Q1 2025 DiaMedica Therapeutics Inc Earnings Call

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Presentation

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 10K and most recent quarterly report, Form 10Q. 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.

Thank you, operator. Hello, everyone, and welcome to our first quarter 2025 conference call. I am joined this morning by Scott Kellen, our Chief Financial Officer Dr. Lorianne Masuokais 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. That's 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 a 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 investigative sponsored preeclampsia trial is very close to identifying a target dose to move forward with it in Part 1 B. Dose selection will be guided primarily 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 modifying.
Currently we expect to be in a position to release those preliminary topline results between the 2nd half of June and the 1st 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 DM 189 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 28th 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, DM 19 is the only novel agent currently being studied in pregnant women with preeclampsia. With this KOL events, 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 DM-189 in preeclampsia. Turning briefly to our stroke program, enrollment is moving ahead steadily, and we're pleased to announce that participant enrollment now is 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 1st 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 Remedy II trial. This individual has spent over 10 years treating stroke patients at a major US research center and also has 5 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.