TriSalus Life Sciences, Inc.

Good morning and welcome to Trisalis Life Sciences' fourth quarter and full year 2023 earnings conference call. Currently, all participants are on a listen-only mode. We will be facilitating 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, Investor Relations and Treasurer at Trisalis, for a few introduction 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 unaudited financial results for the fourth quarter and full year ended December 31st, 2023. 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 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 the statements of historical fact, are forward-looking statements. All forward-looking statements, including without limitation, statements related to our sales and operating trends, business and hiring prospects, financial and revenue expectations, the timing of the filing of our annual report on Form 10-K, 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 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, April 1, 2024. As noted in our press release, Trisalis has filed or will soon file a Form 12-B25 notification of late filing with the SEC related to the company's annual report on Form 10-K for 2023. This filing provides the company an extension of up to 15 days to file the company's annual report. If the company files its annual report within such a 15-day period, the annual report will be deemed to have been filed timely, as if we had filed on the due date prescribed by the SEC. The company filed form 12B25 primarily due to the calculation of non-cash stock compensation expense caused by data errors associated with a transition to a new service provider in 2023. As a result, the operating results provided on the call today are unaudited and subject to potential adjustments. And with that, I'll turn the call over to Mary.

Good morning and thank you for joining today's call. I'm pleased to reflect on the significant milestones achieved by Trisalis in 2023, marking a pivotal year in our company's journey. We've made substantial progress in advancing our disruptive drug delivery technology, PEDD, aimed at enhancing therapeutic outcomes for liver and pancreatic tumors. Furthermore, I'm also excited to highlight our strides in integrating our technology with our investigational immunotherapeutic, melitolamide, a classy toll-like receptor 9 agonist across various liver and pancreatic indications. Together, these advancements signify our commitment to advancing outcomes for patients suffering with liver and pancreatic tumors. This morning, I'd like to speak to you regarding our quarterly results, as well as the achievements in the past year, which have created a strong foundation for future growth. In the midst of a challenging economic environment, our people delivered 77% growth in the fourth quarter and 49% operational growth for the year. We're pleased to report that we delivered another high growth quarter, concluding a very strong year of top line revenue growth. Tricelis continues to execute the key components of our company building strategy, which include 50% top-line revenue growth, advancing our pipeline, improving manufacturing and gross margin, securing permanent reimbursement, continuing to manage costs while investing wisely, and finally, accessing the public markets. Tricelis executed on our key objectives, creating a strong foundation for future growth and pipeline advancement. First, let me begin with the accomplishments in the past year. Trisalis achieved $18.5 million in net sales, 49% growth over 2022, earning Trisalis recognition as one of the fastest growth MedTech technologies. received a unique and permanent HCPCS code for TRINAV from CMS, C9797, which has been assigned to APC5194, level 4 endovascular procedures. And this code can be used without restriction for any embolization or occlusion procedure consistent with the TRINAV instructions for use and is reimbursed in the hospital outpatient and ambulatory surgery settings. This allows for physicians to use TRINAB broadly for both mapping and embolization procedures. We completed enrollment in phase one clinical trials in uveal melanoma liver metastases, hepatocellular cancer, and intrahepatic cholangiocarcinoma in leading academic oncology centers across the United States. In these trials, PEDD devices are used to administer our investigational immunotherapy candidate, Nelotolimog, through a regional intravascular approach for patients with liver and pancreatic tumors. Data from these trials will emerge in the second half of 2024, where we'll determine which indication to progress. We initiated first-in-man phase one clinical trial of our novel pancreatic infusion technology, plus Nelotolimog, to demonstrate safety and efficacy. We conducted a large health economic and outcome research study, 300 million patient data set, covering over 98% of U.S. patients, capturing real-world safety and clinical outcomes for Trinav in its launch phase, 2020 through 2022, demonstrating that Trinav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results that were comparable to patients with a lower disease burden. We advanced our technology pipeline with 510K clearance for Trinav-Large and our TriGuide. And finally, substantially improved manufacturing yield improvements, resulting in gross margins approaching 90%. These results were made possible by the concerted efforts of Trisalis employees united under the leadership of Trisalis management with extensive experience in pioneering new markets, executing on strategic initiatives, and managing complex environments. Now let me turn to the future growth of Trisalis. We believe Trisalis is poised for breakout growth in 2024 due to permanent reimbursement and robust clinical and real-world evidence data for TRINAS. As mentioned earlier, Trisalis published a health economic and outcome research study looking at real-world evidence capturing both safety and clinical complications data for Trinav as compared to conventional catheters over the 2020 to 2022 time period. This study utilized a large 300 million patient data set covering 98% of U.S. payers. These data, which compared key characteristics and clinical complication rates, of 258 PEDD patients with those of 8,940 non-PEDD patients provides valuable insights into the benefits of PEDD technology. This would otherwise have taken many years to accumulate through alternative approaches, for example, randomized controlled trials. Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity as compared to non-TriNav patients, showed overall clinical results comparable to the patients with lower disease burden. The study also revealed the following. TriNav patients were more likely to have received prior systemic therapy and were much more likely to have received a prior embolization. In case procedures, interventional radiologists could deliver significantly more chemotherapeutic to the tumor when using Trinab versus the amount delivered using standard catheters, a critical treatment goal for case procedures. In a matched cohort comparison, Trinab patients had fewer 30-day inpatient visits post-procedure than non-Trinab patients. Trinab HCC patients were more likely to have a post-procedure liver transplant in a matched cohort comparison. TRINAV care patients with liver metastases had fewer clinical complications post-procedure versus non-TRINAV patients in a matched cohort comparison. TRINAV care patients with liver metastases had lower rates of post-procedure fatigue versus non-TRINAV patients. Given that Trinab patients can achieve outcomes similar to patients with lower disease burden overall and given impressive trends towards better outcomes like the successful liver transplants and lower rates of clinical complications, we believe Trinab is well positioned to become standard of care for the complex patient who may benefit from liver embolization. We believe that a significant majority of embolization patients are complex patients defined by one or more of the following. Previous embolization or systemic therapy, multinodal or bilobar lesions or significant tumor burden, large tumors greater than eight centimeters, multiple comorbidities, hypovascular tumors, or diffuse tumors throughout the liver. Given this evidence base, we are positioning Trinab to become standard of care for complex patients and are instructing our sales organizations to focus interventional radiologist utilization of Trinav on these complex patients where Trinav has been shown to provide benefit versus the standard microcatheter. We will be executing a multifaceted strategy, including additional clinical evidence, educational initiatives, comprehensive reimbursement support, as well as the pursuit of guideline inclusion. Another critical milestone for the company was the progress of Melitolamide, in several Phase I clinical trials. Currently, we're investigating Nelotolimod as a therapeutic candidate to reactivate the immune system within the liver and pancreas and to enable deeper and more durable responses to checkpoint inhibitors. We're initially evaluating Nelotolimod for the treatment of uveal melanoma with liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and locally advanced pancreatic ductal adenocarcinoma. We believe delivering Nelitolinod to our proprietary FDA cleared device using our PEDD technology creates a potential opportunity to change the paradigm of how liver and pancreatic cancer are treated. Our current pipeline represents a major market opportunity, particularly in locally advanced pancreatic cancer, and intrapatic cholangiocarcinoma, given the high unmet need in these indications. Phase I data for the PERIO-1 program was presented at a late-breaking oral session by our lead investigator from MD Anderson at the Society of Immunotherapy for Cancer meeting in November of 2023. Data presented included safety data on 56 uveal melanoma patients with liver metastases of whom 65% had failed prior therapy. Grade 3 or greater treatment-related serious adverse event rate was 11% across all doses and cohorts. Pharmacokinetic data from the PERIA-1 trial indicate Trinav is able to achieve high drug levels in the liver, and systemic exposure is limited with drugs undetectable by four hours in more than 95% of patients. Among patients with available data, ctDNA clearance was 59%, with 86% showing reduction in ctDNA. Disease control rate was 58% across all dose levels, and at the presumed optimal biologic dose of 2 milligrams, there was a disease control rate of 81%, median progression-free survival of 11.7 months, and a one-year overall survival of 86%. The optimal biologic dose assessment was made based on PFS, OS, and immune signals, including myeloid-derived suppressor cell elimination from liver metastases. There was also evidence of systemic immune activation as measured by serum cytokines and peripheral immune cell activation. Additionally, study data released in November 2023 for patients receiving Nelotolamide via our novel pancreatic infusion device demonstrated immune signals consistent with what we reported for liver metastasized patients. We anticipate reporting the full Phase I experience in late 2024, and if the data is favorable, we plan to begin Phase Ib enrollment. We have completed Phase I enrollment in uveal melanoma, intrahepatic cholangiocarcinoma, and hepatocellular cancer. We plan to evaluate the data from our Phase I clinical studies and determine which indications will progress into further clinical studies. A chosen indication would be one in which we believe there's evidence of significant treatment effect to support a rapid regulatory pathway and strong commercial success. We anticipate that progression of Nelotolimod would require additional equity financing. Additionally, we've made meaningful progress in our technology pipeline. This year, we received 510 clearance for a larger vessel size of TriNav, TriNavLarge, and its dedicated guide catheter, TriGuide. Currently, we're in market evaluation for both devices and intend to launch the second half of 2024. The launch of Trinav provides a significant market expansion since the larger vessel size can access an incremental 25% of the embolization market. Our commercial organization and manufacturing team are fully prepared for the launch and will also implement a multifaceted launch strategy to drive strong uptake. In summary, we're a science-led company which keeps the patient at the center of everything we do and we're making important advancements for patients suffering with liver and pancreatic tumors. In this building year for the company, we have made considerable progress in advancing our commercialization efforts for Trinav, progressing our technology pipeline in Nelotolamod, as well as strengthening our overall company operations. With our focus on achieving continued operational and strategic excellence, I'm confident in our ability to continue the strong growth of TriNav, the ability to advance our pipeline, and importantly, deliver both short and long-term shareholder value. Finally, I can tell you that I have the confidence because our people who are so committed to our patients are company and delivering for our shareholders. I want to express my gratitude to our dedicated team and our shareholders for their unwavering support. I look forward to providing future updates on our progress and impact. With that, I'll turn it over to our CFO, Sean Murphy.