BioCardia's Q3 2025: Contradictions Emerge on Japan Regulatory Hurdles, CardiAMP Enrollment Strategies, and Trial Progress

Guidance:

• Japan PMDA clinical review anticipated in Q4 2025 for CardiAMP.
• Requesting an FDA meeting on CardiAMP approvability in Q4 2025.
• Manuscript of prior CardiAMP data expected Q1 2026.
• CardiAMP Heart Failure II enrollment continuing (250-patient trial).
• BCDA-02 peer-reviewed publication targeted Q1 2026.
• BCDA-03 nondilutive (federal/NIH) funding expected in Q1 2026 (high probability).
• De novo FDA submission for Helix delivery system expected Q4 2025.

Business Commentary:

* Regulatory Submissions and Approvals: - BioCardia is actively pursuing regulatory submissions for CardiAMP cell therapy and Helix transendocardial delivery system, driven by positive clinical data. - The company is preparing for potential approvals in the US and Japan based on existing data, with ongoing discussions with the FDA and PMDA.

• Clinical Trial Advancements:
• The CardiAMP Heart Failure II confirmatory Phase 3 trial is accelerating, with 4 centers actively enrolling and 3 having randomized their first patients.
  

• Improvements in cell population analysis and Helix system advancements are expected to enhance patient qualification and ease of enrollment.

• Financial Performance:

• Research and development expenses increased due to closeout of the CardiAMP Heart Failure study and new enrollment in the CardiAMP Heart Failure II trial.

• Selling, general, and administrative expenses decreased due to lower professional service fees and share-based compensation expense.

• New Partnership and Funding:

• BioCardia is pursuing funding pathways for the CardiAMP Heart Failure II study, with expected clarity on nondilutive funding in the first quarter of 2026.
• The company is anticipating federal grant funding for BCDA-03, its second therapeutic platform, CardiALLO allogeneic mesenchymal stem cell therapy.

Sentiment Analysis:

Overall Tone: Positive

• Management described "another quarter of solid accomplishment," noted a "positive preliminary clinical consultation with PMDA," expects FDA and PMDA meetings/submissions in Q4 and publication/funding milestones in Q1 2026, and highlighted cash of $5.3M giving runway into Q2 2026 — all indicating constructive forward momentum despite limited runway.

Q&A:

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

• Question from Lander Egaña-Gorroño (H.C. Wainwright & Co, LLC): So you're wrapping it up with 5 patients total, right, for the rolling cohort, open-label?
  Response: Confirmed: the rolling cohort totals 5 patients.

• Question from James Molloy (Alliance Global Partners): You have 3 patients in 4 centers enrolling — can you walk through any anecdotal stories on how recruitment is going and what the challenges or not challenges to get the patients in that trial that the docs are seeing out there?
  Response: Enrollment is proceeding smoothly; cell population analysis and dosing flexibility make screening easier — the primary constraint is company resources/bandwidth rather than patient availability.

• Question from James Molloy (Alliance Global Partners): Did I mishear that you said you had 4 centers enrolling and 3 of them had their first patients enrolled?
  Response: Yes — four centers active and three have randomized their first patients; some sites have treated more than one.

• Question from James Molloy (Alliance Global Partners): What is the current patient count?
  Response: Management will not disclose an aggregate current patient count and will announce site first-patient milestones individually.

• Question from James Molloy (Alliance Global Partners): You said you expected nondilutive funding in Q1 '26 for BCDA-03 — is there a partnership or something lined up that is expected to close in Q1 '26?
  Response: Expect a high-probability federal/NIH grant to provide nondilutive funding for BCDA-03 in Q1 2026, but nothing is guaranteed yet.

• Question from Kumaraguru Raja (Brookline Capital Markets, LLC): What are the next steps with Japanese regulatory authorities before you can submit for approval in Japan, and can you share additional color on the positive interactions?
  Response: Next step is a formal PMDA clinical consultation to decide if combined Phase I–III data suffice for approval; ~95–99% of submission prep is complete and the company is awaiting that consultation.

• Question from Kumaraguru Raja (Brookline Capital Markets, LLC): With regard to HF II, you said 4 clinical sites are on board. What are your expectations for getting additional sites on board?
  Response: Adding sites is limited by internal bandwidth and increased site start-up costs; BioCardia expects enrollment to take at least another year as resources are allocated.

Contradiction Point 1

Regulatory Timeline and Process for Japan

It involves the timeline and nature of the regulatory process in Japan, which affects expectations for market entry and potential partnering opportunities.

What are the next steps required to submit for approval in Japan? Are there additional details on the positive interactions with Japanese regulators? - Kumaraguru Raja (Brookline Capital Markets, LLC)

2025Q3: The process in Japan is a series of consultations. And the key hurdle for us is a formal clinical consultation. - Peter Altman(CEO)

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

2025Q2: The approval process for CardiAMP as a medical device is viewed as a lower hurdle compared to a drug application. - Peter Altman(CEO)

Contradiction Point 2

Enrollment and Dosing Strategy for CardiAMP Heart Failure II Trial

It involves the enrollment strategy and dosing parameters for the CardiAMP Heart Failure II trial, which impacts the timeline and feasibility of the trial.

Could you share examples of how recruitment for the trial is progressing and whether doctors are experiencing challenges or ease in enrolling patients? - James Molloy (Alliance Global Partners, Research Division)

2025Q3: The enrollment is easier in this trial because of our use of the cell population analysis to essentially set dosage where patients previously might have been excluded. - Peter Altman(CEO)

What type of FDA meeting is planned (Type B or C)? How is the screening progressing for the HF II trials, and when can we expect patient enrollment and treatment to begin? - Kumaraguru Raja (Brookline Capital Markets, LLC)

2025Q2: We believe that these patients are in all likelihood going to be treated with the single product dose. - Peter Altman(CEO)

Contradiction Point 3

CardiAMP Trial Status and Challenges

It involves differing perspectives on the enrollment status and challenges of the CardiAMP trial, which is crucial for regulatory approval and commercialization efforts.

Can you share any anecdotal insights on recruitment progress and what challenges or lack thereof doctors are encountering in recruiting patients for the trial? - James Molloy (Alliance Global Partners, Research Division)

2025Q3: The status of CardiAMP Heart Failure II is that it's coming along actually rather smoothly. The enrollment is easier in this trial because of our use of the cell population analysis to essentially set dosage where patients previously might have been excluded. - Peter Altman(CEO)

How will the ongoing CardiAMP confirmatory trial affect FDA approval? - Unknown Attendee (Private Investor)

2025Q1: The ongoing CardiAMP trial is crucial for generating additional data, particularly focusing on patient subgroups that respond best to the therapy. We are utilizing new technologies like Morph DNA and a pre-procedure screening assay. The trial will enroll 250 patients with a 1:1 randomization. - Peter Altman(CEO)

Contradiction Point 4

Japanese Regulatory Discussions and Strategy

It highlights differences in the tone and expectations regarding interactions with Japanese regulatory authorities, which are critical for international expansion and market access.

What are the next steps required to submit for approval in Japan? Are there any additional positive interactions to share? - Kumaraguru Raja (Brookline Capital Markets, LLC, Research Division)

2025Q3: The process in Japan is a series of consultations. And the key hurdle for us is a formal clinical consultation. If -- we've been having preliminary clinical consultations, and they are fully apprised of the data. - Peter Altman(CEO)

What is the significance of submitting a PMDA application for CardiAMP cell therapy in Japan? - Joe Pantginis (H.C. Wainwright)

2025Q1: A positive PMDA submission in Japan would be a significant inflection point, similar to an FDA BLA acceptance. It would take about 6 months to confirm if we can submit for approval. This clarity would be crucial for planning physician outreach and commercialization timelines. - Peter Altman(CEO)

Contradiction Point 5

CardiAMP Heart Failure II Trial Enrollment and Patient Selection

It involves differing explanations about the enrollment process and patient selection criteria for the CardiAMP Heart Failure II trial, which could impact the trial's outcomes and regulatory submissions.

Could you share any anecdotal insights regarding recruitment progress and the challenges or lack thereof in enrolling patients in the trial that doctors are encountering? - James Molloy (Alliance Global Partners)

2025Q3: The enrollment is easier in this trial because of our use of the cell population analysis to essentially set dosage where patients previously might have been excluded. - Peter Altman(CEO)

What is the timeline for sharing the 2-year data with the FDA and how will it impact the CardiAMP-2 trial? Will trial enrollment increase after this data? - Kumar Raja (Brookline Capital Markets)

2024Q4: We'll have a meeting with the FDA to discuss the data, and we expect supportive interactions due to FDA breakthrough designation and the strength of our data. CardiAMP Heart Failure 2 is already approved, and sites are activating. - Peter Altman(CEO)