TriSalus Life Sciences, Inc.

Good afternoon and welcome to the Trisalis Life Sciences first quarter 2026 earnings conference call. All participants are currently in 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.

Thank you, Operator, and thank you all for joining us today. With me from Trisalis Life Sciences are Mary Della, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Medical Director. Mary will provide an overview of our first quarter results and our strategy for the balance of the year. David will then walk through the financial results in detail. Dr. Marshall will join Mary and David for the Q&A portion of the call. Earlier today, Trisalis released its financial results for the quarter ended March 31, 2026. A copy of the press release is available on the Trisalis Investor Relations website. Today, Trisalis also announced the publication of a landmark real-world evidence study evaluating the clinical and economic impact of our pressure-enabled drug delivery, or PEDD, technology. Mary will discuss that study in detail. Before we begin, I would like to remind you that during today's call, management will make forward-looking statements within the meaning of the federal security laws. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements other than statements of historical fact, including, without limitation, statements regarding our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals are forward-looking. They are based on current estimates and assumptions and involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results to differ materially from those anticipated. You should not place undue reliance on these statements. For a description of the risks and uncertainties associated with our business, please refer to the risk factors section of our forms 10Q and 10K on file with the SEC and available on EDGAR, as well as our other periodic filings. Trisalis disclaims any obligation, except as required by law, to update or revise any forward-looking statement, whether due to new information, future events, or otherwise. This call contains time-sensitive information and is accurate only as of today's live broadcast, May 12, 2026. And with that, I'll turn the call over to Mary.

Thank you, Jeremy, and good afternoon, everyone, and thank you for joining us. I'll cover four topics today. First, our first quarter results. Second, the deliberate realignment and significant expansion of our commercial organization, creating a foundation to capture the multi-year growth that a cadence of new clinical and health economic evidence will unlock over the next 18 months. Third, our updated 2026 guidance and the outlook for the balance of the year. And fourth, in my view, the most important news of the quarter, the publication of landmark, real-world evidence on PEDD, the largest study of its kind ever conducted, demonstrating fewer complications, fewer hospitalizations, and roughly 7,700 per patient in cost avoidance. This is meaningful news for Trisalis, and more importantly, for the patients we serve. David will then provide a detailed financial review, and we'll take your questions. As we previewed on our 2025 year-end call, our 2026 plan called for a disciplined investment in commercial infrastructure designed to deepen physician engagement, extend our footprint to cover new applications, and lay the foundation for future growth. And it's why we raised capital this quarter. After several years of significant growth, our territories were expanding beyond what individual representatives and our sales leaders could cover effectively, and the gap was widening as the new applications began to emerge. Continuing to operate at the prior scale was simply not a path to capturing the full opportunity ahead of us in the liver embolization market or the new applications we are entering. The investment had three core dimensions, new commercial leadership, a meaningful expanded talent base, across sales leadership, field management, and clinical specialist roles, a realigned, significantly larger field footprint that scales for future growth. Anchoring the expansion is Chris Sode, who recently joined us as Senior Vice President of Sales and Commercial Operations. Chris brings more than 20 years of commercial leadership in diagnostics and life sciences, with senior roles at Roche, Ventana, Luminex, and most recently, Accelerate Diagnostics, where he led US commercial. He has a proven track record of building and scaling high-performing field organizations and securing strategic partnerships with leading health systems, an important initiative we want to pursue. Chris is precisely the operator we need to lead our commercial organization through this next phase of growth, and we're fortunate to have him on our team. As of May, the new significantly expanded sales organization is largely in place. As with any expansion of this scale, Q1 revenue reflects the transition costs of territory realignment, representative onboarding, representative time out of the field for training, and the rebuilding of account relationships. In roughly 60% of our territories where the rep to physician relationship remained intact, sales performed in line with expectations. In the remaining 40%, we deliberately modified two critical relationships at the same time, rep to physician and rep to manager. Both are primary drivers of execution and unit volume, and modifying them simultaneously was the right strategic choice. We expect sales productivity to improve steadily throughout the balance of the year, complemented by growing contributions from new clinical data, new account capture, and penetration into new applications. Q1 performance was not a function of softer demand or any change in the underlying fundamentals of our business. It reflects the deliberate cost of a build-out phase, investing now in the commercial engine required to scale this organization for our next phase of growth. We are revising our full year 2026 revenue guidance to a range of $54 million to $57 million. The driver of this revision includes both the lower Q1 revenues from the commercial expansion and the delayed FDA clearance timing for Trinav Advance, our next generation device which extends PEDV capability to small distal vessels via microcatheter. FDA review of Trinav Advance is now running approximately five months past the 30-day MDUFA review goal. We've been in active dialogue with the FDA and while we still expect clearance in the second half of the year, we are taking a prudent approach to forecasting the launch given the inherent unpredictability of clearance timing and the appropriate market evaluation period that follows. This timing shift removes our advanced revenue expectations from the second half of the year due to the clearance delay. We remain enthusiastic about the launch. TriNAP Advance creates an incremental market opportunity by enabling interventional radiologists to access the benefits of PEDD while using the microcatheter of their choice. Today, physicians who employ a super selective approach prefer to track to the site of delivery with their existing microcatheter. TriNAP Advance meets them where they are ready in practice. Revising guidance. is an adjustment the Trisalis team nor I take lightly. We remain fully committed to our investors and to executing against the goals we set. We believe taking a measured posture on trying to advance is the right one. Once advance is in our hands, we'll have a complete portfolio supporting the full range of liver embolization procedures. I want to spend a moment on the development of the quarter that matters most for Trisalis. and more importantly, the patients we serve. Today, we published the largest real-world evidence study of PEDD ever conducted. It includes 603 PEDD patients matched against more than 16,210 non-PEDD patients drawn from a 300 million patient population-based claims database covering 96% of U.S. payers, with data spanning January 2020 through March of 2024. The cohort comprises 515 tear patients and 88 case patients, making it the largest tear PEDD dataset ever published and the most comprehensive PEDD dataset across both embolization modalities. The analysis used a rigorous two-stage matching design, coarsened exact matching paired with propensity score matching applied to both the overall cohort and to each modality subgroup. The headline result is compelling. Despite higher baseline disease burden, the data is demonstrating that PEDD is simply not a device, but a highly differentiated therapeutic delivery platform capable of improving liver embolization outcomes, reducing healthcare utilization, and expanding treatment possibilities across multiple indications. PEDD-treated patients achieved statistically significant better outcomes across every measure. Four takeaways stood out. So number one, less fatigue and preserved immune function across the full cohort. Significantly less post-procedure fatigue across the full cohort, 20.9% versus 26.4%. Roughly nine-fold reduction in lymphopenia at high adapter centers, 0.6% versus 5.2%. Preserving lymphocyte counts is clinically critical since lymphopenia is a known barrier to downstream immunotherapy. Bottom line, PED patients leave the procedure with their immune systems more intact and remain eligible for follow-on immunotherapy treatment. Number two, lower 30-day readmissions in the TACE subgroup, driven by significantly improved tumor targeting. PEDD delivered approximately 48% more doxorubicin per procedure PEDD procedures had 30-day inpatient admissions cut by more than half, 8% with PEDD versus 20.5% without. Bottom line, direct evidence of improved tumor targeting with less off-target toxicity. Number three, the more a center uses PEDD, the better the outcomes. At top 5% adoption facilities, the lymphopenia gap widens further and further, and liver metastatic outcomes improve sharply across both the care and case practice patterns. In secondary liver metastases, patients at high adapter centers, fatigue was cut by more than half, 19.2% versus 39.7%. And lymphopenia was nearly eliminated, 0% versus 8.2%. Bottom line, the more a center uses PEDD across either care or taste, the better the outcomes get. Early adoption and institutional experience compound the benefit. Number four, downstream cost avoidance. Per patient cost avoidance of approximately $7,700 across the full 603 patient PEDD cohorts. Roughly 3,100 from fewer inpatient stays and 4,600 from fewer post-procedure complications. Cost avoidance holds across both tear and taste and is not isolated to one modality. Higher and more durable response rates may further reduce total procedures per patient, compounding the economic benefit over time. Bottom line, PEDD effectively reduced downstream costs in both tear and taste cases. This large landmark publication validates what we've been saying for years about the clinical rationale for PEDD, and it does so in patients' representative everyday clinical practice. For our physician customers, it reinforces that the investment in PEDD competency pays compounding dividends. For our commercial team, it's a peer-reviewed evidence at scale that accelerates institutional adoption. Beyond this publication, we continue to generate new clinical evidence on the patient impact of PEDD. We now have 10 active studies underway across 24 clinical sites, generating data on more than 400 TRYNAV-treated patients. Two new prospective investigator-initiated trials are set to begin enrollment this quarter. A study called PRESSURE at Stanford is a randomized study of TRYNAV and TEAR for liver metastases, comparing tumor-absorbed dose, response rate, and disease control to the current standard delivery. PREDICT at MD Anderson, a prospective study evaluating PEDD impact in hypovascular tumors. Both are designed to generate exactly the kind of prospective head-to-head data that drives clinical adoption at top academic centers. We're also preparing to publish results from two completed investigator-initiated trials, the PETR study at Massachusetts General Hospital and TRIFI 90 at MD Anderson. Both have completed data analyses and are targeting publication submission this quarter. We believe these readouts will be a meaningful catalyst for second-half commercial momentum. Lastly, we initiated two large retrospective studies during the quarter, examining TRINAB-delivered tear in HCCs. This will provide cost-efficient evidence on outcomes and target populations and will provide the basis of the clinical trial design of our larger prospective clinical trials we plan to initiate in the second half of 2026. Beyond liver, we continue to build meaningful momentum across our new applications, uterine artery embolization, thyroid artery embolization, and genicular artery embolization, each a significant and independent growth factor. At SIR in 2026, Dr. Francis King of Rutgers Robert Wood Johnson Medical School presented a retrospective analysis of PEDD in uterine artery embolization. The headline is the kind of number you rarely see in interventional medicine. Median dominant fibroid volume reduction of 97.5% versus a historical literature comparator of approximately 50%. This is a step change in clinical effect. achieved with less embolic material and shorter procedure time, exactly what you would expect from a more targeted delivery mechanism. The study also reported 100% technical success with no device-related complications and sustained reductions in pain and heavy menstrual bleeding at both one and six-month follow-ups. In Q1, we approved expanding this study to 50 patients and we're actively designing a prospective trial to further evaluate trying to have potential to streamline workflow, reduce procedure and fluoroscopy time, and improve outcomes in uterine artery embolization. Our PROTECT registry continues to roll across multiple centers, evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for conventional therapies. Preliminary results published in the Journal of Endocrine Society demonstrated 100% technical and clinical success. a 73% reduction in thyroid size, and normalization of thyroid function in 71% of participants with no neurovascular complications. These are remarkable results for a minimally invasive outpatient procedure. In February, Dr. Juan Camacho and his colleagues published a review of thyroid artery embolization in seminars in interventional radiology, highlighting PEDD's unique ability to enhance distal distribution, and reduce the need for carotid circulation catheterization. We now have enrolled more than 50% at our 11 sites who are actively recruiting patients. PROTECT is on track to deliver the first multicenter U.S. data on thyroid artery embolization and to position PEDD-TAE as the leading approach for this procedure. We just concluded a pilot registry and now are preparing to launch a formal clinical trial evaluating genicular artery embolization for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. GAE represents a novel, minimally invasive approach to pain management and mobility preservation with the potential to delay or avoid knee arthroplasty in appropriate patients. This is a merging field and we believe our PEDD platform is uniquely positioned to drive the clinical rigor needed to establish it as standard of care. Collectively, these indications represent a U.S. addressable market of approximately $2.5 billion, and we're methodically building both the clinical evidence base and the commercial infrastructure to address all of them. A brief update on our NELA TOLOMOD program. We remain on track to deliver our consolidated perio phase one readout in the early second half of 2026. As a reminder, that readout will combine data from three completed dose escalation studies along with emerging data from an ongoing investigator initiated study and deliver them as a single complete data set rather than a series of sequential partial releases. This approach reflects our commitment to a rigorous internally validated package one we believe will most clearly demonstrate the program's potential. The timing is not driven by any safety signal or by any efficacy concern or by any change in our strategic priorities. In parallel, we continue to advance our broader pancreatic strategy. Pancreatic cancer remains one of the most significant unmet needs in oncology, and we believe our novel pancreatic PEDD device is uniquely suited to overcome the delivery barriers that have long limited therapies in this disease. As we prepare to share the NOLA-Tolomod data, we're also building the case for PEDD as an adjunct to current and next generation pancreatic regimens. We expect to have more to share as the year progresses. Our commitment to both NOLA-Tolomod and our broader pancreatic program is unchanged. Consistent with the strategy we previously communicated, we intend to advance these programs through a partnership structure, one designed to preserve their long-term value while maintaining the capital discipline required to fund our near-term commercial and clinical priorities. Before I turn the call over to David, let me summarize where we stand and what we're building towards. Entering the remainder of 2026, we have a substantially expanded commercial organization in place, poised to accelerate multi-year growth. The most significant real growth evidence data set in our history, published in a peer-reviewed journal, confirming the statistical significant clinical and economic value of PEDD at scale, and a pipeline of new applications and clinical readouts that build throughout the year. Our near-term milestones include generating differentiated clinical data across UAE, TAE, and GAE, releasing a Nelotolimab data update in the second half, delivering our full-year 2026 revenue of $54 to $57 million, and lastly, subject to FDA clearance, launching Trinab Advance in the second half. We're executing against all of these priorities from a position of financial strength, with the growth capital we raised in Q1 fully supporting our strategic roadmap. I remain deeply confident in our team, our platform, and the long-term value we're creating for both patients and shareholders. With that, I'll turn the call over to David.