DiaMedica Therapeutics(US:DMAC)2020-05-14 16:35Financial Data and Key Metrics Changes - The net loss for Q1 2020 was $2.4 million or $0.19 per share, compared to a net loss of $3.3 million or $0.27 per share in Q1 2019, indicating an improvement in financial performance [54] - Research and development expenses decreased to $1.4 million in Q1 2020 from $2.6 million in Q1 2019, primarily due to non-recurring costs from the previous year [54][55] - Cash, cash equivalents, and marketable securities increased to $12.6 million at the end of Q1 2020 from $7.9 million at the end of 2019, attributed to a public offering of common shares [58][59] Business Line Data and Key Metrics Changes - The ReMEDy Phase 2 study demonstrated that DM199 was safe and well tolerated, with no serious adverse events related to DM199 reported [10][21] - In the ReMEDy study, DM199 showed a 22% improvement in stroke recoveries for participants not receiving mechanical thrombectomy, with 36% achieving full or near full recovery compared to 14% in the placebo group [29][30] Market Data and Key Metrics Changes - The global incidence of strokes is estimated at 15 million annually, with approximately 690,000 acute ischemic strokes occurring in the U.S. each year, highlighting a significant unmet medical need [18] - 90% of patients suffering from acute ischemic strokes have no direct treatment options, emphasizing the potential market for DM199 [18] Company Strategy and Development Direction - The company plans to request a meeting with regulators to discuss ReMEDy results and potential breakthrough therapy designations, while also evaluating strategic partnerships [44] - The focus remains on the 90% of stroke victims who do not receive thrombectomy, positioning DM199 as a treatment option for this population [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the safety profile of DM199, which could facilitate regulatory approval and commercialization [41] - The company is closely monitoring the impact of COVID-19 on clinical trials, particularly the REDUX Phase 2 study for chronic kidney disease, and is adapting protocols to ensure participant safety [60][61] Other Important Information - The company has not observed any negative data from the ReMEDy study, reinforcing confidence in the safety and efficacy of DM199 [43] - The REDUX Phase 2 study is currently enrolling participants, with adjustments made to accommodate social distancing guidelines [46][48] Q&A Session Summary Question: Why was mechanical thrombectomy included in the study? - The inclusion was initially excluded but later added for safety assessment and to evaluate potential clinical benefits, as approximately 20% of patients are eligible for thrombectomy [63][64] Question: What was the response from the stroke advisory board regarding the high rate of mechanical thrombectomy enrollment? - The advisory board was surprised by the high enrollment rate and found the safety results encouraging, noting reductions in stroke recurrences [66] Question: How many patients are currently enrolled in the CKD study? - The company has not provided specific enrollment numbers but anticipates updates once clarity on COVID-19 impacts is achieved [71] Question: What are the expectations for FDA approval regarding efficacy and safety? - The company believes that demonstrating similar efficacy to tPA, combined with a strong safety profile, will create an attractive clinical bar for FDA approval [72][75] Question: What is the design of the Phase 2/3 study going forward? - The design may be adaptive, allowing for a transition from Phase 2 to Phase 3 based on initial results from the first 100 patients [77]