DiaMedica Therapeutics Inc. reported a net loss of $32.8 million for the fiscal year ending December 31, 2025, compared to a net loss of $24.4 million in 2024. The company's total operating expenses increased to $34.4 million from $26.7 million, primarily driven by higher research and development (R&D) costs, which rose to $24.6 million from $19.1 million. This increase reflects ongoing clinical trials for its lead product candidate, DM199, which is being developed for the treatment of preeclampsia (PE), fetal growth restriction (FGR), and acute ischemic stroke (AIS). The company’s general and administrative expenses also rose to $9.8 million from $7.6 million, attributed to increased personnel costs and share-based compensation.

In terms of financial position, DiaMedica reported cash, cash equivalents, and marketable securities totaling $59.9 million as of December 31, 2025, up from $44.1 million in the previous year. The increase was largely due to net proceeds from a private placement and an at-the-market offering, which collectively raised approximately $43.9 million. The company’s working capital improved to $55.5 million from $39.2 million, indicating a stronger liquidity position to support ongoing clinical development activities.

DiaMedica is currently advancing DM199 through a Phase 2/3 clinical trial, known as the ReMEDy2 trial, aimed at treating AIS. This trial is designed to enroll approximately 300 participants across 100 sites globally, with the potential to expand to 728 patients based on interim analysis results. However, the company has faced challenges with slower-than-expected site activations and patient enrollment, attributed to staffing shortages in medical facilities and competition for research staff. To address these issues, DiaMedica has expanded its internal clinical team and is actively working to enhance site activations.

The company has also initiated a Phase 2 investigator-sponsored trial for DM199 in PE patients at Tygerberg Hospital in South Africa, with interim results indicating that DM199 is safe and well-tolerated, showing significant reductions in blood pressure. Preparations are underway for a Phase 2 study in early-onset preeclampsia in North America and the UK, with Health Canada granting approval to commence this study. The company anticipates filing a clinical trial application to expand this study to the UK in the second quarter of 2026.

Looking ahead, DiaMedica expects to continue incurring significant operating losses as it advances its clinical programs. The company has indicated that its current cash resources are sufficient to fund operations for at least the next 12 months, but it may require additional funding to support ongoing and future clinical trials. The success of DM199 in clinical trials and subsequent regulatory approvals will be critical for the company’s future financial performance and market position.

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics is a clinical-stage biopharmaceutical company developing DM199, a recombinant form of human tissue kallikrein-1, to treat severe ischemic diseases like acute ischemic stroke and preeclampsia. Its therapies aim to improve blood flow, reduce inflammation, and promote vascular health. The company focuses on clinical trials, regulatory approval, and strategic partnerships to address unmet medical needs in neurology and obstetrics markets worldwide.

This description was generated via AI from an annual report. Updated 9 months ago.

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