BioCardia, Inc. Q2 FY2025 earnings call

• CardiAMP Heart Failure trial: Lower incidence of all-cause death and nonfatal MACE in treatment group vs control over 24 months (p=0.17), statistically significant composite endpoint in NT-proBNP elevated subgroup (p=0.02). Data to be in peer-reviewed manuscript. Clinical package submitted to PMDA, aiming for Japan approval.
• Regulatory progress: In-person PMDA meeting mid-Q4 2025, FDA meeting in Q4 2025 on CardiAMP. CardiAMP Heart Failure II enrolling patients.
• Other programs: CardiAMP for chronic myocardial ischemia roll-in cohort data ahead. CardiALLO program projecting non-dilutive funding in Q1 2026.
• Helix and Morph: Helix biotherapeutic delivery system with >400 patients in trials, Morph DNA partnering discussions for electrophysiology market, Fusion Imaging partnership upcoming.

Research and development expenses increased to approximately $1.4 million for Q2 2025 from $0.8 million in Q2 2024, and to $2.9 million for the 6 months ended June 2025 from $2.0 million in the same period in 2024. Selling, general and administrative expenses decreased to $0.7 million in Q2 2025 from $0.9 million in Q2 2024, with SG&A remaining $1.9 million for the 6 months ended June 2025 compared to $1.9 million in 2024. Net loss was approximately $2.0 million in Q2 2025 compared to $1.6 million in Q2 2024, and $4.8 million for 6 months ended June 2025 compared to $3.9 million in 2024. Net cash used in operations increased, with $1.6 million in Q2 2025 vs $1.3 million in Q2 2024, and $3.3 million for 6 months ended June 2025 vs $2.8 million in 2024. Cash and cash equivalents ended Q2 2025 at $980,000, with $769,000 raised from stock sales, bringing cash to ~$1.1 million.

• PMDA in-person meeting mid-Q4 2025 for CardiAMP.
• FDA meeting in Q4 2025 on CardiAMP approvability.
• CardiAMP Heart Failure II actively enrolling patients.
• BCDA-02 to deliver final top line data and seek peer review in Q4.
• BCDA-03 projecting non-dilutive funding in Q1 2026.
• Helix FDA submission in Q3 2025, financing in September.

• Uncertainties in regulatory approvals from PMDA and FDA.
• Market adoption challenges for heart failure therapies.
• Competition from other cell therapy products.
• Financial risks related to dilution and burn rate.

Q: Elaborate on PMDA reviewing CardiAMP for heart failure as a medical device, key differences in regulatory reviews, timelines, and potential approval.

A: Approval process similar but nuanced with PMDA's standard consultation. Focus on clinical consultation on data positioning. Japan's cultural preferences align with autologous CardiAMP. Process could take up to a year, with post-marketing requirements possible.

Q: Timing of Japanese and U.S. regulatory meetings, potential outcomes, and partnership impact.

A: Japan PMDA meeting mid-Q4 2025, FDA meeting in Q4 2025. If positive, approval process could take a year. Partnerships not on hold, with active discussions for CardiAMP, Helix, and Morph.

Q: FDA meeting type, CardiAMP Heart Failure II screening status.

A: Haven't decided FDA meeting type, focusing on de novo 510(k) for Helix. CardiAMP Heart Failure II has 4 active centers, 5th to begin, treating few patients, with Hawthorne effect considered.

Q: Expectations for BCDA-02 data readout and partnering.

A: Data to be released, partnering depends on PMDA/FDA outcomes. BCDA-02 has competitive potential with cost advantages over previous programs.

Q: Data release for new observations to PMDA and September financing.

A: New data observations will be in peer-reviewed manuscript. September financing aims to be beneficial for shareholders, with careful consideration of dilution and burn rate management.