BioCardia Reports Per-Share Loss of $0.12 and Cash of $2.2 Million
Key Facts
BioCardia reported on November 12 results for the third quarter ended September 30, 2026, and said it had filed its quarterly report with the U.S. Securities and Exchange Commission. Basic and diluted loss per share was $0.12, compared with a loss of $0.24 in the year-earlier quarter. By contrast, net loss rose to $1.817 million from $1.483 million. The reported figures do not establish a comparison of per-share loss or net loss with analyst estimates. The results therefore center on the divergence between the movements in per-share loss and net loss, and on the company’s available liquidity.
Cash used in operations was $1.7 million in the three months ended September, the same level as in the corresponding period of 2025. But over the first nine months of the year, cash use rose to $5.1 million from $4.9 million. The company attributed the increase over the longer period to the timing of supplier payments. BioCardia ended the quarter with cash and cash equivalents of $2.2 million as of September 30. Management said that balance would not be sufficient, without additional financing, to cover planned expenses and obligations beyond January 2027, warning of substantial doubt about the company’s ability to continue as a going concern.
On expenses, quarterly research and development costs rose to $1.235 million from $936,000 in the third quarter of 2025. The company linked the increase to higher employee bonuses, regulatory activity in Japan and enrollment in the CardiAMP HF II trial. Selling, general and administrative expenses also rose to $600,000 from $552,000, which the company attributed mainly to a higher bonus accrual. Over the first nine months, research and development expenses fell to $3.363 million from $3.834 million. The company attributed the decline mainly to the closeout of the earlier CardiAMP HF trial, while nine-month net loss fell to $5.8 million from $6.2 million.
The company’s plans ahead are tied to its CardiAMP heart failure program. It said the remaining questions raised by Japan’s Pharmaceuticals and Medical Devices Agency before submission of the application had been addressed to the agency’s satisfaction. Four clinical sites are enrolling patients in the CardiAMP HF II trial, the company said, while seven more are being prepared. BioCardia is targeting submission of its CardiAMP application in Japan in the fourth quarter of 2026 or the first quarter of 2027. It also plans to publish a peer-reviewed manuscript on the CardiAMP HF trial in the first quarter of 2027. Chief Executive Peter Altman said the company is targeting treatment of its first patients in Japan and commercial revenue there in 2028, while noting that completing consultations with the agency does not mean regulatory approval has been granted.
BioCardia is also tracking the regulatory path for its Helix platform, after saying the U.S. Food and Drug Administration accepted its amended pre-submission in October. The company expects to complete its De Novo application in the first quarter of 2027. It estimated the likelihood of approval in mid-2027, provided the administration meets its 150-day review goal. More broadly, the accumulated deficit was about $174 million as of September 30, 2026. Management expects operating losses and negative cash flows to continue over the coming years, and said further development of its therapeutic candidates after January 2027 will require additional capital, potentially through collaboration, licensing, debt or equity financing.
The company describes its portfolio as including three cardiac therapeutic candidates in clinical development, along with the Helix and Morph platforms for therapy delivery and vascular navigation. The earlier CardiAMP HF trial included 115 patients at 28 U.S. centers and did not meet its primary efficacy endpoint, despite meeting a key secondary endpoint in a subgroup with elevated markers of cardiac stress. CardiAMP HF II was designed to include up to 250 patients at up to 40 U.S. centers, focusing on patients with active heart failure who showed the greatest benefit in the earlier trial. In the market, the company’s shares, BCDA, closed at $0.826 on November 12, 2026. That closing price puts the quarter’s results and the company’s financing and development plans among the information available to investors during the session in which the results were announced.