TriSalus Life Sciences, Inc.

Good morning, and welcome to Trisalis Life Sciences' first quarter 2024 earnings conference call. Currently, all participants are in listening mode. We will facilitate a question and answer session towards 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 Investment Relations and Treasurer at Trisalis, for a few introductory remarks.

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, and Dr. Stephen Katz, Chief Medical Officer. Earlier this morning, Trisalis released financial results for the first quarter ended March 31st, 2024. A copy of the press release is available on Trisalis' website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Any statements contained in this call, other than the statements of historical fact, are forward-looking statements. All forward-looking statements, including without limitation, statements relating to our projected sales, costs, operating results, and cash runway, business strategies, objectives and growth, products value and adoption, and anticipated product launches, future clinical data, and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factor section of our Form 10-Q on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. Trisalis disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 15, 2024. And with that, I'll turn the call over to Mary.

Good morning, and thank you all for joining today's call. We're thrilled to kick off the discussion by highlighting our strong start in the first quarter of 2024, setting an optimistic tone for the rest of the year. I'm expressing my sincere appreciation for the dedication and efforts of the entire Trisalis team in delivering exceptional results for our patients, physicians, and shareholders. Their unwavering commitment to our mission continues to drive our success, enabling us to achieve significant milestones, advance our pipeline, and reshape our company's future. Today, we'll discuss this quarter's key highlights and provide updates on our groundbreaking drug delivery technology, PEDD, and our promising investigational therapeutics, melitolamide, for liver and pancreatic indications. Starting with quarterly performance, I'm delighted to report a remarkable 116% growth in revenues, all of which is from the sale of Trinav compared to the same period last year. This growth fueled by permanent reimbursement, promising clinical data, and Salesforce expansion, underscores our position as one of the fastest-growing medtech companies with another consecutive quarter of over 50% growth. We've been actively engaging with the interventional radiology and hospital community to share the outcomes of our health, economic, and outcome research study. This study underscores the value of Trinav particularly in treating complex patients with diverse clinical challenges. We're updating our analysis to include the latest clinical data from 2023, further reinforcing Trinav's potential to become the standard of care for these patients. This data, in addition to our previous clinical data, demonstrates the value of Trinav in complex patients, defined by patients involving one or more of the following. previous embolization or therapy, multinodal or bilobar lesions, essentially significant tumor burden, very large tumors greater than 8 centimeters in size, multiple comorbidities, hypovascular tumors, and diffuse tumors. Given this robust data, we are positioning TRINAP to become the standard of care for these patients and implementing a range of educational and reimbursement support programs to facilitate the technology's adoption within the high-volume embolization hospital. As we move ahead, we're eagerly anticipating the launch of Trinav-Large in the second half of the year, along with the forthcoming clinical results from our Nelotolamide trials across various cancer indications. Enrollment has been successfully concluded for our Phase I clinical trial for uveal melanoma liver metastases, PERIO-1, intrahepatic cholangiocarcinoma, and hepatocellular cancer, PERIO2, with enrollment nearing completion for pancreatic cancer, PERIO3. We are currently awaiting the predetermined follow-up period to conclude, during which we will thoroughly evaluate the data and strategize our next steps in terms of which indications to pursue. Our dedication to innovation remains steadfast, and we look forward to presenting promising data from PERI-02 at the upcoming American Society of Clinical Oncology annual meeting. In addition to our clinical advancements, we've made significant strides in optimizing manufacturing and gross margin, achieving an impressive 85% gross margin this quarter. These efforts, coupled with our strategic investments and focus on operational efficiency, position us for sustained growth and pipeline advancement. With recent positive developments in reimbursement, robust clinical data, and the dedication of our seasoned executive team, we're confident in our ability to execute our company-building strategy. Our objectives of achieving over 50% top-line revenue growth, advancing our pipeline, and strengthening our operational foundations remain firmly on track. In summary, We're pleased with this quarter's progress, and I'll now let Sean delve deeper into our financial performance. Sean?