BioCardia, Inc. Q1 FY2025 earnings call

• In March 2025, CardiAMP Heart Failure Trial results showed safety and benefits for heart failure patients. Top priority in Q2 2025 is sharing data with FDA and Japan's PMDA and publishing peer-reviewed manuscript. - CardiAMP Heart Failure II Trial is enrolling patients at three sites, expected to be fully enrolled in next two years with primary readout at one-year follow-up. - Final data from BCDA-02 became available, working towards scientific presentation and publication. - Successful Data Safety Monitoring Board review of safety outcomes in low-dose cohort of CardiALLO. - Actively preparing for submission for approval of Helix biotherapeutic delivery system. - Morph DNA platform has advantages in cardiac electrophysiology market. - Focused on business development for all platforms, with active discussions with large cap strategics.

Total expenses increased by $396,000 quarter-over-quarter to $2.7 million in the first quarter of 2025 compared to $2.3 million in the same quarter of 2024. Research and development expense increased $289,000 to $1.5 million in Q1 2025 versus $1.2 million in Q1 2024, driven by closing out and obtaining final data for the CardiAMP heart failure trial and inception of enrollment in the new CardiAMP heart failure II trial. Selling, general and administrative expenses increased modestly to $1.2 million for Q1 2025 compared to $1.1 million for Q1 2024. Net loss was $2.7 million in Q1 2025 compared to $2.3 million in Q1 2024. Net cash used in operations was $1.6 million for Q1 2025 comparable to $1.5 million in Q1 2024. The company ended Q1 2025 with cash and cash equivalents totaling $949,000 before a modest financing.

• Anticipate R&D expenses to increase modestly in 2025 as advancing therapeutic candidates in US and Japan. - Expect 2025 SG&A expenses to track closely to 2024 levels. - Continue carefully managing use of capital.

• Inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approval. - Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Q: Joe Pantginis with H.C. Wainwright asked about business development levels of maturity.

A: Peter Altman discussed capabilities over deal stages, mentioned active discussions with large cap strategics, and detailed market opportunities like cardiac electrophysiology.

Q: Chris Stevens [ph] asked about CardiAMP BCDA-01 confirmatory trial and its relation to FDA submission.

A: Peter Altman explained CardiAMP-HFII trial details, including changes like using Morph DNA platform and different endpoints to enhance trial power.

Q: Unidentified Analyst asked about tariffs and best price policy affecting CardiAMP.

A: Peter Altman said CardiAMP not currently affected by tariffs, priced based on value with high margins expected, and discussed most favored nation status implications.