BioCardia, Inc. Q4 FY2024 earnings call

• CardiAMP Heart Failure trial results: Primary endpoint not met due to 6-minute walk distance, but had great results in cardiac death equivalents, major adverse cardiac events, and quality of life with statistical significance in certain subgroups. • CardiAMP Heart Failure II trial is active and consenting patients; final data from CardiAMP cell therapy and chronic myocardial ischemia trial (VC-02) being collected. • Completed enrollment in low-dose cohort of CardiALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure (BCDA-03) and scheduling Data Safety Monitoring Board review. • No updates on Helix Biotherapeutic delivery partnering; focused on business development for platforms. • Morph DNA steerable introducer platform details being shared, with no near-term revenues but expected news ahead.

In 2024, total expense decreased 35% year-over-year to $8.1 million. Research and development expense decreased to $4.4 million in 2024 compared to $7.7 million in 2023, a 43% decrease due to reduced costs following the completion of the CardiAMP Heart Failure trial. Selling, general and administrative expenses decreased 16% in 2024 to $3.7 million compared to $4.4 million in 2023. Net loss decreased to $7.9 million in 2024, down $11.6 million from 2023. Net cash used in operations was approximately $8 million in 2024 compared to approximately $10.0 million in 2023. The company ended the year with cash and cash equivalents totaling $2.4 million (approximate).

• Anticipate R&D expenses to increase modestly in 2025 as advancing therapeutic candidates. • Expect 2025 SG&A expenses to remain close to 2024 levels. • Expect cash burn to increase moderately in 2025 while carefully managing resources and capital.

• Inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. • Potential long-term medical device implant and drug safety issues for other therapies, but none for CardiAMP cell therapy for heart failure.

Q: Joe Pantginis asked about PMDA discussions in Japan, the time line for sharing 2-year data with FDA, and details on the study's data and patient therapies.

A: Peter Altman responded on PMDA meeting in November, 2-year data being shared with FDA, and how the data impacts the CardiAMP-2 trial and enrollment.

Q: Kumar Raja asked about the time line for sharing 2-year data with FDA, impact on CardiAMP-2 trial, feedback from physicians, and next steps with PMDA.

A: Peter Altman discussed FDA interactions, CardiAMP-2 trial enrollment, and next steps with PMDA including preparing submission packages.

Q: James Molloy asked about informing Heart Failure II trial from Heart Failure I trial and interim look for HF2.

A: Peter Altman answered on how Heart Failure I data informs HF2 and mentioned HF2 is early with various factors affecting enrollment and progress.