DiaMedica Therapeutics Inc. Q4 FY2025 earnings call

• 2025 was a year of significant progress across the pipeline. Lead candidate DM-109 has potential to enhance blood flow and vascular health. - Preeclampsia program: 2025 marked strong progress with positive interim results from Part 1A of Phase 2 trial in South Africa, showing DM-199 reduced blood pressure and uterine artery pulsatility index without crossing placental barrier. Enrollment continued in Part 1A expansion cohort, protocol amendments for Part 1B and 2 being finalized. Received regulatory clearance from Health Canada to initiate global phase two clinical trial of DM-199 in early onset preeclampsia. - Stroke program: Intensified engagement with study sites, added resources, achieved almost 70% of required enrollment for interim analysis of Remedy 2 trial, reiterating guidance to complete interim analysis by second half of 2026. - Publication of paper on endothelial triple pathway vasorelaxation in resistant hypertension, highlighting DM-109's ability to reduce blood pressure and lower serum potassium levels in certain patients.

As of December 31, 2025, cash, cash equivalents, and short-term investments were $59.9 million. Current liabilities were $5.1 million and working capital was $55.5 million. Research and development expenses for the year ended December 31, 2025 increased to $24.6 million from $19.1 million in the prior year. General and administrative expenses for the full year of 2025 were $9.8 million, up from $7.6 million in 2024.

• Reiterated guidance to complete the interim analysis of the Remedy 2 trial by the second half of 2026. - Anticipate cash position will fund planned clinical studies and corporate operations through the end of 2027.

• Preliminary results from rabbit dose range finding study suggest rabbits may not be suitable animal model for reproductive toxicology studies with DM-199 due to unusual immune response, but no teratogenic effects observed in pups. Need to evaluate alternative animal model to address FDA's request.

Q: On Revit preclinical trials for U.S. IND approval, early thoughts on alternative species with FDA and other preclinical models for reproductive tox studies, key learnings from ISP for early onset preeclampsia cohort, criteria for enrolling preeclampsia study investigators, and plan for pursuing DM-199 in CKD patients.

A: For CKD, focus is on preeclampsia and stroke programs now, will look at CKD later. For alternative species, discussing with FDA on appropriate models. Learnings from ISP include better understanding of PK, considering subcutaneous only for early onset studies. Site selection focuses on sites with preeclampsia study experience and suitable for early onset expectant management.

Q: For evaluation of DM-199 in earlier onset preeclampsia, potential risk of protein crossing placental barrier and evidence it won't, and interim analysis for Phase III stroke program outcomes.

A: Don't think DM-199 will cross placental barrier as it's large. For interim analysis of stroke program, if no drug effect, study terminated for lack of efficacy; otherwise, resample size ranges from 300 to 728.

Q: On Part 1A expansion cohort taking longer, color on that and if Parts 1B and 2 initiate prior to full completion of expansion cohort.

A: Staffing challenges at site led to slower enrollment, but with additional support and new hires, enrollment will pick up. Parts 1B and 2 anticipated to initiate later in Q2 while Part 1A expansion study continues and will be completed in Q2.

Q: On Remedy 2 enrollment momentum, sense of first quarter enrollment compared to fourth quarter of last year.

A: Enrollment increase has been more this year, picked up substantially in last two months, correlating with increase in sites.

Q: On remedy trial and real-world access for DM-199 if approved for AIS indication.

A: Previous challenge with enrolling at large academic centers, but drug's safety profile should allow broad use at small community hospitals and academic centers.

Q: On non-clinical side, differences in prior non-clinical rabbit study and biological rationale for antibody response, timelines for FDA feedback, and stroke enrollment rate.

A: First study had different gestational age, time period, etc. Will provide update when have alignment from FDA on path forward. Stroke enrollment is a combination of increase in enrollment rates per site and number of sites, feeling good about reiterating guidance for this year