-- Received Regulatory Approval from Health Canada Supporting Initiation
of Phase 2 DM199 Study in Early-onset Preeclampsia.
-- DM199 Preeclampsia Phase 2 Investigator-Sponsored Trial (IST) Part 1a
Expansion Cohort Enrolling, Completion Expected in 1H 2026.
-- ReMEDy2 Phase 2/3 AIS Trial of DM199 Approaching 70% of Required
Interim Enrollment; Interim Analysis planned 2H 2026.
-- $60 million in Cash, Cash Equivalents and Investments, Anticipated
Runway through 2H 2027.
-- Conference Call and Webcast on March 31 at 8:00 AM ET / 7:00 AM CT.
MINNEAPOLIS--(BUSINESS WIRE)--March 30, 2026--
DiaMedica Therapeutics Inc. (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 year ended December 31, 2025. Management will host a conference call on Tuesday, March 31, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time to provide a business update and discuss full-year 2025 financial results.
"We continue to make meaningful progress across our clinical programs, highlighted by further advancement of the DM199 preeclampsia (PE) program. In the IST, enrollment continues in the expansion cohort for Part 1a, and we anticipate initiating Parts 2 and 3, which will evaluate participants with early-onset preeclampsia and fetal growth restriction. We are also preparing to initiate a DiaMedica-sponsored Phase 2 study in early-onset preeclampsia later this year. There remains a critical need for differentiated, well-tolerated therapies that can deliver clinically meaningful benefits, prolong pregnancy, and improve outcomes for both the mother and baby," said Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. "We are encouraged by the momentum in our ReMEDy2 acute ischemic stroke trial, which is approaching 70% of the required enrollment for the planned interim analysis, and we remain on track to complete the interim analysis in the second half of 2026. This, combined with a strong cash position expected to fund operations through the second half of 2027, supports our continued focus on advancing DM199 through key clinical and regulatory milestones in 2026."
Recent Corporate Highlights
Preeclampsia Phase 2 IST Clinical Development:
-- Part 1a (PE, planned delivery within 72 hours): Enrollment is ongoing,
with completion anticipated in the first half of 2026, with an updated
Part 1a dataset available later in 2026.
-- Part 1b (PE, planned delivery within 72 hours) and Part 2 (early onset
PE with expectant management): Based on clinical learnings from Part 1a,
protocol amendments for Parts 1b and 2 are being finalized to refine the
treatment regimen, with initiation expected following completion of the
ongoing Part 1a expansion cohort.
-- Part 3 (fetal growth restriction): The first patient with early-onset
fetal growth restriction, who is not diagnosed with preeclampsia, is
expected to be dosed in Q2 2026.
Early-Onset Preeclampsia Phase 2 DiaMedica Sponsored Trial:
-- Open-label, dose-range finding, Phase 2 study of DM199 in participants
with early onset preeclampsia to be conducted in North America (United
States & Canada) and the United Kingdom (UK) to evaluate safety, early
signals of efficacy and selection of an optimal dose regimen.
-- DiaMedica received a "No Objection Letter" (NOL) from Health Canada
enabling the initiation of this trial in Canada.
-- DiaMedica plans to discuss alternate species with the FDA and hopes to
have an update on an agreement with the FDA next quarter, and will
conduct this Phase 2 study while working on an alternate species with the
FDA.
-- Clinical trial application to expand this Phase 2 trial to include
sites in the United Kingdom (U.K.) filing planned for the second quarter
of 2026.
Acute Ischemic Stroke ReMEDy2 Phase 2/3 Clinical Developments:
-- Enrollment in DiaMedica's Phase 2/3 ReMEDy2 (NCT065216) trial is
approaching 70% of the required enrollment for the interim analysis.
-- DiaMedica reaffirms guidance for completion of the interim analysis in
the second half of 2026.
Financial Results Highlights for the Year Ended December 31, 2025
-- Cash Position and Runway -- Cash and short-term investments were $59.9
million as of December 31, 2025, compared to $44.1 million as of December
31, 2024. The increase in cash and short-term investments is due to net
proceeds received from the sale of common shares in the Company's July
2025 private placement and under its at-the-market offering program.
Based on its current plans, the Company anticipates its current cash and
short-term investments will be sufficient to fund its planned clinical
studies and support corporate operations through the second half of
2027.
-- Cash Flows -- Net cash used in operating activities for the year ended
December 31, 2025, was $29.1 million compared to $22.1 million for the
year ended December 31, 2024. The increase in cash used in operating
activities resulted primarily from increased net loss, partially offset
by changes in operating assets and liabilities during the current
period.
-- Research and Development (R&D) -- R&D expenses were $24.6 million for
the year ended December 31, 2025, compared to $19.1 million for the year
ended December 31, 2024. The increase is due primarily to cost increases
driven by the continuation of the Company's ReMEDy2 clinical trial,
including its global expansion, the expansion of the clinical team in the
prior and current year periods, including increased non-cash share-based
compensation costs. These increases were partially offset by cost
reductions related to manufacturing process development work performed
and completed in the prior year period. DiaMedica expects its R&D
expenses to increase moderately in future periods relative to recent
periods, as the Company continues its clinical development program in PE
and the ReMEDy2 trial continues to enroll, including its global
expansion.
-- General and Administrative (G&A) -- G&A expenses were $9.8 million for
the year ended December 31, 2025, up from $7.6 million for the year ended
December 31, 2024. The increase was due to a series of factors, including
increased non-cash share-based compensation expense, increased personnel
costs, increased investor relations expenses and increased patent
prosecution costs. DiaMedica expects G&A expenses to remain steady or
increase slightly in future periods relative to recent periods.
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to discuss its business update and full year 2025 financial results on Tuesday, March 31, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time:
Date: Tuesday, March 31, 2026 Time: 7:00 AM CDT / 8:00 AM EDT Web access: https://app.webinar.net/bxPLk6nkE0q Dial In: (646) 357-8766 Conference ID: 4545194
Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on the Company's website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until April 7, 2026, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4545194#.
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. For more information, visit the Company's website at www.diamedica.com.
Cautionary Note Regarding Forward-Looking Statements
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,
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