BioCardia (NASDAQ:BCDA – Get Free Report) issued its quarterly earnings results on Friday. The company reported ($0.21) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.17) by ($0.04), FiscalAI reports.
Here are the key takeaways from BioCardia’s conference call:
- BioCardia said the CardiAMP heart failure data showed compelling benefits versus control, including reduced adverse remodeling and a statistically significant composite outcome in a high-risk biomarker subgroup.
- The company reported that Japan’s PMDA is inclined to accept the trial data as the basis for a regulatory submission and initial approval, and BioCardia is preparing a Shonin application over the next ~7 months.
- BioCardia said the FDA found the safety profile acceptable and discussed a pre-market approval pathway, while encouraging completion of the ongoing CardiAMP Heart Failure II study to support the filing.
- For its Helix delivery system, FDA indicated no safety or compatibility concerns and suggested potential approval paths, including aligning it with CardiAMP or pursuing a standalone de novo route.
- First-quarter 2026 expenses fell year over year to $2.3 million, with net loss improving to $2.3 million, but cash and cash equivalents ended at only $951,000, underscoring the company’s need for additional funding.
BioCardia Price Performance
Shares of NASDAQ BCDA opened at $1.01 on Friday. The company has a market cap of $11.05 million, a price-to-earnings ratio of -0.78 and a beta of 0.56. The stock’s 50-day moving average is $1.18 and its two-hundred day moving average is $1.26. BioCardia has a 1-year low of $1.00 and a 1-year high of $2.49.
Wall Street Analyst Weigh In
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Hedge Funds Weigh In On BioCardia
A number of institutional investors and hedge funds have recently made changes to their positions in BCDA. Cetera Investment Advisers acquired a new stake in BioCardia in the second quarter valued at approximately $40,000. DRW Securities LLC acquired a new position in BioCardia during the 4th quarter worth approximately $72,000. Finally, Geode Capital Management LLC grew its holdings in BioCardia by 70.4% during the 4th quarter. Geode Capital Management LLC now owns 66,003 shares of the company’s stock worth $83,000 after acquiring an additional 27,263 shares in the last quarter. 20.57% of the stock is owned by institutional investors and hedge funds.
BioCardia Company Profile
BioCardia, Inc is a clinical-stage biotechnology company dedicated to developing novel cell-based therapies for patients with cardiovascular disease. The company’s core focus lies in advancing regenerative medicine approaches that address both chronic heart failure and acute myocardial infarction. BioCardia leverages proprietary delivery technologies to optimize the targeted administration of therapeutic cells directly into the heart muscle.
The company’s flagship products include the Helix Transendocardial Delivery System and the CardiAMP Cell Therapy System.
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