Diamyd Medical (DMYD) Company presentation summary

Mission and market opportunity

• Aims to cure type 1 diabetes through precision medicine targeting genetic subgroups.

• Addresses a significant unmet need, with over 500,000 new cases annually and a $90 billion economic burden.

• Focuses on preserving pancreatic function to extend health and lifespan by reducing complications.

• Market cap as of February 2026 is approximately MSEK 2,250, with cash reserves of MSEK 233 as of November 2025.

• Estimated US peak sales for lead product exceed $2 billion, with additional upside from label expansions.

Product pipeline and clinical development

• Lead candidate retogatein (rhGAD65) targets HLA DR3-DQ2 positive type 1 diabetes, representing about 40% of patients.

• Phase 3 DIAGNODE-3 trial underway for Stage 3 type 1 diabetes, with interim efficacy readout expected March 2026.

• Phase 2 programs address earlier stages and adult-onset type 1 diabetes (LADA).

• Discovery platform aims to target additional genetic subgroups, covering up to 90% of type 1 diabetes.

• Precision medicine ecosystem includes AI-driven risk prediction, disease screening, and in-house biologics manufacturing.

Clinical efficacy and safety

• Meta-analysis and Phase 2b DIAGNODE-2 trial confirm significant preservation of C-peptide and improved glycemic outcomes in HLA DR3-DQ2 positive patients.

• Retogatein shows a favorable safety profile, with no new or unexpected safety signals and a low drop-out rate (<2%).

• Exploratory analyses indicate benefits in continuous glucose monitoring outcomes and reduced glycemic variability.

• Long-term follow-up in children suggests delayed onset of type 1 diabetes by nearly 7 years.

• Adult-onset type 1 diabetes (LADA) patients with HLA DR3-DQ2 maintain C-peptide levels over 12 months.