Quarterly Report 1 23/24, January 24, 2024

Dear Shareholders

As we progress into 2024, I am pleased to report significant advancements in Diamyd Medical's journey towards making the first-ever precision medicine treatment available for patients with type 1 diabetes.

The recent U.S. market research has yielded promising insights. It demonstrates a strong willingness among healthcare practitioners and payers to consider prescribing Diamyd® for type 1 diabetes to the approximately 40% of patients identified as responders with a readily available genetic test. The indicative price range is around USD 200,000 per patient for a three-injection regimen. The positive reception is a testament to the value of Diamyd® as a disease-modifying, precision medicine treatment with a strong safety profile and simple mode of administration. These new insights together with our strong clinical database strengthen our confidence that Diamyd® has the potential of a first- and best-in-class therapy.

Our ongoing, registrational Phase 3 trial DIAGNODE-3 enrolls an easily identified genetic subgroup – 40% of type 1 diabetes patients. Our focus on likely responders should dramatically increase the probability of success of DIAGNODE-3 and is the key differentiator compared to the previous Phase 3 program with Diamyd® that enrolled all patients regardless of their genetics. It is also the key difference compared to how clinical trials have been conducted hitherto in type 1 diabetes. This precision medicine approach – which treats only likely responders and spares non-responders’ exposure to the treatment – resonates strongly among patients, healthcare providers, payers and regulators, which in turn supports the willingness to prescribe and reimburse treatment with Diamyd®. Our approach is further fortified by the Orphan Drug Designation granted by the FDA, emphasizing Diamyd®’s potential in treating type 1 diabetes patients with residual beta cell function.

DIAGNODE-3 is ongoing in both Europe and the United States, aiming for full enrollment by the end of 2024. With more clinical sites being activated in the US and additional sites being planned, we are doing our utmost to reach this goal. During a busy annual JP Morgan Healthcare week with a focus on partnering meetings, we also visited the DIAGNODE-3 clinical site at Stanford University Hospital, where the team is eagerly preparing for activation and first patient enrolment. Site visits are enlightening for us as they provide first-hand information on how clinics perceive the trial with insights into the local provider perspective on how Diamyd® may be prescribed in the future.

We recently gave an update on the Phase 3 interim analysis planned for July 2024 that will include 70-80 currently enrolled patients and will provide insights into the progression of the trial regarding preservation of endogenous insulin production measured as C-peptide. The analysis is blinded, which maintains the registrational nature of the trial; and will be evaluated by the independent Data Safety and Monitoring Board. The interim analysis will provide an estimate of whether the trial, given the data from patients followed for 6 months and certain assumptions regarding the rest of the patients, is proceeding according to plan.

The importance of C-peptide in managing glycemic control cannot be overstated. Diamyd® has demonstrated significant preservation of C-peptide in previous trials. Recent research including our own data as well as a comprehensive meta-analysis published recently in the renowned journal The Lancet Diabetes & Endocrinology underscores its critical role in controlling blood glucose levels. This is compounded by significant research supporting its central role in reducing the complications of type 1 diabetes. These findings reinforce the strong potential of Diamyd® for improving patient outcomes.

The new market research insights, the ongoing JDRF-partnered Phase 3 trial with important upcoming milestones, and progress at our biologics facility that we aim to have GMP-certified this year, all promise to make 2024 an important and exciting year for Diamyd Medical and our shareholders.

I am grateful for your continued support.

Stockholm, January 24, 2024
Ulf Hannelius, President and CEO


The recent U.S. market research has yielded promising insights, demonstrating a strong willingness among healthcare practitioners and payers to consider prescribing Diamyd® for type 1 diabetes.
Ulf Hannelius, President and CEO

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