BioCardia (BCDA) Q2 2024 earnings summary

Executive summary

• CardiAmp Heart Failure I trial is nearing completion with final patient follow-up expected by end of September 2024, and interim data showed improved survival, reduced major adverse cardiac events, and better quality of life for treated patients.

• CardiAmp Heart Failure II trial launched as a confirmatory pivotal study, targeting patients with elevated NT-proBNP, with enrollment underway and preliminary data showing an 86% relative risk reduction in mortality and 24% reduction in non-fatal major adverse events.

• The company is commercializing FDA-cleared devices, including the AVANCE and Morph DNA steerable introducers, and has entered into new biotherapeutic delivery partnerships.

• Progress made in other programs, including chronic myocardial ischemia and acute myocardial infarction, with the Helix delivery system demonstrating versatility and positive phase II data.

• Robust IP portfolio with over 60 patents, including two new US patents granted in June and July 2024.

Financial highlights

• Q2 2024 revenues were $3,000, down from $43,000 in Q2 2023; six-month revenue was $58,000, down from $107,000 year-over-year.

• Research and development expenses decreased to $800,000 from $2.3 million year-over-year; six-month R&D was $2.04 million, down from $4.70 million.

• Selling, general, and administrative expenses fell to $852,000 from $1.2 million year-over-year.

• Net loss narrowed to $1.6 million in Q2 2024 from $3.4 million in Q2 2023; net loss per share improved to $(0.88) from $(2.52).

• Cash and cash equivalents as of June 30, 2024, were $1.4 million.

Outlook and guidance

• Expectation to complete last patient visit for CardiAmp Heart Failure I and submit for general consultation with Japan PMDA this quarter, with final data expected in Q4 2024.

• Anticipate FDA clearance for Morph DNA product family by end of current quarter.

• Cash on hand is not sufficient to fund planned expenditures and meet obligations through September 2024; additional capital is required.

• Plan to become compliant with Nasdaq listing requirements and continue business development efforts across all platforms.

• Cash burn expected to increase moderately as trials advance, but operational efficiency remains a focus.