DiaMedica Therapeutics Inc.

Good morning, ladies and gentlemen, and welcome to the Diametica Therapeutics Q3 2025 earnings conference call. An audio recording of this webcast will be available shortly after the call today on Diametica's website at www.diametica.com in the investor relations section. After our speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, please press star 1 on your telephone keypad. Before the company proceeds with its remarks, please note that the company will be making forward-looking statements on today's call. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results, appear in the section entitled Cautionary Statement Note Regarding Forward-Looking Statements in the company's press release issued yesterday and under the heading Risk Factors in Diomedica's most recent annual report on Form 10-K and most recent quarterly report on Form 10-Q. Diomedica's SEC filings are available at www.sec.gov and on its website. Please also note that any comments made on today's call speak only as of today, November 13, 2025, and may no longer be accurate at the time of any replay or transcript rereading. Diomedica disclaims any duty to update its forward-looking statements. Following the prepared remarks, we will open the phone lines for questions. I would now like to introduce your host for today's call, Rick Pauls, Diomedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

Thank you all for joining us for our Q3 2025 earnings call. I am joined this morning by Dr. Julie Kropp, our Chief Medical Officer, and Scott Kellen, our Chief Financial Officer. We've continued to make meaningful progress across both our clinical programs since Q2, and I'm pleased to share our recent developments and upcoming milestones with you today. As most of you know, DMY9 is our lead product candidate. It's a recombinant form of the naturally occurring human tissue KOK1 protein. KOK1 enhances blood flow and vascular health by increasing levels of three key endothelium-derived basal dilating factors through activation of the bradykinin pathway. These are nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factor. We believe that this mechanism is why DM-189 is well-suited to improve patient outcomes for preeclampsia, fetal growth restriction, and acute ischemic stroke. indications associated with vascular pathology. Starting with the preeclampsia program, meaningful progress has been made since we announced the positive interim results in July from Part 1A of our investigator-sponsored Phase 2 trial being conducted in South Africa. We believe that these interim results validate the biological activity of PM-109 and provide a strong basis for the expansion of this clinical study into the early onset preeclampsia and fetal growth restriction cohorts. Additionally, this data, which includes a confirmation that DM-189 did not cross the placental barrier, places DM-189 in a unique position with respect to safety and reduced risk in this very vulnerable patient population. We're grateful for Professor Kluver and her team as their work helped us tremendously as we prepare for our planned upcoming U.S. trial. Just to briefly review the interim results, Part 1A of this study was conducted in pregnant women with preeclampsia, planned for delivery within 72 hours. We continue to believe that these interim results demonstrate that DM1A9 has the potential to be a first-in-class disease-modifying treatment option for preeclampsia. We base our assessment on three key factors. First, blood pressure data from cohorts six through nine demonstrated clear dose-dependent and statistically significant reductions in both systolic and diastolic blood pressure, signaling DM-109's potential to control maternal hypertension associated with preeclampsia. I would point out the importance of this given the results of one of the more recent preeclampsia trials, the PRESERVE-1 antithrombin study, in which approximately half of deliveries were initiated due to out-of-control hypertension, suggesting that better control of blood pressure could have prolonged pregnancies in these patients. Two, improved placental perfusion. In Part 1A of our recent Phase 2 results, DM-189 treatment produced a statistically significant reduction in the uterine artery pulsatility index, a Doppler-based assessment of arterial resistance, suggesting improved uterine artery blood flow and enhanced placental perfusion. And three, we believe that these improvements were driven by improving endothelial function, believed to be an on-target mechanistic response to DM-189 therapy. By improving or restoring endothelial function, DM-189 has the potential to reverse vascular injury caused by preeclampsia. Having the potential to control hypertension, improve endothelial dysfunction, and improve placental perfusion supports our belief in the potential for DM-109 to be a first-in-class disease-modifying therapy for this life-threatening condition, which has no available treatment options. During the third quarter, Professor Kluver advanced and completed Cohort 10 of Part 1A, which dose participants at 2.5 micrograms per kg IV, and 15 micrograms per kg subcutaneously, and further initiated dosing in expansion cohorts of an up to 12 additional patients at the expected therapeutic dose level. We anticipate completion of this expansion cohort in the first half of 2026. For Parts 1B and 2, protocol amendments are being implemented based on clinical learnings from Part 1A to refine the treatment regimen. Part 1B includes patients who will be delivering within 72 hours. Part 2 will enroll women with early-onset preeclampsia who are candidates for expected management or prolongation of pregnancy. Part 3, the fetal growth restriction cohort, includes participants with fetal growth restriction but who do not have preeclampsia. We anticipate screening to start in the coming weeks. We're also preparing to conduct a Phase II preeclampsia trial in the U.S., We completed an in-person pre-IND meeting with the FDA where we believe we've had a productive meeting and we look forward to providing an update after receiving the final meeting minutes. We anticipate the upcoming U.S. Phase II trial will be conducted in early-onset preeclampsia patients. This treatment for this group is referred to as expected management, which is the preeclampsia patient population with the greatest unmet medical need. Turning to our stroke program, let me ask Julie to provide an update.

Thanks, Rick, and good morning, everyone. We continue to make steady progress in operationalizing our Phase 2b3 Remedy 2 stroke trial. As the trial has progressed, it's become clear that current enrollment rates are lower than what we initially projected based on historical enrollment data. We believe this is primarily due to changes in stroke referral patterns driven by the adoption of technologies such as this AI and increases in the use of tele-neurology. When patients present to smaller community hospitals and are not eligible for mechanical thrombectomy, they are currently more likely than in the past to remain at those hospitals rather than get transferred to the larger comprehensive stroke centers that typically serve as our research sites. As a result, our participating centers are now seeing fewer of our target patient population than they did five or more years ago. The team continues to develop and implement strategies to offset these challenges and support our clinical sites. Based on this information, we recently updated our Remedy 2 enrollment forecast using actual enrollment rates from our current clinical trial sites in lieu of the historical rates we originally used. That said, there remains a lot of enthusiasm among the investigators who are highly motivated to find additional treatment options for this high unmet medical need. We continue to make steady progress with enrollment, and as of today, are approaching 50% of our enrollment target for our interim futility analysis that includes a sample size re-estimation. We now expect the interim analysis based on the first 200 patients to be completed in the second half of 2026. As a reminder, after reviewing safety data from the first 50 participants in the study, the Independent Data Safety Monitoring Board reported no safety concerns and unanimously recommended that enrollment continue without modification.