Precision Medicine for type 1 diabetes
Aiming for Accelerated Market Approval

Diamyd Medical develops a proprietary platform of precision medicines for type 1 diabetes, a progressive autoimmune disease in which the immune system destroys the body's own insulin production. Aligned with FDA, the Company plans for a March-2026 Early-Readout of its unique and registrational Phase 3 trial, with potential for an accelerated approval process in the United States.

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, 2025 - November 30, 2025

• Net sales: MSEK 0.2 (0.0)
• Net result: MSEK -48.8 (-36.2)
• Result per share before and after dilution: SEK -0.4 (-0.4)
• Cash flow from operating activities: MSEK -43.7 (-41.8)
• Cash and short-term investments at November 30, 2025: MSEK 233.2 (152.9)

Events during the first quarter

• Diamyd Medical's pivotal Phase 3 type 1 diabetes trial cleared the last safety review ahead of early readout in March 2026
• Hong Kong granted precision medicine patent to Diamyd Medical for insulin antigen treatment in type 1 diabetes
• New analysis presented at EASD supports potential of retogatein to delay the progression of Stage 3 type 1 diabetes
• Eurasia to grant precision medicine patent to Diamyd Medical for insulin antigen treatment in type 1 diabetes
• ASSET partnership, coordinated by Diamyd Medical, organized its second annual type 1 diabetes screening conference

Other events after the first quarter

• Diamyd Medical deepens long-term manufacturing collaboration for retogatein
• Diamyd Medical announced the completion of screening in pivotal Phase 3 DIAGNODE-3 trial
• Diamyd Medical's lead immunotherapy for type 1 diabetes received global non-proprietary name retogatein
• Diamyd Medical accelerated primary efficacy readout by 9 months in type 1 diabetes Phase 3 trial following FDA alignment and guidance

Comments by CEO Ulf Hannelius

Dear Shareholders,

We are now entering the final stage of our pivotal Phase 3 trial DIAGNODE-3-a landmark study in precision medicine for type 1 diabetes evaluating retogatein (rhGAD65), our investigational antigen-specific immunotherapy. Patient screening has been completed, a monumental achievement that reflects the dedication and coordination of our internal team, investigators, and partners across Europe and the U.S., and I extend my sincere gratitude to everyone involved-as well as to you, our shareholders, for your continued support.

With 310-320 genetically defined participants expected to be enrolled, we have established a strong foundation for the upcoming interim and full efficacy analyses. The interim readout, based on approximately 170 participants who will have completed their 15-month visit, remains on track for the end of March 2026. This analysis will provide early insights into retogatein's potential to preserve insulin production in individuals newly diagnosed with type 1 diabetes, and can support an accelerated approval pathway in the United States.

Our progress has been further strengthened by constructive discussions with the U.S. FDA, which led to a shortening of the primary efficacy follow-up from 24 to 15 months. This adjustment accelerates the full readout by nearly a year and reflects the FDA's recognition of the strength of our clinical and regulatory strategy. In parallel, the trial has successfully completed five independent safety reviews by the Data Safety Monitoring Board, with no concerns raised-further supporting retogatein's consistent and favorable safety profile.

This quarter, retogatein was also officially assigned its global non-proprietary name by the World Health Organization and the U.S. Adopted Names Council-a milestone that underscores its maturity as a late-stage clinical candidate.

On the manufacturing front, our biologics facility in Umeå, Sweden, continues to progress toward GMP certification. We have completed extensive internal audits and received initial feedback from the Swedish Medical Products Agency, and we are awaiting site inspection. To further prepare for potential commercialization, we have expanded our partnerships with APL and NorthX Biologics, two Swedish contract manufacturing organizations. These collaborations strengthen our preparations ahead of a future BLA and reinforce Sweden's role as a hub for advanced biologics production.

Retogatein represents a novel approach to treating autoimmune diseases. Unlike current therapies that suppress the immune system, retogatein is designed to restore immune tolerance in individuals with specific genetic profiles. By preserving insulin production, we aim to reduce complications, improve glycemic control, and to enhance the long-term quality of life for those newly diagnosed individuals with type 1 diabetes. This approach aligns with growing scientific consensus-underscored by the 2025 Nobel Prize in Physiology or Medicine, which recognized discoveries in peripheral immune tolerance. With Orphan Drug and Fast Track designations from the FDA, and regulatory acceptance of C-peptide as a surrogate endpoint that can support an accelerated approval pathway, retogatein is advancing as a leading candidate in precision immunotherapy.

Looking ahead, our focus remains on executing our clinical and regulatory strategy with rigor and transparency. The interim analysis in March 2026 will mark a key milestone as we prepare for the next phases of regulatory engagement, manufacturing and pre-commercial preparations.

Thank you for your continued support. Together, we are working to pioneer a new era of precision medicine in type 1 diabetes, and I look forward to sharing further updates as we move forward.

Stockholm, January 28, 2026
Ulf Hannelius, President and CEO

*** The above is an excerpt from the report. To read the complete report, please visit https://www.diamyd.com, or see attached PDF ***

About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein 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. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US, is being conducted at 57 clinics in eight European countries and in the US in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific 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 retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy.

Diamyd Medical is a 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