DiaMedica Therapeutics (DMAC) Q2 FY26 earnings call: guidance and Q&A

Enrollment has been completed for the first cohort of six participants in the Phase II IST Fetal Growth Restriction (FGR) study, treated at the 5 mcg/kg dose level. This study evaluates DM-19 in early onset FGR patients (27-32 weeks gestation, <3rd percentile body weight), a serious complication of pregnancy with no approved therapies. Enrollment in the second cohort at 10 mcg/kg is expected to begin shortly, with the third cohort's dose to be determined based on initial results. Key endpoints include safety, tolerability, prolongation of gestation, and flow-mediated dilation. A Key Opinion Leader (KOL) event in September will share top-line results from the completed first cohort.

The extension cohort from Part 1A of the late-stage preeclampsia study has been completed, enrolling 12 additional patients. This cohort, along with the initial dose escalation phase, provided clinical support for selecting the mid-dose range for future studies. Statistically significant and sustained reductions in maternal systolic (29.1 mmHg from 169.3 mmHg, p<0.001) and diastolic (17 mmHg from 103.7 mmHg, p<0.01) blood pressure were observed. Health Canada authorized the initiation of DiaMedica's open-label Phase II dose-ranging study in early-onset preeclampsia patients, with the first patient expected to be dosed in Q4 2026. Expansion of this study to the United Kingdom is also planned for later this year, subject to regulatory authorization.

To support a US IND application for early onset preeclampsia, DiaMedica is conducting a pharmacokinetic and pharmacologic activity study of DM-19 in rats. This study aims to demonstrate sufficient DM-19 exposure and enzymatic activity, as well as adequate pharmacologic effects, to satisfy FDA requirements. Completion of the study is anticipated in September 2026, with reports in October 2026. Following these results, the company plans to present the data to the FDA and work towards initiating clinical development in the US, as the FDA indicated this was the last piece needed to open the IND.

Enrollment for the Phase 2-3 Acute Ischemic Stroke Trial (Remedy 2) has surpassed 85% of the 200 patients required to trigger the pre-specified interim efficacy analysis. This analysis is now anticipated in Q1 2027, a slight shift from the previously expected Q4 2026 due to a slowdown in July enrollment. The trial currently has approximately 70 active sites across the U.S., Canada, the UK, and six European countries, with European site activation adding meaningful enrollment capacity. The independent Data Safety Monitoring Board (DSMB) will conduct the interim analysis to assess whether a sample size re-estimation is warranted, with the final size potentially ranging from 300 to 728 patients.

DM-19 is a recombinant form of the naturally occurring human KLK1 protein. KLK1 acts through BK2 receptors present in endothelial blood vessels to restore the body's natural ability to increase levels of nitric oxide, prostacyclin, and end-of-field drive hyperpolarizing factors. This novel mechanism is believed to improve vascular biology, making DM-19 unique and well-suited to address the endothelial and perfusion-related dysfunction common in preeclampsia, fetal growth restriction, and acute ischemic stroke. The company believes this mechanism supports its broad clinical development program.