DiaMedica Therapeutics(DMAC) - 2022 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2022, net losses were $9.9 million compared to $10.3 million for the same period in 2021, resulting in an accumulated deficit of $92.4 million as of September 30, 2022[88]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $8.7 million, a slight decrease from $9.4 million in the same period of 2021[105]. - Net cash provided by investing activities was $6.8 million for the nine months ended September 30, 2022, compared to a net cash used of $11.8 million in the prior year[106]. - Net cash used in financing activities was $5,000 for the nine months ended September 30, 2022, down from $30.1 million provided in the same period of 2021[107]. - The company has incurred losses while advancing the R&D of its DM199 product candidate and has not generated any revenues from product sales[108]. - The company expects to continue incurring substantial operating losses in the near term as it advances research and clinical studies for DM199[108]. Research and Development - Research and Development (R&D) expenses decreased to $1.6 million for the three months ended September 30, 2022, down from $2.3 million for the same period in 2021, and decreased to $5.6 million for the nine months ended September 30, 2022, down from $6.9 million in 2021[99]. - The company has identified a potential new treatment for inflammatory diseases, DM300, which is in the preclinical stage of development[87]. - The company anticipates needing substantial additional capital to further R&D activities and clinical studies for DM199[110]. Clinical Trials - The ReMEDy2 trial aims to enroll approximately 350 patients and is designed to serve as a pivotal registration study for DM199 in treating acute ischemic stroke[82]. - The FDA placed a clinical hold on the ReMEDy2 trial due to three instances of clinically significant hypotension, which the company is currently addressing[84]. - The company completed patient enrollment in the REDUX clinical trial for chronic kidney disease (CKD) with a total of 79 patients as of December 31, 2021[86]. Cash Resources and Funding - As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $36.1 million, down from $45.1 million as of December 31, 2021[104]. - The company anticipates that its current cash resources will be sufficient to continue operations for at least the next twelve months, but may require additional funding earlier than expected[91]. - Current cash resources are expected to be sufficient for at least the next twelve months to continue operations and clinical trials[110]. - The company has historically financed operations primarily through sales of equity securities and expects to continue this practice[111]. - If additional capital is raised through equity or convertible debt, shareholder ownership interests will be diluted[112]. - Inadequate funding may require the company to scale back operations or implement cost reduction strategies[113]. Operating Expenses - General and Administrative (G&A) expenses increased to $1.5 million for the three months ended September 30, 2022, up from $1.1 million in 2021, and increased to $4.5 million for the nine months ended September 30, 2022, up from $3.5 million in 2021[100]. - The company expects to incur significant expenses and increased operating losses for at least the next several years as it advances clinical programs, particularly if the clinical hold on the ReMEDy2 trial is lifted[90].