BioCardia (NASDAQ:BCDA – Get Free Report) issued its quarterly earnings data on Wednesday. The company reported ($0.13) EPS for the quarter, topping analysts’ consensus estimates of ($0.18) by $0.05, FiscalAI reports.
Here are the key takeaways from BioCardia’s conference call:
- Japan’s PMDA supported advancing CardiAMP toward a Shonin approval submission, which BioCardia expects to file in the fourth quarter of 2026. The company estimates an initial indication of roughly 20,000 patients, with approval potentially about 12 months after submission.
- FDA feedback indicated that the ongoing CardiAMP Heart Failure II trial could serve as the confirmatory study supporting U.S. premarket approval, with no safety or delivery concerns raised. BioCardia is continuing enrollment and discussing how to define the quality-of-life component of the primary endpoint.
- FDA also identified potential approval pathways for the Helix transendocardial delivery catheter, including simultaneous clearance with CardiAMP or a de novo route. Approval could strengthen BioCardia’s partnering opportunities and facilitate future cardiac biologic therapies.
- Heart Failure II enrollment remains slow, with four active recruiting sites and no disclosed total enrollment; management said accelerating enrollment would require additional resources. The company may pursue modest financing to speed the program, creating potential dilution.
- BioCardia ended the quarter with $5.4 million in cash and said its runway extends into 2027, while raising $4.9 million through its at-the-market facility. Operating cash use was $1.7 million in the quarter, and management said available capital should fund the planned Japan submission.
BioCardia Trading Down 5.6%
Shares of BCDA opened at $0.88 on Thursday. BioCardia has a 52 week low of $0.75 and a 52 week high of $2.29. The firm has a market cap of $10.01 million, a price-to-earnings ratio of -0.97 and a beta of 0.48. The stock has a 50 day moving average of $0.94 and a 200-day moving average of $1.08.
Insider Activity
Institutional Investors Weigh In On BioCardia
A number of hedge funds have recently added to or reduced their stakes in BCDA. Cetera Investment Advisers acquired a new position in shares of BioCardia during the second quarter valued at $40,000. DRW Securities LLC bought a new stake in BioCardia in the 4th quarter valued at about $72,000. Finally, Geode Capital Management LLC lifted its position in BioCardia by 70.4% in the 4th quarter. Geode Capital Management LLC now owns 66,003 shares of the company’s stock valued at $83,000 after purchasing an additional 27,263 shares during the last quarter. 20.57% of the stock is currently owned by institutional investors.
Analyst Upgrades and Downgrades
BCDA has been the topic of several recent analyst reports. Weiss Ratings reiterated a “sell (e+)” rating on shares of BioCardia in a research note on Friday, July 17th. Wall Street Zen raised BioCardia to a “sell” rating in a research report on Saturday, July 18th. Zacks Research raised shares of BioCardia from a “strong sell” rating to a “hold” rating in a research report on Tuesday. Finally, HC Wainwright reaffirmed a “buy” rating and issued a $25.00 price target on shares of BioCardia in a report on Tuesday, June 9th. One research analyst has rated the stock with a Buy rating, one has issued a Hold rating and one has assigned a Sell rating to the company. According to MarketBeat.com, BioCardia currently has a consensus rating of “Hold” and a consensus price target of $25.00.
Get Our Latest Analysis on BioCardia
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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