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- DM199 Preeclampsia Phase 2 Investigator-Sponsored Trial (IST) Part 1a Expansion Cohort Enrolling, Updated Dataset Expected 2Q 2026<\/i><\/b><\/li>\n
- ReMEDy2 Phase 2\/3 AIS Trial of DM199 Surpassed 70% of Required Interim Enrollment; Interim Analysis planned in 4Q 2026<\/i><\/b><\/li>\n
- $51.3 million in Cash, Cash Equivalents and Investments, Anticipated Runway through 2027<\/i><\/b><\/li>\n
- Conference Call and Webcast on May 7 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 quarter ended March 31, 2026. Management will host a conference call on Thursday, May 7, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time to discuss the Company\u2019s business update and first quarter 2026 financial results.<\/p>\n\n\u201cWe continue to focus on moving our clinical programs forward. Looking ahead, we anticipate four separate preeclampsia data readouts and a readout from our fetal growth restriction trial between now and the end of 2027. Collectively, these datasets are anticipated to inform dose selection for a potential multi-national Phase 3 program in early-onset preeclampsia. We will also weigh the risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts,\u201d stated Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. “In acute ischemic stroke, ReMEDy2 has surpassed 70% of the required enrollment for, and we are now focused on completing, the interim analysis in the fourth quarter of 2026, which will determine the final number of participants required to complete the study.\u201d<\/p>\n
Corporate Highlights<\/b><\/p>\n
Preeclampsia – Phase 2 IST Clinical Trial:<\/b><\/p>\n
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- Part 1 Late-Onset Preeclampsia:<\/span>\n
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- \nDM199 dose-escalation extension cohort: 12 participants with results anticipated in the second quarter of 2026.<\/p>\n<\/li>\n
- \nDM199 continuous IV dosing cohort: dosing until delivery in up to 30 PE participants.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- Part 2 Early-Onset Preeclampsia:<\/span>\n
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- \nDM199 SC dosing every 3 days in PE subjects until delivery, in up to 30 participants with three dose levels identified in the dose-escalation cohort.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
Fetal Growth Restriction \u2013 Phase 2 IST Clinical Trial:<\/b><\/p>\n
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- Part 3 Early-onset fetal growth restriction:<\/span>\n
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- \nDM199 Initial IV\/SC loading doses followed by repeated SC dosing every 3 days in up to 30 participants with three dose levels identified in the dose-escalation cohort.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
Early-Onset Preeclampsia – Phase 2 Clinical Trial:<\/b><\/p>\n
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- \nOpen-label, dose-range finding 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 for phase 3 trial. These participants are candidates for expected management or prolongation of pregnancy.<\/p>\n<\/li>\n
- \nSites have been selected in Canada after having received approval from Health Canada. First patient is anticipated to be dosed before the end of 2026.<\/p>\n<\/li>\n
- \nPreliminary results of the rabbit study suggest that the animals developed an antibody response to DM199, a humanized recombinant protein, preventing us from completing the requested embryo-fetal development and pre- and postnatal development (ePPND) study in the rabbit model. We have proposed to the FDA performing the ePPND study in a second rodent model and are awaiting the FDA\u2019s response.<\/p>\n<\/li>\n
- \nA clinical trial application (CTA) to expand this Phase 2 trial to include sites in the U.K. is planned to be filed in 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 (the ReMEDy2 trial \u2013 NCT065216<\/a>) trial has surpassed 70% of the required enrollment.<\/p>\n<\/li>\n
- \nInterim analysis remains planned for completion in the fourth quarter of 2026.<\/p>\n<\/li>\n<\/ul>\n
Financial Results Highlights for the First Quarter Ended March 31, 2026<\/b><\/p>\n
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- Cash Position and Runway <\/b>\u2013 Cash and short-term investments were $51.3 million as of March 31, 2026, compared to $59.9 million as of December 31, 2025. The Company anticipates its current cash and short-term investments will be sufficient to fund its planned clinical studies and support corporate operations through 2027.\n<\/li>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities was $9.1 million for the three months ended March 31, 2026, compared to $7.1 million for the same period in the prior year. The increase in cash used in operating activities resulted primarily from the increased net loss in the current quarter ended March 31, 2026 as compared with the prior year period.\n<\/li>\n
- Research and Development (R&D) \u2013 <\/b>R&D expenses were $8.0 million for the three months ended March 31, 2026, compared to $5.7 million for the three months ended March 31, 2025. This increase was driven primarily by the continuation of the ReMEDy2 clinical trial and its global expansion; the expansion of the clinical team; and costs related to additional reproductive toxicity testing being performed in support of the Company\u2019s PE program in the United States. These increases were partially offset by net cost reductions in manufacturing development activity related to work performed and completed in the prior year period. DiaMedica expects that R&D expenses will moderately increase in future periods relative to recent prior periods as it continues the ReMEDy2 trial and its clinical development program in PE and FGR.\n<\/li>\n
- General and Administrative (G&A) \u2013 <\/b>G&A expenses were $2.5 million for the three months ended March 31, 2026 and 2025. While small changes occurred within a number of expense categories, the differences were not material individually or in the aggregate, and the overall net changes offset each other. DiaMedica expects G&A expenses to remain relatively consistent in future periods.\n<\/li>\n
- Net Loss \u2013 <\/b>Net loss was $10.0 million for the three months ended March 31, 2026, compared to $7.7 million for the three months ended March 31, 2025.\n<\/li>\n<\/ul>\n
Conference Call and Webcast Information<\/b><\/p>\n
\nManagement will host a conference call and webcast to discuss its business update and first quarter 2026 financial results on Thursday, May 7, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time:<\/p>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities was $9.1 million for the three months ended March 31, 2026, compared to $7.1 million for the same period in the prior year. The increase in cash used in operating activities resulted primarily from the increased net loss in the current quarter ended March 31, 2026 as compared with the prior year period.\n<\/li>\n
- \nInterim analysis remains planned for completion in the fourth quarter of 2026.<\/p>\n<\/li>\n<\/ul>\n
- \nEnrollment in DiaMedica\u2019s Phase 2\/3 ReMEDy2 (the ReMEDy2 trial \u2013 NCT065216<\/a>) trial has surpassed 70% of the required enrollment.<\/p>\n<\/li>\n
- \nDM199 Initial IV\/SC loading doses followed by repeated SC dosing every 3 days in up to 30 participants with three dose levels identified in the dose-escalation cohort.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
- Part 3 Early-onset fetal growth restriction:<\/span>\n
- \nDM199 SC dosing every 3 days in PE subjects until delivery, in up to 30 participants with three dose levels identified in the dose-escalation cohort.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
- ReMEDy2 Phase 2\/3 AIS Trial of DM199 Surpassed 70% of Required Interim Enrollment; Interim Analysis planned in 4Q 2026<\/i><\/b><\/li>\n
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