DiaMedica Therapeutics Reports Full-Year 2025 Financial Results and Highlights Clinical Progress
DiaMedica Therapeutics a clinical-stage biopharmaceutical company focused on developing innovative treatments for serious conditions such as preeclampsia (PE), fetal growth restriction (FGR), and acute ischemic stroke (AIS), has announced its financial results for the year ended December 31, 2025, along with a comprehensive update on its clinical and corporate progress. The company also confirmed that it will host a conference call and webcast on March 31, 2026, to discuss these developments in detail.
Strong Clinical Momentum Across Key Programs
DiaMedica continues to advance its lead investigational therapy, DM199, across multiple clinical programs. The company’s progress in preeclampsia and stroke research remains a central focus, with several important milestones achieved and upcoming.
In the preeclampsia program, DiaMedica is actively conducting a Phase 2 investigator-sponsored trial (IST). Enrollment is ongoing in the expansion cohort for Part 1a, which involves patients with preeclampsia scheduled for delivery within 72 hours. The company expects to complete this portion of the study in the first half of 2026, with updated data anticipated later in the year.
Building on insights from Part 1a, DiaMedica is finalizing protocol amendments for subsequent study phases, including Part 1b and Part 2. These phases aim to refine the treatment regimen and expand evaluation to patients with early-onset preeclampsia managed expectantly. Initiation of these phases is planned following completion of the current cohort.
Additionally, Part 3 of the IST will focus on fetal growth restriction. The company expects to dose the first patient in this cohort during the second quarter of 2026. This marks an important step in exploring DM199’s potential benefits beyond preeclampsia.
Advancing a Company-Sponsored Phase 2 Trial
In parallel with the IST, DiaMedica is preparing to launch its own Phase 2 clinical trial targeting early-onset preeclampsia. This open-label, dose-ranging study will be conducted across multiple regions, including North America and the United Kingdom. The trial is designed to evaluate safety, identify early signs of efficacy, and determine the optimal dosing regimen for DM199.
A key regulatory milestone has already been achieved, with Health Canada issuing a “No Objection Letter,” allowing the company to initiate the trial in Canada. DiaMedica also plans to expand the study into the United Kingdom, with a clinical trial application expected to be filed in the second quarter of 2026.
Furthermore, the company is in discussions with the U.S. Food and Drug Administration (FDA) regarding the use of an alternate species in its development program. DiaMedica anticipates providing an update on these discussions in the coming quarter while proceeding with the Phase 2 study.
Progress in Acute Ischemic Stroke Trial
DiaMedica is also making steady progress in its ReMEDy2 Phase 2/3 clinical trial, which evaluates DM199 for the treatment of acute ischemic stroke. Enrollment in the study is approaching 70% of the target required for the planned interim analysis.
The company remains on track to complete this interim analysis in the second half of 2026. This milestone is expected to provide critical insights into the therapy’s potential efficacy and safety in stroke patients and could play a significant role in guiding дальнейшие development decisions.
Financial Performance and Position
For the year ended December 31, 2025, DiaMedica reported a solid financial position, supported by increased cash reserves and continued investment in research and development.
Cash, cash equivalents, and short-term investments totaled approximately $59.9 million at year-end 2025, compared to $44.1 million at the end of 2024. This increase was primarily driven by proceeds from a private placement completed in July 2025, as well as funds raised through the company’s at-the-market (ATM) offering program.
Based on its current operating plans, DiaMedica expects its available cash to fund clinical studies and corporate operations through the second half of 2027. This extended runway provides the company with the financial stability needed to advance its key programs through important clinical and regulatory milestones.
Operating Cash Flow and Expenses
Net cash used in operating activities for 2025 was $29.1 million, compared to $22.1 million in the prior year. The increase reflects higher net losses, partially offset by favorable changes in working capital.
Research and development (R&D) expenses rose to $24.6 million in 2025, up from $19.1 million in 2024. This increase was largely driven by continued investment in the ReMEDy2 trial, including its global expansion, as well as the growth of the clinical team and higher non-cash share-based compensation costs. Some of these increases were offset by reduced spending on manufacturing process development, which had been completed in the previous year.
Looking ahead, DiaMedica expects R&D expenses to increase moderately as it continues to advance its clinical programs, particularly in preeclampsia and stroke.
General and administrative (G&A) expenses also increased, reaching $9.8 million in 2025 compared to $7.6 million in 2024. The rise was attributed to higher personnel costs, increased investor relations activities, patent-related expenses, and additional share-based compensation. The company anticipates that G&A expenses will remain stable or rise slightly in future periods.
Leadership Perspective
DiaMedica’s leadership highlighted the company’s continued progress and optimism regarding its clinical pipeline. The advancement of the DM199 program, particularly in preeclampsia, reflects the company’s commitment to addressing significant unmet medical needs.
There remains a critical demand for safe and effective therapies that can improve outcomes for both mothers and babies affected by preeclampsia. DiaMedica aims to develop treatments that not only manage symptoms but also prolong pregnancy and enhance overall health outcomes.
The company also emphasized the importance of its stroke program, noting that the ReMEDy2 trial represents a major opportunity to deliver meaningful benefits to patients suffering from acute ischemic stroke.
Upcoming Conference Call Details
DiaMedica will host a conference call and webcast on Tuesday, March 31, 2026, at 8:00 AM Eastern Time (7:00 AM Central Time). During the call, management will provide further insights into the company’s financial performance, clinical progress, and future plans.
Interested participants are encouraged to join the webcast or dial in approximately 15 minutes before the scheduled start time. A replay of the webcast will be available on the company’s website for up to 12 months, while a telephonic replay will be accessible through April 7, 2026.
Outlook
With a strong financial foundation and multiple clinical programs advancing steadily, DiaMedica is well-positioned for continued growth in 2026 and beyond. The company’s focus on innovative therapies for serious and underserved conditions underscores its long-term vision.
Key upcoming milestones—including data updates from the preeclampsia program, initiation of new clinical trials, and interim analysis from the stroke study—are expected to drive momentum and potentially unlock significant value.
Overall, DiaMedica’s progress in 2025 reflects a year of meaningful advancement, setting the stage for further achievements in the years ahead.
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
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” or “will,” the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. Forward-looking statements and information in this press release include statements regarding the Company’s expectations regarding the timing, nature and requirements for regulatory applications and approvals, including its application for an IND for the study of DM199 as a treatment for preeclampsia and fetal growth restriction and its conducting a Phase 2 trial in these indications; ReMEDy2 trial enrollment and timing of interim analysis; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke; future R&D and G&A expenses and the Company’s projected cash runway. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing and outcomes of non-clinical studies; risks and uncertainties relating to the timing of studies and trials; risks and uncertainties relating to the clinical expansion into preeclampsia and associated trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction, and acute ischemic stroke and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia, fetal growth restriction, and acute ischemic stroke; and the risks identified under the heading “Risk Factors” in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.
