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Our CardiAMP cell therapy for HFrEF is supported by three completed clinical trials with consistent results supporting safety and patient benefit, with a fourth active trial enrolling. Benefits are seen across all patients enrolled in our completed trials, with the strongest signals in our two randomized controlled double-blind trials, TACHFT and CardiAMP HF, in patients having elevated biomarkers of heart stress. In this patient population, both trials demonstrated statistical significance in the primary composite outcome used in our actively enrolling CardiAMP HF II trial.

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In September, we had a positive preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Heart Failure Trial results. We have responded to PMDA questions from this meeting and anticipate our next consultation in the coming months, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.

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This quarter, FDA has received and accepted our annual report. We anticipate requesting a meeting on the approvability of the FDA Designated Breakthrough CardiAMP System in the fourth quarter of 2025.

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Our confirmatory CardiAMP HF II phase 3 trial is underway in the United States, focusing on patients with elevated biomarkers of heart stress. The study has a primary composite endpoint of all cause heart death, non-fatal major adverse cardia and cerebral vascular events (MACCE), and quality of life which would have been met in both CardiAMP HF and in TACHFT. Four world class centers are actively enrolling patients.

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In September, we announced top line primary outcomes from the open-label roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. Results showed that patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty percent of the patients showed substantial improvements in both measures. The minimally invasive therapy was well tolerated with no treatment emergent major adverse cardiac events. All patients were on guideline-directed medical therapy (GDMT) and responded positively to the autologous cell therapy.

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The Investigational New Drug application (IND) for our phase 1/2 includes a 3+3 roll-in dose escalation up to a dose of 200 million cells followed by a randomized double-blind controlled study of 30 patients. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed based on the 30-day data safety assessment from this cohort. This study is the first study to focus prospectively on the ischemic etiology heart failure patients with active inflammation. Steps are being taken to secure nondilutive funding to advance this effort.

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The Helix™ transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart and underlies BCDA-01, 02, and 03 programs. We have completed a comprehensive update to our Master File for this delivery device which supports our therapeutic programs and those of our therapeutic partners. This effort prepares the way for the submission for approval of the Helix transendocardial delivery catheter via DeNovo 510(k) in the fourth quarter of 2025 based on the performance of the Helix system in clinical trials.

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Heart3D™ fusion imaging has performed well in preclinical settings using both MRI and CT imaging. Recent procedures with machine learning annotated Heart3D integrated with twenty orthogonal real time two dimensional X-ray imaging views, required only 30 minutes while performing ten intramyocardial deliveries as specified in each of our clinical programs.

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In September, BioCardia closed a $6.0 million financing, with net proceeds totaling $5.2 million.

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Research and development expenses increased to $936,000 for the three months ended September 2025 from $931,000 in the three months ended September 2024, and increased to $3.8 million in the nine months ended September 2025 from $3.0 million for the nine months ended June 2024, primarily due to closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.

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Selling, general and administrative expenses decreased to $0.6 million in the three months ended September 2025 from $0.8 million for the three months ended September 2024, primarily due to lower executive compensation expense. Selling, general and administrative expenses decreased to $2.4 million in the nine months ended September 2025 from $2.8 million in the nine months ended September 2024, primarily due to lower professional service fees coupled with lower share-based compensation expense.

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Our net loss decreased to $1.5 million for the three months ended September 2025, compared to $1.7 million for the three months ended September 2024, primarily due to lower compensation expense, including share-based compensation. Our net loss increased to $6.2 million for the nine months ended September 2025, compared to $5.7 million for the nine months ended September 2024 primarily due to the increased expenses associated with closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.

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Net cash used in operations for the three months ended September 2025 decreased to $1.7 million, as compared to $2.6 million for the three months ended September 2024. Net cash used in operations for the nine months ended September 2025 decreased to $4.9 million, as compared to $5.5 million for the nine months ended September 2024.

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Our cash balance on September 30, 2025, was $5.3 million, providing runway into the second quarter 2026 exclusive of additional capital.

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Publication of CardiAMP HF manuscript – Q1 2026

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CardiAMP HF Japan PMDA Clinical Review – Q4 2025

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CardiAMP HF FDA meeting request on approvability – Q4 2025

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CardiAMP HF II Enrollment – ongoing

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Publication of roll in cohort data – Q1 2026

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CardiALLO HF nondilutive funding – Q1 2026

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Helix biotherapeutic delivery Denovo 510(k) submission for FDA approval – Q4 2025

BioCardia, Inc.

Selected Balance Sheet Data

(amounts in thousands)

(1)  September 30, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025.