Diamyd’s report for 1Q of the fiscal year ending in August 2024 was in line with our expectations. The operating result came in at SEK -32m (-33), while cash flow reach SEK 51m (10) following the completed rights issue. Diamyd’s cash position at the end of November was around SEK 177m. According to our estimates, this is sufficient to finance operations a little way into 2025.

Interim data from the DIAGNODE-3 study should be released in July. This is an especially important data point as it will reveal whether the study has a clear likelihood of achieving its objectives based on the assumptions Diamyd made at the design stage. Interim analysis will be based on 70–80 patients and will evaluate the effect of Diamyd with regards to the C-peptide. We consider the bar for achieving the criteria to continue the study to be relatively low. Previous studies with Diamyd have shown a clear differentiation in the C-peptide between the treatment and the placebo group after six months. Meta analysis published in The Lancet in 2023 (Taylor et al.) to evaluate the relationship between the C-peptide and HbA1 showed that a clear separation in the C-peptide curves occurs particularly early after treatment initiation.

Aiming to recruit the last patient in 2024