Diamyd Medical (DMYD) Q4 24/25 earnings summary

Executive summary

• Fiscal year marked by significant progress in clinical, regulatory, manufacturing, and financial fronts, with DIAGNODE-3 Phase 3 trial recruitment exceeding 275 participants and early readout planned for March 2026.

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

• Expanded intellectual property portfolio with new patents granted in Eurasia and Hong Kong, covering up to 90% of Type 1 Diabetes genetic subtypes.

• Biomanufacturing facility in Umeå advancing toward GMP certification, supporting future commercial production.

• Financial position strengthened by SEK 315 million raised through warrants, rights issue, and direct placement.

Financial highlights

• Net sales for the year: MSEK 0.1 (unchanged year-over-year); Q4: MSEK 0.0.

• Net result: MSEK -169.8 (vs. -151.8 prior year); Q4: MSEK -44.9 (vs. -49.7 prior year).

• Cash flow from operating activities: MSEK -169.7 (vs. -129.2 prior year); Q4: MSEK -35.9.

• Cash and short-term investments at year-end: MSEK 277.2 (vs. 132.4 prior year).

• Research and development costs: MSEK 119.5 (vs. 96.5 prior year).

Outlook and guidance

• Early readout of DIAGNODE-3 Phase 3 trial scheduled for March 2026, with potential for accelerated FDA approval.

• Screening for DIAGNODE-3 expected to complete before year-end; focus on achieving GMP certification and advancing manufacturing capabilities.

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