Release Date: November 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioCardia Inc (BCDA, Financial) has received FDA breakthrough designation for its lead autologous cardiac cell therapy for heart failure, which is also reimbursed by Medicare and Medicaid.
- The company is conducting two active clinical trials for its cardiac cell therapy, with promising interim results showing improved survival and reduced major adverse cardiac events.
- BioCardia Inc (BCDA) has secured FDA approval for its Morph DNA steerable introducer platform, which has potential applications in various clinical procedures.
- The company successfully closed a $7.2 million public offering, ensuring compliance with Nasdaq's listing requirements and extending its financial runway.
- Research and development expenses have decreased significantly, reflecting efficient management and completion of enrollment in the cardiac heart failure one trial.
Negative Points
- Enrollment in the cardiac heart failure two trial has been delayed due to external factors such as hurricanes, impacting the company's timeline.
- BioCardia Inc (BCDA) does not expect significant near-term revenues from its Morph DNA platform despite FDA approval.
- The company faces challenges in the competitive market for electrophysiology products, which could impact the commercial success of its Morph DNA platform.
- There is uncertainty regarding the outcome of regulatory consultations in Japan, which could affect the company's ability to commercialize its therapies in that market.
- BioCardia Inc (BCDA) anticipates a moderate increase in cash burn over the coming year, which could strain financial resources if not managed carefully.
Q & A Highlights
Q: What are the potential options for BioCardia's Morph DNA platform beyond individual partnerships?
A: Dr. Peter Altman, President and CEO, explained that Morph DNA is a significant product due to its advantages in cardiac procedures. The market is large, with significant potential for partnerships or even selling the business unit. BioCardia is open to selling the business unit, provided they retain exclusive rights for biotherapeutic interventions. They are currently reaching out to executives at companies that could benefit from this technology, aiming to demonstrate its utility and potentially divest the business for significant non-dilutive capital.
Q: Can you provide insights into BioCardia's ex-US efforts, particularly in Japan, and the potential for Sakaki status?
A: Dr. Altman noted that BioCardia is in discussions with Japan's PMDA and is hopeful for a clinical consultation, which is a significant step towards approval. The company aims to use data from US trials to support approval in Japan, where the therapy will be regulated as a device system. While Sakaki status is more common for biologics, BioCardia's therapy is considered a device due to its manufacturing process. Approval in Japan would be a full approval, and BioCardia is considering partnerships for commercialization.
Q: How does the protocol amendment to the Cardiac Heart Failure Two trial impact patient enrollment?
A: Dr. Altman described the amendment as transformative, allowing more patients to qualify for treatment by adjusting the dosage based on cell population analysis. Previously, patients not meeting specific criteria were excluded, but now those close to the threshold can receive additional dosages. This change is expected to significantly increase enrollment, with about 85% of patients expected to qualify under the new criteria.
Q: What is BioCardia's commercialization strategy in Japan?
A: Dr. Altman indicated that BioCardia plans to partner for commercialization in Japan. The strategy involves a post-marketing study to build awareness and data, with a gradual rollout. Distribution in Japan involves multiple layers, and BioCardia is in discussions with potential partners. Approval without a clinical trial is seen as valuable due to the high cost and difficulty of trials in Japan.
Q: How does the potential approval of Mesoblast's product impact BioCardia's allogeneic cell therapy platform?
A: Dr. Altman noted that Mesoblast's cells are similar to BioCardia's allogeneic mesenchymal stem cells. Success in Mesoblast's PDUFA meeting could enhance interest in BioCardia's platform, as both companies are delivering similar cells. This could increase partnering opportunities for BioCardia's clinical-grade cells in various indications.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
