Financial Performance - For the nine months ended September 30, 2024, the net loss was $16.5 million, compared to $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 $5.68 million from $5.99 million[79]. - Net cash used in operating activities was $15.6 million for the nine months ended September 30, 2024, compared to $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 $4.98 million for the three months ended September 30, 2024, up from $3.27 million for the same period in 2023, and to $12.59 million for the nine months ended September 30, 2024, up from $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 $50.2 million, down from $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 $4.3 million as of September 30, 2024, compared to $2.8 million at the end of 2023, marking a rise of about 53.6%[81]. - Net cash provided by investing activities was $3.4 million for the nine months ended September 30, 2024, a significant improvement from a net cash outflow of $24.4 million in the same period of 2023[85]. - Net cash provided by financing activities decreased to $11.9 million for the nine months ended September 30, 2024, down from $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