DiaMedica Therapeutics(DMAC) - 2022 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of March 31, 2022, the company's combined cash and investments totaled $41 million, down $4.1 million from $45.1 million at December 31, 2021, indicating a strong balance sheet that supports operations into early 2024 [18] - Research and development expenses for Q1 2022 were $2 million, a decrease of $400,000 from $2.4 million in Q1 2021, primarily due to reduced costs related to the REDUX CKD trial and lower DM199 manufacturing costs [19] - General and administrative expenses increased to $1.6 million in Q1 2022 from $1.2 million in Q1 2021, reflecting higher professional services costs and personnel expenses [20] Business Line Data and Key Metrics Changes - The ReMEDy2 stroke trial is progressing with nine hospital sites activated, up from four since the last call, with a target of approximately 17 sites activated by June [7] - The company is focusing on clinical study sites with the highest enrollment potential, aiming for a target of one patient per site per month [12][22] Market Data and Key Metrics Changes - The company is addressing staffing challenges at study sites by engaging a clinical support service firm to assist with patient recruitment and management [10][11] - The ongoing COVID-19 pandemic has impacted site staffing, but the reduction in cases is contributing to an increase in site activity [26] Company Strategy and Development Direction - The company is committed to advancing DM199, a synthetic form of KLK1 protein, which has the potential to improve recovery and reduce recurrence in stroke patients [13] - The focus remains on the stroke program while also preparing for the chronic kidney disease (CKD) program, with plans to select a lead cause of CKD for further development [15][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in the ReMEDy2 trial and the potential for DM199, citing positive results from previous studies [14] - The interim analysis for the ReMEDy2 trial is expected to be completed in 2023, with guidance indicating a focus on the first half of the year [23] Other Important Information - The company has made key personnel investments, including the hiring of a new Chief Commercial Officer to prepare for future product launches [28] - The company is exploring opportunities in both IG nephropathy and hypertensive African-American patient populations for CKD treatment [38] Q&A Session Summary Question: Enrollment rates at activated sites - Management indicated that it is still early to assess enrollment rates, targeting 0.25 patients per site per month for the interim analysis [22] Question: Cash runway and CKD investment - The cash runway primarily focuses on the stroke trial, with minimal investment in CKD development anticipated [23] Question: Support service for the stroke study - The support service went live in the last few weeks, with incremental costs expected to be several hundred thousand dollars, included in the current budget [25] Question: Total number of sites for the trial - The plan remains to activate up to 75 sites, focusing on those with higher enrollment potential [31] Question: Competing programs at study sites - Management does not foresee any competing programs interfering with enrollment, as ongoing studies target different treatment windows [36]