• Cash and Investments: $44.1 million as of December 31, 2024.
• Current Liabilities: $5.4 million as of December 31, 2024.
• Working Capital: $39.2 million as of December 31, 2024.
• Net Cash Used in Operating Activities: $22.1 million for the full year 2024.
• Research and Development Expenses: $19.1 million for the year ended December 31, 2024.
• General and Administrative Expenses: $7.6 million for the full year 2024.
• Net Other Income: $2.3 million for the full year 2024.

• Warning! GuruFocus has detected 3 Warning Signs with DMAC.

Release Date: March 18, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• DiaMedica Therapeutics Inc (NASDAQ:DMAC) has made significant progress in its preeclampsia clinical program, obtaining ethics approval and beginning dosing in South Africa.
• The company's DM199 treatment shows promise due to its safety profile, ability to produce nitric oxide, and potential to lower blood pressure without crossing the placental barrier.
• The stroke program has activated 30 clinical sites, increasing the potential for steady enrollment and expanding the eligible patient population.
• The ReMEDy2 trial protocol allows for refrigerated storage of DM199, simplifying logistics for patient treatment over a three-week period.
• DiaMedica Therapeutics Inc (NASDAQ:DMAC) has a strong financial position with $44.1 million in cash and investments, providing a runway into Q3 of 2026.

Negative Points

• Enrollment in the ReMEDy2 trial has been slower than expected due to lower staffing levels in research units post-COVID.
• The company has updated its expectations for interim analysis to the first half of 2026, indicating delays in trial progress.
• Research and development expenses increased significantly to $19.1 million in 2024, driven by the continuation of the ReMEDy2 trial and expansion of the clinical team.
• The company anticipates only moderate increases in R&D expenses, which may limit the pace of clinical development.
• Despite progress, the company acknowledges that the enrollment rate is still not at the desired level, impacting trial timelines.

Q & A Highlights

Q: Of the 30 activated sites for the ReMEDy2 trial, how many are among the top 15 sites previously identified, and how many are actively enrolling? A: Of the 30 sites identified and activated, about 13 are among the top 15 sites, and many of them are currently enrolling. - Lorianne Masuoka, Chief Medical Officer

Q: Regarding the DSMB review completed in January, how much data did they have on the patients? Was it just from the acute phase or the full treatment period? A: The DSMB had access to the entire database, meaning all data entered for those patients up to the cutoff date was available for review. - Rick Pauls, President, Chief Executive Officer, Director

Q: What are the expectations for enrollment rates and the number of trial sites activated for the ReMEDy2 trial? A: We currently have 30 active sites in the U.S. and plan to open more in Canada, Australia, and Europe. We anticipate doubling the number of enrolling sites, targeting one to two patients per month per site. - Lorianne Masuoka, Chief Medical Officer

Q: Since the protocol amendments, particularly regarding tPA non-responders, have you seen an improvement in enrollment rates in this subpopulation? A: Yes, there has been a significant increase in enrollment, driven in part by the protocol amendment to include tPA non-responders and M2 patients. - Rick Pauls, President, Chief Executive Officer, Director

Q: For the preliminary top-line results in preeclampsia expected in Q2, what is the meaningful threshold for impacting maternal blood pressure? A: We are looking for a 10 to 20 drop in systolic pressure, aiming to bring it down to about 140. We are also monitoring for safety indicators like the absence of DM199 crossing the placental barrier and improved placental perfusion. - Lorianne Masuoka, Chief Medical Officer

Q: Has the amended statistical analysis plan for ReMEDy2, including thrombolytic non-responders, been finalized with the FDA? A: Yes, the amended statistical analysis plan has been finalized with the FDA. - Lorianne Masuoka, Chief Medical Officer

For the complete transcript of the earnings call, please refer to the full earnings call transcript.