Earnings

DiaMedica Completes Two FGR Cohorts, Hits Stroke Interim Threshold

The Tip Desk · November 13, 2026 · 3 min read

Cash, cash equivalents and short-term investments were $34.9 million as of September 30, 2026, down from $43.5 million at June 30.

DiaMedica Therapeutics Inc. (DMAC), a clinical-stage biopharmaceutical company developing DM199 for preeclampsia, fetal growth restriction and acute ischemic stroke, completed enrollment in the first two of three planned cohorts of its Phase 2 early-onset fetal growth restriction trial and reached the 200-participant threshold that triggers a planned interim analysis in its ReMEDy2 stroke study.

The FGR study, the first clinical use of DM199 in early-onset fetal growth restriction, enrolled 12 participants at 5 µg/kg and 10 µg/kg dose levels. The company said it will host a virtual key opinion leader event on November 24, 2026, to present preliminary, interim topline results from those two cohorts. A third cohort of up to 30 subjects is planned, with the dose to be set between 1 and 15 µg/kg based on the first two.

In the second quarter only the first FGR cohort of six participants had been completed. Two quarters earlier, Part 3 had not yet started enrollment.

ReMEDy2, the pivotal Phase 2/3 trial in acute ischemic stroke, has now reached the prespecified 200-participant enrollment threshold. The independent Data Safety Monitoring Board will conduct the interim analysis after the 200th participant completes 90-day follow-up, which the company expects in the first quarter of 2027. The DSMB will assess a sample-size re-estimation or stopping for futility on the proportion of participants with a modified Rankin Scale score of 0 or 1. If the trial continues, the final sample size will range from 300 to 728 participants. Recruitment continues while the 200th participant completes follow-up.

In the first quarter the company had said ReMEDy2 enrollment had surpassed 70% of required interim enrollment, with the interim analysis then planned for the fourth quarter of 2026.

Health Canada authorized a global Phase 2 early-onset preeclampsia dose-finding study of about 30 participants in September 2026. In October the European Medicines Agency granted conditional authorization, creating the opportunity for United Kingdom expansion subject to country-specific ethical and site requirements. DiaMedica said it is working with Canadian sites and preparing to expand the study to the U.K.

The company continues work on U.S. Food and Drug Administration feedback for a preeclampsia IND. Based on June 2026 written feedback, DiaMedica said a previously completed rat reproductive toxicity study may be adequate if it can demonstrate adequate DM199 exposure, enzymatic activity and pharmacologic effect in rats. The in-life portion is complete; pharmacokinetic and pharmacologic results are due in the coming weeks, after which the company plans to submit the data package to the FDA.

Research and development expenses were $9.2 million for the three months ended September 30, 2026, up from $6.4 million a year earlier. The company attributed the increase to clinical-team expansion, ReMEDy2 global expansion, Phase 2 preeclampsia start-up in Canada and the U.K., additional U.S. reproductive-toxicity testing, manufacturing development and higher share-based compensation. It expects R&D to moderately increase in future periods as ReMEDy2 enrollment continues and the Phase 2 preeclampsia trial starts up.

General and administrative expenses were $2.4 million in the quarter, down slightly from $2.6 million a year earlier, driven primarily by lower professional fees, partially offset by higher share-based compensation. The company expects G&A to remain steady.

Net loss widened to $11.3 million, or $0.21 a share, from $8.6 million, or $0.17 a share, a year earlier.

Cash, cash equivalents and short-term investments were $34.9 million as of September 30, 2026, compared with $59.9 million as of December 31, 2025. Working capital was $28.0 million. Based on current plans, the company said that cash is expected to fund planned clinical studies and corporate operations into the fourth quarter of 2027, matching runway language used in the second-quarter and first-quarter releases.

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