Earnings Call Transcript - DMAC Q2 2025

Operator, Operator

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Q2 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 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 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 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 13, 2025, 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 you for your host for today's call, Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

Dietrich John Pauls, CEO

Thank you all for joining us for our Q2 2025 earnings call. I am joined this morning by Scott Kellen, our Chief Financial Officer; and our new Chief Medical Officer, Dr. Julie Krop. We truly have made significant progress since Q1, and I'm happy to be able to share that with you today. Starting with our preeclampsia program. In July, we announced very positive interim results from Part 1a, the ascending dose portion of our investigator-sponsored Phase II trial of DM199 for the treatment of preeclampsia. As a reminder, DM199 is our lead candidate and the recombinant form of the KLK1 protein, which enhances blood flow and vascular health by increasing levels of three key endothelial-derived basal diluting factors through the bradykinin pathway. These are nitric oxide, prostacyclin and endothelial-derived hyperpolarizing factor. Preeclampsia is an ischemic condition that affects millions of women worldwide and has no approved treatments and really no viable therapeutic options to target the underlying vascular dysfunction. We held a key opinion leader webinar back in May on the unmet need in preeclampsia and on the potential of DM199 in this indication with professors Baha Sibai, Stephen Tang and Susan Walker. A recording of this webinar is available on DiaMedica's website in the Investor Relations section. Based on the interim results from Part 1a of our Phase II study, we believe that DM199 has the potential to be the first-in-class disease-modifying treatment for preeclampsia. In dosing cohort 6 to 9 of the study, DM199 demonstrated highly statistically significant and clinically meaningful reductions in both systolic and diastolic blood pressure, highlighting its potential efficacy in managing maternal hypertension associated with the disease. DM199 was also found to be safe and generally well tolerated with no evidence of placental transfer at any of the dose levels, a key safety indicator in the development of a treatment for pregnant women. Additionally, treatment with DM199 led to a statistically significant reduction in the uterine artery pulsatility index, suggesting improved uterine artery blood flow and enhanced placental perfusion. Improved perfusion may be a key in reducing placental hypoxia, supporting the potential for DM199 to be a disease-modifying treatment, as well as a treatment for fetal growth restriction. Based on the interim results and recent analysis of the pharmacokinetics, a decision was made to advance to and enroll cohort 10 in Part 1a of the ongoing Phase II trial. From there, we plan to finalize a dosing regimen for Part 1b as well as for Part 2 preeclampsia expected management and the Part 3 fetal growth restriction cohorts, all of which can be enrolled concurrently. For clarity, the remaining parts of the investigator-sponsored preeclampsia trial include Part 1b, an expansion cohort of 30 preeclampsia patients, where the decision has been made to deliver within the next 72 hours a patient population similar to those dosed in Part 1a. Part 2, a cohort of 30 patients evaluating DM199 in early onset preeclampsia. In this cohort, patients will start receiving DM199 at first diagnosis with the intent to dose DM199 until delivery and demonstrate extension of gestational days along with other key clinical and safety endpoints. Part 3, a cohort of 30 patients who are experiencing fetal growth restriction or FGR. FGR is a condition in which the fetus is not growing as expected, due to lack of blood flow, oxygen and critical nutrients. The expansion to this indication, which is related to preeclampsia, is based on our recently announced interim results in which we measure a statistically significant reduction in the pulsatility index, suggesting improved dilation of intrauterine arteries and placental perfusion. In addition, we are now preparing to conduct a Phase IIb trial in the United States and other countries and are currently preparing our FDA IND application. We look forward to sharing upcoming updates on these cohorts and the new preeclampsia trial. Additional details of the interim Phase II Part 1a results, including a replay of the investor call discussion of the results are available on our website under the Investor Relations tab and can be found in our July 17 results press release. Following the announcement of the positive interim results from Part 1a of the preeclampsia last month, we completed a $30 million private placement of common shares, which extends our cash runway into the second half of 2027. We intend to use this capital to also fund the new Phase IIb study of DM199 in the United States and other countries for the continued development of our ongoing stroke and preeclampsia programs. Turning to our stroke program. We had a poster presented at this year's 11th European Stroke Organization Conference held in May in Finland. The poster was presented by Dr. J. Volpi from Houston Methodist and covered the safety and clinically relevant outcomes from the ReMEDy1 Phase II clinical trial evaluating DM199 in patients with acute ischemic stroke and pretreated with TPA. We'd like to remind people that in patients pretreated with TPA, DM199 demonstrated a significant improvement in full recoveries when compared to placebo. Turning to our current ReMEDy2 stroke trial. We continue to make progress as enrollment continues, and we expect the interim analysis of the first 200 patients to be completed in Q2 2026. I wanted to take a moment to clarify our communication practices for ReMEDy2 enrollment milestones. We will provide updates during our quarterly conference calls when we achieve 50% and 75% of the interim enrollment sample size and press release when we enroll our 200th patient. At present, enrollment is now tracking well above the 25th percent milestone and steadily advancing towards the halfway mark. I would also note that we completed the Data System Monitoring Board or DSMB meeting to review the safety profile required after the first 50 ReMEDy2 participants. The meeting was positive, meaning no safety concerns, and at the conclusion of the meeting, the DSMB unanimously concluded that ReMEDy1 enrollment should continue. In other developments, DiaMedica was added to the U.S. small-cap Russell 2000 and the Russell 3000 indexes, enhancing our visibility among the broader investment community, including institutional investors. Finally, Dr. Julie Krop joined our team as Chief Medical Officer this month. She has extensive experience in the biopharma industry working with both clinical and commercial stage organizations and was also previously involved in the development of an orphan drug candidate for the treatment of severe preeclampsia. Dr. Krop adds invaluable experience to our team as we invent DM199 to address the significant unmet needs for both of our key programs.

Scott Kellen, CFO

Thank you, Rick, and good morning, everyone. As of June 30, 2025, our cash, cash equivalents and short-term investments were $30 million, compared to $44.1 million as of December 31, 2024. However, including net proceeds from the July private placement, our pro forma cash position is approximately $60 million. As Rick mentioned previously, we feel confident about our current cash position and anticipate that it will fund our planned clinical studies and corporate operations into the second half of 2027. We used $14.7 million of cash in net operating activities for the six months ended June 30, 2025, compared to $11.2 million for the same period in 2024. This increase is primarily a result of the increased net loss in the first half of 2025 compared to the prior year period. Our R&D expenses were $5.8 million and $11.5 million for the three- and six-month time periods ended June 30, 2025. This was an increase from $3.9 million and $7.6 million for the same time periods in the prior year. The increases were due primarily to cost increases resulting from the continued progress of our ReMEDy2 clinical trial, including its global expansion, as well as the expansion of the clinical team during the current and prior year periods. These increases were partially offset by cost reductions related to end-use study work performed and completed in the prior year periods. Our general and administrative expenses were $2.2 million and $4.7 million for the three- and six-month time periods ended June 30, 2025. These expenses also increased compared to the same time periods in 2024, which were $1.7 million and $3.8 million, respectively. These increases resulted primarily from additional non-cash share-based compensation and increased personnel costs, partially offset by reductions in legal fees incurred in connection with our lawsuit against PRA Netherlands. Overall, our net losses were $7.7 million and $15.4 million for the three- and six-month periods ending June 30, 2025. These are higher than the $5.1 million and the $10.3 million reported during the same periods in 2024.

Dietrich John Pauls, CEO

Thank you, Scott. We would like to open the call for questions. Operator, if you could please introduce the first analyst.

Operator, Operator

Your first question comes from Thomas Flaten with Lake Street.

Thomas Flaten, Analyst

Maybe, Julie, if I can start with you, I'm curious to kind of get your take on why you joined the company, particularly in light of your past experience with preeclampsia, but then perhaps even more importantly, your thoughts on the stroke program, which I know is going on in the background.

Julie Krop, Chief Medical Officer

Yes. Thanks for the question. Hello, everyone. Really having worked in the space of women's health before, I really have a strong commitment to this area and I'm really excited by the programs that I saw at DiaMedica, as well as the team that's in place to execute upon them. So I think preeclampsia and ischemic stroke are both areas of large unmet need. There's de-risked biology, I believe, with the known role of KLK1 protein as both a vasodilator and its role in vascular repair. And I think this product really addresses the underlying pathophysiology of both conditions and has already shown promising clinical data and really evidence even of some biologic activity. So this really excited me when I saw this. So I think for both programs, I'm really excited to be here.

Thomas Flaten, Analyst

Excellent. Rick, I know you have a lot of work starting in preeclampsia. I was wondering if you could outline a calendar for us. I assume each of the cohorts in South Africa will enroll at slightly different rates due to the varying types of patients. Could you also clarify the target indication for the U.S. Phase IIb study?

Dietrich John Pauls, CEO

Sure. Thanks, Thomas. So in terms of what's coming up next, as I mentioned in the prepared remarks, moving into Cohort 10 of Part 1b should be starting next week. We wanted to push the dosing a little bit higher to see if we can achieve any further improvement beyond what we've already seen, which would be wonderful. Based upon that and some of the pharmacokinetics data that we already have, we'll be analyzing that to ensure a smooth transition into Part 1b. We will also be moving into Part 2, which will be the expected management cohort. By expected management, we mean that these patients are first diagnosed and will start being treated. Those will be typically early-onset patients. Then the third cohort we talked about is the fetal growth restriction cohort. So all three of these cohorts can be dosed concurrently. As we get these studies underway, we'll have more updates regarding the timelines. We do know that our site in South Africa, Dr. Cluver, has a very unique scenario, as patients in Cape Town with preeclampsia basically all filter into Cathy Cluver’s site. She gets 4 to 5 preeclampsia patients a day, so we're very encouraged about how rapidly we can get these patients dosed, but we'll have more as the study gets started. For the U.S. study, we're currently planning to file a pre-IND request to the FDA, which will be followed immediately by an IND, and then we're looking to initiate that study next year. We are currently finalizing the protocol, and as we get more clarity, we will be sharing those details with the market.

Operator, Operator

Your next question comes from Chase Knickerbocker with Craig Hallum.

Chase Knickerbocker, Analyst

Maybe, Rick, just to start, can you give us an update on current active sites and how enrollment rates are trending in the stroke study? And just secondly, as we're now well across the 25% kind of milestone here. How are you feeling about this new expectation for Q2 '26? Do you feel like it's firmed up at this point? You've got a lot more visibility, or just general thoughts there.

Dietrich John Pauls, CEO

Sure. We're currently at approximately 40 sites. We are at the point now where we're actually dropping off sites that are performing below expectations, which I think is important to communicate clearly to our network. On top of that, we are working on onboarding sites in the UK and Europe. Coming through last year into early this year, things were very slow with the trial. However, we've definitely seen a very encouraging uptick in the last few months, which gives us comfort with our guidance of Q2 of 2026.

Chase Knickerbocker, Analyst

Any thoughts around kind of current enrollment rates?

Dietrich John Pauls, CEO

It really does vary. We haven't publicly stated specific figures, but we are observing a bit of an 80-20 rule, where we have a smaller number of sites that are producing a large number of patients. Last quarter, we had an investigators meeting that was really helpful with around 80-90 participants from across the U.S. and Canada. I believe that had a significant impact on awareness and I think the strategies we are implementing will really help us continue the momentum we're building.

Chase Knickerbocker, Analyst

Got it. Regarding preeclampsia and the U.S. study, is it reasonable to assume this will be part of the expected management? Do you need any additional details from Part 1b and Part 2 of the South African study to submit that IND to the FDA, or do you feel you already have everything necessary?

Dietrich John Pauls, CEO

Yes, it’s definitely going to be the expected management. That’s where we see the real need for this patient population. The data we've announced is fantastic; we couldn’t have hoped for better. So we are very encouraged by that. We feel this is an opportunity to add another cohort, which may provide insights and allow us to tweak the dosing a bit more. But we are confident about proceeding with the dosing in cohorts 6 to 9 that we recently announced for the U.S. IND.

Chase Knickerbocker, Analyst

And then just last for me, Rick. Could we see something in the Phase IIb where we have a primary endpoint in the study that closely reflects what a pivotal regulatory endpoint will be in a Phase III study? Or just how should we think about the data generation in that U.S. study?

Dietrich John Pauls, CEO

Yes. Please give us a little more time as we finalize the protocol. We want to ensure that we get the right expert opinions around this, and then we will share a very clear pathway. We feel comfortable based on some recent feedback we've received from the FDA regarding potential primary endpoints. But we want to finalize this before we publicly share what that endpoint will look like.

Operator, Operator

There are no further questions at this time. I would like to hand the call back over to Rick Pauls for any closing remarks.

Dietrich John Pauls, CEO

This concludes our call. Thank you.

Operator, Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.