Dear Shareholders

As we move into the second half of 2025, our preparations for the anticipated Phase 3 readout of DIAGNODE-3 continue at full pace, reinforced by a solid financial base, an expanding organization, and robust progress across all operational fronts.

In a capital market marked by cautious investor sentiment, Diamyd Medical has secured significant new funding under exceptionally favorable conditions. The recently completed preferential rights issue, complemented by a direct new share issue, provided the Company with approximately SEK 267 million before issue costs. This strengthens our cash position at a critical time—approximately nine months before the expected early readout of DIAGNODE-3—and provides flexibility to accelerate activities across clinical development, business development, and regulatory planning.

Recruitment into DIAGNODE-3 continues according to plan, with 250 patients now randomized and patient screening expected to be completed this calendar year. The trial recently cleared its fifth safety review by the independent Data Safety Monitoring Board (DSMB) with no concerns, reaffirming the favorable safety profile of Diamyd^®. This represents the second-to-last scheduled safety review before early readout, which may form the basis of a Biologics License Application under the U.S. FDA's accelerated approval pathway.

In parallel, our DiaPrecise prevention trial evaluating Diamyd^® in children and adolescents with presymptomatic Type 1 Diabetes also cleared its first safety review, marking a new milestone in the development of preventive immunotherapy for autoimmune diabetes.

In Umeå, we prepare for GMP readiness and inspection by the Swedish Medical Products Agency (MPA) later this year. This is an important milestone for the manufacturing facility and for future inspections during a BLA (marketing application) process.

Diamyd Medical continues to contribute to advancing scientific and regulatory dialogue in the field of Type 1 Diabetes. I had the honor to participate in the panel for Critical Path Institute’s workshop, “21st Century Trials in New-Onset Type 1 Diabetes,” which brought together regulators, researchers, clinicians and industry stakeholders to align on the use of C-peptide as a primary endpoint in disease-modifying trials. Our experience with DIAGNODE-3, where C-peptide serves as the principal endpoint, provided a valuable case study to inform this important regulatory discourse.

We were also present at the ADA 2025 Scientific Sessions in Chicago last week, where we co-hosted a breakfast panel with Breakthrough T1D (formerly JDRF) titled “Precision in Diagnosis, Power in Treatment: The Future of Type 1 Diabetes”. The panel included thought leaders from clinical research, regulatory science and patient advocacy to explore the evolving landscape of precision immunotherapies. Together, these platforms underscore our growing role as a frontrunner in shaping the future of care for autoimmune diabetes.

As we count down the months to the early Phase 3 readout, my conviction grows stronger that Diamyd^® may become the first precision immunotherapy approved for Type 1 Diabetes. Diamyd Medical’s strategy is sharply focused: to deliver a safe, durable, and genetically guided therapy that transforms the standard of care for autoimmune diabetes.

Thank you for your continued support as we work to realize this vision.

Stockholm, June 25, 2025
Ulf Hannelius, President and CEO