Diamyd Medical (DMYD) Q4 2025 earnings summary

Executive summary

• Patient recruitment for the phase 3 study has exceeded 275 participants, with screening expected to close this year and early readout planned for March 2026, potentially enabling accelerated approval in the US.

• The company focuses on precision immunotherapy for Type 1 Diabetes, aiming for accelerated FDA approval based on C-peptide endpoint data.

• SEK 315 million in funding was secured during a challenging financial market, ensuring operations are fully funded through the phase 3 readout.

• Manufacturing facility in Umeå is advancing toward GMP certification, with regulatory feedback expected in the coming months to support future commercial production.

• Recent scientific presentations at major diabetes conferences have strengthened the clinical case for the investigational drug.

Financial highlights

• SEK 315 million raised through a mix of warrants, rights issues, and direct placement, with costs below 5%.

• Net sales for the year: MSEK 0.1; net result: MSEK -169.8; cash and short-term investments at year-end: MSEK 277.2.

• Research and development costs: MSEK 119.5 for the year.

• Funding is sufficient to cover operations past the upcoming phase 3 data readout.

• Fundraising costs were kept below 5%, significantly lower than the typical 15-20%.

Outlook and guidance

• Screening for the phase 3 trial will close this year, with early data expected in March 2026 and preparations for potential accelerated approval in the US.

• Expansion into earlier disease stages and broader genetic subgroups is planned, potentially increasing the addressable market.

• Continued expansion of the precision medicine platform and ongoing clinical trials in both pre-symptomatic and symptomatic Type 1 Diabetes.