Quarterly Report 3 23/24, June 26, 2024

Dear Shareholders

The recent share issue, including warrants, has strengthened our financial position at this pivotal time. This capital infusion supports our efforts in advancing clinical programs and scaling operations. Importantly, this was achieved with minimal dilution for existing shareholders and at a cost substantially below prevailing market rates. With the cash position end of May of approximately 162 MSEK and a warrant structure including warrants in September this year and March 2025, there is an opportunity to finance our operations well into 2026.

An important milestone in our Phase 3 trial, DIAGNODE-3, was reached with the recruitment of 100 patients. This is a significant achievement given that these patients are recently diagnosed with Type 1 Diabetes and carry the specific genetic profile associated with a high likelihood of a positive clinical response to Diamyd®. Notably, no serious adverse events or dropouts have been reported to date. With nearly all clinical sites operational and an accelerating screening rate, this milestone underscores both the safety and convenience of Diamyd® treatment and the dedication of our clinical teams.

The ASSET consortium that Diamyd Medical is coordinating is also making progress. A recent workshop was arranged in Stockholm that brought together experts to discuss screening programs for T1D. This and other similar activities highlight our commitment to advancing preemptive medicine and integrating predictive analytics with targeted immunotherapies like Diamyd®. Additionally, our partner MainlyAI that also participates in ASSET is making strides in artificial intelligence and machine learning. Their collaborative AI platform is especially relevant as large-scale generative AI models continue to gain traction and fuel the adoption of AI across all industries including pharma and biotech. At Diamyd Medical, we are leveraging AI in our DIAGNODE-3 project to reach underserved patient communities. As also demonstrated at the recent international diabetes conference, the ADA Scientific Sessions in Orlando, we utilize avatars that communicate trial information in the patient’s native language, ensuring better understanding and engagement.

At our biomanufacturing facility in Umeå, we have been diligently working on the production of technical batches. This facility is crucial for ensuring the supply of high-quality GAD65 protein, the active ingredient in Diamyd®. As we move towards the manufacturing of clinical batches and eventually commercial production, we are also in the process of employing a Business Development Director in Umeå to focus on commercial opportunities beyond GAD manufacturing.

Our partnership with Breakthrough T1D (formerly JDRF) is instrumental in supporting our phase 3 clinical trial and increasing our visibility. We are further strengthened by the regulatory advancements with Diamyd®, where we have been granted both Fast Track Designation and Orphan Drug Designation by the U.S. FDA. These designations facilitate expedited review and approval processes, and the granting of these underscores the critical need for new treatments in Type 1 Diabetes.
Looking ahead, the upcoming interim analysis expected in early August is a significant milestone. It will provide insights into the progression of DIAGNODE-3, specifically informing whether the trial is still on track to reach its key endpoint. We are also pursuing discussions with regulatory agencies regarding C-peptide as a reasonably likely surrogate endpoint, which may open up accelerated approval pathways.

To conclude, this quarter has been marked by significant advancements in our ongoing projects, strategic collaborations, and financing activities, setting the stage for an exciting and transformative period ahead.

Stockholm, June 26, 2024
Ulf Hannelius, President and CEO

The upcoming interim analysis is a significant milestone. It will provide insights into the progression of DIAGNODE-3, specifically informing whether the trial is still on track to reach its key endpoints.
Ulf Hannelius, President and CEO

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