Dia Medica Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate and Clinical Updates
Dia Medica Therapeutics, a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction, and acute ischemic stroke (AIS), today announced its financial results for the third quarter ended September 30, 2025, and provided a business update. Management will host a conference call and webcast on Thursday, November 13, 2025, at 8:00 a.m. ET / 7:00 a.m. CT to review these results and developments.
Preeclampsia Phase 2 IST Clinical Program
- Part 1a (PE; planned delivery within 72 hours): Completed cohort 10 with results consistent across cohorts 6–9. Enrollment has advanced to an expansion cohort of up to 12 additional participants at the expected therapeutic dose. Completion is anticipated in 1H 2026.
- Parts 1b and 2 (early-onset PE): A protocol amendment is being implemented based on clinical insights from Part 1a to refine treatment regimens.
- Part 3 (fetal growth restriction): Screening is expected to begin in the coming weeks for participants without PE but with early-onset fetal growth restriction.
FDA Pre-IND Meeting for U.S. Preeclampsia Program
DiaMedica recently held an in-person pre-IND meeting with the U.S. FDA to discuss plans for initiating a U.S. Phase 2 study of DM199 in preeclampsia. The Company anticipates providing a further update once it receives the official meeting minutes.
Acute Ischemic Stroke (AIS) – ReMEDy2 Phase 2/3 Trial
Enrollment in the ReMEDy2 trial (NCT065216) is progressing steadily, with the Company nearing 50% of its interim target of 200 participants. The interim analysis remains on track for the second half of 2026.
Financial Results for the Third Quarter Ended September 30, 2025
- Cash Position:
Cash, cash equivalents, and short-term investments totaled $55.3 million as of September 30, 2025, compared to $44.1 million at December 31, 2024. The increase reflects net proceeds from the Company’s July 2025 private placement.
DiaMedica expects its current cash resources to fund planned clinical studies and operations into the second half of 2027. - Cash Flow:
Net cash used in operating activities was $21.3 million for the nine months ended September 30, 2025, compared with $15.6 million for the same period in 2024. The increase primarily reflects a higher net loss, partially offset by working capital changes. - Research and Development (R&D):
R&D expenses were $6.4 million for Q3 2025 and $17.9 million for the first nine months, up from $5.0 million and $12.6 million, respectively, for the comparable 2024 periods. The increase was driven by ongoing progress in the ReMEDy2 trial, global trial expansion, advancement of the Phase 2 IST in PE, and clinical team growth, partially offset by lower manufacturing process development costs. - General and Administrative (G&A):
G&A expenses totaled $2.6 million for Q3 2025 and $7.3 million year-to-date, compared with $1.9 million and $5.7 million, respectively, for the same periods in 2024. The increases reflect higher share-based compensation, personnel costs, investor relations, and professional fees. - Net Loss:
DiaMedica reported a net loss of $8.6 million for Q3 2025 and $24.0 million for the nine-month period, compared to $6.3 million and $16.5 million, respectively, in the prior year.
Net loss per share (basic and diluted) was $(0.17) for Q3 2025 versus $(0.15) in Q3 2024.
Management Commentary
We are pleased to have completed cohort 10 and initiated enrollment in the expansion cohort of our ongoing Phase 2 investigator-sponsored trial in preeclampsia,” said Rick Pauls, President and CEO of DiaMedica. “We also appreciate the FDA’s engagement during our pre-IND meeting and look forward to advancing DM199 into a U.S. Phase 2 study in preeclampsia. Meanwhile, enrollment in our ReMEDy2 trial for acute ischemic stroke continues to progress well, nearing 50% of our interim enrollment target.”
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases.
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