DiaMedica Therapeutics (NASDAQ:DMAC) expects a key interim analysis of its acute ischemic stroke trial in the first quarter of 2027, after reaching the required enrollment threshold in October, executives said on the company’s third-quarter earnings call.
The company also completed enrollment in the first two groups of a small fetal growth restriction study and plans to discuss preliminary results on November 24. Both programs are evaluating DM199, an investigational drug also being developed for preeclampsia.
For the third quarter, DiaMedica reported a net loss of $11.3 million, or $0.21 per share, compared with a loss of $8.6 million, or $0.17 per share, a year earlier. Higher research and development spending contributed to the wider loss.
Stroke Trial Approaches Interim Review
President and CEO Rick Pauls said the ReMEDy2 study enrolled its 200th participant in October, meeting the prespecified threshold for an interim analysis. An independent data safety monitoring board will conduct the review after the 200th participant completes 90 days of follow-up.
The board will assess the proportion of patients achieving an excellent functional outcome, defined as a modified Rankin Scale score of 0 or 1 at day 90. It will determine whether the trial should continue and whether its final enrollment target should be adjusted. If the study continues, the target will range from 300 to 728 participants under its statistical plan.
DiaMedica will remain blinded to the treatment-effect data reviewed by the board. Pauls said enrollment is continuing and that the company hopes to be closer to 300 participants by the time of the interim analysis.
During the question-and-answer session, Pauls said the study would stop for futility if no drug effect is observed. An effect comparable to that seen in the company’s earlier phase II study could result in a target closer to 300 patients, while an effect closer to 6% could put the target near the high end of the range, he said.
Chief Medical Officer Julie Krop said the randomized, double-blind, placebo-controlled trial is studying patients who begin treatment within 24 hours of stroke symptoms and are not candidates for mechanical thrombectomy. DM199 is designed to improve blood flow to threatened brain tissue surrounding the area affected by a clot, she said.
Pregnancy Studies and Upcoming Data
DiaMedica plans to present preliminary findings from two completed groups in an investigator-sponsored phase II study of early-onset fetal growth restriction at a virtual event on November 24. The groups enrolled six participants each at doses of 5 and 10 micrograms per kilogram.
The open-label study is assessing safety, blood-flow measures, birth weight percentile and pregnancy duration. Krop cautioned that the study is small and said experts at the event would provide context using outcomes from patients receiving current standard care.
Pauls said the company would share pregnancy-prolongation data alongside historical comparisons, taking disease severity into account. He also said the next group’s dose would be selected using the initial findings and would likely be higher, although lower doses could also be assessed in the future.
Two additional investigator-sponsored preeclampsia studies are expected to begin enrollment by the end of 2026. One will evaluate repeated subcutaneous dosing in up to 30 women with early-onset disease; the other will study intravenous dosing in up to 30 women with late-onset preeclampsia who have acute hypertension and are expected to deliver within 72 hours.
DiaMedica is also preparing a company-sponsored phase II dose-finding study in early-onset preeclampsia. Health Canada authorized a protocol amendment in September, and the company plans to expand the study into the United Kingdom subject to regulatory authorization. Pauls said DiaMedica would like to begin enrollment this year, but that it could start in early 2027.
For a potential U.S. application to study DM199 in preeclampsia, Pauls said the animal-treatment portion of an additional rat study was complete and the drug was well tolerated. DiaMedica expects pharmacokinetic and pharmacologic results in the coming weeks and plans to submit the completed report to the Food and Drug Administration. The agency’s acceptance of existing reproductive toxicology studies depends on additional evidence concerning drug exposure, activity and the suitability of rats as a testing species.
Cash Runway and Spending
Chief Financial Officer Scott Kellen said DiaMedica had $34.9 million in cash equivalents and short-term investments at September 30, down from $59.9 million at the end of 2025. Based on current plans, the company expects those funds to support its clinical studies and operations into the fourth quarter of 2027.
Third-quarter research and development expense rose to $9.2 million from $6.4 million a year earlier. Kellen attributed the increase primarily to clinical team expansion, ReMEDy2 activities, preeclampsia study preparations, additional testing and manufacturing development, among other factors. He said research and development expenses are expected to increase moderately from recent periods.
General and administrative expense was $2.4 million, compared with $2.6 million a year earlier. Net cash used in operating activities for the first nine months of 2026 was $26 million, up from $21.3 million in the comparable period of 2025.
About DiaMedica Therapeutics (NASDAQ:DMAC)
DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company developing treatments for serious diseases, with a focus on preeclampsia and neurological conditions. Its lead candidate, DM199 (rinvecalinase alfa), is a recombinant form of human tissue kallikrein-1, an enzyme involved in regulating blood flow. DiaMedica is investigating DM199 for acute ischemic stroke and preeclampsia; it remains an investigational drug and is not approved for commercial use. The company is headquartered in Minneapolis, Minnesota, and conducts clinical development of its therapies.
