BioCardia(US:BCDA)2023-08-09 21:45Financial Data and Key Metrics Changes - Revenues for Q2 2023 were approximately $43,000, a significant decrease compared to approximately $975 million for Q1 2022, primarily due to the timing of collaboration agreement revenues [21] - Net loss for Q2 2023 was approximately $3.4 million, compared to $2.5 million in Q2 2022, mainly due to fluctuations in collaboration revenues [21] - Cash and cash equivalents at the end of the quarter were approximately $4.3 million, providing a runway into November without additional capital [22] Business Line Data and Key Metrics Changes - The CardiAMP Autologous Cell Therapy for heart failure (BCDA-01) is currently paused for new patient enrollment following a recommendation from the Data Safety Monitoring Board (DSMB) [7][8] - Enrollment for the Cardiac autologous cell therapy for chronic myocardial ischemia (BCDA-02) is progressing, with expectations to complete enrollment in the rolling cohort by Q4 2023 [15] - The CardiALLO allogeneic cell therapy for ischemic heart failure (BCD03) is in Phase I/II trials, with patient enrollment expected to begin in Q3 2023 [16] Market Data and Key Metrics Changes - The company is seeing significant enrollment increases in its clinical trials, including patients from Canada [6] - The CardiAMP Cell Therapy system submission to Japan's PMDA for ischemic heart failure is progressing, with the consultation expected to take up to four months [12] Company Strategy and Development Direction - The company is focused on advancing its cell therapy platforms to address unmet needs in cardiovascular and pulmonary diseases [5] - BioCardia aims to gather more information to decide next steps for the BCDA-01 program, including the possibility of restarting the trial with a new protocol [9][10] - Business development activities are ongoing, with the goal of closing meaningful deals by the end of the year to avoid financing [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confusion regarding the DSMB's recommendation to pause enrollment, noting that there were no reported safety issues and that patients appeared to show clinical improvement [8][9] - The company remains optimistic about the safety and efficacy of its therapies, with expectations for significant near-term catalysts from its clinical programs [20] Other Important Information - The company has received patents in Japan and Europe for its delivery systems, enhancing its intellectual property portfolio [18][19] - The allogeneic cell therapy trial for acute respiratory distress syndrome (BCDA04) has been deprioritized due to reduced patient populations [17] Q&A Session Summary Question: Focus on DSMB review and trial status - The DSMB's recommendation to pause enrollment is unique, and management is analyzing the data to understand the implications while continuing to randomize patients [24][26] Question: Benchmarks for patient follow-up - Management indicated that key metrics to monitor include mortality rates, major adverse cardiac events, and functional endpoints like the six-minute walk test [30][31]