DiaMedica Therapeutics(US:DMAC)2021-03-11 18:11Financial Data and Key Metrics Changes - The net loss for the full year of 2020 was $12.3 million or $0.78 per share, compared to a net loss of $10.6 million or $0.89 per share for the prior year, indicating a worsening in financial performance [20] - Research and development expenses increased to $8.3 million in 2020 from $7.9 million in 2019, primarily due to costs associated with the REDUX Phase 2 CKD study [20][21] - General and administrative expenses rose to $4.4 million in 2020 from $3.7 million in 2019, driven by increased non-cash share-based compensation and professional services [23] - Total other income decreased to $0.4 million in 2020 from $1 million in 2019, primarily due to reduced R&D incentives from the Australian Government [24] - Cash, cash equivalents, and marketable securities at the end of Q4 2020 were $27.5 million, up from $7.9 million at the end of 2019, reflecting successful public offerings [25][26] Business Line Data and Key Metrics Changes - The REDUX trial for DM199 in chronic kidney disease (CKD) has enrolled 68 participants, with full enrollment in the diabetic kidney disease cohort and 70% enrollment in the IgA Nephropathy cohort [16][17] - The company anticipates preliminary top-line results from the DKD cohort in Q2 2021, with completion of the IgA Nephropathy and African American cohorts expected in the second half of 2021 [17][18] Market Data and Key Metrics Changes - The FDA accepted the company's request for a pre-IND meeting for the Acute Ischemic Stroke program, indicating a positive regulatory environment for the company's stroke treatment initiatives [6][7] - AstraZeneca's label expansion for Brilinta to reduce stroke recurrence is viewed as a potential opportunity for DM199, which showed an 86% reduction in severe stroke recurrence in prior studies [11][12] Company Strategy and Development Direction - The company is focused on advancing its Acute Ischemic Stroke program and chronic kidney disease studies, with plans to submit an investigational new drug application for the Phase 2/3 study later in March 2021 [8][9] - The strategy includes pursuing IgA Nephropathy as an orphan indication while considering partnerships for broader CKD indications in the future [34][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's guidance for the stroke program, believing it provides a clear path forward [8] - The company is preparing for potential partnerships to support the development of DM199 for both stroke and kidney disease indications, with a focus on obtaining more data before finalizing partnerships [42] Other Important Information - The company plans to host a Stroke Key Opinion Leader Webinar on March 19, 2021, to discuss the treatment landscape for Acute Ischemic Stroke [10] - The company is on track to complete significant milestones, including data readouts for the REDUX study and initiating the Phase 2/3 study in Acute Ischemic Stroke [27] Q&A Session Summary Question: Could you speak to the label expansion for stroke recurrence? - The company plans to reach out to the FDA after filing the IND to discuss clinical paths and powering for the pivotal study [29] Question: Any update on the timing for the pivotal stroke study? - The study is expected to start in summer 2021, with an estimated cost of around $30 million for 350 patients [31] Question: What are the exclusion criteria for the stroke study? - The protocol will exclude patients on tPA or those who have undergone mechanical thrombectomy [38] Question: How will the company handle potential pricing differentials for different indications? - The company is considering distinct product positioning for stroke and kidney disease, with a focus on finding the right partner for both indications [41][42] Question: What new data is anticipated at the upcoming Stroke Conference? - Potential new data may be presented, but specifics will be withheld until the event [43]