DiaMedica Therapeutics Highlights DM199 Preeclampsia Data, Stroke Interim Catalyst at RedChip Conference

Key Points

• DiaMedica’s lead candidate DM199 is a recombinant KLK1 “protein replacement” therapy for preeclampsia; interim data showed no placental transfer and dose‑dependent blood pressure reductions (~25 mmHg systolic / ~13 mmHg diastolic) plus a 13% reduction in uterine artery resistance, and a Phase II trial is expected to start soon ahead of a ~250‑patient Phase III base case.
• For acute ischemic stroke, a pivotal trial of DM199 (IV within 24 hours followed by twice‑weekly subcutaneous dosing) includes an interim analysis after 200 patients expected before year‑end to assess futility or re‑estimate sample size, with the design excluding severe strokes to target a broader treated population.
• DiaMedica says it has a “clean” capital structure with no debt or warrants and a cash runway through the end of 2027, and the company is covered by five analysts.

DiaMedica Therapeutics NASDAQ: DMAC President and CEO Rick Pauls outlined the company’s development programs for its lead candidate, DM199, during a presentation at the RedChip Biotech Investor Conference, highlighting ongoing work in preeclampsia and acute ischemic stroke as well as upcoming clinical catalysts and its balance sheet.

Recombinant KLK1 as “protein replacement therapy”

Pauls said DiaMedica is developing DM199, a recombinant (synthetic) form of tissue kallikrein-1 (KLK1), a naturally occurring protein found in humans. He noted that patients who have, or are at risk for, conditions including preeclampsia, stroke, hypertension, and kidney disease tend to have lower levels of KLK1. In “simple terms,” Pauls described DiaMedica’s approach as “protein replacement therapy.”

He also emphasized that other forms of KLK1 have been used clinically for decades in Asia, citing porcine-derived KLK1 used for hypertension in Japan and China and a human urinary-derived form used in China for acute ischemic stroke. Pauls said the human urinary-derived product, marketed in China by Shanghai Pharma, treats “almost 1 million patients a year.” DiaMedica’s focus, he said, is that it has “figured out how to manufacture the recombinant or synthetic form” of the protein for clinical use.

Preeclampsia focus: early-onset disease and placental blood flow

Pauls said the company’s “primary focus” is the treatment of preeclampsia and that it reported “very encouraging proof of concept data” last year showing DM199 could lower blood pressure and increase blood flow to the placenta, which he said could potentially target the “root cause” of the disease.

He described preeclampsia as a hypertensive disease of pregnancy that typically occurs after the 20th week, with DiaMedica focused on early-onset cases before 34 weeks, where the clinical need is greatest. He contrasted outcomes at later gestational ages with earlier delivery, stating that delivery around 28 weeks can mean extended NICU stays and that before 28 weeks there is a significant risk of long-term disability.

Pauls estimated roughly 200,000 U.S. patients per year develop preeclampsia, including about 30,000 early-onset cases, and cited an additional related population of about 20,000 patients with fetal growth restriction, which the company believes DM199 may also help treat.

He argued that existing options are limited, noting that some effective blood pressure drug classes, such as ACE inhibitors and ARBs, are contraindicated in pregnancy. Current therapies such as labetalol and nifedipine can acutely lower blood pressure for “a few extra days,” he said, but do not address underlying pathology. Pauls emphasized that DM199 is a large-molecule protein that the company believes should not cross the placental barrier, calling that an important safety consideration.

Interim proof-of-concept findings in preeclampsia

Discussing DiaMedica’s prior interim analysis in pregnant patients who were expected to deliver within 72 hours, Pauls said the study was designed to assess whether DM199 crosses the placental barrier and to look for dose-related changes in blood pressure and uterine blood flow.

According to Pauls, the company observed no serious treatment-emergent events. Reported adverse events included some facial flushing that self-resolved, and other events he described as expected in this high-risk population (including postpartum hemorrhage, eclampsia, HELLP syndrome, and pulmonary edema). He also said there were no signs of hypotension in this cohort, while noting that rapid IV infusion can cause a transient hypotensive episode that resolves within minutes if the infusion is stopped.

On placental transfer, Pauls said DM199 levels increased in mothers across cohorts, but none was detected in cord blood, which he said confirmed the drug did not cross the placental barrier in the tested patients.

On signals of activity, he described a dose-response pattern for blood pressure reductions, and said that in the cohorts the company plans to target next, combined results showed a 25 mmHg drop in systolic pressure and a 13 mmHg drop in diastolic pressure shortly after infusion. He also said systolic blood pressure remained below 160 mmHg during measured time points within 24 hours, a threshold he said often prompts obstetricians to prepare for delivery.

Pauls added that Doppler ultrasound measurements showed a statistically significant 13% reduction in uterine artery resistance index after two hours, which he said correlates with increased placental blood flow.

Looking ahead, Pauls said DiaMedica expects to initiate a Phase II trial in the coming months, beginning in Canada and later expanding to the U.K. and the U.S., alongside an investigator-sponsored study in Cape Town, South Africa. He said the company anticipates multiple clinical readouts over the coming year to help select a Phase III dose, with a Phase III “base case” of roughly 250 patients.

Stroke program: pivotal trial with interim analysis expected this year

Pauls also detailed DiaMedica’s acute ischemic stroke program, describing DM199 as a therapy intended to increase blood flow to ischemic brain tissue via a bradykinin-mediated mechanism. He said bradykinin B2 receptors on endothelial cells are upregulated “35-fold” following a stroke, and that DM199 can release bradykinin systemically, which then acts at these receptors to promote focal vasodilation and collateral circulation.

He contrasted DM199’s proposed 24-hour treatment window with existing interventions, noting that tPA is used in about 10% of patients due to a 4.5-hour window, and mechanical thrombectomy is used in about 10% of patients with large vessel occlusions. Pauls said only about 20% of acute ischemic stroke patients are treated today and suggested DM199 could address a broader population.

Reviewing Phase II learnings, Pauls said patients who received mechanical thrombectomy did not show a benefit when DM199 was added, and he highlighted an observed improvement when those patients were excluded. He also said DiaMedica’s pivotal trial design excludes severe stroke patients based on analyses of its Phase II results and its review of published data from the urinary KLK1 product used in China.

The pivotal trial includes an IV dose within 24 hours followed by subcutaneous dosing twice weekly over three weeks, with the primary endpoint at day 90 measured by a modified Rankin score of 0–1. Pauls said the company plans an interim analysis after the first 200 patients to stop for futility or to re-estimate sample size, and he expects that interim analysis before year-end. If the re-estimated sample size is close to 300 patients, he said the company would aim to complete enrollment in the following quarter.

Capital position and analyst coverage

Pauls stated DiaMedica has a “clean cap structure,” with no warrants and no debt, and described a cash runway through the end of 2027. During the Q&A, he said the company is covered by five analysts, naming Cantor (Josh Schimmer), TD Cowen (Stacy Ku), H.C. Wainwright, Lake Street, and Craig-Hallum.

Pauls said physicians have shown strong interest in the preeclampsia program due to limited treatment options and the importance of safety, adding that clinicians respond positively to data indicating DM199 does not cross the placental barrier and may dilate uterine arteries. On stroke, he said interest grows as physicians understand the collateral-circulation mechanism and review data from both DiaMedica and published experience with KLK1 products in Asia.

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.

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