TORONTO, Canada and GERMANTOWN, Maryland — September 8, 2026
Sernova Biotherapeutics Inc. and Seraxis Holdings, Inc. announced a definitive merger agreement to create BetaNova Biotherapeutics, Inc., a clinical-stage biotechnology company focused on developing next-generation islet cell replacement therapies for type 1 diabetes (T1D). The transaction will combine Sernova’s Cell Pouch Bio-hybrid Organ with Seraxis’ stem cell-derived pancreatic islet cells, immune-evasion strategies and in-house cGMP manufacturing capabilities. Following completion, Sernova and Seraxis shareholders are expected to each own approximately 50% of BetaNova. The combined company will be headquartered in Germantown, Maryland, with integrated research and manufacturing operations designed to support development of its cell replacement pipeline. The merger is expected to close in November 2026, subject to shareholder, court and regulatory approvals, with BetaNova planning to pursue a NASDAQ listing in the first quarter of 2027.
BetaNova Builds Integrated Islet Replacement Platform
BetaNova’s strategy centers on combining cell production, implantation and immune protection within a single development platform. The company’s lead candidate, SR-02, is an allogeneic stem cell-derived pancreatic islet therapy intended to work with next-generation, lower-toxicity immunosuppressive approaches, with the longer-term objective of establishing immune tolerance and reducing or eliminating chronic immunosuppression. The follow-on candidate, SR-03, incorporates gene edits designed to enable immune evasion and potentially eliminate the need for immunosuppression. These programs will be paired with Sernova’s Cell Pouch Bio-hybrid Organ, an implantable and retrievable device designed to support islet cell survival, engraftment and function. By integrating Seraxis’ cell manufacturing and immune-evasion technologies with Sernova’s clinically validated device platform, BetaNova aims to address multiple technical barriers that have limited the scalability and durability of islet replacement approaches.
SR-02 Phase 1/2 Trial Targets Q1 2027 Dosing
The merger creates an immediate clinical development pathway for SR-02, with BetaNova expecting to begin dosing patients in a Phase 1/2 clinical trial during the first quarter of 2027 under an FDA-cleared IND. The study, identified as NCT07581197, is expected to generate initial clinical data by mid-2027. The development program is supported by Sernova’s existing clinical experience with its Cell Pouch platform, including completed patient treatment and follow-up in its Phase 1/2 study using human donor pancreatic islets in people with T1D. Sernova reported that the study met its primary and secondary endpoints and has accumulated more than 30 years of cumulative patient safety data associated with the platform. BetaNova expects this clinical foundation, combined with Seraxis’ stem cell-derived islet technology, to accelerate development of a scalable cell replacement strategy for patients who have lost endogenous insulin production.
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$10 Million Financing Supports Key Development Milestones
BetaNova has secured commitments for a US$10 million non-brokered convertible note financing from existing insider shareholders of Sernova and Seraxis, with the financing remaining open to additional qualified investors through September 30, 2026. Following completion of the merger, the notes are expected to automatically convert into non-voting common stock of BetaNova, subject to the transaction terms. The financing is intended to support several near-term value-driving milestones, including cGMP manufacturing of SR-02, first-patient dosing in the Phase 1/2 T1D study, clinical data generation, preparation for a potential NASDAQ listing and advancement of the SR-03 IND program, which is expected to be submitted in the second half of 2027. The transaction also establishes a proposed seven-member BetaNova board and executive leadership structure combining management from both companies, with Jonathan Rigby expected to serve as CEO and Will Rust, Ph.D., as President and Chief Scientific Officer. Together, the merger and financing create an integrated corporate structure intended to advance BetaNova’s cell-replacement platform toward key clinical and regulatory milestones.
Source: Sernova press release
