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- Enrollment Complete in First Two Cohorts of Phase 2 Early-Onset Fetal Growth Restriction Trial; KOL Event Featuring Preliminary Results Scheduled for November 24<\/i><\/b><\/li>\n
- ReMEDy2 Phase 2\/3 Acute Ischemic Stroke Trial Surpasses 200-Participant Enrollment Threshold; Interim Analysis Expected Q1 2027<\/i><\/b><\/li>\n
- Conference Call and Webcast November 13 at 8:00 AM Eastern Time \/ 7:00 AM Central Time<\/i><\/b><\/li>\n<\/ul>\n
MINNEAPOLIS–(BUSINESS WIRE<\/a>)–
\nDiaMedica Therapeutics Inc. (\u201cDiaMedica\u201d or the \u201cCompany\u201d) (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today provided a business update and reported financial results for the third quarter ended September 30, 2026. Management will host a conference call Friday, November 13, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time to discuss its business update and third quarter 2026 financial results.<\/p>\n\n“During the third quarter and recent weeks, we continued to advance DM199 across each of our clinical programs, including completing enrollment in the first two cohorts of our Phase 2 early-onset fetal growth restriction study and reaching the 200-participant enrollment threshold for the planned interim analysis of ReMEDy2,” said Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. “We believe these programs address serious diseases in which impaired blood flow and vascular dysfunction play a meaningful role and where new treatment options are needed. We look forward to presenting preliminary results from the first two FGR cohorts at our November 24 key opinion leader (KOL) event and to the ReMEDy2 interim analysis expected in the first quarter of 2027.”<\/p>\n
\n“Our clinical programs are providing important opportunities to evaluate the pharmacologic effects of DM199 across pregnancy-related vascular disorders and acute ischemic stroke,” said Julie Krop, MD, Chief Medical Officer of DiaMedica Therapeutics. “In preeclampsia, the Part 1a results demonstrated rapid and sustained reductions in maternal blood pressure and supported advancement into studies of early-onset disease. In FGR, enrollment of the first two dose cohorts has now been completed, and we look forward to reviewing the preliminary safety and clinical findings with leading maternal-fetal medicine experts later this month. In ReMEDy2, reaching the 200-participant threshold enables the prespecified interim analysis in AIS once the 200th participant completes their 90-day follow-up.”<\/p>\n
Recent Corporate Highlights<\/b><\/p>\n
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- Fetal Growth Restriction Phase 2 Update: <\/b>Enrollment has been completed in the first two of three planned cohorts of the investigator-sponsored Phase 2 early-onset FGR trial, consisting of 12 participants treated at the 5 \u00b5g\/kg and 10 \u00b5g\/kg dose levels. This is the first clinical study of DM199 in patients with early-onset FGR. DiaMedica will host a virtual KOL event on November 24, 2026, featuring leading maternal-fetal medicine experts Professor Catherine Cluver, MD, PhD; Professor Stephen Tong, MBBS, PhD; Professor Susan Walker, AO, MBBS, MD; and Professor Andrew Shennan, OBE, MBBS, MD. The event will include preliminary, interim topline results from the first two FGR cohorts and a discussion of FGR, the current treatment landscape and the clinical rationale for evaluating DM199 as a potential treatment in the management of FGR.\n<\/li>\n
- Health Canada Authorizes Global Phase 2 Early-Onset Preeclampsia Study: <\/b>Following the September 2026 authorization from Health Canada, DiaMedica is preparing to initiate its open-label, Phase 2 dose-finding study in early-onset preeclampsia. The study is designed to enroll approximately 30 participants across three dose levels informed by results from both the initial dose-escalation cohort (Part 1a) and preliminary FGR results from the investigator sponsored trial. DiaMedica is working with clinical sites in Canada and is also preparing to expand this PE study to the United Kingdom, subject to regulatory authorization.\n<\/li>\n
- European Authorization for Early-Onset Preeclampsia Phase 2 Trial:<\/b> In October 2026, DiaMedica received conditional authorization from the European Medicines Agency (EMA) for its open-label, Phase 2 dose-finding study in early-onset preeclampsia with consideration for full approval after submission of country-specific ethical and site requirements. This creates the opportunity for future global expansion.\n<\/li>\n
- U.S. Regulatory Update for Preeclampsia:<\/b> DiaMedica continues its work to address U.S. Food and Drug Administration (FDA) feedback regarding the nonclinical reproductive toxicity information needed to support a U.S. Investigational New Drug (IND) application for DM199 in preeclampsia. In June 2026, DiaMedica received written feedback from FDA on this topic. Based on this feedback, the Company believes that the previously completed rat reproductive toxicity study may be adequate to support IND clearance, provided DiaMedica can demonstrate adequate DM199 exposure, enzymatic activity, and pharmacologic effect in rats. The in-life portion of this study has been completed and pharmacokinetic and pharmacologic results are due in the coming weeks. Once these results are completed, DiaMedica plans to submit the data package to FDA for review.\n<\/li>\n
- Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2\/3 Clinical Developments:<\/b> Enrollment in the pivotal Phase 2\/3 ReMEDy2 trial (NCT05065216) has reached the prespecified threshold of 200 participants for the trial’s planned interim analysis. The independent Data Safety Monitoring Board (DSMB) will conduct the interim analysis after the 200th participant completes their 90-day follow-up. The DSMB will assess the need for a sample-size re-estimation or stopping for futility based upon a primary efficacy endpoint analysis of the proportion of participants with a modified Rankin Scale (mRS) score of 0 or 1, indicating an excellent outcome. If the trial continues, the final sample size will range between 300 and 728 participants according to a predetermined statistical plan. DiaMedica will remain blinded to the data at the interim analysis. Patient recruitment will continue at clinical sites while the 200th participant completes 90-day follow-up and the interim analysis is conducted. The Company expects the interim analysis to be completed in the first quarter of 2027.\n<\/li>\n<\/ul>\n
Financial Results Highlights for the Quarter Ended September 30, 2026<\/b><\/p>\n
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- Cash Position and Runway <\/b>\u2013 Cash, cash equivalents and short-term investments were $34.9 million as of September 30, 2026, compared to $59.9 million as of December 31, 2025. Current liabilities were $7.5 million as of September 30, 2026, resulting in working capital of $28.0 million, compared to current liabilities of $5.1 million and working capital of $55.5 million as of December 31, 2025. Based on its current plans, the Company anticipates its current cash, cash equivalents and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into Q4, 2027.\n<\/li>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities for the nine months ended September 30, 2026 was $26.0 million compared to $21.3 million for the same period in 2025. The increase resulted primarily from the increased net loss, partially offset by changes in operating assets and liabilities during the current year period.\n<\/li>\n
- Research and Development (R&D) \u2013 <\/b>R&D expenses were $9.2 million and $25.4 million for the three and nine months ended September 30, 2026, respectively, up from $6.4 million and $17.9 million for the three and nine months ended September 30, 2025, respectively. The increases are primarily due to cost increases driven by the expansion of the Company\u2019s clinical team; the ongoing ReMEDy2 clinical trial, including its global expansion; the start-up of the Phase 2 PE trial in Canada and the UK; additional reproductive toxicity testing being performed in support of the PE program in the United States; increased manufacturing development activity and increased non-cash share-based compensation. The Company expects that R&D expenses will moderately increase in future periods relative to recent prior periods as enrollment continues in the ReMEDy2 trial and start-up progresses in the Phase 2 PE trial.\n<\/li>\n
- General and Administrative (G&A) \u2013 <\/b>G&A expenses were $2.4 million and $7.2 million for the three and nine months ended September 30, 2026, respectively, down slightly from $2.6 million and $7.3 million for the three and nine months ended September 30, 2025, respectively. The decrease for the three-month period was driven primarily by decreased professional fees, partially offset by increased non-cash share-based compensation expense. The decrease for the nine-month period resulted primarily from a reduction in current-year legal and other professional fees, partially offset by increased personnel costs incurred in conjunction with staff expansion. The Company expects G&A expenses to remain steady in future periods as compared to recent prior periods.\n<\/li>\n
- Net Loss \u2013 <\/b>Net losses were $11.3 million and $31.5 million for the three and nine months ended September 30, 2026, respectively, up from $8.6 million and $24.0 million for the three and nine months ended September 30, 2025, respectively.\n<\/li>\n<\/ul>\n
Conference Call and Webcast Information<\/b><\/p>\n
\nDiaMedica management will host a conference call and webcast to discuss its business update and third quarter 2026 financial results on Friday, November 13, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time:<\/p>\n
- Cash Flows<\/b> \u2013 Net cash used in operating activities for the nine months ended September 30, 2026 was $26.0 million compared to $21.3 million for the same period in 2025. The increase resulted primarily from the increased net loss, partially offset by changes in operating assets and liabilities during the current year period.\n<\/li>\n
- Health Canada Authorizes Global Phase 2 Early-Onset Preeclampsia Study: <\/b>Following the September 2026 authorization from Health Canada, DiaMedica is preparing to initiate its open-label, Phase 2 dose-finding study in early-onset preeclampsia. The study is designed to enroll approximately 30 participants across three dose levels informed by results from both the initial dose-escalation cohort (Part 1a) and preliminary FGR results from the investigator sponsored trial. DiaMedica is working with clinical sites in Canada and is also preparing to expand this PE study to the United Kingdom, subject to regulatory authorization.\n<\/li>\n
- ReMEDy2 Phase 2\/3 Acute Ischemic Stroke Trial Surpasses 200-Participant Enrollment Threshold; Interim Analysis Expected Q1 2027<\/i><\/b><\/li>\n
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