BioCardia, Inc. (BCDA) Earnings

Management highlights

### Clinical Trial Progress and Clinical Data Accomplishments - Blinded long-term contrast-enhanced echocardiography data from the completed CARDI-AMP ischemic heart failure trial, analyzed by the Yale University ECHO Core Laboratory, showed that treated patients did not experience pathological negative cardiac remodeling (increasing heart volume that reduces pumping efficiency and correlates with poor outcomes), while control patients did see this negative progression. - In the subgroup of patients with elevated heart stress biomarkers, the improvements in heart function during relaxation and contraction were statistically significant, and the trial's composite primary endpoint (improved survival without heart replacement therapy, fewer major adverse cardiac events, better quality of life) also achieved statistical significance, with benefits added on top of standard maximum guideline-directed medical therapy. - Results from the company's second clinical program for chronic myocardial ischemia have been accepted for oral presentation at the upcoming EuroPCR conference. ### Regulatory Achievements - Japan's Pharmaceutical and Medical Devices Agency (PMDA) indicated during a formal clinical consultation that it is inclined to accept the existing CARDI-AMP trial data as the basis for marketing approval, aligned with the trial's indication, given the unmet medical need for this therapy in Japan. A draft written advisory record received by the company matches the meeting outcome. - BioCardia held a Q-Sub meeting with the U.S. FDA CBER to discuss extending the already-approved CARDI-AMP processing platform labeling to a therapeutic indication for ischemic heart failure with reduced ejection fraction. The FDA confirmed premarket approval (PMA) is the appropriate pathway, raised no safety concerns, noted the efficacy results are intriguing, and encouraged the company to complete the ongoing CARDI-AMP HF2 trial to support the PMA submission, while agreeing to provide input on statistical analysis nuances for the study's composite endpoint. - The company completed a pre-submission meeting with the FDA for its Helix Transcendental Cardio Delivery System. The FDA raised no concerns over safety, device performance or agent compatibility, identified the preferred approval pathway as concurrent approval with the CARDI-AMP cell therapy system, and noted that a follow-on pre-submission could enable standalone de novo pathway approval for the device. ### Corporate Priorities - Completing the preparation and submission of the Shonin premarket approval application to PMDA in Japan, and accelerating enrollment in the CARDI-AMP HF2 trial, are the company's top two priorities.

Guidance

- The Shonin premarket approval application for CARDI-AMP in Japan is expected to take approximately 7 months to prepare and submit, with a 12-month review period after submission, putting potential approval at roughly 19 months from the call date. - The company expects to complete one or more capital raising transactions in Q2 2026 to fund the Japan PMDA submission process and the CARDI-AMP HF2 trial enrollment. - The ongoing CARDI-AMP HF2 trial is designed for 250 total patients, with 160 patients required to achieve 80% statistical power. Four centers are currently activated and enrolling, and the company plans to onboard additional interested centers and expand enrollment as quickly as available resources allow.

Segment performance

BioCardia is a clinical-stage biotech focused exclusively on cardiac cell therapy and delivery systems, and no separate product segment financials are reported in the call. Total operating expenses for Q1 2026 were $2.3 million, a $400,000 decrease from $2.7 million in Q1 2025. Research and development (R&D) expenses were $1.2 million, a $295,000 decrease from $1.5 million in Q1 2025, driven by closeout of the original CARDI-AMP heart failure trial, partially offset by costs for early enrollment in the CARDI-AMP HF2 trial and Japan regulatory activities. Selling, general and administrative (SG&A) expenses were $1.0 million, a $200,000 decrease from $1.2 million in Q1 2025, primarily due to lower professional service fees. Net loss for Q1 2026 was $2.3 million, down from $2.7 million in Q1 2025. Net cash used in operating activities was $1.7 million, compared to $1.6 million in Q1 2025, a difference driven by timing of supplier payments. The company ended Q1 2026 with $951,000 in cash and cash equivalents.

Risks & headwinds

- Forward-looking statements related to regulatory approval timelines, clinical trial outcomes, commercial launch plans, and capital raising are inherently uncertain, as developing and gaining approval for new advanced therapies carries inherent risks that could lead to actual results differing materially from expectations. - The company has very limited cash reserves ($951,000 at the end of Q1 2026), so its ability to advance key priorities depends entirely on successfully completing planned capital raising transactions in Q2 2026. - Regulatory review for product approval carries residual risk of unidentified issues with clinical data, manufacturing, or quality systems that could delay or prevent approval, even after positive initial regulatory interactions.

Analyst Q&A

• Q: What additional work is needed to prepare the Japan Shonin submission, what is the review timeline after filing, and what will happen after approval? /

  A: Extensive preparation is still required, including internal pre-audit of clinical data and manufacturing with local Japanese regulatory representatives, with submission expected in approximately seven months. After submission, PMDA will conduct a ~12-month review covering data, manufacturing, and sterility, similar to a U.S. PMA review, with approval expected ~19 months from the call date. Post-approval, a required post-marketing study will be conducted in partnership with leading Japanese cardiac societies, and reimbursement will be available during this early launch period.

• Q: What is the size of the Japanese market opportunity for CARDI-AMP, and how will the therapy integrate into local standard of care? /

  A: There are roughly 300,000 total eligible patients with ischemic heart failure in Japan, with initial reachable market size under approved appropriate use conditions estimated at ~20,000 patients. While Japanese standards of care have small regulatory meaningful differences from the U.S., they are broadly similar, so no major integration changes are needed. Using the current U.S. Medicare reimbursement rate of $20,000 per procedure, the initial addressable market would total $400 million.