DiaMedica Therapeutics Inc. (DMAC) Earnings Call Transcript & Summary

Morgan, thank you, and I'm glad everyone could join us today. With me this morning are our Chief Medical Officer, Dr. Julie Kropp, and our Chief Financial Officer, Scott Kellan. For Diomedica, Q2 was a major quarter, bringing progress on three fronts involving D-19: early onset fetal growth restriction, pre- preeclampsia, and acute ischemic stroke. Our clinical strategy for pregnancy-related work advanced, we maintained momentum on preparations for the Phase 2 early-onset preeclampsia study in Canada and the U.K., and we gained further ground toward the planned Phase 2 to 3 Remedy 2 interim analysis in acute ischemic stroke. Four key updates are what I want to walk you through. To start, on the IST that Professor Kluver is running: the first group in the Phase II Early Onset Fetal Growth Restriction Study has finished enrolling. Six people are in that group, and they received treatment at a dose of 5 micrograms per kilogram. Why this is significant is that it brings the clinical application of DM-19 into a second major women's health condition for which there are no approved treatments. In September, we plan to hold a Key Opinion Leader event featuring Professor Kathy Kluver, who serves as the study's principal investigator, together with additional experts, to discuss what DMV9 might offer in fetal growth restriction and to present top line results from the open label phase two trial's completed first cohort. Next, enrollment has wrapped up for the extension group tied to Part 1A of the IST. That group was the original dose escalation set, and it involved treating women whose preeclampsia had progressed to a late stage. As we mentioned in the earnings press release, pooling the findings across the dose escalation and extension arms proved important, since those results supply the clinical backing that guided our choice of the mid-dose range to test in both the early onset fetal growth restriction and early onset preeclampsia trials. Julie will walk through those data afterward in this call. And finally, we continue to push our early onset preeclampsia efforts forward on both the regulatory and operational sides, something I'll touch on shortly. And number four — the Remedy 2 trial, which covers phases 2 and 3 for acute ischemic stroke, is getting close to the point where 200 patients have been enrolled, the threshold that sets off the pre-specified interim efficacy analysis. Enrollment did lose a bit of momentum during July, but we've still moved past 85% of our target for the study, and we're looking at a readout from the interim analysis during the first quarter of 2027. Just to remind everyone, DME9 is a recombinant version of KLK1, the protein that occurs naturally in humans. KLK1 works as a serum protease, operating via the BK2 receptors found in the enthalial blood vessels, and it brings back the body's own capacity to raise nitric oxide, prostacyclin, and end-of-field drive hyperpolarizing factors. According to our understanding, this new mechanism leads to better vascular biology, which means DM-19 stands apart and is particularly appropriate for tackling the endothelial and perfusion-linked problems often seen in preeclampsia, fetal growth restriction, and acute ischemic stroke. As I noted earlier, we are happy to share that as of today, all patients have now been enrolled into the opening cohort of the Fable Phase II IST Fetal Growth Restriction Study, which is open-labeled. That first group consisted of six people, each treated at 5 micrograms per kg. Right now, this trial is in the process of enrolling patients who have early onset fetal growth restriction, regardless of whether preeclampsia is also present. Through this broadening of our development efforts, we can assess FGR, which is a clinical indication related to preeclampsia but distinct from it. A severe pregnancy complication known as early onset FGR is tied to insufficient uteroplasental blood flow. At present, there are no approved treatments for FTR—only early delivery, and that may lead to extremely grave outcomes for the infants. Three dose levels are being examined in the study; now that the first group has been completely enrolled, the second group at 10 micrograms per kg ought to start enrollment soon. For the third group, the dose is going to fall somewhere between 1 and 15 micrograms per kg, determined by what the first two groups show. Safety and tolerability, extended gestation, flow-mediated dilation, and several additional measures make up the primary endpoints for the FGR trial. There's a lot riding on this particular study — DM-1A9 has not previously been administered to patients with early onset disease. Come September, we're planning a Key Opinion Leader event featuring Professor Kuhler, the trial's principal investigator, where we'll discuss why DM-1A9 makes sense as a treatment for fetal growth restriction, and we'll also share top line data from the initial cohort that has completed the study. This particular use case is compelling to us because it represents a broadening of the potential scope for DM-109, and it extends the work based on the resistance index — that is, the pulsatility improvement — observed in the initial Part 1A trial in preeclampsia. On top of that, we anticipate that the earliest participants will be dosed shortly across the IST early onset preeclampsia trial and the continuous IV infusion preeclampsia trial. In light of the results from the late onset preeclampsia study that wrapped up recently, we filed a protocol amendment during July to permit modification of the dosing schedule, which creates more room to maneuver for dosing in the mid-2040s, extending down into the lower level range. Once that protocol amendment gains clearance — something we anticipate occurring within the coming weeks — dosing should get underway shortly thereafter. Turning now to the Global Phase II Early-Onset Preeclampsia Program: earlier in the year, Health Canada cleared us to launch an open-label Phase II study examining dose-ranging in patients with early-onset preeclampsia. That trial is also designed to bring in about 30 patients spanning three dose levels, and we're working alongside SISIM Canada and Anticipate to Dose. Enrollment of the first patient is expected during Q4 of this year. In addition, we're looking to expand the study into the United Kingdom later this year, provided regulators grant authorization and sites are ready. Data from the multi-preeclampsia and FGR studies will prove essential when it comes to selecting the dose for the Phase III registrational trial covering one or both indications. Now moving on to extending the early-onset preeclampsia trial into the U.S. Regarding sites, as we shared back in June, we hold the view that, drawing on input from the FDA, the reproductive toxicology work we finished earlier on RET could potentially be used to back a US IND filing, so long as we are able to show adequate proof of DMOE9 exposure and enzymatic activity across the rat study we previously completed, along with pharmacologic effects in rats strong enough to justify that species as a suitable toxicology model. In response to what the FDA asked for, a study of DM-19 in rats examining pharmacokinetic and pharmacologic activity is now underway. Once that work wraps up — expected during September — and reports arrive in October, our plan is to bring the findings before the FDA and collaborate with the agency as we move toward kicking off clinical development inside the US. Now, lastly, on to Remedy 2, the Phase 2 to 3 Acute Ischemic Stroke Trial we have running. More than 85% of the 200 patients needed to set off the pre-specified interim analysis have been enrolled, with that analysis anticipated during Q1 of 2027. At present we have roughly 70 sites up and running throughout the U.S., Canada, the UK, and 6 European nations. Activation of sites in Europe keeps contributing meaningful capacity for enrollment. Once the 90-day follow-up required by the protocol has finished, the Independent Data Safety Monitoring Board, or DSMB, will conduct the interim efficacy analysis. Its job is to decide if adjusting the sample size is warranted. The eventual number of patients could range between 300 and 728, or the study could be stopped for futility. Diomedica will remain unaware of the data and of any treatment effect estimates examined by the independent DSMB. At this point I'll turn it over to Julie, who will provide a more detailed update on the phase two part 1A clinical trial for late onset preeclampsia.

Thank you, Rick. Rick mentioned that the Part 1A Extension cohort is now finished, following administration of the drug to the last 12 patients at the Stellenbosch University site located in South Africa. Enrolled in this cohort were women suffering from late-stage preeclampsia, who presented with severe hypertension and, under the existing treatment protocol, were anticipated to give birth within 72 hours. The extension cohort was designed to better define the profile of the highest dose of DM-199 and to generate further dose response, safety, pharmacokinetic, and pharmacodynamic data that would inform dose selection for later trials. The highest dose analysis covers 15 patients — three who came from the initial dose escalation phase, plus 12 more enrolled in the extension cohort. After DM-199 was given, we saw reductions from baseline in both systolic and diastolic maternal blood pressuresicdeclined by 17 millimeters of mercury from a baseline mean of 103.7 millimeters of mercury, with a p-value less than 0.01. At every time point measured across 24 hours, mean systolic blood pressure stayed under 160, a threshold that matters because delivery is required above it to lower the mother's risk of brain hemorrhage. These results matched the dose-responsive reductions in systolic and diastolic blood pressure reported earlier. Among the dose-ranging cohorts, the pharmacodynamic effects with the greatest clinical meaning seen in Part 1a of the study occurred in the mid-dose range cohorts 4 through 8; those participants demonstrated clinically meaningful decreases in maternal blood pressure as well as in the uterine artery pulsatility index. Keep in mind that lower pulsatility index values align with reduced uteroplacental vascular resistance, which points to better blood flow reaching the baby — something we believe is central to potentially altering the underlying disease process in these patient populations; such findings justify testing dose levels drawn from the mid-dose range in further clinical evaluation as we proceed to the early onset preeclampsia and fetal growth restriction studies. Dosing for the upcoming studies will start at 5 micrograms per kilogram and then go to 10 micrograms per kilogram in the second cohort. Selection of the dose for the third cohort will depend on results from the first two cohorts, landing somewhere in the range of 1 to 15 micrograms per kilogram; that flexibility is deliberate, so the optimal dose range can be pinned down further using the data as it emerges. All told, we believe these results demonstrate a mechanistically on-target pharmacodynamic response for DM-199 in preeclampsia. The study investigators intend to present the complete dataset, covering safety, pharmacokinetic, and pharmacodynamic analyses, at an upcoming medical conference and and submit the results for publication in a peer-reviewed journal later this year.

Rick, I'll hand the call over to you now. Thank you, Julie. At this point, I want to have Scott walk through the quarter's financial results.

Thanks, Rick, and hello everybody. Now, going through our Q2 financials, dated June 30, 2026, we held $43.5 million in cash, cash equivalents, and short-term investments. Current liabilities stood at $6.6 million, with working capital of $37.7 million. That compares against $59.9 million in cash and investments, $5.1 million in current liabilities, and $55.5 million in working capital as of December 31, 2025. Our view remains that the TASH position we currently hold will support our planned clinical studies and corporate operations through 2027. For the six months ending June 30, 2026, net cash used in operating activities came to $17.2 million, versus $14.7 million during the equivalent stretch of 2025. That rise was driven mainly by a larger net loss this year. Moving to the income statement, R&D expenses totaled $8.2 million and $16.1 million across the three- and six-month periods ending June 30, 2026. That's up from $5.8 million and $11.5 million in those same periods a year earlier. The growth stems largely from building out our clinical team, ongoing work on our Remedy 2 clinical trial, including its global expansion, tied to extra reproductive toxicity testing being conducted to support our PE program in the United States, higher manufacturing and development activities, and greater non-cash share-based compensation; we anticipate R&D expenses will rise moderately in future periods versus recent ones as we carry on both our Remedy 2 trial and the expansion of our DM-199 clinical development program in preeclampsia. General and administrative expenses came in at $2.3 million and $4.8 million for the three- and six-month periods ending June 30, 2026. Those expenses ticked up slightly from the same periods in 2025, which were $2.2 million and $4.7 million, respectively. The three-month bump came mainly from higher non-cash share-based compensation and professional fees, while the six-month increase was primarily due to greater personnel costs from growing our team, partly offset by lower legal and other professional fees this year. We anticipate G&A expenses will stay fairly flat in future periods compared with recent ones. To sum up, we're well-funded, with a cash runway reaching through 2027. That carries us past our key upcoming milestones, among them the Remedy 2 interim analysis, planned data readouts from our preeclampsia and fetal growth restriction programs, and ongoing progress of our Phase 2 preeclampsia program in Canada and the United Kingdom. With that, I'll ask the operator to open the lines for.

Thanks for the opportunity to ask — I have a couple of quick items. First, I'm working through what you said about dosing. For the late onset preeclampsia program, your focus sits on the four to eight microgram per kilogram cohorts rather than the higher doses, but with early onset preeclampsia, the higher doses are what you're examining. How do those two fit together, and can you walk us through the thinking? Second, regarding the fetal growth restriction program, do you have any inclusion criteria in place to identify patients most likely to respond, or those showing evidence of impaired placental perfusion?

at baseline, thank you. Sure, thanks, thanks Josh. Regarding part 1a, the pattern matches what other clinical trials have shown: there's a particular dosage range where DM1, or dm-199, works best. The idea is that koki one targets uterine blood flow for improvement while keeping blood pressure in check. However, when the dose goes beyond a certain level, blood pressure still appears controlled, yet receptor desensitization seems to set in, which results in reduced dilation. So that actually lines up with what we've observed in glucose research and among type two diabetics; the same pattern has shown up in kidney disease trials where we looked at EGFR and UACR, and there we find a stronger clinical response at 3 micrograms than at 15. Beyond that, we have a patent that's been granted for the nonlinear dose response curve. So from our standpoint, I believe having some flexibility matters—we're able to adjust the dose, but our focus is really on that middle range. Then, to address your second question about FGR: those patients are very severe, with FGR cases occurring between weeks 27 and 32. And their body weight puts them at the 3% percentile or below. So they are extremely severe. If these infants went untreated, they would typically deliver within one to six days. We believe there's real promise in things like lengthening the gestational period, opening up the intrudern arteries, and other elements. Dilation is truly the key focus for us here. If we end up seeing promising signals, we'd view that favorably as we shift attention to early onset preeclampsia, because with that condition, our thinking is that we could address both blood pressure and dilation. That's why we're eagerly anticipating the KOL event we'll be hosting in September.

Hi there, good morning. We're grateful that you set aside time to field our questions, and congratulations on all your achievements. To start with fetal growth restriction—specifically that cohort one readout coming in September—could you walk us through why the chronic dosing we expect to see there matters so much? What number of doses do you anticipate possibly sharing? Once more, I realize it's extremely early, so simply to assist us in grasping that, sort of that dynamic. And afterward when we consider perhaps the growth restriction and what might be clinically meaningful, would it be a week of extension prior to delivery? Would it be beyond that? Just assist us in grasping the sort of dynamics or perhaps even a small preview for the KOL event regarding the unmet; so that's the initial question on FGR. Moving on to the next item, which concerns what you've learned about early onset preeclampsia. Please give us a refresher on where things stand regarding intravenous delivery compared with subcutaneous delivery, and maybe what kinds of adjustments you're making as you look at the different cohorts. I know you just brought up receptor desensitization, but help us understand the latest thinking on how often dosing happens, and so on. Then the last question is a point of clarification about the FDA IND submission: is it fair to expect that once this enzymatic study is done — it sounds like that wraps up in October — you'll be in a position to submit the.

and to the FDA. Thanks very much. Sure, absolutely — so to start with your first question. Regarding FGR, the key point here is that the data we have so far looks pretty promising for the late-onset patients, who got one IV dose followed by a subcutaneous dose. But this will really be the first time we've dosed early-onset patients. Those patients will come in, and they'll get subcutaneous dosing every three days up until delivery. And like I said, we believe Standard of care — which is really quite limited — we were anticipating somewhere in the range of one to six days. From where we sit, we'd said before that getting an extra five or six days might meaningfully change what happens for these infants. With luck, we'll gain a few weeks in that regard. As for early onset preeclampsia, one change we've made involves stopping the IV infusion and instead giving subcutaneous doses every three days, three times before delivery. A future preeclampsia cohort will use a continuous IV infusion, and those will be late onset patients. The thinking behind that is our belief that adjusting the dose lets us tune blood pressure into the desired range. So assuming we see beneficial results from that, our next step in phase three for preeclampsia would be to give doses every three days, up until the point systolic blood pressure gets close to 160. At that point, the patient would be moved to a continuous IV infusion, and our hope is that this gives us a few additional days. That aligns well with the rat study that is currently in progress and still ongoing. It's expected to wrap up in the first part of September. After it concludes, our plan is to file for a US IND. In our discussion with the FDA on this, their final comment was that they viewed this as the single remaining item required before the IMD could get underway.