Diamyd Medical AB (publ) announced that the interim analysis will be conducted in July by ICON plc, the appointed global CRO for the Phase 3 trial, and will be assessed by an independent Data Safety and Monitoring Board (DSMB). The DSMB is currently scheduled to convene on July 30th to evaluate the Interim Analysis outcome. The DSMB has approximately a week to inform Diamyd Medical of the conclusion of their meeting.

As previously announced, an Interim Analysis of the ongoing precision medicine Phase 3 trial DIAGNODE-3 in Type 1 Diabetes will assess 6-month data from approximately 70-80 patients. The trial specifically enrolls patients that carry the genetic HLA DR3-D Second Quarter haplotype and the interim analysis evaluates the likelihood of the trial to achieve one of the primary endpoints, endogenous insulin production measured as stimulated C-peptide. The analysis will guide decisions on the continuation of the trial and is designed to maintain the registrational integrity of the trial.

Specifically, the analysis will inform whether the trial is still likely to reach its endpoint regarding C- peptide while the exact efficacy observed at the interim readout is blinded. Activities to accelerate patient enrollment At the date, May 16, 2024, 109 patients have been enrolled and 27 patients are in active screening phase. A total of 335 patients have so far been screened in the trial and no patients have discontinued the trial.

As expected, approximately 50 % of all the screened individuals carry the genetic HLA DR3-D Second Quarter haplotype that has been associated with a positive response to Diamyd treatment. Also as expected, up to 40 % of screened patients fulfill all inclusion criteria for the trial. Current enrollment projections indicate that the trial will be fully enrolled during 2025.

Activities are ongoing to accelerate recruitment, both in the US and Europe. Patient enrollment in Europe has steadily increased and screening efforts in the US are improving. In total 55 clinics are currently open for screening patients in the trial and an additional 6 clinics are preparing to start screening.

Diamyd Medical's commitment to reach underserved patient communities Activities to reach underserved patient communities in the US are ongoing. Recent research in the US has highlighted significant inequities among diabetes patients across racial/ethnic groups or insurance types, which is reflected in worse glycemic control and lower use of novel diabetes technologies. Also, it is a well known fact that people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research.

The efforts to inform clinical sites serving patients from underrepresented groups underscores Diamyd Medical's commitment to a robust and diverse participant base to ensure comprehensive assessment of Diamyd.