Dear Shareholders

Diamyd^® is uniquely positioned as the only investigational drug in the FDA’s Fast Track program for all stages of type 1 diabetes. We have ongoing trials for all stages of the disease, from delaying the time to clinical diagnosis of the disease to preserving insulin production in newly diagnosed patients. This means we are well positioned to address the full spectrum of autoimmune diabetes and offer patients a solution that can change the course of the disease.

With Fast Track designation and confirmation from the FDA that C-peptide can be used as a surrogate endpoint to predict clinical benefit, we have paved the way for accelerated approval of our investigational drug. The preservation of C-peptide, which is a marker of endogenous insulin production, is crucial for reducing complications and improving quality of life in patients with type 1 diabetes. The preservation of C-peptide protects beta-cell function, allowing patients to maintain some degree of their endogenous insulin production, which in turn leads to better glycemic control and fewer episodes of severe hypoglycaemia. This is key to changing the course of the disease and creating real long-term benefits for patients.

The type 1 diabetes field is entering a strong new phase, where the first approved disease-modifying therapy in the US, TZIELD, owned by the global pharmaceutical company Sanofi, is paving the way for new and innovative immunotherapies. This momentum is reflected in a higher willingness to invest, not least in an increased focus on screening – identifying patients at an early stage and offering personalized treatment options. Diamyd^® lies at the forefront of this development and is potentially the next immunotherapy to reach the market, and the first-ever precision medicine for type 1 diabetes.

The planned early readout of the DIAGNODE-3 trial, which is expected around March 2026, may enable us to reach the US market faster through an accelerated approval process. We have significantly advanced our positions over the past year, and we are now intensifying our preparations for a possible application and commercialization. We also see a strong willingness to pay for disease-modifying treatments in type 1 diabetes, which is strengthening our conviction that Diamyd^® will meet significant demand. With less than 18 months to go before the planned interim analysis of the DIAGNODE-3 trial, we are accelerating our commercial, regulatory and manufacturing preparations. The increasingly higher level of activity will drive costs as we move forward, but we are doing this to be ready to act on positive results, and meet the expected demand as fast as possible.

Thank you for your support.

Stockholm, November 13, 2024
Ulf Hannelius, President and CEO