DiaMedica Therapeutics — Third Quarter 2026 Earnings Summary
Financial Performance:
- Cash, cash equivalents, and short-term investments totaled $34.9 million as of September 30, 2026, down from $59.9 million as of December 31, 2025.
- Current liabilities were $7.5 million as of September 30, 2026, compared to $5.1 million as of December 31, 2025.
- Working capital was $28.0 million as of September 30, 2026, compared to $55.5 million as of December 31, 2025.
- Net cash used in operating activities for the nine months ended September 30, 2026, was $26.0 million, an increase from $21.3 million in the same period of 2025.
- Research and development (R&D) expenses were $9.2 million for the three months ended September 30, 2026 (up from $6.4 million in 2025) and $25.4 million for the nine months ended September 30, 2026 (up from $17.9 million in 2025).
- General and administrative (G&A) expenses were $2.4 million for the three months ended September 30, 2026 (down from $2.6 million in 2025) and $7.2 million for the nine months ended September 30, 2026 (down from $7.3 million in 2025).
- Net loss was $11.3 million for the three months ended September 30, 2026, compared to $8.6 million in 2025.
- Net loss was $31.5 million for the nine months ended September 30, 2026, compared to $24.0 million in 2025.
- Basic and diluted net loss per share was $0.21 for the three months ended September 30, 2026, compared to $0.17 in 2025.
- Basic and diluted net loss per share was $0.58 for the nine months ended September 30, 2026, compared to $0.53 in 2025.
Guidance and Future Outlook:
- The Company anticipates its current cash position will fund planned clinical studies and support corporate operations into the fourth quarter of 2027.
- R&D expenses are expected to moderately increase in future periods as ReMEDy2 trial enrollment continues and the Phase 2 PE trial start-up progresses.
- G&A expenses are expected to remain steady in future periods compared to recent prior periods.
- Interim analysis for the ReMEDy2 Phase 2/3 trial is expected to be completed in the first quarter of 2027.
- Enrollment for Part 1b (late-onset PE) and Part 2 (early-onset PE) of the investigator-sponsored trial is expected to initiate by the end of 2026.
Business Segments and Product Lines:
- Enrollment was completed in the first two cohorts of the Phase 2 early-onset fetal growth restriction (FGR) trial, consisting of 12 participants treated at 5 µg/kg and 10 µg/kg dose levels.
- ReMEDy2 Phase 2/3 acute ischemic stroke (AIS) trial enrollment surpassed the 200-participant threshold required for the planned interim analysis.
- Health Canada authorized the global Phase 2 early-onset preeclampsia (PE) study; DiaMedica is preparing to initiate the open-label, dose-finding study in Canada and plans to expand to the United Kingdom subject to regulatory authorization.
- The European Medicines Agency (EMA) granted conditional authorization for the Phase 2 early-onset PE study in October 2026.
- DiaMedica is addressing FDA feedback regarding nonclinical reproductive toxicity data needed to support an Investigational New Drug (IND) application for DM199 in preeclampsia; the in-life portion of the rat study is complete, with pharmacokinetic and pharmacologic results expected in the coming weeks.
- Part 1a of the investigator-sponsored PE trial demonstrated rapid and sustained reductions in maternal blood pressure.
Market and Competitive Landscape:
- No new therapeutics have been approved for acute ischemic stroke in over 25 years.
- FGR affects an estimated 10% of pregnancies worldwide and is associated with increased risks of stillbirth, preterm birth, and neonatal morbidity.
- Preeclampsia affects up to 8% of pregnancies worldwide and poses significant risks to mother and baby, including stroke and death; delivery is currently the only option to stop progression.
- DM199 is the first pharmaceutically active recombinant form of the KLK1 protein, an established therapeutic modality in Asia for AIS, PE, and other vascular diseases.
Risks and Challenges:
- Risks include the timing and outcomes of nonclinical studies, specifically whether the FDA will determine the completed rat reproductive toxicity study is adequate for IND clearance.
- There is a risk that the ReMEDy2 interim analysis may result in a recommendation to stop the trial for futility or increase the sample size, potentially increasing costs and delaying completion.
- Risks exist regarding the conditional nature of regulatory authorizations and the ability to obtain additional authorizations in other jurisdictions.
- Potential impacts from hospital staffing shortages, increased tariffs, and global supply chain shortages could affect site activation and enrollment goals.
- Preliminary, interim, or topline data may change as more data become available and are subject to audit and verification.
Management Commentary and Tone:
- Rick Pauls, President and CEO, stated the company continued to advance DM199 across all clinical programs, noting these programs address serious diseases where impaired blood flow and vascular dysfunction play a meaningful role.
- Julie Krop, Chief Medical Officer, highlighted that clinical programs provide opportunities to evaluate DM199's pharmacologic effects across pregnancy-related vascular disorders and AIS.
- Management expressed confidence in presenting preliminary results from the first two FGR cohorts at a Key Opinion Leader (KOL) event on November 24, 2026.
Other Key Points:
- A virtual KOL event featuring preliminary interim topline results from the first two FGR cohorts is scheduled for November 24, 2026, with experts including Professor Catherine Cluver, Professor Stephen Tong, Professor Susan Walker, and Professor Andrew Shennan.
- The ReMEDy2 trial's independent Data Safety Monitoring Board (DSMB) will conduct the interim analysis after the 200th participant completes their 90-day follow-up to assess the need for sample-size re-estimation or stopping for futility.
- If the ReMEDy2 trial continues, the final sample size will range between 300 and 728 participants according to a predetermined statistical plan.
- The Company will host a conference call and webcast on November 13, 2026, at 8:00 AM Eastern Time to discuss business updates and financial results.
- Share-based compensation was a contributing factor to increased R&D expenses and partially offset decreases in professional fees for G&A expenses.
- Company
- DIAMEDICA THERAPEUTICS INC
- Sector
- Healthcare
- Industry
- Biotechnology