Germantown-based biotechnology company Seraxis has entered into a definitive merger agreement with Sernova Biotherapeutics to create BetaNova Biotherapeutics, a new company focused on developing cell-replacement treatments for type 1 diabetes.
Announced September 8, the merger is expected to close in November 2026, subject to shareholder approval. The combined company will be headquartered in Germantown, with integrated research laboratories and manufacturing capabilities.
Seraxis, a private biotechnology company launched in 2013, is located at 20400 Century Blvd, Suite 150, in Germantown. Under the proposed agreement, shareholders of Seraxis and Sernova will each own approximately 50% of BetaNova.
The merger would bring together Seraxis’ stem cell-derived pancreatic islet cells and manufacturing operations with Sernova’s Cell Pouch Bio-hybrid Organ, an implantable and retrievable device designed to support transplanted islet cells. The companies aim to develop treatments that replace insulin-producing cells while addressing challenges involving cell survival and immune rejection.
“This merger is deeply personal to me,” said Jonathan Rigby, Sernova’s president and CEO and the proposed CEO of BetaNova, who shared that he has lived with type 1 diabetes for most of his life.
BetaNova’s lead investigational therapy, SR-02, is expected to begin dosing patients in a Phase 1/2 clinical trial during the first quarter of 2027, with data anticipated by midyear. According to the announcement, the trial will proceed under an FDA-cleared investigational new drug application. That clearance allows clinical testing and does not constitute approval of the treatment for general use.
The company also plans to advance SR-03, a next-generation, gene-edited islet cell therapy intended to evade immune rejection, with the goal of eliminating the need for immunosuppressive medication. An investigational new drug application for that candidate is expected in the second half of 2027.
The companies said they have secured $10 million in convertible note financing commitments from existing insider shareholders to support initial development milestones, including manufacturing, clinical testing, and preparations for a potential Nasdaq listing. BetaNova intends to seek that listing in the first quarter of 2027, subject to applicable requirements and approvals.
Will Rust, Seraxis’ president and CEO, is proposed to serve as BetaNova’s president and chief scientific officer. Rust said successful cell replacement requires more than producing insulin-making cells, emphasizing the need to manufacture them at scale, establish their function after transplantation, and protect them from immune destruction.
The companies also reported that treatment and follow-up in Sernova’s Phase 1/2 study of its Cell Pouch with human donor pancreatic islets are complete, with all primary and secondary endpoints met. The announcement described more than 30 years of cumulative patient safety data supporting the platform.
The proposed combined company’s therapies remain investigational, with further clinical development needed to establish their safety and effectiveness.
