TriSalus Life Sciences, Inc.

Good day, and welcome to the Tristellis Life Sciences fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. Jeremy Pfeffer, Investor Relations. Please go ahead.

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. Mazzella will provide an overview of the company's first quarter results and strategy for the balance of the year, and then David 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 covering analysts. Earlier this afternoon, Trisalis released its financial results for the quarter and year end of December 31st, 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 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 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 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 sections of our Forms 10Q and 10K 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, March 5th, 2026. And to 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 2025 fourth quarter and year end financial results. I'll begin with a high level review of our results for the quarter in the year, recap some of the highlights from recent weeks, and then provide an overview of our longer term strategy and expectations for 2026 and beyond. David will follow my remarks with a more in-depth review of our financial and operational results for the reporting periods. And we'll be happy to open up the call for your questions. Let's begin. I'm pleased to report that our results for both the fourth quarter and the full year were strong. Fourth quarter revenues were $13.2 million and full year revenues were $45.2 million, representing a 60% and 53% increase respectively over the prior year period. Importantly, we achieved our revenue growth guidance for the 2025 fiscal year. Our strong commercial performance for the year was driven by consistent execution of our commercial strategy and our expansion of our Trinia product suite and proprietary PEDD platform across a broad range of indications beyond the liver. In recent weeks, we took significant steps to strengthen both our board and our balance sheet. In February, we announced the appointment of veteran healthcare investor Michael Stansky to our board of directors. Michael has a strong track record as an investor and board member across the healthcare landscape with deep experience in capital markets, governance, and value creation. We believe he will be a meaningful asset to Trisalis as we continue to execute on our growth objectives. Also in February, we announced the completion of a public offering through which we raised 46 million in gross proceeds from fundamental healthcare investors. The financing was more than two times oversubscribed and was supported by experienced healthcare investors who share in our conviction in the long-term value of the PEDD platform. Importantly, these investors understand that building a category defining company requires disciplined investment in commercial infrastructure, clinical evidence, and product innovation. This capital enables us to lean into our strategic priorities from a position of strength. Our primary strategic priority is to expand our sales and commercial infrastructure, which we initiated at the beginning of the year to more effectively drive adoption, and long-term success across our portfolio. Second, we are investing aggressively in foundational clinical studies to further demonstrate and validate the value of pressure-enabled drug delivery, PEDD. These studies are critical to reinforcing the clinical and economic differentiation of our PEDD platform and will fuel continued growth in 2027 and beyond. And third, we're continuing to enhance and evolve our PEDD technology to strengthen physician adoption and utilization, not only in liver embolization, but also across our expanding set of new applications. The success of this upsized financing and the quality of investors brought into the company through the process are highly validating of our strategy and the growth opportunities before us. Based on our performance in 2025 and our visibility entering 2026, we are reaffirming our revenue guidance of $60 million to $62 million. As is typical for emerging growth companies investing ahead of a steep adoption curve, expanding our commercial footprint requires upfront hiring, onboarding, training, and current territory realignment, which will influence revenue cadence in the first half of the year to be approximately 40%, and revenue in the back half of the year to be approximately 60%. We believe that significant investment in the sales force, virtually doubling our commercial footprint, positions us for meaningful, stronger productivity exiting 2026 and beyond. The revenue cadence will build meaningfully throughout the year as the realignment is completed. Trying to have advances launched and the increasing productivity of the significantly expanded sales organization progress. Importantly, this cadence should not be interpreted as a change in underlying demand trends. We continue to see strong physician engagement, utilization, and interest in the PEDD platform. The first half weighting is instead a function of timing, specifically the onboarding training and territory development associated with our commercial expansion, as well as the expected timing of new product contribution. We made a conscious decision to lean into these investments early in the year. Deploying growth capital to expand our sales infrastructure and accelerate clinical and commercial initiatives affects near-term revenue phasing modestly, but it meaningfully enhances our growth trajectory exiting 2026 and positions us for sustained acceleration beyond our long-range plan. Now turning now to our commercial strategy, we've assembled a comprehensive PEDD portfolio that enables interventional radiologists to address virtually every vascular anatomy that they encounter. With a complete solution set, physicians now can competently standardize on PEDD across a broader range of cases, increasing utilization with existing accounts, and accelerating adoption in new ones. At the beginning of 2025, we had two core commercial products. As we move into 2026, our portfolio will expand to seven differentiated offerings across the embolization spectrum. This portfolio depth enhances the productivity of our sales organization by allowing each representative to drive more procedures per account, reduce selling complexity, and position Trisalis as a single source partner rather than a point solution provider. To fully leverage this opportunity is why we're expanding our sales resources now and why we pursued the growth capital to increase our market coverage, improve our count penetration, and scale the commercial execution in a disciplined, high-return manner. Over the course of 2025, we launched TriNav LV, TriGuide, and TriNav Flex, each addressing a particular vascular anatomy challenge that the interventional radiologist encounters. The TriNav Flex improves trackability and access to torturous anatomy. Torturous anatomy is commonly found in tougher-to-treat, complex patients. During our fourth quarter, we launched the TriNav XP infusion system, which was engineered specifically for compatibility with larger embolic particles, a more flexible distal tip for improved trackability, and multiple lengths and vessel sizes. These features were also important to use in lobar liver procedures, mapping or simulation procedures, and for application in uterine artery embolization. Market reception of Trinab XP thus far has been outstanding. The KOLs we surveyed highlighted the exceptional trackability, enhanced visualization for precise targeting, and improved procedural efficiency. As I mentioned, our next expansion of the Trinab product suite will be Trinab Advance, which we anticipate launching in the first half of 2026. trying to advance an important addition to our embolization portfolio. This device is designed to facilitate selective therapy delivery to small distal vessels via a standard microcatheter, but still allow for PEDD to enhance therapeutic delivery to the tumor and protect against off-target delivery. The ability for an interventional radiologist to still use the microcatheter of their preference, but also benefit from improved delivery opens up a significant market opportunity for the use of PEDD. We are currently awaiting 510 of clearance and plan to conduct a rapid market evaluation before fully launching in the second half of the year. With the launch of Trinav Advance, we'll have a complete portfolio of products that support all aspects of liver embolization procedures, which alone represents a total addressable market of approximately 480 million. Additionally, this portfolio of embolization devices supports embolization procedures in thyroid, uterine artery embolization, genicular artery embolizations, or GAE, along with other embolization procedures, collectively representing 2.3 billion U.S. addressable market. The commercial adoption of the platform was bolstered earlier in 2025 by the introduction of the Centers for Medicare and Medicaid Services CMS HCPCS code C8004. This code expanded coverage to include simulation 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 are observing. Now, interventional radiologists are able to use TRINAB across a full spectrum of radioembolization care. Early feedback from key accounts and users highlights the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption throughout 2026. In December, we hosted a second in a series of key opinion leader events focused on our platform's potential in new clinical applications. The event featured Dr. Juan Camacho of Florida State University discuss the unmet needs and current treatment landscape for multinatural or goiter thyroid disease. In 2026, we intend to continue this program further to educate stakeholders on the advantages of the TRINIF platform for our multiple indications. Enrollment continues in our PROTECT registry, a multi-center initiative evaluating PEDD for patients with thyroid nodules or goiters who are not candidates 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. Preliminary results published in the Journal of the Endocrine Society were highly encouraging. showing 100% technical and clinical success, no neurovascular complications, mild and transient discomfort in 81% of patients, all resolved within two weeks, a 73% reduction in thyroid size and normalization of thyroid function in 71% of participants. These findings reinforce the promise of this minimally invasive alternative to thyroidectomy. In 2025, We also initiated a pilot registry in GAE. This is an emerging field 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 registry evaluating GAE as a treatment option for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. This study aims to determine whether GAE can effectively reduce pain and delay the need for knee replacement surgery. Now turning to our Nelotolimod program. Last year, we communicated our intention to release updated clinical data in the fourth quarter of 2025. We did not meet that timeline, and I want to address that directly. As the PERIO 3 study progressed towards completion, it became clear that the most responsible and strategically valuable approach would be to consolidate data across all three PERIO Phase 1 studies into a comprehensive update, rather than releasing partial data sets sequentially. In addition, we evaluated the potential inclusion of emerging data from an ongoing investigator-initiated study to provide a more complete view the program's clinical potential final database lock and report preparation for perio 3 extend beyond our original expectations and as a result we elected to delay disclosure to ensure that data package is thorough internally validated and positioned appropriately for potential partners we now anticipate releasing a consolidated clinical update in the second half of 2026. importantly This timing shift is not driven by safety concerns, efficacy signals, or changes in our strategic priorities. All three Perio Phase 1 dose escalation studies are complete, enrollment in Perio 3 has concluded, and clinical study reports are in preparation. The decision to delay reflects our commitment to presenting a complete and cohesive data set that we believe will better support partnership discussions and maximize long-term value. As previously discussed, we have substantially reduced internal development spending related to NELA-TOLOMOD following study completion. This allows us to preserve the program's optionality while maintaining capital discipline and focusing our resources on the near-term growth opportunities within our PEDD platform. We continue to advance partnership discussions and to support ongoing investigator-initiated studies. Before turning the call over to David for a review of our financial results, I want to reiterate that Trisalis remains focused on executing on our near-term milestones, including achieving our 2026 annual revenue in the range of 60 to 62 million, with growth weighted toward the second half of the year, launching TriNav Advance in the first half of 2026, publishing HEOR data on TriNav use in complex liver patients, delivering differentiated clinical data across the liver, UAE, TAE, and GAE indications. As we look ahead to the balance of 2026, our strategy is fully funded. We're executing on our commitments of the recently raised growth capital and are confident in the commercial opportunities before us. We believe Trisalis PEDD technology represents a transformative opportunity with substantial long-term value across a wide range of solid tumors and interventional treatment approaches. With that, I'll turn the call over to David.