BioCardia, Inc.

Good afternoon and welcome to the BioCardia third quarter financial results and business update conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touch screen or keypad. To withdraw your question, please press star, then two. Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call. I would now like to turn the call over to Miranda Pato of BioCardia Investor Relations. Please go ahead, Miranda.

Thank you. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, references to management's intentions, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in Biocardia's report on Form 10-K, filed with the SEC on March 26, 2025, and in subsequently filed reports on Form 10-Q. The content of this call contains time-sensitive information that is accurate only as of today, November 12, 2025. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. This has been another quarter of solid accomplishment for BioCardio, as we have been working on regulatory submissions on the strength of our clinical data for cardiac cell therapy for the treatment of ischemic heart failure of reduced ejection fraction, and for our Helix Transendocardial Delivery System, as well as advancing the cardiac heart failure two clinical study. Today, I will provide brief updates on our active clinical programs and progress on our Helix biotherapeutic delivery system and heart 3D fusion imaging. On BCDA01, our CARDI-AMP autologous cell therapy to treat microvascular dysfunction for the treatment of ischemic heart failure, which has potential to help roughly 2 million ischemic heart failure patients with New York Heart Association Class II and III symptoms. Many of these patients have a prognosis worse than many cancers and few remaining options. This places a terrible burden on patients, their families, and the healthcare system. The CAR-DAM cell therapy selects patients based on the nature of their marrow cells, which are then harvested, processed, and delivered to the heart in a single procedure. The CAR-DAM system has received FDA breakthrough designation based on our clinical results And we now have three remarkably consistent clinical trial results demonstrating promise for the treatment of these patients. Even as we are actively enrolling in the confirmatory cardiac heart failure two clinical study, we are having discussions with the FDA and PMDA on the approvability of the cardiac system for these patients. In this third quarter, we announced a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency, or PMDA. We have since responded to all questions from this meeting and anticipate our next consultation with PMDA soon, the outcome of which could enable us to submit for approval of the CAR-DMP system for market entry in Japan. Japan has a strong interest in heart failure therapies due to its aging population, the limited use of heart transplantation and left ventricular assist devices due in part to cultural issues, and Japan's PMDA has approved other cell therapies, including for heart failure. Our cardiac cell processing platform is approved in Japan for orthopedic applications, which makes our Helix catheter system the only new product to be introduced with good performance in more than 400 clinical procedures. In parallel, we anticipate requesting a meeting with the FDA on the approvability of the FDA-designated breakthrough CARDI-AMP system based on our clinical data in the fourth quarter of 2025. The CARDI-AMP Heart Failure 2 Confirmatory Phase 3 250-patient randomized placebo-controlled trial is starting to accelerate now that staff is coming off the enormous effort of closing up the CARDI-AMP HF study. four centers are actively enrolling, three have randomized their first patients, and additional centers are actively being onboarded. The CARDI-AMP HF2 study uses a similar three-tier composite primary outcome measure to the CARDI-AMP HF study, consisting of all-cause death, non-fatal major adverse cardiac events, and a validated quality of life measure. In both our phase two TAC-HIFT study, and Phase III CardiAMP-HF study, both randomized double-blind placebo-controlled studies, this CardiAMP-HF2 composite efficacy endpoint was achieved with statistical significance in the patients with elevated NT-proBNP, who are the focus of the CardiAMP-HF2 study. CardiAMP Heart Failure II trial advances include using the cell population analysis and screening, to define treatment dose and improvements to the Helix system, including our FDA-approved MorphDNA Steerable Guide platform. These advances are expected to enable more patients to qualify for the therapy, enhance the ease of enrollment, and improve physician control during the interventional cell therapy procedure. CAR-DNF HF2 is supported by the Center for Medicare and Medicaid Services with reimbursement for both treated and control patients. In addition to the potential for approvals based on existing data, we are pursuing pathways to fund this study to completion. BCDAO2 is our second indication for this therapy, the CARDI-AMP cell therapy in chronic myocardial ischemia. The top line primary outcomes from the open label rolling cohort of the CARDI-AMP cell therapy in chronic myocardial ischemia trial show patients experienced increased exercise tolerance of an average of 80 seconds with 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. We are preparing results for scientific presentation and publication. The promise of these results suggests that the opportunity to positively impact patient lives may be double that of the ischemic heart failure indication we are pursuing as our lead program. BCDA03 is our second therapeutic platform, our cardi-allo-allogeneic mesenchymal stem cell therapy. This off-the-shelf cell therapy is manufactured at Biocardia. and is being advanced in the first prospective trial focused on inflammatory ischemic heart failure of reduced ejection fraction. We believe this program is well-positioned for near-term non-dilutive funding to complete the Phase 1-2 39-patient trial. The results of this trial, if in line with our previous experience in the 30-patient dose escalation TRIGEN study, are expected to enable submission for conditional approval in Japan. We expect clarity on the anticipated non-dilutive funding in the first quarter of 2026. On the Helix agent delivery front, we have completed an update to our master file for this delivery device, which supports our therapeutic agent programs and those of therapeutic agent partners. We are actively preparing a de novo 510 submission based on the strength of our clinical data. This helix submission and anticipated approval of our low-risk agent delivery device should enhance support of regulatory agencies for the CARDI-AMP programs, as the CARDI-AMP cell processing is already approved in the United States, the European Union, and Japan for other indications. Related to biotherapeutic delivery, in August, we announced our partnership to develop and commercialize Heart3D Fusion Imaging for Biotherapeutic Delivery and Cardiac Biopsy with Cartek, a Netherlands company developing enhanced real-time fusion imaging solutions for interventional procedures. Together, we have already realized promising results for Heart3D Fusion Imaging in animal studies using both MRI and CT imaging and intend to advance to the clinic in 2026. Looking forward, we have updated our milestones in our press release today. For BCD01, our cardiac autologous cell therapy and heart failure, we expect Japan PMDA clinical review in Q4, FDA meeting requests on approvability also in Q4, and a manuscript published in Q1 with cardiac heart failure two enrollment continuing. For BCD02, cardiac autologous cell therapy and chronic myocardial ischemia. We are seeking peer-reviewed publication of the positive results in Q1, 2025, 2026, excuse me. And for BCD03, cardiallo-allogeneic mesenchymal stem cell therapy in heart failure, we anticipate non-dilutive funding coming together in the first quarter of 2026. For our Helix biotherapeutic delivery system, we anticipate FDA submission for approval in the fourth quarter of this year. I will now pass the call to David McClung, our CFO, who will review our third quarter 2025 financial results. David?