Dear Shareholders,

We are now entering the final stage of our pivotal Phase 3 trial DIAGNODE-3—a landmark study in precision medicine for type 1 diabetes evaluating retogatein (rhGAD65), our investigational antigen-specific immunotherapy. Patient screening has been completed, a monumental achievement that reflects the dedication and coordination of our internal team, investigators, and partners across Europe and the U.S., and I extend my sincere gratitude to everyone involved—as well as to you, our shareholders, for your continued support.

With 310–320 genetically defined participants expected to be enrolled, we have established a strong foundation for the upcoming interim and full efficacy analyses. The interim readout, based on approximately 170 participants who will have completed their 15-month visit, remains on track for the end of March 2026. This analysis will provide early insights into retogatein’s potential to preserve insulin production in individuals newly diagnosed with type 1 diabetes, and can support an accelerated approval pathway in the United States.

Our progress has been further strengthened by constructive discussions with the U.S. FDA, which led to a shortening of the primary efficacy follow-up from 24 to 15 months. This adjustment accelerates the full readout by nearly a year and reflects the FDA’s recognition of the strength of our clinical and regulatory strategy. In parallel, the trial has successfully completed five independent safety reviews by the Data Safety Monitoring Board, with no concerns raised—further supporting retogatein’s consistent and favorable safety profile.

This quarter, retogatein was also officially assigned its global non-proprietary name by the World Health Organization and the U.S. Adopted Names Council—a milestone that underscores its maturity as a late-stage clinical candidate.

On the manufacturing front, our biologics facility in Umeå, Sweden, continues to progress toward GMP certification. We have completed extensive internal audits and received initial feedback from the Swedish Medical Products Agency, and we are awaiting site inspection. To further prepare for potential commercialization, we have expanded our partnerships with APL and NorthX Biologics, two Swedish contract manufacturing organizations. These collaborations strengthen our preparations ahead of a future BLA and reinforce Sweden’s role as a hub for advanced biologics production.

Retogatein represents a novel approach to treating autoimmune diseases. Unlike current therapies that suppress the immune system, retogatein is designed to restore immune tolerance in individuals with specific genetic profiles. By preserving insulin production, we aim to reduce complications, improve glycemic control, and to enhance the long-term quality of life for those newly diagnosed individuals with type 1 diabetes. This approach aligns with growing scientific consensus—underscored by the 2025 Nobel Prize in Physiology or Medicine, which recognized discoveries in peripheral immune tolerance. With Orphan Drug and Fast Track designations from the FDA, and regulatory acceptance of C-peptide as a surrogate endpoint that can support an accelerated approval pathway, retogatein is advancing as a leading candidate in precision immunotherapy.

Looking ahead, our focus remains on executing our clinical and regulatory strategy with rigor and transparency. The interim analysis in March 2026 will mark a key milestone as we prepare for the next phases of regulatory engagement, manufacturing and pre-commercial preparations.

Thank you for your continued support. Together, we are working to pioneer a new era of precision medicine in type 1 diabetes, and I look forward to sharing further updates as we move forward.

Stockholm, January 28, 2026
Ulf Hannelius, President and CEO