DiaMedica Therapeutics(DMAC) - 2021 Q4 - Annual Report

Financial Performance - Net losses for the years ended December 31, 2021, and 2020 were $13.6 million and $12.3 million, respectively, with an accumulated deficit of $82.5 million as of December 31, 2021[451]. - The company has not generated any revenues from product sales and relies on financing from equity sales and government grants[451]. - The company expects to incur substantial operating losses until product sales can generate sufficient revenues, with no revenue expected for at least three to five years[479]. - Net cash used in operating activities was $12.3 million in 2021, up from $9.2 million in 2020, reflecting increased net loss and changes in operating assets and liabilities[476]. - Net cash provided by financing activities increased to $30.1 million in 2021 from $28.8 million in 2020, driven by greater net proceeds from the September 2021 private placement[478]. Clinical Trials - The ReMEDy2 trial aims to enroll approximately 350 patients at 75 sites in the U.S., focusing on AIS patients who do not have treatment options due to tPA limitations[441]. - The Phase 2 REDUX trial for CKD completed enrollment with 79 subjects, including 21 African American subjects, 25 with IgAN, and 33 with Type 2 diabetes[446]. - Interim results from the REDUX trial indicated a -55% geometric mean decrease in UACR for African American patients with moderate to severe albuminuria[448]. - DM199 demonstrated clinically significant reductions in blood pressure for hypertensive patients in the REDUX trial, with a mean decrease of -19/-13 mmHg[448]. - Dosing the first patient in the ReMEDy2 trial triggered a $185,000 milestone payment to Catalent Pharma Solutions[444]. - A milestone payment of $185,000 was made in Q4 2021 for the initiation of dosing in the ReMEDy2 trial, with another milestone payment of $185,000 due upon the first regulatory approval of DM199[489]. Expenses and Funding - Research and development (R&D) expenses increased to $8.8 million in 2021 from $8.2 million in 2020, primarily due to costs for the Phase 2/3 ReMEDy2 trial and increased personnel costs[469]. - General and administrative (G&A) expenses rose to $4.9 million in 2021 from $4.5 million in 2020, driven by higher professional service costs and milestone payments[471]. - Significant expenses are expected to continue as the company activates sites and enrolls subjects in ongoing clinical trials[453]. - The company anticipates needing additional funding earlier than expected due to ongoing development efforts and potential new programs[454]. Cash and Assets - Cash, cash equivalents, and marketable securities increased to $45.1 million as of December 31, 2021, compared to $27.5 million in 2020, attributed to net proceeds from a private placement[474]. - Net cash used in investing activities was $20.5 million in 2021, compared to $16.1 million in 2020, primarily due to investments in marketable securities from the private placement proceeds[477]. - Future operating lease commitments total approximately $45,000 over the remainder of the lease, due within the next 12 months[488]. - Other income decreased to $0.1 million in 2021 from $0.4 million in 2020, mainly due to the cessation of R&D incentive receivables from the Australian Government[472].