Sernova Biotherapeutics (SVA) investor relations material

Merger and mission

• Two companies are merging to form BetaNova Biotherapeutics, aiming to develop a functional cure for type 1 diabetes using integrated cell therapy technologies.

• The merger is subject to shareholder approval, expected in December, with sufficient votes anticipated.

• The new entity will focus on being a differentiated leader in cell therapy for type 1 diabetes.

Technology and clinical approach

• SR-02 are allogeneic insulin-producing cells cleared by the FDA for clinical trials; dosing is planned for early next year.

• SR-03 are gene-edited, immune-evading insulin-producing cells, with IND-enabling studies ongoing and IND filing targeted for next year.

• The Cell Pouch device, already proven in phase I/II trials, enables safe, retrievable, and long-term functioning of implanted islet cells.

• Advanced immune management strategies include co-stimulatory blockers and collaborations with Eledon Pharmaceuticals.

Differentiation and innovation

• The proprietary stem cell source is engineered from human pancreas, offering more potent and efficient insulin-secreting cells compared to embryonic stem cell-derived alternatives.

• SR-03 cells are designed to be invisible to the immune system, potentially eliminating the need for immune suppression.

• The Cell Pouch is the only clinically demonstrated device to support long-term survival and function of islet cells.