DiaMedica Therapeutics (DMAC) Q3 2024 earnings summary

Executive summary

• Significant progress in both stroke (ReMEDy2) and pre-eclampsia programs, with 2025 expected to be transformative for the company.

• Majority of top U.S. and Canadian clinical sites for the AIS study are activated or near activation, aiming to accelerate patient enrollment.

• DiaMedica Therapeutics is a clinical-stage biopharmaceutical company focused on developing DM199 for acute ischemic stroke (AIS) and preeclampsia (PE), with a Phase 2/3 ReMEDy2 trial ongoing and a Phase 2 PE trial recently initiated.

• The company reported a net loss of $16.5 million for the nine months ended September 30, 2024, and expects continued operating losses as clinical programs progress.

• First patient enrolled in the pre-eclampsia study in South Africa, with DM199 positioned as a potential first-in-class therapy.

Financial highlights

• Cash, cash equivalents, and investments totaled $50.2 million as of September 30, 2024, down from $52.9 million at year-end 2023.

• Net cash used in operating activities was $15.6 million for the nine months ended September 30, 2024.

• Research and development expenses rose to $5 million for Q3 2024 (from $3.3 million in Q3 2023) and $12.6 million for the nine months (from $9.4 million in 2023).

• General and administrative expenses were steady at $1.9 million for Q3 2024, with a slight decrease for the nine months to $5.7 million.

• Net loss for Q3 2024 was $6.1 million, compared to $4.5 million in Q3 2023; net loss for the nine months ended September 30, 2024, was $16.5 million, up from $14.2 million year-over-year.

Outlook and guidance

• Current cash and investments provide a runway through Q3 2026.

• R&D expenses expected to increase moderately as global site activations and enrollments expand.

• Interim analysis for ReMEDy2 now expected in Q4 2025, with full enrollment of 200 patients anticipated by next summer.

• Topline results from Part 1A of the Phase 2 PE trial are expected in the first half of 2025.

• G&A expenses projected to remain steady.