Summary of BioCardia (BCDA) Q3 2025 Earnings Call

1Key Financial Results and Metrics

Research and Development (R&D) Expenses:: Increased to $936,000 for Q3 2025 from $931,000 in Q3 2024; year-to-date R&D expenses rose to $3.8 million from $3.0 million.

Selling, General, and Administrative (SG&A) Expenses:: Decreased to $600,000 in Q3 2025 from $800,000 in Q3 2024; year-to-date SG&A expenses fell to $2.4 million from $2.8 million.

Net Loss:: Reported at $1.5 million for Q3 2025, down from $1.7 million in Q3 2024; year-to-date net loss increased to $6.2 million from $5.5 million.

Cash Position:: Ended Q3 2025 with $5.3 million in cash, bolstered by a $6 million financing and share sales under the ATM program. Cash is expected to fund operations into 2026 without the need for additional financing.

2Strategic Updates and Business Highlights

Clinical Programs:: Progressing with the CardiAmp autologous cell therapy for ischemic heart failure, receiving FDA breakthrough designation. Active enrollment in the confirmatory Phase III CardiAmp Heart Failure II trial is underway.

Regulatory Engagements:: Positive preliminary consultations with Japan's PMDA regarding the CardiAmp system, with expectations for further discussions to facilitate market entry in Japan.

Helix Delivery System:: Updates to the Helix system have been completed, and a de novo submission for FDA approval is anticipated in Q4 2025.

Partnerships:: Collaboration with CAR TECH for Heart 3D Fusion Imaging is progressing, with plans to advance to clinical trials in 2026.

3Forward Guidance and Outlook

Clinical Milestones:: Anticipate PMDA clinical review in Japan and FDA meeting request in Q4 2025. A manuscript for publication regarding the CardiAmp Heart Failure II trial is expected in Q1 2026.

Funding Expectations:: Non-dilutive funding for the CARDI allo allogeneic mesenchymal stem cell therapy (BCDA03) is anticipated in 2026, with high probability of support from NIH.

4Challenges and Points of Concern

Increased R&D Costs:: Continued investment in clinical trials may lead to higher R&D expenses in the near term.

Enrollment Challenges:: While enrollment in the CardiAmp Heart Failure II trial is progressing, bandwidth and resource constraints are noted as potential hurdles.

Regulatory Uncertainties:: The need for successful consultations with Japanese regulatory authorities poses a risk to timely market entry.

Market Competition:: The company faces competition in the cell therapy space, particularly in the context of regulatory approvals and clinical outcomes.

5Notable Q&A Insights

Patient Enrollment:: Management indicated that enrollment for the CardiAmp Heart Failure II trial is smoother due to improved patient selection criteria, but resource limitations are a concern.

Data Presentation:: Clarification was provided regarding the incremental data from the cardiac CMI study, emphasizing the compelling nature of the results despite being based on a small cohort.

Funding Discussions:: Management expressed optimism about securing federal grant funding for BCDA03, highlighting ongoing discussions with the NIH as a potential source of support. This summary encapsulates the key financial metrics, strategic initiatives, forward-looking statements, and challenges faced by BioCardia as discussed in the Q3 2025 earnings call.