Diamedica Therapeutics ((DMAC)) has held its Q4 earnings call. Read on for the main highlights of the call.
During the recent earnings call, DiaMedica Therapeutics expressed a generally optimistic sentiment, despite acknowledging certain challenges. The company highlighted significant progress in its preeclampsia and stroke programs, particularly with the expansion of clinical sites and positive safety reviews. While there were concerns about delayed enrollment in the stroke program and increased R&D expenses, the overall tone remained positive due to the advancements and financial stability reported.
Progress in Preeclampsia Program
DiaMedica has made notable strides in its preeclampsia program by obtaining ethics approval and initiating dosing for preeclamptic mothers in their DM199 study. This marks a significant milestone as it is the first study of DM199 in a pregnancy-related condition, highlighting its potential as a treatment for preeclampsia, a condition currently lacking FDA-approved treatments.
Expansion of Stroke Program
The company has activated 30 clinical sites for its stroke study and plans to expand globally. The updated study protocol now includes a broader range of patient populations, which could potentially increase enrollment and enhance the study’s impact.
Strong Financial Position
DiaMedica reported a robust financial position with a total combined cash and investments of $44.1 million, providing a financial runway into the third quarter of 2026. This financial stability is crucial for supporting ongoing and future clinical trials.
Positive Safety Review
A comprehensive safety review conducted by the Data Safety Monitoring Board found no significant safety concerns, allowing the ReMEDy2 trial to proceed without modifications. This positive safety assessment is a critical step in maintaining the trial’s momentum.
Delayed Enrollment in Stroke Program
Despite the progress, the company faced challenges with slower-than-anticipated enrollment in the ReMEDy2 trial. This delay is attributed to underestimated start-up times and post-COVID staffing challenges, pushing the expectations for interim analysis to the first half of 2026.
Increased R&D Expenses
Research and development expenses saw a significant increase, rising to $19.1 million for 2024 from $13.1 million in the previous year. This increase is driven by the continuation of the ReMEDy2 clinical trial and heightened manufacturing activities.
Forward-Looking Guidance
DiaMedica provided substantial guidance regarding its clinical development programs and financial outlook. For the preeclampsia program, the company anticipates results from Part 1A of the trial in the second quarter of 2025, emphasizing the safety profile of DM199. In the stroke program, improvements in drug storage logistics and broader patient criteria aim for an interim analysis in the first half of 2026. Financially, the company projects a runway into the third quarter of 2026, supported by its current cash and investments.
In summary, DiaMedica Therapeutics’ earnings call conveyed a sense of optimism, driven by advancements in clinical programs and a strong financial position. Despite facing challenges such as delayed enrollment and increased R&D expenses, the company remains focused on its strategic goals and future growth prospects.