Clinical Trials - DM199 clinical trial (ReMEDy2) is currently enrolling approximately 350 patients globally, with an adaptive design allowing for sample size adjustments based on interim analysis results [61]. - The ReMEDy2 trial aims for a primary endpoint of physical recovery from stroke, measured by the modified Rankin Scale (mRS) at day 90 [62]. - The company plans to conduct a Phase 2 trial for DM199 in treating preeclampsia, with an estimated cost of approximately $1.5 million and initial results expected in the first half of 2025 [65]. - The Phase 2 trial for preeclampsia is expected to begin enrolling subjects in Q4 2024, with a total of up to 120 subjects planned for evaluation [65]. Financial Performance - The company reported net losses of $10.3 million for the six months ended June 30, 2024, compared to $9.7 million for the same period in 2023, with an accumulated deficit of $125.8 million as of June 30, 2024 [66]. - Net cash used in operating activities was $11.2 million for the six months ended June 30, 2024, compared to $10.1 million for the same period in 2023, reflecting an increase of approximately 10.9% [81]. - Net cash provided by financing activities was $11.7 million for the six months ended June 30, 2024, down from $36.8 million in the same period of 2023, a decrease of approximately 68.2% [83]. - The company has not generated any revenues from product sales and does not expect to do so for at least three to four years, indicating ongoing reliance on external funding [84]. - The company expects to incur substantial operating losses as it continues research and development of its DM199 product candidate, with anticipated increases in losses compared to prior periods [84]. Expenses - Research and Development (R&D) expenses increased to $3.9 million for Q2 2024, up 54% from $2.5 million in Q2 2023; for the six months ended June 30, 2024, R&D expenses were $7.6 million, up 23% from $6.2 million in the same period of 2023 [74]. - General and Administrative (G&A) expenses decreased to $1.7 million for Q2 2024, down 23% from $2.2 million in Q2 2023; for the six months ended June 30, 2024, G&A expenses were $3.8 million, down 7% from $4.1 million in the same period of 2023 [75]. Cash and Funding - Cash, cash equivalents, and marketable securities totaled $54.1 million as of June 30, 2024, compared to $52.9 million as of December 31, 2023 [77]. - As of June 30, 2024, the company had working capital of $51.9 million, an increase from $50.9 million as of December 31, 2023, reflecting a growth of approximately 2% [80]. - The company received net proceeds of $11.7 million from a private placement in June 2024, but expects to need substantial additional capital for ongoing R&D activities [85]. - Future funding requirements will depend on various factors, including the timing and results of ongoing clinical trials, indicating potential volatility in cash flow needs [85]. - The company may need to seek additional funding through equity or debt financing, which could dilute existing shareholders' interests [88]. - If adequate funding is not available, the company may be forced to scale back operations or delay product development, impacting long-term growth prospects [90]. Other Income - Other income increased to $526 thousand for Q2 2024, compared to $271 thousand in Q2 2023, driven by higher interest income from increased marketable securities [76].
DiaMedica Therapeutics(DMAC) - 2024 Q2 - Quarterly Report