Financial Data and Key Metrics Changes - As of September 30, 2024, the company's cash, cash equivalents, and investments totaled 52.9 million as of December 31, 2023 [30] - Net cash used in operating activities for the nine months ended September 30, 2024, was 14.9 million in the same period of the prior year [30] - Research and development expenses increased to 3.3 million in the prior year period [31] - General and administrative expenses were $1.9 million for each of the three months ended September 30, 2024, and 2023 [33] Business Line Data and Key Metrics Changes - The company is making solid progress on its stroke and preeclampsia programs, with expectations for 2025 to be transformative [4] - The ReMEDy2 trial is seeing updates to its protocol and statistical analysis plan to enhance enrollment rates and improve trial outcomes [11][12] Market Data and Key Metrics Changes - The company anticipates that the activation of top U.S. sites for the AIS study will lead to a significant increase in patient enrollment [5][6] - The preeclampsia program has secured regulatory approval in South Africa, with the first participant enrolled [9] Company Strategy and Development Direction - The company is focused on building momentum with high-quality research institutions and expanding its clinical trial sites [28] - The updates to the ReMEDy2 trial are expected to improve the probability of success and accelerate the timeline for completion [16][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of DM199 in treating preeclampsia and its first and best-in-class potential [9] - The company believes that the changes in the ReMEDy2 trial will lead to a more efficient study and significant cost savings [27] Other Important Information - The company expects its current cash and investments to provide a runway to Q3 of 2026 [30] - The interim analysis for the ReMEDy2 trial is now expected in Q4 2025, with completion anticipated by next summer [50] Q&A Session Summary Question: What prompted the re-evaluation of the ReMEDy2 protocol? - The changes were driven by a combination of wanting to simulate enrollment and extensive discussions with experts [37] Question: At what point will patients now be randomized? - Patients will be randomized into the study only if they do not receive tPA prior to randomization [38] Question: Is the total number of patients for the study still viable? - The total number of patients is expected to be lower than the previously planned 364 based on the new interim analysis [39] Question: What are the assumptions for a quicker final readout with the changes? - The changes allow for greater precision in sample size assessment, potentially reducing the total number of patients needed [42] Question: Will the changes impact DM199's commercial opportunity? - The company believes that expanding the label to include tPA non-responders could significantly increase the patient population and revenue potential [48] Question: Is there any risk of FDA feedback necessitating trial modifications? - The chances of receiving substantive FDA feedback are low at this point, as the company is well past the 30-day mark for comments [55]
DiaMedica Therapeutics(DMAC) - 2024 Q3 - Earnings Call Transcript