Financial Performance - For the nine months ended September 30, 2024, the net loss was 14.2 million for the same period in 2023, reflecting an increase in losses due to ongoing clinical trials and operational costs[68]. - The company has an accumulated deficit of 132.1 million as of September 30, 2024, with substantial operating losses primarily from product candidate development and R&D activities[68]. - General and administrative expenses were 1.9 million for the three months ended September 30, 2024, consistent with the same period in 2023, while for the nine months, expenses decreased to 5.99 million[79]. - Net cash used in operating activities was 14.9 million for the same period in 2023, indicating an increase of approximately 4.7%[84]. - The company expects to incur significant expenses and increased operating losses for at least the next several years as it expands its clinical trials and development programs[69]. - The company expects to incur substantial operating losses as it continues research and development of its DM199 product candidate, with no revenue expected for at least three to four years[87]. Research and Development - Research and development expenses increased to 3.27 million for the same period in 2023, and to 9.43 million in 2023[78]. - The ReMEDy2 clinical trial aims to enroll approximately 350 patients globally, with a potential sample size adjustment based on interim analysis results[63]. - The company received regulatory approval to initiate a study of DM199 for the treatment of preeclampsia, which affects up to 8% of pregnancies worldwide[65]. - The first subject in the investigator-sponsored study of DM199 for preeclampsia was enrolled in Q4 2024, with topline data expected to demonstrate initial proof-of-concept[67]. Cash and Liquidity - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling 52.9 million as of December 31, 2023, representing a decrease of approximately 5.1%[81]. - The company anticipates that its current cash resources will be sufficient to fund operations for at least the next 12 months, although future funding requirements may arise sooner than expected[71]. - Total current liabilities increased to 2.8 million at the end of 2023, marking a rise of about 53.6%[81]. - Net cash provided by investing activities was 24.4 million in the same period of 2023[85]. - Net cash provided by financing activities decreased to 36.8 million in the prior year, a decline of approximately 67.6%[86]. - The company anticipates needing substantial additional capital to support ongoing R&D activities and clinical studies, with current cash resources expected to last for at least the next twelve months[88]. - Future funding requirements will depend on various factors, including the timing and results of ongoing development efforts and the potential expansion of current programs[88]. - The company has historically financed operations primarily through equity sales and expects to continue this practice, with no existing credit facilities available[90]. - If adequate funding is not available, the company may need to scale back operations, which could include cost reduction strategies and potential divestitures[92].
DiaMedica Therapeutics(DMAC) - 2024 Q3 - Quarterly Report