BioCardia Inc (NAS:BCDA)

Q1 2026 BioCardia Inc Earnings Call Transcript

May 15, 2026 / 08:30 PM GMT

Release Date Price: $1.01 (-7.34%)

Transcript 8-K10-Q

Key Points

Positve

BioCardia Inc (BCDA) received FDA breakthrough designation and Medicare reimbursement of $20,000 per treatment for their cardiac cell therapy.
The CARDIAMP heart failure trial showed compelling signals of enhanced heart function in treated patients, with statistically significant benefits in heart function and quality of life.
Japan's Pharmaceutical and Medical Devices Agency is inclined to accept BioCardia's data for regulatory submission and approval, recognizing an unmet need in Japan.
BioCardia completed a Q-sub meeting with the FDA, which found the efficacy results intriguing and encouraged the completion of the ongoing CardiAmp HF2 trial.
BioCardia's financial management resulted in a decrease in total expenses and net loss compared to the previous year, demonstrating effective cost control.

Negative

BioCardia Inc (BCDA) ended the quarter with cash and cash equivalents totaling only $951,000, indicating limited financial resources.
The regulatory process in Japan is extensive, requiring a seven-month preparation for submission and a year-long review process.
The CardiAMP Heart Failure II trial is still ongoing, requiring significant resources and time to complete.
The market opportunity in Japan, while promising, is initially limited to 20,000 patients, which may restrict immediate revenue potential.
BioCardia's net cash used in operations increased slightly compared to the previous year, reflecting ongoing financial challenges.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

BCDA.OQ - BioCardia Inc
Q1 2026 BioCardia Inc Earnings Call
May 15, 2026 / 08:30PM GMT

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Presentation
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Unidentified_1 [1]
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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.

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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.

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