TriSalus Life Sciences, Inc.

Good morning, and welcome to Trisalis Science Second Quarter 2024 Earnings Conference Call. Currently, all participants are on listen-only mode. We will facilitate a question and answer session toward the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host, Jim Young. Senior Vice President of Investor Relations and Treasurer at Trisalis for a few introductory comments.

Thank you all for participating in today's call. Joining me today from Trisalis Life Sciences are Mary Zella, President and Chief Executive Officer, Sean Murphy, Chief Financial Officer, Dr. Alex Kim, Senior Vice President, Interventional Radiology, and Dr. Steven Katz, Chief Medical Officer. Earlier this morning, Trisalis released financial results for the second quarter ended June 30th of 2024. A copy of the press release is available on Trisalis' website. Before we begin, I would like to remind you that we will be making forward-looking statements based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please see the risk factors in our SEC filings for additional details. And with that, I'll turn the call over to Mary.

Good morning, and thank you all for joining today's call. This quarter we made significant progress in advancing our strategic priorities and continued to achieve robust revenue growth. Today, We'll discuss the key highlights of the quarter and provide updates on our pioneering drug delivery technology, the PEDD technology, and our promising investigational therapeutic, melitolamide, for liver and pancreatic indications. Starting with our second quarter performance, I'm thrilled to report a substantial growth of 60% in TRYNAV revenues compared to the second quarter of last year. This impressive growth, driven by permanent, specific reimbursement, compelling clinical data, and the expansion of our sales force, reinforces our status as one of the fastest growing med tech companies in the United States, marking another consecutive quarter of over 50% growth. As previously shared, we're actively engaging with the interventional radiology community and hospital communities to disseminate the outcomes of our recent health economic and outcome research study. This study highlighted the value of the TriNAP system, particularly in treating complex patients with diverse clinical challenges and large tumor burdens in the liver. In short, the study demonstrated economic and clinical benefits to using the TriNAP system to treat sicker, treatment refractory, and higher disease burden patients. And given the high unmet medical needs of these patient populations and the significant impact of our technology, we are planning to launch a series of investigator-initiated clinical trials focusing on various complex patient types across numerous research sites and institutions in the U.S. This comprehensive clinical initiative aims to gather real-world clinical use data and further evidence supporting the use of TriNav technology in complex patient populations. This program, named the DELIVER program, is designed to further demonstrate TriNav's enhanced efficacy and safety across a broad spectrum of complex patient populations who may otherwise not be candidates for case and care procedures. We define these complex patients as those involving one or more of the following. previous embolization and therapy, multifocal diffuse or bilobular lesions, large tumors, eight centimeters in size, multiple comorbidities, including liver dysfunction, hypovascular tumors, and diffuse tumors throughout the liver. A new complex patient type has emerged based on the work of Dr. Juan Camacho from Sarasota General Hospital, who achieved significant treatment success using bland embolization via the TriNAP technology for multinodular goiter. Later in the call, Dr. Alex Kim will discuss the inherent benefits of trans-arterial embolization with the TriNAP technology compared to competing therapies. The DELIVER program encompasses a series of investigator-initiated clinical trials involving numerous research sites and hospitals across the United States, enabling access to a wide range of complex patient populations and clinical outcome data collection. A central theme of this program will be to investigate innovative approaches to highlight the impact of improved therapeutic delivery and enhanced safety through sparing of normal tissue when using the TRINAP system in these complex patients. Essentially, our goal is to explore the potential of combination therapies with transarterial chemo and radioembolization delivered via the TRINAP system, which we expect will demonstrate enhanced efficacy and overcome resistant mechanisms in difficult-to-treat cancers. We expect soon to initiate the first of our investigator-initiated clinical trials under the program called PROTECT for pressure-enabled retrograde occlusive therapy with embolization for control of thyroid disease, which aims to demonstrate the benefits of this approach versus surgery. We also intend to deliver studies to include ELIMINATE, which stands for embolization of liver metastasis in anatomically complex patients for therapeutic enhancement, integrating Y90 and the TRINAP system with systemic therapy for patients with anatomically complex colorectal and neural endocrine liver tumors. The second study is SPARE. It stands for pressurized redistribution of Embolic Chemotherapy Investigation for Safety Enhancement. This focuses on the benefits of TRINAV system with chemoembolization in complex sarcoma liver tumors. And the next study is called PRECISE. It stands for Embolization of Liver Metastases in Anatomically Complex Patients for Therapeutic Enhancement, CTASE, plus the TRINAV system, with systemic therapy for patients with anatomically complex colorectal and neuroendocrine liver tumors. We emphasize patient centricity in all our clinical trials, aiming to improve the overall patient experience during the procedure. This includes reducing the burden on patients, improving education, and ensuring their voices are heard throughout the clinical trial and development process. Importantly, the safety and tissue-sparing effects of our technology may enable patients to be treated with embolization who have not been eligible previously. Additionally, we believe these studies will allow us to update our real-world evidence to complement our clinical data and ensure we understand how our technology performs in everyday clinical practice. We will leverage advanced data analytics to generate insights from complex patients and datasets within our real-world evidence approach. Overall, the DELIVER program exemplifies our commitment to transforming the care of patients undergoing intravascular procedures for treatment of solid tumors or benign conditions with similar mechanical treatment barriers, ultimately striving to deliver a life-changing impact to the patients we serve. Regarding our pipeline, we plan to initiate the full launch of TrinabLARGE system later this year as well as share the full clinical results of PERIO-1, our Phase I clinical trial for uveal melanoma liver metastases, and PERIO-3, our Phase I clinical trial for locally advanced pancreatic cancer. At the end of the year, we'll provide results of PERIO-1 and PERIO-3, which will inform our next steps in clinical development in combination with the TRiNAV system. I'll turn the call to Dr. Alex Kim, our Senior Vice President of Interventional Radiology, to share further details on the initiation of PROTECT for multinodular goiter, and then have Dr. Stephen Katz, our Chief Medical Officer, briefly summarize the results of PERI-O2, our Phase I trial in intrahepatic cholangiocarcinoma and hepatocellular cancer. Before I hand it over to Alex, I want to conclude by saying We're pleased with the company's progress and confident in our ability to execute our company-building strategy. We remain on track against our objectives to achieve over 50% top-line revenue growth, advance our pipeline, and strengthen our operational foundations. Alex, over to you.