Diamyd Medical Secures Up to USD 125m in Equity Financing as Phase 3 Trial Completes Enrollment
Stockholm-headquartered Diamyd Medical, a biotech company developing precision medicine therapies for type 1 diabetes, has entered into equity financing agreements with US sector specialist investors for up to USD 125 million. The transaction comprises a directed issue of 17,226,500 new Class B shares at SEK 13.54 per share, generating approximately SEK 233 million before transaction costs, alongside two directed issuances of an aggregate 46,649,362 warrants. Each warrant entitles the holder to subscribe for one new Class B share at SEK 20. Concurrent with the financing, the company announced full enrollment of its Phase 3 DIAGNODE-3 trial evaluating retogatein in type 1 diabetes.
The round drew participation from ten US-based institutional investors: Perceptive Advisors, Vestal Point Capital, RA Capital Management, Vivo Capital, Caligan Partners, Seven Fleet Capital, ADAR1 Capital Management, Great Point Partners, Logos Capital, and Sphera Healthcare. Leerink Partners acted as exclusive placement agent. The company said proceeds from the share issue will fund completion of the DIAGNODE-3 trial, while proceeds from any warrant exercises will support pre-commercial activities, life cycle management, and pipeline development.
Diamyd Medical's lead candidate, retogatein (rhGAD65), is an antigen-specific immunotherapy formulated with alum and designed to induce immune tolerance to GAD65, preserving endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 genotype — approximately 40% of patients in Europe and the US. The DIAGNODE-3 trial has randomized 321 patients across 57 clinical sites in Europe and the US, and interim results from a Data Safety Monitoring Board meeting are expected. Retogatein holds Orphan Drug Designation and Fast Track Designation from the US FDA for Stage 3 type 1 diabetes, as well as Fast Track Designation for Stage 1 and 2 disease.