Diamyd Medical AB (publ): Quarterly Report 3 24/25

Precision Medicine for Autoimmune Diabetes
Aiming for Accelerated Market Approval

Autoimmune or Type-1 Diabetes (T1D) is a progressive disease, diagnosed as at least two antibodies to the insulin producing beta cells are found. The disease advances to Stage-3 where the patient requires daily insulin administrations for survival. LADA (latent autoimmune diabetes in the adult), formerly often misdiagnosed as Type 2 Diabetes, is today reclassified as a form of Type 1 Diabetes.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.
Further information is available on https://www.diamyd.com

September 1, 2024 - May 31, 2025

• Net income: MSEK 0.1 (0.1), third quarter: MSEK 0.0 (0.1)
• Net result: MSEK -124.9 (-102.1), third quarter: MSEK -43.9 (-40.1)
• Result per share before and after dilution: SEK -1.2 (-1.1), third quarter: SEK -0.4 (-0.4)
• Cash flow from operating activities: MSEK -133.7 (-100.0), third quarter: MSEK -43.5 (-36.8)
• Cash and short-term investments at May 31, 2025: MSEK 319.3 (162.4), of which approximately MSEK 267 before issue costs were received in an oversubscribed rights issue and in a direct issue during the third quarter.

Significant events during the third quarter

• Diamyd Medical expanded a rights issue with a directed new issue of SEK 41.6 million
• Diamyd Medical's rights issue was oversubscribed and raised SEK 225 million before issue costs.

Other events during the third quarter

• Diamyd Medical appointed Niklas Axelsson as CFO
• Europe grants precision medicine patent to Diamyd Medical for insulin antigen treatment in autoimmune diabetes
• DIAGNODE-3 cleared second-to-last safety review ahead of early readout in March 2026
• The prevention trial DiaPrecise with Diamyd® clears first safety milestone
• Australia granted Diamyd Medical patent for novel antigen combination in autoimmune diabetes treatment
• Diamyd Medical plans for GMP Certification in 2025
• Diamyd Medical highlighted clinical benefits of C-peptide preservation at ATTD 2025
• Diamyd Medical advanced AI-powered screening for Type 1 Diabetes within the Vinnova financed ASSET Project

Other events after the third quarter

• Diamyd Medical participated in two key US Diabetes events

Comments by CEO Ulf Hannelius

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

*** The above is an excerpt from the report. The complete report is attached as a PDF, also available at https://www.diamyd.com. ***

About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes. Diamyd^® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying a HLA DR3-DQ2 gene. Diamyd^® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes. Diamyd^® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial with potential for an accelerated approval pathway in the US is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a largescale meta-analysis as well as in the Company's prospective European Phase IIb trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with Type 1 Diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®.
Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.

Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.

Further information is available on https://www.diamyd.com

For more information, please contact:
Ulf Hannelius, President and CEO, [e-mail]

Anna Styrud, CFO, [e-mail]

Diamyd Medical AB (publ), Box 7349, SE-103 90 Stockholm, Sweden
Phone: [phone] E-mail: [e-mail] Reg. no: 556242-3797

The information was submitted for publication, through the agency of the contact person set out above,
at 08.15 CET on June 25, 2025.