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BioCardia(BCDA) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total expenses decreased by 35% year-over-year to $8.1 million in 2024 from $12.1 million in 2023, primarily driven by a 43% reduction in research and development expenses to $4.4 million from $7.7 million [35][36] - Net loss decreased to $7.9 million in 2024, down from $11.6 million in 2023, with net cash used in operations approximately $8 million, a 20% decrease from $10 million in 2023 [37][38] - The company ended the year with cash and cash equivalents totaling $2.4 million, with expectations of a moderate increase in cash burn in 2025 [38] Business Line Data and Key Metrics Changes - The CARDI-AMP Heart Failure Trial showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events, with a clinically meaningful 10.5% improvement in quality of life score [14][19] - The trial did not meet its primary endpoint due to the six-minute walk distance test, but showed strong results in other key areas [12][19] Market Data and Key Metrics Changes - The market reaction to the trial results was surprising, as the data was in line with expectations, indicating a strong need for therapies in ischemic heart failure [18][22] - The FDA granted cardiac cell therapy a breakthrough device designation, highlighting the significant unmet clinical need in this area [22][24] Company Strategy and Development Direction - The company is focused on advancing its cardiac cell therapy programs, with plans to share two-year data with the FDA and Japan's PMDA to align on pathways for making therapies available [21][22] - Ongoing discussions with regulatory agencies aim to ensure the safety and efficacy of cardiac cell therapy, with a focus on the unique benefits of the therapy compared to traditional medical devices [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strength of the data from the CARDI-AMP trial and its implications for future trials, particularly the CAR-DMHF2 trial [20][21] - The company anticipates modest increases in R&D expenses in 2025 as it continues to advance therapeutic candidates [36] Other Important Information - The company completed enrollment in the low-dose cohort of its cardi-allo-allogeneic mesenchymal stem cell therapy in ischemic heart failure [26] - The Helix biotherapeutic delivery platform is expected to enhance commercialization and clinical development efficiency [31][32] Q&A Session Summary Question: Can you provide more details on PMDA discussions in Japan? - Management met with PMDA in November and is preparing to share two-year data, which looks promising, potentially leading to conditional approval in Japan [42][43] Question: Were there any subsequent therapies that could have impacted the data read? - All patients were on guideline-directed medical therapy, and no other medications were introduced during the trial [46][48] Question: What is the expected timeline for sharing two-year data with the FDA? - The company is preparing a submission package and expects to request a consultation with the FDA soon, with timelines potentially ranging from three to eight weeks [78][80] Question: How does the data from the Heart Failure 1 trial inform the Heart Failure 2 trial? - The primary endpoint structure remains the same, and the company aims to replicate the positive outcomes seen in the first trial [88][90] Question: What are the next steps with the PMDA? - The company is finalizing the submission package and scheduling the next consultation with PMDA, aiming for a thorough and detailed presentation [78][82]