TriSalus Life Sciences, Inc.

Good afternoon and welcome to Trisalis Life Science third quarter 2025 earnings conference call. Currently, all participants are on a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. As a reminder, this call is being recorded for replay purposes. I will now turn the call over to Jeremy Pfeffer, Managing Director with LifeSci Advisors Please go ahead, sir.

Thank you, operator, and thank you all for participating in today's call. Joining me today from Tricelis Life Sciences are Mary Zella, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Medical Director. Ms. Zella will provide an overview of the company's third quarter results and strategy for the balance of the year. Then Mr. Patience will review the financial results for the quarter in detail. Following their prepared remarks, Dr. Marshall will join the call to help address questions from covered analysts. Earlier this afternoon, Trisalis released its financial results for the quarter ended September 30th, 2025. A copy of this 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 meeting 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 sales and operating trends, business and hiring prospects, financial and revenue expectations, 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 statements. Accordingly, we 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 our other reports filed periodically with the SEC. Tricelis disclaims any intention or obligation except as required by law to update or revise any financial projections or forwarded statements, whether because of new information, future events, or otherwise. The conference call contains time sensitive information and is accurate only as of this live broadcast today, November 13th, 2025. And with that, I'll turn the call over to Mary.

Thank you, Jeremy, and good afternoon, everyone. Thank you for joining us for a review of our third quarter 2025 results. I will begin with a high-level review of the quarter in recent weeks and provide a quick update of our longer-term strategy. David will then follow my remarks to provide a more in-depth review of our financial and operational results for the quarter. We will then be happy to open the call to questions. Let's begin. I'm pleased to report that our third quarter results were strong, revenues were 11.6 million, representing 57% increase over the prior year quarter, and a 3% sequential gain over the second quarter of 2025. During the quarter, we also continued to expand our Trinav platform, launching our Trinav Flex infusion system and advancing new clinical applications to expand our market opportunities. We also simplified our capital structure through the successful completion of our exchange offer and consent solicitation for preferred stock. Operationally, we continued to manage cash efficiently, ensuring resources were allocated strategically to advance our key priorities. We increased commercial investment to maintain our strong goals, a deliberate decision that extends our timeline to reach EBITDA positive and cash flow break even. Our commercial momentum in the third quarter remained strong. The commercial organization continued to drive deeper penetration within the complex liver embolization market. Bolstered by the Centers for Medicare and Medicaid Services, CMS, HCPCS code C8004 introduced in April. This new code expands coverage to include simulation angiogram or mapping procedures using Trinav, enabling interventional radiologists to utilize Trinav for other treatment planning and delivery using radioembolization. As a result, the reimbursable use of our technology within the radioembolization market has effectively doubled, supporting the broader adoption we're observing. Now, interventional radiologists are able to use Trinav across the full continuum of radioembolization care. Early feedback from key accounts and users highlight the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption into 2026. We are reaffirming our 50% revenue growth guidance, reflecting strong confidence in our growth momentum and market opportunities. Consistent with our prior commitment, we continue to invest in long-term growth via increasing commercial resources and funding of new applications. We believe trisalasis pressure-enabled drug delivery, or PEDD technology, represents a transformative opportunity with substantial long-term value across a wide range of solid tumors and interventional treatment approaches. We continue to execute a focused strategy to expand our platform with technologies that address the complex challenges of tumor vasculature and improved delivery. Momentum across our programs remains strong. reflecting the growing clinical and commercial impact of our PEDD technology. In the last year, we launched TriNav LV TriGuide and the TriNav Flex, each advancing our commitment to innovation and improving therapeutic delivery precision. Expanding our product suite broadens our addressable market, strengthens physician adoption due to a technological solution for all the various vascular challenges, and extends our reach beyond the liver into new therapeutic areas. Expanding our product portfolio remains a core pillar of our growth strategy. By broadening our addressable market and delivering solutions with greater versatility and precision, we're enabling more physicians to treat complex patients and extending our reach beyond the liver into new therapeutic areas. Following the quarter, we began market evaluation of our next generation Trinav XP, which features compatibility with larger particles and a more flexible distal tip, an important advancement for lobar liver and uterine artery embolization procedures. Although early, feedback from over 20 initial cases with key opinion leaders have been outstanding, which highlighted exceptional trackability, enhanced visualization for precise targeting, and improve professional efficiency. These advances reinforce our confidence in TriNav, powered by PEDD. As a platform that helps interventional radiologists address their most difficult tumor drug delivery challenges, we continue to invest in the TriNav portfolio to deepen its clinical impact, to improve drug penetration, reduce complications, and expand patient eligibility. Our results this quarter demonstrate that TriNav is well positioned to become the standard of care in liver embolization for complex patients. We remain focused on strengthening the clinical evidence base, engaging closely with key medical societies, and driving commercial expansion to fully realize TriNav's market potential. As previously discussed, beyond leveraging our PEDD technology in liver cancer, we're also expanding the clinical application through the Trinav infusion system. Yesterday, we hosted the first in a series of key opinion leader events focused on the potential use of Trinav infusion for the treatment of uterine fibroids. The events featured Dr. Nicole Lamparello of Weill Cornell Medicine and New York Presbyterian Hospital and Dr. Francis Kang, of Rutgers Robert Wood Johnson University Hospital and University Radiology Group. Both speakers highlighted the significant unmet need in uterine fibroid treatment and reviewed the current therapeutic landscape. In addition, enrollment continues in our PROTECT registry, a multicenter initiative evaluating PEDD for patients with thyroid nodules or goiters who are not candidate for surgery, radioiodine, or ablation. This study is designed to assess disease-related quality of life, thyroid function, and outcomes following PEDD-based thyroid artery embolization. As previously noted, preliminary results published in the Journal of Endocrine Society were highly encouraging, showing 100% technical and clinical success, no neurovascular complications, mild and transient discomfort, in 81 of all patients, all resolved within two weeks, and a 73% reduction in thyroid size, and importantly, normalization of thyroid function in 71% of participants. These findings reinforce the promise of this minimally invasive alternative to thyroidectomy. We also initiated a pilot registry in the emergent field of genicular artery embolization, or called GAE. which offers a novel, minimally invasive approach to pain management and mobility preservation for patients with knee osteoarthritis. GAE has the potential to delay or avoid total knee arthroplasty in select patients. In parallel, we're preparing to launch a clinical trial evaluating Trinav and GAE as a treatment option for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. The study aims to determine whether Trinav and GAE can effectively reduce pain and delay the need for knee replacement surgery. In parallel with expanding the clinical utility of Trinav, we're also advancing our efforts to begin partnership discussions to maximize the long-term value of Nelotolimod across several high-value oncology indications. This transition will eliminate the vast majority of development-related expenses for Nelotolimod by the end of 2025 while preserving the program's potential upside. It also allows us to focus internal resources on the near-term high-impact opportunities within our PEDD platform. Phase 1 studies of melatolamide in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma, or HCC, cholangiocarcinoma are now complete. Enrollment has also concluded in PERIO3, are phase one trial and locally advanced pancreatic cancer with final data expected by year end. Clinical study reports for all three perio phase one dose escalation trials are in preparation with data releases anticipated in Q4. We're currently finalizing reports and data presentations to support future partnership discussions. Completion of enrollment and closure of these studies will drive a reduction in R&D expenditures in the second half of 2025, and we continue to support several ongoing investigator-initiated studies. Before turning the call over to David for a review of our third quarter financials, I want to reiterate that Trisalis remains focused on executing our near-term milestones, including advancing the TriNav platform across multiple indications focused on the interventional radiology call points, advancing PEDD solutions designed to optimize therapeutic delivery and address the full spectrum of vascular access and perfusion challenges based by the interventional radiologist, generating and publishing new clinical and HEOR data to validate the effectiveness, safety, and economic value of our technology, enhancing operational performance in our manufacturing and improving gross margins, and also building a scalable, high-growth organization. As we look ahead to the balance of 2025 and into 2026, we're energized by our long-term vision of bringing our PEDD technology platform to a broader range of patients, improving outcomes and redefining standards of care. Trisalis remains a science-driven organization with patients at the center of everything we do. Our progress continues to make meaningful difference for people living with liver, pancreatic, and other solid tumors. And with that, I'll turn the call over to David.