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