Earnings Call Transcript - DMAC Q1 2025

Operator, Operator

Good morning ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2025 Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. Before DiaMedica 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 appears in the section entitled Cautionary Note regarding forward-looking statements in the company's press release issued yesterday and under the heading Risk Factors in the company’s most recent annual report on Form 10-K and most recent quarterly report Form 10-Q. DiaMedica's SEC filings are available on the SEC's website, www.sec.gov, and on its website, diamedica.com. Please also note that any comments made on today's call speak only as of today, May 14, 2025, and may no longer be accurate at the time of any replay or transcript re-reading. DiaMedica disclaims any duty to update its forward-looking statements. Following the prepared remarks, the phone lines will be open for questions. I would now like to turn you over to your host for today's call, Mr. Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls?

Rick Pauls, President & CEO

Thank you, operator. Hello everyone, and welcome to our first quarter 2025 conference call. I am joined this morning by Scott Kellan, our Chief Financial Officer. Dr. Lorianne Masuoka is currently on short-term medical leave, and 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'll 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. I'll start with an update on our preeclampsia program. Building upon the significant accomplishments of this program within a very short time frame as we discussed in March, we're pleased to be able to disclose that we believe Part 1a of our Phase 2 investigator-sponsored preeclampsia trial is very close to identifying a target dose to move forward with 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 1, safety and tolerability, including results of a placental transfer analysis; 2, the amount of decrease in systolic and diastolic blood pressure levels; and 3, 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 in the pulsatility index may suggest decreased downstream resistance and improved uterine and placental blood flow, which could also be an indication of disease modification. Currently, we expect to be in a position to release those preliminary top-line results between the second half of June and the first half of 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 8 a.m. 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 2 trial of DM199 in preeclampsia. Turning briefly to our stroke program, enrollment is moving ahead steadily, and we're pleased to announce that participant enrollment is now between the 20th and 25th percentile mark of patients enrolled for the interim analysis. Our next enrollment update will be at the 50th 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 will be completed in the first half of 2026. I would also note for you that we have engaged an experienced stroke neurologist to support site engagement during Lorianne's leave in order to maintain our enrollment momentum in the ReMEDy2 trial. This individual has spent over 10 years treating stroke patients at a major U.S. research center and also has five years of recent biotech drug development experience. He has 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.

Scott Kellen, CFO

Thanks Rick, and good morning everyone. As the operator mentioned, we announced our first quarter 2025 financial results and filed our quarterly report on Form 10-Q yesterday after the market closed. These documents are both available on either the DiaMedica or the SEC websites. As of March 31, 2025, we reported a total combined cash and investments of $37.3 million, current liabilities of $4.7 million, and working capital of $32.8 million. This compares to a total combined cash and investments of $44.1 million, $5.4 million in current liabilities, and $39.2 million in working capital as of December 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. The net cash used in operating activities for the first quarter of 2025 was $7.1 million compared to $6.7 million for the first quarter of 2024. The increase in cash used in operating activities resulted primarily from our increased net loss, partially offset by changes in operating assets and liabilities occurring during the current year period. We anticipate that our current cash and investments provide us a runway into Q3 of 2026. Our research and development expenses increased to $5.7 million for the three months ended March 31, 2025, up from $3.7 million for the three months ended March 31, 2024. The increase was due primarily to cost increases resulting from the continuation of our ReMEDy2 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 end-use study work performed and completed in the prior year period. We expect that our R&D expenses will moderately increase in future periods relative to our recent prior periods as we continue our ReMEDy2 trial including the global expansion and our continued expansion of our DM199 clinical development program in preeclampsia. Our general and administrative expenses were $2.5 million and $2.1 million for the three months ended March 31, 2025, and 2024 respectively. This increase resulted primarily from additional noncash 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&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 March 31, 2025, compared to $597,000 for the three months ended March 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.

Operator, Operator

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

Thomas Flaten, Analyst

Good morning. I appreciate you taking the questions. Hey Rick, just to clarify, the laboratory test results that seem to be the variable in terms of the readout between June and July. Is that primarily the test for DM199 crossing the placental barrier or is there something else that we should be aware of?

Rick Pauls, President & CEO

Yes, Thomas. Absolutely. The primary focus is on the placental transfer. We have an assay that we are finalizing to achieve lower limits of detection. It's just a matter of time for the results to be processed. We plan to provide a timeframe for when we expect those results.

Thomas Flaten, Analyst

Makes sense. And then I see you mentioned that you're expecting to start Part 1b in Q3. What are the triggers for Parts 2 and 3, so the expected management and the fetal growth restriction components of the study?

Rick Pauls, President & CEO

So, I'll start off 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 Part 2 when we disclose the results here in the coming weeks.

Thomas Flaten, Analyst

Excellent. I appreciate you taking the questions. Thank you.

Rick Pauls, President & CEO

Thanks, Thomas.

Operator, Operator

Your next question comes from Matthew Caufield with H.C. Wainright. Please go ahead.

Matthew Caufield, Analyst

Hi, good morning guys. Thanks for taking our questions. I was wondering if you could speak to the anticipated read-through or any de-risking between the initial preeclampsia data and how that profile could translate to AIS development and the ReMEDy2 trial?

Rick Pauls, President & CEO

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 serve as 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 protein isolated from human urine that today is treating close to one million patients per year for acute ischemic stroke. And then it's also from the protein isolate from pig pancreas in both Japan and China. And we've been able to track down about ten publications with that form of the protein treating preeclampsia. So, I think it looks to be very encouraging, and they know that we have an active protein. What we're seeing in some of the validation and rationale for going into both of these indications is the crude forms in Asia today.

Matthew Caufield, Analyst

Thanks a lot, appreciate it guys.

Rick Pauls, President & CEO

Thank you.

Operator, Operator

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

Chase Knickerbocker, Analyst

Good morning. Thank you for taking the questions. Rick, regarding stroke, could you provide some additional details on enrollment? Specifically, starting with those high-volume or potentially high-volume centers, can you update us on the percentage of those high-volume accounts that are currently achieving the goal of one to two per month?

Rick Pauls, President & CEO

I would add that as we had kind of talked on past calls, we really do think that there would be a small number of sites, particularly 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. So, some of these high enrolling sites are seeing the one to two patients per site per month. And so we're working on building momentum and then really working hard on some of those other sites to expand the relationship here to encourage. But I say currently, we are above our plan here now, and we're encouraged with the momentum that's being built.

Chase Knickerbocker, Analyst

So, maybe just an update on overall centers as well as again it's only been a couple of months here; but, have we expanded that past 30? And then maybe on the geographic footprint of those centers have we started to see some international enrollment come in?

Rick Pauls, President & CEO

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 so that is the country of Georgia.

Chase Knickerbocker, Analyst

Yes. Yes. Got it. And just kind of, I guess, sum all this up. First half interim analysis I think, at least implies that enrollment rates continue to pick up. And I mean you're seeing that trajectory in recent weeks, recent months as far as that curve continuing to steepen?

Rick Pauls, President & CEO

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

Chase Knickerbocker, Analyst

Got it, that’s it from me. Thanks.

Rick Pauls, President & CEO

Great. Thanks, Chase.

Operator, Operator

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

Thomas Flaten, Analyst

Thanks for taking another question. Regarding preeclampsia, will the Part 2 and 3 studies primarily take place in South Africa, or is there a possibility of including a U.S. component that would require an IND filing?

Rick Pauls, President & CEO

Part 2 and Part 3 are still part of the same protocol. Our collaborators will not need to go back for regulatory clearance.

Thomas Flaten, Analyst

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

Rick Pauls, President & CEO

We do plan in the future to expand this to the U.S. and globally, and we'll have more to share at a later date. Right now, again, the focus is on getting the Part 1a and then moving into Part 1b as well as Parts 2 and then 3 hopefully.

Thomas Flaten, Analyst

Got it, appreciate it. Thank you.

Rick Pauls, President & CEO

Thanks, Thomas.

Operator, Operator

There are no further questions at this time. I would like to turn the call back to Mr. Rick Pauls.

Rick Pauls, President & CEO

All right. In closing, we're very encouraged by our steady progress and clear momentum across both the preeclampsia and stroke programs. We 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 for their continued trust and commitment. Please also mark your calendars for May 28 at 8 a.m. Eastern Time for our preeclampsia KOL event. We'll be sending out the 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.

Operator, Operator

Ladies and gentlemen, you may now disconnect.