DiaMedica Therapeutics(DMAC) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The net loss for the full year of 2021 was $13.6 million or $0.65 per share, compared to a net loss of $12.3 million or $0.78 per share in the prior year [32] - Cash position improved to $45.1 million as of December 31, 2021, up from $27.5 million at the end of the prior year [33] - Research and development expenses increased slightly to $8.8 million for 2021, up from $8.2 million in 2020 [34] - General and administrative expenses rose to $4.9 million in 2021 from $4.5 million in 2020 [35] - Net cash used in operating activities increased to $12.3 million in 2021 from $9.2 million in 2020 [36] Business Line Data and Key Metrics Changes - The ReMEDy2 trial is the primary focus, with plans to enroll approximately 350 patients [18] - The REDUX trial has completed enrollment and is preparing for final analysis [29] Market Data and Key Metrics Changes - The company has engaged with over 70% of targeted sites for the ReMEDy2 trial, with 10 sites under contract [25] - Four to five sites are currently actively recruiting patients [44] Company Strategy and Development Direction - The company aims to advance stroke care with DM199, which has received FDA Fast Track designation [24] - The focus is on the ReMEDy2 trial for acute ischemic stroke, with an adaptive trial design allowing for interim analysis and potential adjustments [20][21] - The company is exploring opportunities in chronic kidney disease, particularly targeting hypertensive African-Americans and IgA nephropathy patients [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the enrollment rates for the ReMEDy2 trial, especially with declining COVID-19 cases [27] - The company is focused on ensuring a successful clinical trial and is well-positioned financially to support its operations into early 2024 [33][36] Other Important Information - The company has added two new executive team members with significant experience in neurology and commercial leadership [6][7] - The adaptive design of the ReMEDy2 trial allows for increased sample size if needed to achieve statistically significant outcomes [22] Q&A Session Summary Question: Additional studies for DM199 - The company is currently focused on the ReMEDy2 trial and is considering next steps for the kidney program [39] Question: Regulatory landscape for chronic kidney disease - New guidance suggests potential for conditional approval based on UACR and eGFR metrics [41][42] Question: Enrollment status of trial sites - Currently, four to five sites are actively recruiting, with over 50 sites contracted or in the process [44][46] Question: Importance of interim analysis - The interim analysis will allow for recommendations on whether to continue, increase patient numbers, or stop the study based on efficacy [50] Question: Final CKD data and potential partnerships - Final CKD data is expected later this year, and the company is exploring partnership options while ensuring funding for the stroke program [52]