DiaMedica Therapeutics Reports Positive Interim Phase 2 Preeclampsia Results: Statistically Significant Reductions in Blood Pressure and No Placental Transfer

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• DM199 Demonstrated Highly Statistically Significant and Clinically Meaningful Reductions in Systolic and Diastolic Blood Pressure for Combined Cohorts 6-9
• DM199 Did Not Cross the Placental Barrier and was Generally Safe and Well Tolerated
• Highly Statistically Significant Reduction in Uterine Artery Pulsatility Index
• Robust Evidence Supports a Potential Best-In-Class Mechanism Enhancing Placental Perfusion, Protecting the Endothelium and Reducing Blood Pressure

MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced positive interim results from Part 1a of the Phase 2 study of DM199 for the treatment of preeclampsia. The study achieved pre-specified safety and efficacy endpoints for the Part 1a dose escalation phase, reinforcing the therapeutic potential of DM199. DM199, rinvecalinase alfa, is a recombinant form of the KLK1 protein expected to influence blood pressure regulation and vascular health in the treatment of preeclampsia (PE). Currently, there are no approved pharmacological treatments for the management of PE in the United States and Europe, representing a significant global unmet medical need.

“These interim results exceeded our expectations demonstrating DM199’s potential to be a first-in-class, disease modifying therapy for preeclampsia, coupled with a promising fetal exposure profile,” said Rick Pauls, President and CEO of DiaMedica Therapeutics. “We believe that the statistically significant reductions in blood pressure and pulsatility index represent on-target responses consistent with DM199’s mechanism of action signaling the potential of DM199 to greatly benefit this underserved patient population. These results are bolstered by data showing that DM199 did not cross the placental barrier, which historically has been a safety hurdle faced in developing treatments for PE. DM199 could potentially offer a significant safety advantage for both mothers and their babies.”

The Phase 2 study of DM199 for PE is an investigator-sponsored, open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept study of DM199 in treating preeclampsia. It is being conducted at the Tygerberg Hospital, Cape Town, South Africa (SA), under the direction of Catherine Cluver, MD, PhD, Professor of Maternal/Fetal Medicine, Stellenbosch University, Stellenbosch, SA, in collaboration with DiaMedica. This trial will enroll up to 90 women with preeclampsia and 30 women with fetal growth restriction.

Blood Pressure Reduction

The study revealed a dose-dependent reduction in both systolic blood pressure (SBP) and diastolic blood pressure (DBP):

• Cohort 9 (n=3; highest dose) achieved the most substantial mean reductions at 5 minutes post-infusion:
  • SBP reductions: -35 mmHg (p

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