September 2025 - August 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026
Financial summary (September 2025 - August 2026)
Events during the fourth quarter (June - August 2026)
Events after the fourth quarter
Comments by CEO
Dear Shareholders,
The past year has been one of challenges, discipline, and renewed focus for Diamyd Medical. Following the decision to close the DIAGNODE-3 study, we acted decisively to reduce costs, preserve our financial strength, and reassess where we believe the company can create the greatest shareholder value. Expenses associated with closing the study have now been taken, and based on our approved budget, our current cash position is expected to fund operations for more than two years.
I am pleased to share encouraging news regarding our retogatein (GAD-alum) drug candidate. A peer-reviewed publication in Diabetologia reported that retogatein may delay progression from early, non-insulin-requiring Type 1 Diabetes (Stage 1 and 2 T1D) to insulin-requiring Stage 3 disease by more than five years in a genetically defined subgroup. This randomized study evaluated individuals with GAD autoantibodies and at least one additional islet autoantibody who had not yet progressed to insulin-requiring disease. With this finding, Diamyd Medical is actively engaging with clinical investigators on the potential design of clinical trials seeking to identify individuals who match retogatein's genetically defined responder profile, persons who could represent a relevant population for future treatment. We are also continuing discussions with pharmaceutical companies that see potential strategic value in retogatein as a complement to their metabolic and autoimmune disease portfolios.
Given our strong cash position, we also evaluated a range of investment opportunities during the past quarter, both within and outside Type 1 Diabetes therapeutics, including other autoimmune disease areas. This process reaffirmed our belief that the company's greatest strengths reside in its current drug candidates, including retogatein.
Retogatein has demonstrated a favorable safety profile across more than 15 clinical studies involving over 1,000 patients. Together with the encouraging results described above, these data strengthen our interest in developing retogatein as a potential therapy to delay or prevent progression to insulin-requiring Type 1 Diabetes. We believe this represents a logical path forward for Diamyd Medical to pursue. Another potential target population is patients with Latent Autoimmune Diabetes in Adults (LADA), which may account for approximately 10% of patients initially diagnosed with Type 2 Diabetes and may instead have autoimmune diabetes. We also remain open to participating with retogatein in investigator-initiated studies, and several discussions are ongoing. Taken together, the characteristics of retogatein provide a compelling basis for continued development: a long-term efficacy signal extending beyond five years; antigen-specific immune tolerance rather than broad immunosuppression; a favorable safety profile; an identified genetically defined responder group; and straightforward administration for patients.
Our GMP-approved biomanufacturing facility in Umeå is operational, with the next batch of retogatein drug substance scheduled for production before the end of the year. Diamyd Medical is open to working with partners on Contract Development and Manufacturing Organization projects, including those that contribute to preparedness and manufacturing capabilities in the event of future pandemics and other biological threats.
The company intends to remain open to selected, limited investments that have the potential to generate additional value over a two- to three-year horizon. Diamyd Medical currently holds investments in NextCell Pharma and Waterise.
Another recently formed initiative is the company's development of DiaTrapper, an AI-based application trained using datasets from various Type 1 Diabetes-related research efforts. The application is one outcome of the Vinnova-financed ASSET project. It is intended to assess an individual's risk of progressing to Stage 3 Type 1 Diabetes over time.
Our priorities are clear: advance retogatein toward the market for the early stages of Type 1 Diabetes; expand our Biomanufacturing activities in Umeå to include additional projects; continue and broaden partner discussions; and remain open to limited investments in promising assets.
I look forward to the coming years with great enthusiasm. The long-term data strengthen our conviction that retogatein deserves continued development. At the same time, our financial position and focused strategy provide Diamyd Medical with a disciplined pathway to pursue that opportunity. I strongly believe in retogatein and its potential to make a meaningful difference for people at risk of progressing to insulin-requiring Type 1 Diabetes.
This optimism would not be possible without the support of two special groups deserving our appreciation. First, I thank our more than 18,000 shareholders and supporters, including Breakthrough T1D, for their continued support. I also want to express my sincere gratitude to the over 1,000 patients who have participated in clinical studies with retogatein as part of our efforts to combat autoimmune Type 1 Diabetes.
Stockholm, October 7, 2026
Anders Essen-Möller, CEO
*** This 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 is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The company's lead investigational drug candidate is retogatein (GAD-alum), based on recombinant GAD65. The Company has established a GMP-approved facility for manufacturing of biological products in Umeå, Sweden.
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