TORONTO and GERMANTOWN, Md. — October 5, 2026
Sernova Biotherapeutics Inc. and Seraxis Holdings, Inc. announced the closing of a US$11.2 million financing supporting their proposed merger to form BetaNova Biotherapeutics, Inc. The financing is expected to fund manufacturing, clinical preparation and development activities for SR-02, an allogeneic stem cell-derived pancreatic islet cell therapy being developed for type 1 diabetes (T1D). The companies are targeting Phase 1/2 enrollment in the fourth quarter of 2026, with first-patient dosing expected in Q1 2027 under an FDA-cleared IND and initial clinical data anticipated in the first half of 2027.
BetaNova to Combine Cell Therapy and Bio-Hybrid Organ Technologies
The proposed BetaNova merger will combine Seraxis’ stem cell-derived pancreatic islet platform and cGMP manufacturing capabilities with Sernova’s Cell Pouch Bio-hybrid Organ technology. SR-02 is designed as an allogeneic stem cell-derived islet cell product intended to restore insulin-producing cell function in people with T1D. Seraxis is pursuing an immune-tolerizing strategy intended to enable transplantation without chronic immune suppression. The combined company is expected to integrate cell replacement with Sernova’s implantation technology, creating a development platform focused on regenerative approaches to T1D.
SR-02 Advances Toward Phase 1/2 Clinical Development
Financing proceeds will support cGMP manufacturing of SR-02 and preparations for the upcoming Phase 1/2 clinical trial. The companies expect to enroll T1D patients beginning in Q4 2026 and dose the first participant in Q1 2027. Initial clinical data are anticipated in the first half of 2027. The financing will also support development of SR-03, a next-generation gene-edited pancreatic islet cell program designed to enhance immune evasion and improve compatibility with the recipient. BetaNova is targeting an IND submission for SR-03 in the second half of 2027, extending the combined company’s pipeline beyond its initial SR-02 program.
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Proposed Merger Establishes BetaNova
Sernova and Seraxis entered into a definitive merger agreement in September 2026 to create BetaNova Biotherapeutics. Subject to required approvals and customary closing conditions, shareholders of Sernova and Seraxis are expected to collectively own approximately 50% each of BetaNova on a non-diluted basis. The proposed company will operate as a clinical-stage regenerative medicine company focused on cell-replacement therapies for T1D. In addition to clinical development, BetaNova is targeting Nasdaq listing readiness in Q1 2027, subject to applicable requirements and approvals. The $11.2 million financing provides near-term capital for manufacturing and clinical execution as the companies work toward completing the merger and advancing SR-02 into human testing.
Source: Sernova Biotherapeutics, press release
