DiaMedica Therapeutics(DMAC) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The net loss for Q2 2020 was $2.5 million or $0.17 per share, compared to a net loss of $2.5 million or $0.21 per share in Q2 2019 [26] - For the six months ended June 30, 2020, the net loss was $4.9 million or $0.36 per share, compared to $5.7 million or $0.48 per share for the same period in 2019 [26] - Cash, cash equivalents, and marketable securities at the end of Q2 2020 were $11.8 million, an increase from $7.9 million at the end of 2019 [31] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $1.6 million for Q2 2020 from $1.9 million in Q2 2019, and for the six months ended June 30, 2020, R&D expenses were $3 million compared to $4.5 million in the same period of 2019 [27] - General and administrative expenses increased to $1.1 million for Q2 2020 from $867,000 in Q2 2019, and for the six months ended June 30, 2020, G&A expenses were $2.1 million compared to $1.7 million in the same period of 2019 [29] Market Data and Key Metrics Changes - The company completed a public offering raising gross proceeds of $23 million, which included the exercise of the full over-allotment option [4] - The net proceeds from the offering are intended to support clinical and product development activities for DM199, including the addition of a third cohort in the REDUX study [7] Company Strategy and Development Direction - The company plans to initiate a third cohort in the REDUX Phase II CKD trial focused on participants with diabetic kidney disease, expanding the study to include 90 participants across three cohorts [14] - The strategy includes leveraging the current clinical sites and potentially adding more if conditions allow, while also addressing the impact of COVID-19 on recruitment [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential for DM199 to improve kidney function and reduce blood glucose levels in diabetic patients, based on positive results from the ReMEDy stroke trial [12] - The company anticipates that the COVID-19 pandemic will continue to affect recruitment but is seeing an increase in screening activity [17] Other Important Information - The company is finalizing a meeting request for a Type B meeting with the USFDA to discuss the Phase III study protocol for DM199 in stroke treatment [23] - The cash position is expected to support operations for the next two years, including the initiation of a Phase III study in acute ischemic stroke [33] Q&A Session Summary Question: How has enrollment been trending in early August? - Management noted an increase in screening but acknowledged patient hesitance to visit clinics due to COVID-19 concerns [36] Question: Is there a risk in including diabetic African Americans in the cohort? - Management indicated no concerns about identifying patients for the cohorts, emphasizing the importance of patient comfort in attending clinics [38] Question: What are the expected outcomes for the third cohort in kidney disease? - The rationale is to demonstrate that DM199 can improve kidney function and reduce blood glucose levels, with expectations for quicker enrollment [39] Question: Why was the FDA meeting for stroke pushed back? - The delay is due to the need for thorough analysis and feedback from a consulting firm to refine the product profile before submission [41] Question: What endpoints will be proposed for the Phase III study? - Management plans to propose an excellent outcome of either MRS or the NIHSS stroke scale, with death considered a secondary endpoint [46]