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- Received Regulatory Approval from Health Canada Supporting Initiation of Phase 2 DM199 Study in Early-onset Preeclampsia.<\/i><\/b><\/li>\n
- DM199 Preeclampsia Phase 2 Investigator-Sponsored Trial (IST) Part 1a Expansion Cohort Enrolling, Completion Expected in 1H 2026.<\/i><\/b><\/li>\n
- ReMEDy2 Phase 2\/3 AIS Trial of DM199 Approaching 70% of Required Interim Enrollment; Interim Analysis planned 2H 2026.<\/i><\/b><\/li>\n
- $60 million in Cash, Cash Equivalents and Investments, Anticipated Runway through 2H 2027.<\/i><\/b><\/li>\n
- Conference Call and Webcast on March 31 at 8:00 AM ET \/ 7:00 AM CT.<\/i><\/b><\/li>\n<\/ul>\n
MINNEAPOLIS–(BUSINESS WIRE<\/a>)–
\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR), and acute ischemic stroke (AIS), today provided a business update and reported financial results for the year ended December 31, 2025. Management will host a conference call on Tuesday, March 31, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time to provide a business update and discuss full-year 2025 financial results.<\/p>\n\n\u201cWe continue to make meaningful progress across our clinical programs, highlighted by further advancement of the DM199 preeclampsia (PE) program. In the IST, enrollment continues in the expansion cohort for Part 1a, and we anticipate initiating Parts 2 and 3, which will evaluate participants with early-onset preeclampsia and fetal growth restriction. We are also preparing to initiate a DiaMedica-sponsored Phase 2 study in early-onset preeclampsia later this year. There remains a critical need for differentiated, well-tolerated therapies that can deliver clinically meaningful benefits, prolong pregnancy, and improve outcomes for both the mother and baby,\u201d said Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. \u201cWe are encouraged by the momentum in our ReMEDy2 acute ischemic stroke trial, which is approaching 70% of the required enrollment for the planned interim analysis, and we remain on track to complete the interim analysis in the second half of 2026. This, combined with a strong cash position expected to fund operations through the second half of 2027, supports our continued focus on advancing DM199 through key clinical and regulatory milestones in 2026.\u201d<\/p>\n
Recent Corporate Highlights<\/b><\/p>\n
Preeclampsia Phase 2 IST Clinical Development:<\/b><\/p>\n
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- \nPart 1a (PE, planned delivery within 72 hours): Enrollment is ongoing, with completion anticipated in the first half of 2026, with an updated Part 1a dataset available later in 2026.<\/p>\n<\/li>\n
- \nPart 1b (PE, planned delivery within 72 hours) and Part 2 (early onset PE with expectant management): Based on clinical learnings from Part 1a, protocol amendments for Parts 1b and 2 are being finalized to refine the treatment regimen, with initiation expected following completion of the ongoing Part 1a expansion cohort.<\/p>\n<\/li>\n
- \nPart 3 (fetal growth restriction): The first patient with early-onset fetal growth restriction, who is not diagnosed with preeclampsia, is expected to be dosed in Q2 2026.<\/p>\n<\/li>\n<\/ul>\n
Early-Onset Preeclampsia Phase 2 DiaMedica Sponsored Trial:<\/b><\/p>\n
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- \nOpen-label, dose-range finding, Phase 2 study of DM199 in participants with early onset preeclampsia to be conducted in North America (United States & Canada) and the United Kingdom (UK) to evaluate safety, early signals of efficacy and selection of an optimal dose regimen.<\/p>\n<\/li>\n
- \nDiaMedica received a \u201cNo Objection Letter\u201d (NOL) from Health Canada enabling the initiation of this trial in Canada.<\/p>\n<\/li>\n
- \nDiaMedica plans to discuss alternate species with the FDA and hopes to have an update on an agreement with the FDA next quarter, and will conduct this Phase 2 study while working on an alternate species with the FDA.<\/p>\n<\/li>\n
- \nClinical trial application to expand this Phase 2 trial to include sites in the United Kingdom (U.K.) filing planned for the second quarter of 2026.<\/p>\n<\/li>\n<\/ul>\n
Acute Ischemic Stroke ReMEDy2 Phase 2\/3 Clinical Developments:<\/b><\/p>\n
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- \nEnrollment in DiaMedica\u2019s Phase 2\/3 ReMEDy2 (NCT065216<\/a>) trial is approaching 70% of the required enrollment for the interim analysis.<\/p>\n<\/li>\n
- \nDiaMedica reaffirms guidance for completion of the interim analysis in the second half of 2026.<\/p>\n<\/li>\n<\/ul>\n
Financial Results Highlights for the Year Ended December 31, 2025<\/b><\/p>\n
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- Cash Position and Runway <\/b>\u2013 Cash and short-term investments were $59.9 million as of December 31, 2025, compared to $44.1 million as of December 31, 2024. The increase in cash and short-term investments is due to net proceeds received from the sale of common shares in the Company\u2019s July 2025 private placement and under its at-the-market offering program. Based on its current plans, the Company anticipates its current cash and short-term investments will be sufficient to fund its planned clinical studies and support corporate operations through the second half of 2027.\n<\/li>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities for the year ended December 31, 2025, was $29.1 million compared to $22.1 million for the year ended December 31, 2024. The increase in cash used in operating activities resulted primarily from increased net loss, partially offset by changes in operating assets and liabilities during the current period.\n<\/li>\n
- Research and Development (R&D) \u2013 <\/b>R&D expenses were $24.6 million for the year ended December 31, 2025, compared to $19.1 million for the year ended December 31, 2024. The increase is due primarily to cost increases driven by the continuation of the Company\u2019s ReMEDy2 clinical trial, including its global expansion, the expansion of the clinical team in the prior and current year periods, including increased non-cash share-based compensation costs. These increases were partially offset by cost reductions related to manufacturing process development work performed and completed in the prior year period. DiaMedica expects its R&D expenses to increase moderately in future periods relative to recent periods, as the Company continues its clinical development program in PE and the ReMEDy2 trial continues to enroll, including its global expansion.\n<\/li>\n
- General and Administrative (G&A) \u2013 <\/b>G&A expenses were $9.8 million for the year ended December 31, 2025, up from $7.6 million for the year ended December 31, 2024. The increase was due to a series of factors, including increased non-cash share-based compensation expense, increased personnel costs, increased investor relations expenses and increased patent prosecution costs. DiaMedica expects G&A expenses to remain steady or increase slightly in future periods relative to recent periods.\n<\/li>\n<\/ul>\n
Conference Call and Webcast Information<\/b><\/p>\n
\nDiaMedica Management will host a conference call and webcast to discuss its business update and full year 2025 financial results on Tuesday, March 31, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time:<\/p>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities for the year ended December 31, 2025, was $29.1 million compared to $22.1 million for the year ended December 31, 2024. The increase in cash used in operating activities resulted primarily from increased net loss, partially offset by changes in operating assets and liabilities during the current period.\n<\/li>\n
- \nDiaMedica reaffirms guidance for completion of the interim analysis in the second half of 2026.<\/p>\n<\/li>\n<\/ul>\n
- \nEnrollment in DiaMedica\u2019s Phase 2\/3 ReMEDy2 (NCT065216<\/a>) trial is approaching 70% of the required enrollment for the interim analysis.<\/p>\n<\/li>\n
- DM199 Preeclampsia Phase 2 Investigator-Sponsored Trial (IST) Part 1a Expansion Cohort Enrolling, Completion Expected in 1H 2026.<\/i><\/b><\/li>\n
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