BioCardia, Inc. (BCDA) Earnings

Management highlights

### Regulatory Milestones - Completed three positive key regulatory meetings in Q2 2026 for CARDiAmp autologous cardiac cell therapy (for ischemic heart failure) and the HELIX transendocardial cardio delivery catheter, across Japan and the U.S. - Japan PMDA provided consultation guidance supporting a premarket Shonin submission for CARDiAmp, noting trial outcomes are credible; outstanding requests focus on verifying patient eligibility, providing additional event details, and developing a post-marketing study framework. - FDA CBER confirmed the ongoing Phase III CARDiAmp Heart Failure II trial may support single-trial premarket approval, with no outstanding safety or delivery concerns; FDA is yet to issue final formal meeting minutes for the HELIX de novo pre-submission, but verbal confirmation aligns with management's understanding. - FDA agreed two approval pathways exist for HELIX, and raised no concerns over its safety, performance, or agent compatibility; HELIX is already CE-marked and approved for commercial sale in Europe, with clinical data from approximately 500 patients across 12+ trials. ### Operational Progress - The company is addressing PMDA's requests, completing electronic trial master files, conducting GCP audits aligned with PMDA standards, formatting data per CDISC requirements, and expects to imminently sign an agreement with a local Designated Marketing Authorization Holder (DMAH) for the Japanese submission. - CARDiAmp Heart Failure II trial has 4 active enrolling sites, with 3 additional patients expected to qualify and 2 procedures scheduled for August 2026, with no reported safety issues; enrollment acceleration is tied to resource deployment, and the company is onboarding additional sites. - Business development discussions are active in the Asia-Pacific region for CARDiAmp, with potential deals that could include funding for CARDiAmp's second chronic myocardial ischemia indication and allogeneic CardiALLO therapy for inflammatory heart failure; delivery platform partnerships are also being pursued for gene therapy development. - The company is collaborating with CARTO to integrate 3D heart fusion imaging for Helix-enabled procedures to bring the technology to clinical practice. ### Financial Updates - Raised $4.9 million in net proceeds in Q2 2026 via the company's at-the-market offering facility, at an average price of $1.22 per share, with no warrants or excess dilution. - Ended the quarter with $2.7 million in equity, maintaining compliance with NASDAQ listing requirements.

Guidance

- BIOCARDIA expects to complete the Japanese Shonin submission for CARDiAmp imminently after resolving PMDA's outstanding requests, with approval anticipated approximately 12 months post-submission. - No changes to overall operational timelines are expected related to PMDA requests or DMAH onboarding; CDISC data formatting is currently the longest lead-time activity for the Japanese submission. - The company expects existing $5.4 million cash balance will be sufficient to reach the PMDA submission milestone; a modest financing from existing long-term investors would accelerate enrollment in the U.S. Phase III CARDiAmp Heart Failure II trial. - Management expects adoption of CARDiAmp in Japan after approval and reimbursement will be relatively rapid, potentially outpacing adoption of percutaneous aortic valves due to a simpler procedure and lack of competing surgical options for the target patient population. - The pending SEC proposal to eliminate the baby shelf limitation for smaller company registered offerings is expected to benefit BIOCARDIA if implemented in Q1 2027.

Segment performance

BIOCARDIA is a clinical-stage biotech company with no commercial product sales as of Q2 2026, so no product segment revenue is reported. All financial activity consists of R&D and SG&A operating expenses: Q2 2026 total expenses were $1.6 million, a $0.4 million (19%) decrease from Q2 2025's $2.1 million. Q2 2026 R&D expense was $0.9 million (56% of total expenses), a $0.5 million decrease year-over-year; SG&A expense held steady at $0.7 million (44% of total expenses). For the first half of 2026, total expenses were $3.9 million, a $0.9 million decrease from the first half of 2025. First half 2026 R&D expense was $2.1 million, a $0.8 million year-over-year decrease; SG&A was $1.8 million, a $0.1 million decrease. Q2 2026 net loss was $1.6 million, compared to $2.0 million in Q2 2025. Year-to-date net loss 2026 was $3.9 million, compared to $4.9 million in 2025 YTD. Net cash used in operations was $1.7 million in Q2 2026, slightly up from $1.6 million in Q2 2025. Ending cash and cash equivalents as of Q2 2026 were $5.4 million, providing operating runway into 2027.

Risks & headwinds

- Clinical and regulatory uncertainty: Final FDA meeting minutes for the HELIX de novo submission have been delayed beyond the original June 12, 2026 expected release date. - Regulatory approval risks: FDA has not previously approved a transendocardial biotherapeutic delivery catheter, so approval pathways for HELIX remain untested and require creative navigation of FDA internal processes. - Competitive entry risk: If HELIX is approved via the de novo pathway, competitors could submit 510(k) clearances referencing BIOCARDIA's de novo clearance, though management notes significant performance data barriers to entry remain. - Enrollment risk: Enrollment in the U.S. Phase III CARDiAmp Heart Failure II trial is currently proceeding at a slower pace than an accelerated timeline, constrained by the company's current resource prioritization on the Japanese submission. - Operational risk: A small number of patient records require follow-up to document why patients were not on full guideline-directed medical therapy for the PMDA submission, though the volume is very low and management expects this to be resolved quickly. - Market competition: Another competing cell therapy for the same indication has already been approved and reimbursed in Japan, creating an existing competitor in the market.

Analyst Q&A

• Q: What key outstanding items remain for the FDA HELIX de novo submission, and what are the implications for the field if approved? /

  A: The only outstanding item is formal FDA confirmation of the required submission tweaks for the first-ever transendocardial delivery catheter approval via the de novo pathway. FDA prefers to approve HELIX simultaneously with CARDiAmp cell therapy, but management is hopeful the agency will approve Helix standalone to enable broader cardiac biologic development. While approval would open a 510(k) pathway for competitors, BIOCARDIA's unique 500-patient clinical dataset creates a significant barrier to entry.

• Q: How can the initial 20,000-patient CARDiAmp indication in Japan be expanded, and how does CARDiAmp compare to the already approved competing ReHeart therapy? /

  A: The indication will expand through positive post-marketing study results; Japan has a large pool of 300,000 total ischemic heart failure patients with limited treatment options, so strong clinical and procedural outcomes will drive expansion quickly. Unlike ReHeart, which requires open surgical implantation, uses allogeneic iPS cells that likely require chronic immunosuppression, and has only treated ~8 patients to date, CARDiAmp is delivered minimally invasively via catheter, uses the patient's own autologous cells with no need for immunosuppression, and has extensive large-scale clinical trial data.

• Q: How does the Japanese DMAH partnership work, when will it be signed, and what is its impact on commercialization? /

  A: The DMAH is a contracted regulatory representative that handles local regulatory and quality compliance for the submission, not a commercial sales partner; their marketing authorization is fully transferable, so it does not prevent future broader commercial partnership or licensing deals. The contract is nearly finalized with a pre-vetted qualified party, and the cost is not significant. BIOCARDia will retain commercial rights for the post-marketing study, working with local Japanese distributors as standard for the market.

• Q: How much incremental work is required to address PMDA's outstanding requests, and will this delay the Shonin submission timeline? /

  A: Almost all requested data is already collected from the completed trial. The only new data collection needed is clarifying the rationale for why ~8-9 trial patients were not on all four guideline-directed heart failure medications, which is a straightforward low-effort process. CDISC data formatting is the current longest lead activity, but no delays to the submission timeline are expected.