BioCardia's 2025 Q2 Earnings Call: Navigating Contradictions in CardiAMP's Regulatory Journey

Regulatory path for CardiAMP, FDA milestone for CardiAMP, regulatory expectations and approval pathways, enrollment progress for CardiAMP Heart Failure II Trial, and regulatory process for CardiAMP in Japan are the key contradictions discussed in BioCardia's latest 2025Q2 earnings call.



Regulatory Progress and Market Opportunities:
- BioCardia reported significant progress in regulatory consultations with Japan's PMDA and the FDA, with meetings expected in Q4 2025.
- The company anticipates potential approvals for its CardiAMP system, which is seen as a key therapeutic option for heart failure management.
- The regulatory pathway is contingent on the safety and efficacy data from ongoing trials, including the CardiAMP Heart Failure II trial.

Clinical Trial Advancements:
- BioCardia completed the CardiAMP Heart Failure trial, with primary outcomes demonstrating reduced all-cause death and MACE in the treatment group.
- The trial also showed statistical significance in the subgroup of patients with elevated NT-proBNP, indicating potential benefits for specific patient populations.
- The company is actively enrolling in the CardiAMP Heart Failure II trial, which aims to further validate the therapy's efficacy and support regulatory submissions.

Financial Metrics and Cash Management:
- Research and development expenses increased to approximately $1.4 million for Q2 2025, driven by trial closure activities and regulatory efforts.
- Net cash used in operations increased by $300,000 to approximately $1.6 million compared to Q2 2024.
- The company ended the quarter with $980,000 in cash and cash equivalents, and raised additional capital through an ATM facility to extend runway into October.

Partnership and Market Potential:
- BioCardia anticipates non-dilutive funding for its CardiALLO program in Q1 2026, supported by successful data safety monitoring board reviews.
- The company is actively pursuing partnerships for its Helix biotherapeutic delivery system, seeing it as a key platform for both cardiovascular and other therapeutic applications.
- BioCardia aims to leverage its technology and product portfolio to create meaningful value for shareholders through strategic partnerships and collaborations.