DiaMedica Therapeutics Inc. Q3 FY2025 earnings call

• Progress in preeclampsia program: Positive interim results from Part 1a of Phase 2 trial in South Africa, validating DM199's biological activity, potential for expansion into early onset preeclampsia and fetal growth restriction cohorts, and safety as it doesn't cross placental barrier. Upcoming U.S. trial preparation, including interaction with FDA in pre-IND meeting.
• Stroke program update: Steady progress in ReMEDy2 stroke trial, but lower enrollment rates due to changes in stroke referral patterns. Independent Data Safety Monitoring Board reported no safety concerns from first 50 participants. Enrollment approaching 50% of target for interim futility analysis by second half of 2026.

As of September 30, 2025, cash, cash equivalents and short-term investments were $55.3 million. R&D expenses were $6.4 million for Q3 2025 compared to $5 million in Q3 2024, and $17.9 million for the 9 months ended September 2025 compared to $12.6 million in the same period in 2024. General and administrative expenses were $2.6 million for Q3 2025 compared to $1.9 million in Q3 2024, and $7.3 million for the 9 months ended September 2025 compared to $5.7 million in the same period in 2024. Net losses were $8.6 million for Q3 2025 compared to $6.3 million in Q3 2024, and $24.0 million for the 9 months ended September 2025 compared to $16.5 million in the same period in 2024.

• Preeclampsia: Anticipate upcoming U.S. Phase 2 trial in early onset preeclampsia patients, with ongoing work with KOLs and clinical trialists. - Stroke: Updated enrollment forecast using actual site rates instead of historical, with interim analysis of first 200 patients expected in second half of 2026. Current over 35 sites activated, with more in Europe and U.K. expected.

• Stroke trial enrollment challenges: Lower than projected due to changes in stroke referral patterns driven by technologies like AI and tele neurology, leading to fewer target patients at participating centers.

Q: As we await minutes from pre-IND FDA meeting, talk about work with KOL community and clinical trialists for preeclampsia, and key factors for U.S. trial sites. Also, detail on protocol amendments and doses seen so far.

A: Extensive outreach to KOLs globally, positive feedback on DM199's safety (not crossing placental barrier) and blood pressure reduction. For Part 1b, IV only with dosing adjustment ahead of delivery, using Cohort 10 from Part 1a with clear blood pressure drops.

Q: Follow-up on Part 1b, purpose of 12-patient expansion cohort and trigger for U.S. Phase 2 study.

A: Cohort expansion at highest dose replaces Part 1b plan; IV only now. Proceeding with U.S. Phase 2 study with analyzed data including efficacy, safety, and PK data, plan for ~30 participants.

Q: Specifics on Cohort 10 and stroke enrollment rate, site activation.

A: Clear and immediate blood pressure drop in Cohort 10 patients with resistant hypertension. Stroke enrollment rates revised using current site rates, over 35 sites activated, regulatory clearance in U.K., Europe sites coming on board.

Q: Enrollment rhetoric for second half target in stroke.

A: Not providing that at this point.

Q: Meaningful change in Modified Rankin Scale score for AIS interim analysis.

A: Initial powering based on Phase 2 results, 15% absolute improvement in MRS 0 to 1 in Phase 2, adjusted protocol excluding severe stroke patients, currently powered for around 15% with final sample size 300-350 patients