DMAC

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics first quarter 2026 earnings conference call. An audio recording of this webcast will be made 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 sections entitled Cautionary Statement Notes regarding forward-looking statements in the company's press release issued yesterday 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 on its website. Please note that any comments made on today's call speak only as of today, May 7th, 2026, and may no longer be accurate at the time of any replay or transcript rereading. 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.

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 five 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'll 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 enrollments 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.

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 two 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 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 two preeclampsia cohorts, which we'll 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 this 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 non-clinical 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 rabbits 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 three 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 six additional European countries and now have approximately 70 sites activated. In April, we sponsored an investigator meeting for our European study teams 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.

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 zero or one on the modified Rankin Scale. Furthermore, ReMEDy2 is enrolling patients presenting with moderate stroke severity, defined as an NIHSS score between five 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.

Thanks, Julie. I'd like to now ask Scott to review the financial results for the quarter.

Thank you, Rick, 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 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 2026 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 three 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 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. 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.

At this time, if you would like to ask a question, press star followed by the number one on your telephone keypad. If you would like to withdraw your self from the queue, you may press star followed by the number one. We'll pause for just a moment to compile the Q&A roster. Your first question is from the line of Josh Schimmer with Cantor.

Great. Thanks for taking this question. For 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. There are biomarkers like sFlt. At what point will you have data to share on those parameters?

Yeah. Thanks, Josh. The expansion cohort that we're running is gonna be 12 additional patients. We're almost completing that right now. It's gonna be at the cohort 10 from the Part 1a. It's really just gonna give us just additional clarification here, particularly on blood pressure, dilation of the uterine arteries. At this point, we're really not expecting any changes in some of the biomarkers like sFlt because these patients really only got two doses. It's really, we believe, is that having the drug on board for, you know, ideally a week, two weeks, that we really would see some of those biomarkers improve.

Okay. Got it. I think at one point, the lead investigator suggested that there was an improvement in edema. At the very least, maybe urine output might be something that can improve within a short period of time. Is that something you're looking for?

That's something that if there is an improvement in the endothelial health, and it is something that Dr. Cathy Cluver has very clearly seen in some of these patients that the edema did resolve, you know, even within, you know, 12 to 24 hours of getting DM199, which is encouraging. You know, it's a small number of patients, but we'll be looking to see maybe there's some additional insight there as well.

Just a couple of other quick questions, if I may. What are the gating steps to start initiating enrollment in the early-onset preeclampsia study? Why is that not going to occur until later this year?

Yeah. Julie, do you want to take that one?

Yes. Are you referring to the IST cohort? Or are you referring to our sponsor trial?

To your sponsor trial.

Yeah. 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 all of, you know, our CRO selection process, all of that completed, and then we'll be initiating. It's a combination of factors, but we should be, again, in Canada later this year.

Last question, I guess.

Yeah, Josh.

Yeah, sorry. Go ahead.

Oh, sorry. Yeah, if I can add. Importantly, we know as Julie mentioned, we have selected the two sites in Canada, and one site in particular is already in our stroke trial. You know, we're looking forward to leveraging the relationships, the existing contract that we have to basically do what we can here to expedite and get those sites activated as soon as we can.

Got it. Last question, timelines for completing the second animal toxicology study and then ultimately reengaging with the FDA for an IND.

Yeah. It really depends on the feedback that we get from the FDA. If it is a rat study that, you know, we propose and if they agree to that, I mean, that's a matter of a few months. It's probably three to four months to complete. Again, while that's all happening, you know, we'll be running the, you know, the phase II in Canada and then expanding into the U.K.

Great. Thanks so much. Appreciate it.

Your next question is from the line of Stacy Ku with TD Cowen.

Hey. Good morning, everyone. We have a couple of questions. I guess first, two follow-ups. When could you expect to hear from the FDA on the mouse study? Is there a possibility the FDA could ask for another animal model? How are you looking to prepare for all these different scenarios? Sounds like the rat study is pretty straightforward, but just help us understand how you view the next few necessary steps. Again, just to clarify, sounds like you are expecting a potential study initiation of the global phase II by year-end. Just wanna make sure you're reiterating that timeline. We're looking forward to the updated preeclampsia results in Q2.

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? Julie, just a clarification again, what is the timing of potentially starting the early onset preeclampsia IST? 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. Thanks so much.

Okay, great. We'll try to take those. I'll start off here. Maybe Julie you can help me out here. We did our submission to the FDA over a month ago and we're just waiting to hear their feedback. As soon as we get clarity from the FDA we'll provide an update. We have looked at alternative you know kind of backup plans in case they want something different. We think we've got a very you know strong rationale for the proposed rat study. I think it's encouraged that you know Health Canada's already approved us to start the trial in Canada.

With the PE trial in terms of, yeah, it's potential that we could get some data, as soon as we have a cohort that's completed and if we see some compelling data, we would look at potentially press releasing or getting that at a late-breaking conference. The last question there you had with regards to the outcomes at 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 three and 700 patients.

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 a year being treated with that form, we would look at completing the enrollment the following quarter.

Helpful. Thank you so much.

Your next question is from the line of Thomas Flaten with Lake Street.

Hey, Rick. Just to clarify, given that you've got 70+ sites and 70% enrolled, when you said we're gonna complete enrollment the following quarter, do you mean the first quarter of 2027 or which quarter were you referring to on the full enrollment?

Yeah. Assuming that we have the interim analysis at the end of this year, we would anticipate completing the enrollment the following quarter. The Q1 of next year.

Does that assume an upsize in the total population? 'Cause 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?

We will be. 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 four weeks for the interim analysis to occur. During that approximately four months, we'll be continuing to enroll. We'll be getting closer to the 300 patient number during that period of time.

Got it. Just to clarify a prior response. Once you get the Part 1a expansion data out this quarter, is it reasonable to assume that you would start Part 1b and Part 2 in the third quarter or should we expect a maybe a fourth quarter start on that?

Nope, those should be starting here this summer. We're just, we've finalized the dosing that will be going into those cohorts. We'll be doing three doses at 5 mcg/kg, 10 mcg/kg, and 15 mcg/kg, a subcutaneous every three days until delivery. Those cohorts should be starting very soon. You know, we had some, we've now got our site, Cape Town, South Africa, has had some challenges with some staffing, and they've added some new staff. They've been very active recently in the Part 1a extension study. We feel very good that, you know, that study will be enrolling soon.

Got it. Thank you.

Your next question is from the line of Chase Knickerbocker with Craig-Hallum Capital Group.

Good morning. Thanks for taking the questions. One for Scott. Appreciate your comments on forward R&D, maybe just a little bit more color there. You know, you'd said kind of modest increase. I would imagine kind of enrollment is still ticking up on an absolute number for stroke. Can you just give us an idea, you know, kind of what the magnitude of that increase you expect sequentially in stroke and then kind of the incremental cost you expect for PE through the year? Thanks.

Sure. Thanks, Chase. With respect to the stroke, modest increases. I mean, and you're correct, it's all gonna be driven by the enrollment rates. 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. With respect to the incremental cost for PE, they'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. Again, moderate, modest to moderate increases, nothing, order of magnitude change-wise.

Could you just define modest or moderate for us, if you don't mind? Just one for Rick. Just as we think about the resample, you know, should we kind of just expect to receive, you know, the number on the resample or anything else at that point that we'll be able to provide? Thanks.

Sure. For the interim analysis, we'll be providing an update on the expected timelines to complete the enrollment.

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, you know, 10%, a quarter.

Helpful. Thank you.

I will now hand today's call over to Rick Pauls for any closing remarks.

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.

Thank you for joining. You may now disconnect your lines.

Morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics full year 2025 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 the actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results, appear in the section entitled "Cautionary Statement Note Regarding Forward-Looking Statements" in the company's press release issued yesterday and under the heading "Risk Factors" in DiaMedica's most recent annual report on Form 10-K. 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, March 31, 2026, and may no longer be accurate at the time of any replay or transcript rereading. DiaMedica disclaims any duty to update its forward-looking statements. Following the prepared remarks, we will open the phone lines for questions. I would now like to introduce your host for today's call, Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

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 B2 receptors in the walls or endothelium of our blood vessels to increase the level of nitric oxide, prostacyclin, and endothelium-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 turn the call over to Julie to provide an update on our preeclampsia and stroke programs.

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 utero-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 this 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 expectant 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 expectant 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. With respect to the additional reproductive tox study in rabbits requested by the FDA, preliminary result 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.

Thanks, Julie. We're also pleased to note the paper titled Endothelial Triple-Pathway Vasorelaxation as an Adjunctive 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 three-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.

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 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 to 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 non-cash 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 of 2025, up from $7.6 million for the full year of 2024. G&A expenses increased by $2.2 million due to a number of factors, including increased non-cash 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.

Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star, then the number one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. Your first question comes from Stacy Ku with TD Cowen. Your line is open.

Good morning, everyone, and thanks so much for taking our questions. 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. Just help us understand what are your early thoughts on the alternative species with the FDA? What other preclinical models are best for reproductive tox studies? That's the first question, if you could maybe further elaborate there.

As we think about the IST and clearly a lot of great signals that we're gonna 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? Just help us understand where you all are and potential timing there.

Of course, ahead of the U.S. trial, Julie, we kind of heard all the high level of preparation ahead of moving forward in the U.S., but just help us understand how are conversations progressing, what criteria is the team focused on when it comes to enrolling the right preeclampsia study investigators? 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? Thanks so much.

Right. Thanks, Stacey. I'll start off maybe with the key, the CKD, the fourth question is that, you know, 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 you know, many of these patients have elevated levels of potassium. That puts these patients at risk of hyperkalemia. I think first we can treat these patients, control their blood pressure when they frankly don't have a lot of options. 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.

At the appropriate time, you know, we'll look at potentially advancing into CKD, but right now we wanna make sure we're really focused here near term on our other two programs. Then maybe I'll hand it off to Julie.

Yeah. Hi, Stacy. All very good questions. I think, you know, it's premature right now to say exactly which species that we're gonna focus on. We wanna first be able to. We have 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 give an update once we have that discussion. With regards to your question around what have we learned from previous cohorts, I think, you know, we understand the PK better after running the initial studies.

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's one element. I think it's, you know, as far as site selection, we are, you know, highly focused on selecting sites that have, both experience with preeclampsia studies as well as a practice that's well suited for early onset, you know, expectant management, which is, something most, you know, some sites are very adept at and other sites are more conservative about when to deliver patients.

Again, it's that tightrope between treating, you know, between the mother's health and the baby's health and making sure that we select centers that are comfortable, you know, keeping the mother even though there's some, you know, severe—there's potentially severe complications going on, they feel like they can stabilize them enough to prolong the pregnancy. Those are kind of the considerations that we're focused on.

Yeah. Incredibly helpful. Thank you so much.

Your next question comes from Josh Schimmer with Cantor. Your line is open.

Thanks for taking the questions. 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? Then for the interim analysis for the phase II/III stroke program, what are the potential outcomes there? Are there stopping criteria over either positive or negative or resizing criteria? Maybe you can share a little bit more about what you expect the interim to inform. Thank you.

Sure. Thanks, Josh. So starting off with the early onset and crossing of the placenta, we don't think it'll happen. I mean, we've done now over 35+ patients with more late onset preeclampsia where we didn't see this crossing. The size to cross would be about 500 daltons.

500 daltons.

Where our protein is about 26 kilodaltons, so, you know, 50 times larger. It would be very shocking if it did occur. We also did an earlier study in a rat model. We also did not see it. It 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 resample size will range from 300-728.

How we designed this trial and we believe, you know, base case that, you know, 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 the study in China. Looking at the modified Rankin Scale of 0-1 as the primary endpoint, and we're anticipating that, if we see again, drug effect comparable, we'll be looking at something, you know, ideally in the 300-350 range. If we need to go above 500 patients, we'll have to really evaluate the next steps for the program in light of, you know, the high prospects we think as well for the preeclampsia program.

Thank you.

Your next question comes from Thomas Flaten with Lake Street. Your line is open.

Hey, good morning. I appreciate you taking the questions. 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.

Sure. Yeah, it's a good question. It really has been a result of some staffing challenges that Catherine Cluver's had at her site. We've recently provided some additional financial support and with the hiring of a couple new nurses just in the last few weeks. You know, we anticipate that enrollment's gonna pick up again.

Following on from that, if I understood the press release and your commentary correctly, are Parts 2 and 3 or 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?

We've made a few protocol amendments that are going through shortly, and we're anticipating later in Q2 that those two cohorts should initiate. Parts 1a expansion study is ongoing and, you know, will be completed as well in Q2.

Got it. Understood. 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, you know, in the first quarter of this year, you know, 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.

Yeah. I would just say at a high level, the enrollment increase really has been more so it's been this year. Even going into the end of, you know, 2025, it was still relatively slow, but really has picked up substantially in the, you know, last month, last two months. But really it's the more recent months is where we've seen the really uptick. You know, that also correlates to where we've had, you know, the increase in sites and all the work that Julie and her team have been doing has been wonderful. I think we're now starting to see, you know, the benefits of all that work.

Great. Appreciate it. Thank you.

Your next question comes from Matthew Caufield with H.C. Wainwright. Your line is open.

Hey, good morning, guys. For the ReMEDy2 trial, there had been some prior discussion of some challenges with stroke enrollment formerly 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? Thanks again.

Yeah, good question. So I think there's a difference between the challenges that we've, you know, 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'll be a wonderful drug because of that safety profile.

Got it. Thank you. Appreciate it.

Your next question comes from Chase Knickerbocker with Craig-Hallum. Your line is open.

Good morning. Thanks for taking the questions. Was just hoping to work one more in on the non-clinical side here. Can you just maybe walk us through kind of the differences in your prior non-clinical 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?

Yeah. Julie, can you take that one, please?

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. It's, you know, 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, you know, malformations or teratogenicity from the control group in either study.

I think the concern with the FDA is finding a NOEL, an effective dose where they don't see any adverse effects. The maternal, you know, toxicity that we saw, which we believe is due to immunogenicity, which is not uncommon to see in rabbits and, you know, immune responses very quickly to human proteins.

I think really it was in both studies we had maternal toxicity, so I don't think they were really that different other than, you know, gestational ages being different and the FDA wanting us to dose primarily after the first trimester, after the, you know, development, the early development of the fetus, because that's closer to the way we're gonna dose humans. It just turns out, I think the rabbits just are not a good species, and we're gonna just have to do it in a different species.

Got it. Just maybe a little bit on timelines as far as when you'd expect to get that feedback that you need to continue with the different species or, you know, 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 timelines there.

You know, we'll provide an update as soon as we have, you know, something to update. I don't think we're giving a, you know, forecast yet, until we understand and get alignment from the FDA on the path forward.

Understood. Just last from me, Rick. On the stroke timing, could you just give us a little bit more color as to kinda what you're seeing from an enrollment rate perspective? I mean, is it kinda being driven by kinda breadth increasing, or is that depth really kind of increasing as we thought it would to kinda drive this acceleration in enrollment in the stroke study?

Yeah. It's a combination of, you know, in particular, over the last few months, an increase in the enrollment rates per site, and also for a greater number of sites. Then with, you know, being at 61 sites now and, you know, having sites a chance to, you know, to be in the trial and understand, you know, some of the challenges and opportunities of running the trial. Then, you know, I think also having a number of sites that are also on the verge of coming on board here in the coming weeks, you know, we feel good about reiterating our guidance for this year.

Got it. Thank you.

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.

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.

This concludes today's call. Thank you so much for attending. You may now disconnect and have a wonderful rest of your day.