Quarterly Report 2 25/26

September 2025 – February 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026

Precision Medicine for type 1 diabetes       

Fully enrolled registrational Phase 3 program
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. The Company is advancing the fully enrolled registrational Phase 3 trial DIAGNODE-3 in the United States and Europe with an upcoming interim readout end of March 2026.

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 – February 28, 2026

• Net sales: MSEK 0.3 (0.1), second quarter MSEK 0.1 (0.0)
• Net result: MSEK -111.7 (-81.0), second quarter MSEK -62.9 (-44.9)
• Result per share before and after dilution: SEK -0.6 (-0.8), second quarter: SEK -0.3 (-0.4)
• Cash flow from operating activities: MSEK -83.2 (-90.2), second quarter MSEK -39.5 (-48.4)
• Cash and short-term investments at February 28, 2026: MSEK 190.7 (103.8)

Events during the second 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

Other events after the second quarter

• Diamyd Medical gives notice of extraordinary general meeting on April 8th, 2026
• Diamyd Medical enters into equity financing agreements with new U.S. sector specialist investors for up to USD 125 million and announces full enrollment in Phase 3 trial
• Diamyd Medical receives Notice of Grant in Japan for insulin-based antigen therapy patent in type 1 diabetes
• Diamyd Medical announced that ADA will feature retogatein Phase 3-trial in dedicated symposium
• Diamyd Medical finalized the database for interim analysis readout in DIAGNODE-3 trial
• Diamyd Medical announced the strengthening of its IP-position in the US

Comments by CEO Ulf Hannelius

Dear Shareholders,

Diamyd Medical has now reached a defining stage in the development of retogatein as we prepare for the interim efficacy readout from our pivotal Phase 3 trial DIAGNODE-3, anticipated on March 27, 2026. Earlier this week, we achieved a major operational milestone with the completion of randomization in the study. A total of 321 patients has now been randomized across 57 clinical sites in Europe and the United States, bringing this groundbreaking precision medicine trial to full enrollment.

Importantly, and directly aligned with this milestone, we have secured significant new funding to support DIAGNODE-3 through its next phase. We recently entered into directed equity financing agreements with new U.S. sector specialist investors, raising approximately USD 25 million before transaction costs. In addition, the newly issued warrants may provide an additional USD 100 million upon full exercise. Together with the existing TO5 warrants, which can contribute approximately USD 35 million, this establishes a total potential financing capacity of around USD 160 million. Both the new warrants and the TO5 warrants can be exercised following the upcoming interim analysis, directly linking this potential additional financing to a key value-inflection point. This structure provides financial flexibility to scale investment in line with clinical outcomes, supporting completion of the Phase 3 program, preparations for potential commercialization as well as life cycle management and pipeline opportunities. The financing was executed at a pivotal moment for the program—following full enrollment and ahead of the interim analysis—and the participation of specialized U.S. healthcare investors further validates both the quality of our data and the potential of our precision medicine approach in type 1 diabetes.

The upcoming interim analysis evaluates preservation of C-peptide from baseline to month 15, reflecting the body’s own insulin production, in a genetically defined patient population representing approximately 40 percent of individuals with the disease in Europe and the United States. Should the interim analysis demonstrate statistically significant efficacy, the results may support further regulatory interactions with the FDA regarding the potential Biologics License Application (BLA) pathway in the United States. The trial continues with follow-up of all participants toward the full study readout expected in the third quarter of 2027, intended to support a potential BLA for full approval.

Scientific interest in our Phase 3 program continues to grow, and we are particularly pleased that DIAGNODE-3 has been selected for a dedicated symposium at the American Diabetes Association’s 86th Scientific Sessions in June 2026. The symposium will highlight the scientific rationale for precision medicine in type 1 diabetes and present the interim Phase 3 outcomes together with leading international experts in the field. Being selected for a dedicated scientific session at one of the world’s largest diabetes conferences underscores both the scientific relevance of our program and the increasing recognition of precision medicine approaches in autoimmune diabetes.

In parallel with the clinical progress, our manufacturing capabilities in Umeå continue to advance. During the quarter, the Swedish Medical Products Agency conducted an inspection of our biomanufacturing facility as part of the ongoing process toward Good Manufacturing Practice (GMP) certification for the production of material for clinical studies. The inspection outcome was positive, and the observations raised were limited to minor findings that are currently being addressed in dialogue with the Agency ahead of their final assessment. Importantly, we also received constructive feedback from the Agency regarding requirements for future commercial manufacturing, providing valuable guidance as we continue developing our long-term production capabilities for retogatein. In parallel, we continue to work closely with our manufacturing partners to advance process validation, analytical methods and other CMC activities required for late-stage development and future commercialization.

I am also very pleased to report that the long-term incentive program launched three years ago reached its first vesting during the quarter, with participants receiving shares after successfully meeting the program’s performance criteria, defined as a 50 percent increase in the Company’s market capitalization since its inception. This outcome reinforces the strong alignment between employees and shareholders. The team has executed in an exemplary fashion to advance both the Phase 3 program and our manufacturing capabilities in circumstances that periodically have been challenging.

As we approach the interim analysis of DIAGNODE-3, the entire organization remains focused on disciplined execution across clinical development, regulatory engagement and manufacturing readiness. Our focus now is on delivering the upcoming milestone whilst continuing to advance the program toward the full Phase 3 readout and the next stages of regulatory engagement.

I would like to extend my sincere gratitude to our employees, clinical investigators, partners and shareholders for their continued commitment and support.

Stockholm, March 25, 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 ***

INVITATION TO PRESENTATION OF THE QUARTERLY REPORT 2 2025/2026
Diamyd Medical’s CEO Ulf Hannelius and CFO Niklas Axelsson will be interviewed in connection to the Company’s second quarterly report for the financial year 2025-26, published on March 25. 

The presentation will be held in English
When: Wednesday March 25 at 09:00 am CEST

Live webcast: https://www.youtube.com/live/qj2_tVpxIfY

The YouTube chat is open for questions. The broadcast is produced by Biostock. The presentation will also be made available on www.diamyd.com

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

Diamyd Medical AB (publ), Box 7349, SE-103 90 Stockholm, Sweden
Phone: +46 8 661 00 26 E-mail: info@diamyd.com Reg. no: 556242-3797

The information was submitted for publication, through the agency of the contact persons set out above,
at 08.15 CET on March 25, 2026.

For more information, please contact:
Ulf Hannelius, President and CEO, ulf.hannelius@diamyd.com
Niklas Axelsson, CFO, niklas.axelsson@diamyd.com

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