BioCardia, Inc. Q3 FY2024 earnings call

• BioCardia is advancing targeted cellular precision medicines for cardiovascular disease, with clinical stage cell-based therapies like CardiAMP for heart failure. • CardiAMP Heart Failure I trial is a randomized placebo procedure-controlled study with ~92% of patients having two-year follow-up, final results expected in Q1 2025. • CardiAMP Heart Failure II trial is a 250-patient pivotal study, with FDA protocol amendment increasing eligible patients, and enrollment expected to be enhanced. • Other programs: Last rolling cohort patient in CardiAMP cell therapy and chronic myocardial ischemia trial enrolled, CardiALLO allogeneic mesenchymal stem cell therapy enrollment ongoing. • Helix biotherapeutic delivery partnering: No updates, focused on long-term partnerships. • Morph DNA product family FDA approved, with commercial plans and physician usage focus. • Q3 2024 financials: Total expenses decreased 41% q-o-q to $1.8 million, R&D expenses down to $931,000, SG&A expenses down to $825,000, net loss decreased to $1.7 million.

No specific product segment financial performance with absolute revenue and contribution % breakdown provided in the transcript.

• Cash burn expected to increase moderately over the coming year. • Anticipation of final data from CardiAMP Heart Failure I trial in Q1 2025. • Upcoming consultation with Japan PMDA for CardiAMP cell therapy. • Protocol amendment in CardiAMP Heart Failure II trial expected to enhance enrollment.

• Inherent uncertainties associated with developing new product technologies and obtaining regulatory approvals. • Hurricanes in Florida impacting trial enrollment in CardiAMP Heart Failure II trial.

Q: What are the potential options for monetizing the Morph DNA program?

A: Options include distribution, selling the business unit outright; demonstrating physician utility, exploring divestment pathways while retaining exclusive rights to the platform technology for biotherapeutic intervention.

Q: Regarding Japan efforts for CardiAMP, what's the process and timing?

A: Scheduled consultation with Japan PMDA this month, aiming for clinical consultation and potential approval pathway in heart failure in Japan, with positive signals from PMDA so far.

Q: What percentage of patients would fit the protocol amendment profile in CardiAMP II trial and how were similar patients treated in CardiAMP I trial?

A: About 85% of patients are expected to pass the threshold, with previously excluded patients within 35% of the threshold now able to receive additional dosages; in CardiAMP I trial, patients were excluded if not meeting pre-specified criteria, now amendment allows more patients to be eligible with additional dosages.