September 10, 2026
This week, Seraxis and Sernova Biotherapeutics, two clinical-stage biotechs focused on a T1D functional cure, announced a definitive merger agreement expected to finalize in November 2026. The merger will form a new entity, BetaNova Biotherapeutics, combining Seraxis’ SR-02 stem cell-derived insulin-producing islets, a sustainable and scalable cell source, and Sernova’s Cell Pouch, a scaffold enabling cell health and engraftment.
Both companies are listed in JDCA’s Half-Year Practical Cure Portfolio Review, a comprehensive tracker of forty-four for-profits working toward one or more aspects of a T1D cure. Sernova and Seraxis have actively worked toward their individual cure components for over a decade. With this merger, both stand to emerge stronger than they were individually, without losing their cure focus.
Company Details
Seraxis is a private biotechnology company founded in 2013, based in Maryland, US. Since inception, it has focused solely on creating a reliable cell solution for type 1 diabetes. Its core product, SR-02, is a universal stem cell-derived cell line in clinical trials today. Seraxis is working on a second-generation product that will incorporate gene editing to make the cells invisible to the immune system.
Sernova Biotherapeutics is a publicly traded Canadian company founded in 1998. Its pipeline centers on its proprietary Cell Pouch, which is being explored in three regenerative disease areas, including T1D.
The Cell Pouch is a bio-hybrid organ the size of a credit card, designed to provide an ideal environment for cells to live. It is not an encapsulation device and does not protect cells from the immune system. Instead, it promotes cell vascularization, ensuring transplanted islets receive enough oxygen and nutrients to survive in the body. Quick and robust vascularization is difficult to establish but necessary for cell survival.
About the Merger
The merger, announced September 8, 2026, will combine both organizations into a new US-based company with a NASDAQ listing anticipated for Q1 2027. SR-02 will be the focus of the new company’s pipeline.
A financing round remains underway until September 30, 2026, for qualified investors. To date, the company has secured $10 million in non-brokered convertible note financing from both organizations’ insider shareholders.
When the merger closes, notes will be converted into non-voting BetaNova common shares, which holders can convert into voting shares subject to ownership restrictions. This financing will provide capital to support cGMP manufacturing of SR-02 and dosing the first patients in Seraxis’ phase I/II clinical trial in 2027. After the merger, shareholders from both companies will hold approximately 50% of BetaNova shares.
BetaNova’s Proposed Executive Structure:
- CEO: Jonathan Rigby | Current CEO and President of Sernova.
- President and Chief Scientific Officer: Will Rust | Current CEO and President of Seraxis.
- Chief Financial Officer: James Parsons | Current CFO of Sernova.
In a press release detailing the merger, Jonathan Rigby expressed excitement: “This merger is deeply personal to me – I’ve lived with and suffered from type 1 diabetes most of my life and it drives my passion to overcome it . . . . Combining Sernova’s Cell Pouch Bio-hybrid Organ with Seraxis’ stem cell-derived pancreatic islet cells lets us approach the problem differently, bringing us closer to a functional cure. This is very exciting to me and our entire team.”
Practical Cure Potential
BetaNova’s future pipeline, if successful, could qualify as a full Practical Cure. A Practical Cure for T1D requires two components: A sustainable supply of insulin-producing cells and a way to protect them from the immune system.
Seraxis brings to the table SR-02, a universal, scalable stem cell-derived islet line with established in-house cGMP manufacturing. The second-generation product in preclinical development, SR-03, will add gene editing to render the cells invisible to the immune system. If SR-03 is successful, both Practical Cure attributes will be fulfilled.
SR-02 Clinical Trial
Today, SR-02 is registered on the clinical trial database as a phase I/II study. Enrollment has not started, but it will target adults with severe hypoglycemia and less than forty years of age. The company expects to start dosing patients in early 2027, with interim data by mid-2027. SR-02 will be paired with an unnamed, low-toxicity immunosuppressant regimen.
Seraxis plans to submit an Investigational New Drug (IND) application for its second-generation product next year.
What Comes Next
The merger between Seraxis and Sernova is good news, and both stand to emerge stronger together than they did individually. Combined, they could create a full Practical Cure solution for T1D.
Looking into the future, we want to see BetaNova hit its stated milestones, with the first patients dosed in SR-02 and an IND for the next-generation product following suit in 2027. It is not yet clear when the Cell Pouch will be integrated into future clinical trials.
Most anticipated is the introduction of a clinical trial that does not use full-body immunosuppression. Though farther off, it will need to be the cornerstone in testing SR-03. Here is where data showing true safety and efficacy will be revealed. It is the turning point in all trials testing a Practical Cure solution—seeing if the cell line thrives and if devices still work without medications that broadly impact the immune response.
