• Total Expense: Decreased 35% year-over-year to $8.1 million in 2024 from $12.1 million in 2023.
• Research and Development Expense: Decreased 43% to $4.4 million in 2024 from $7.7 million in 2023.
• Selling, General and Administrative Expenses: Decreased 16% to $3.7 million in 2024 from $4.4 million in 2023.
• Net Loss: Decreased to $7.9 million in 2024 from $11.6 million in 2023.
• Net Cash Used in Operations: Approximately $8 million in 2024, down from approximately $10 million in 2023.
• Cash and Cash Equivalents: Ended the year with $2.4 million.

• Warning! GuruFocus has detected 7 Warning Signs with BCDA.

Release Date: March 31, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• BioCardia Inc (NASDAQ:BCDA) reported a significant reduction in mortality rates in their CardiAMP HF clinical trial, which is a positive outcome in a field where no current therapy reduces mortality.
• The trial demonstrated meaningful reductions in major adverse cardiac events, which could potentially lower the cost of heart failure care.
• The CardiAMP HF trial showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events.
• The company observed a clinically meaningful 10.5% improvement in quality-of-life scores and a 13.9-meter improvement in the six-minute walk distance test.
• BioCardia Inc (NASDAQ:BCDA) has a strong safety profile for their CardiAMP cell therapy, with trends indicating reduced cardiac arrhythmias, addressing a primary safety concern with cell therapy.

Negative Points

• The CardiAMP HF clinical trial did not meet its primary endpoint due to the six-minute walk distance test, which offset the benefits seen in other areas.
• The market reaction to the trial results was unexpectedly negative, despite the company achieving its anticipated outcomes.
• BioCardia Inc (NASDAQ:BCDA) anticipates an increase in research and development expenses in 2025, which could impact financial performance.
• The company ended the year with cash and cash equivalents totaling only $2.4 million, indicating potential financial constraints.
• There is uncertainty regarding the timeline and outcome of regulatory discussions with the FDA and Japan's PMDA, which could affect the future availability of their therapies.

Q & A Highlights

Q: Can you provide more details on your discussions with Japan's PMDA regarding the CardiAMP heart failure trial? A: We met with PMDA in November, and they requested to see the two-year data, which we now have. The data looks even better than before, and we are optimistic about the potential for conditional or full approval in Japan. We are preparing the submission package for further consultation with PMDA. Peter Altman, President and CEO

Q: Were there any subsequent therapies that patients went on after the study that could have impacted the data? A: All patients were on guideline-directed medical therapy, and there were no other medications beyond those under current guidelines. We have a bio repository to analyze patient samples for future insights, but no patients received therapies other than CardiAMP. Peter Altman, President and CEO

Q: How balanced were the NT-proBNP populations between the two arms, and how important is this marker going forward? A: Approximately half the patients in both groups had elevated NT-proBNP levels. This marker is a pre-specified parameter for covariate analysis, and we will continue to explore its significance in future analyses. Peter Altman, President and CEO

Q: What are the next steps for sharing the two-year data with the FDA, and how will it impact the CardiAMP heart failure 2 trial? A: We plan to meet with the FDA to discuss the data. Our interactions with the FDA have been positive, and we expect creative approaches based on the strength of our data. The CardiAMP heart failure 2 trial is already approved and activated, and we are working on covariate analysis to inform future steps. Peter Altman, President and CEO

Q: What should we look for in the CardiAMP heart failure 2 trial, and what would be the most positive outcome? A: The primary endpoint is the same composite endpoint structure as in CardiAMP heart failure 1, where we achieved a P value of 0.02. We aim to replicate this result in the subgroup already approved by the FDA for CardiAMP heart failure 2. The trial's success could attract significant interest, similar to other therapies in the field. Peter Altman, President and CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.