DiaMedica Therapeutics(US:DMAC)2021-05-09 20:31Financial Data and Key Metrics Changes - The net loss for Q1 2021 was $3.6 million or $0.19 per share, compared to a net loss of $2.4 million or $0.19 per share for the same period in the prior year [18] - Research and development expenses increased to $2.4 million from $1.4 million year-over-year, attributed to costs for the REDUX Phase 2 CKD study and increased staffing [19] - General and administrative expenses rose slightly to $1.2 million from $1.1 million, primarily due to higher insurance premiums and personnel costs [20] - Cash, cash equivalents, and marketable securities at the end of Q1 2021 were $23.4 million, down from $27.5 million at the end of 2020 [21][22] Business Line Data and Key Metrics Changes - The Acute Ischemic Stroke program is advancing with a Phase 2/3 study of DM199, with the IND submitted on April 16, 2021 [8][9] - Enrollment in the REDUX study reached 70 participants, with full enrollment of the diabetic kidney disease cohort and 70% completion in the IgA Nephropathy cohort [15][16] Market Data and Key Metrics Changes - The company is preparing for discussions with the FDA regarding stroke recurrence as a clinically significant endpoint, following positive results from the ReMEDy Phase 2 study [11][12] Company Strategy and Development Direction - The company plans to submit an application for fast-track designation for DM199 as part of the study initiation [13] - The strategy includes engaging a contract research organization to identify and qualify clinical sites for the upcoming studies [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the timelines for the Phase 2/3 study and does not anticipate significant issues with the IND submission [10][25] - The company expects to report preliminary top-line data from the diabetic kidney disease cohorts during the current quarter [15][28] Other Important Information - The company has sufficient drug supply for the study, with a shelf-life extending two years [49] - The current capital position is expected to fund operations through mid-2022, allowing completion of the REDUX study and initiation of the Phase 2/3 study [22] Q&A Session Summary Question: Status of fast-track designation submission - Management confirmed that the fast-track designation has not yet been submitted but plans to do so after receiving approval to proceed with the study [23][24] Question: Insights on kidney readout data - Management indicated that they would like to see a decrease in UACR proteinuria while maintaining or increasing eGFR [26][27] Question: Patient disposition in DKD trial - Management stated they prefer to wait for complete data before analyzing individual patient outcomes [30] Question: Implications of DKD data for IgA Nephropathy - Management discussed the potential for DM199 to improve kidney function across different causes of kidney disease, with a focus on differences among cohorts [39][40] Question: Timing for FDA approach regarding stroke recurrence - Management is exploring multiple pathways for stroke recurrence, including potential sub-studies or co-primary endpoints [35][36] Question: Activation of study sites - Management confirmed that they are in the process of identifying and activating clinical study sites, aiming for up to 75 sites [46] Question: Initial data readout expectations - Management anticipates interim results in 2022, with the study completion expected in 2023 [51]