Diamyd Medical (DMYD) Q1 2026 earnings summary

Executive summary

• Completed patient screening for the pivotal Phase 3 trial of retogatein in type 1 diabetes, with 310–320 genetically defined participants expected to be enrolled and randomization of the last patients underway.

• Achieved a significant milestone by securing the ability to conduct the primary efficacy analysis 9 months earlier than planned, now at 15 months follow-up instead of 24, following positive discussions with the FDA.

• Interim efficacy analysis is on track for late March 2026, focusing on C-peptide as the primary endpoint, which could support accelerated approval in the US if statistically significant.

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

• Secured over SEK 230 million in cash at the end of November, ensuring sufficient funds to complete the upcoming interim analysis.

Significant events and developments

• The final safety review in the phase 3 trial was completed with no serious adverse events and a very low dropout rate, highlighting a strong safety profile.

• Manufacturing partnerships expanded and GMP certification process for Umeå facility progressing, with collaborations deepened with APL and NorthX Biologics.

• Participated in the JP Morgan conference, engaging with potential partners, investors, and commercial stakeholders to prepare for market entry.

• Patents granted in Hong Kong and Eurasia for insulin antigen treatment in genetically defined type 1 diabetes.

• New analysis presented at EASD supports retogatein's potential to delay progression of Stage 3 type 1 diabetes.

Outlook and guidance

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

• Full primary efficacy readout expected around Q2 2027, 15 months after the last patient is randomized.

• Commercialization preparations are ongoing but not yet fully financed; discussions with potential partners and larger organizations are underway to ensure readiness.

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