DiaMedica Therapeutics(DMAC) - 2024 Q4 - Annual Report

Financial Performance - DiaMedica Therapeutics Inc. reported net losses of $24.4 million and$19.4 million for the years ended December 31, 2024 and 2023, respectively[375]. - The company had cash, cash equivalents, and marketable securities of $44.1 million as of December 31, 2024, with an accumulated deficit of$140.0 million[375]. - General and administrative (G&A) expenses decreased to $7.6 million in 2024 from$8.2 million in 2023[379]. - Other income, net, increased to $2.3 million in 2024 from$1.9 million in 2023, driven by higher interest income related to increased marketable securities[393]. - Cash, cash equivalents, and marketable securities decreased to $44.1 million as of December 31, 2024, from$52.9 million in 2023, due to net cash used in operating activities[396]. - Net cash used in operating activities was $22.1 million for 2024, compared to$18.7 million in 2023, primarily due to increased net loss and advance deposit funds for the ReMEDy2 trial[397]. - Net cash provided by financing activities was $12.0 million in 2024, down from$36.8 million in 2023, mainly from the June 2024 private placement[399]. - The company expects to incur substantial operating losses until product sales or licensing fees are generated, with operating losses expected to moderately increase as clinical studies continue[401]. - As of December 31, 2024, the company estimates outstanding commitments of approximately $19.3 million, with$14.5 million due within the next 12 months[406]. - Future operating lease obligations total approximately $316,000, with about$90,000 due over the next 12 months[407]. - The company does not expect to generate any revenue from product sales for at least three to four years, pending regulatory approvals[401]. Research and Development - Research and development (R&D) expenses were $19.1 million for 2024, up from$13.1 million in 2023, primarily due to clinical development costs[378]. - Research and development (R&D) expenses increased to $19.1 million for the year ended December 31, 2024, up from$13.1 million in 2023, primarily due to the continuation of the ReMEDy2 clinical trial and expansion of the clinical team[391]. - The ReMEDy2 clinical trial for DM199 aims to enroll approximately 300 participants globally, with a potential final sample size of up to 728 patients[367]. - The Phase 2 trial for preeclampsia (PE) is expected to evaluate up to 90 women, with results from the initial part anticipated in Q2 2025[371]. - DM199 is designed to enhance blood flow and neuronal survival in AIS patients, addressing a critical unmet need as up to 80% of AIS patients are ineligible for current treatments[366]. - The company expects to incur significant expenses and increased operating losses for at least the next few years as it expands its clinical trials[376]. - The company plans to continue monitoring and potentially expanding its clinical development programs based on ongoing results and market conditions[377]. Licensing and Obligations - The company has entered into a license agreement with Catalent Pharma Solutions for gene expression technology and manufacturing of DM199[408]. - A milestone payment obligation remains due upon the first regulatory approval of DM199 for commercial sale as of December 31, 2024[408]. - Following the product launch, the company will incur a royalty obligation of less than 1% of net sales, with an indefinite royalty term[408]. - The license agreement can be canceled by the company with 90 days' prior written notice[408]. - Catalent cannot terminate the license unless the company fails to make required milestone and royalty payments[408].