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Sernova Biotherapeutics Inc. (TSX: SVA) and Seraxis Holdings Inc. announced on September 8, 2026, that they have entered into a definitive agreement to combine their businesses. The merger will create a new clinical-stage biotechnology company named BetaNova Biotherapeutics. The combined entity will be domiciled in the United States and headquartered in Germantown, Maryland. Upon completion of the transaction, shareholders of both Sernova and Seraxis will each own approximately 50 percent of the new company.
Sernova Biotherapeutics Inc. is a biotechnology company focused on developing treatments for type 1 diabetes. The company is known for its Cell Pouch Bio-hybrid Organ, an implantable device designed to support islet cell survival. Seraxis Holdings Inc. brings to the merger its expertise in stem cell-derived pancreatic islet cells and in-house current Good Manufacturing Practice manufacturing capabilities. The merger aims to unite these technologies to create a differentiated approach to islet cell replacement therapy.
The new pipeline for BetaNova Biotherapeutics will be anchored by SR-02, an allogeneic stem cell-derived pancreatic islet therapy. The company stated that SR-02 is developed to be paired with next-generation, low-toxicity immune suppressants. The goal is to eliminate the need for chronic immunosuppression by establishing tolerance. A follow-on candidate, SR-03, incorporates gene edits expected to eliminate immunosuppression through immune evasion. Sernova Biotherapeutics Inc. noted that its Phase 1/2 clinical study evaluating the Cell Pouch Bio-hybrid Organ with human donor pancreatic islets is now complete. The company said all primary and secondary endpoints were met, supported by over 30 years of cumulative patient safety data.
Financial commitments have been secured to support the initial development plans. The companies announced a US$10 million non-brokered convertible note financing from existing insider shareholders of both Sernova and Seraxis. The financing round remains open to additional qualified investors until September 30, 2026. Upon completion of the merger, these notes will automatically convert into non-voting common stock of BetaNova. The company said this capital is expected to fund key milestones, including the dosing of the first patients in a Phase 1/2 clinical trial for SR-02 in the first quarter of 2027. Data from this trial is anticipated by mid-2027.
The merger is expected to close in November 2026, subject to shareholder approval. Upon completion, BetaNova intends to seek listing on the NASDAQ in the first quarter of 2027, subject to satisfaction of applicable listing requirements. An IND submission for the next-generation SR-03 therapy is expected in the second half of 2027.
Jonathan Rigby, President and CEO of Sernova and proposed CEO of BetaNova, described the merger as deeply personal. He stated that people with type 1 diabetes struggle to manage the loss of insulin production. The company said the combination of Sernova’s device and Seraxis’ cells allows them to approach the problem differently. The merger represents a significant consolidation of assets in the diabetes treatment space, creating a new entity with integrated research and manufacturing capabilities.
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