DiaMedica Therapeutics (DMAC) investor relations material

Transformative therapies for preeclampsia and stroke

• DM199, a recombinant human KLK1 protein, is in late-stage development for preeclampsia, fetal growth restriction (FGR), and acute ischemic stroke (AIS), targeting large unmet needs in $5B+ and $10B+ U.S. markets respectively.

• No FDA-approved disease-modifying therapies exist for preeclampsia or FGR; current treatments are limited to symptom management and early delivery, which increases neonatal morbidity and costs.

• DM199’s mechanism increases placental blood flow, reduces blood pressure, and repairs endothelial dysfunction, with a favorable safety profile and no placental transfer observed.

• Interim phase 2 results in preeclampsia show significant reductions in blood pressure and uterine artery resistance, suggesting improved placental perfusion and potential to safely extend gestation.

• DM199 is also being evaluated in a pivotal phase 2/3 trial for AIS, aiming to improve collateral circulation and outcomes in patients not eligible for current first-line therapies.

Clinical development and results

• Over 300 patients have been dosed with DM199 across multiple studies, demonstrating general safety and tolerability in both IV and SC formulations.

• In preeclampsia phase 2 trials, DM199 was not detected in umbilical cord blood, indicating no placental crossing, and showed significant reductions in systolic and diastolic blood pressure.

• Uterine artery Doppler studies revealed a 13.2% reduction in blood flow resistance post-infusion, supporting enhanced placental perfusion.

• In AIS, phase 2 data showed improved functional outcomes (mRS ≤1 at 90 days) in non-mechanical thrombectomy patients, with a treatment window up to 24 hours, five times longer than tPA.

• Human urinary KLK1 (HUK), a related therapy, is widely used in China for AIS, supporting the rationale for DM199’s development and dosing.

Intellectual property, financials, and leadership

• DM199 benefits from strong IP protection, with patents extending to 2039 (plus potential 5-year extension) and anticipated 12 years of regulatory exclusivity in the U.S.

• Manufacturing challenges have been overcome, enabling scalable production and trade secret protection for key processes.

• As of September 30, 2025, the company holds $67M in cash, providing runway into the second half of 2027, with no warrants or debt.

• The leadership team and board bring extensive experience in drug development, commercialization, and regulatory affairs, including prior roles at major biopharma companies and successful product launches.