BioCardia (BCDA) Q3 Earnings call transcript Nov 13, 2024

BioCardia, a leading biotechnology company specializing in cell-based therapies for cardiovascular diseases, held its third quarter 2024 earnings call, revealing a promising outlook for its targeted cellular precision medicines. The call, led by CEO Dr. Peter Altman, detailed the company's advancements in clinical trials, regulatory approvals, and strategic partnerships.

Clinical Trial Progress and Regulatory Milestones

BioCardia's lead autologous CardiAMP cell therapy for heart failure has made significant strides, with two active clinical trials currently underway. The CardiAMP Heart Failure I trial, which has received Food and Drug Administration (FDA) breakthrough designation and is reimbursed by the Center for Medicare and Medicaid Services, is expected to provide critical data for future product approvals and commercialization in the United States and Japan. Preliminary data from this trial shows promising results, including improved survival, reduced major adverse cardiac events, and improved quality of life for patients.

The company also announced the completion of enrollment in the CardiAMP cell therapy and chronic myocardial ischemia trial (BCDA-02) and the approval to enroll patients in the CardiALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure (BCDA-03) trial. These developments underscore BioCardia's commitment to advancing its cell therapies through rigorous clinical trials and regulatory processes.

Strategic Partnerships and Commercialization

In addition to its clinical progress, BioCardia is actively pursuing strategic partnerships to expand the reach of its therapies. The recent FDA approval of its proprietary Morph DNA Steerable Introducer platform is a significant milestone, opening up opportunities for partnerships and commercial collaborations. This platform, designed to enhance many other clinical procedures, has already received FDA approval for commercial release. The company is actively engaging with senior management at other companies to showcase the benefits of the Morph DNA products, with plans to conduct first-in-man procedures in the near future.

Financial Outlook and Future Prospects

The earnings call also provided an update on BioCardia's financial performance, with a $7.2 million public offering bringing the company into compliance with NASDAQ's listing requirements and extending its runway past expected results in the pivotal CardiAMP Heart Failure trial in Q1 2025. The company's net loss decreased to $1.7 million for the third quarter of 2024, down from $2.6 million in the prior year's third quarter, reflecting reduced research and development and selling, general, and administrative expenses.

Looking ahead, BioCardia is optimistic about its prospects, with the expectation of significant progress in the coming quarters. The company is working to complete several key milestones, including a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA), data lock on the CardiAMP Heart Failure I trial data set, and the enrollment of patients in the CardiAMP Heart Failure II trial. These efforts are expected to pave the way for regulatory approvals and commercialization of its cell therapies in key markets.

In conclusion, BioCardia's earnings call painted a picture of a company on the cusp of significant achievements in the field of cardiovascular cell therapies. With promising clinical trial results, regulatory approvals, and strategic partnerships, BioCardia is well-positioned to make a meaningful impact on the treatment of cardiovascular diseases. As the company continues to advance its therapies and forge new collaborations, investors and stakeholders can look forward to a promising future for BioCardia and its innovative approaches to cardiovascular care.