Diamyd Medical (DMYD) investor relations material

Executive summary

• Achieved full enrollment of 321 patients in the pivotal phase III DIAGNODE-3 trial for retogatein in type 1 diabetes, a significant milestone for a genetically defined subgroup, with interim efficacy readout expected by end of March 2026.

• The phase III trial has been selected for a dedicated one-hour session at the ADA conference in June 2026, highlighting its scientific relevance.

• Secured $25 million in equity financing from U.S. sector specialists, with total potential new cash up to $160 million through warrants and additional upside post-interim readout.

• Manufacturing facility in Umeå underwent a successful GMP inspection with only minor findings, advancing readiness for clinical material production and ongoing certification.

• Deepened long-term manufacturing collaboration for retogatein and initiated strategic partnership with NorthX Biologics.

Financial highlights

• Cash and short-term investments stood at SEK 191 million ($20 million) as of February 28, with period-end cash at MSEK 190.7.

• New equity financing of $25 million is imminent and unconditional, focused on funding the DIAGNODE-3 trial.

• Additional potential financing includes up to SEK 1,166 million (~$125 million) from new warrants and SEK 35 million (~$3 million) from existing TO5 warrants, both conditional on exercise.

• Total potential new cash, including conditional elements, could reach $160 million.

• Net result for the six months: MSEK -111.7; research and development costs: MSEK 75.6.

Outlook and guidance

• Interim readout of the phase III trial is imminent, focusing on C-peptide as a surrogate endpoint for endogenous insulin production, with potential to support accelerated BLA pathway in the US.

• Full trial readout is expected in Q3 2027, nine months earlier than previously planned due to FDA alignment.

• Organization and commercial build-up will proceed in steps, scaling up as milestones are achieved.

• Financing structure provides flexibility to scale investment based on clinical outcomes.