I would now like to turn you over to your host for today's call, mister Rick Pauls, DiaMedica's president and chief executive o officer. Mister Pauls, Thank you, operator. Hello, everyone, and welcome to our first quarter twenty twenty five conference call. Am joined this morning by Scott Kellen, our Chief Financial Officer. Doctor. Lorianne Mascioca is currently on short term medical leave we hope she gets well soon. We're happy to be here today to update you on the progress on our two clinical development programs. It has only been a short interval since our last update, thus I will keep my remarks brief. That said, I'm pleased to report that we continue to make substantial progress in both of our clinical development programs. Start with an update on our preeclampsia program. Building upon the significant accomplishments of the program within a very short timeframe, as we discussed in March, we're pleased to be able to disclose that we believe Part 1a of our Phase two investigator sponsored preclampsia trial is very close to identifying a target dose. To move forward with it in Part 1B. Dose selection will be guided primarily by a few key data points, which we expect to be sharing in our upcoming preliminary top line results from the Part 1a proof of concept portion of the trial.

These key data points include: one, safety and tolerability including results of a placental transfer analysis two, the amount of decrease in systolic and diastolic blood pressure levels. And three, changes in uterine and placental blood flow as assessed by the Doppler ultrasound measurement of the uterine artery pulsatility index. This measure is important as reductions the pulsatility index may suggest decreased downstream resistance, and improved uterine and placental blood flow, which could also be an indication of June and the July. The final timing will be primarily dependent on the schedules at the outside laboratories running the various tests, including the pharmacodynamic biomarkers, and the assay, which will be used to determine if DM199 crosses the placental barrier. One additional update, May is preeclampsia awareness month. And we will be sponsoring a preeclampsia key opinion leader call on May 28 at 8AM Eastern. Compared to other therapeutic areas like oncology, which have advanced more rapidly in recent years, the treatment of pregnancy complications remains outdated and is not well understood. No FDA approved treatments exist for preeclampsia despite the growing burden of this disease. To our knowledge, DM199 is the only novel agent currently being studied in pregnant women with preeclampsia.

With this KOL event, we will continue our work to educate investors, physicians, and other interested parties on preeclampsia as a disease and the current state of treatment. With this background, we will also discuss the design of our current Phase II trial of DM199 in pre gram CL. Turning briefly to our stroke program, enrollment is moving ahead steadily, we're pleased to announce that participant enrollment now is between the twentieth and twenty fifth percentile mark of patients enrolled for the interim analysis. Our next enrollment update will be at the fiftieth percentile mark. We believe that our efforts over the past year to engage with sites to promote communications between the sites, and to simplify study logistics, have been important in driving the recent uptick in enrollment. Accordingly, we reiterated our guidance that the interim analysis on those first 200 participants be completed in the first half of twenty twenty six. We would also note for you that we have engaged an experienced stroke neurologist to support site engagement during Lori Ann's leave in order to maintain our enrollment momentum in the REMEDY two trial. This individual has spent over ten years treating stroke patients at a major US research center, and also has five years of recent, biotech drug development experience.

He's been doing a tremendous job connecting with and maintaining our relationships with sites and supporting our recent enrollment momentum. Now, I'd like to hand the call over to Scott Kellen to review this quarter's financial results. Thanks Rick, and good morning everyone. As the operator mentioned, we announced our first quarter twenty twenty five financial results and filed our quarterly report on Form 10 Q yesterday after the markets closed. These documents are both available on either the DiaMedica or the SEC websites. As of 03/31/2025, we reported a total combined cash and investments of 37,300,000.0 current liabilities of 4,700,000.0 and working capital of 32,800,000.0 This compares to a total combined cash and investments of $44100000.05400000.0 dollars in current liabilities and $39,200,000 in working capital as of 12/31/2024. The decreases in combined cash and investments and in working capital were due primarily to the net cash used to fund our operations. Net cash used in operating activities for the first quarter of twenty twenty five was 7,100,000.0 compared to 6,700,000.0 for the first quarter of twenty twenty four. The increase in cash used in operating activities resulted primarily from our increased net loss partially offset by changes in operating assets abilities occurring during the current year period.

We anticipate that our current cash and investments provides us a runway into Q3 of twenty twenty six. Our research and development expenses increased to $5,700,000 for the three months ended 03/31/2025, up from 3,700,000.0 for the three months ended 03/31/2024. The increase was due primarily to cost increases resulting from the continuation of our REMEDY two clinical trial including our global expansion increased manufacturing development activity and the expansion of our clinical team during 2024. Now these increases were partially offset by cost reductions related to in use study work performed and completed in the prior year period. We expect that our R and D expenses will moderately increase in future periods relative to our recent prior periods. As we continue our REMEDY two trial including the global expansion and our continued expansion of our DM199 clinical development program in preeclampsia. Our general and administrative expenses were $2,500,000 and 2,100,000.0 for the three months ended 03/31/2025, 2024 respectively. This increase resulted primarily from additional non cash share based compensation expense recognized as a result of the approval of an extension of the post termination exercise period for stock options held by a retiring member of our Board of Directors.

We expect G and A expenses to remain steady in future periods as compared to recent prior periods. Our net other income was 443,000 for the three months ended 03/31/2025, compared to 597,000 for the three months ended 03/31/2024. This decrease was driven by reduced interest income recognized during the current year period related to lower average marketable securities balances during the current year period as compared to the prior year period. With that, let me ask the operator to open the lines for questions.

Thank you so much. Ladies and gentlemen, we will now begin our question and answer session. One on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to remove your hand from the queue, please press star followed by 2. If you're using a speakerphone, please lift the handset before pressing any keys. And your first question comes from Thomas Flaten with Lake Street. Please go ahead.

Good morning. I appreciate you taking the questions. Hey, Rick, just to clarify, the laboratory test results that seem to be the variable variable in terms of the readout between June and July Is that primarily the test for DM199 crossing the placental barrier? So, in the umbilical cord, or is there something else there that we should be aware of? Yes, Thomas. Yes, absolutely. So that's the main main item is going to be the placental transfer. So we have an assay that we're just having finalized in terms of getting to lower limits of detection. And so it's just a question of time for them to run it. So we want to at least give a range today in terms of when we anticipate the results. Makes sense. And then I see you mentioned that you're expecting to start Part 1b in Q3. What are the triggers for Part II and III, so the expected management and the fetal growth restriction components of the study. So I'll start with the fetal growth restriction. So if we see dilation of the intrauterine arteries our investigators are prepared to move ahead with that cohort. And then we'll have more to talk about the part two when we daylight the results here in in the coming weeks.

Got it. Excellent. I appreciate you taking the questions. Thank you. Thanks, Thomas. Your next question comes from Matthew Caulfield with H. C. Wainwright. Please go ahead.

Hi, good morning, Thanks for taking our question. I was wondering if you could speak to the anticipated read through or any derisking between the initial preeclampsia data and how that profile could translate to AIS development and the REMEDY two trial. Thanks again. Sure, I mean, I'll start off by saying that these are definitely two very unique indications. But I will add that a positive effect here in preeclampsia will just be another confirmation that this protein is active. And I would also mention around that we've previously talked about the fact that there are two forms of this protein in Asia that are being used. So the form of the protein isolated from human urine that today is treating to a million patients per year for acute ischemic stroke. And then there's also from the protein isolate from pig pancreas in both Japan and China. And we've been able to track track down about 10 publications with that form of the protein to treat preeclampsia. So I think it will just be very encouraged and that we have an active protein and what we're seeing in some of the validation and for going into both of these indications is the what we'll call the crude forms in Asia today.

Thanks a lot. Appreciate it, guys. Thank you.

Your next question comes from Chase Knickerbocker with Craig Hallum. Please go ahead.

Good morning. Thanks for taking the questions. Rick, just on on stroke, be good to kinda get some incremental details on, on enrollment. Mean, just kind of starting out with those high volume or potential high volume centers. Can you kind of give us an update on what percentage of kind of those high volume accounts are now at that one to two per that you want to see? I would add that as we had kind of talked on past calls, we really do we really did think that there would be a small number of sites in particular in The U. S. That would drive enrollment. And as we're starting to build some momentum that's clearly what we're starting to see. Some of these high enrolling sites are seeing the one to two patients per site per month. And so we're working on just building momentum and then really working hard on some of those other sites to expand the relationship here to encourage But I'd say currently we are above our plan here now and we're encouraged. With momentum that's being built. So maybe just an update on overall centers as well as you know again, it's only been a a couple months here.

But, you know, have we have we expanded that past 30? And then maybe on the geographic footprint of those centers that we started to see some international enrollment come in? Yes. So we're currently in mid-30s. And keeping in mind that there are sites now that are not performing that we're shutting down. And so we're really again focusing on the high enrolling sites. We also have sites in Georgia that have been performing very well. And that is the country of Georgia.

Yeah, yeah, got it. And just kinda, I guess, summon all this up. You know, first half, twenty six interim analysis. Think, at least implies that enrollment rates continue to pick up. I mean, you're seeing that trajectory in recent weeks, recent months as far as that curve continuing to steepen?

Yes, absolutely. And from the last earnings call, we're definitely seeing an encouraging uptick.

Got it. That's it for me. Thanks.

Great. Thanks, Chase.

Your next question comes from Thomas Flaten with Lake Street. Please go ahead.

Yes. Hey, thanks for taking another question.

Just back to preeclampsia real quick. The Part two and three, those are those studies will be primarily based out of South Africa or are you thinking that there's going to be a U. S. Component of those which would necessitate an IND filing?

So that part Parts two and Part three are still part of the same protocol. And so our collaborators will not need to go back for regulatory clearance.

And at some point will you expand the study and if so when into The U. S?

We do plan in the future to expand this to The U. S. And global. And we'll have more to share at a later date. Right now again the focus is you're getting the Part 1a and then moving into Part 1b as well as Parts two and then three hopefully.

Got it. Appreciate it. Thank you. Thanks, Thomas.

Thank you. There are no further questions at time. I would like to turn the call back to Mr. Rick Puls.

All right. In closing, we're very encouraged by our steady progress in clear momentum across both the preeclampsia and stroke programs. Look forward to sharing upcoming key milestones including the top line results from our preeclampsia proof of concept trial and the interim analysis from our stroke program. We thank our dedicated team, investigators and importantly our patients and their families. The continued trust and commitment. Please also mark your calendars from May 28 at eight a. M. Eastern Time for our preeclampsia KOL event, be sending out call in details via press release early next week. As always, we appreciate the ongoing support of our shareholders and look forward to updating you further in the months ahead. Thank you again for joining our call today. This concludes our call.

Ladies and gentlemen, you may now disconnect.