DiaMedica Therapeutics (NASDAQ:DMAC) said its second-quarter progress centered on advancing DM199 across early-onset fetal growth restriction (FGR), preeclampsia and acute ischemic stroke, while the company reported a cash runway it expects to extend through 2027.
President and Chief Executive Officer Rick Pauls said the company completed enrollment in the first cohort of an investigator-sponsored, open-label Phase II study of DM199 in early-onset FGR. The cohort included six participants treated at a dose of 5 micrograms per kilogram. DiaMedica plans to host a key opinion leader event in September to discuss the treatment rationale and provide top-line results from the first cohort.
FGR and Preeclampsia Development Plans
Pauls said the FGR study is enrolling patients with early-onset disease, with or without concurrent preeclampsia. There are no approved therapies for FGR, he said, and current management can require early delivery. The study’s first cohort used the 5 micrograms-per-kilogram dose, while a second cohort at 10 micrograms per kilogram is expected to begin shortly. The third dose level, ranging from 1 to 15 micrograms per kilogram, will be selected based on results from the first two cohorts.
Key study measures include safety, tolerability, prolongation of gestation and flow-mediated dilation, among other assessments. In response to analyst questions, Pauls said the study population includes severe FGR patients between 27 and 32 weeks of pregnancy whose babies are at or below the third percentile for body weight.
The company also completed an extension cohort in its Phase II Part 1a investigator-sponsored study in late-stage preeclampsia. Chief Medical Officer Dr. Julie Krop said the extension enrolled 12 additional patients at Stellenbosch University in South Africa, adding to three patients from the initial dose-escalation phase for a 15-patient highest-dose analysis.
According to Krop, patients in that analysis had severe hypertension and were expected to deliver within 72 hours under current treatment protocols. Five minutes after completion of IV infusion, mean systolic blood pressure declined by 29.1 millimeters of mercury from a baseline of 169.3 mmHg, while mean diastolic blood pressure fell by 17 mmHg from a baseline of 103.7 mmHg. Krop said both changes were statistically significant, and mean systolic blood pressure remained below 160 mmHg at all measured points during the 24-hour period.
Across the dose-ranging cohorts, Krop said the most clinically meaningful pharmacodynamic effects were observed in mid-dose cohorts, identified as cohorts 4 through 8. Those patients showed reductions in maternal blood pressure and uterine artery pulsatility index, which she said was consistent with reduced uteroplacental vascular resistance and potentially improved blood flow to the baby.
Pauls said the company believes DM199 has a “sweet spot” for dosing and that higher doses may lead to receptor desensitization, potentially resulting in less dilation. DiaMedica intends to use the mid-dose range in further early-onset preeclampsia and FGR studies.
Early-Onset Preeclampsia Expansion
Health Canada previously authorized DiaMedica’s open-label Phase II dose-ranging study in early-onset preeclampsia. The study is designed to enroll about 30 patients across three dose levels, and the company expects to dose its first patient in Canada during the fourth quarter. DiaMedica is also pursuing expansion into the United Kingdom, subject to regulatory authorization and site readiness.
Pauls said the company has identified three U.K. sites and two Canadian sites for the program. The company expects the U.K. study to begin around late 2026 or potentially early 2027.
Separately, DiaMedica filed a protocol amendment in July for investigator-sponsored early-onset preeclampsia and continuous IV infusion preeclampsia studies. The amendment is intended to provide greater flexibility for dosing in the mid- to lower-dose range. The company expects dosing to begin after the amendment is accepted in the coming weeks.
For the early-onset preeclampsia program, Pauls said DiaMedica is dropping IV infusion in favor of subcutaneous dosing every three days until delivery. A separate late-onset preeclampsia cohort will evaluate continuous IV infusion, with the company seeking to assess whether dosing can be adjusted to maintain blood pressure within a target range.
Regarding a potential U.S. investigational new drug application, Pauls said DiaMedica is conducting a rat pharmacokinetic and pharmacologic activity study requested following FDA feedback. The company expects to complete the study in September and receive reports in October, after which it plans to present results to the FDA and work toward initiating U.S. clinical development.
Stroke Trial Approaches Interim Analysis
DiaMedica said enrollment in its Phase II/III ReMEDy2 acute ischemic stroke trial has surpassed 85% of the 200 patients needed to trigger a prespecified interim efficacy analysis. While enrollment slowed in July, Pauls said the company expects the interim analysis readout during the first quarter of 2027.
The trial has about 70 active sites across the U.S., Canada, the U.K. and six European countries. Following enrollment of the 200th patient, the company expects a 90-day follow-up period and an additional four to six weeks for data analysis. An independent data safety monitoring board will conduct the analysis, while DiaMedica remains blinded to the data and treatment-effect estimates.
The interim review will assess whether a sample-size re-estimation is warranted. The final study size may range from 300 to 728 patients, according to Pauls.
Second-Quarter Financial Position
Chief Financial Officer Scott Kellen reported that cash equivalents and short-term investments totaled $43.5 million as of June 30, compared with $59.9 million at the end of 2025. Working capital was $37.7 million, compared with $55.5 million as of Dec. 31.
- Net cash used in operating activities was $17.2 million for the first six months of 2026, compared with $14.7 million in the prior-year period.
- Research and development expense was $8.2 million in the second quarter and $16.1 million for the first half, up from $5.8 million and $11.5 million, respectively, a year earlier.
- General and administrative expense was $2.3 million for the quarter and $4.8 million for the first half, compared with $2.2 million and $4.7 million in the respective 2025 periods.
Kellen attributed the higher R&D spending primarily to clinical team expansion, the ongoing ReMEDy2 trial and its global expansion, reproductive toxicity testing supporting the U.S. preeclampsia program, manufacturing and development work, and share-based compensation. He said DiaMedica expects R&D expenses to increase moderately as the company continues the stroke trial and expands DM199 development in preeclampsia.
The company said its current cash position is expected to fund planned clinical studies and corporate operations through 2027, including the ReMEDy2 interim analysis and anticipated readouts from its preeclampsia and FGR programs.
About DiaMedica Therapeutics (NASDAQ:DMAC)
DiaMedica Therapeutics, Inc (NASDAQ: DMAC) is a clinical‐stage biopharmaceutical company focused on developing novel therapies for acute and chronic central nervous system conditions. The company’s lead product candidate, DM199, is a recombinant form of human tissue kallikrein-1 designed to promote neuroprotection and tissue repair through modulation of the kallikrein‐kinin system. DiaMedica’s research and development efforts are centered on translating the regenerative potential of DM199 into effective treatments for disorders with high unmet medical need.
DM199 is being evaluated in acute ischemic stroke, where preclinical studies have demonstrated potential benefits in blood flow restoration, inflammation reduction and neuronal survival.
