BioCardia's Q3 2025 Earnings Call: Contradictions Emerge on Japan Approval, CardiAMP Enrollment, Recruitment, and BCDA-03 Funding

Guidance:

• Japan PMDA clinical review for CardiAMP expected in Q4 2025.
• Request meeting with FDA on CardiAMP approvability in Q4 2025.
• Manuscript on CardiAMP to be published in Q1 2026; CardiAMP HF II enrollment to continue.
• Seek peer‑reviewed publication for BCDA-02 (CMI) in Q1 2025.
• Anticipate nondilutive funding for BCDA-03 in Q1 2026 (high probability, not guaranteed).
• Submit Helix 510(k) to FDA in Q4 2025.
• Cash runway expected into Q2 2026 without additional financing.

Business Commentary:

* Regulatory Submissions and Clinical Program Advancements: - BioCardia is actively pursuing regulatory approvals, with plans to request meetings with the FDA and PMDA in Q4 2025. - The company is advancing its CardiAMP Heart Failure II clinical study, with 4 centers actively enrolling and 3 having randomized their first patients. - These efforts are driven by consistent clinical trial results and the potential to address a significant unmet medical need in heart failure patients.

• CardiAMP Cell Therapy and Indications:
• BioCardia is expanding the indications for its CardiAMP autologous cell therapy, with initial results showing promise in chronic myocardial ischemia.
• The company is also advancing its CardiALLO allogeneic mesenchymal stem cell therapy in a Phase I/II trial, potentially paving the way for near-term nondilutive funding.

• These initiatives are part of the company's strategy to broaden the therapeutic applications of its cell therapies and tap into new funding sources.

• Financial Performance and cash runway:

• BioCardia's research and development expenses increased to $936,000, driven by regulatory activities and new clinical trial enrollment.
• The company ended the quarter with $5.3 million in cash, reflecting a recent financing round and ATM program sales.
• The cash runway is expected to last into Q2 2026 without additional financing, supporting ongoing research and development efforts.

Sentiment Analysis:

Overall Tone: Positive

• Management described "another quarter of solid accomplishment," cited a "positive preliminary clinical consultation with PMDA," outlined planned FDA engagement in Q4 2025, noted Helix 510(k) submission plans, and highlighted catalytic near‑term milestones while reporting cash runway into Q2 2026.

Q&A:

• Question from Lander Egaña-Gorroño (H.C. Wainwright & Co, LLC, Research Division): For the CardiAMP CMI data announced in September, could you please clarify how many patients were part of this data set and how these results are incremental to the initial 4-patient rolling cohort presented in April last year?
  Response: The CMI rolling cohort contains five patients with 6‑month endpoints; it's a modest incremental addition to the prior 4‑patient data, the cohort is complete and being prepared for publication.

• Question from James Molloy (Alliance Global Partners, Research Division): Can you walk through recruitment progress and any challenges to getting patients into the CardiAMP HF II trial?
  Response: Enrollment is progressing smoothly; cell‑population dosing expands eligibility and the main constraint is BioCardia's bandwidth/resources rather than patient supply; enrollment should accelerate as the team completes other tasks.

• Question from James Molloy (Alliance Global Partners, Research Division): You previously said nondilutive funding for BCDA-03 would be completed in Q1 2026— is there a partnership or funding expected to close then?
  Response: Management expects a high‑probability NIH/federal grant to provide nondilutive funding in Q1 2026 to fully fund BCDA‑03, though nothing is guaranteed.

• Question from Kumaraguru Raja (Brookline Capital Markets, LLC, Research Division): What are the next steps with Japanese regulators before you can submit for approval in Japan, and any additional color on PMDA interactions?
  Response: The next key step is a formal PMDA clinical consultation to decide if combined existing data suffice for approval; ~95–99% of submission work is complete and the company is now awaiting that consultation.

• Question from Kumaraguru Raja (Brookline Capital Markets, LLC, Research Division): With four clinical sites on board for HF II, what are your expectations for getting additional sites on board?
  Response: Site activations are limited mainly by BioCardia's bandwidth and contracting/start‑up tasks (some sites request higher start‑up costs); management expects at least another year of enrollment.

Contradiction Point 1

Regulatory Approval Process in Japan

It involves differing expectations and timelines regarding the regulatory approval process for CardiAMP in Japan, which could impact BioCardia's international expansion strategy and potential revenue.

What are the next steps for submission in Japan and the details of your interactions with Japanese regulators? - Kumaraguru Raja(Brookline Capital Markets, LLC, Research Division)

2025Q3: The process in Japan involves a series of consultations, with the key hurdle being a formal clinical consultation. BioCardia is awaiting feedback on whether current clinical data is sufficient for approval. - Peter Altman(CEO)

What are the expectations for PMDA reviewing CardiAMP as a heart failure medical device, and what are the key differences in regulatory reviews, timelines, and potential approval? - Lander Egaña-Gorroño(H.C. Wainwright & Co, LLC, Research Division)

2025Q2: The approval process for CardiAMP cell therapy as a medical device in Japan is similar to the U.S., but it may be seen as a lower hurdle. ... The key differences center around the clinical consultation with PMDA to address positioning and data alignment. - Peter A. Altman(CEO)

Contradiction Point 2

CardiAMP CMI Program Enrollment and Data Presentation

It involves differing statements about the CardiAMP CMI program's enrollment and data presentation, which could impact investor understanding of the program's progress and clinical significance.

How many patients were in the CardiAMP CMI dataset? How are these results incremental to the initial four-patient rolling cohort data presented last April? - Lander Egaña-Gorroño(H.C. Wainwright & Co, LLC, Research Division)

2025Q3: The CardiAMP CMI data contains 5 patients who have reached their 6-month primary endpoint. The results in this open-label rolling cohort are compelling and build on previous data. - Peter Altman(CEO)

Are the rolling cohort data from the CardiAMP CMI program related to the primary endpoint results at 6 months? - Lander Egaña-Gorroño(H.C. Wainwright & Co, LLC, Research Division)

2025Q2: Yes, the CardiAMP CMI program's rolling cohort data relate to the primary endpoint results at 6 months. The data is closely monitored, and we are proceeding with the final analysis. - Peter A. Altman(CEO)

Contradiction Point 3

Recruitment Challenges and Ease of Enrollment

It involves differing perspectives on the ease of recruitment and enrollment in BioCardia's trials, which could impact the timeline and success of their clinical trials.

Can you share updates on recruitment progress and any challenges physicians are facing in patient enrollment for the trial? - James Molloy (Alliance Global Partners, Research Division)

2025Q3: Recruitment for CardiAMP Heart Failure II is proceeding smoothly, with easier enrollment due to updated dosing approaches. - Peter Altman(CEO)

How is the CardiAMP trial related to the FDA submission process, and can they proceed concurrently? - Unknown Attendee (Private Investor)

2025Q1: The CardiAMP HF II trial is actively enrolling. Changes in the trial design, such as using Morph DNA and a new endpoint measure, aim to improve enrollment and trial efficacy. - Peter Altman(CEO)

Contradiction Point 4

Partnership and Funding Expectations for BCDA-03

It involves differing expectations regarding the timeline and nature of partnerships or funding for BCDA-03, which could impact the resources available for the program's development.

Is a partnership or agreement expected to close in Q1 2026 for BCDA-03? - James Molloy (Alliance Global Partners, Research Division)

2025Q3: Yes, there is potential for nondilutive funding through federal grants. BioCardia is expecting funding from the NIH for the BCDA-03 program, pending federal budget approval. - Peter Altman(CEO)

Can you discuss the maturity of business development deals and their impact on shareholder value? - Joe Pantginis (H.C. Wainwright)

2025Q1: As we continue to make progress with CardiAMP and our other programs, we're also making progress on our partnership efforts. We are in a variety of strategic talks with large-cap companies focusing on Morph, which could provide additional shareholder value. - Peter Altman(CEO)

Contradiction Point 5

Data Subset and Trial Design

It involves the interpretation and presentation of data subsets and trial designs, which are crucial for understanding the validity and progress of the ongoing trial and its potential impact on regulatory approval.

How many patients are in the CardiAMP CMI data set? How do these results compare to the initial 4-patient rolling cohort data presented in April last year? - Lander Egaña-Gorroño(H.C. Wainwright & Co, LLC, Research Division)

2025Q3: The CardiAMP CMI data contains 5 patients who have reached their 6-month primary endpoint. The results in this open-label rolling cohort are compelling and build on previous data. - Peter Altman(CEO)

What are the key points from your PMDA discussions in Japan, and when will the 2-year data be submitted to the FDA? - Joe Pantginis(H.C. Wainwright)

2024Q4: We met with PMDA in November and they asked for 2-year data. We now have this data and will submit it for a consultation. - Peter Altman(CEO)