DiaMedica Therapeutics - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 EPS of $(0.18) modestly beat Wall Street consensus of $(0.19); net loss was $7.70M driven by higher R&D as ReMEDy2 expanded globally and preeclampsia programs advanced. Values retrieved from S&P Global.
• Positive interim Phase 2 Part 1a preeclampsia data showed statistically significant SBP/DBP reductions, no placental transfer, and meaningful uterine artery PI improvement; management moved to enroll additional cohorts and prepare a U.S. Phase 2b IND.
• Cash runway extended into H2 2027 following a $30.1M private placement (8.6M shares at $3.50); pro forma cash ~$60M supports preeclampsia and AIS milestones.
• ReMEDy2 stroke trial enrollment improved; interim analysis timing tightened to Q2 2026, with ~40 active sites and DSMB safety review positive after first 50 participants.

What Went Well and What Went Wrong

What Went Well

• Strong preeclampsia signal: pooled cohorts 6–9 showed SBP reductions up to −25 mmHg at 5 minutes (p=0.0003) and DBP reductions up to −13 mmHg (p=0.0007); cohort 9 reached −35/−15 mmHg SBP/DBP at 5 minutes (p<0.05). “These interim results exceeded our expectations…potential to be a first-in-class, disease modifying therapy” — Rick Pauls.
• Safety profile supportive for pregnancy: no evidence of placental transfer and no serious TEAEs; PI improvement of −13.2% at 2 hours (p=0.0003) suggests improved placental perfusion.
• Strengthened balance sheet/visibility: $30.1M private placement extended runway into 2027 and Russell 2000/3000 inclusion broadened investor reach.

What Went Wrong

• OpEx stepped up: R&D rose to $5.82M (+49% y/y) and G&A to $2.19M (+28% y/y) on global trial expansion and team growth; operating loss widened to $8.01M.
• Continued losses: net loss increased to $7.70M vs $5.12M in Q2 2024 as program investment escalated.
• Stroke enrollment uneven across sites: management noted “80/20” contribution and actively discontinued non-performing sites; Europe/UK onboarding ongoing, implying execution risk until consistent rates sustain.

Transcript

Speaker 4

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 re-reading. 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 to your host for today's call, Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

Speaker 3

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 a recombinant form of the KLK1 protein, which enhances blood flow and vascular health by increasing levels of three key endothelial-derived vasodilating 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 Bahas Sabai, Devin Tong, and Susan Walker. A recording of this webinar is available on the DiaMedica Therapeutics website in the Investor Relations section. Based on the interim results from the 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 cohorts 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 a pregnant woman. 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 the Part 1B, as well as for the 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 the 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 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 measured a statistically significant reduction in the uterine artery pulsatility index, suggesting improved dilation of intrauterine arteries and placental perfusion. In addition, we are now preparing to conduct a Phase IIB preeclampsia trial in the U.S. 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 17th results press release.

Following the announcements 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 U.S. 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. Jay Volpe from Houston Methodist and covered the safety and clinically relevant outcomes from a REMEDY-1 Phase II clinical trial evaluating DM199 in patients with acute ischemic stroke and pre-treated with TPA.

We'd like to remind people that in patients pre-treated with TPA, DM199 demonstrated a significant improvement in full recoveries when compared to placebo. Turning to our current REMEDY-2 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 REMEDY-2 enrollment milestones. We will provide updates during our quarterly conference calls when we have achieved 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 25% milestone and steadily advancing towards the halfway mark. I would also note that we completed a Data Safety Monitoring Board, or DSMB, meeting to review the safety profile required after the first 50 REMEDY-2 participants.

The meeting is positive, meaning no safety concerns, and at the conclusion of the meeting, the DSMB unanimously concluded that REMEDY-2 enrollment should continue. In other developments, DiaMedica Therapeutics 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 advance DM199 to address the significant unmet needs for both of our key programs. I would now like to ask Scott Kellen, our Chief Financial Officer, to review the financial results for the quarter.

Speaker 5

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 REMEDY-2 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 in-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. Now, let me turn the call back over to Rick.

Speaker 3

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

Speaker 4

Absolutely. Be happy to. Ladies and gentlemen, as a reminder, if you have a question, please press star followed by one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by two. If you're using a speakerphone, please lift the handset before pressing any keys. Your first question comes from Thomas Flaten with Lake Street Capital Markets LLC. Please go ahead.

Speaker 1

Good morning. I appreciate you guys taking the questions. Maybe, Julie, if I could 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.

Speaker 2

Yeah, thanks for the question. Hello, everyone. Having worked in the space of women's health before, I really have a strong commitment to this area and am excited by the program that I saw, the programs that I saw at DiaMedica Therapeutics, as well as the team that's in place to execute upon them. 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. I think this product really addresses the underlying pathophysiology of both conditions and has already shown promising clinical data and evidence even of some biologic activity. This really excited me when I saw this. For both programs, I'm really excited to be here.

Speaker 1

Excellent. Rick, I know you've got a lot of work that's going to kick off here in preeclampsia. I was wondering if you could maybe map out kind of a calendar for us, right? I'm assuming each of the cohorts in South Africa will enroll at slightly different rates given that there are different patients, different types of patients. Maybe you could clarify the U.S. Phase IIB study, what exactly will be the target indication for that?

Speaker 3

Sure. Thanks, Thomas. In terms of what's coming up next, as I mentioned in the prepared remarks, we're moving into Cohort 10 of the Part 1B that should be starting next week. We wanted to push the dosing a little bit higher to see if we can see any further improvement than what we've already seen, which would be wonderful. Based upon that and some of the pharmacokinetics data that we have already, we'll be analyzing that to be moving into the Part 1B. We'll also be able to be moving into the Part 2. That'll be the expected management. By expected management, we mean that when these patients are first diagnosed, they'll start being treated. Those will be typically early-onset patients. The third cohort that we talked about is the fetal growth restriction. All three of these cohorts can be dosed concurrently.

As we get those studies to start, we'll have more updates in terms of some of the timelines. We do know that our site in South Africa with Dr. Kluivert is just a very unique scenario. If these patients in Cape Town have preeclampsia, they basically all filter into Kathy Kluivert's site, and she gets four to five preeclampsia patients a day. We're very encouraged on 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, and that'll be followed immediately after with an IND and then looking at getting that study started next year. We're currently finalizing the protocol, and as we get more clarity and finalize, we'll be sharing that details with the market.

Speaker 1

Excellent. I appreciate it. Thanks, Rick.

Speaker 3

Thanks, Thomas.

Speaker 4

Your next question comes from Chase Richard Knickerbocker with Craig-Hallum Capital Group LLC. Please go ahead.

Speaker 0

Good morning. Thanks for taking the questions. 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? Just secondly, as we're now well across the 25% kind of milestone here, how are you kind of feeling about this new expectation for Q2 2026? Do you feel like it's firmed up at this point? You've got a lot more visibility or just kind of general thoughts there?

Speaker 3

Sure. We're currently at approximately 40 sites. We are at the point now where we're actually dropping off sites that are non-performing. I think that's important with sending the right message to the sites. On top of that, we are working to having sites in the UK and Europe come on board. I would say that, coming through to last year, coming early into the new year, things were very slow with the trial. We've definitely seen a very encouraging uptick in the last few months. That gives us comfort here with the guidance of Q2 of 2026.

Speaker 0

Any thoughts around current enrollment rates?

Speaker 3

It really does vary. We haven't publicly stated, I mean, what we are seeing is kind of a bit of an 80-20 rule where we've got a smaller number of sites that are producing a large number of patients. I will mention that the last quarter as well, we had an investigators' meeting that was really helpful. We had maybe 80, 90 participants from across the country and Canada. I think that really helped with awareness. I think that some of these aspects that we're taking are really going to help us here with continuing the momentum that we're building.

Speaker 0

Got it. Just on preeclampsia, on the U.S. study, I mean, is it a fair, I think it's probably a fair assumption that this will be in expected management. Any sort of additional detail that you would need from Part 1B and Part 2 of the South African study to put that IND in front of FDA, or do you feel like you kind of have what you need?

Speaker 3

Yeah, so definitely it's going to be the expected management. That's where we see the real need for this patient population. No, I think what we, I mean, the data we announced here a few weeks ago was just fantastic. I mean, we really could not have expected anything better than what we saw. Very encouraged by that. We just thought here that we've got an opportunity here to add in another cohort, that let's do it and let's see if there's any change and that may help us to tweak the dosing a little bit more. We do feel that for this patient population, it's very severe. I mean, these are very sick mothers. They have very severe endothelial dysfunction and a lot of vasoconstrictors. We do see some value in potentially going a little bit higher on the dose.

What we've seen already, we'd be very happy with going ahead with the dosing in Cohort 6 to 9 that we recently announced for the U.S. IND.

Speaker 0

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? How should we think about the data generation in that U.S. study?

Speaker 3

I think give us a little bit more time here as we finalize the protocol. We want to make sure we get the right expert opinions around this. Then we'll come out with a very clear path. We're very comfortable in terms of some recent feedback we've had from the FDA on the primary endpoint. We want to nail this down here before we publicly share what that endpoint will look like.

Speaker 0

Great. Thank you, Rick.

Speaker 3

Thank you, Chase.

Speaker 4

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

Speaker 3

All right. Thank you all for joining us today. We greatly appreciate your interest in DiaMedica Therapeutics and hope you enjoy the rest of the day. This concludes our call.

Speaker 0

Thank you.

Speaker 4

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