject to satisfaction of applicable listing requirements and approvals
  • Webinar to be held September 11, at 10 a.m. EDT

TORONTO and GERMANTOWN, Md., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics Inc. ("Sernova") (TSX: SVA) (OTC: SEOVF) (FSE/XETRA: PSHO) and Seraxis Holdings, Inc. ("Seraxis") today announced a definitive agreement to combine their technologies and businesses to create a clinical-stage company, BetaNova Biotherapeutics ("BetaNova") focused on advancing a differentiated approach to type 1 diabetes (T1D) islet cell replacement (the "Merger"). BetaNova will be a U.S.-domiciled biotechnology company headquartered in Germantown, Maryland, with integrated research laboratories and cGMP manufacturing capabilities. Upon completion of the Merger, the shareholders of Seraxis and Sernova will each own approximately 50% of BetaNova.

In connection with the Merger, commitments for a US$10 million non-brokered convertible note financing have been secured from existing insider shareholders of both Sernova and Seraxis. The financing round remains open to additional qualified investors until September 30, 2026, by referring to the contact details below. Upon completion of the Merger, the convertible notes issued pursuant to the financing will automatically convert into non-voting common stock of BetaNova. Holders of non-voting common stock of BetaNova can elect to convert their non-voting common stock into voting common stock subject to beneficial ownership limitations. The financing is expected to provide sufficient capital to advance several key value-driving milestones for BetaNova, including cGMP manufacturing of SR-02 stem cell-derived pancreatic islet cells, dosing of the first patients in a Phase 1/2 clinical trial in patients with T1D in the first quarter of 2027, with data anticipated by mid-2027, Nasdaq listing readiness in the first quarter of 2027, and advancement of an IND for SR-03 in the second half of 2027.

BetaNova's pipeline will be anchored by its lead allogeneic product candidate, SR-02, a stem cell-derived pancreatic islet therapy developed to be paired with next-generation, low-toxicity immune suppressants with the goal of eliminating immunosuppression through establishment of tolerance. In addition, BetaNova's follow-on stem cell-derived pancreatic islet product candidate, SR-03, incorporates gene edits expected to eliminate immunosuppression through immune-evasion.

These product candidates will be complemented by Sernova's established clinical foundation. Patient treatment and follow-up in Sernova's Phase 1/2 clinical study evaluating the Cell Pouch Bio-hybrid Organ with human donor pancreatic islets in patients with T1D is now complete. All primary and secondary endpoints were met, complemented by over 30 years of cumulative patient safety data supporting the platform's clinical profile.

"This merger is deeply personal to me - I've lived with and suffered from type 1 diabetes most of my life and it drives my passion to overcome it," said Jonathan Rigby, President and CEO of Sernova and proposed CEO of BetaNova. "People with T1D struggle to manage the life-altering loss of insulin production, often resulting in serious co-morbidities. Combining Sernova's Cell Pouch Bio-hybrid Organ with Seraxis' stem cell-derived pancreatic islet cells lets us approach the problem differently, bringing us closer to a functional cure. This is very exciting to me and our entire team."

BetaNova's integrated platform combines Seraxis' SR-02 and SR-03 stem cell-derived pancreatic islets with in-house scalable cGMP manufacturing, and Sernova's Cell Pouch Bio-hybrid Organ, a clinically validated implantable and retrievable device proven to support islet cell survival, engraftment and function. We believe this combination, including strategies to reduce or eliminate chronic immunosuppression, addresses the key challenges in islet cell replacement therapy for T1D.

"The central challenge in islet cell replacement isn't just differentiating insulin-producing cells," said Will Rust, PhD, President and CEO of Seraxis and proposed President and Chief Scientific Officer of BetaNova. "Those cells must be manufactured with a clinically compliant process at scale, successfully engraft and function, and ultimately be protected from immune-mediated destruction. By combining Seraxis' islet cells and manufacturing capabilities and immune evasion strategy with Sernova's Cell Pouch Bio-hybrid Organ, BetaNova brings together critical components of a potential cell-replacement solution within a single strategy."

Noble Capital Markets, Inc, acted as exclusive financial advisor for the merger.

A webinar to discuss the definitive merger agreement will be held on September 11 at 10 a.m. EDT. Register here. Or register at www.sernova.com

For further information about the transaction or investment interest contact:

Nathan Cali
Managing Partner
Head of Healthcare Investment Banking, Merchant Banking, Noble Capital Markets
ncali@noblecapitalmarkets.com

David Burke
VP Investor Relations, Sernova
david.burke@sernova.com

For media:

Gloria Gasaatura
VP, LifeSci Communications
SernovaPR@lifescicomms.com

ABOUT THE MERGER TRANSACTION AND THE FINANCING:

The Merger will be effected by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia), pursuant to an arrangement agreement (the “Arrangement Agreement”) entered into between Sernova and Seraxis. Under the terms of the Arrangement Agreement, all outstanding Sernova convertible securities shall be exchanged for similar securities of Seraxis pursuant to the terms set forth in the plan of arrangement. Upon completion of the Merger, existing Sernova shareholders are expected to collectively hold approximately 50% of the issued and outstanding shares of Seraxis on a non-diluted basis.

Prior to completion of the Merger, Seraxis will seek shareholder approval to change its legal name to “BetaNova Biotherapeutics, Inc.” Upon completion of the Merger, the outstanding common stock of Seraxis are expected to be listed and posted for trading on the Toronto Stock Exchange (the “TSX”), subject to satisfaction of all applicable TSX listing requirements and receipt of final TSX approval.

The Merger is expected to require the approval of at least (i) 66⅔ percent of the votes cast by holders of common shares and preferred shares of Sernova present or represented by proxy at the meeting of shareholders of Sernova to be held to consider the Merger (the “Meeting”), voting together as a single class, and (ii) a simple majority of the votes cast by holders of common shares and preferred shares of Sernova present or represented by proxy at the Meeting in each case excluding the Sernova shares required to be excluded from such vote pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) at the Meeting. The Meeting is expected to be held in the fourth quarter of 2026.

The completion of the Merger is subject to, among other things, receipt of the requisite shareholders approvals of both Sernova and Seraxis, final approval of the TSX, court approval and standard closing conditions, including receipt of all required consents and waivers from material third parties. The Arrangement Agreement contains customary representations, warranties and covenants for a transaction of this nature. The Arrangement Agreement also contains customary pre-completion covenants, including the obligation of each of Sernova and Seraxis to conduct their respective businesses in the ordinary course consistent with past practice and to refrain from taking certain specified actions without the consent of the other party.

The Arrangement Agreement also includes customary deal protections, including provisions that allow Sernova to consider unsolicited acquisition proposals and for the Sernova board to terminate the transaction to accept a superior proposal (subject to a right to match) or to change its recommendation that shareholders vote to approve the Merger in those circumstances. A break fee in the amount of US$5 million will be payable by Sernova or Seraxis in certain circumstances.

Upon completion of the Merger, BetaNova is expected to be governed by a seven-member board of directors, with the composition to be mutually agreed upon by Sernova and Seraxis. BetaNova's executive leadership team is expected to include Jonathan Rigby as Chief Executive Officer, James Parsons as Chief Financial Officer, and Will Rust, Ph.D. as President and Chief Scientific Officer, providing continuity of leadership from both organizations.

In connection with the Merger, each director and officer of Sernova has entered into voting and support agreements with Seraxis agreeing to vote their shares in favor of the Merger, which represents in the aggregate 10.8% of the outstanding common shares of Sernova.

Copies of the Arrangement Agreement and Voting and Support Agreements, and when finalized, the meeting materials relating to the Meeting, will be filed under Sernova’s profile on SEDAR+ at www.sedarplus.ca.

Concurrently with the closing of the financing, and until the Merger is approved, Sernova and Seraxis have also entered into a development and commercialization agreement pursuant to which the parties will jointly develop and commercialize its products and have the ability to transfer required capital between the companies. Sernova has also provided notice of termination in respect of its iPSC development program with Evotec GmbH, with such termination to become effective three months after the notice date.

Board Recommendation

The board of directors of Sernova (with interested directors abstaining) (the “Board”) determined that the Merger is fair to shareholders and is in the best interest of Sernova. In arriving at its recommendation in favor of the Merger, the Board considered several factors, including the oral opinion of Noble Capital Markets, Inc. (“Noble”) financial advisor to the Board, that as of September 8, 2026, based on Noble’s analysis and subject to the assumptions, limitations and qualifications to be set forth in Noble’s written valuation, the consideration to be received by Sernova shareholders pursuant to the Merger is fair, from a financial point of view, to such Sernova shareholders.

FORWARD-LOOKING STATEMENTS:

This press release contains “forward-looking information” within the meaning of applicable securities laws. Particularly, information regarding our expectations of future results, performance, achievements, prospects or opportunities is forward-looking information. In some cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “budget”, “scheduled”, “estimates”, “outlook”, “forecasts”, “projection”, “prospects”, “strategy”, “intends”, “anticipates”, “does not anticipate”, “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “will”, “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events or circumstances. These statements include, without limitation, statements regarding the receipt, in a timely manner, of shareholder, court and regulatory approvals in respect of the Merger, the timing for the Meeting to consider the Merger, the expected closing date for the Merger and BetaNova’s leadership, business prospects and operations following closing of the Merger and the anticipated use of proceeds from the non-brokered financing. Undue reliance should not be placed on forward-looking information. The forward-looking information in this press release is based on our opinions, estimates and assumptions in light of our experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we currently believe are appropriate and reasonable in the circumstances. Despite a careful process to prepare and review the forward-looking information, there can be no assurance that the underlying opinions, estimates and assumptions will prove to be correct. Further, forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to, those described in this press release. In addition, factors that could cause actual results to differ materially from expectations include, among other things, the possibility that the Merger will not be completed on the terms and conditions, or on the timing, currently contemplated, and that it may not be completed at all, due to a failure to obtain or satisfy, in a timely manner or otherwise, required regulatory, shareholder and court approvals and other conditions to the closing of the Merger or for other reasons, the risk that competing offers or acquisition proposals will be made, the negative impact that the failure to complete the Merger for any reason could have on the price of the shares or on the business of Sernova, general economic and market conditions, the impact of pandemics or epidemics, changes in government regulations or in tax laws, industry competition, technological developments and other factors described or discussed in Sernova’s disclosure materials filed with applicable securities regulatory authorities from time to time. Additional information about the risks and uncertainties of Sernova’s business and material risk factors or assumptions on which information contained in forward‐looking information is based is provided in Sernova’s disclosure materials, including Sernova’s most recently filed annual information form and any subsequently-filed interim management’s discussion and analysis, which are available under our profile on SEDAR+ at www.sedarplus.ca. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information, which speaks only as of the date made. The forward-looking information contained in this press release represents our expectations as of the date of this news release and is subject to change after such date. Sernova disclaims any intention or obligation or undertaking to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

ABOUT BETANOVA BIOTHERAPEUTICS

BetaNova Biotherapeutics is the proposed combined company of Sernova Biotherapeutics and Seraxis Holdings. Subject to completion of the proposed transaction, BetaNova will be a clinical-stage regenerative medicine company focused on advancing cell-replacement therapies for type 1 diabetes. BetaNova will combine Seraxis' stem cell-derived islet cell and cGMP manufacturing platform with Sernova's Cell Pouch Bio-hybrid Organ.

ABOUT SERNOVA BIOTHERAPEUTICS

Sernova Biotherapeutics is a clinical-stage company developing a regenerative medicine solution for T1D that combines its Cell Pouch implantation device, deep clinical experience in the engraftment of functional pancreatic cells, and therapeutic cells to create a Bio-hybrid, functional surrogate endocrine organ.

ABOUT SERAXIS

Seraxis develops stem cell-derived pancreatic islets under cGMP manufacturing processes. Seraxis’ mission is to demonstrate safety and potency of its islets in T1D patients without immune suppression therapy. To accomplish this goal, its lead allogeneic product, SR-02, is paired with an immune tolerizing strategy. Seraxis’ follow-on product SR-03 adds gene edits to SR-02 that increase compatibility with the host and potentially enhance long-term engraftment without immune suppression.