TriSalus Life Sciences, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Good afternoon, and thank you all for participating in today's call.

Joining me from TriSalus are Mary Szela, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Chief Medical Officer, who will join for Q&A. Earlier today, TriSalus issued a press release announcing financial results for the quarter ended June 30, 2026. A copy of the press release is available on the investor relations section of the company's website. Before we begin, I would like to remind you that management will make remarks during this call that include forward-looking statements within the meaning of federal securities laws, and that these are being made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

These statements involve material risks and uncertainties 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 description of the risks and uncertainties associated with our business, please refer to the risk factors section of our Forms 10-Q and 10-K on file with the SEC and available on EDGAR, as well as our other periodic filings. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 6, 2026. TriSalus 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. With that, I will turn the call over to Mary.

Good afternoon, and thank you all for joining us. I am pleased to report a strong second quarter with total revenue of over $11.4 million. This reflects sequential and year-over-year growth as we continued to raise awareness of TriNav while building clinical evidence and strengthening our commercial foundation. Our growth was driven by the continued execution of our team in the field and was underpinned by progress across our strategic priorities. Elevating our commercial team and infrastructure, investing in foundational clinical studies to validate the value of Pressure-Enabled Drug Delivery, or PEDD, and lastly, innovating and evolving our PEDD technology and portfolio. Before we continue, I want to highlight why what we are doing at TriSalus is so important. There has been little innovation in catheter-assisted oncology drug delivery for the past several decades.

While this critical area of patient care has been stagnant, in that same stretch of time, we've seen significant leaps forward in therapeutic drug discovery and innovation. We developed the TriNav system to address this shortfall, enabling interventional radiologists to deliver any therapy to a tumor with enhanced perfusion, tightened precision and greater concentration, and importantly, avoidance of off-target delivery. We remain excited about the opportunity ahead of us as we continue to educate clinicians and patients about the benefits of the TriNav system. As we outlined at the beginning of the year, our primary strategic focus has been on making a disciplined, intentional investment into our commercial infrastructure to deepen physician engagement and adoption of TriNav. As a reminder, we more than doubled our commercial footprint over the first half of the year to better capture the full scope of the opportunity ahead of us.

This build-out was deliberate and necessary, we're excited about the caliber of talent that we've brought on board. We're already seeing positive results from our commercial evolution in the form of ramping engagement and productivity, we look forward to sharing more of this team's progress over the coming quarters. Turning to a significant development that will expand our commercial opportunity, in July, we received notification from CMS of a G-code that extends reimbursement of the TriNav system into the physician office setting, commonly referred to as an office-based lab, or OBL. At its core, moving into the OBL environment is a big win for patients and meaningfully expands the access for our platform once in effect.

As a reminder, TriSalus holds two unique HCPCS C codes established by CMS to specifically reimburse our technology of complex embolization procedures by using a pressure-generating catheter in the outpatient environment, or HOPD, and the ambulatory surgery center, or ASC sites of service. These codes have been a foundational commercial driver for TriSalus and provide appropriate reimbursement for HOPDs and ASCs, yet we're seeing treatment for patients with certain liver cancers migrate from these traditional settings into the OBLs. This includes both TACE and TARE procedures. The rationale for this transition is simple. OBLs offer patients more accessible community-based settings versus large hospitals with shorter wait times and more flexible scheduling. For a patient recently diagnosed with liver cancer, the ability to be seen and treated in weeks rather than months can be the difference between a treatable disease and potentially a fatal one.

The new G-code facilitates patient access to PEDD regardless of the treatment site of care. This marks a seminal moment for TriSalus as it expands our reach to an increasingly important and growing site of care and gives clinicians more flexibility in where and how they practice. We are genuinely excited about this rule, we want to take a moment to express our gratitude to all of our constituents at CMS whom we've maintained a positive dialogue. Over the years, CMS has spent significant energy reviewing our clinical evidence and diligencing the benefits of the TriNav system. We're excited to continue our engagement with the agency. We also continue to anticipate 510K clearance near term from the U.S. Food and Drug Administration for TriNav Advance, which we believe will further expand our set of solutions for our customers.

As a reminder, we believe the TriNav Advance will expand our liver market access by extending PEDD to small distal vessels via microcatheter that are currently not addressable with our existing TriNav technology. The TriNav Advance will allow an interventional radiologist to use the microcatheter of their choice while still delivering the full benefit of pressure-enabled drug delivery to patients. Review is running past the MDUFA goal, we remain in close dialogue with the FDA and hope to receive clearance in the near future. Our second priority has been to demonstrate and validate the value of pressure-enabled drug delivery, PEDD, to drive greater future awareness and adoption. Our team is hard at work on this objective, and we now have 11 active studies underway across 27 clinical sites. There's data being generated and evaluated across more than 400 patients who have been treated with TriNav.

The completed PETER study, the investigator-initiated, randomized, multi-center trial conducted at Massachusetts General Hospital, evaluates how TriNav improves the tumor-to-normal ratio in both hepatocellular carcinoma and hypovascular tumors, has been submitted for publication in a peer-reviewed journal. We believe the PETER readout, once published, can be a meaningful catalyst for commercial momentum. The other completed investigator-initiated trial, TRI590 at MD Anderson, remains in data review. We look forward to sharing that news with you when it becomes available. The two retrospective studies we initiated last quarter examining TriNav-delivered TARE in HCC continue to progress. We're ultimately looking to generate cost-efficient evidence on outcomes and target populations. The findings here will directly inform the design of our larger prospective trials, which we look to initiate in the second half of the year. The PREDICTT study at MD Anderson officially launched in the second quarter and is actively enrolling.

This is a prospective study evaluating PEDD's impact in hypovascular tumors, we expect enrollment to take approximately 12-18 months to complete. A second investigator-initiated trial, PRESSURE at Stanford, will launch open enrollment in the third quarter. This is a randomized study of TriNav and TARE for liver metastases comparing tumor-absorbed dose, response rate, and disease control against current standard delivery. Both are designed to generate exactly the kind of perspective head-to-head data that drives clinical adoption at top academic centers. In addition to PRESSURE, there are additional large studies we're looking to kick off in the second half of 2026. We have a new prospective TARE study designed specifically to prove TriNav's superiority over a microcatheter. We're evaluating liver metastases response to therapy prospectively, an important consideration for physicians to adopt TriNav.

We're undertaking a multi-center prospective TACE study in neuroendocrine tumors that is being conducted in collaboration with the University of Pennsylvania, a nationally recognized leader in both liver embolization and the treatment of neuroendocrine tumors. The trial will compare TriNav directly to a standard microcatheter in neuroendocrine tumor patients undergoing TACE and is designed to demonstrate TriNav's superiority in this indication. This study is an expansion of an existing pilot study that already showed TriNav's superiority over a microcatheter, giving us high confidence in the hypothesis we're testing at scale. At the recent American Society of Clinical Oncology meeting, AstraZeneca presented exciting data from their EMERALD-3 trial comparing TACE alone to TACE plus AstraZeneca's STRIDE immunotherapy regimen and to TACE plus STRIDE plus the tyrosine kinase inhibitor, lenvatinib.

This study showed that both combination arms showed meaningful improvements in progression-free survival, the still maturing overall survival data looks particularly promising. We believe that these important data will help drive medical oncologists to consider combinations of immunotherapy and liver-directed therapy. This could potentially expand the pool of patients receiving TACE and TARE procedures where we have a particularly strong foothold. We're making concerted efforts to expand awareness and appreciation for the value of PEDD with our broader base of stakeholders. In June, we hosted a webinar to further contextualize the groundbreaking real-world evidence study of PEDD in liver cancer. The webinar highlighted findings from a real-world outcome study evaluating over 300 million patient lives, including 16,210 embolizations. Of those patients who went through embolization procedures, 1,200 patients were compared using sophisticated matching to produce the largest and the most robust PEDD data set to date.