DiaMedica Therapeutics (DMAC) investor relations material

Lead program and clinical pipeline

• DM199, a recombinant human KLK1 protein, targets vascular and ischemic diseases, with lead indications in preeclampsia (PE), fetal growth restriction (FGR), and acute ischemic stroke (AIS).

• Ongoing and planned Phase 2 trials for PE and FGR, with a global Phase 2 in early-onset PE expected to start in late 2026 and FGR cohort in Q2 2026.

• ReMEDy2 Phase 2/3 trial for AIS is enrolling, with over 75% enrollment achieved and interim analysis planned for 2H 2026.

• Five clinical readouts for PE and FGR expected between Q2 2026 and end of 2027.

• $51M cash on hand as of March 31, 2026, provides runway through 2H 2027, with no warrants or debt.

Mechanism of action and scientific rationale

• DM199 activates the kallikrein-kinin pathway, increasing bradykinin and stimulating vasodilators (NO, prostacyclin, EDHF) to restore vascular function.

• KLK1 levels are significantly lower in preeclampsia, correlating with disease severity.

• DM199 augments all three major endothelial-derived vasodilating pathways, critical for regulating blood flow and pressure, especially in small vessels.

• In preeclampsia, impaired NO/PGI2 signaling increases reliance on EDHF-mediated vasodilation.

• DM199 does not cross the placental barrier, ensuring fetal safety.

Preeclampsia and FGR: market and clinical need

• Early-onset PE and FGR are severe conditions with no approved disease-modifying therapies and a $5B+ U.S. market opportunity.

• Early delivery in PE leads to higher neonatal morbidity, mortality, and costs; extending gestation improves outcomes.

• Current treatments are limited to antihypertensives and symptom management; delivery remains the only cure.