BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia Second 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 touchscreen 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 Pito of BioCardia Investor Relations. Please go ahead, Miranda.

Thank you very much. Good afternoon, and thank you all for participating in today's conference call. Joining me from BioCardio'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 BioCardio'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 BioCardio'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, August 11, 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. In our second quarter of 2025, we have been completing the cardiac heart failure trial. whose primary outcomes were presented as a late-breaking clinical trial at the American College of Cardiology's annual scientific sessions on March 30th, 2025. For study patients, all on stable guideline-directed medical therapy, the cardiac heart failure treatment group had a lower incidence of both all-cause death and non-fatal MACE than the control group during the entire 24-month period of the cardiac heart failure study with a p-value of 0.17. And the composite endpoint of all-cause death, non-fatal MACE, and quality of life was statistically significant in the subgroup of patients with elevated NT-proBNP with a p-value of 0.02. As we have reviewed the data, there have been additional compelling observations that we anticipate will be detailed in the upcoming peer-reviewed manuscript. For our long-standing investors, this data is to your credit as it provides objective evidence that together we have helped patients in a rigorous double-blind placebo procedure-controlled trial. The CARDI-AMP Heart Failure Trial Clinical Package detailing this data has been provided to Japan's Pharmaceutical and Medical Device Agency, or PMDA, and we hope to soon align on pathways to make this therapy available for physicians and their patients. Japan has a strong interest in heart failure therapy, and Japan's PMDA has approved other cell therapies, including for heart failure. Our own cell processing platform is also approved in Japan by our partner Zimmer Biomet for orthopedic applications, which makes our Helix catheter system the only truly new product to be introduced. We expect two other cardiac cell therapies to be considered for approval by PMDA in the coming year, in addition to our CardiAmp cell therapy. We view the sponsors of these other cell therapies as potential partners for our Helix biotherapeutic delivery system. which is supported by our experience and its use in clinical trials, which have enrolled more than 400 patients. It is expected that the in-person meeting on the clinical consultation with PMDA, requested in July of 2025, will take place mid-Q4 2025. If the parties are aligned, this could enable BioCardi to submit for approval of the Cardi-M system for market entry in Japan. In parallel, we have ongoing efforts towards requesting a meeting with the FDA on the approvability of the FDA-designated breakthrough cardiac system based on this clinical data also in the fourth quarter of 2025. We are continuing to gather evidence to support the therapy as well, and the cardiac heart failure two trial is actively enrolling patients at four clinical sites with the fifth to be activated in a few weeks' time. Our second program, the Cardi-AMP Cell Therapy and Chronic Myocardial Ischemia, or BCD02, the rolling cohort final data for scientific presentation and publication is ahead. The data to date has been excellent, and we have no more details to share until that data is publicly available. In Q2 2025, we had a successful Data Safety Monitoring Board review of the safety outcomes in the low-dose cohort in our cardi allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCD03, our third program. Management's assessment is that we have good potential of receiving non-dilutive funding for this program in Q1, 2026. On the Helix biotherapeutic delivery partnering front, we are actively preparing for submission for approval of this product via de novo 510 pathway based on the strength of our clinical data. Our Helix has potential to be the first approved transendocardial biotherapeutic delivery system in the United States. We remain interested in partnering this technology and providing support to the many other cell and gene therapy firms working to enhance the therapeutic options for patients with cardiovascular disease. We continue to be focused on partnerships where our contributions to the success of partners will reward our shareholders. One element of the Helix delivery system is our proprietary FDA-approved MorphDNA steerable introducer platform. We are continuing to detail its advantages to physicians and partners who may benefit from these products. Our goal is to partner this product and its underlying technology for the enormous cardiac electrophysiology market for the mapping and ablation of both atrial and ventricular tachyarrhythmias. The DNA technology design prevents whip in this catheter, which we developed in value for all of our helix procedures and is expected to have even greater value for ventricular ablation procedures should they require advancing the steerable introducer sheath in the left ventricle of the heart. On the business development front, We believe partnering can create meaningful value for shareholders with respect to each of our four platforms, CardiAmp, CardiAllo, Helix, and MorphDNA. For CardiAmp cell therapy business development, we expect the clarity on anticipated approvals ahead will enhance interest by distribution partners and strategics. For CardiAllo cell therapy business development, our allogeneic cell therapy we have the ability to manufacture our clinical grade cells at a cost profile that is likely less than that of all our peers. We are also open to partnerships broadly in the many indications we are not currently pursuing. For our Helix biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain active in discussions. Current partners realize that minimally invasive delivery not only enhances future commercialization, but is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their therapeutic development. Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery, We believe this advantage underlies our positive cardiac heart failure data and is due to the stability of the helix in the beating heart and the self-sealing helical pathway into the tissue. On the more front, partnering discussions are underway for the greater than $10 billion per year electrophysiology market described in my earlier comments. We expect to soon announce more details on the fusion imaging partnership we have entered into that has potential to be valuable for all of our product offerings and partnering efforts. Looking forward, we have updated our milestones in our press release today that are reflected in our updated corporate presentation available on our website. For BCD01, our cardiac autologous cell therapy and heart failure, in the fourth quarter, we will aim to have the peer-reviewed manuscript accepted meetings with Japan, PMDA, and FDA on approvability based on current data, as we also enroll in CARDI-AMP Heart Failure II. For BCD02, CARDI-AMP Autologous Cell Therapy and Chronic Myocardial Ischemia, in the fourth quarter, we intend to deliver final top-line data from the rolling cohort and seek peer-reviewed publication of the results. For BCD03, CARDI-ALO Allogeneic Mesenchymal Stem Cell Therapy and Heart Failure, We are projecting 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 third quarter of this year. This is the current quarter. We also anticipate a financing in September that we are working to have be a success for current shareholders. Insider investors have supported recent financings in 2025 as they recognize the great potential we have to be impactful for patients with cardiovascular disease and while also doing well. I will now pass the call to David McClung, our CFO, who will review our second quarter 2025 financial results.