DiaMedica Therapeutics Q1 Earnings Call Highlights

Key Points

• The ReMEDy2 acute ischemic stroke trial has surpassed 70% enrollment and an interim analysis is planned by end‑2026, starting with a futility check and potentially triggering a sample‑size re‑estimation and enrollment completion in early 2027 if results mirror prior phase II data.
• In preeclampsia, the Part 1a extension cohort is near completion with a data update expected this quarter, the company plans Part 1b and Part 2 cohorts (up to 30 patients each) plus a fetal growth restriction cohort starting this quarter, and Health Canada has approved the global phase II while DiaMedica addresses an FDA request for additional embryo‑fetal studies by proposing an alternative rodent study.
• DiaMedica closed Q1 with $51.3 million in cash and says existing funds should support planned clinical programs and operations “through 2027,” while Q1 net cash used in operations was $9.1M and R&D rose to $8.0M driven by ReMEDy2 expansion and reproductive toxicity testing.

DiaMedica Therapeutics NASDAQ: DMAC executives outlined progress across the company’s DM199 clinical programs in preeclampsia and acute ischemic stroke during the company’s first-quarter 2026 earnings call, while also reviewing quarter-end liquidity and spending trends as development work expands globally.

Management highlights near-term clinical milestones

President and CEO Rick Pauls said the company is “pleased with the progress we’ve made so far in 2026” as it advances DM199 in both preeclampsia and stroke. Pauls said DiaMedica expects “multiple clinical milestones between now and the end of 2027,” and added the company is weighing the “risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts.”

On the stroke program, Pauls emphasized the importance of the planned interim analysis for the ReMEDy2 trial, noting enrollment has surpassed 70% and that the company expects the interim analysis to “validate all of the hard work that has gone into the program.”

Preeclampsia program: near-term data update and cohort expansion plans

Chief Medical Officer Julie Krop said enrollment is “near completion” in the extension cohort for Part 1a of the investigator-sponsored trial (IST), a dose escalation study in late-onset preeclampsia patients who are “planned to deliver within 72 hours.” Krop said the cohort is intended to help determine the dose or doses to be used in upcoming IST cohorts, and the company expects to complete the cohort and “provide a data update later this quarter.”

Krop referenced prior interim results indicating DM199’s potential to reduce blood pressure and improve placental perfusion “without crossing the placental barrier,” while acknowledging the dataset remains small. “The results we observed were highly consistent and encouraging,” she said.

Krop added that learnings from Part 1a are guiding protocol amendments for two remaining preeclampsia study groups:

• Part 1b: An expansion study of up to 30 additional late-onset preeclampsia patients receiving DM199 via continuous IV infusion until delivery, aimed at understanding how physicians may use DM199 to support blood pressure control “at this late stage of the disease.”
• Part 2: A study of up to 30 early-onset preeclampsia patients evaluating three doses to help inform phase III dosing and to identify a dose level that could extend pregnancy duration and increase gestational age at delivery.

Krop also discussed an IST cohort in fetal growth restriction (FGR) in patients without preeclampsia, describing FGR as “the leading cause of stillbirth” and associating survival with “enduring adverse health effects over the child’s lifespan.” She said the company expects to enroll the first patient in this cohort during the current quarter.

Regulatory and geographic expansion plans for early-onset preeclampsia study

In parallel with the IST, DiaMedica is advancing a global phase II study in early-onset preeclampsia in North America and the U.K. Krop said Health Canada approved the study in March 2026, sites have been selected, and the company is working to initiate enrollment in Canada by year-end. She added the company expects to file a clinical trial application in the U.K. during the current quarter.

Regarding U.S. plans, Krop said the FDA requested an additional non-clinical 10-day modified embryo-fetal development and pre- and postnatal development study in rabbits. However, she said a non-GLP dose-ranging rabbit study suggested an “adverse immune response to DM199,” which prevented completion of the requested rabbit study. The company proposed conducting the study in a second rodent model and is awaiting FDA feedback.

During Q&A, Pauls said the company submitted its proposal to the FDA “over a month ago” and will provide an update once it receives clarity. He said if the FDA agrees to the proposed rat study, it would take “three to four months to complete.” Pauls also highlighted that DiaMedica is moving ahead with Canada and intends to add U.K. sites while completing any additional preclinical work requested by the FDA.

Analyst Josh Schimmer of Cantor asked what incremental observations investors should look for in the upcoming late-onset cohort update beyond blood pressure control. Pauls said the Part 1a expansion cohort includes “12 additional patients” and should provide additional clarity, “particularly on blood pressure” and “dilation of the uterine arteries.” He added the company does not expect changes in biomarkers like sFlt after only two doses, suggesting improvements may be more likely when the drug is on board for “a week, two weeks.”

Schimmer also asked about potential edema improvement. Pauls said lead investigator Dr. Cathy Cluver has observed edema resolving in some patients “even within, you know, 12 to 24 hours of getting DM199,” though he emphasized the small patient count.

On timing for the sponsor-run early-onset preeclampsia study, Krop said initiation depends on dosing data from the IST study, along with site contracting and CRO work, reiterating that initiation in Canada is expected later this year. Pauls added that one of the selected Canadian sites is already involved in the company’s stroke trial, which he said could help expedite activation.

Stroke program: ReMEDy2 enrollment progress and interim analysis framework

Krop said the ReMEDy2 acute ischemic stroke trial has now passed 70% of the target required for the interim analysis, and site activations and enrollments have recently begun in Europe. She said the company has added six European countries and now has “approximately 70 sites activated.” Krop also said DiaMedica hosted an investigator meeting for European study teams in April and reiterated the plan to complete the interim analysis by the end of 2026.

Krop reviewed prior phase II ReMEDy1 findings that informed ReMEDy2’s design and powering assumptions. She said DM199 was associated with “clinically meaningful improvements in functional outcomes” in the subgroup most similar to ReMEDy2 enrollees. In patients who did not undergo thrombectomy, Krop said the study observed a 15% absolute increase versus placebo in favorable recovery (modified Rankin Scale 0–1). In the moderate stroke severity subgroup (NIHSS 5–15), she said the absolute improvement was 19%, with a “50% reduction in the number of patient deaths” and a 13.3% reduction in recurrent strokes versus placebo.

During Q&A, Pauls described the interim analysis approach as starting with a futility assessment. “If there’s not a drug effect, we’ll terminate,” he said. Otherwise, he said there will be a sample-size re-estimation, with total enrollment between “three and 700 patients.” He added that if the interim signal is comparable to prior phase II data, the company would look to complete enrollment the following quarter.

Lake Street analyst Thomas Flaten sought clarification on timing. Pauls said that assuming an interim analysis at year-end 2026, the company would anticipate completing enrollment in the following quarter, “Q1 of next year.” Pauls also explained that after patient 200 is dosed, there is a 90-day window for the primary endpoint and about four additional weeks for the interim analysis, during which the company expects to continue enrolling and get closer to 300 patients.

Asked what information the company would share at interim, Pauls said DiaMedica would provide “an update on the expected timelines to complete the enrollment.”

Quarterly financial results and cash runway

Chief Financial Officer Scott Kellen said DiaMedica ended the quarter with $51.3 million in cash, cash equivalents, and short-term investments as of March 31, 2026, compared with $59.9 million at Dec. 31, 2025. Current liabilities were $5.7 million, and working capital was $46.6 million at quarter-end, compared to $55.5 million in working capital at year-end 2025.

Kellen said the company expects its current cash and investments to be sufficient to fund planned clinical studies and operations “through 2027.” Net cash used in operating activities was $9.1 million in the first quarter, up from $7.1 million in the first quarter of 2025, driven primarily by a higher net loss.

Research and development expenses increased to $8.0 million for the quarter from $5.7 million a year earlier, reflecting continued ReMEDy2 activity and global expansion, clinical team expansion, and additional reproductive toxicity testing to support the preeclampsia program in the U.S. Kellen said these increases were partially offset by reduced manufacturing development spending versus the prior-year period. He said R&D expenses are expected to “moderately increase” as ReMEDy2 continues and DM199 advances in preeclampsia.

General and administrative expenses were $2.5 million, unchanged year over year, and Kellen said G&A is expected to remain “relatively consistent” in future periods.

In response to questions about expense trends, Kellen said quarterly R&D changes are driven by enrollment rates and geography, with the U.S. being “probably the most expensive,” followed by the U.K., Canada, and Europe. Pressed to define “modest,” Kellen said he would not expect R&D to rise “more than, you know, 10%, a quarter.”

About DiaMedica Therapeutics NASDAQ: DMAC

DiaMedica Therapeutics, Inc NASDAQ: DMAC is a clinical‐stage biopharmaceutical company focused on developing novel therapies for acute and chronic central nervous system conditions. The company's lead product candidate, DM199, is a recombinant form of human tissue kallikrein-1 designed to promote neuroprotection and tissue repair through modulation of the kallikrein‐kinin system. DiaMedica's research and development efforts are centered on translating the regenerative potential of DM199 into effective treatments for disorders with high unmet medical need.

DM199 is being evaluated in acute ischemic stroke, where preclinical studies have demonstrated potential benefits in blood flow restoration, inflammation reduction and neuronal survival.

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