BioCardia (NASDAQ:BCDA) released first-quarter financial results and hosted an earnings call on Friday. Read the complete transcript below.
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The full earnings call is available at https://event.choruscall.com/mediaframe/webcast.html?webcastid=Rt7kKGAp
Summary
BioCardia reported significant progress with its cardiac cell therapy for ischemic heart failure, achieving FDA breakthrough designation and Medicare reimbursement.
The company presented compelling echocardiography data showing improved heart function in treated patients, which is supporting regulatory discussions in Japan and the U.S.
BioCardia is preparing for a formal Japanese submission, expected to take seven months, and has engaged with the FDA on a premarket application, with the ongoing Heart Failure 2 trial being a priority.
Financially, the company decreased total expenses to $2.3 million in Q1 2026 from $2.7 million in Q1 2025, with a net loss of $2.3 million for the quarter and cash reserves of $951,000.
Management expressed optimism about future regulatory approvals and market opportunities in Japan, targeting an initial market of 20,000 patients with a reimbursement potential of $400 million.
Full Transcript
OPERATOR
Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia 2026 First Quarter Financial Results and Business Update conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchscreen or keypad. To withdraw your question, please Press Star Then 2. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call. I would now like to turn the call over to Miranda Pato of BioCardia Investor Relations. Please go ahead, Miranda.
Miranda Pato (Investor Relations)
Thank you very much. Good afternoon and thank you for participating in today’s conference call. Joining me from BioCardia’s leadership team are Peter Altman, President and Chief Executive officer, and David McClung, the company’s Chief Financial Officer. During this call, management will be making forward looking statements, including statements that address BioCardia’s expectations for future performance and operational results, references to management’s intentions, beliefs, projections, outlook analyses and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products technologies and obtaining regulatory approvals. Forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia’s report on Form 10K filed with the SEC on March 24, 2026. The content of this call contains time sensitive information that is accurate only as of today, May 15, 2026. Except as required by law, the Company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia’s President and CEO. Peter, please go ahead.
Peter Altman (President and Chief Executive Officer)
Thank you. Thank you, Miranda. And good afternoon to everyone on the call. We have had significant accomplishments this last quarter for our cardiac cell therapy for the treatment of ischemic heart failure. This is a significant unmet clinical need for which we have FDA breakthrough designation and Medicare reimbursement at $20,000 per treatment procedure. Today I’m going to share these accomplishments as they happened so you can appreciate the dynamics of the recent developments. First, the blinded echocardiography Data from the Cardiac Heart Failure trial presented at the Technology and Heart Failure Therapeutics Conference in Boston in early March was excellent. We described this data readout in our Last call, but it bears repeating as the clinical data underlies the value we are creating and the regulatory meetings that have been happening in parallel. This echocardiography data analyzed by the World Class Echocor Laboratory at Yale University is data which few if any advanced therapies for heart failure have in their trials and it is long term truly blinded. Contrast Enhanced echocardiography the CARDIAP heart failure echocardiography results showed compelling signals of enhanced heart function in the treated patients relative to the control patients over time. More specifically, the heart volumes of both full heart relaxation and maximum heart contraction did not increase over time in the treated subjects but did increase in the control subjects who did not receive therapy. Increased heart volumes is the normal course for these patients and results in the heart becoming more spherical and losing its pumping efficiency. Increased volumes have long been known to be correlated with poor long term outcomes in CardiAMP HF. The treated patients did not experience this negative remodeling in the subgroup having elevated biomarkers of heart stress. These heart function benefits for both full relaxation and full contraction were statistically significant and aligned with the three tiers of the composite outcome of one living longer without heart replacement therapy such as lvad or transplant 2 having fewer major adverse events such as heart attacks, strokes and hospitalizations and three having a better quality of life. This composite endpoint also achieved statistical significance. All of the patients were on maximum guideline directed medical therapy and these benefits …
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