DiaMedica Therapeutics Inc. Common Stock 2026 Q2 Earnings Call

Thank you, Morgan, and thank you all for joining us today. With me this morning are Dr. Julie Krop, our Chief Medical Officer, and Scott Kellen, our Chief Financial Officer. Q2 was an important quarter for DiaMedica with progress across DM19 in early onset fetal growth restriction, preeclampsia, and acute ischemic stroke. We advanced our pregnancy-related clinical strategy, continued preparations for our phase II early onset preeclampsia study in Canada and the U.K., and made further progress towards reaching the planned phase II/III ReMEDy2 interim analysis in acute ischemic stroke. There are four key updates I would like to highlight. First, with respect to the IST being conducted by Professor Kluver, enrollment has been completed in the first cohort of the phase II early onset fetal growth restriction study. The cohort consists of six participants treated at the 5 microgram per kg dose level.

This is important as it expands the clinical use of DM19 into a second serious women's health disorder for which there are no approved therapies. We plan to host a KOL event in September with Professor Kathy Kluver, the study's principal investigator, and other experts to discuss the potential of DM19 in fetal growth restriction and share top-line results for the completed first cohort open-label phase II trial. Second, the extension cohort from the Part 1a of the IST has been completed. This was the initial dose escalation cohort treating women with late-stage preeclampsia. The combined results from the dose escalation and extension groups were important, as noted in our earnings press release, as they provide the clinical support driving the selection of the mid-dose range for the evaluation, both for early onset fetal growth restriction and early onset preeclampsia studies.

Julie will review the data later in the call. Third, we continue to advance our early onset preeclampsia programs on the regulatory and operational fronts, which I will discuss in a moment. Fourth, ReMEDy2, our phase II/III acute ischemic stroke study, is approaching the 200th patient required to trigger the pre-specified interim efficacy analysis. Although enrollment slowed somewhat in July, we now have surpassed 85% of the enrollment target, and we anticipate the interim analysis readout in the first quarter of 2027. As a reminder, DM199's recombinant form of the naturally occurring human KLK1 protein. KLK1 is a serum protease that acts through the BK2 receptors present in endothelial blood vessels to restore the body's natural ability to increase levels of nitric oxide, prostacyclin, and endothelial-derived hyperpolarizing factors.

We believe that this novel mechanism improves vascular biology, makes DM199 both unique and well-suited to address the endothelial and perfusion-related dysfunction common in preeclampsia, fetal growth restriction, and acute ischemic stroke. As I mentioned, we are pleased to report today that enrollment has been completed in the first cohort of the open label phase II IST fetal growth restriction study. The first cohort consisted of six participants treated at the 5 microgram per kg dose level. This study is enrolling early onset fetal growth restriction patients with or without concurrent preeclampsia. This expansion of our development program allows us to evaluate FGR, a related yet distinct clinical indication to preeclampsia. Early onset FGR is a serious complication of pregnancy associated with inadequate utero-placental blood flow. There are currently no therapies approved to treat FGR, just early delivery, which can have very serious consequences for the babies.

This study is evaluating three dose levels. With the first cohort now fully enrolled, enrollment in the second cohort at 10 microgram per kg should begin shortly. The dose for the third cohort will be between 1 and 15 micrograms per kg and will be based on the results from the first two cohorts. Key FGR study endpoints include safety and tolerability, prolongation of gestation Flow-mediated dilation, among other measures. This is an important study. It is the first time that DM199 has been used in early onset patients. We plan to host a key opinion leader event in September featuring Professor Kluger, the study's principal investigator, where rationale for DM199 in treating fetal growth restriction will be discussed along with top-line results from the completed first cohort.

We are excited about this indication because it represents an expansion of DM199's potential reach based upon the demonstrated improvement in the pulsatility or the resistance index observed in the initial preeclampsia Part 1a study. We also anticipate the first patients to be dosed shortly in the IST early onset preeclampsia and continuous IV infusion preeclampsia studies. Based on the results of the recently completed late onset preeclampsia study, a protocol amendment was filed in July to adjust the dosing regimen to provide more flexibility on dosing at the mid to lower level range. Dosing will start shortly after the acceptance of the protocol amendment is completed in coming weeks. Moving to the global Phase II early onset preeclampsia program, Health Canada authorized initiation of our open label Phase II dose-ranging study in early onset preeclampsia patients earlier this year.

The study is also designed to enroll approximately 30 patients at three dose levels. We are working with sites in Canada and anticipate to dose the first patient in Q4 of this year. We are also working to expand the study to the U.K. later this year, subject to regulatory authorization and site readiness. The results of the multi preeclampsia and FGR studies will be important in defining the dosing for the phase III registrational trial in one or both indications. Turning to expanding the early onset preeclampsia trial into U.S. sites.

As we announced in June, we believe that based on the FDA feedback, our previously completed rat reproductive toxicology study may be acceptable to support a U.S. IND application, provided that we can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout the previously completed rat study, as well as the adequate pharmacologic effects in rats to support their use as an appropriate toxicology species. To address FDA's request, we are conducting a pharmacokinetic and pharmacologic activity study of DM199 in rats. Following completion of the study anticipated in September and reports in October, we plan to present results to the FDA and work with the agency towards initiating clinical development in the U.S. Finally, turning to the ReMEDy2, our ongoing phase II/III acute ischemic stroke trial.

Enrollment has now surpassed the 85% of the 200 patients required to trigger the pre-specified interim analysis, which is expected in Q1 of 2027. We currently have approximately 70 active sites across the U.S., Canada, the U.K. and six countries in Europe. Site activation in Europe are adding meaningful enrollment capacity. The interim efficacy analysis, which occurs after completion of the protocol-defined 90-day follow-up, will be conducted by the independent Data Safety Monitoring Board, or the DSMB, and is intended to assess whether a sample size re-estimate is warranted. The final size may range between 300 and 728 patients or fetality. DiaMedica will remain blinded to data and treatment effect estimates reviewed by the independent DSMB. I will now turn the call over to Julie to walk through the late onset preeclampsia phase II Part 1a clinical update in more detail.

Thank you, Rick. As Rick notes, the Part 1a extension cohort has been completed with the dosing of the final 12 patients at Stellenbosch University site in South Africa. The cohort enrolled women with late stage preeclampsia who had severe hypertension and were expected to deliver within 72 hours under the current treatment protocol. The purpose of the extension cohort was to more fully characterize the highest dose of DM199 and provide additional dose response, safety, pharmacokinetic, and pharmacodynamic information to support dose selection for subsequent studies. The highest dose analysis including 15 patients, three from the initial dose escalation phase and 12 additional patients enrolled in the extension cohort. Following DM199 administration, we observed statistically significant and sustained reductions from baseline in both systolic and diastolic maternal blood pressure.

At the pre-specified assessment 5 minutes after completion of the IV infusion, mean systolic blood pressure decreased by 29.1 millimeters of mercury from a baseline of 169.3 millimeters of mercury with a P value less than 0.001. Mean diastolic blood pressure decreased by 17 millimeters of mercury from a baseline mean of 103.7 millimeters of mercury with a P value less than 0.01. Mean systolic blood pressure remained below 160 at all measured time points over 24 hours, an important threshold systolic blood pressure for required delivery to reduce the risk of brain hemorrhage in the mother. These findings were consistent with the previously reported dose-responsive reductions in systolic and diastolic blood pressure.

Across the dose ranging cohorts, the most clinically meaningful pharmacodynamic effects observed in Part 1a of the study were produced in the mid-dose range cohorts 4 through 8. These participants showed clinically meaningful reductions in both maternal blood pressure and the uterine artery pulsatility index. Note that reductions in the pulsatile index are consistent with reduced uteroplacental vascular resistance suggesting improved blood flow to the baby, which we believe is key to potentially modifying the underlying disease process in these patient populations. These findings support setting dose levels from the mid-dose range for further clinical evaluation as we move to the early-onset pre-eclampsia and fetal growth restriction studies. The dose levels for the next studies will begin at 5 micrograms per kilogram and advance to 10 micrograms per kilogram in the second cohort.