DMAC — DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Q4 2025 Earnings Call Summary

1. Key Financial Results and Metrics:

• As of December 31, 2025, DiaMedica reported cash, cash equivalents, and short-term investments of $59.9 million, an increase from $44.1 million in 2024.
• Current liabilities were $5.1 million, slightly down from $5.4 million the previous year.
• Working capital rose to $55.5 million from $39.2 million in 2024.
• Net cash used in operating activities increased to $29.1 million from $22.1 million year-over-year.
• Research and development expenses grew to $24.6 million, up from $19.1 million, attributed to ongoing clinical trials and team expansion.
• General and administrative expenses increased to $9.8 million from $7.6 million, driven by higher personnel costs and share-based compensation.

2. Strategic Updates and Business Highlights:

• DiaMedica's lead candidate, DM199, showed promising interim results in its preeclampsia program, demonstrating significant reductions in blood pressure and improved uteroplacental perfusion without crossing the placental barrier.
• The company received regulatory clearance from Health Canada to initiate a global Phase II trial for early onset preeclampsia, with plans to activate sites in the U.K. and Canada.
• Enrollment in the ReMEDy2 trial for acute ischemic stroke has accelerated, achieving nearly 70% of the target enrollment of 200 participants, with plans to complete the interim analysis by the second half of 2026.
• The company is exploring alternative animal models for reproductive toxicology studies after challenges with rabbit studies.

3. Forward Guidance and Outlook:

• DiaMedica expects its cash position to fund clinical studies and operations through the end of 2027.
• The company anticipates completing the Part 1a expansion cohort for the preeclampsia study in the first half of 2026, with subsequent cohorts (Part 1b and 2) expected to initiate in Q2 2026.
• The interim analysis for the stroke program is projected for the second half of 2026.

4. Bad News, Challenges, or Points of Concern:

• The increase in net cash used in operating activities indicates rising costs associated with clinical trials and operations.
• Enrollment in the preeclampsia study has faced delays due to staffing challenges at clinical sites, although recent support measures are expected to improve this.
• The need for alternative animal models for reproductive toxicology studies may introduce further delays in regulatory processes.
• The company is still navigating the complexities of FDA requirements for animal studies, which could impact timelines.

5. Notable Q&A Insights:

• Management expressed confidence that DM199 will not cross the placental barrier, based on previous studies and its molecular size.
• Discussions with the FDA regarding alternative species for reproductive toxicology studies are ongoing, with no specific timeline provided for resolution.
• The company emphasized the importance of selecting clinical sites with experience in managing preeclampsia to ensure effective patient care during trials.
• Management acknowledged the challenges faced in stroke enrollment but noted recent improvements in both the number of sites and patient recruitment rates.

Overall, DiaMedica is making significant strides in its clinical programs, particularly for DM199 in preeclampsia and stroke, while managing financial pressures and regulatory hurdles.