DMAC

Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 8:00 a.m. ET President and Chief Executive Officer - Dietrich Pauls Chief Medical Officer - Julie Krop Chief Financial Officer - Scott Kellen Operator: Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Second Quarter 2026 Earnings Conference Call. An audio recording of this webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. 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 Statements Note regarding Forward-Looking Statements in the company's press release issued yesterday and under the heading Risk Factors in DiaMedica's most recent annual report on Form 10-K and most recent quarterly report on Form 10-Q. DiaMedica'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, August 11, 2026, and may no longer be accurate at the time of any replay or transcript reading. Following management's remarks, we will open the phone lines for questions. I would now like to introduce your host for today's call, Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls, you may begin. Dietrich Pauls: 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 DM199 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 Cluver, 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 DM199 into a second serious women's health disorder for which there are no approved therapies. We plan to host a key opinion leader event in September with Professor Cathy Cluver, the study's principal investigator and other experts to discuss the potential of DM199 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. And third, we continue to advance our early onset preeclampsia programs on the regulatory and operational fronts, which I'll discuss in a moment. And fourth, ReMEDy2, our Phase II/III acute ischemic stroke study is approaching the 200th patients required to trigger the prespecified 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 is a 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 uterine 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 3 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 2 cohorts. Key FGR study endpoints include safety and tolerability, prolongation of gestation, flow-mediated dilation, among other measures. This is an important study. It's 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 Cluver, 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're also working to expand the study to the United Kingdom 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 85% of the 200 patients required to trigger the prespecified 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 6 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 reestimate is warranted. The final size may range between 300 and 728 patients or futility. DiaMedica will remain blinded to data and treatment effect estimates reviewed by the independent DSMB. I'll now turn the call over to Julie to walk through the late-onset preeclampsia Phase II Part 1a clinical update in more detail. Julie Krop: Thank you, Rick. As Rick noted, 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 included 15 patients, 3 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 prespecified 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 uterine placental 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 preeclampsia 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. The dose level for the third cohorts will be selected based on results from the first 2 cohorts and will range somewhere between 1 and 15 micrograms per kilogram. This is intended to provide flexibility to further define the optimal dose range based on the emerging data. Taken together, we believe these findings provide evidence of a mechanistically on-target pharmacodynamic response for DM199 in preeclampsia. The study investigators plan to present the full data set, including safety, pharmacokinetic and pharmacodynamic analyses at an upcoming medical conference and submit the results for publication in a peer-reviewed journal later this year. Let me now turn the call back to Rick. Dietrich Pauls: Thanks, Julie. I'd like to now ask Scott to review the financial results for the quarter. Scott Kellen: Thank you, Rick, and good morning, everyone. So in walking through the financial results for the second quarter, as of June 30, 2026, our cash, cash equivalents and short-term investments were $43.5 million. Current liabilities were $6.6 million and working capital was $37.7 million compared to cash and investments of $59.9 million, current liabilities of $5.1 million and working capital of $55.5 million as of December 31, 2025. We continue to believe that our current cash position will fund our planned clinical studies and corporate operations through 2027. Net cash used in operating activities for the 6 months ended June 30, 2026, was $17.2 million compared to $14.7 million for the same period in 2025. The increase resulted primarily from the increased net loss in the current year. Turning to the income statement. R&D expenses were $8.2 million and $16.1 million for the 3- and 6-month time periods ending June 30, 2026. This was an increase from $5.8 million and $11.5 million for the same time periods in the prior year. The increases are primarily due to the expansion of our clinical team, continuation of our ReMEDy2 clinical trial, including its global expansion, costs related to additional reproductive toxicity testing being performed in support of our PE program in the United States, increased manufacturing and development activities and increases in noncash share-based compensation. We expect that our R&D expenses will moderately increase in future periods relative to recent prior periods as we continue both our ReMEDy2 trial and continue the expansion of our DM199 clinical development program in preeclampsia. Our general and administrative expenses were $2.3 million and $4.8 million for the 3- and 6-month time periods ending June 30, 2026. These expenses increased slightly compared to the same time periods in 2025, which were $2.2 million and $4.7 million, respectively. The increase for the 3-month period was driven primarily by increased noncash share-based compensation and professional fees, while the increase for the six-month period resulted primarily from increased personnel costs incurred in conjunction with expanding our team, partially offset by a reduction in current year legal and other professional fees. We expect G&A expenses to remain relatively consistent in future periods as compared to recent prior periods. In summary, we remain well funded with a cash runway through 2027. This covers through our major upcoming milestones, including the ReMEDy2 interim analysis, planned data readouts from our preeclampsia and fetal growth restriction programs and continued advancement of our Phase II preeclampsia program in Canada and the United Kingdom. With that, let me ask the operator to open lines for questions. Operator: [Operator Instructions] Your first question comes from Josh Schimmer with Cantor. Joshua Schimmer: Great. Two quick ones. First, just trying to understand the commentary around dosing why you're focusing on the 4 to 8 microgram per kilogram cohort and not the higher doses for the late onset preeclampsia program, but then you are exploring higher doses the early onset preeclampsia program. So maybe you can kind of square that and help us understand that strategy. And then for the fetal growth restriction program, are there any inclusion criteria that you're using to try to focus on patients who you might think might be most likely to respond and/or have evidence of impaired placental perfusion at baseline? Dietrich Pauls: Sure. Thanks, Josh. Yes, for -- so what we're seeing from the Part 1a, as we've seen in other clinical trials, there's really a sweet spot for dosing DM199. And we believe KLK1 selectively improves uterine blood flow while also controlling blood pressure. But what we see is happening if we go too high, we think we're still controlling blood pressure, but we think that we run into receptor desensitization. And because of that, we see less of the dilation. And so this is consistent to actually what we've seen in glucose studies in for type 2 diabetics. We've seen the same effect in kidney disease studies looking at eGFR and UACR where we see a greater clinical effect at the 3 microgram compared to the 15. And in addition, we also have an issued patent as well on this nonlinear dose response curve. So I think for us, it's important that we've got some flexibility here that we can adjust the dose, but really more targeting this midrange. In regards to your second question, in terms of FGR, so we're really -- these are very severe patients. So these are FGR between weeks 27 and 32, and there will be patients that are in the 3% or less percentile in terms of body weight. So they're very severe. So we think that these babies typically, if they were not being treated that they would be delivering between 1 and 6 days. And so we think extending the gestational days, dilating the arteries and other factors, we think this could be very exciting. So this really is focusing on the dilation. And then we also believe that if we do see positive signals, this will be encouraging ahead of early onset preeclampsia because there, we think we can also be controlling blood pressure in addition to the dilation. So we're really excited to have this KOL event in September. Operator: Your next question comes from Stacy Ku with TD Cowen. Stacy Ku: Congratulations on all the progress. So first, on the fetal growth restriction, let's say, Cohort 1 data that we're going to get in September, maybe just help us understand the importance of maybe that chronic dosing that we're going to see. How many doses do you think you might disclose? Again, I know very early days, but just help us understand kind of that dynamic. And then as we think to maybe the growth restriction and what's maybe clinically meaningful, is it a week of extension before delivery? Is it longer than that? Just help us understand the type of dynamics or maybe even a little sneak peek for the KOL event when it comes to the unmet need. So that's the first question on FGR. The second is on maybe your learnings for early onset preeclampsia. Just remind us what are the, I guess, ongoing thoughts around IV versus subcutaneous administration? Maybe what kind of refinements you might be applying as you think about the different cohorts? I know you just talked about the receptor desensitization, but just help us understand what's the most up-to-date thinking on the frequency of dosing, et cetera. And then the last question is a clarification on the FDA IND submission. Is it fair to assume after we finish this enzymatic study, it sounds like it's going to be completed in October that you'll be able to kind of submit the IND to the FDA? Dietrich Pauls: Yes, sure. So talking to the first question. So for FGR, I think it's important here that we think we've got very encouraging data thus far with the late onset patients where the patients got 1 dose IV and then 1 dose subcutaneous. But this is really going to be the first time that we've actually dosed early onset patients. And the patients will come in, they're getting subcutaneous dosing every 3 days until delivery. And as I mentioned that we think that standard of care, which basically is really limited, we were anticipating somewhere between 1 and 6 days. So from our perspective, I mean, we had indicated earlier that if we could get another 5, 6 days, that could have a profound impact in terms of outcomes for these babies. Hopefully, we'll get a few weeks on that front. In terms of the early onset preeclampsia, we've -- one of the changes as well we've made is that we're going to be -- we're dropping the IV infusion and focusing on subcutaneous dosing every 3 days until delivery. One of the cohorts coming up for preeclampsia is a continuous IV infusion, and that will be in late onset patients. And the premise there is that we believe by adjusting the dose, we can dial in the blood pressure to the targeted range. And so if we see positive effects there, what we would then anticipate for Phase III for preeclampsia is dosing every 3 days until systolic blood pressure approaches 160. And then at what point we would switch over to continuous IV infusion that can hopefully get us even a few extra days. And then turning to your third question with the IND. Yes, assuming all goes well with the rat study that's already been initiated, it's ongoing. We should be completing that in the early part of September. The plan would be the idea then to submit for a U.S. IND. When we did meet with the FDA to discuss this topic, the last comment they had indicated to us that this was the last piece that they thought we needed to open up the IND. Operator: Your next question comes from Thomas Flaten with Lake Street. Thomas Flaten: Rick, just following up on the FGR, what's clinically meaningful, what's not. So you mentioned days of gestation. Is there going to be an endpoint looking at what percentile the baby grows to? I know you said these are third percentile or less. Are you trying to get the baby up to 5th, 10th percentile? I don't really know what the number would be? Or is this simply gestational extension, which hopefully leads to an improvement in baby weight too? Dietrich Pauls: Yes. We'll be looking for changes to that. I think the 2 main ones we're looking at initially is the gestational days because we do believe keeping baby in mom longer should result in larger, healthier babies. We'll also be looking at the dilation of intrauterine arteries. If a -- typically, if a mother is not getting a treatment with this is known fact that, that dilation should be worsening with time. So if we can even see a stabilization to an improvement, that would be super encouraging. Yes. And there will be a series of other endpoints that we'll be looking at as well for the study. Thomas Flaten: And then just for the Part 1a data that you shared today, I'm assuming you did -- you track the same endpoints that you did in prior cohorts around placental transfer, uterine dilation and intrauterine artery dilation. Will that be presented at some point? Or how are you thinking about disclosing those other endpoints? Dietrich Pauls: Yes. So our collaborators are preparing to submit for publication in the peer-reviewed journal and sharing the full data set there. Thomas Flaten: Got it. And then one final one on ReMEDy2 assuming enrollment pace picks up from July, once you hit the 200 and get past the endpoint for the data to get to the DSMB, how close will you be to that initial target of total enrollment do you think at that point when you do the interim analysis readout? Dietrich Pauls: Yes. So after patient 200 is dosed, there'll be a 90-day follow-up for the primary endpoint. And then there'll be another 4 to 6 weeks for the data analysis and then at what point we'll provide a public update. And during that period of time, we will continue to be dosing patients. So hopefully, we'll be getting closer and closer to 300 patients that we think would be potential the base case in terms of the study. Operator: Your next question comes from Matthew Caufield with H.C. Wainwright. Matthew Caufield: On the interim data set. So for the Phase II/III ReMEDy2 trial, the interim analysis looks like it's slightly shifted from fourth quarter to early '27. You've noted the 85% enrolled towards the interim analysis. Have there been any nuances for the recruitment process to date or how that could possibly translate to the ease of real-world patient selection in the future? Dietrich Pauls: Yes. I mean this trial has been very interesting. It's -- we can get -- we'll get one month where we get very significant enrollment and then the following drops off substantially. And so it's odd in terms of how it goes. But in terms of practical in terms of real-world use, I think the big benefit of this drug here is the safety profile. So we think we'll be able to -- this drug will be able to be used in community hospitals. And so because of that, I think we're very excited about the prospects of getting completing this trial and getting this drug to patients and starting to treat them. Operator: Your next question comes from Chase Knickerbocker with Craig-Hallum. Unknown Analyst: This is Jake on for Chase. I was wondering, for the company-sponsored Phase II, can you just walk us through the timelines to be in the clinic in both the U.K. and the U.S.? Dietrich Pauls: Yes. So we are -- for the company-sponsored trial for the early onset preeclampsia, we're targeting late this year. And then for the U.K., we're just going through the regulatory process. And so hopefully, a similar time maybe back into early 2027. Unknown Analyst: Okay. And is there any more detail on the regulatory process in the U.K. that we could get? Dietrich Pauls: No, we're going through the process. We've identified through the submission process, we have identified 3 great sites and we're working through them in terms of getting the study to launch. So in total, we've got 5 sites. So we've got 3 in the U.K. and 2 in Canada. And again, in total, we're targeting 30 patients. And the protocol is very similar to the IST that's also running concurrently. Operator: That concludes our Q&A session. I will now turn the conference back over to Rick Pauls for any closing remarks. Dietrich Pauls: All right. Thank you, operator. So before we close today's call, I want to say that please keep an eye out for a press release announcing the date of our KOL event focusing on early onset fetal growth restriction. At that event, we look forward to sharing scientific rationale for using DM199 to treat FGR along with top line results from the first patient cohort in our open-label Phase II trial. We believe DM199 represents an important opportunity in treating pregnant mothers with FGR, and we're really excited to share more details with you soon. Thank you again for joining us today and for your continued interest and support. We look forward to updating you on the progress in the coming months. Operator, you may now close the call. Operator: This concludes today's call. Thank you for attending. You may now disconnect, and have a wonderful rest of your day. 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Interested in DiaMedica Therapeutics, Inc.? Here are five stocks we like better. DM199 development advanced across reproductive health and stroke. DiaMedica completed the first six-patient FGR cohort, plans to begin a higher-dose cohort, and reported blood-pressure and uterine blood-flow improvements in late-stage preeclampsia patients. The ReMEDy2 acute ischemic stroke trial surpassed 85% enrollment toward its interim-analysis threshold. The company expects the independent interim efficacy review in the first quarter of 2027, with potential sample-size re-estimation. DiaMedica reported $43.5 million in cash and short-term investments at June 30. Despite increased R&D spending and $17.2 million in first-half operating cash use, management expects its cash runway to extend through 2027. DiaMedica Therapeutics (NASDAQ:DMAC) said its second-quarter progress centered on advancing DM199 across early-onset fetal growth restriction (FGR), preeclampsia and acute ischemic stroke, while the company reported a cash runway it expects to extend through 2027. President and Chief Executive Officer Rick Pauls said the company completed enrollment in the first cohort of an investigator-sponsored, open-label Phase II study of DM199 in early-onset FGR. The cohort included six participants treated at a dose of 5 micrograms per kilogram. DiaMedica plans to host a key opinion leader event in September to discuss the treatment rationale and provide top-line results from the first cohort. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat DM199 is a recombinant form of human KLK1, a protein that the company said acts through BK2 receptors in endothelial blood vessels. DiaMedica believes the mechanism may improve vascular biology and address endothelial and perfusion-related dysfunction in preeclampsia, FGR and acute ischemic stroke. Pauls said the FGR study is enrolling patients with early-onset disease, with or without concurrent preeclampsia. There are no approved therapies for FGR, he said, and current management can require early delivery. The study’s first cohort used the 5 micrograms-per-kilogram dose, while a second cohort at 10 micrograms per kilogram is expected to begin shortly. The third dose level, ranging from 1 to 15 micrograms per kilogram, will be selected based on results from the first two cohorts. → 3 Dividend Champion Utilities for a Market That Can't Sit Still Key study measures include safety, tolerability, prolongation of gestation and flow-mediated dilation, among other assessments. In response to analyst questions, Pauls said the study population includes severe FGR patients between 27 and 32 weeks of pregnancy whose babies are at or below the third percentile for body weight. The company also completed an extension cohort in its Phase II Part 1a investigator-sponsored study in late-stage preeclampsia. Chief Medical Officer Dr. Julie Krop said the extension enrolled 12 additional patients at Stellenbosch University in South Africa, adding to three patients from the initial dose-escalation phase for a 15-patient highest-dose analysis. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War According to Krop, patients in that analysis had severe hypertension and were expected to deliver within 72 hours under current treatment protocols. Five minutes after completion of IV infusion, mean systolic blood pressure declined by 29.1 millimeters of mercury from a baseline of 169.3 mmHg, while mean diastolic blood pressure fell by 17 mmHg from a baseline of 103.7 mmHg. Krop said both changes were statistically significant, and mean systolic blood pressure remained below 160 mmHg at all measured points during the 24-hour period. Across the dose-ranging cohorts, Krop said the most clinically meaningful pharmacodynamic effects were observed in mid-dose cohorts, identified as cohorts 4 through 8. Those patients showed reductions in maternal blood pressure and uterine artery pulsatility index, which she said was consistent with reduced uteroplacental vascular resistance and potentially improved blood flow to the baby. Pauls said the company believes DM199 has a “sweet spot” for dosing and that higher doses may lead to receptor desensitization, potentially resulting in less dilation. DiaMedica intends to use the mid-dose range in further early-onset preeclampsia and FGR studies. Health Canada previously authorized DiaMedica’s open-label Phase II dose-ranging study in early-onset preeclampsia. The study is designed to enroll about 30 patients across three dose levels, and the company expects to dose its first patient in Canada during the fourth quarter. DiaMedica is also pursuing expansion into the United Kingdom, subject to regulatory authorization and site readiness. Pauls said the company has identified three U.K. sites and two Canadian sites for the program. The company expects the U.K. study to begin around late 2026 or potentially early 2027. Separately, DiaMedica filed a protocol amendment in July for investigator-sponsored early-onset preeclampsia and continuous IV infusion preeclampsia studies. The amendment is intended to provide greater flexibility for dosing in the mid- to lower-dose range. The company expects dosing to begin after the amendment is accepted in the coming weeks. For the early-onset preeclampsia program, Pauls said DiaMedica is dropping IV infusion in favor of subcutaneous dosing every three days until delivery. A separate late-onset preeclampsia cohort will evaluate continuous IV infusion, with the company seeking to assess whether dosing can be adjusted to maintain blood pressure within a target range. Regarding a potential U.S. investigational new drug application, Pauls said DiaMedica is conducting a rat pharmacokinetic and pharmacologic activity study requested following FDA feedback. The company expects to complete the study in September and receive reports in October, after which it plans to present results to the FDA and work toward initiating U.S. clinical development. DiaMedica said enrollment in its Phase II/III ReMEDy2 acute ischemic stroke trial has surpassed 85% of the 200 patients needed to trigger a prespecified interim efficacy analysis. While enrollment slowed in July, Pauls said the company expects the interim analysis readout during the first quarter of 2027. The trial has about 70 active sites across the U.S., Canada, the U.K. and six European countries. Following enrollment of the 200th patient, the company expects a 90-day follow-up period and an additional four to six weeks for data analysis. An independent data safety monitoring board will conduct the analysis, while DiaMedica remains blinded to the data and treatment-effect estimates. The interim review will assess whether a sample-size re-estimation is warranted. The final study size may range from 300 to 728 patients, according to Pauls. Chief Financial Officer Scott Kellen reported that cash equivalents and short-term investments totaled $43.5 million as of June 30, compared with $59.9 million at the end of 2025. Working capital was $37.7 million, compared with $55.5 million as of Dec. 31. Net cash used in operating activities was $17.2 million for the first six months of 2026, compared with $14.7 million in the prior-year period. Research and development expense was $8.2 million in the second quarter and $16.1 million for the first half, up from $5.8 million and $11.5 million, respectively, a year earlier. General and administrative expense was $2.3 million for the quarter and $4.8 million for the first half, compared with $2.2 million and $4.7 million in the respective 2025 periods. Kellen attributed the higher R&D spending primarily to clinical team expansion, the ongoing ReMEDy2 trial and its global expansion, reproductive toxicity testing supporting the U.S. preeclampsia program, manufacturing and development work, and share-based compensation. He said DiaMedica expects R&D expenses to increase moderately as the company continues the stroke trial and expands DM199 development in preeclampsia. The company said its current cash position is expected to fund planned clinical studies and corporate operations through 2027, including the ReMEDy2 interim analysis and anticipated readouts from its preeclampsia and FGR programs. DiaMedica Therapeutics, Inc (NASDAQ: DMAC) is a clinical‐stage biopharmaceutical company focused on developing novel therapies for acute and chronic central nervous system conditions. The company's lead product candidate, DM199, is a recombinant form of human tissue kallikrein-1 designed to promote neuroprotection and tissue repair through modulation of the kallikrein‐kinin system. DiaMedica's research and development efforts are centered on translating the regenerative potential of DM199 into effective treatments for disorders with high unmet medical need. DM199 is being evaluated in acute ischemic stroke, where preclinical studies have demonstrated potential benefits in blood flow restoration, inflammation reduction and neuronal survival. 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This article first appeared on GuruFocus. Release Date: August 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. DiaMedica Therapeutics Inc (NASDAQ:DMAC) completed enrollment in the first cohort of the Phase II early-onset fetal growth restriction (FGR) study, expanding DM199's clinical use into a second serious women's health disorder with no approved therapies. The extension cohort of the late-onset preeclampsia study showed statistically significant and sustained reductions in both systolic (29.1 mmHg, p<0.001) and diastolic (17 mmHg, p<0.01) blood pressure, with mean systolic pressure remaining below the critical 160 mmHg threshold over 24 hours. The company identified a 'sweet spot' mid-dose range (cohorts 4-8) that produced clinically meaningful reductions in both maternal blood pressure and uterine artery pulsatility index, supporting dose selection for future studies and suggesting improved blood flow to the baby. The REMEDY 2 acute ischemic stroke trial has surpassed 85% of the 200-patient enrollment target for the interim analysis, with the readout anticipated in Q1 2027, and the company remains on track with a cash runway through 2027. DiaMedica Therapeutics Inc (NASDAQ:DMAC) is advancing regulatory efforts, with Health Canada authorizing the Phase II early-onset preeclampsia study (first patient dosing expected Q4 2026), and plans to submit a US IND following the completion of a rat PK/PD study in October 2026. The company plans to host a key opinion leader (KOL) event in September to discuss the FGR program and share top-line results from the first cohort, which could provide significant positive catalysts for the stock. Enrollment in the REMEDY 2 trial slowed in July, causing the interim analysis readout to shift from Q4 2026 to Q1 2027, indicating potential variability in patient recruitment. The company's cash position decreased significantly, with cash and investments falling from $59.9 million at the end of 2025 to $43.5 million as of June 30, 2026, and net cash used in operating activities increased to $17.2 million for the first half of 2026. R&D expenses increased substantially, rising to $16.1 million for the six months ended June 30, 2026, compared to $11.5 million in the prior year period, driven by expanded clinical trials and additional testing. The US IND submission for the preeclampsia program remains contingent on the completion and positive results of a new rat pharmacokinetic and pharmacologic activity study, which is not expected to be completed until September/October 2026, delaying potential US clinical development. The company is still in early stages for the FGR and early-onset preeclampsia programs, with no efficacy data yet available from the FGR study, and the first patients in the early-onset preeclampsia IST have not yet been dosed, pending protocol amendment acceptance. The company faces uncertainty regarding the final sample size for the REMEDY 2 trial, which could range between 300 and 728 patients, potentially increasing costs and extending the timeline depending on the interim analysis results. Warning! GuruFocus has detected 1 Warning Sign with DMAC. Is DMAC fairly valued? Test your thesis with our free DCF calculator. Q: Can you explain the strategy behind focusing on the mid-dose range (cohorts 4-8) for late-onset preeclampsia while exploring higher doses in the early-onset program, and what inclusion criteria are being used for the fetal growth restriction (FGR) study to target patients most likely to respond?A: Rick Pauls (CEO) explained that there is a "sweet spot" for DM199 dosing, as seen in other clinical trials. While higher doses control blood pressure, they may lead to receptor desensitization, reducing the vasodilatory effect. This non-linear dose-response curve is supported by an issued patent. For the FGR study, they are enrolling very severe patients (between weeks 27 and 32, at or below the 3rd percentile for body weight) who would typically deliver within 1-6 days without treatment. The focus is on extending gestation and dilating uterine arteries, which could be very exciting if positive signals emerge. Q: Regarding the FGR cohort one data expected in September, how important is the chronic dosing data, and what would be considered a clinically meaningful extension of gestation? Also, what are the latest thoughts on IV versus subcutaneous administration for early-onset preeclampsia, and is it fair to assume a US IND will be submitted after the enzymatic study completes in October?A: Rick Pauls (CEO) stated that this is the first time DM199 has been dosed in early-onset patients, using subcutaneous dosing every three days until delivery. Since standard of care is limited and delivery is expected within 1-6 days, gaining an additional 5-6 days could have a profound impact on outcomes. For early-onset preeclampsia, they are dropping the IV infusion in favor of subcutaneous dosing every three days, with a separate cohort testing continuous IV infusion in late-onset patients to dial in blood pressure. For the US IND, assuming the ongoing rat study goes well, they plan to submit, as the FDA indicated this was the last piece needed to open the IND. Q: For the FGR study, is the goal to improve the baby's growth percentile, or is it simply about extending gestation to improve birth weight? Also, will the Part 1A data on uterine artery dilation be presented?A: Rick Pauls (CEO) clarified that the two main endpoints are gestational days and dilation of uterine arteries. Keeping the baby in utero longer should result in larger, healthier babies. Since uterine artery dilation typically worsens over time without treatment, even stabilization or improvement would be highly encouraging. Regarding the Part 1A data, the collaborators are preparing to submit the full dataset for publication in a peer-reviewed journal. Q: For the REMEDY 2 trial, given the interim analysis has shifted slightly to early 2027, how close will you be to the total enrollment target when the interim readout occurs?A: Rick Pauls (CEO) noted that after the 200th patient is dosed, there is a 90-day follow-up period plus 4-6 weeks for data analysis before a public update. During that time, enrollment will continue, so they hope to be closer to the 300-patient base case for the study when the interim analysis is conducted. Q: Can you walk us through the timelines for the company-sponsored Phase 2 study in the UK and the US?A: Rick Pauls (CEO) stated that for the company-sponsored early-onset preeclampsia trial, they are targeting the first patient dose in Canada in Q4 of this year. For the UK, they are going through the regulatory process and hope to launch around the same time or into early 2027. They have identified three sites in the UK and two in Canada, targeting a total of 30 patients with a protocol similar to the investigator-sponsored trial. Q: Can you provide more detail on the regulatory process for the UK expansion?A: Rick Pauls (CEO) said they are going through the submission process and have identified three great sites in the UK. They are working through the process to get the study launched, with a total of five sites across the UK and Canada, targeting 30 patients. Q: Have there been any nuances in the recruitment process for REMEDY 2 that could translate to real-world patient selection?A: Rick Pauls (CEO) noted that enrollment has been variable, with some months seeing significant enrollment followed by substantial drops. However, the key benefit of the drug is its safety profile, which should allow it to be used in community hospitals, making it exciting for real-world use once the trial is complete. Q: What were the key financial results for the second quarter of 2026?A: Scott Kellen (CFO) reported cash and investments of $43.5 million as of June 30, 2026, down from $59.9 million at the end of 2025. Net cash used in operating activities was $17.2 million for the first half of 2026, up from $14.7 million in the prior year. R&D expenses increased to $8.2 million for the quarter, driven by the expansion of the clinical team, the REMEDY 2 trial, and additional reproductive toxicity testing. The company believes its current cash position will fund operations through 2027. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management successfully expanded the clinical utility of DM199 into early onset fetal growth restriction (FGR), completing enrollment for the first cohort at the 5 microgram per kg dose level. Performance in the late-stage preeclampsia extension cohort demonstrated statistically significant reductions in maternal blood pressure, with mean systolic levels remaining below the critical 160 mmHg threshold for 24 hours. Strategic dose selection for upcoming studies is being driven by a 'sweet spot' identified in the mid-dose range (cohorts 4 through 8), where management observed optimal vascular dilation without receptor desensitization. The ReMEDy2 Phase II/III stroke trial has surpassed 85% of the enrollment required for the interim analysis, supported by meaningful capacity additions from new European sites. Management attributes the potential of DM199 across stroke and pregnancy indications to its unique ability to restore nitric oxide and improve vascular biology through the BK2 receptor pathway. Operational focus in the U.S. is currently centered on addressing FDA requests for additional rat pharmacokinetic data to support the initiation of clinical development for preeclampsia. The prespecified interim efficacy analysis for the ReMEDy2 stroke trial is now anticipated in Q1 2027, following a 90-day patient follow-up and subsequent data analysis period. Management expects to host a Key Opinion Leader event in September 2026 to share top-line results from the first cohort of the Phase II fetal growth restriction study. First patient dosing for the company-sponsored Phase II early onset preeclampsia study in Canada is projected for Q4 2026, with U.K. expansion following in early 2027. Current cash and short-term investments of $43.5 million are projected to fund operations and clinical milestones through 2027. R&D expenses are expected to increase moderately as the company advances global expansion of the ReMEDy2 trial and the broader DM199 program. A protocol amendment was filed in July to adjust preeclampsia dosing regimens, providing greater flexibility to target the mid-to-lower dose range based on recent clinical findings. The U.S. IND application for preeclampsia is contingent upon a new rat study demonstrating sufficient DM199 exposure and enzymatic activity, with results expected in October 2026. Enrollment for the ReMEDy2 trial experienced a temporary slowdown in July, though management maintains the Q1 2027 timeline for the interim readout. The ReMEDy2 interim analysis will allow for a sample size re-estimate ranging from 300 to 728 patients, or a potential stop for futility. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that DM199 exhibits a nonlinear dose response where higher doses may lead to receptor desensitization, reducing the desired vascular dilation effect. The mid-dose range is considered the 'sweet spot' for improving uterine blood flow while simultaneously controlling maternal blood pressure. The primary goal is extending gestation; management noted that adding even 5-6 days could profoundly impact neonatal outcomes compared to the current 1-6 day expectation for severe cases. Secondary measures include monitoring the dilation of intrauterine arteries, where stabilization or improvement would be viewed as a highly encouraging signal. DiaMedica is shifting toward subcutaneous dosing every three days for early onset preeclampsia to improve practical application. Continuous IV infusion remains a strategic option for late-stage patients to 'dial in' blood pressure control if they approach the 160 mmHg systolic threshold. Management believes the ongoing rat pharmacokinetic study is the final piece required by the FDA to open the IND. Following the completion of reports in October, the company plans to present data to the agency to initiate U.S. clinical development.

Enrollment Complete in First Cohort of Phase 2 Early-Onset Fetal Growth Restriction Trial; Key Opinion Leader Call and Topline Results to Be Held in September Positive Topline Results from Phase 2 Late-Onset Preeclampsia Part 1a Dose-Extension Cohort, Demonstrating Rapid, Clinically Meaningful, and Statistically Significant Reductions in Maternal Blood Pressure Enrollment for Acute Ischemic Stroke Phase 2/3 Trial Progressing with Interim Analysis Anticipated Q1 2027 $43.5 million in Cash, Cash Equivalents and Investments, Anticipated Runway through 2027 Conference Call and Webcast August 11 at 8:00 AM Eastern Time / 7:00 AM Central Time MINNEAPOLIS, August 10, 2026--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today provided a business update and reported financial results for the second quarter ended June 30, 2026. Management will host a conference call Tuesday, August 11, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and second quarter 2026 financial results. "With the recent positive interim results from Part 1a of our Phase 2 study evaluating DM199 in preeclampsia, we’re eager to continue advancement of this promising candidate to address ischemic diseases in the second half of this year," said Rick Pauls, President and CEO of DiaMedica. "Preeclampsia, fetal growth restriction and stroke are areas with high unmet medical need due to the lack of approved treatment options, and we believe DM199 has the potential to provide a disease-modifying solution for patients suffering from these ischemic conditions. We look forward to sharing results of the recently completed first cohort of fetal growth restriction and initiating subsequent studies in the ongoing investigator-sponsored Phase 2, open label trial in these indications." "In Part 1a of the Phase 2 study evaluating DM199 in women with preeclampsia with expected delivery within 72 hours, the most clinically meaningful pharmacodynamic effects were observed in the mid-dose range, Cohorts 4 through 8, where patients showed reductions in both maternal blood pressure and uterine artery pulsatility index (PI). Reductions in PI are consistent with reduced uteroplacental vascular resistance, improved blood flow and the potential to modify the underlying disease process in these patient populations," said Julie Krop, MD, Chief Medical Officer of DiaMedica. "These findings represent significant progress for our preeclampsia program as they support selection of the mid-dose range for further clinical evaluation in our early-onset preeclampsia and fetal growth restriction studies." Recent Corporate Highlights Fetal Growth Restriction (FGR) Phase 2 Update: Enrollment of the first of three planned cohorts has been completed, consisting of 6 participants at the 5 µg/kg dose level. This is the first time DM199 has been used to treat early-onset fetal growth restriction patients. A key opinion leader (KOL) call is being scheduled in September, with leading preeclampsia OBGYN and study Principal Investigator Dr. Cathy Cluver, to discuss the clinical case for DM199’s therapeutic potential in FGR and top line results from the first cohort. Preeclampsia (PE) Phase 2 Part 1a Topline Results: DM199 produced clinically meaningful and statistically significant, sustained reductions in maternal blood pressure in late-onset PE. In the combined final, highest-dose cohorts (n=15; cohort 10 and extension cohort), DM199 produced a mean 29.1 mmHg reduction in systolic blood pressure (SBP) from a baseline mean of 169.3 mmHg (pDetailed Part 1a results, including pharmacokinetic and pharmacodynamic analyses, are expected to be presented at an upcoming medical conference and submitted for publication.DiaMedica is also preparing to initiate a concurrent open-label three dose Phase 2 study in early-onset preeclampsia in North America and the United Kingdom to further support Phase 3 dose selection. Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Clinical Developments: Enrollment in the Company’s Phase 2/3 ReMEDy2 (the ReMEDy2 trial – NCT05065216) trial has surpassed 85% of the 200 participants required to trigger the prespecified interim analysis. The Company now has approximately 70 activated sites across the United States, Canada, the United Kingdom, and six European countries added earlier this year, and expects the interim analysis to read out in early 2027. Health Canada Authorizes Global Phase 2 Early-Onset Preeclampsia Study: Health Canada authorized initiation of the Company’s open-label, sequential-cohort Phase 2 dose-finding study in early-onset preeclampsia, designed to enroll approximately 30 PE patients across three dose levels informed by the Part 1a results. DiaMedica is working with sites in Canada and expects to dose its first patient in the fourth quarter of 2026, and is also preparing to expand the study to the United Kingdom later this year, subject to regulatory authorization and site readiness. U.S. Regulatory Update on IND Pathway: In June 2026, DiaMedica received written feedback from the FDA regarding the nonclinical reproductive toxicity information needed to support a U.S. IND application for DM199 in preeclampsia. Based on this feedback, the Company believes that the previously completed rat reproductive toxicity study may be adequate to support IND clearance, provided DiaMedica can demonstrate adequate DM199 exposure, enzymatic activity, and pharmacologic effect in rats. DiaMedica has initiated a rat pharmacokinetic and pharmacologic activity study and, once complete, plans to submit the data package to FDA for review. Financial Results Highlights for the Quarter Ended June 30, 2026 Cash Position and Runway – Cash, cash equivalents and short-term investments were $43.5 million as of June 30, 2026, compared to $59.9 million as of December 31, 2025. Current liabilities were $6.6 million as of June 30, 2026, resulting in working capital of $37.7 million, compared to current liabilities of $5.1 million and working capital of $55.5 million as of December 31, 2025. Based on its current plans, the Company anticipates its current cash, cash equivalents and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations through 2027. Cash Flows – Net cash used in operating activities for the six months ended June 30, 2026 was $17.2 million compared to $14.7 million for the same period in 2025. The increase resulted primarily from the increased net loss, partially offset by changes in operating assets and liabilities during the current year period. Research and Development (R&D) – R&D expenses were $8.2 million and $16.1 million for the three and six months ended June 30, 2026, respectively, up from $5.8 million and $11.5 million for the three and six months ended June 30, 2025, respectively. The increases were due primarily to the expansion of the Company’s clinical team, its ongoing ReMEDy2 clinical trial, including its global expansion, costs related to additional reproductive toxicity testing performed in support of the Company’s preeclampsia program in the United States, increased manufacturing development activity, and increased non-cash share-based compensation. The Company expects R&D expenses to increase moderately in future periods relative to recent prior periods as it continues the ReMEDy2 trial, including its global expansion, and continues to expand its DM199 clinical development program into preeclampsia. General and Administrative (G&A) – G&A expenses were $2.3 million and $4.8 million for the three and six months ended June 30, 2026, respectively, up slightly from $2.2 million and $4.7 million for the three and six months ended June 30, 2025, respectively. The increase for the three-month period was driven primarily by increased non-cash share-based compensation and professional fees, while the increase for the six-month period resulted primarily from increased personnel costs incurred in conjunction with expanding our team, partially offset by a reduction in current-year legal and other professional fees. The Company expects G&A expenses to remain relatively steady in future periods compared to recent prior periods. Net Loss – Net losses were $10.1 million and $20.2 million for the three and six months ended June 30, 2026, respectively, up from $7.7 million and $15.4 million for the three and six months ended June 30, 2025, respectively. Conference Call and Webcast Information DiaMedica Management will host a conference call and webcast to discuss its business update and second quarter 2026 financial results on Tuesday, August 11, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time: Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on the Company’s website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 18, 2026, by dialing (880) 770-2030 (US Toll Free) and entering the replay passcode: 2224408#. About the Phase 2 IST of DM199 in Preeclampsia and Fetal Growth Restriction The Phase 2 study is an open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored trial of DM199 for the treatment of PE is currently being conducted at the Tygerberg Hospital in Cape Town, South Africa. This Phase 2 study consists of three studies (Part 1a, Part 1b and Part 2) in PE and a single study in FGR. Part 1a has been completed; the FGR study has initiated enrollment, and its first cohort of 6 participants has been enrolled; and Parts 1b and 2 are expected to initiate in September or October of 2026, as follows:" Preeclampsia (PE) Part 1a late-onset PE: dose-escalation study evaluating single intravenous (IV) / single subcutaneous (SC) DM199 doses in late-onset PE subjects enrolled within 72 hours of delivery, including a confirmatory extension cohort of up to 12 participants at the cohort 10 dose level, which was completed in June 2026. Part 1b late-onset PE: dose-expansion study evaluating continuous IV infusion in up to 30 late-onset PE subjects enrolled within 72 hours of delivery, using a dosing level identified in Part 1a; initial enrollment expected in September or October 2026. Part 2 early-onset PE: evaluation of repeated SC dosing of DM199 in up to 30 early-onset PE subjects until delivery (expectant management), using three dose levels at 5, 10 and up to 15 µg/kg. The dose for the third cohort will be between 1 and 15 µg/kg based on results from the first two cohorts; initial enrollment expected in September or October 2026. Fetal Growth Restriction (FGR) Part 3 early-onset FGR: evaluating repeated SC dosing in up to 30 early-onset FGR subjects until delivery, using up to three dose levels initially based on Part 1a data; enrollment commenced in June 2026 and the first cohort of 6 participants has been enrolled. Dosing levels are at 5, 10 and up to 15 µg/kg. The dose for the third cohort will be between 1 and 15 µg/kg based on results from the first two cohorts. About Fetal Growth Restriction Fetal growth restriction (FGR) occurs when a fetus fails to reach its genetically determined growth potential in the womb, most commonly due to placental insufficiency. FGR affects an estimated 10% of pregnancies worldwide and is associated with significantly increased risks of stillbirth, preterm birth, and neonatal morbidity, as well as long-term neurodevelopmental, cardiovascular, and metabolic complications. In severe, early-onset cases, FGR often necessitates delivery before 32 weeks of gestation, when the risks of prematurity must be weighed against the dangers of continued growth restriction in utero. See the recently released white paper, "The Potential of DM199 to Treat Fetal Growth Restriction." About Preeclampsia Preeclampsia is a serious pregnancy disorder that typically develops after the 20th week of gestation, characterized by high blood pressure and damage to organ systems, often the kidneys and liver. Affecting up to 8% of pregnancies worldwide, preeclampsia can pose significant risks to both the mother and baby, including risk of stroke, placental abruption, progression to eclampsia, premature delivery, and death. Preeclampsia occurs in two stages. First, in early pregnancy, the placenta fails to embed properly in the wall of the uterus, and the spiral arteries in the uterine wall that are supposed to dilate to promote healthy blood flow to the placenta do not widen. Stage 2 then occurs after 20 weeks of pregnancy as the placenta, which has been chronically starved of oxygen from the blood, begins to release noxious factors into the mother’s circulation, inflicting widespread damage to her blood vessels and causing systemic endothelial dysfunction. Symptoms may include severe headaches, vision changes, upper abdominal pain and swelling in the hands and face. Delivery of the baby, often very prematurely, is the only available option for stopping the progression of preeclampsia. Women who have had preeclampsia have three to four times the risk of high blood pressure and double the risk for heart disease and stroke. About Acute Ischemic Stroke Acute ischemic stroke (AIS) occurs when a blood clot blocks a vessel supplying blood to the brain, leading to a sudden loss of oxygen and nutrients and, if not corrected, ultimately neuronal cell death. According to the U.S. Center for Disease Control, stroke causes approximately one out of every 20 deaths in the U.S. each year, and nearly nine out of 10 strokes are ischemic. No new therapeutics have been approved for acute ischemic stroke in over 25 years. When a blood vessel in the brain becomes blocked during a stroke, a core area of the affected brain tissue will typically suffer a nearly complete loss of blood flow, while the surrounding area (the "ischemic penumbra") receives only about 20-40% of normal blood flow. Cells in the core area are rapidly depleted of their oxygen and glucose stores, leading, often within minutes, to cell death. The cells in the penumbral area may remain viable for several hours but are eventually at risk of damage. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at www.diamedica.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "will," or "would," the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the timing, nature and requirements for regulatory applications and approvals, including its application for an IND for the study of DM199 as a treatment for preeclampsia and fetal growth restriction and its conducting a Phase 2 trial in these indications; continued ReMEDy2 trial enrollment and timing of the interim analysis; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke; future R&D and G&A expenses and the Company’s projected cash runway. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing and outcomes of non-clinical studies; risks and uncertainties relating to the timing of studies and trials; risks and uncertainties relating to the clinical expansion into preeclampsia and associated trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction, and acute ischemic stroke and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia, fetal growth restriction, and acute ischemic stroke; and the risks identified under the heading "Risk Factors" in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports, including our most recent quarterly report on Form 10-Q. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260810989621/en/ Contacts Scott KellenChief Financial OfficerPhone: (763) [email protected] For Investor Inquiries: Mike MoyerManaging Director, LifeSci Advisors, LLCPhone: (617) [email protected] Media Contact: Madelin HawtinLifeSci [email protected]

Image source: The Motley Fool. Thursday, May 7, 2026 at 8 a.m. ET Chief Executive Officer — Dietrich Pauls Chief Medical Officer — Dr. Julie Krop Chief Financial Officer — Scott Kellen Need a quote from a Motley Fool analyst? Email [email protected] Dietrich Pauls: Thank you, Morgan, and thank you all for joining us for our fiscal year 2025 earnings call. With me this morning are Dr. Julie Krop, our Chief Medical Officer; and Scott Kellen, our Chief Financial Officer. Looking back for a moment, 2025 is a year in which we made significant progress across our pipeline, achieving a number of key milestones. As most of you know, our lead candidate, DM199, is a recombinant form of the naturally occurring KLK1 protein, a serum protease that acts through the bradykinin 2 receptors in the walls or endothelium of our blood vessels to increase the level of nitric oxide, prostacyclin and endothelial-derived hyperpolarizing factor. The combination of these factors has the potential to more effectively enhance blood flow and vascular health than any other factor given by itself. We believe that this mechanism is why DM199 is so well suited to improve patient outcomes for preeclampsia, fetal growth restriction, acute ischemic stroke and other indications associated with vascular pathology. I'll now turn the call over to Julie to provide an update on our preeclampsia and stroke programs. Julie Krop: Thanks, Rick, and good morning, everyone. Starting with our preeclampsia program, 2025 marked a very strong year of progress. In July, we announced positive interim results from Part 1a, the ascending dose portion of our investigator-sponsored Phase II trial being conducted in South Africa. These results showed that DM199 produced statistically significant reductions in blood pressure and in the uterine artery pulsatility index, consistent with reductions in vascular resistance that suggest a potential improvement in blood flow to the placenta. Importantly, the interim data demonstrated that DM199 did not cross the placental barrier. These interim results were observed in hypertensive women expected to deliver within the next 72 hours. We believe these results demonstrate an on-target mechanistic response, which supports DM199's potential to be a first-in-class disease-modifying therapy for preeclampsia. Key findings from the interim analysis of Part 1a, specifically from Cohorts 6 through 9 in pregnant women with preeclampsia planned for delivery within 72 hours include the following: First, blood pressure data demonstrated clear dose-dependent and statistically significant sustained reductions in both systolic and diastolic blood pressure, underscoring DM199's potential to control maternal hypertension associated with preeclampsia. Second, DM199 significantly reduced the uterine artery pulsatility index, a Doppler-based measure of arterial resistance that suggests improved uteroplacental perfusion. Third and most importantly, DM199 did not cross the placental barrier, placing it in a unique position with respect to safety and reduced fetal risk in this highly vulnerable patient population. Through additional analysis, we have also demonstrated that DM199 does not pass to babies through breast milk, further reinforcing its confinement to the maternal circulation. This advantageous safety profile combined with DM199's novel mechanism of action may enable earlier initiation and longer treatment duration, which has the potential to drive meaningful prolongation of pregnancy without added safety burden. We believe the observed improvements in vascular resistance reflect restoration of normal endothelial function, consistent with an on-target mechanistic response to DM199 therapy. By improving endothelial health, DM199 has the potential to address the underlying vascular dysfunction driving the disease that should result in stabilization of maternal vascular pathology and prolonged pregnancy as opposed to current therapies that simply manage symptoms. Taken together, the ability to reduce blood pressure, improve uterine placental perfusion and restore endothelial function reinforces our belief in DM199's potential to be a first-in-class disease-modifying therapy for this life-threatening condition for which there are currently no approved treatment options. During the fourth quarter, under the leadership of Professor Cluver, enrollment continued in the Part 1a expansion cohort, which will include up to 12 additional patients to provide us with a more comprehensive data set. We anticipate completion of this cohort in the first half of 2026. Protocol amendments are being finalized for Part 1b and 2 of the study. Part 1b will enroll up to 30 hypertensive women with late-stage preeclampsia expected to deliver within 72 hours to further confirm the Part 1a results. These participants will receive continuous IV administration of DM199 that will be titrated to maintain blood pressure in the targeted range. Part 2 will enroll up to 30 women with early onset preeclampsia, who are candidates for expected management where the therapeutic goal is to prolong the pregnancy as long as possible while also providing increased blood flow to promote larger, healthier babies. These protocol amendments represent refinements to the previous treatment regimens based upon learnings from Part 1a. The fetal growth restriction cohort will be enrolling patients without preeclampsia, but with impaired placental function, further expanding the potential application of DM199 across placental vascular disorders. The first patient in that cohort is anticipated to be dosed in Q2 2026. Importantly, we have also recently received regulatory clearance from Health Canada to initiate a global Phase II clinical trial of DM199 in early onset preeclampsia. This is an important regulatory milestone for our PE program. We are currently finalizing plans to commence site activation in the second half of the year. We intend this trial to be a global Phase II study. It is an open-label dose-finding trial designed to enroll approximately 30 participants with early onset preeclampsia between 24 and 32 weeks of gestation. This expected management population represents patients with the greatest unmet medical need where safely prolonging pregnancy can have the most meaningful maternal and neonatal impact. The study will evaluate the safety, tolerability and preliminary efficacy of DM199 with dosing anticipated to continue until delivery. We are assessing 3 dose levels to inform dose selection of the optimal regimen for Phase III. Primary study endpoints include maternal pharmacokinetics and further confirmation that DM199 does not cross the placental barrier, an important safety consideration for both regulatory review and patient acceptance. In addition, we will evaluate clinical and biomarker outcomes, including prolongation of pregnancy, blood pressure control, uterine artery blood flow, circulating pathogenic biomarkers and renal function. We are also preparing to seek approval to expand the study to include sites in the U.K. And with respect to the additional reproductive tox study in rabbits requested by the FDA, preliminary results from a dose range finding study in rabbits suggests that rabbits may not be a suitable animal model for reproductive toxicology studies with DM199. This is likely due to an unusual immune response to the recombinant human protein unique to rabbits that has not been seen in rats, monkeys or humans thus far. Most importantly, from our perspective, there were no teratogenic effects observed in the approximately 200 pups or baby rabbits produced in a prior study. This included no external visceral or skeletal malformations. We are currently evaluating an alternative animal model to address the FDA's request, and we will work with FDA to find a solution in parallel to initiating the Phase II trial in Canada and other potential jurisdictions. Turning to our ReMEDy2 trial. 2025 was also a good year for our stroke program. Over the past several months, we have intensified our engagement with study sites to share best practices and build friendly competition. We've also added additional resources to support sites through the enrollment and follow-up process, and we continue to work on additional ways to support our study sites. These activities, along with increased site activations globally have resulted in encouraging enrollment momentum over the last few months. At present, I'm very pleased to report that with these additional efforts in the United States and Canada, along with expansion into the U.K. and Europe, we have achieved almost 70% of the required enrollment of 200 participants for the interim analysis. We currently have close to 61 active sites, including 4 in the U.K. and an additional 12 across Europe, and approximately 25 more sites are expected to activate in the coming quarter. With our recent progress, we are reiterating our guidance to complete the interim analysis by the second half of 2026. Since the last earnings call, an independent Data Safety Monitoring Board meeting was conducted after the enrollment of 100 patients. Following review of the safety data from these participants, the independent DSMB unanimously recommended that enrollment continue without modification. I will now turn the call back to Rick. Dietrich Pauls: Thanks, Julie. We're also pleased to note the paper titled Endothelial Triple Pathway Basal Relaxation as an adjuvant strategy in resistant hypertension was recently published in the Journal of Hypertension. The article authors included Dr. Luke Laffin, a recognized key opinion leader in the treatment of resistant hypertension. This publication underscores the need for new treatment approaches to lower blood pressure in patients with chronic kidney disease. It also highlights findings from our prior Phase II REDUX trial, which demonstrated DM199's ability to significantly reduce blood pressure in patients with elevated levels over a 3-month treatment period. DM199 was also observed to lower serum potassium levels in patients whose potassium levels were elevated, placing these patients at risk of developing hyperkalemia. We look forward to sharing more on the potential use of DM199 to control blood pressure in patients with chronic kidney disease in the future. I would like to now ask Scott to review the financial results for the quarter. Scott Kellen: Thank you, Rick, and good morning, everyone. We announced our full year financial results for 2025 and filed our annual report on Form 10-K yesterday. As of December 31, 2025, our cash, cash equivalents and short-term investments were $59.9 million. Current liabilities were $5.1 million and working capital of $55.5 million compared to cash and investments of $44.1 million, current liabilities of $5.4 million and working capital of $39.2 million as of December 31, 2024. The increase in cash and short-term investments is due to the net proceeds received from the sale of common shares in the company's July 2025 private placement and under its at-the-market offering program. We feel confident about our cash position and anticipate it will fund our planned clinical studies and corporate operations through the end of 2027. Net cash used in operating activities for the full year 2025 was $29.1 million compared to $22.1 million for the full year of 2024. This increase is primarily a result of the increase in net loss for the full year of 2025 as compared to the prior year period. Turning to the income statement. Our research and development expenses increased to $24.6 million for the year ended December 31, 2025, up from $19.1 million for the prior year. This $5.5 million increase is driven by a combination of factors, including the continuation of our ReMEDy2 clinical trial and its global expansion, the expansion of our clinical team in both the prior and current year periods and increased noncash share-based compensation costs. These increases were partially offset by cost reductions related to manufacturing process development work performed and completed in the prior year period. Our general and administrative expenses were $9.8 million for the full year 2025, up from $7.6 million for the full year 2024. G&A expenses increased by $2.2 million due to a number of factors, including increased noncash share-based compensation expense, increased personnel costs, increased investor relations expenses and increased patent prosecution costs. With that, let me ask the operator to open the lines for questions. Operator: [Operator Instructions] Your first question comes from Stacy Ku with TD Cowen. Stacy Ku: So we have a couple. If we could just stay with preeclampsia for now. The first question is on kind of your update with the rabbit preclinical trials for the U.S. IND approval. So just help us understand what are your early thoughts on the alternative species with the FDA? Are there -- what other preclinical models are best for reproductive tox studies? So that's the first question. If you could maybe further elaborate there. And then as we think about the ISP and clearly, a lot of great signals that we're going to get -- continue to get there, what key learnings are you hoping to carry into the early onset preeclampsia kind of cohort? As we think about Part 2 and Part 3 so fetal growth as well. Is there any potential that we can get an update later this year? So just help us understand where you all are in potential timing there? And then, of course, ahead of the U.S. trial, Julia, we kind of heard all the high level of preparation ahead of moving forward in the U.S., but just help us understand how our conversations progressing? What criteria is the team focused on when it comes to enrolling the right preeclampsia study investigators. And then if I could sneak in a tiny question on CKD. Clearly, a big opportunity. When could we expect a detailed plan or a more detailed plan for pursuing DM199 in treatment-resistant hypertension in CKD patients? Dietrich Pauls: So I'll start off maybe with the CKD, the fourth question is that we're very excited about the opportunity for our drug to lower blood pressure. We've clearly seen it in numerous trials. I think there's a huge clinical need, in particular in patients with chronic kidney disease as many of these patients have elevated levels of potassium that puts these patients at risk of hyperkalemia. So I think first, we can treat these patients, control their blood pressure when they frankly don't have a lot of options and what we did see in our previous trial, the ability to lower potassium levels, which could be a very exciting opportunity. Right now, really the focus though is on our preeclampsia and stroke program. And at the appropriate time, we'll look at potentially advancing into CKD. But right now, we want to make sure we're really focused here near term on our other 2 programs. And then maybe I'll hand it off to Julie. Julie Krop: Yes. Stacy, all very good questions. I think it's premature right now to tell -- to say exactly which species that we're going to focus on. We want to first be able to -- we submitted a package to the FDA, and we're having a discussion with them further on appropriate models. There are several appropriate models we're considering. But again, we'll hold back until we will give an update once we have that discussion. And then with regards to your question around what have we learned from previous cohorts, I think I think we understand the PK better after running the initial studies. And one -- one of the learnings we're taking forward is for our early onset studies using the subcutaneous only and probably reserving the IV for the later onset as we've been doing previously. So that was one element. I think as far as site selection, we are highly focused on selecting sites that have both experience with preeclampsia studies as well as a practice that's well suited for early onset expectant management, which is something -- some sites are very adept at and other sites are more conservative about when to deliver patients. So again, it's that tight rope between treating -- between the mother's health and the baby's health and making sure that we select centers that are comfortable keeping the mother even though there's some severe -- there's potentially severe complications going on, it feels like they can stabilize them enough to prolong the pregnancy. So those are kind of the considerations that we're focused on. Operator: Your next question comes from Josh Schimmer with Cantor. Joshua Schimmer: Two quick ones. For the evaluation of DM199 in earlier onset preeclampsia, how do you think about the potential risk of the protein crossing the placental barrier at that stage? And what evidence do you have to suggest that it in that setting as well will not cross in any meaningful extent to the placenta? And then for the interim analysis for the Phase II/III stroke program, what are the potential outcomes there? Are there stopping criteria either positive or negative or resizing criteria? Maybe you can share a little bit more about what you expect the interim to inform? Dietrich Pauls: Sure. Thanks, Josh. So starting off with the early onset and crossing of the placenta. We don't think it will happen. I mean we've done now over 35-plus patients with more late onset preeclampsia where we didn't see this crossing. To cross the placental barrier is about -- the size to cross will be about 500 daltons, where our protein is about 26 kilodaltos, so 50x larger. So it would be very shocking if it did occur. We also did an earlier study in the rat model, we also did not see it. So it's just -- I think we're at this point here, another check the box, but we feel very good the fact that in the South African patient population, we didn't see it. With regards to your second question, the ongoing Phase II/III stroke program, for the interim analysis, first off, if we're not seeing a drug effect, we will terminate the study for lack of efficacy. Otherwise, there'll be a resample size and the sample size will range from 300 to 728. How we designed this trial, and we believe a base case that if we're seeing a drug effect that's comparable to our Phase II, which is comparable to the many studies that have been shown with the human urinary form of the study in China. Looking at the modified ranking score of 0 to 1 as the primary endpoint, we're anticipating that if we see, again, a drug effect comparable, we'll be looking at something ideally in the 300 to 350 range. If we need to go above 500 patients, we'll have to really evaluate the next steps for the program in light of the high prospects we think as well for the preeclampsia program. Operator: Your next question comes from Thomas Flaten with Lake Street. Thomas Flaten: Just a question on the Part 1a expansion cohort. It strikes me that it's taking a bit longer than I might have thought in my mind given how many patients Dr. Cluver sees on a weekly basis. Is this a slow and deliberate approach she's taking? Or has something else been going on there? Just some additional color on that expansion cohort would be great? Dietrich Pauls: Sure. Yes, it's a good question. It really has been a result of some staffing challenges that Cathy Cluver has had at her site. We've recently provided some additional financial support. And with the hiring of a couple of new nurses just in the last few weeks, we anticipate that enrollment is going to pick up again. Thomas Flaten: And then following on from that, if I understood the press release and your commentary correctly, are Parts 2 and 3 -- are Parts 1b and 2, sorry, dependent on the completion of the expansion cohort? Or will they initiate prior to the full completion of that cohort? Dietrich Pauls: Those -- so we've made a few protocol amendments that are going through shortly. And so we're anticipating later in Q2 that those 2 cohorts should initiate. Part 1a expansion study is ongoing and will be completed as well in Q2. Thomas Flaten: Got it. Understood. And then just a quick one on ReMEDy2. You mentioned some acceleration or some momentum building. I was wondering if you could just give us a sense of in the first quarter of this year, how many patients did you enroll compared to what you did in the fourth quarter of last year, just to give us some kind of scope and scale of that momentum? Dietrich Pauls: Yes. I would just say at a high level, the enrollment increase really has been more so it's been this year. So even going into the end of 2025, it was still relatively slow, but it really has picked up substantially in the last month, last 2 months. But really, the more recent months is where we've seen the really uptick. And that also correlates to where we've had the increase in sites and all the work that Julia and her team have been doing has been wonderful. And I think we're now starting to see the benefits of all that work. Operator: Your next question comes from Matthew Caufield with H.C. Wainwright. Matthew Caufield: For the ReMEDy2 trial, there had been some prior discussion of some challenges with stroke enrollment formally being slower in the U.S. due to initial triage in the community hospitals. Kind of thinking bigger picture, do you ultimately foresee any limitations for real-world access if or when DM199 could ultimately be approved for the AIS indication? Dietrich Pauls: Yes. Good question. So I think there's a difference between the challenges that we had been seeing with enrolling at more of these hub-and-spoke hospitals. But ultimately, for commercialization, the wonderful thing about our drug is the safety profile should be great in being able to be used very broadly at small community hospitals and big academic centers. So I think that the previous challenge we're having is really more with enrolling patients at the large academic centers. But in terms of -- again, at the commercial side, I think it will be a wonderful drug because of that safety profile. Operator: Your next question comes from Chase Knickerbocker with Craig-Hallum. Chase Knickerbocker: I was just hoping to work one more in on the nonclinical side here. Can you just maybe walk us through kind of the differences in your prior nonclinical rabbit study that you had kind of mentioned where you didn't see any toxicity in this one? Was there kind of a different species used here? Or maybe just kind of your biological rationale as to why this antibody response arose? Dietrich Pauls: Yes, Julie, can you take that one? Julie Krop: Yes. So that's a very good question. The first study was a different gestational age time period for the pre- and postnatal rabbit study. We studied an earlier -- I mean, a slightly later gestational age as well as a slightly different duration of treatment, different doses. So it's hard to explain. We did see maternal toxicity in that study as well. It wasn't quite as significant. But I think the difference here and the issue really with the FDA is not related to concern on the part of the fetus -- I mean, sorry, the pups, if you will. The pups really did not show any increase in malformations or teratogenicity from the control group in either study. But I think the concern with the FDA is finding a NOAEL effect dose where they don't see any adverse effects and the maternal toxicity that we saw, which we believe is due to immunogenicity, which is not uncommon to see in rabbits and immune responses very quickly to human proteins. So I think really, it was in both studies, we weren't -- we had maternal toxicity. So I don't think they were really that different other than gestational ages being different and the FDA wanting us to dose primarily after the first trimester after the development -- the early development of the fetus because that's closer to the way we're going to dose humans. So it just turns out, I think the rabbits just are not a good species, and we're going to just have to do it in a different species. Chase Knickerbocker: Got it. And then just maybe a little bit on time lines as far as when you'd expect to get that feedback that you need to continue with the different species or just kind of color from FDA on what they would like to move forward. Do you have a meeting scheduled in Q2? Maybe just walk us through time lines there. Julie Krop: So we are going to -- we'll provide an update as soon as we have something to update. I don't think we're giving a forecast yet until we understand and get alignment from the FDA on the path forward. Chase Knickerbocker: Understood. And then just last for me, Rick, on the stroke timing, could you just give us a little bit more color as to kind of what you're seeing from an enrollment rate perspective? I mean, is it kind of being driven by kind of breadth increasing? Or is that depth really kind of increasing as we thought it would to kind of drive this acceleration in enrollment in the stroke study? Dietrich Pauls: Yes. And it's a combination of, in particular, over the last few months, an increase in the enrollment rate per site and also for a greater number of sites. And then with being at 61 sites now and having sites having a chance to be in the trial and understand some of the challenges and opportunities of running the trial. And then I think also having a number of sites that are also on the verge of coming on board here in the coming weeks, we feel good about reiterating our guidance for this year. Operator: That concludes our question-and-answer session. I would like to now turn the conference back over to Rick Pauls, DiaMedica's President and Chief Executive Officer, for closing remarks. Dietrich Pauls: Well, thank you all for joining us today. We greatly appreciate your interest in DiaMedica and hope you enjoy the rest of the day. This concludes our call. Thank you. Operator: This concludes today's call. Thank you so much for attending. 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Image source: The Motley Fool. Thursday, May 7, 2026 at 8 a.m. ET Chief Executive Officer — Dietrich Pauls Chief Medical Officer — Dr. Julie Krop Chief Financial Officer — Scott Kellen Need a quote from a Motley Fool analyst? Email [email protected] Dietrich Pauls: Thank you, operator, 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. Given that our last call was only 5 weeks ago, we'll try to keep our remarks short. We are pleased with the progress we've made so far in 2026 as we continue to advance DM199 across both our preeclampsia and acute ischemic stroke programs. Most importantly, for our shareholders, we're poised to deliver multiple clinical milestones between now and the end of 2027, all of which could provide significant validation of the value of DM199. We also weigh the risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts. We're particularly interested in completing the interim analysis for our stroke program. We've been working diligently on the ReMEDy2 stroke trial for a long time, battling through some significant challenges emanating from the COVID pandemic. With enrollment having surpassed 70%, we expect that the interim analysis will validate all of the hard work that has gone into the program. I now turn the call over to Julie to provide additional detail on our preeclampsia and stroke programs. Julie Krop: Thank you, Rick. In the Phase II investigator-sponsored trial, enrollment is near completion in the extension cohort for the Part 1a dose escalation study in late-onset preeclampsia patients. Late onset patients are planned to deliver within 72 hours. This cohort will allow us to detect the dose or doses we plan to use for the upcoming cohorts of the IST. We expect to complete this cohort and provide a data update later this quarter. As you may recall, the interim results from this study demonstrated DM199's potential to reduce blood pressure and improve placental perfusion without crossing the placental barrier. While we only have data in a relatively small number of patients, the results we observed were highly consistent and encouraging. We look forward to sharing the data from the extension cohort to further support the interim results. Additionally, learnings from Part 1a are guiding protocol amendments for the 2 remaining preeclampsia study groups. The first group referred to as Part 1b is an expansion study with up to 30 additional late-onset preeclampsia patients who will receive DM199 as a continuous IV infusion until delivery. In this cohort, we hope to learn more about the ability of doctors to use DM199 to effectively support blood pressure control management at this late stage of the disease. The second part referred to as Part 2 will study up to 30 early onset preeclampsia patients. Three doses will be evaluated to support dosing for a Phase III trial and an optimal dose level to extend the time mom is able to carry the baby, increasing the gestational age at the delivery. As you've seen in our investor presentations, the medical complications for the baby are expected to decrease significantly the longer mom carries the baby. With the potential for DM199 to help manage blood pressure and improve blood flow to the placenta, we believe DM199 has a chance to be a transformative therapy for preeclampsia. Initiation of these 2 preeclampsia cohorts which will recruit concurrently, is expected to begin after the completion of the ongoing Part 1a extension cohort. The IST also includes a study in women experiencing fetal growth restriction. In this group, we will be evaluating the effects of DM199 on fetal growth restriction in patients without preeclampsia. FGR is a condition with diminished fetal growth due to a poorly functioning placenta, the life support system of the unborn child. FGR is the leading cause of stillbirth and for infants that survive the FGR pregnancy, it is associated with enduring adverse health effects over the child's lifespan. In this cohort, we will evaluate the potential for DM199 to increase placental perfusion and improve fetal development. Enrollment of the first patient for this study is expected in the current quarter. In parallel with the IST, we are advancing our global Phase II study in early onset preeclampsia. We intend to conduct this study in North America, both the United States and Canada and the United Kingdom. In March 2026, we received approval from Health Canada to initiate this study and study sites have been selected. We are working to initiate enrollment in Canada by the end of this year. We expect to file a clinical trial application in the U.K. in the current quarter. With respect to the status of the IND submission in the United States, as we discussed previously, the FDA requested an additional nonclinical 10-day modified embryo fetal development and pre- and postnatal development study in a rabbit model. Results of a non-GLP dose-ranging study in rabbit suggest that the animals developed an adverse immune response to DM199, preventing us from completing the requested modified pre- and postnatal development study in a rabbit model. We have proposed to the FDA performing this study in a second rodent model and are awaiting their response. That said, I would highlight for everyone that we are moving forward in parallel with the study in Canada and are planning to add U.K. sites while we complete any additional preclinical work requested by the FDA. This study will evaluate 3 dose groups of DM199 in patients with early onset preeclampsia to further establish safety, pharmacokinetics and pharmacodynamics in a more ethnically diverse patient group prior to initiating a registration study. Turning now to our stroke program. We are encouraged by the continued progress on the ReMEDy2 trial. Enrollment has now surpassed 70% of the target required for the interim analysis. Site activations and enrollments have recently commenced in Europe as well. In addition to the United States, Canada and the U.K., we've added 6 additional European countries and now have approximately 70 sites activated. In April, we sponsored an investigator meeting for our European study team that was well attended and had many productive sessions and discussions, which we believe are the key to getting the study teams excited about and focused on patient enrollment. And we are reiterating our intention to complete the interim analysis by the end of 2026. As a reminder, in the Phase II ReMEDy1 stroke study, treatment with DM199 was associated with clinically meaningful improvements in functional outcomes for the patient group that most closely resembles the patients enrolling in our ReMEDy2 trial. In the subset of patients that did not undergo a thrombectomy, we observed a 15% absolute increase over placebo in the proportion of patients achieving favorable recovery as measured by a score of 0 or 1 on the modified Rankin Scale. Furthermore, ReMEDy2 is enrolling patients presenting with moderate stroke severity defined as an NIHSS score between 5 and 15. Looking at that subgroup in the ReMEDy1 study, there was a 19% absolute improvement over placebo in functional outcomes. There was also a 50% reduction in the number of patient deaths and a 13.3% reduction in recurrent strokes compared to placebo. These data inform the design and powering assumptions for the ongoing ReMEDy2 trial. I think you can understand why we are eagerly awaiting the results of the interim analysis. Let me now turn the call back to Rick. Dietrich Pauls: Thanks, Julie. I'd like to now ask Scott to review the financial results for the quarter. Scott Kellen: Thank you, Rick, and good morning, everyone. We announced our first quarter 2026 financial results and filed our quarterly report on Form 10-Q yesterday after the markets closed. As of March 31, 2026, our cash, cash equivalents and short-term investments were $51.3 million, current liabilities were $5.7 million and working capital was $46.6 million compared to cash and investments of $59.9 million, current liabilities of $5.1 million and working capital of $55.5 million as of December 31, 2025. We anticipate that our current cash and investments will be sufficient to fund our planned clinical studies and operations through 2027. Net cash used in operating activities for the first quarter of '26 was $9.1 million compared to $7.1 million for the first quarter of 2025. The increase in cash used in operating activities resulted primarily from the increased net loss for the current year period, partially offset by changes in operating assets and liabilities during the current year quarter. Turning to the income statement. Our research and development expenses increased to $8 million for the 3 months ended March 31, 2026, up from $5.7 million for the same period in the prior year. The increase is due primarily to the increased costs resulting from the continuation of our ReMEDy2 clinical trial and its global expansion, the expansion of our clinical team and costs related to additional reproductive toxicity testing being performed in support of our PE program in the United States. These increases were partially offset by net cost reductions in manufacturing development activity related to work performed and completed in the prior year period. We expect that our R&D expenses will moderately increase in future periods relative to recent prior periods as we continue our ReMEDy2 trial and continue to advance our DM199 clinical development program into PE. Our general and administrative expenses were $2.5 million for the 3 months ended March 31, 2026, and 2025. While small changes occurred within a number of expense categories, the differences were not material individually or in the aggregate and the overall net changes offset each other. We expect G&A expenses to remain relatively consistent in future periods as compared to recent prior periods. With that, let me ask the operator to open the lines for questions. Operator: Your first question is from the line of Josh Schimmer with Cantor. Joshua Schimmer: The preeclampsia data updates that we'll get this quarter for the late onset cohort, what incremental observations should we be looking for beyond blood pressure control? Obviously, preeclampsia can affect urine output, kidney function, liver function platelets and biomarkers like sFlt. At what point will you have data to share on those parameters? Dietrich Pauls: Yes. Thanks, Josh. So the expansion cohort that we're running is going to be 12 additional patients. We're almost completing that right now. It's going to be at the cohort 10 from the Part 1a. And so it's really just going to give us additional clarification here, particularly on blood pressure, dilation of the intrauterine arteries. At this point, we're really not expecting any changes in some of the biomarkers like sFlt because these patients really only got 2 doses. It's really we believe that having the drug on board for ideally a week, 2 weeks that we really would see some of those biomarkers improve. Joshua Schimmer: Okay. Got it. So I think at one point, the lead investigators suggested that there was an improvement in edema at the very least maybe might be something that can improve within a short period of time. Is that something you're looking for? Dietrich Pauls: Yes, that's something that if there is an improvement in endothelial health, and it is something that Dr. Cathy Cluver very clearly seen in some of these patients that the edema did resolve even within 12 to 24 hours of getting DM199, which is encouraging. It's a small number of patients, but we'll be looking to see maybe there's some additional insight there as well. Joshua Schimmer: Just a couple of other quick questions, if I may. What are the steps to start initiating enrollment in the early onset preeclampsia study? Why is that not going to occur until later this year? Dietrich Pauls: Yes. Julie, do you want to take that one? Julie Krop: Yes. Are you referring to the IST cohort? Or are you referring to the -- to our sponsored trial? Joshua Schimmer: Sponsored trial. Julie Krop: Yes. We are in the midst of getting our dosing data from -- again, from the IST study before we select our final doses for that protocol as well as getting sites contracted up and running and our CRO selection process, all of that completed and then we'll be initiating. So it's a combination of factors, but we should be again in Canada later this year. Joshua Schimmer: And then last sorry... Dietrich Pauls: Sorry, if I can add. And so importantly, as we mentioned, so we have selected the 2 sites in Canada and one site in particular, is already in our stroke trial. So we're looking forward to leveraging the relationships, the existing contract that we have to basically doing what we can to expedite and get those sites activated as soon as we can. Joshua Schimmer: Got it. And then last question, timelines for completing the second animal toxicology study and then ultimately reengaging with the FDA for IND. Dietrich Pauls: Yes. So it will really depend on the feedback that we get from the FDA. And so it is a rat study that we proposed. And if they agree to that, that's a matter of a few months, probably 3 to 4 months to complete. And so again, while that's all happening, we'll be running the Phase II in Canada and then expanding to the U.K. Operator: Your next question is from the line of Stacy Ku with TD Cowen. Stacy Ku: So we have a couple of questions. So I guess, first, follow-ups. When could you expect to hear from the FDA on the mouse study? And is there a possibility the FDA could ask for another animal model? And how are you looking to prepare for all these different scenarios? It sounds like the rat study is pretty straightforward, but just help us understand how you view the next 2 necessary steps. And again, just to clarify, it sounds like you are expecting a potential study initiation of the global Phase II by year-end. Just want to make sure you're reiterating that time line. And then we're looking forward to the updated preeclampsia results in Q2. But as we think about the early onset preeclampsia or fetal growth restriction subgroups of the IST, could we think about any potential for low-dose updates by year-end for either of these groups? And then, Julie, just a clarification again, what is the timing of potentially starting the early onset preeclampsia IST? And then last, just a reminder, what's the go and no-go decisions on the interim results for stroke? I can repeat some of these questions. Dietrich Pauls: Okay. Great. So we'll try to take those. I'll start off here. Maybe Julie, you can help me out here. So in terms of the -- we did our submission to the FDA over a month ago. And so we're just waiting to hear the feedback. So as soon as we get clarity from the FDA, we'll provide an update. We have looked at alternative kind of backup plans in case they want something different. But we think we've got a very strong rationale for the proposed rat study. And I think it's encouraged that the Health Canada has already approved us to start the trial in Canada. With the PE trial in terms of, yes, potential that we could get some data as soon as we have a cohort that's completed and we see some compelling data, we would look at potentially press releasing or getting that at a late-breaking conference. And the last question that you had with regards to the outcomes of the interim analysis for the stroke program. First, we'll do a futility analysis. So if there's not a drug effect, we'll terminate. Otherwise, there'll be a resample size. And the resample size will be between 300 and 700 patients. And we believe if we see a drug effect comparable to what we see from our Phase II, which is comparable to the data we've seen with the data with the human urinary form in China, and there's about 1 million patients either being treated with that form. We would look at completing the enrollment in the following quarter. Operator: Your next question is from the line of Thomas Flaten with Lake Street. Thomas Flaten: Rick, just following up on that last response, just to clarify, given that you've got 70-plus sites and 70% enrolled, if you -- when you said we're going to complete enrollment in the following quarter, do you mean the first quarter of '27 or the -- which quarter were you referring to on the full enrollment? Dietrich Pauls: Yes. So assuming that we have the interim analysis at the end of this year, then we would anticipate completing the enrollment the following quarter, so the Q1 of next year. Thomas Flaten: And does that assume an upsize in the total population? Because it seems to me it's only May. And by year-end, when the interim analysis reads out, you should be pretty close to full enrollment on the original study size, right? Dietrich Pauls: We will be. So that after patient 200 is dosed, there'll be a 30 -- sorry, a 90-day window here for the primary endpoint and then another approximately 4 weeks for the interim analysis to occur. And during that approximately 4 months, we'll be continuing to enroll. So we'll be getting closer to the 300 patient number during that period of time. Thomas Flaten: Got it. And then just to clarify a prior response. So once you get the Part 1a expansion data out this quarter, there's -- is it reasonable to assume that you would start Part 1b and Part 2 in the third quarter? Or should we expect maybe a fourth quarter start on that? Dietrich Pauls: No, those should be starting here this summer. And so we're just -- we finalized the dosing that will be going into those cohorts. So we'll be doing 3 doses at 5, 10 and 15 micrograms per kg subcutaneous every 3 days until delivery. So those cohorts should be starting very soon. We had some -- we've now got our sites, Cape Town South Africa has had some challenges with some staffing and they've added some new staff. And so they've been very active recently in the Part 1a expansion study. So we feel very good that, that study will be enrolling soon. Operator: Your next question is from the line of Jason (sic) [ Chase ] Knickerbocker with Craig-Hallum Capital Group. Chase Knickerbocker: One for Scott. I appreciate your comments on forward R&D, but maybe just a little bit more color there. You said kind of modest increase. I would imagine kind of enrollment is still picking up on an absolute number for stroke. And then can you just give us an idea kind of what the magnitude of that increase you expect sequentially in stroke and then kind of the incremental costs you expect for PE through the year. Scott Kellen: Sure. Thanks, Chase. Yes, with respect to the stroke, modest increases. I mean the -- and you're correct, it's all going to be driven by the enrollment rates. And to some extent, it depends on whether those patients are enrolled in the U.S. or Europe. U.S. is probably the most expensive followed by U.K., Canada and Europe. And then with respect to the incremental cost for PE, there'll be -- well, we're still working on the estimates for the Phase II trial. The financial support we provide for the IST is very modest. It's an incredible bargain. So again, moderate -- modest to moderate increases, nothing order of magnitude change-wise. Chase Knickerbocker: Could you just define modest or moderate for us, if you don't mind? And then just one for Rick. Just as we think about the resample, should we kind of just expect to receive the number on the resample or anything else at that point that we'll be able to provide? Dietrich Pauls: Sure. For the interim analysis, we'll be providing an update on the expected timelines to complete the enrollments. Scott Kellen: Chase, it's hard to give a specific number because there's movement inside all the different expense categories. I mean I wouldn't expect it to go up more than 10% a quarter. Operator: I will now hand today's call over to Rick Pauls for any closing remarks. Dietrich Pauls: All right. Well, thank you all for joining us today. We greatly appreciate your interest in DiaMedica and hope that you enjoy the rest of the day. This concludes our call today. Thank you. Operator: Thank you for joining. You may now disconnect your lines. Before you buy stock in DiaMedica Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and DiaMedica Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Interested in DiaMedica Therapeutics, Inc.? Here are five stocks we like better. The ReMEDy2 acute ischemic stroke trial has surpassed 70% enrollment and an interim analysis is planned by end‑2026, starting with a futility check and potentially triggering a sample‑size re‑estimation and enrollment completion in early 2027 if results mirror prior phase II data. In preeclampsia, the Part 1a extension cohort is near completion with a data update expected this quarter, the company plans Part 1b and Part 2 cohorts (up to 30 patients each) plus a fetal growth restriction cohort starting this quarter, and Health Canada has approved the global phase II while DiaMedica addresses an FDA request for additional embryo‑fetal studies by proposing an alternative rodent study. DiaMedica closed Q1 with $51.3 million in cash and says existing funds should support planned clinical programs and operations “through 2027,” while Q1 net cash used in operations was $9.1M and R&D rose to $8.0M driven by ReMEDy2 expansion and reproductive toxicity testing. DiaMedica Therapeutics (NASDAQ:DMAC) executives outlined progress across the company’s DM199 clinical programs in preeclampsia and acute ischemic stroke during the company’s first-quarter 2026 earnings call, while also reviewing quarter-end liquidity and spending trends as development work expands globally. President and CEO Rick Pauls said the company is “pleased with the progress we’ve made so far in 2026” as it advances DM199 in both preeclampsia and stroke. Pauls said DiaMedica expects “multiple clinical milestones between now and the end of 2027,” and added the company is weighing the “risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? On the stroke program, Pauls emphasized the importance of the planned interim analysis for the ReMEDy2 trial, noting enrollment has surpassed 70% and that the company expects the interim analysis to “validate all of the hard work that has gone into the program.” Chief Medical Officer Julie Krop said enrollment is “near completion” in the extension cohort for Part 1a of the investigator-sponsored trial (IST), a dose escalation study in late-onset preeclampsia patients who are “planned to deliver within 72 hours.” Krop said the cohort is intended to help determine the dose or doses to be used in upcoming IST cohorts, and the company expects to complete the cohort and “provide a data update later this quarter.” → A Prada Payday: Is AMC Back in Style? Krop referenced prior interim results indicating DM199’s potential to reduce blood pressure and improve placental perfusion “without crossing the placental barrier,” while acknowledging the dataset remains small. “The results we observed were highly consistent and encouraging,” she said. Krop added that learnings from Part 1a are guiding protocol amendments for two remaining preeclampsia study groups: Part 1b: An expansion study of up to 30 additional late-onset preeclampsia patients receiving DM199 via continuous IV infusion until delivery, aimed at understanding how physicians may use DM199 to support blood pressure control “at this late stage of the disease.” Part 2: A study of up to 30 early-onset preeclampsia patients evaluating three doses to help inform phase III dosing and to identify a dose level that could extend pregnancy duration and increase gestational age at delivery. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Krop also discussed an IST cohort in fetal growth restriction (FGR) in patients without preeclampsia, describing FGR as “the leading cause of stillbirth” and associating survival with “enduring adverse health effects over the child’s lifespan.” She said the company expects to enroll the first patient in this cohort during the current quarter. In parallel with the IST, DiaMedica is advancing a global phase II study in early-onset preeclampsia in North America and the U.K. Krop said Health Canada approved the study in March 2026, sites have been selected, and the company is working to initiate enrollment in Canada by year-end. She added the company expects to file a clinical trial application in the U.K. during the current quarter. Regarding U.S. plans, Krop said the FDA requested an additional non-clinical 10-day modified embryo-fetal development and pre- and postnatal development study in rabbits. However, she said a non-GLP dose-ranging rabbit study suggested an “adverse immune response to DM199,” which prevented completion of the requested rabbit study. The company proposed conducting the study in a second rodent model and is awaiting FDA feedback. During Q&A, Pauls said the company submitted its proposal to the FDA “over a month ago” and will provide an update once it receives clarity. He said if the FDA agrees to the proposed rat study, it would take “three to four months to complete.” Pauls also highlighted that DiaMedica is moving ahead with Canada and intends to add U.K. sites while completing any additional preclinical work requested by the FDA. Analyst Josh Schimmer of Cantor asked what incremental observations investors should look for in the upcoming late-onset cohort update beyond blood pressure control. Pauls said the Part 1a expansion cohort includes “12 additional patients” and should provide additional clarity, “particularly on blood pressure” and “dilation of the uterine arteries.” He added the company does not expect changes in biomarkers like sFlt after only two doses, suggesting improvements may be more likely when the drug is on board for “a week, two weeks.” Schimmer also asked about potential edema improvement. Pauls said lead investigator Dr. Cathy Cluver has observed edema resolving in some patients “even within, you know, 12 to 24 hours of getting DM199,” though he emphasized the small patient count. On timing for the sponsor-run early-onset preeclampsia study, Krop said initiation depends on dosing data from the IST study, along with site contracting and CRO work, reiterating that initiation in Canada is expected later this year. Pauls added that one of the selected Canadian sites is already involved in the company’s stroke trial, which he said could help expedite activation. Krop said the ReMEDy2 acute ischemic stroke trial has now passed 70% of the target required for the interim analysis, and site activations and enrollments have recently begun in Europe. She said the company has added six European countries and now has “approximately 70 sites activated.” Krop also said DiaMedica hosted an investigator meeting for European study teams in April and reiterated the plan to complete the interim analysis by the end of 2026. Krop reviewed prior phase II ReMEDy1 findings that informed ReMEDy2’s design and powering assumptions. She said DM199 was associated with “clinically meaningful improvements in functional outcomes” in the subgroup most similar to ReMEDy2 enrollees. In patients who did not undergo thrombectomy, Krop said the study observed a 15% absolute increase versus placebo in favorable recovery (modified Rankin Scale 0–1). In the moderate stroke severity subgroup (NIHSS 5–15), she said the absolute improvement was 19%, with a “50% reduction in the number of patient deaths” and a 13.3% reduction in recurrent strokes versus placebo. During Q&A, Pauls described the interim analysis approach as starting with a futility assessment. “If there’s not a drug effect, we’ll terminate,” he said. Otherwise, he said there will be a sample-size re-estimation, with total enrollment between “three and 700 patients.” He added that if the interim signal is comparable to prior phase II data, the company would look to complete enrollment the following quarter. Lake Street analyst Thomas Flaten sought clarification on timing. Pauls said that assuming an interim analysis at year-end 2026, the company would anticipate completing enrollment in the following quarter, “Q1 of next year.” Pauls also explained that after patient 200 is dosed, there is a 90-day window for the primary endpoint and about four additional weeks for the interim analysis, during which the company expects to continue enrolling and get closer to 300 patients. Asked what information the company would share at interim, Pauls said DiaMedica would provide “an update on the expected timelines to complete the enrollment.” Chief Financial Officer Scott Kellen said DiaMedica ended the quarter with $51.3 million in cash, cash equivalents, and short-term investments as of March 31, 2026, compared with $59.9 million at Dec. 31, 2025. Current liabilities were $5.7 million, and working capital was $46.6 million at quarter-end, compared to $55.5 million in working capital at year-end 2025. Kellen said the company expects its current cash and investments to be sufficient to fund planned clinical studies and operations “through 2027.” Net cash used in operating activities was $9.1 million in the first quarter, up from $7.1 million in the first quarter of 2025, driven primarily by a higher net loss. Research and development expenses increased to $8.0 million for the quarter from $5.7 million a year earlier, reflecting continued ReMEDy2 activity and global expansion, clinical team expansion, and additional reproductive toxicity testing to support the preeclampsia program in the U.S. Kellen said these increases were partially offset by reduced manufacturing development spending versus the prior-year period. He said R&D expenses are expected to “moderately increase” as ReMEDy2 continues and DM199 advances in preeclampsia. General and administrative expenses were $2.5 million, unchanged year over year, and Kellen said G&A is expected to remain “relatively consistent” in future periods. In response to questions about expense trends, Kellen said quarterly R&D changes are driven by enrollment rates and geography, with the U.S. being “probably the most expensive,” followed by the U.K., Canada, and Europe. Pressed to define “modest,” Kellen said he would not expect R&D to rise “more than, you know, 10%, a quarter.” DiaMedica Therapeutics, Inc (NASDAQ: DMAC) is a clinical‐stage biopharmaceutical company focused on developing novel therapies for acute and chronic central nervous system conditions. The company's lead product candidate, DM199, is a recombinant form of human tissue kallikrein-1 designed to promote neuroprotection and tissue repair through modulation of the kallikrein‐kinin system. DiaMedica's research and development efforts are centered on translating the regenerative potential of DM199 into effective treatments for disorders with high unmet medical need. DM199 is being evaluated in acute ischemic stroke, where preclinical studies have demonstrated potential benefits in blood flow restoration, inflammation reduction and neuronal survival. The article "DiaMedica Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. 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DM199 Preeclampsia Phase 2 Investigator-Sponsored Trial (IST) Part 1a Expansion Cohort Enrolling, Updated Dataset Expected 2Q 2026 ReMEDy2 Phase 2/3 AIS Trial of DM199 Surpassed 70% of Required Interim Enrollment; Interim Analysis planned in 4Q 2026 $51.3 million in Cash, Cash Equivalents and Investments, Anticipated Runway through 2027 Conference Call and Webcast on May 7 at 8:00 AM ET / 7:00 AM CT MINNEAPOLIS, May 06, 2026--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today provided a business update and reported financial results for the quarter ended March 31, 2026. Management will host a conference call on Thursday, May 7, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss the Company’s business update and first quarter 2026 financial results. "We continue to focus on moving our clinical programs forward. Looking ahead, we anticipate four separate preeclampsia data readouts and a readout from our fetal growth restriction trial between now and the end of 2027. Collectively, these datasets are anticipated to inform dose selection for a potential multi-national Phase 3 program in early-onset preeclampsia. We will also weigh the risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts," stated Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. "In acute ischemic stroke, ReMEDy2 has surpassed 70% of the required enrollment for, and we are now focused on completing, the interim analysis in the fourth quarter of 2026, which will determine the final number of participants required to complete the study." Corporate Highlights Preeclampsia - Phase 2 IST Clinical Trial: Part 1 Late-Onset Preeclampsia: DM199 dose-escalation extension cohort: 12 participants with results anticipated in the second quarter of 2026. DM199 continuous IV dosing cohort: dosing until delivery in up to 30 PE participants. Part 2 Early-Onset Preeclampsia: DM199 SC dosing every 3 days in PE subjects until delivery, in up to 30 participants with three dose levels identified in the dose-escalation cohort. Fetal Growth Restriction – Phase 2 IST Clinical Trial: Part 3 Early-onset fetal growth restriction: DM199 Initial IV/SC loading doses followed by repeated SC dosing every 3 days in up to 30 participants with three dose levels identified in the dose-escalation cohort. Early-Onset Preeclampsia - Phase 2 Clinical Trial: Open-label, dose-range finding in participants with early-onset preeclampsia to be conducted in North America (United States & Canada) and the United Kingdom (UK) to evaluate safety, early signals of efficacy and selection of an optimal dose regimen for phase 3 trial. These participants are candidates for expected management or prolongation of pregnancy. Sites have been selected in Canada after having received approval from Health Canada. First patient is anticipated to be dosed before the end of 2026. Preliminary results of the rabbit study suggest that the animals developed an antibody response to DM199, a humanized recombinant protein, preventing us from completing the requested embryo-fetal development and pre- and postnatal development (ePPND) study in the rabbit model. We have proposed to the FDA performing the ePPND study in a second rodent model and are awaiting the FDA’s response. A clinical trial application (CTA) to expand this Phase 2 trial to include sites in the U.K. is planned to be filed in the second quarter of 2026. Acute Ischemic Stroke ReMEDy2 Phase 2/3 Clinical Developments: Enrollment in DiaMedica’s Phase 2/3 ReMEDy2 (the ReMEDy2 trial – NCT065216) trial has surpassed 70% of the required enrollment. Interim analysis remains planned for completion in the fourth quarter of 2026. Financial Results Highlights for the First Quarter Ended March 31, 2026 Cash Position and Runway – Cash and short-term investments were $51.3 million as of March 31, 2026, compared to $59.9 million as of December 31, 2025. The Company anticipates its current cash and short-term investments will be sufficient to fund its planned clinical studies and support corporate operations through 2027. Cash Flows – Net cash used in operating activities was $9.1 million for the three months ended March 31, 2026, compared to $7.1 million for the same period in the prior year. The increase in cash used in operating activities resulted primarily from the increased net loss in the current quarter ended March 31, 2026 as compared with the prior year period. Research and Development (R&D) – R&D expenses were $8.0 million for the three months ended March 31, 2026, compared to $5.7 million for the three months ended March 31, 2025. This increase was driven primarily by the continuation of the ReMEDy2 clinical trial and its global expansion; the expansion of the clinical team; and costs related to additional reproductive toxicity testing being performed in support of the Company’s PE program in the United States. These increases were partially offset by net cost reductions in manufacturing development activity related to work performed and completed in the prior year period. DiaMedica expects that R&D expenses will moderately increase in future periods relative to recent prior periods as it continues the ReMEDy2 trial and its clinical development program in PE and FGR. General and Administrative (G&A) – G&A expenses were $2.5 million for the three months ended March 31, 2026 and 2025. While small changes occurred within a number of expense categories, the differences were not material individually or in the aggregate, and the overall net changes offset each other. DiaMedica expects G&A expenses to remain relatively consistent in future periods. Net Loss – Net loss was $10.0 million for the three months ended March 31, 2026, compared to $7.7 million for the three months ended March 31, 2025. Conference Call and Webcast Information Management will host a conference call and webcast to discuss its business update and first quarter 2026 financial results on Thursday, May 7, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time: Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on the Company’s website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until May 14, 2026, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 6195397#. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction, and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information, visit the Company’s website at www.diamedica.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words "anticipate," "believe," "continue," "could," "expect," "intend," "may," "plan," "potential," "should," or "will," the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the timing, nature and requirements for regulatory applications and approvals, including its application for an IND for the study of DM199 as a treatment for preeclampsia and fetal growth restriction and its conducting a Phase 2 trial in these indications; continued ReMEDy2 trial enrollment and timing of the interim analysis; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia, fetal growth restriction and acute ischemic stroke; future R&D and G&A expenses and the Company’s projected cash runway. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing and outcomes of non-clinical studies; risks and uncertainties relating to the timing of studies and trials; risks and uncertainties relating to the clinical expansion into preeclampsia and associated trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia, fetal growth restriction, and acute ischemic stroke and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia, fetal growth restriction, and acute ischemic stroke; and the risks identified under the heading "Risk Factors" in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports, including our most recent quarterly report on Form 10-Q. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506239545/en/ Contacts Scott Kellen Chief Financial Officer Phone: (763) 496-5118 [email protected] For Investor Inquiries: Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 [email protected] Media Contact: Madelin Hawtin LifeSci Communications [email protected]