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- Enrollment Complete in First Cohort of Phase 2 Early-Onset Fetal Growth Restriction Trial; Key Opinion Leader Call and Topline Results to Be Held in September<\/i><\/b><\/li>\n
- Positive Topline Results from Phase 2 Late-Onset Preeclampsia Part 1a Dose-Extension Cohort, Demonstrating Rapid, Clinically Meaningful, and Statistically Significant Reductions in Maternal Blood Pressure<\/i><\/b><\/li>\n
- Enrollment for Acute Ischemic Stroke Phase 2\/3 Trial Progressing with Interim Analysis Anticipated Q1 2027<\/i><\/b><\/li>\n
- $43.5 million in Cash, Cash Equivalents and Investments, Anticipated Runway through 2027<\/i><\/b><\/li>\n
- Conference Call and Webcast August 11 at 8:00 AM Eastern Time \/ 7:00 AM Central Time<\/i><\/b><\/li>\n<\/ul>\n
MINNEAPOLIS–(BUSINESS WIRE<\/a>)–
\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today provided a business update and reported financial results for the second quarter ended<\/strong> June 30, 2026. Management will host a conference call Tuesday, August 11, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time to discuss its business update and second quarter 2026 financial results.<\/p>\n\n\u201cWith the recent positive interim results from Part 1a of our Phase 2 study evaluating DM199 in preeclampsia, we\u2019re eager to continue advancement of this promising candidate to address ischemic diseases in the second half of this year,\u201d said Rick Pauls, President and CEO of DiaMedica. \u201cPreeclampsia, fetal growth restriction and stroke are areas with high unmet medical need due to the lack of approved treatment options, and we believe DM199 has the potential to provide a disease-modifying solution for patients suffering from these ischemic conditions. We look forward to sharing results of the recently completed first cohort of fetal growth restriction and initiating subsequent studies in the ongoing investigator-sponsored Phase 2, open label trial in these indications.\u201d<\/p>\n
\n\u201cIn Part 1a of the Phase 2 study evaluating DM199 in women with preeclampsia with expected delivery within 72 hours, the most clinically meaningful pharmacodynamic effects were observed in the mid-dose range, Cohorts 4 through 8, where patients showed reductions in both maternal blood pressure and uterine artery pulsatility index (PI). Reductions in PI are consistent with reduced uteroplacental vascular resistance, improved blood flow and the potential to modify the underlying disease process in these patient populations,\u201d said Julie Krop, MD, Chief Medical Officer of DiaMedica. \u201cThese findings represent significant progress for our preeclampsia program as they support selection of the mid-dose range for further clinical evaluation in our early-onset preeclampsia and fetal growth restriction studies.\u201d<\/p>\n
Recent Corporate Highlights<\/b><\/p>\n
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- Fetal Growth Restriction (FGR) Phase 2 Update: <\/b>Enrollment of the first of three planned cohorts has been completed, consisting of 6 participants at the 5 \u00b5g\/kg dose level. This is the first time DM199 has been used to treat early-onset fetal growth restriction patients. A key opinion leader (KOL) call is being scheduled in September, with leading preeclampsia OBGYN and study Principal Investigator Dr. Cathy Cluver, to discuss the clinical case for DM199\u2019s therapeutic potential in FGR and top line results from the first cohort.\n<\/li>\n
- Preeclampsia (PE) Phase 2 Part 1a Topline Results: <\/b>DM199 produced clinically meaningful and statistically significant, sustained reductions in maternal blood pressure in late-onset PE. In the combined final, highest-dose cohorts (n=15; cohort 10 and extension cohort), DM199 produced a mean 29.1 mmHg reduction in systolic blood pressure (SBP) from a baseline mean of 169.3 mmHg (p<0.001) and a 17.0 mmHg reduction in diastolic blood pressure (DBP) from a baseline mean of 103.7 mmHg (p<0.001) at the pre-specified time point of five minutes after completion of the IV infusion. SBP was maintained below 160 mmHg at all measured time points over 24 hours (p<0.01). The combined cohort consisted of 15 PE subjects, three from the initial dose escalation phase and 12 additional subjects enrolled in the extension cohort.\n
Detailed Part 1a results, including pharmacokinetic and pharmacodynamic analyses, are expected to be presented at an upcoming medical conference and submitted for publication.<\/p>\n
DiaMedica is also preparing to initiate a concurrent open-label three dose Phase 2 study in early-onset preeclampsia in North America and the United Kingdom to further support Phase 3 dose selection.<\/p>\n<\/li>\n<\/ul>\n
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- Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2\/3 Clinical Developments: <\/b>Enrollment in the Company\u2019s Phase 2\/3 ReMEDy2 (the ReMEDy2 trial \u2013 NCT05065216) trial has surpassed 85% of the 200 participants required to trigger the prespecified interim analysis. The Company now has approximately 70 activated sites across the United States, Canada, the United Kingdom, and six European countries added earlier this year, and expects the interim analysis to read out in early 2027.\n<\/li>\n
- Health Canada Authorizes Global Phase 2 Early-Onset Preeclampsia Study: <\/b>Health Canada authorized initiation of the Company\u2019s open-label, sequential-cohort Phase 2 dose-finding study in early-onset preeclampsia, designed to enroll approximately 30 PE patients across three dose levels informed by the Part 1a results. DiaMedica is working with sites in Canada and expects to dose its first patient in the fourth quarter of 2026, and is also preparing to expand the study to the United Kingdom later this year, subject to regulatory authorization and site readiness.\n<\/li>\n
- U.S. Regulatory Update on IND Pathway:<\/b> In June 2026, DiaMedica received written feedback from the FDA regarding the nonclinical reproductive toxicity information needed to support a U.S. IND application for DM199 in preeclampsia. 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. DiaMedica has initiated a rat pharmacokinetic and pharmacologic activity study and, once complete, plans to submit the data package to FDA for review.\n<\/li>\n<\/ul>\n
Financial Results Highlights for the Quarter Ended June 30, 2026<\/b><\/p>\n
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- Cash Position and Runway <\/b>\u2013<\/b> Cash, cash equivalents and short-term investments were $43.5 million as of June 30, 2026, compared to $59.9 million as of December 31, 2025. Current liabilities were $6.6 million as of June 30, 2026, resulting in working capital of $37.7 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 through 2027.\n<\/li>\n
- Cash Flows<\/b>\u2013<\/b> Net cash used in operating activities for the six months ended June 30, 2026 was $17.2 million compared to $14.7 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 $8.2 million and $16.1 million for the three and six months ended June 30, 2026, respectively, up from $5.8 million and $11.5 million for the three and six months ended June 30, 2025, respectively. The increases were due primarily to the expansion of the Company\u2019s clinical team, its ongoing ReMEDy2 clinical trial, including its global expansion, costs related to additional reproductive toxicity testing performed in support of the Company\u2019s preeclampsia program in the United States, increased manufacturing development activity, and increased non-cash share-based compensation. The Company expects R&D expenses to increase moderately in future periods relative to recent prior periods as it continues the ReMEDy2 trial, including its global expansion, and continues to expand its DM199 clinical development program into preeclampsia.\n<\/li>\n
- General and Administrative (G&A) \u2013 <\/b>G&A expenses were $2.3 million and $4.8 million for the three and six months ended June 30, 2026, respectively, up slightly from $2.2 million and $4.7 million for the three and six months ended June 30, 2025, respectively. The increase for the three-month period was driven primarily by increased non-cash share-based compensation and professional fees, while the increase for the six-month period resulted primarily from increased personnel costs incurred in conjunction with expanding our team, partially offset by a reduction in current-year legal and other professional fees. The Company expects G&A expenses to remain relatively steady in future periods compared to recent prior periods.\n<\/li>\n
- Net Loss \u2013 <\/b>Net losses were $10.1 million and $20.2 million for the three and six months ended June 30, 2026, respectively, up from $7.7 million and $15.4 million for the three and six months ended June 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 second quarter 2026 financial results on Tuesday, August 11, 2026, at 8:00 AM Eastern Time \/ 7:00 AM Central Time:<\/p>\n
- Cash Flows<\/b>\u2013<\/b> Net cash used in operating activities for the six months ended June 30, 2026 was $17.2 million compared to $14.7 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>Health Canada authorized initiation of the Company\u2019s open-label, sequential-cohort Phase 2 dose-finding study in early-onset preeclampsia, designed to enroll approximately 30 PE patients across three dose levels informed by the Part 1a results. DiaMedica is working with sites in Canada and expects to dose its first patient in the fourth quarter of 2026, and is also preparing to expand the study to the United Kingdom later this year, subject to regulatory authorization and site readiness.\n<\/li>\n
- Preeclampsia (PE) Phase 2 Part 1a Topline Results: <\/b>DM199 produced clinically meaningful and statistically significant, sustained reductions in maternal blood pressure in late-onset PE. In the combined final, highest-dose cohorts (n=15; cohort 10 and extension cohort), DM199 produced a mean 29.1 mmHg reduction in systolic blood pressure (SBP) from a baseline mean of 169.3 mmHg (p<0.001) and a 17.0 mmHg reduction in diastolic blood pressure (DBP) from a baseline mean of 103.7 mmHg (p<0.001) at the pre-specified time point of five minutes after completion of the IV infusion. SBP was maintained below 160 mmHg at all measured time points over 24 hours (p<0.01). The combined cohort consisted of 15 PE subjects, three from the initial dose escalation phase and 12 additional subjects enrolled in the extension cohort.\n
- Positive Topline Results from Phase 2 Late-Onset Preeclampsia Part 1a Dose-Extension Cohort, Demonstrating Rapid, Clinically Meaningful, and Statistically Significant Reductions in Maternal Blood Pressure<\/i><\/b><\/li>\n
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