The first clinical site in the United States is pending imminent initiation in the precision medicine Phase III trial DIAGNODE-3, which is ongoing in eight European countries. DIAGNODE-3 is designed to confirm the efficacy and safety of the antigen-specific immunotherapy Diamyd®? in patients aged 12 to 29 years recently diagnosed with type 1 diabetes and carrying the genetic HLA DR3-DQ2 marker.

The goal is to have the trial fully enrolled in the second half of 2024. Final preparations are in place to initiate the first clinical site for DIAGNODE-3 in the United States, and additional sites are expected to be initiated over the coming months. Approximately 10-12 clinical sites across the US are planned to be initiated, expanding the DIAGNODE-3 trial in the US and eight European countries to approximately 60 clincal sites in total.

An Investigators' Meeting for the US clinical sites will be held on September 15th in Washington DC with several US key opinion leaders in attendance. Approximately 40% of all screened patients carry the genetic HLADR3-DQ2 haplotype. This proportion aligns well with expectations based on previous Diamyd®?

clinical trials and published epidemiological research. Supported by published retrospective analyses and prospective clinical trials, the presence of the genetic HLA DR3 -DQ2 haplotype determines the likelihood of responding to Diamyd®? therapy, and serves as one of the main inclusion criteria in the DIAGNODE- 3 trial.

The screening rate (the average number of patients assessed for eligibility per site during a period of time) in DIAGNODE-3 has steadily been increasing in recent months and is in line with comparable late-phase clinical trials in Type 1 Diabetes. The trial has reached and passed operational recruitment milestones defined in the Industry Discovery & Development Partnership with JDRF that was announced in April 2023. Additional milestones will be reached as the trial expands to the US.

The partnership with JDRF, the largest Type 1 Diabetes patient advocacy organisation in the US, forms the backbone of Diamyd Medical's focus on completing enrolment of the registrational trial within the expected timeframe.