DiaMedica Therapeutics Charts Costly Path to Key Trials

Diamedica Therapeutics ((DMAC)) has held its Q1 earnings call. Read on for the main highlights of the call.

DiaMedica Therapeutics’ latest earnings call struck a cautiously optimistic tone, with management emphasizing strong clinical momentum in stroke and preeclampsia programs despite rising R&D spend and regulatory questions in the U.S. The company highlighted a clear path to multiple clinical readouts through 2027, underpinned by a cash runway it believes will last into that same period.

ReMEDy2 Stroke Trial Moves Past 70% Enrollment

Enrollment in the global ReMEDy2 acute ischemic stroke trial has surpassed 70% of the target needed for its interim analysis, underscoring steady progress in a competitive space. Roughly 70 sites are now activated across the U.S., Canada, the U.K. and six other European countries, with management reiterating its goal of completing the interim analysis by the end of 2026.

Phase II ReMEDy1 Results Shape Phase III Strategy

Management leaned heavily on prior Phase II ReMEDy1 data, which showed a 15% absolute gain in favorable recovery in non thrombectomy patients and a 19% absolute benefit in moderate stroke cases. The study also suggested fewer deaths and recurrent strokes versus placebo, and these signals are now being used to power and refine the design of the larger ReMEDy2 program.

Preeclampsia Program Advances with New Cohorts

In preeclampsia, an investigator sponsored Phase II trial continues to advance, with the Part 1a extension in late onset patients nearing completion and a data update expected later this quarter. DiaMedica plans to run Part 1b and Part 2 concurrently, enrolling up to 30 late onset and 30 early onset patients to fine tune dosing, and expects to dose the first fetal growth restriction cohort patient this quarter.

Health Canada Approval Bolsters Global Preeclampsia Plans

Regulatory progress outside the U.S. provided a key bright spot as DiaMedica secured Health Canada approval in March 2026 for its global Phase II early onset preeclampsia study. Sites have been selected and the company is targeting Canadian enrollment by year end, while a U.K. clinical trial application is expected to be filed later this quarter.

Cash Runway Extends Into 2027

On the balance sheet, DiaMedica reported $51.3 million in cash, cash equivalents and short term investments as of March 31, 2026, down from $59.9 million at year end. Management believes this capital is sufficient to fund planned clinical studies and operations through 2027, a key reassurance as the company pushes several programs toward critical inflection points.

Operational Momentum and Site Activation Gains

The company highlighted operational momentum, pointing to a well attended investigator meeting in Europe that helped reinforce enrollment efforts. Additional European countries have been brought into the fold and existing site relationships, particularly in Canada, are being leveraged to accelerate activation across both stroke and preeclampsia programs.

Structured Stroke Interim Analysis Framework

DiaMedica detailed a well defined interim analysis plan for ReMEDy2, which will first assess futility and allow for trial termination if no drug effect is seen. If signals are positive, the design permits a resample decision that could increase the total patient count into a 300 to 700 range, with the company targeting full enrollment as early as the first quarter of 2027.

Cash and Working Capital Trend Lower

Financially, the company’s cash and short term investments fell about 14% quarter over quarter, with working capital declining roughly 16% over the same period. These movements reflect the ramp up in clinical activity, underscoring the balance DiaMedica must strike between funding ambitious trials and preserving flexibility.

Operating Cash Burn Accelerates

Net cash used in operating activities rose to $9.1 million in the first quarter of 2026 from $7.1 million a year earlier, an increase of about 28%. The higher burn rate is tied to expanded trial activity and underscores that, while the current runway reaches into 2027, continued progress will depend on disciplined spending and potential future capital decisions.

R&D Spending Climbs on Global Expansion

Research and development expenses jumped to $8.0 million in the March quarter from $5.7 million in the prior year, a roughly 40% increase. Management attributed the rise to the global expansion of ReMEDy2, growth in the clinical team and extra reproductive toxicity testing, signaling a deliberate choice to invest heavily in late stage validation.

Regulatory Hurdles in U.S. Preclinical Testing

The company acknowledged a key regulatory overhang after U.S. regulators requested additional embryo fetal and pre/postnatal development data. A non GLP rabbit study produced an adverse immune response, preventing completion of the requested work, and DiaMedica has now proposed an alternative rat study while warning that further requests could delay U.S. timelines.

Potential Upsizing of Stroke Trial and Cost Implications

Investors were reminded that ReMEDy2 could become a larger and more expensive study if the interim analysis supports a resample. A potential upsizing to as many as 700 patients would push timelines and require additional enrollment and funding, though management framed this as an acceptable tradeoff if the efficacy profile seen in Phase II is confirmed.

Site Level Operational Risks Persist

While operational momentum is generally positive, DiaMedica called out localized site staffing issues, such as those previously seen in Cape Town, that have affected enrollment pacing. The company believes these hurdles have been addressed but cautioned that similar site level disruptions remain a practical risk to meeting aggressive recruitment targets.

Guidance Highlights: Timelines, Spend and Clinical Milestones

Looking ahead, management reiterated that its $51.3 million cash position should fund operations through 2027, with R&D expected to rise moderately and G&A to stay relatively flat. On the clinical side, the company is guiding to an interim ReMEDy2 stroke analysis by late 2026, potential full enrollment in early 2027, multiple preeclampsia cohort readouts over the coming quarters and completion of the proposed rat study in roughly three to four months if accepted.

DiaMedica’s earnings call painted the picture of a company leaning into its clinical opportunities while navigating financial and regulatory headwinds. With key stroke and preeclampsia milestones on the horizon and a self described runway into 2027, investors will be watching closely to see if the company can convert promising signals into definitive late stage success without overextending its balance sheet.