Diamyd Medical (DMYD) Company presentation summary

Mission and market opportunity

• Aims to cure type 1 diabetes through precision medicine and disease-modifying therapies.

• 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.

• Targets all stages of type 1 diabetes, including prevention and early intervention.

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

Lead product and clinical development

• Retogatein (rhGAD65) is an antigen-specific immunotherapy targeting HLA DR3-DQ2 positive patients, about 40% of type 1 diabetes cases.

• Demonstrated durable, disease-modifying effects and favorable safety in 16 trials with ~1,300 patients.

• Phase 3 DIAGNODE-3 trial is fully enrolled, with interim efficacy readout in March 2026 and full readout in Q3 2027.

• Fast Track and Orphan Drug Designations from FDA; aligned for potential accelerated approval.

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

Clinical efficacy and safety

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

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

• Favorable safety profile with no new or unexpected safety signals; <2% drop-out rate in intralymphatic administration trials.

• Subcutaneous injections in children delayed onset of type 1 diabetes by nearly 7 years in HLA DR3-DQ2 positive subgroup.

• Adult-onset type 1 diabetes (LADA) patients with HLA DR3-DQ2 showed preserved C-peptide at 12 months.