DiaMedica Therapeutics Inc.

Good morning, ladies and gentlemen, and welcome to Diametica Therapeutics' third quarter 2026 earnings conference call. An audio recording of today's webcast will be available following the call on Diametica's website, diametica.com, in the investor relations section. Before we begin, please note that management will be making forward-looking statements. These statements are subject to risks and uncertainty, that could cause actual results to differ materially from those expressed or implied. Additional information about these risks appears in the cautionary statement in the company's earnings press release issued yesterday and in Diomedica's filings with the Security and Exchange Commission, including its most recent Form 10-K and Form 10-Q. Statements on this call speak only as of today, November 13th, 2026. Following prepared remarks, we will open the call for questions. I would now like to introduce Rick Pauls, Diomedica's President and Chief Executive Officer. Rick, please go ahead.

Thank you, Operator, and good morning, everyone. Thank you for joining our third quarter earnings call. With me today are Dr. Julie Krop, our Chief Medical Officer, and Scott Kellen, our Chief Financial Officer. Since our last earnings call, we achieved two major clinical milestones. First, enrollment was completed, and the first two cohorts of the investigator-sponsored Phase II early onset fetal growth restriction study. Second, in October, we enrolled the 200th participant in Remedy 2, our pivotal Phase II-III trial in acute ischemic stroke. With this, we attained the pre-specified enrollment threshold required for the Remedy 2 interim analysis. Together, these milestones bring us closer to important clinical readouts that could help define the next stage of development for DM-19 in fetal growth restriction, preeclampsia, and acute ischemic stroke. We also continue to prepare for additional studies in preeclampsia, including our company-sponsored Phase II trial and made progress addressing FDA feedback on the non-clinical package needed for U.S. investigational new drug applications for preeclampsia. I will walk through the major updates Julie will discuss the clinical objectives in more detail, and Scott will review our financial results. As a reminder, DM-1A9, generic name rinbacalinase alpha, is a recombinant form of human tissue calocrine 1, or KLK1. Through activation of the bradykinin-2 receptor pathway, we believe DM-1A9 has the potential to improve vascular health and function, ultimately improving blood flow. This is a completely novel mechanism of action and provides a common therapeutic rationale across preeclampsia, fetal growth restriction, acute ischemic stroke, and other diseases, even though the clinical objectives and endpoints differ across these indications. Let me begin with Early-Onset Fetal Growth Restriction Program, or FGR. Professor Kluver has now completed enrollment in the first two cohorts of the Phase II study being conducted at Tiger Bird Hospital in Cape Town, South Africa. Together, these cohorts include 12 participants with six treated at 5 micrograms per kg and six treated at 10 micrograms per kg. This is the first clinical evaluation of D-109 in women with early onset fetal growth restriction. Early onset FGR is a pregnancy disorder associated with significant risks to the fetus frequently resulting from placental insufficiency, creating impaired blood flow that restricts the supply of oxygen and nutrients to the baby. Currently, no therapy is approved to treat FGR. The only option today for physicians is to closely monitor both mother and baby, balancing the risk of stillbirth and fetal complications from worsening placental insufficiency against the serious neonatal risk of delivering very prematurely. In pregnancies complicated by preeclampsia, maternal risk also includes severe hypertension and organ injury. The current early onset SGR study is evaluating repeated subcutaneous dosing of DM-19 with the objective of assessing whether DM-19 can safely prolong pregnancy while minimizing risk to the mother and baby. Assessments include maternal and fetal safety, measures of utero placental vascular resistance, birth weight, centile, and duration of pregnancy. The dose for the third cohort will be selected based on the findings from the first two cohorts. On Tuesday, November 24th at 8 a.m. Eastern Time, we will host a virtual Key Opinion Leader event focusing on fetal growth restriction, featuring preliminary results from both completed cohorts. Professor Kluver will be joined by Professor Stephen Tong and Professor Susan Walker, both from the University of Melbourne, and Professor Andrew Shannon from King's College London. The panel will discuss the treatment landscape and unmet need, The Clinical Rationale for DM-19 and Preliminary Safety and Clinical Observations in the Context of Current Maternal Fetal Medicine Best Practices. Within the investigation response for trial, two additional preeclampsia studies are expected to begin enrollment by the end of 2026. One comprised of up to 30 women with early onset preeclampsia receiving repeated subcutaneous dosing of DM-19 until delivery. This is referred to as our part two of the study. The second study will include up to 30 women with late onset or late stage preeclampsia who are acutely hypertensive with delivery expected within 72 hours, referred to as Part 1B. In the second study, patients will receive DME9 via continuous intravenous infusion, which may provide insight into whether IV dosing of DME9 can help control severe hypertension. We believe every day matters for mom and baby. Switching to IV DM-19 may enable further prolongation of pregnancy for these women beyond sub-Q dosing. We're also advancing our company-sponsored Phase 2 program in early-onset preeclampsia. Health Canada authorized a protocol amendment to the open-label Phase 2 dose-finding study in September, and preparations continue to initiate enrollment at Canadian sites. We also plan to expand the study into the United Kingdom, subject to regulatory authorization. In October, the study received conditional authorization from the European Medicines Agency, or EMA, with consideration for full approval after country-specific ethical insight requirements, creating an opportunity for future European expansion. This trial is designed to evaluate approximately 30 patients with early-onset preeclampsia across three dose levels, drawing on the Part Ia preeclampsia experience and emerging FGR observations. Together, both of these studies will provide further information on dosing and pharmacologic activity in different clinical settings, allowing us to develop the dosing plan for use in larger preeclampsia trials. In the United States, our focus remains on addressing FDA's feedback regarding the non-clinical reproductive toxicology data to support an investigational new drug application, or IND, to study DM-109 in preeclampsia in the United States. Last quarter, we discussed FDA feedback indicating that our completed rat reproductive toxicology studies may be acceptable to support an IND application. FDA's acceptance would depend on our ability to demonstrate that DM-19 exposure and enzymatic activity were maintained at adequate levels throughout those studies and that DM-19 produces a sufficient pharmacologic effect in rats to justify their use as a toxicology species. We initiated an additional rat study during the third quarter to generate this data and please report that the in-life portion of the study has been complete and DM-19 was well tolerated by the animals. We expect the pharmacokinetics and pharmacologic results in the coming weeks, and once the report is complete, we plan to submit to the FDA. Our other major recent clinical milestone was an acute ischemic stroke, where Remedy 2 reached the enrollment threshold for its pre-specified interim analysis. Acute ischemic stroke, when a blood clot blocks blood flow to the brain, can cause profound lasting disability or death. Current reperfusion treatments, including thrombolytic drugs, which attempt to dissolve the clot, and mechanical thrombectomy, which attempts to physically remove the clot, can be highly effective for certain eligible patients, but their use is limited by clinical eligibility, treatment time window, and the location of the clot. Most stroke patients either cannot receive these treatments were still experiencing significant disability despite treatment. This is why stroke also remains a significant unmet medical need and additional approaches to preserve at-risk brain tissue and improve function recovery are urgently needed. Following the required 90-day follow-up of the 200th participant, the Independent Data Safety Monitoring Board, or DSMB, will examine the primary efficacy endpoints. The proportion of participants with a modified rank and Dr. Kahn. As part of the trial's prespecified adaptive design, the DSMB will use its efficacy data to determine whether the study should continue, and if so, whether the final sample size should be adjusted. If the trial continues, the final enrollment target will range from 300 to 728 participants under the prespecified statistical plan. Diomedica will remain blinded to the treatment effect data reviewed by the DSMB. If successful, Remedy 2 has the potential to serve as a pivotal trial supporting a future new drug application or NDA for use of D-1-9 in acute ischemic stroke. Patient recruitment continues during the completion of the follow-up period and data preparations for interim review. We expect the DSMB to complete its analysis in the first quarter of 2027. With that, I will turn the call over to Julie to discuss the clinical program in more detail. Julie?

Thank you, Rick, and good morning, everyone. I would like to expand on two aspects of our pregnancy-related development strategy. First, what are we seeking to learn from the FGR cohorts? And second, how the initial preeclampsia findings are informing the next studies. Severe early onset fetal growth restriction presents a substantial challenge because impaired placental function can severely limit the fetus's ability to grow and develop. As Rick noted, clinical management requires balancing the potential benefit of prolonging gestation against the maternal and fetal risk of continuing the pregnancy. We are evaluating whether and to what degree DM-199 can favorably affect vascular physiology to improve vascular health and blood flow and ultimately support improved outcomes for both the mother and the baby. The ongoing phase two FGR IST trial is evaluating repeated subcutaneous dosing of DM-199 in women with early onset disease. Key assessments include safety and tolerability and umbilical artery Doppler indices that reflect the degree of resistance to blood flow from the fetus to the placenta. Abnormal Doppler findings, particularly absent or reversed end diastolic flow, help guide the timing of delivery in pregnancies complicated by fetal growth restriction. Changes in these physiologic parameters will provide important information about the pharmacologic activity of DM-199 and help inform further development. At the November 24th KOL event, We will review preliminary observations from the two six-participant cohorts tested at DM-199 subcutaneous dose levels 5 and 10 micrograms per kilogram, respectively. Although this is an early open-label study involving a small number of patients, the findings will provide an initial opportunity to assess DM-199 safety, pharmacologic activity, and potential clinical effects in women with early-onset FGR and importantly, the experts will help put the open label data into context by providing benchmarking data on outcomes in patients receiving current standard of care treatment. In part 1A of the investigator-sponsored trial, patients with late onset preeclampsia were studied. If you recall, that data showed rapid and sustained reductions in maternal systolic and diastolic blood pressure following DM-199 treatment. We also observed pharmacodynamic effects, including trends suggesting reduction in the uterine artery pulsatility index, a measure of resistance, and an indirect measure of uteroplacental blood flow. Together, these observations support dose selection and provide a strong rationale for conducting additional studies to determine whether DM-199 can deliver meaningful clinical benefits, particularly in early-onset disease. I would also like to highlight the clinical rationale for DM-199 in acute ischemic stroke. Unlike thrombolytic therapies, which dissolve blood clots, or mechanical thrombectomy, which physically remove them, DM-199 is designed to improve collateral blood flow within the ischemic penumbra, the surrounding brain tissues that are adversely impacted by the clot and that remain viable for a period of time, are at risk of irreversible injury if adequate blood flow is not restored. By improving oxygen delivery to the threatened tissue, we believe DM-199 may help preserve neurologic function, which ultimately may lead to improved recovery following stroke. Remedy 2 is a randomized double-blind placebo-controlled study evaluating DM-199 in patients with acute ischemic stroke who begin treatment The study focuses on patients who are not candidates for mechanical thrombectomy, a population with substantial unmet medical need. Across these programs, our goal is to determine whether DM-199's effect on vascular function and blood flow can translate into meaningful clinical benefits for patients with these serious conditions. Rick, back to you.