DiaMedica Therapeutics(US:DMAC)2024-03-20 20:14Financial Data and Key Metrics Changes - As of December 31, 2023, the total combined cash and investments increased to $52.9 million from $33.5 million in 2022, with working capital rising to $50.9 million from $31.7 million [40] - Research and development expenses rose to $13.1 million in 2023, up from $7.8 million in 2022, primarily due to costs related to the ReMEDy2 trial and increased personnel costs [20] - Net cash used in operating activities increased to $18.7 million in 2023 from $11.5 million in the previous year, driven by a higher net loss and increased amortization of discounts on marketable securities [41] Business Line Data and Key Metrics Changes - The ReMEDy2 trial is expected to have 25 to 30 sites active and recruiting by the end of Q2 2024, with a total of approximately 75 sites anticipated by the end of 2024 [15] - The ReMEDy1 trial showed an 18% improvement in full recovery for patients treated with DM199 compared to placebo [38] Market Data and Key Metrics Changes - The Canadian Stroke Consortium has endorsed the ReMEDy2 trial protocol, with six Canadian hospitals identified for participation [7] - The Australian Stroke Trials Network has provisionally endorsed the protocol, with plans to activate study sites by the end of 2024 [14] Company Strategy and Development Direction - The company aims to position DM199 as a potential breakthrough treatment for acute ischemic stroke, focusing on enhancing clinical success probabilities through protocol revisions [17] - The strategy includes expanding clinical operations and engaging reputable stroke research hospitals to increase patient enrollment [13][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ReMEDy2 trial's design and its potential to provide definitive evidence for DM199's efficacy [6] - The company anticipates a substantial ramp-up in site activations and patient enrollment in the second half of 2024, with expectations for the interim analysis to be completed by Q1 2025 [35][37] Other Important Information - The company is currently evaluating options regarding a lawsuit against PRA, with a court finding PRA in breach of the study agreement but not entitling the company to a return of fees paid [43] - Other income increased to $1.9 million in 2023 from $0.4 million in 2022, driven by higher interest rates and increased marketable securities [21] Q&A Session Summary Question: What is the expected lag from site activation to patient enrollment? - Management indicated a reasonable expectation of a 3- to 4-month lag due to multiple layers of IRB approvals at academic institutions [44] Question: Will the interim analysis be representative of the full patient enrollment? - Management anticipates a mix of patients from the U.S., Canada, Australia, and the EU, with full enrollment expected by the end of Q1 2025 [46] Question: What are the expectations around the interim read and study design? - If a drug effect of less than approximately 4% versus placebo is observed, the study will be terminated; otherwise, a resampling size will be determined [49] Question: What is the current status of the PRA lawsuit? - The company is evaluating options regarding the appeal, with a court ruling that they are entitled to the full results of the study but not to a return of fees paid [43][59]