BioCardia (BCDA) Q2 Earnings call transcript Aug 13, 2024

BioCardia, a pioneering company in the development of cell therapies for cardiovascular diseases, recently held its Q2 2024 earnings call, shedding light on the company's current position and future prospects. The call was led by Dr. Peter Altman, President and CEO, and David McClung, CFO, who provided insights into BioCardia's financial performance, ongoing clinical trials, and strategic partnerships.

Financial Performance and Future Outlook

BioCardia reported a decrease in revenues from $43,000 in Q2 2023 to $3,000 in Q2 2024. This decrease is attributed to the completion of enrollment in the CardiAMP Heart Failure trial, coupled with related reductions in clinical and supporting function expenses. The net loss for the second quarter of 2024 was $1.6 million, down from $3.4 million in the previous year, signaling a more efficient use of capital. Despite the financial challenges, BioCardia remains optimistic about its future, particularly with the progress of its lead autologous cell therapy for heart failure.

Clinical Trials and Regulatory Approvals

The most significant discussion revolved around BioCardia's CardiAMP Heart Failure II trial, a confirmatory clinical trial focusing on the remarkable benefits in patients treated with elevated NT-proBNP, a biomarker of active heart failure. Preliminary results from this trial showed a remarkable 86% relative risk reduction in heart death equivalents and a 24% relative risk reduction in nonfatal major adverse cardiac and cerebrovascular events. This trial is the first confirmatory pivotal trial of a cell therapy in heart failure, and its success could pave the way for future product approvals and commercialization of the CardiAMP cell therapy in Japan and the United States.

BioCardia is also seeking regulatory approval for its Morph DNA steerable introducer, a device designed to enhance many other clinical procedures. The FDA submission for market clearance is expected to be granted by the end of this quarter, which could lead to new revenue streams for the company.

Strategic Partnerships and Business Development

BioCardia has been actively engaging in partnering discussions across its platforms, including CardiAMP, CardiALLO, Helix, and Morph. The company is exploring distribution partnerships in Japan, Brazil, and the United Arab Emirates, anticipating that approvals in first-world countries will enable distribution partnerships in other regions. BioCardia also aims to streamline clinical trials and enhance enrollment by leveraging the positive data and experience from the CardiAMP Heart Failure I trial.

Conclusion

BioCardia's Q2 2024 earnings call presented a mixed picture, with financial challenges offset by the promising progress in its clinical trials and strategic partnerships. The company's focus on heart failure therapies, particularly the CardiAMP cell therapy, could lead to significant breakthroughs in the treatment of cardiovascular diseases. The completion of the CardiAMP Heart Failure II trial and the expected FDA clearance for the Morph DNA product family are key milestones that could bolster BioCardia's position in the market and generate new opportunities for growth. As BioCardia continues to navigate the complex landscape of cardiovascular disease treatments, it remains committed to its mission of developing and enhancing therapies that can make a difference in patients' lives.