TriSalus Life Sciences, Inc.

Good afternoon and welcome to Trifellas Life Sciences Second Quarter 2025 Earnings Conference Call. Currently, all participants are in a listen-only mode. Following management-prepared remarks, we will hold a question-and-answer session. As a reminder, this call is being recorded for replay purposes. I will now attend the call over to Jeremy Pfeffer, Managing Director with Life Sci-Fi Advisor. Please go ahead, sir.

Thank you, Operator, and thank you all for participating in today's call. Joining me today from Trisalis 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 second 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 ended June 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 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 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 section of our Form 10-Q on file with the SEC and available on EDGAR and in 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-centered information and is accurate only as of the live broadcast today, August 12, 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 our review of our second quarter 2025 results. Before we begin, I'd like to personally welcome David Patience to the Trisalis team as our Chief Financial Officer. David joins Trisalis with deep expertise in capital markets and a proven track record of financial leadership and operational excellence. His strategic insight and executional strength will be instrumental as we accelerate into our next phase of growth. We're thrilled to welcome him to the team. David will follow my remarks to provide a more in-depth review of our financial results for the quarter. With that, let's begin. I'm pleased to report that our second quarter results were strong, with $11.2 million in net sales, a 52% increase compared to Q2 2024, and a 22% sequential gain over our first quarter 2025 results. During the quarter, we also announced the launch of the TriNavFlex infusion system. successfully completed a 22 million private placement with healthcare-focused institutional investors, pursued new clinical applications, expanded our market opportunity, and simplified our capital structure through the successful completion of our exchange offer and consent solicitation for preferred stock. This additional capital raise strengthens our balance sheet and provides the resources needed to invest further in our commercial strategy. Trisalis remains sharply focused on executing a strategy that expands the clinical and commercial potential of our pressure-enabled drug delivery, PEDD, platform across multiple solid tumor types and novel interventional procedures. In parallel, we are advancing partnership discussions for Nelitolamide to support its development across several high-value oncology indications. These initiatives are central to unlocking long-term value and we're encouraged by the growing momentum across our programs. Our strategic priorities include driving adoption of PEDD across a broad range of solid tumors, advancing new clinical applications for TriNav, expanding our TriNav product portfolio with the launch of the TriNav Flex infusion system, along with new TriNav devices specific to future indications where needed, improving operational performance in manufacturing and gross margins, and continuing to build a high-growth, scalable organization. Specific to our commercial strategy and Trinab adoption, we've maintained strong momentum in the quarter, gaining further penetration in the complex liver embolization market, while continuing to expand the Trinab platform into new clinical settings. In April, we announced that the Centers for Medicare and Medicaid Services issued HCPCS code C8004 providing coverage for simulation or mapping procedures using TriNav. This new code allows clinicians to use TriNav for both treatment planning and delivery in radioembolization, effectively doubling the reimbursable use of our technology and supporting broader adoption. We see the key requirement for interventional radiologists to effectively treat a broad range of tumors is access to a portfolio of devices that address varying anatomical and delivery challenges. Trisalis continues to expand our product suite to meet these needs, offering a range of technologies with differentiated features and sizes tailored to the complexity of the tumor vasculature. As part of our innovation-driven strategy, we recently launched TriNav LV and TriGuide, enabling pressure-enabled drug delivery, PEDD, in larger vessels. Additionally, we are pleased to announce the full commercial launch of TriNavFlex, formerly TriNav 2.0, which has demonstrated improved trackability and is engineered specifically for use in torturous vascular anatomy. This next generation device strengthens our PEDD platform and enhances our ability to support interventional radiologists in addressing some of the most challenging clinical scenarios. We will continue to invest in the TriNav product portfolio to further deliver superior drug penetration, reduce complications, and expand patient eligibility for TriNav usage. Initial sales since launch are exceeding our internal projections, which we're pleased to see our continual investment within our product suite is further fueling our commercial momentum. We believe TriNav is well-positioned to become the standard of care in liver embolization for complex patients. To accelerate this trajectory, we are executing a focused strategy centered on three pillars, strengthening the clinical evidence base, deepening engagement with key medical societies, and driving sustained commercial expansion. These efforts are critical to establishing TRINAV as the preferred solution in complex embolization procedures and unlocking its full market potential. Moving to an update on our development on melatolamide, Following the successful completion of our Phase I trials for NELA-TOLOMOD, we announced last quarter our strategic shift to a partnership-focused approach. This transition will eliminate all development-related expenses for NELA-TOLOMOD by the end of 2025, while preserving the long-term value of the program. It also enables us to focus internal resources on the more immediate and expansive opportunities within our PEDD device technology platform. Phase I studies in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma, or HCC, and cholangiocarcinoma are now complete. Additionally, enrollment has concluded in PERIO3, our Phase I trial evaluating melatolemide in patients with locally advanced pancreatic cancer. We remain on track for final data from PERI-03 in the second half of 2025. Currently, we're in the midst of preparing final reports and data presentations to support future partnership interactions. The completion of patient enrollment and closure of these trials are anticipated to result in a meaningful reduction in R&D expenditures, particularly in the second half of 2025. with no further development spend projected for 2026. While early days, we see strong tailwinds from our strategic shift to partner NELA-TOLOMOD development and focus on near-term investment in both expanding our TRINAB product portfolio as well as our clinical body of evidence to further support our commercial efforts. We see this as an example of our prudent capital allocation strategy as we continue to streamline expenses and focus on meaningful near-term growth. Now turning to our strategy and new clinical applications for the Trinab product portfolio, last quarter we launched the Protect Registry, a multi-center effort led by Sarasota Memorial and others, evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for surgery, radioiodine, or ablation. The goal is to assess disease-related quality of life, thyroid function, and outcomes following PEDD-based thyroid artery embolization. This novel approach, called PED-TAE, was pioneered by Dr. Juan Camacho. Dr. Camacho has now treated over 40 patients and presented outcomes at NASID and SAR, and we're encouraged by the growing interest in this application. A preliminary readout has been published in the Journal of Endocrine Society for this minimally invasive vascular intervention for patients with large, non-cancerous thyroid nodules using a pressure-enabled device. The primary outcome was a successful embolization via the inferior thyroid artery, volume reduction of thyroid, and normalization of thyroid function. The results were quite impressive with 100% technical and clinical success, no neurovascular complications, 81% of patients experienced mild pain or discomfort, all of which were resolved within two weeks, 73% thyroid shrinkage, and 71% achieved normal thyroid function. We're extremely encouraged by these results as this minimally invasive procedure is now available to patients in lieu of a complicated thyroidectomy surgery. Additionally, we've now launched a pilot registry within the emerging space of genicular artery embolization, or GAE, which provides patients with an alternative pain management and mobility option with minimally invasive procedure to potentially delay total knee arthroplasty. Now turning to our operational performance, we're reiterating our guidance of 50% revenue growth to reflect our confidence in future growth. As stated last quarter, we remain committed to improving EBITDA performance while also making a deliberate decision to invest in strategic areas of the business. As discussed, we have accelerated development of new clinical applications, as well as expanding our commercial organization, which we believe will expand our addressable market and drive significant long-term value while delaying being EBITDA positive or cash flow positive until 2026. As always, we remain a science-driven organization, committing to putting patients at the center of everything we do. Our progress is making a real difference for people living with liver, pancreatic, and other solid tumors. Looking ahead, we're entering the second half of 2025 with strong tailwinds. Our strategic priorities are clear. Deepening penetration in the liver embolization market advancing the TriNav platform for multiple indications focused on the interventional radiology call point, generating and publishing new HUR and clinical data, improving operational performance in manufacturing and gross margins, and continuing to build a high-growth, scalable organization. And with that, I'll turn the call over to David.