Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioCardia Inc (BCDA, Financial) reported positive interim results from the CardiAMP Heart Failure I trial, showing improved survival, reduced major adverse cardiac events, and enhanced quality of life for patients.
- The CardiAMP Heart Failure II trial is the only confirmatory pivotal trial of a cell therapy in heart failure, with a high statistical probability of success based on interim results.
- BioCardia Inc (BCDA) has expanded its Executive Steering Committee with two additional world-class heart failure clinicians, enhancing the trial's credibility and support.
- The company has made significant progress in other programs, including the CardiAMP cell therapy for chronic myocardial ischemia and a partnership with CellProthera for acute myocardial infarction.
- BioCardia Inc (BCDA) has submitted an FDA application for market clearance of the Morph DNA Steerable Introducers, which could enhance revenue generation and partnering interests.
Negative Points
- BioCardia Inc (BCDA) experienced a tough quarter for its share price, despite delivering on business milestones.
- Revenues for the second quarter of 2024 were significantly lower compared to the same period in 2023, indicating financial challenges.
- The company reported a net loss of $1.6 million for the second quarter of 2024, although this was an improvement from the previous year.
- BioCardia Inc (BCDA) is exploring pathways to secure funding to meet Nasdaq listing requirements, which may involve potential dilution for current shareholders.
- There is uncertainty regarding the approval timeline for CardiAMP in Japan, as the company awaits final data from the CardiAMP Heart Failure I trial.
Q & A Highlights
Q: How is the data from the CardiAMP Heart Failure I trial influencing enrollment for the CardiAMP Heart Failure II study?
A: Peter Altman, President and CEO, explained that the positive data from Heart Failure I, showing improved survival and reduced major adverse cardiac events, is significantly aiding enrollment for Heart Failure II. The compelling safety and efficacy data, particularly the 86% relative risk reduction in mortality for the NTproBNP population, is a strong incentive for physicians to enroll patients in the trial.
Q: Can you discuss any streamlining efforts already in place for the CardiAMP Heart Failure II trial?
A: Peter Altman noted that the trial design has been streamlined by allowing certain follow-up visits to be conducted via phone, reducing the burden on clinical sites and costs for BioCardia. This streamlining is expected to make the trial more efficient and less expensive.
Q: What is the expected gender ratio for the CardiAMP Heart Failure II trial, given the male-dominated enrollment in Heart Failure I?
A: Peter Altman acknowledged the challenge of gender imbalance in heart failure research and expressed a desire to achieve a more balanced enrollment in Heart Failure II. He hopes the compelling safety data will encourage more female participation, although achieving a 50% ratio may be challenging.
Q: What is the status of the CardiAMP submission for approval in Japan, and is approval expected next year?
A: Peter Altman stated that BioCardia is in a good position to submit for approval in Japan, pending final data from the CardiAMP Heart Failure I trial. The company is optimistic about approval due to the extensive patient data and existing approvals for related technologies in Japan.
Q: How is BioCardia planning to comply with Nasdaq listing requirements, and will this affect current shareholders?
A: Peter Altman explained that BioCardia is exploring funding options to meet Nasdaq's requirements, including maintaining a share price above $1 and meeting equity or market capitalization thresholds. The company is mindful of potential dilution but is focused on advancing its business and achieving significant milestones.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
