A merger between Germantown’s Seraxis and Sernova Biotherapeutics will lead to the formation of BetaNova Biotherapeutics, a new entity dedicated to developing cell-replacement therapies for type 1 diabetes. The announcement was made on September 8, with the merger anticipated to finalize in November 2026, pending shareholder approval.
The new company will be based in Germantown and will feature integrated research laboratories and manufacturing facilities. Seraxis, founded in 2013 and located at 20400 Century Blvd, Suite 150, will join forces with Sernova, with both companies’ shareholders expected to hold approximately equal stakes in BetaNova.
This merger aims to combine Seraxis’ expertise in stem cell-derived pancreatic islet cells with Sernova’s innovative Cell Pouch Bio-hybrid Organ, which is designed to support the survival of transplanted islet cells. The goal is to create effective treatments that not only replace insulin-producing cells but also tackle issues related to cell survival and immune rejection.
Jonathan Rigby, president and CEO of Sernova and proposed CEO of BetaNova, expressed a personal connection to the merger, stating, “This merger is deeply personal to me,” as he has lived with type 1 diabetes for most of his life.
BetaNova’s primary investigational therapy, SR-02, is set to begin patient dosing in a Phase 1/2 clinical trial in the first quarter of 2027, with results expected by mid-year. This trial will be conducted under an FDA-cleared investigational new drug application, which allows for clinical testing but does not imply general approval for the treatment.
Additionally, the company plans to advance SR-03, a next-generation, gene-edited islet cell therapy aimed at avoiding immune rejection, potentially eliminating the need for immunosuppressive medications. An investigational new drug application for this therapy is anticipated in the latter half of 2027.
To support initial development efforts, including manufacturing and clinical testing, the companies have secured $10 million in convertible note financing from existing shareholders. BetaNova is also looking to pursue a Nasdaq listing in the first quarter of 2027, contingent upon meeting necessary requirements and obtaining approvals.
Will Rust, president and CEO of Seraxis, is proposed to take on the roles of president and chief scientific officer at BetaNova. Rust emphasized that successful cell replacement involves more than just creating insulin-producing cells; it requires large-scale production, ensuring their functionality post-transplantation, and protecting them from immune attacks.
Furthermore, the companies reported that treatment and follow-up for Sernova’s Phase 1/2 study involving its Cell Pouch with human donor pancreatic islets have concluded, achieving all primary and secondary endpoints. The announcement highlighted over 30 years of cumulative patient safety data backing the platform.
It is important to note that the therapies being developed by the proposed combined company are still investigational, requiring further clinical development to confirm their safety and efficacy.
