Dear Shareholders

With full speed ahead, we continue advancing Diamyd^®— our precision immunotherapy for Type 1 Diabetes — toward an FDA supported Phase-3 Study early read-out, that may be followed by an application for an accelerated market approval.

Our recently updated market analysis estimates that approximately 60,000 patients in the U.S. could be eligible for Diamyd^® annually in the launch indication (i.e. newly diagnosed insulin dependent patients, Stage-3 Type 1 Diabetes). Market research indicates strong interest from payers and prescribers in targeted disease-modifying therapies, reinforcing the blockbuster potential of Diamyd^®. Our genetically validated approach—-addressing the approximately 40 % of Type 1 Diabetes patients with a specific HLA genotype—aligns with the growing demand for precision medicine solutions that offer both clinical and economic benefits.

Recruitment in DIAGNODE-3, our pivotal Phase-3 study, continues to progress, with over 200 patients (more than needed for the planned early read-out in March-26) now randomized across 60 clinical sites in the U.S. and Europe.

Beyond the launch indication, we see significant commercial potential in follow-on indications, particularly Latent Autoimmune Diabetes in Adults (LADA), which represents a market opportunity expected to be equal to or larger than Stage-3 Type 1 Diabetes. LADA shares important immunological features with Type 1 Diabetes and is often diagnosed before the patient requires insulin, much like someone in the early stages (Stage 2) of Type 1 Diabetes. There is currently no approved therapy addressing its underlying disease process.

Scientific and clinical validation of Diamyd^® continues to grow. At the 20th Immunology of Diabetes Society Congress, we presented an in-depth analysis demonstrating robust treatment effects across clinical trials, reinforcing the potential of Diamyd^® to modify disease progression. Additionally, a peer-reviewed publication on the “redosing” DIAGNODE-B trial highlighted the safety and potential efficacy of additional injections of Diamyd^®.

Patient engagement and recruitment remain a priority, and our strategic partnership with INNODIA, a leading international research network, is expected to further enhance trial visibility and patient awareness and enrollment into DIAGNODE-3.

We recently expanded our Scientific Advisory Board with Dr. Emily Sims and Dr. Alice Long. With these two leading US-based researchers, we gain additional important expertise in pediatric endocrinology, translational immunology and diabetes research, which is particularly important as we are now well advanced in our clinical development program.

Our financial position was strengthened with approximately SEK 48 million raised through the exercise of series TO 3 warrants - a subscription rate of 95 %. Another opportunity for warrant exercise is in March 2025, which, if fully subscribed, would provide approximately SEK 100 million to support our clinical, regulatory and manufacturing activities as we continue preparing for a potential accelerated Biologics License Application (BLA).

FDA’s confirmation that C-peptide can serve as a reasonably likely surrogate endpoint to predict clinical benefit is a significant development for Diamyd^®. With Fast Track and Orphan Drug Designations already granted, we have aligned our development program with the FDA, and the interim analysis expected in March 2026 will provide key data, with C-peptide as the primary endpoint, that may support a BLA under the accelerated approval pathway. A Type C meeting held in December with the FDA confirmed alignment on critical milestones and on the statistical plan for the accelerated approval process.

Stockholm, January 29, 2025
Ulf Hannelius, President and CEO