DiaMedica Therapeutics Reports 2025 Financial Results and Advances Clinical Pipeline in Preeclampsia and Acute Ischemic Stroke
DiaMedica Therapeutics Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for serious and life-threatening conditions, has reported its financial results for the full year ended December 31, 2025, alongside a comprehensive business update highlighting progress across its key clinical programs. The company continues to focus on advancing its lead candidate, DM199, which is being evaluated in multiple indications including preeclampsia (PE), fetal growth restriction (FGR), and acute ischemic stroke (AIS).
The update reflects a year of steady clinical execution, expanding trial activity, and strengthened financial positioning, enabling the company to pursue critical development milestones through 2026 and beyond. With ongoing trials progressing and additional studies planned, DiaMedica is positioning itself to address significant unmet medical needs in maternal-fetal health and stroke care.
Continued Progress in Preeclampsia Clinical Development
One of the central pillars of DiaMedica’s pipeline is the development of DM199 for the treatment of preeclampsia, a serious pregnancy-related condition characterized by high blood pressure and potential organ damage that can threaten both maternal and fetal health. Despite advances in obstetric care, treatment options for preeclampsia remain limited, particularly for early-onset disease, where premature delivery is often the only intervention.
During 2025, DiaMedica made meaningful progress in its ongoing Phase 2 Investigational Study Trial (IST) evaluating DM199 in preeclampsia. Enrollment is actively continuing in Part 1a of the study, which focuses on patients with preeclampsia who are scheduled for delivery within 72 hours. The company expects to complete enrollment for this portion in the first half of 2026, with updated data anticipated later in the year.
Insights gained from Part 1a are helping to inform the design of subsequent study segments. Protocol amendments for Part 1b and Part 2 are currently being finalized, incorporating clinical learnings to refine dosing strategies and optimize treatment regimens. These next phases will expand the scope of investigation to include patients with early-onset preeclampsia who are managed expectantly, representing a population with particularly high unmet need.
In addition, DiaMedica is preparing to initiate Part 3 of the IST, which will evaluate DM199 in patients with fetal growth restriction who do not have a diagnosis of preeclampsia. The first patient in this cohort is expected to be dosed in the second quarter of 2026, marking an important step in exploring the broader therapeutic potential of DM199 in pregnancy-related complications.
Planned Phase 2 Study in Early-Onset Preeclampsia
Complementing its IST program, DiaMedica is also advancing plans for a company-sponsored Phase 2 clinical trial focused specifically on early-onset preeclampsia. This open-label, dose-ranging study is designed to evaluate the safety profile of DM199, identify early signals of efficacy, and determine the optimal dosing regimen for future development.
The trial is expected to be conducted across multiple regions, including North America and the United Kingdom, reflecting the company’s commitment to generating robust, globally relevant clinical data. Regulatory progress has already been made, with DiaMedica receiving a “No Objection Letter” from Health Canada, clearing the way for trial initiation in Canada.
The company is also actively engaging with the U.S. Food and Drug Administration (FDA) regarding preclinical requirements, including discussions on alternative species for certain studies. DiaMedica expects to provide an update on these regulatory interactions in the coming quarter, while continuing preparations to initiate the Phase 2 trial later in 2026.
A clinical trial application to expand the study into the United Kingdom is planned for submission in the second quarter of 2026, further supporting the company’s strategy to broaden its clinical footprint and accelerate development timelines.
Momentum in Acute Ischemic Stroke Program
In addition to its maternal health programs, DiaMedica is advancing DM199 in acute ischemic stroke, a leading cause of death and long-term disability worldwide. The company’s ReMEDy2 trial, a Phase 2/3 study, is evaluating the safety and efficacy of DM199 in patients experiencing acute ischemic stroke.
As of the latest update, enrollment in the ReMEDy2 trial is approaching 70% of the target required for a planned interim analysis. This milestone underscores the steady progress of the study, which has expanded globally to include a diverse patient population.
DiaMedica remains on track to complete the interim analysis in the second half of 2026. The results of this analysis will be a critical inflection point for the program, potentially informing subsequent development decisions and regulatory strategy.
The continued advancement of the ReMEDy2 trial reflects the company’s broader commitment to addressing unmet needs in stroke treatment, where therapeutic options remain limited and time-sensitive intervention is critical to improving patient outcomes.
Strengthened Financial Position Supports Clinical Execution
DiaMedica reported a strong financial position at the end of 2025, providing the resources necessary to support its expanding clinical programs. As of December 31, 2025, the company held cash and short-term investments totaling $59.9 million, a significant increase from $44.1 million at the end of 2024.
This improvement was primarily driven by net proceeds from a private placement of common shares completed in July 2025, as well as capital raised through the company’s at-the-market offering program. These financing activities have bolstered DiaMedica’s balance sheet and enhanced its ability to execute on its strategic priorities.
Based on its current operating plan, the company expects its available cash resources to be sufficient to fund clinical development activities and corporate operations through the second half of 2027. This extended cash runway provides a solid foundation for advancing DM199 through key milestones, including interim data readouts and potential regulatory interactions.
Increased Investment in Research and Development
Reflecting its commitment to advancing its pipeline, DiaMedica reported research and development (R&D) expenses of $24.6 million for 2025, compared to $19.1 million in the previous year. The increase in R&D spending was primarily driven by ongoing activities related to the ReMEDy2 trial, including its global expansion.
Additional factors contributing to higher R&D costs included the expansion of the company’s clinical team and increased share-based compensation expenses. These investments are aligned with the company’s strategy to accelerate clinical development and build the infrastructure necessary to support its growing pipeline.
Partially offsetting these increases were lower costs associated with manufacturing process development, as certain activities in this area were completed during 2024.
Looking ahead, DiaMedica anticipates that R&D expenses will continue to rise moderately as it advances its preeclampsia programs and continues enrollment in the ReMEDy2 trial. This trend is consistent with the progression of clinical-stage companies, where costs typically increase as programs move into later-stage development and expand geographically.
Growth in General and Administrative Expenses
General and administrative (G&A) expenses also increased in 2025, totaling $9.8 million compared to $7.6 million in 2024. The rise in G&A costs was attributed to several factors, including higher personnel expenses, increased share-based compensation, and greater investment in investor relations activities.
Additionally, the company incurred higher patent prosecution costs as it continued to strengthen its intellectual property portfolio. Protecting proprietary technologies and securing global patent coverage is a critical component of long-term value creation in the biopharmaceutical industry.
DiaMedica expects G&A expenses to remain relatively stable or increase slightly in future periods, reflecting ongoing investments in corporate infrastructure and public company operations.
Cash Flow Reflects Expanded Clinical Activity
Net cash used in operating activities for 2025 was $29.1 million, compared to $22.1 million in 2024. The increase in cash utilization was primarily driven by a higher net loss, consistent with increased spending on clinical development and operational expansion.
Changes in working capital partially offset the increase in cash burn, but overall, the higher level of investment reflects the company’s active clinical development agenda.
Looking Ahead: Key Milestones in 2026
As DiaMedica moves into 2026, several key milestones are expected to shape the company’s trajectory. These include the completion of enrollment and data readout from Part 1a of the preeclampsia IST, initiation of additional study cohorts, and the launch of the Phase 2 trial in early-onset preeclampsia.
Equally important will be the interim analysis of the ReMEDy2 trial in acute ischemic stroke, which could provide critical insights into the therapeutic potential of DM199 in this indication.
With a strong cash position, expanding clinical programs, and ongoing regulatory engagement, DiaMedica is well-positioned to advance its pipeline and address significant unmet medical needs across multiple therapeutic areas.
Conference Call and Investor Engagement
To provide further insights into its financial results and business update, DiaMedica’s management team will host a conference call and webcast on March 31, 2026. During the call, company leadership is expected to discuss clinical progress, financial performance, and strategic priorities in greater detail.
The webcast will also be available for replay on the company’s investor relations website for up to 12 months, offering stakeholders continued access to the discussion.
DiaMedica Therapeutics’ 2025 performance reflects a year of steady advancement and strategic investment. The company has made meaningful progress in its clinical programs, particularly in preeclampsia and acute ischemic stroke, while strengthening its financial position to support future growth.
As it enters 2026, DiaMedica remains focused on executing its clinical strategy, achieving key milestones, and ultimately delivering innovative therapies that have the potential to improve outcomes for patients facing serious and underserved medical conditions.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia, and other vascular diseases.
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