In This Article:
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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BioCardia Inc (NASDAQ:BCDA) reported positive safety and meaningful benefits from their cardiac cell therapy for heart failure patients, addressing a significant unmet clinical need.
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The company is actively engaging with the FDA and Japan's PMDA to align on pathways for making their therapy available, indicating progress towards regulatory approval.
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BioCardia Inc (NASDAQ:BCDA) is enrolling patients in the Cardiac Heart Failure 2 trial, which aims to confirm previous results and enhance enrollment.
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The Helix biotherapeutic delivery system is being prepared for submission for approval, potentially becoming the first approved transendocardial biotherapeutic delivery system in the U.S.
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BioCardia Inc (NASDAQ:BCDA) has a strong focus on partnerships, which could create meaningful value for shareholders across their four platforms: CardiAM, Cardiello, Helix, and Morph DNA.
Negative Points
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Total expenses increased by $396,000 quarter over quarter, driven primarily by research and development costs.
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The company reported a net loss of $2.7 million in Q1 2025, up from $2.3 million in Q1 2024.
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Cash and cash equivalents were low at $949,000 at the end of the quarter, necessitating a small financing to support ongoing operations.
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The Cardiac Heart Failure trial did not hit its primary endpoint, introducing significant risks to the approval pathway.
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BioCardia Inc (NASDAQ:BCDA) faces challenges in the lengthy and uncertain process of deal discussions and partnerships, which can take a long time to finalize.
Q & A Highlights
Q: Can you discuss the levels of maturity in your business development deals and any ongoing discussions? A: Peter Altman, CEO: We have several active discussions with large-cap strategics, particularly around our Morph Axis pro product family, which is already approved and in use. The cardiac electrophysiology market is growing rapidly, and our technology can help access this market. On the Helix side, we are in talks with potential partners for biotherapeutic delivery. Our Cardialo cell therapy has demonstrated safety, and we are open to partnerships for other clinical indications. For Cardiam, we are focused on the approval process in Japan and have ongoing discussions with potential distributors.
Q: How does the potential approval process in Japan compare to the FDA's BLA acceptance, and what is its significance? A: Peter Altman, CEO: The process in Japan is similar to the FDA's BLA acceptance. Japan's PMDA is rigorous, and we expect clarity on approval submission within six months. Approval would provide clarity for distribution partners and help us prepare for commercial launch. Our extensive clinical data and minimally invasive delivery method position us favorably compared to peers in Japan.