Diamyd Medical (DMYD) DNB Carnegie Småbolagsdag summary

Leadership and organizational updates

• New CFO Niklas Axelsson introduced, bringing experience from biotech and investment banking.

• CFO joins during a critical period as the company prepares next year's budget and strategic plans.

Clinical development and medical focus

• Focus on developing disease-modifying therapies for type 1 diabetes, aiming to intervene early and prevent complications.

• Only one approved drug exists for pre-diagnosis stage; no approved disease-modifying therapies for diagnosed patients.

• Type 1 diabetes leads to significant health risks, including a 10x higher risk of cardiovascular disease and up to 35 years shorter healthy life.

• Girls diagnosed before age 10 have an average of 18 years shorter lifespan.

Scientific approach and clinical trial design

• Therapy aims to preserve pancreatic beta-cell function by inducing antigen-specific immune tolerance, not general immunosuppression.

• Safety profile is strong, with no significant difference between active drug and placebo; main side effect is injection site irritation.

• Efficacy is linked to specific HLA genetics, present in about 40% of type 1 diabetes patients in the West.

• Clinical trials use C-peptide as a biomarker for endogenous insulin production.