September 2024 - August 2025, Diamyd Medical AB (publ), Fiscal year 2024/2025
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, 2024 - August 31, 2025
- Net sales: MSEK 0.1 (0.1), fourth quarter: MSEK 0.0 (0.0)
- Net result: MSEK -169.8 (-151.8), fourth quarter: MSEK -44.9 (-49.7)
- Result per share before and after dilution: SEK -1.5 (-1.6), fourth quarter: SEK -0.3 (-0.5)
- Cash flow from operating activities: MSEK -169.7 (-129.2), fourth quarter: MSEK -35.9 (-29.2)
- Cash and short-term investments at August 31, 2025: MSEK 277.2 (132.4)
Events during the fourth quarter
- Diamyd Medical released the full video recording from a panel discussion at the American Diabetes Association (ADA) meeting in June
- Diamyd Medical participated at the ADA 2025 Scientific Sessions in Chicago to showcase its work in disease-modifying therapies and precision medicine
- Diamyd Medical participated in the Critical Path Institute Workshop titled "21st Century Trials in New-Onset Type 1 Diabetes: How the use of C-peptide can accelerate the development of next-gen disease-modifying therapies for T1D"
Other events after the fourth quarter
- Diamyd Medical presented a new analysis at European Association for the Study of Diabetes (EASD), confirming the potential of Diamyd® to delay the progression of Stage 3 Type 1 Diabetes
- The Eurasian Patent Office informed Diamyd Medical that the patent application protecting the use of insulin-based antigens for the treatment of individuals with Type 1 Diabetes carrying the HLA DR4-DQ8 genetic marker will be granted
- Diamyd Medical - a coordinating member of the ASSET innovation partnership - informed about a new conference on the future of screening, early detection and treatment of Type 1 Diabetes to be held in Stockholm, October 9
- Diamyd Medical reported that it has been granted a patent in Hong Kong protecting the use of insulin-based antigens to treat individuals with type 1 diabetes carrying the HLA DR4-DQ8 genetic marker
Comments by CEO Ulf Hannelius
Dear Shareholders,
The fiscal year 2024/2025 has been a transformative and defining period for Diamyd Medical. With only six months remaining until the planned first readout of our registrational Phase 3 trial DIAGNODE-3, we have advanced with precision, focus, and conviction across every strategic front: clinical, regulatory, manufacturing, and financial.
Recruitment in DIAGNODE-3 now exceeds 275 randomized individuals with Stage 3 Type 1 Diabetes (where the disease has advanced to require lifelong insulin therapy for patient survival) and carrying the HLA DR3-DQ2 haplotype gene. At the current pace, we expect screening of new participants to be completed before year-end. Our near-term focus is on the early readout in March 2026, which has the potential to support a Biologics License Application (BLA) under the FDA's accelerated approval pathway. This readout will be based on data from approximately 170 individuals who by that time will have completed their 15-month visit, with C-peptide - a measure of the body's own insulin production - as the endpoint. With significant results at this readout, which will be communicated by the independent safety monitoring board (DSMB), we will commence interactions with the FDA for an Accelerated Market Approval submission.
Diamyd Medical had a strong presence at the EASD 2025 Annual Meeting in Vienna, with representatives from business development, clinical development and medical affairs. We presented a preliminary retrospective data analysis during an oral session, highlighting the significant disease-modifying effect of our therapy on C-peptide preservation in individuals with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 haplotype gene. In addition, Diamyd Medical was featured in the INNODIA symposium on life-changing therapies, underscoring our leadership in the field of disease-modifying precision treatments for Type 1 Diabetes. Discussions at EASD also reflected the growing momentum, where precision immunotherapy for early disease interception is becoming a central theme. Screening for early disease received strong attention, reinforcing the importance of initiatives such as ASSET where Diamyd Medical, as coordinating member, recently announced a next edition of the conference on the future of screening, early detection, and prevention of Type 1 Diabetes taking place on October 9, 2025, in Stockholm.
We have made important progress in expanding our Precision Medicine Platform. DiaPrecise, our clinical trial in persons with not yet insulin requiring Stage 1 and 2 Type 1 Diabetes, where we successfully cleared the first safety review.
On our intellectual property portfolio front, we are happy to report that our existing patents for insulin-based antigen therapies targeting the DR4-DQ8 genotype now has been extended to also cover Eurasia and Hong Kong. Together with our patents covering the use of GAD-molecules for individuals with the DR3-DQ2 gene, these two genetic subtypes represent up to 90% of all individuals with Type 1 Diabetes, creating a strong foundation for the long-term growth of our immunotherapy platform.
In Umeå, our biomanufacturing facility is advancing toward GMP certification. Ahead of the upcoming inspection by the Swedish Medical Products Agency, we have completed comprehensive internal and external audits, ensuring our facilities, quality systems, documentation, routines, logistics and personnel are fully aligned with what is required to produce our biologic products at the highest level of compliance. The Medical Products Agency has been contacted, and we are eagerly awaiting their inspection and feedback in the coming months.
Our financial foundation was significantly strengthened during the year. Through redemption of warrants, a preferential rights issue and direct placement, we raised SEK 315 million. We are also thankful to Breakthrough T1D, that increased their milestone-based support for the DIAGNODE-3 trial by USD 1.75 million, now totaling USD 6.75 million. These resources ensure that we can confidently deliver on our clinical, regulatory, and manufacturing priorities in the critical months ahead.
We are also inspired by this year's Nobel Prize in Physiology or Medicine that recognized the discovery of peripheral immune tolerance - a fundamental principle of how the immune system maintains balance and prevents autoimmunity. At Diamyd Medical, this concept lies at the core of our work. Our investigational precision immunotherapy, Diamyd®, is designed to induce antigen-specific immune tolerance in individuals with Type 1 Diabetes, aiming to retrain the immune system rather than suppress it.
As the world celebrates discoveries in immune tolerance, we're driven by the same vision - turning that scientific understanding into real therapeutic breakthroughs for people with Type 1 Diabetes. Looking forward, our focus is clear: complete screening in DIAGNODE-3, achieve GMP certification in Umeå, and conduct the early readout in March 2026. We see a clear potential to establish Diamyd® as the first precision immunotherapy that safely and effectively modifies the course of Stage 3 Type 1 Diabetes, and we are advancing with determination towards this goal.
My sincere thanks to All involved in this so important endeavor.
Stockholm, October 8, 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 (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 individuals 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 group of individuals with Stage 3 Type 1 Diabetes - both in a largescale meta-analysis as well as in the Company's prospective European Phase IIb trial. The DIAGNODE-3 trial is only including individuals that carry the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of individuals 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 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, ulf.hannelius@diamyd.com
Niklas Axelsson, CFO, niklas.axelsson@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 person set out above,
at 08.15 CET on October 8, 2025.
