BioCardia (NASDAQ:BCDA) Issues Earnings Results

BioCardia (NASDAQ:BCDA) issued its quarterly earnings data on Thursday. The company reported ($0.12) EPS for the quarter, topping the consensus estimate of ($0.13) by $0.01, FiscalAI reports.

Here are the key takeaways from BioCardia’s conference call:

• BioCardia said it has resolved the remaining questions to Japan’s PMDA’s satisfaction and is preparing a Shonin submission for CardiAMP with its local marketing authorization holder. The company expects approval about 12 months after submission, though it cautioned that documentation or testing requirements could affect the timeline.
• The FDA has accepted BioCardia’s supplemental De Novo pre-submission for the Helix delivery catheter, with feedback expected within six weeks. If the agency supports the pathway, BioCardia aims to submit in Q1 2027 and anticipates a mid-2027 decision; otherwise, further discussions may be needed.
• CardiAMP Heart Failure II has four active recruiting sites, with seven more being onboarded, but management described enrollment as progressing gradually and did not provide enrollment totals. The company said its near-term focus is on regulatory work in Japan and the U.S.
• BioCardia ended Q3 with $2.2 million in cash and said its runway extends into 2027. Q3 operating cash use was $1.7 million and net loss was $1.8 million, leaving limited cash on hand relative to its ongoing development efforts.
• The company is discussing potential licensing partnerships for CardiAMP in Japan and collaborations involving its delivery technologies, including gene therapy. These discussions remain early, with no agreements announced; management expects to lead the initial Japanese post-marketing study, potentially involving about 200 patients.

BioCardia Stock Performance

BioCardia stock traded down $0.10 during mid-day trading on Thursday, reaching $0.83. The company’s stock had a trading volume of 288,452 shares, compared to its average volume of 996,888. The firm’s fifty day moving average price is $1.02 and its two-hundred day moving average price is $1.06. BioCardia has a 12-month low of $0.66 and a 12-month high of $1.80. The company has a market capitalization of $12.50 million, a P/E ratio of -1.29 and a beta of 0.69.

Wall Street Analyst Weigh In

Several equities analysts have weighed in on the company. Weiss Ratings reissued a “sell (e+)” rating on shares of BioCardia in a report on Thursday, October 15th. HC Wainwright restated a “buy” rating on shares of BioCardia in a research note on Monday, August 24th. Zacks Research raised BioCardia from a “strong sell” rating to a “hold” rating in a research report on Tuesday, August 11th. Finally, Wall Street Zen upgraded BioCardia from a “sell” rating to a “hold” rating in a research note on Saturday, August 15th. One analyst has rated the stock with a Buy rating, one has given a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat, BioCardia currently has a consensus rating of “Hold” and an average price target of $25.00.

About BioCardia

BioCardia, Inc. is a biotechnology company focused on developing regenerative cell therapies and delivery systems for the treatment of cardiovascular diseases. The company’s programs are designed to address conditions in which damaged or poorly functioning heart tissue may benefit from cellular therapy. BioCardia’s principal product candidates include CardiAMP Cell Therapy, an autologous treatment that uses a patient’s own bone marrow-derived cells, and CardiALLO Cell Therapy, an investigational allogeneic therapy based on mesenchymal precursor cells from a donor source.