Sernova Biotherapeutics (SVA) investor relations material

Merger and mission

• Sernova and Seraxis have merged to form Betanova Biotherapeutics, aiming to develop a functional cure for Type 1 Diabetes (T1D) by integrating stem cell-derived islets, an implantable medical device, and advanced immune management strategies.

• The merger agreement is executed, with closing expected in November and patient recruitment beginning in Q4 2026.

• Key milestones include a Phase 1/2 SR-02 study starting Q1 2027, data readout in H1 2027, and Nasdaq IPO readiness by year-end 2026.

Technology and product pipeline

• SR-02 is an allogeneic, human pancreas-derived stem cell line with high insulin secretion and glucose responsiveness, designed for organ transplant compatibility and streamlined manufacturing.

• SR-03 is a gene-edited, immune-evading insulin-producing cell line in preclinical development, showing no detectable antibodies in humanized rodent models.

• The Cell Pouch is an implantable, retrievable device that has completed Phase 1/2 trials, demonstrating safety, tolerability, and long-term engraftment of insulin-producing cells.

• Manufacturing processes enable high-purity, high-potency islets from a single donor source, with established cGMP master cell banks and scalable logistics.

Clinical and preclinical data

• SR-02 cells show potency similar to human donor islets, with independent testing confirming glucose-linked calcium influx and insulin secretion.

• Preclinical animal studies demonstrate effective blood glucose control and successful engraftment of manufactured islets in immunocompromised mice and rats.

• Phase 1/2 clinical trials of the Cell Pouch met primary and secondary endpoints, including safety, islet survival, and reduction in severe hypoglycemic events.

• Five-year histology data confirm abundant, vascularized, insulin-producing beta cells within the Cell Pouch, with no detrimental fibrotic tissue.