BioCardia Announces Q2 2024 Business Highlights and Financial Results

BioCardia, Inc., headquartered in Sunnyvale, California, has announced its financial results for the second quarter of 2024. The company, listed on Nasdaq under the ticker BCDA, specializes in developing cellular and cell-derived therapies for cardiovascular and pulmonary diseases. BioCardia has also submitted its quarterly report on Form 10-Q for the period ending June 30, 2024, to the Securities and Exchange Commission. A conference call scheduled for 4:30 PM ET will discuss the company's business highlights, followed by a Q&A session.

Recent Business Developments

BCDA-01: CardiAMP® Autologous Cell Therapy for Ischemic Heart Failure
BioCardia is actively monitoring data from the CardiAMP Heart Failure I trial involving its lead autologous cell therapy. The final patient data is expected by late Q3 2024. Additionally, patient enrollment has started for the confirmatory pivotal CardiAMP Heart Failure II trial, with five patients already consented.

BCDA-02: CardiAMP Autologous Cell Therapy for Chronic Myocardial Ischemia with Refractory Angina
Early results from an open-label cohort for patients with refractory angina are encouraging, showing improved exercise tolerance and significantly reduced angina episodes.

BCDA-03: CardiALLO Cell Therapy in Ischemic Heart Failure
The second patient in the low-dose cohort has passed the safety readout without any adverse events.

Helix Biotherapeutic Delivery
BioCardia and CellProthera announced the success of a collaborative Phase II trial of ProtheraCytes for acute myocardial infarction treatment. Plans to continue the collaboration into Phase III have been confirmed.

Morph Access Innovations
BioCardia submitted a 510(k) application for approval of its Morph® DNA™ Steerable Introducer Sheath product family, intended for cardiac, aorto-ostial, and peripheral clinical procedures.

Financial Overview

BioCardia has reported an operational cash burn of $1.3 million for the quarter. The company also completed a reverse stock split to comply with Nasdaq listing requirements.

CEO Peter Altman highlighted significant progress, citing reduced operational cash burn and imminent data releases from ongoing trials, which he believes will drive shareholder value. Altman emphasized BioCardia’s unique position, having received breakthrough designation from the FDA and Medicare reimbursements for two clinical indications. BioCardia is one of the few companies that has treated hundreds of patients in its Phase III clinical trial for heart failure cell therapy.

Intellectual Property

The company’s intellectual property portfolio is robust, with over 60 patents and applications worldwide. In June, BioCardia received Patent No: 11,986,611 for "Radial and Transendocardial Delivery Catheter," which will expire in 2036. In July, Patent No: 12,036,371 was granted for a "Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter," set to expire in 2035.

Financial Results for Q2 2024

- Revenue: Approximately $3,000 for Q2 2024, compared to $43,000 for Q2 2023.
- R&D Expenses: About $800,000 in Q2 2024, down from $2.3 million in Q2 2023, following the completion of patient enrollment in the CardiAMP Cell Therapy Heart Failure Trial in late 2023.
- SG&A Expenses: Approximately $852,000 for Q2 2024, down from $1.2 million in Q2 2023.
- Net Loss: $1.6 million for Q2 2024, compared to $3.4 million for Q2 2023.
- Net Cash Used in Operations: $1.3 million for Q2 2024, compared to $3.2 million for Q2 2023.

Upcoming Milestones

- BCDA-01: Final patient follow-up and data submission to the FDA and Japan’s PMDA in Q3-Q4 2024.
- BCDA-02: Final patient treatment in the roll-in cohort expected in Q3 2024.
- Helix Biotherapeutic Delivery: Anticipated partnership revenues in Q3-Q4 2024.
- Morph Access Innovations: FDA approval for Morph DNA steerable introducer sheath product family expected in Q3 2024.

In summary, BioCardia is advancing its therapeutic programs with promising results, while maintaining a strong financial and intellectual property position. The company is well-positioned to achieve significant milestones in the near future, potentially benefiting both patients and shareholders alike.

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