Diamyd Medical (DMYD) Status update summary

Update on phase 3 trial timeline

• Primary efficacy readout moved from 24 to 15 months, reducing risk and aligning with robust prior results.

• Interim readout expected in March 2026, offering an early look at primary efficacy.

• Early positive results could enable discussions with the FDA for accelerated approval.

Scientific rationale and endpoints

• Treatment aims to retrain the immune system to preserve insulin-producing cells in a specific genetic subgroup.

• Main endpoints are preservation of endogenous insulin (C-peptide) and blood sugar control (HbA1c).

• Preserving the body's own insulin production is critical for preventing long-term organ damage.

Regulatory and market implications

• Durability of effect will be evaluated up to 24 months, supporting strong labeling and market positioning.

• Collaboration with the FDA has enabled a faster path to potential approval.

• Imminent phase 3 results position the company as a leader in Type 1 diabetes innovation.