TriSalus Life Sciences, Inc.

Good morning, and welcome to Trisalis Life Sciences' third quarter 2023 earnings conference call. At this time, all participants are on listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, the 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 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, and Dr. Steven Katz, Chief Medical Officer. Earlier this morning, Trisalis released financial results for the quarter ended September 30th, 2023. A copy of the press release is available on Trisalis's website. Before we begin, I would like to remind you that management will make statements during this call that includes 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 statements of historical fact, are forward-looking statements. All forward-looking statements, including without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, reimbursement proposals, 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 factors section of our form 10Q 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, November 14th, 2023. And with that, I'll turn the call over to Mary.

Good morning, everyone, and thank you for joining us today to review Trisalis Life Sciences' third quarter results for 2023. This marks our first quarterly earnings call as a publicly traded company. and we're excited to report on our progress towards our mission to extend and improve the lives of people living with liver and pancreatic tumors. We greatly appreciate your presence today on the call. Trifalus was founded in 2018 to address the two main barriers that inhibit treatment success in liver and pancreas tumors via the combination of our proprietary technology that can deliver high concentrations of a range of therapeutics to the site of disease with a novel immunotherapeutic focused on attacking the immunosuppression environment and enabling checkpoint inhibitor response. Intertumoral hypertension is a pervasive and underappreciated problem that causes collapse of vessels and tumors, limiting blood flow and therapeutic uptake. Our pressure-enabled drug delivery, PEDD technology, has been shown to enable superior delivery of a broad range of therapeutics into tumors with improved accuracy, predictability, and at higher tissue levels in association with better clinical outcomes. PEDD allows enhanced delivery to increase therapeutic delivery to the tumor while decreasing exposure in normal tissue to minimize toxicity and enable treatment of patients with more advanced disease. Our TriNav infusion system, which was launched in 2020, leverages our PEDD technology to overcome the infusion barriers that limit therapeutic uptake in solid tumors, including pancreatic adenocarcinoma, hepatocellular carcinoma, and liver metastases. TriNav has demonstrated the ability to deliver high concentrations of therapeutics into high-pressure tumors while limiting exposure to normal tissue avoiding off-target toxicity. We believe this is game-changing, first-of-a-kind technology, and the adoption by interventional radiologists we have achieved to date is a reflection of its patient impact and efficacy. Our trying-to-have business has grown at an annualized growth rate of approximately 50%, despite having lost at the same time at the start of the pandemic. And in the third quarter, we achieved our highest-ever sales figure of $5.2 million. We're delighted to report that this business continues to demonstrate robust revenue and market share growth throughout the United States. Our strategic investments in physician education, clinical and sales personnel have allowed us to successfully educate the interventional radiology physician community and drive adoption. This business has single-digit market share and superior growth margins. which provides significant opportunity for future profitability. Following my remarks, Sean Murphy, our Chief Financial Officer, will provide a more in-depth analysis of our quarterly results and key operating metrics. In addition to our Trinab technology, in 2020, we acquired SD101, an investigational toll-like receptor 9 agonist. In clinical studies performed prior to the acquisition, SD-101 demonstrated the ability to favorably reprogram the tumor microenvironment and promote responses to immunotherapy. Later in the call, Dr. Stephen Capps, our Chief Medical Officer, will share recent encouraging data from our Phase I PERIO-1 trial for uveal melanoma with liver metastases and our PERIO-3 trial for pancreatic adenocarcinoma. These results further validate our company's proof of concept, the effectiveness of our pressure-enabled drug delivery in combination with SC-101 in overcoming critical mechanical and biological barriers in the treatment of solid tumors. In summary, we're very encouraged by the remarkable progress our team has made in our commercial and clinical endeavors and are very excited about the future of Trisalis. At this time, I'm proud to introduce Sean Murphy, our Chief Financial Officer, to discuss our operating results and key financial metrics.