Dr. Beaston brings 24 years of FDA leadership experience in islet cell transplantation, cell and gene therapies, and type 1 diabetes
GERMANTOWN, Md. and TORONTO, Oct. 19, 2026 (GLOBE NEWSWIRE) — Seraxis Holdings, Inc. (“Seraxis”) and Sernova Biotherapeutics Inc. (“Sernova”) (TSX: SVA) (OTC: SEOVF) (FSE/XETRA: PSHO) today announced the appointment of Patricia Beaston, MD, PhD, as Chief Medical Officer (CMO) of Seraxis. Upon completion of the companies’ proposed merger to form BetaNova Biotherapeutics, Inc. (“BetaNova”), Dr. Beaston will assume the same role at the combined company.
Dr. Beaston brings 24 years of experience as a Medical Officer at the U.S. Food and Drug Administration (FDA), with expertise spanning endocrine therapeutics, medical devices, islet cell transplantation, immune modulation in type 1 diabetes (T1D), and cell and gene therapies. Her appointment strengthens Seraxis’ clinical and regulatory leadership as it prepares to initiate the Phase 1/2 clinical trial of SR-02, pancreatic stem cell-derived insulin producing islets, with first patient dosing targeted for Q1 2027.
“Patricia brings an exceptional combination of clinical expertise and regulatory experience that is directly relevant to our programs,” said Will Rust, PhD, President and Chief Executive Officer of Seraxis and proposed President and Chief Scientific Officer of BetaNova. “Her extensive FDA experience, particularly in islet transplantation and T1D cell therapies, will be invaluable as we advance SR-02 into the clinic and execute our broader development strategy.”
“Building a strong leadership team is central to our vision for BetaNova, and Patricia’s appointment is an important step forward,” said Jonathan Rigby, President and Chief Executive Officer of Sernova and proposed Chief Executive Officer of BetaNova. “Her experience across cell therapies, medical devices, and diabetes aligns exceptionally well with our integrated approach. We’re bringing together complementary science, technology, and expertise to advance meaningful new treatment options for people living with T1D.”
During her FDA tenure, Dr. Beaston served across three of the agency’s principal centers. At the Center for Drug Evaluation and Research (CDER), she evaluated endocrine therapeutics and subsequently joined the Center for Devices and Radiological Health (CDRH). Most recently, at the Center for Biologics Evaluation and Research (CBER), her review responsibilities included islet cell transplantation, immune modulation in T1D, cell and gene therapies, and xenotransplantation.
“I am excited to join Seraxis at such an important stage of its development as it merges with Sernova to become BetaNova. The opportunity to advance innovative islet cell therapies for people living with T1D is particularly meaningful, and I look forward to working with the team to translate this promising science into clinical progress and ultimately a commercial functional cure,” said Dr. Beaston.
Dr. Beaston earned her PhD in Anatomy and Neurobiology and MD from the Medical College of Pennsylvania, following a BS in Zoology from the University of Maryland. She completed her residency in Internal Medicine at the Medical College of Pennsylvania and a fellowship in Diabetes, Endocrinology, and Metabolism at Penn State/Hershey.
Advancing BetaNova’s Clinical Strategy
The appointment comes as Sernova and Seraxis advance their proposed merger to become BetaNova, combining Seraxis’ proprietary stem cell-derived pancreatic islets and cGMP manufacturing capabilities with Sernova’s clinically validated Cell Pouch Bio-hybrid Organ. The proposed business combination remains subject to numerous closing conditions, and there can be no assurance that the transaction closes in the expected time frame, or at all.
The proposed combined company’s lead program, SR-02, has received FDA Investigational New Drug (IND) clearance for a Phase 1/2 clinical trial, with first patient dosing targeted for Q1 2027. The initial study will evaluate SR-02 through direct omental administration to establish safety, dosing, and early functional activity, with subsequent plans to evaluate the cells in combination with the Cell Pouch, subject to regulatory approvals.
BetaNova also intends to advance SR-03, a next-generation gene-edited islet cell therapy designed to reduce immune recognition and potentially eliminate the need for chronic immunosuppression, with an IND submission targeted for the second half of 2027.
About Sernova Biotherapeutics
Sernova Biotherapeutics Inc. 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 Holdings, Inc.
Seraxis Holdings, Inc. 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.
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Forward-Looking Information
This news release contains “forward-looking statements” and “forward-looking information” within the meaning of applicable securities laws. Particularly statements and information regarding the proposed business combination of Sernova and Seraxis, the expected benefits of Dr. Beaston’s contributions, the timing of patient dosing and availability of clinical data, development of SR-03, and the anticipated completion of the Merger. 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. 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: risks relating to regulatory interactions, manufacturing, patient recruitment, clinical development, financing requirements; the occurrence of any event, change or other circumstances that could give rise to the termination of the arrangement agreement providing for the business combination between Seraxis and Sernova (the “Arrangement Agreement”); the failure to obtain necessary regulatory approvals and shareholder approvals or to satisfy any of the other conditions to the transaction on a timely basis or at all; risks related to disruption of management’s attention from the ongoing business operations of Seraxis and Sernova due to these transactions; the possibility that the anticipated benefits of the transaction are not realized when expected or at all, including as a result of the impact of, or problems arising from, the integration of the two companies; the outcome of any legal proceedings, regulatory proceedings or enforcement matters that may be instituted against Seraxis, Sernova and others relating to the Arrangement Agreement; the possibility that the transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; diversion of management’s attention from ongoing business operations and opportunities; potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the transaction; and other risks contained in Sernova’s disclosure materials, including Sernova’s most recently filed news release, annual information form and any subsequently-filed interim management’s discussion and analysis, which are available under Sernova’s profile on SEDAR+ at www.sedarplus.ca. Accordingly, readers should not place undue reliance on forward-looking information, which speaks only as of the date made. 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.