Diamyd Medical (DMYD) Q1 2026 earnings summary

Executive summary

• Completed patient screening for pivotal Phase 3 DIAGNODE-3 trial of retogatein in type 1 diabetes, with 310–320 genetically defined participants expected to be enrolled.

• Interim efficacy readout for retogatein remains on track for March 2026, potentially supporting accelerated approval in the US.

• Retogatein received its global non-proprietary name and continues to show a favorable safety profile after multiple independent reviews.

• Manufacturing partnerships expanded and GMP certification process for Umeå facility progressing.

Financial highlights

• Net sales for the quarter were MSEK 0.2, up from MSEK 0.0 year-over-year.

• Net result was MSEK -48.8, compared to MSEK -36.2 for the same quarter last year.

• Cash flow from operating activities was MSEK -43.7, versus MSEK -41.8 year-over-year.

• Cash and short-term investments at period end totaled MSEK 233.2, up from MSEK 152.9 a year earlier.

• Research and development costs increased to MSEK 30.5 from MSEK 26.1 year-over-year.

Outlook and guidance

• Interim analysis of DIAGNODE-3 trial scheduled for March 2026, with potential to support accelerated US approval.

• Full primary efficacy readout accelerated by nine months following FDA alignment, now expected 15 months after trial start.

• Continued focus on clinical execution, regulatory engagement, and manufacturing readiness for commercialization.