NASDAQ:TLSI TriSalus Life Sciences Q2 2025 Earnings Report $3.95 +0.30 (+8.22%) Closing price 04:00 PM EasternExtended Trading$3.84 -0.11 (-2.66%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast TriSalus Life Sciences EPS ResultsActual EPS-$0.27Consensus EPS -$0.22Beat/MissMissed by -$0.05One Year Ago EPSN/ATriSalus Life Sciences Revenue ResultsActual Revenue$11.21 millionExpected Revenue$10.69 millionBeat/MissBeat by +$520.00 thousandYoY Revenue GrowthN/ATriSalus Life Sciences Announcement DetailsQuarterQ2 2025Date8/12/2025TimeAfter Market ClosesConference Call DateTuesday, August 12, 2025Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by TriSalus Life Sciences Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 12, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Strong Q2 financial performance with net sales of $11.2 million (up 52% YoY and 22% sequentially), complemented by a $22 million private placement and successful preferred stock exchange to simplify the capital structure. Positive Sentiment: New reimbursement code (HCPCS C8004) for TriNav mapping procedures doubles reimbursable use, accelerating adoption and confidence among interventional radiologists. Positive Sentiment: Launch of the next-generation TriNav Flex infusion system (alongside TriNav LV and TriGuide) is exceeding sales projections and expands clinical reach into tortuous anatomy. Positive Sentiment: Early data from the PROTECT Registry for thyroid artery embolization reported 100% technical success, 73% nodule shrinkage, and 71% normalization of thyroid function, offering a minimally invasive alternative to surgery. Positive Sentiment: Strategic shift to partner nalotolimod development will eliminate related R&D expenses by 2026 and free up resources to focus on PEDD device innovation, with cash runway into early 2026 and EBITDA positivity expected that year. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallTriSalus Life Sciences Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 10 speakers on the call. Operator00:00:00Good afternoon, and welcome to Triphala's Life Sciences Second Quarter twenty twenty five Earnings Conference Call. Currently, all participants are 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 Feffer, managing director with Life SciFi Advisor. Operator00:00:24Please go ahead, sir. Speaker 100:00:27Thank you, operator, and thank you all for participating in today's call. Joining me today from Trisales Life Sciences are Mary Zella, president and chief executive officer David Patience, chief financial officer and doctor 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, doctor Marshall will join the call to help address questions from covering analysts. Speaker 100:00:57Earlier this afternoon, Tricellis released its financial results for the quarter ended 06/30/2025. A copy of this press release is available on Tricellis' 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, 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. Speaker 100:01:42These 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 Factors section of our Form 10 Q on file with the SEC and available on EDGAR and in other reports filed periodically with the SEC. Trisales 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, 08/12/2025. Speaker 100:02:34And with that, I'll turn the call over to Mary. Speaker 200:02:37Thank you, Jeremy, and good afternoon, everyone. Thank you for joining us for our review of our second quarter twenty twenty five results. Before we begin, I'd like to personally welcome David Patience to the Trisales team as our Chief Financial Officer. David joins Trisales 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. Speaker 200:03:10We'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 $11,200,000 in net sales, a 52% increase compared to Q2 twenty twenty four and a 22% sequential gain over our first quarter twenty twenty five results. During the quarter, we also announced the launch of the TriNavFlex infusion system, successfully completed a $22,000,000 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. Speaker 200:04:08This additional capital raise strengthens our balance sheet and provides the resources needed to invest further in our commercial strategy. Trisales 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 nalotolimod 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. Speaker 200:05:19Specific to our commercial strategy and TriNav adoption, we've maintained strong momentum in the quarter, gaining further penetration in the complex liver embolization market, while continuing to expand the TriNav 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 TriNet for both treatment planning and delivery in radio embolization, effectively doubling the reimbursable use of our technology in 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. Trisales 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. Speaker 200:06:28As 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 TriNav Flex, formerly TriNav two point zero, 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. Speaker 200:07:33We 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 nalotolimod. Following the successful completion of our Phase I trials for nalotolimod, we announced last quarter our strategic shift to a partnership focused approach. Speaker 200:08:21This transition will eliminate all development related expenses for nalotolimod by the 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 PERI O3, our phase one trial evaluating melatonimod in patients with locally advanced pancreatic cancer. We remain on track for final data from PERI O3 in the 2025. Speaker 200:09:14Currently, 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 and D expenditures, particularly in the 2025, with no further development spend projected for 2026. While early days, we see strong tailwinds from our strategic shift to partner nalotolimod development and focus on near term investment in both expanding our TriNav 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 TriNav product portfolio. Speaker 200:10:13Last quarter, we launched the PROTECT Registry, a multicenter 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 PEDTAE was pioneered by Doctor. Juan Camacho. Doctor. Speaker 200:10:50Camacho has now treated over 40 patients and presented outcomes at NASSET 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 the successful embolization via the inferior thyroid artery, volume reduction of thyroid, and normalization of thyroid function. The results were quite impressive with one hundred percent technical and clinical success, no neurovascular complications, eighty one percent of patients experienced mild pain or discomfort, all of which were resolved within two weeks, seventy three percent thyroid shrinkage, and seventy one percent 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. Speaker 200:12:02Additionally, 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. Speaker 200:13:07Our progress is making a real difference for people living with liver, pancreatic and other solid tumors. Looking ahead, we're entering the 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 HEOR 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. Speaker 300:13:50Good afternoon, everyone, and thank you, Mary, for the warm introduction. I'm truly excited to join Tri Salus Life Sciences at such an inflection point in the commercial trajectory of TriNet. As we build on this momentum, I've committed to seizing growth opportunities while maintaining the financial discipline needed to achieve near term cash flow positivity. As Mary stated earlier, results for the quarter were strong. Revenue for the period was $11,200,000 which is an increase of 52% year over year and an increase of 22% quarter over quarter. Speaker 300:14:23We also increased the number of unique ordering accounts by 28% year over year, as well as increased TriNet utilization per unique ordering account. This is consistent with our expectations as we expand our reach within existing accounts, leveraging physician champions and broadening the product portfolio to increase both physician adoption and usage. Gross margin was 84% for the quarter compared to 88% for the 2024. This year over year decline was primarily driven by lower manufacturing efficiency associated with the newly launched products, a dynamic we expect to improve as production scales and processes mature over the course of the year. Research and development expenses for the second quarter were $3,900,000 compared to $4,700,000 in the 2024. Speaker 300:15:14During the second quarter, we incurred approximately $500,000 of nonrecurring expenses related to the nalutolimod closeout of clinical trial sites. As previously noted, we anticipate concluding the nalutolimod related expenses by year end. Moving forward, our focus will be on device innovation and expanding our rapidly growing clinical body of evidence with TriNav to further support market penetration in the liver embolization market and new applications of TriNav to further drive revenue growth. This strategic transition will reduce our ongoing R and D run rate expenses. Sales and marketing expenses for the second quarter was $7,200,000 compared to $6,000,000 in the 2024. Speaker 300:15:59The increase reflects our previously communicated investment in the expansion of our commercial organization to scale our sales and marketing efforts for continued commercial momentum and growth. General and administrative expenses for the second quarter were $5,700,000 compared to $4,000,000 in the 2024. The increase in G and A costs were primarily driven by approximately $1,000,000 of non reoccurring legal and audit professional service expenses for our auditor transition and our various registration statements filed during the period. Moving forward, we plan to streamline G and A costs to meaningfully reduce the run rate expenses. Operating losses for the second quarter were $7,300,000 compared to operating losses of $8,200,000 in the 2024. Speaker 300:16:49The reduction in operating losses were due to increased sales and reduced R and D expense associated with the ramp down of nalatolimod clinical trial spending. Adjusted EBITDA loss for the 2025 was $5,300,000 compared to $6,700,000 in the 2024. The decreased loss can be attributed to increased sales, reduced R and D expense and higher non cash stock based compensation in 2025. At quarter end, cash and cash equivalents were $26,500,000 which includes approximately $22,000,000 in gross proceeds through the private placement we conducted in April. We have sufficient liquidity to fund operations throughout 2025 and expect to become cash flow positive in early twenty twenty six. Speaker 300:17:38As part of the private placement, we reached agreement with 55% of preferred shareholders to proceed with the exchange offer and consent solicitation completed in July with 99% of the outstanding preferred shares being tendered. Preferred shareholders exchanged one preferred share for 3.3 common shares. Non tendered preferred shares were automatically converted and the exchange settled on 08/01/2025. This results in approximately 50,000,000 basic shares outstanding, eliminated the 2027 reset provision and better aligned our long term investor base with a more simplified capital structure moving forward. With that, we are ready to open the line for questions. Speaker 300:18:22Operator? Operator00:18:23Thank Our first question coming from the line of Frank Takkinen with Lake Street Capital Markets. Your line is now open. Speaker 400:18:51Great. Thanks for taking the questions. This is Nelson Cox on for Frank. Congrats on all the progress this quarter. And I guess we'll start with the new mapping code that's now effective since April. Speaker 400:19:02Maybe just talk about that a bit more, any incremental color on the reception in the market there and what kind of contribution you're starting to see from that would be helpful. Speaker 200:19:11Yeah. We're really excited to get that in early April. And I'll even have Doctor. Marshall talk about it. This is a really important addition to the reimbursement because previously we didn't have coverage on the mapping, so people were just using it for treatment. Speaker 200:19:30And it's really important to use the same technology both in the simulation mapping case as well as in treatment. So we're really starting to see physicians really appreciate that we got that so rapidly. That's really contributing to some of the momentum that we have underway. I'll have Doctor. Marshall comment on it from a user perspective, because I think this is such an important addition from a reimbursement perspective. Speaker 500:19:57Thanks Mary. I can comment a lot on it because I'm part of this. So as you may know, procedures are performed prior to delivering Y-ninety radiation into the liver, And it's very important to know exactly where that's going to go and being able to map with the same catheter that you're going to treat with gives the physician a lot of confidence in what they're going to do. Previously, there was some hesitancy when physicians were mapping patients and thought they might not get reimbursed for the catheter. Now, can reliably use it map with an apple treat with an apple. Speaker 500:20:36So I think it gives gives physicians a lot more confidence to pull that and use it when they see fit for it. Speaker 400:20:44Perfect. Thank you. That's helpful color. Then for David, just one on the operating expense side, heard the one timers in there. But maybe just walk us through how you're thinking about some of the OpEx moving forward. Speaker 400:20:55What kind of base we should be running off of and the mix as we should be as we think about modeling through the remainder of the year into cash flow positivity and adjusted EBITDA in next year? And then, yeah, just directionally with some of the strategic shifts with the partnerships would be helpful. Speaker 300:21:12Yeah, of course. Thank you Speaker 600:21:13for the question. So yeah, we remain confident in having an adjusted EBITDA positivity early next year. With that, we're going to see Nelatolemaud really, at the end of the day, close out mainly in the third quarter. You'll see the last real numbers coming through. And then from there, we should be thinking closer to a run rate of something in the neighborhood of two, maybe 3,000,000 early next year, moving to two, as we focus on a device innovation and building out our clinical body of evidence, in R and D. Speaker 600:21:43And then sales and marketing, there are some one timers with shows and the timing of those shows typically are in the second quarter in the summer. But with that, we're pretty confident with the current run rate where it is today. And then G and A is going to be my main focus moving forward. We think we can get that down back to around, like, the low fours here just by, you know, improving our audit and reducing our registration statements. And a lot of that is gonna be seen here in the in the coming quarters. Speaker 400:22:15Great. Thanks and congrats guys. Speaker 200:22:17Thanks. Operator00:22:19Thank you. Our next question coming from the line of William Plavanek with Canaccord. Your line is now open. Speaker 700:22:28Great, thanks. Good evening. Thanks for taking my questions. First off, if I could, in terms of I think you said unique ordering accounts was up 28% year over year. By my math, that only puts it up like three or four sequentially. Speaker 700:22:46I was wondering if you could comment on that and then maybe give us a little more granularity. And then also just on the investments in the commercial organization, I think you said you're making some investments there. Help us understand that a little better. Thanks. Speaker 600:23:01Yeah, of course. So with the unique ordering accounts, I think last quarter we discussed that it was going to be about 30 accounts from a back approval. So from that standpoint, unique ordering accounts are in kind of the low 300s, while back approvals are mid 300s from an approval standpoint. And then that's driving the increased utilization. Does that answer your question on unique ordering accounts and back approvals? Speaker 700:23:28Well, help us understand what it was in first quarter and what it was in the second quarter and how much of an increase was that sequentially. Speaker 300:23:36Yeah, of course. And so Some with that Speaker 700:23:39of the terminology is changing. That's what I'm trying to understand. Speaker 600:23:42Yeah. No, fair question. So unique ordering accounts was up about 10% quarter over quarter. And then back approvals was up something in the neighborhood of 300, mid-300s, so that's roughly about 10% as well. Speaker 700:24:01Okay. So, Speaker 500:24:02the focus for us for Speaker 600:24:04the past few years has been really opening a ton of accounts, and now we're shifting that focus to utilization per account, as we're building off of our champions in each account and broadening the champion base within the account. Speaker 700:24:18Okay. And then just on the new products, what type of contribution did the large or the Tri Guide versus the Flex provide? Is Flex more of a second half of the year into next year type of opportunity? And then, yeah, let's go to that, and then I have one last follow-up on prostate. Speaker 200:24:41Yeah. So, Bill. How are you? Tri Nav Large was about, we're estimating that it's around 10% to 15%, so we're getting a nice bump from having that available. And Flex, which we just launched, is actually exceeding our expectations. Speaker 200:24:58This was a technology that really addresses tortuosity, where physicians, when we were in a case, they felt like, wow, I couldn't navigate a TriNav to the location that I'd like. This has really helped giving them a new tool to do that. And I'll have Doctor. Marshall comment on that. So when we look at the back half of the year and why we're confident in our acceleration in the back half of the year, we contemplated and we knew that Flex would really help us add to that utilization and address some of those missed case opportunities. Speaker 200:25:29And maybe I'll have Doctor. Marshall just comment on it, because we're really excited about this product. It really rounds out the portfolio for us right now. Previously we just had TriNav, then we added the large. Now that we have FLEX, we really have a complete portfolio to offer the interventional radiologists to use TriNav in virtually every case. Speaker 500:25:47Yes, thanks Mary. I think this is an important part of our portfolio, and this is a product of physician feedback. I've specifically when physicians look at a case before they start or they, at the beginning of the case, we do an angiogram and we find out what the anatomy of the arteries is. This addresses the physicians who will look at anatomy and say wow I don't think I can get a catheter into that tortuous artery. I'm not going to use Tri Nav in this situation. Speaker 500:26:17We heard that from physicians and now we can give physicians a tool to do that. I use it quite frequently. I've actually used it for a thyroid last week and it works really well. We can get it around some pretty tight corners, but the real impact is that physician confidence when they pull it they know that they can go where they want to go. Speaker 700:26:39And then my question was actually on thyroid, which is with that data single site data published. Does that drive adoption or do you need to enroll a DELIVER trial to really get that going? Speaker 500:26:58So that's very exciting data for us. This is the first major publication of this novel application. And can tell you that the buzz is real from physicians around the country. We have inquiries from physicians who want to use it. We are still driving most of our we're still pushing our PROTECT registry as our main vehicle for thyroid artery embolization, but we are receiving inquiries about the procedure and physician interest from all over. Speaker 200:27:36Yeah, and Bill, what we'd like to do is really build out a robust database. If a physician has interest, we'll train them and get them involved. I think this is the first publication, so we're really excited about that. And we anticipate impact from thyroid just beginning the back half of the year, but real impact in 2026. Speaker 700:27:57Okay, that's fantastic. And then last question, I promise, is really how do we think about the third quarter in terms of cadence for the back half of the year and the 50% plus growth? I think consensus is somewhere between 11,500,000 and $12,000,000 for the third quarter and close to 13,000,000 for the fourth. Just kind of I know you reiterated the 50% plus guidance, but just wanted to kind of zero in more on the third quarter here, if I could. Speaker 600:28:26Yes, Bill, this is David. Thanks for the question. And we're really proud of where we are for the second quarter with 22% growth sequentially. So we can get low double digit growth in the next two quarters and then get to our target, and we've taken a decent amount of that growth out of the equation, if you will, and we're confident we can get there. Just to round out your question on investment in the sales team, what we're doing is really bringing in a lot of structure and process into our sales commercial organization. Speaker 600:28:56And so with that, we're investing in sales leadership, process, and structure to further improve that account utilization on a per rep basis and a per account basis. And so, for us, that's giving us confidence in hitting those numbers. Speaker 700:29:11Great. Thanks for taking my questions. Operator00:29:14Thank you. Our next question coming from the line of Ross Osborne with Cantor Fitzgerald. Your line is now open. Speaker 800:29:24Hey, guys. This is Matt Park on for Ross today. Thanks for taking the questions. I guess just starting on gross margin, it came in a little bit softer than what we had. And I know you guys highlighted some lower manufacturing efficiencies as you start to ramp these newly launched products. Speaker 800:29:38Can you just walk us through the levers to see incremental margin expansion in the back half of this year and then into 2026? Speaker 600:29:45Yes. No, it's a great point. So we're confident we can get back on track with gross margin after, which was a minor setback for the quarter. Where we are is really getting a strong understanding of understanding our business, understanding the product mix from what's going to be TriNav, Flex, and LV, and then just really getting in that cadence of understanding the use cases for a forecasting perspective, and then getting our teams to have optimal lot size when they're going to be manufacturing. But this is something that we're taking very seriously, and this is something we're confident we can get back on track. Speaker 800:30:20Got it. That's helpful. And then I guess one more from me on these registry trials. So please correct me if I'm wrong, but you initiated a pilot registry in GAE and then discussed previously about initiating one uterine fibroid. I guess, you just walk us through what type or level of evidence you need and you believe will be the most compelling to guideline committees as they evaluate TriNet in these procedures? Speaker 200:30:49Yeah, what we do is we just did a phase zero in GAE. We did that specifically for collecting just a really broad array of various endpoints, and then we'll sit with our advisory committee, figure out what we think is the most powerful and influential and ones to focus on, and then power the registry so we have the appropriate number of patients and follow ups so we can have a robust data set that we can include in guidelines. So our process really is let's collect the initial data, then we sit with our advisory panel, we formulate what we think are the right endpoints to focus on, and then we scale up the study to actually have the appropriate impact. So we did that on GAE, we hope to do that on Eufy in the fourth quarter of this year. So we're starting quite a number of different studies to actually implement that across this broad array of new applications. Speaker 800:31:43Got it. Super helpful. Thanks for taking the questions, and congrats on the quarter. Operator00:31:51Thank you. Our next question coming from the line of Suraj Kalia with Oppenheimer. Your line is now open. Speaker 900:32:04Hi, Mary and David. This is Seamus on for Suraj. Congrats on the nice quarter, and thank you for taking our questions. To start, I guess, can you I know this is kind of reiterating an earlier question, but just trying to get out of the different way. How is mapping usage with TriNet since the mapping code been instituted kind of changed? Speaker 900:32:27Like, kind of what was you know, what percentage of physicians were using that mapping cone kinda before that was instituted versus kind of what is what are you seeing after? You know, and what are you doing to kind of increase that mapping utilization for physicians? Speaker 200:32:44Well, let me take it first with the second point. So how we're helping people increase the mapping utilization is we onboarded a reimbursement consultant called Z Health. I don't know if you guys are familiar with this company. The key person who leads this event is an interventional radiologist. He's been in coding for twenty five years. Speaker 200:33:05He actually leads many webinars, and we now have him as our back office support for reimbursement, so he can work with coders directly on how to code specifically for mapping and for treatment. And that's been just an incredible resource. Just to give you a flavor of that, he had a webinar at the July. We had close to 8,000 people on the webinar. So that's kind of the key metric of how we're getting information out to the individuals of how to code for it. Speaker 200:33:34That's really been the biggest barrier on mapping. People are concerned about, will I get reimbursed? How do I do this with this new C code? So that's helped immensely. I will tell you since April, it's really starting to grow. Speaker 200:33:47And we track it through our Veeva data, so it's rep reported. We can't really see the code until we have kind of another quarters of data and we can go into the data. But based on reports from our representatives, we're really starting to see a big acceleration following the reimbursement, and that really began in the May and June timeframe. Speaker 900:34:10Got it. Appreciate that. That's helpful color. Just one last one from our end. You know, I know you guys are focusing a partnership for nalotolimod. Speaker 900:34:19I guess Yep. When could we expect to potentially hear something? You know, What are you looking for in a partner that you're going to bring in? Just any color there. Thank you again for taking our questions. Speaker 200:34:30Yeah, sure. So in nalatolimod, we're kind of winding down to the end. I know we've been talking about it for while, but we hope to roll out the data in Q3. And I think what we're looking for in a partner is someone that can advance that to the next stage and bring it to the market. And that would be a partner that's really focused in the liver and pancreas, that has an understanding of this mechanism, the TLR9 mechanism, that understands the impact of a reduction in myeloid derived suppressor cells. Speaker 200:35:03We actually have a very clear target list, kind of a first tier, second tier, third target list, where strategically this would be a nice addition to their portfolio. And so once we have the final data, and then we're gonna begin those discussions in Q3, so we're really excited to begin those. I think the challenge that we have is just the market right now in biotech is not as robust as I would like. But it's hard to find a phase one asset that has good data. So we're excited to start the discussions and hopefully can move this ahead. Operator00:35:42Thank you. And I'm showing there are no further questions in the queue at this time. I will now turn the call back over to Mary Zella for any closing remarks. Speaker 200:35:53Thank you, everyone. Really appreciate your interest in Trysalis. Operator00:35:59This concludes today's conference call. Thank you for your participation, and you may now disconnect.Read morePowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) TriSalus Life Sciences Earnings HeadlinesTriSalus Life Sciences Reports Strong Q2 2025 GrowthAugust 13 at 6:20 AM | msn.comTriSalus Life Sciences, Inc. (TLSI) Q2 2025 Earnings Call TranscriptAugust 12 at 9:01 PM | seekingalpha.comSilver Demand Is Exploding—and Supply Can’t Keep UpElon's Next Market Move Could Send Silver Soaring Every industry Elon Musk touches explodes—from Tesla to SpaceX to AI. And now, whispers are growing that his next move could be in silver. Why? 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Email Address About TriSalus Life SciencesTriSalus Life Sciences (NASDAQ:TLSI), a medical technology company, researches, develops, and sells drug delivery technologies and immune-oncology therapeutics for the treatment of liver and pancreatic cancer. The company offers Pressure Enabled Drug Delivery infusion systems, such as the TriNav infusion system, which is used in transarterial radioembolization and chemoembolization procedures for patients with liver cancer and metastases; and the Pancreatic Retrograde Venous Infusion device, which is in Phase 1 clinical trial, for locally advanced pancreatic cancer. It also develops nelitolimod, an investigational immunotherapeutic in Phase 1 clinical trial for the treatment of uveal melanoma with liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and locally advanced pancreatic ductal adenocarcinoma. The company serves interventional radiologists, IR technicians, medical oncologists, nursing support, value analysis committee staff, and patients through its sales representatives and sales managers. TriSalus Life Sciences, Inc. was founded in 2009 and is headquartered in Westminster, Colorado.View TriSalus Life Sciences ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Why BigBear.ai Stock's Dip on Earnings Can Be an Opportunity CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move HigherAirbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings BeatIs Eli Lilly’s 14% Post-Earnings Slide a Buy-the-Dip Opportunity? 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There are 10 speakers on the call. Operator00:00:00Good afternoon, and welcome to Triphala's Life Sciences Second Quarter twenty twenty five Earnings Conference Call. Currently, all participants are 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 Feffer, managing director with Life SciFi Advisor. Operator00:00:24Please go ahead, sir. Speaker 100:00:27Thank you, operator, and thank you all for participating in today's call. Joining me today from Trisales Life Sciences are Mary Zella, president and chief executive officer David Patience, chief financial officer and doctor 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, doctor Marshall will join the call to help address questions from covering analysts. Speaker 100:00:57Earlier this afternoon, Tricellis released its financial results for the quarter ended 06/30/2025. A copy of this press release is available on Tricellis' 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, 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. Speaker 100:01:42These 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 Factors section of our Form 10 Q on file with the SEC and available on EDGAR and in other reports filed periodically with the SEC. Trisales 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, 08/12/2025. Speaker 100:02:34And with that, I'll turn the call over to Mary. Speaker 200:02:37Thank you, Jeremy, and good afternoon, everyone. Thank you for joining us for our review of our second quarter twenty twenty five results. Before we begin, I'd like to personally welcome David Patience to the Trisales team as our Chief Financial Officer. David joins Trisales 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. Speaker 200:03:10We'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 $11,200,000 in net sales, a 52% increase compared to Q2 twenty twenty four and a 22% sequential gain over our first quarter twenty twenty five results. During the quarter, we also announced the launch of the TriNavFlex infusion system, successfully completed a $22,000,000 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. Speaker 200:04:08This additional capital raise strengthens our balance sheet and provides the resources needed to invest further in our commercial strategy. Trisales 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 nalotolimod 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. Speaker 200:05:19Specific to our commercial strategy and TriNav adoption, we've maintained strong momentum in the quarter, gaining further penetration in the complex liver embolization market, while continuing to expand the TriNav 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 TriNet for both treatment planning and delivery in radio embolization, effectively doubling the reimbursable use of our technology in 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. Trisales 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. Speaker 200:06:28As 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 TriNav Flex, formerly TriNav two point zero, 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. Speaker 200:07:33We 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 nalotolimod. Following the successful completion of our Phase I trials for nalotolimod, we announced last quarter our strategic shift to a partnership focused approach. Speaker 200:08:21This transition will eliminate all development related expenses for nalotolimod by the 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 PERI O3, our phase one trial evaluating melatonimod in patients with locally advanced pancreatic cancer. We remain on track for final data from PERI O3 in the 2025. Speaker 200:09:14Currently, 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 and D expenditures, particularly in the 2025, with no further development spend projected for 2026. While early days, we see strong tailwinds from our strategic shift to partner nalotolimod development and focus on near term investment in both expanding our TriNav 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 TriNav product portfolio. Speaker 200:10:13Last quarter, we launched the PROTECT Registry, a multicenter 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 PEDTAE was pioneered by Doctor. Juan Camacho. Doctor. Speaker 200:10:50Camacho has now treated over 40 patients and presented outcomes at NASSET 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 the successful embolization via the inferior thyroid artery, volume reduction of thyroid, and normalization of thyroid function. The results were quite impressive with one hundred percent technical and clinical success, no neurovascular complications, eighty one percent of patients experienced mild pain or discomfort, all of which were resolved within two weeks, seventy three percent thyroid shrinkage, and seventy one percent 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. Speaker 200:12:02Additionally, 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. Speaker 200:13:07Our progress is making a real difference for people living with liver, pancreatic and other solid tumors. Looking ahead, we're entering the 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 HEOR 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. Speaker 300:13:50Good afternoon, everyone, and thank you, Mary, for the warm introduction. I'm truly excited to join Tri Salus Life Sciences at such an inflection point in the commercial trajectory of TriNet. As we build on this momentum, I've committed to seizing growth opportunities while maintaining the financial discipline needed to achieve near term cash flow positivity. As Mary stated earlier, results for the quarter were strong. Revenue for the period was $11,200,000 which is an increase of 52% year over year and an increase of 22% quarter over quarter. Speaker 300:14:23We also increased the number of unique ordering accounts by 28% year over year, as well as increased TriNet utilization per unique ordering account. This is consistent with our expectations as we expand our reach within existing accounts, leveraging physician champions and broadening the product portfolio to increase both physician adoption and usage. Gross margin was 84% for the quarter compared to 88% for the 2024. This year over year decline was primarily driven by lower manufacturing efficiency associated with the newly launched products, a dynamic we expect to improve as production scales and processes mature over the course of the year. Research and development expenses for the second quarter were $3,900,000 compared to $4,700,000 in the 2024. Speaker 300:15:14During the second quarter, we incurred approximately $500,000 of nonrecurring expenses related to the nalutolimod closeout of clinical trial sites. As previously noted, we anticipate concluding the nalutolimod related expenses by year end. Moving forward, our focus will be on device innovation and expanding our rapidly growing clinical body of evidence with TriNav to further support market penetration in the liver embolization market and new applications of TriNav to further drive revenue growth. This strategic transition will reduce our ongoing R and D run rate expenses. Sales and marketing expenses for the second quarter was $7,200,000 compared to $6,000,000 in the 2024. Speaker 300:15:59The increase reflects our previously communicated investment in the expansion of our commercial organization to scale our sales and marketing efforts for continued commercial momentum and growth. General and administrative expenses for the second quarter were $5,700,000 compared to $4,000,000 in the 2024. The increase in G and A costs were primarily driven by approximately $1,000,000 of non reoccurring legal and audit professional service expenses for our auditor transition and our various registration statements filed during the period. Moving forward, we plan to streamline G and A costs to meaningfully reduce the run rate expenses. Operating losses for the second quarter were $7,300,000 compared to operating losses of $8,200,000 in the 2024. Speaker 300:16:49The reduction in operating losses were due to increased sales and reduced R and D expense associated with the ramp down of nalatolimod clinical trial spending. Adjusted EBITDA loss for the 2025 was $5,300,000 compared to $6,700,000 in the 2024. The decreased loss can be attributed to increased sales, reduced R and D expense and higher non cash stock based compensation in 2025. At quarter end, cash and cash equivalents were $26,500,000 which includes approximately $22,000,000 in gross proceeds through the private placement we conducted in April. We have sufficient liquidity to fund operations throughout 2025 and expect to become cash flow positive in early twenty twenty six. Speaker 300:17:38As part of the private placement, we reached agreement with 55% of preferred shareholders to proceed with the exchange offer and consent solicitation completed in July with 99% of the outstanding preferred shares being tendered. Preferred shareholders exchanged one preferred share for 3.3 common shares. Non tendered preferred shares were automatically converted and the exchange settled on 08/01/2025. This results in approximately 50,000,000 basic shares outstanding, eliminated the 2027 reset provision and better aligned our long term investor base with a more simplified capital structure moving forward. With that, we are ready to open the line for questions. Speaker 300:18:22Operator? Operator00:18:23Thank Our first question coming from the line of Frank Takkinen with Lake Street Capital Markets. Your line is now open. Speaker 400:18:51Great. Thanks for taking the questions. This is Nelson Cox on for Frank. Congrats on all the progress this quarter. And I guess we'll start with the new mapping code that's now effective since April. Speaker 400:19:02Maybe just talk about that a bit more, any incremental color on the reception in the market there and what kind of contribution you're starting to see from that would be helpful. Speaker 200:19:11Yeah. We're really excited to get that in early April. And I'll even have Doctor. Marshall talk about it. This is a really important addition to the reimbursement because previously we didn't have coverage on the mapping, so people were just using it for treatment. Speaker 200:19:30And it's really important to use the same technology both in the simulation mapping case as well as in treatment. So we're really starting to see physicians really appreciate that we got that so rapidly. That's really contributing to some of the momentum that we have underway. I'll have Doctor. Marshall comment on it from a user perspective, because I think this is such an important addition from a reimbursement perspective. Speaker 500:19:57Thanks Mary. I can comment a lot on it because I'm part of this. So as you may know, procedures are performed prior to delivering Y-ninety radiation into the liver, And it's very important to know exactly where that's going to go and being able to map with the same catheter that you're going to treat with gives the physician a lot of confidence in what they're going to do. Previously, there was some hesitancy when physicians were mapping patients and thought they might not get reimbursed for the catheter. Now, can reliably use it map with an apple treat with an apple. Speaker 500:20:36So I think it gives gives physicians a lot more confidence to pull that and use it when they see fit for it. Speaker 400:20:44Perfect. Thank you. That's helpful color. Then for David, just one on the operating expense side, heard the one timers in there. But maybe just walk us through how you're thinking about some of the OpEx moving forward. Speaker 400:20:55What kind of base we should be running off of and the mix as we should be as we think about modeling through the remainder of the year into cash flow positivity and adjusted EBITDA in next year? And then, yeah, just directionally with some of the strategic shifts with the partnerships would be helpful. Speaker 300:21:12Yeah, of course. Thank you Speaker 600:21:13for the question. So yeah, we remain confident in having an adjusted EBITDA positivity early next year. With that, we're going to see Nelatolemaud really, at the end of the day, close out mainly in the third quarter. You'll see the last real numbers coming through. And then from there, we should be thinking closer to a run rate of something in the neighborhood of two, maybe 3,000,000 early next year, moving to two, as we focus on a device innovation and building out our clinical body of evidence, in R and D. Speaker 600:21:43And then sales and marketing, there are some one timers with shows and the timing of those shows typically are in the second quarter in the summer. But with that, we're pretty confident with the current run rate where it is today. And then G and A is going to be my main focus moving forward. We think we can get that down back to around, like, the low fours here just by, you know, improving our audit and reducing our registration statements. And a lot of that is gonna be seen here in the in the coming quarters. Speaker 400:22:15Great. Thanks and congrats guys. Speaker 200:22:17Thanks. Operator00:22:19Thank you. Our next question coming from the line of William Plavanek with Canaccord. Your line is now open. Speaker 700:22:28Great, thanks. Good evening. Thanks for taking my questions. First off, if I could, in terms of I think you said unique ordering accounts was up 28% year over year. By my math, that only puts it up like three or four sequentially. Speaker 700:22:46I was wondering if you could comment on that and then maybe give us a little more granularity. And then also just on the investments in the commercial organization, I think you said you're making some investments there. Help us understand that a little better. Thanks. Speaker 600:23:01Yeah, of course. So with the unique ordering accounts, I think last quarter we discussed that it was going to be about 30 accounts from a back approval. So from that standpoint, unique ordering accounts are in kind of the low 300s, while back approvals are mid 300s from an approval standpoint. And then that's driving the increased utilization. Does that answer your question on unique ordering accounts and back approvals? Speaker 700:23:28Well, help us understand what it was in first quarter and what it was in the second quarter and how much of an increase was that sequentially. Speaker 300:23:36Yeah, of course. And so Some with that Speaker 700:23:39of the terminology is changing. That's what I'm trying to understand. Speaker 600:23:42Yeah. No, fair question. So unique ordering accounts was up about 10% quarter over quarter. And then back approvals was up something in the neighborhood of 300, mid-300s, so that's roughly about 10% as well. Speaker 700:24:01Okay. So, Speaker 500:24:02the focus for us for Speaker 600:24:04the past few years has been really opening a ton of accounts, and now we're shifting that focus to utilization per account, as we're building off of our champions in each account and broadening the champion base within the account. Speaker 700:24:18Okay. And then just on the new products, what type of contribution did the large or the Tri Guide versus the Flex provide? Is Flex more of a second half of the year into next year type of opportunity? And then, yeah, let's go to that, and then I have one last follow-up on prostate. Speaker 200:24:41Yeah. So, Bill. How are you? Tri Nav Large was about, we're estimating that it's around 10% to 15%, so we're getting a nice bump from having that available. And Flex, which we just launched, is actually exceeding our expectations. Speaker 200:24:58This was a technology that really addresses tortuosity, where physicians, when we were in a case, they felt like, wow, I couldn't navigate a TriNav to the location that I'd like. This has really helped giving them a new tool to do that. And I'll have Doctor. Marshall comment on that. So when we look at the back half of the year and why we're confident in our acceleration in the back half of the year, we contemplated and we knew that Flex would really help us add to that utilization and address some of those missed case opportunities. Speaker 200:25:29And maybe I'll have Doctor. Marshall just comment on it, because we're really excited about this product. It really rounds out the portfolio for us right now. Previously we just had TriNav, then we added the large. Now that we have FLEX, we really have a complete portfolio to offer the interventional radiologists to use TriNav in virtually every case. Speaker 500:25:47Yes, thanks Mary. I think this is an important part of our portfolio, and this is a product of physician feedback. I've specifically when physicians look at a case before they start or they, at the beginning of the case, we do an angiogram and we find out what the anatomy of the arteries is. This addresses the physicians who will look at anatomy and say wow I don't think I can get a catheter into that tortuous artery. I'm not going to use Tri Nav in this situation. Speaker 500:26:17We heard that from physicians and now we can give physicians a tool to do that. I use it quite frequently. I've actually used it for a thyroid last week and it works really well. We can get it around some pretty tight corners, but the real impact is that physician confidence when they pull it they know that they can go where they want to go. Speaker 700:26:39And then my question was actually on thyroid, which is with that data single site data published. Does that drive adoption or do you need to enroll a DELIVER trial to really get that going? Speaker 500:26:58So that's very exciting data for us. This is the first major publication of this novel application. And can tell you that the buzz is real from physicians around the country. We have inquiries from physicians who want to use it. We are still driving most of our we're still pushing our PROTECT registry as our main vehicle for thyroid artery embolization, but we are receiving inquiries about the procedure and physician interest from all over. Speaker 200:27:36Yeah, and Bill, what we'd like to do is really build out a robust database. If a physician has interest, we'll train them and get them involved. I think this is the first publication, so we're really excited about that. And we anticipate impact from thyroid just beginning the back half of the year, but real impact in 2026. Speaker 700:27:57Okay, that's fantastic. And then last question, I promise, is really how do we think about the third quarter in terms of cadence for the back half of the year and the 50% plus growth? I think consensus is somewhere between 11,500,000 and $12,000,000 for the third quarter and close to 13,000,000 for the fourth. Just kind of I know you reiterated the 50% plus guidance, but just wanted to kind of zero in more on the third quarter here, if I could. Speaker 600:28:26Yes, Bill, this is David. Thanks for the question. And we're really proud of where we are for the second quarter with 22% growth sequentially. So we can get low double digit growth in the next two quarters and then get to our target, and we've taken a decent amount of that growth out of the equation, if you will, and we're confident we can get there. Just to round out your question on investment in the sales team, what we're doing is really bringing in a lot of structure and process into our sales commercial organization. Speaker 600:28:56And so with that, we're investing in sales leadership, process, and structure to further improve that account utilization on a per rep basis and a per account basis. And so, for us, that's giving us confidence in hitting those numbers. Speaker 700:29:11Great. Thanks for taking my questions. Operator00:29:14Thank you. Our next question coming from the line of Ross Osborne with Cantor Fitzgerald. Your line is now open. Speaker 800:29:24Hey, guys. This is Matt Park on for Ross today. Thanks for taking the questions. I guess just starting on gross margin, it came in a little bit softer than what we had. And I know you guys highlighted some lower manufacturing efficiencies as you start to ramp these newly launched products. Speaker 800:29:38Can you just walk us through the levers to see incremental margin expansion in the back half of this year and then into 2026? Speaker 600:29:45Yes. No, it's a great point. So we're confident we can get back on track with gross margin after, which was a minor setback for the quarter. Where we are is really getting a strong understanding of understanding our business, understanding the product mix from what's going to be TriNav, Flex, and LV, and then just really getting in that cadence of understanding the use cases for a forecasting perspective, and then getting our teams to have optimal lot size when they're going to be manufacturing. But this is something that we're taking very seriously, and this is something we're confident we can get back on track. Speaker 800:30:20Got it. That's helpful. And then I guess one more from me on these registry trials. So please correct me if I'm wrong, but you initiated a pilot registry in GAE and then discussed previously about initiating one uterine fibroid. I guess, you just walk us through what type or level of evidence you need and you believe will be the most compelling to guideline committees as they evaluate TriNet in these procedures? Speaker 200:30:49Yeah, what we do is we just did a phase zero in GAE. We did that specifically for collecting just a really broad array of various endpoints, and then we'll sit with our advisory committee, figure out what we think is the most powerful and influential and ones to focus on, and then power the registry so we have the appropriate number of patients and follow ups so we can have a robust data set that we can include in guidelines. So our process really is let's collect the initial data, then we sit with our advisory panel, we formulate what we think are the right endpoints to focus on, and then we scale up the study to actually have the appropriate impact. So we did that on GAE, we hope to do that on Eufy in the fourth quarter of this year. So we're starting quite a number of different studies to actually implement that across this broad array of new applications. Speaker 800:31:43Got it. Super helpful. Thanks for taking the questions, and congrats on the quarter. Operator00:31:51Thank you. Our next question coming from the line of Suraj Kalia with Oppenheimer. Your line is now open. Speaker 900:32:04Hi, Mary and David. This is Seamus on for Suraj. Congrats on the nice quarter, and thank you for taking our questions. To start, I guess, can you I know this is kind of reiterating an earlier question, but just trying to get out of the different way. How is mapping usage with TriNet since the mapping code been instituted kind of changed? Speaker 900:32:27Like, kind of what was you know, what percentage of physicians were using that mapping cone kinda before that was instituted versus kind of what is what are you seeing after? You know, and what are you doing to kind of increase that mapping utilization for physicians? Speaker 200:32:44Well, let me take it first with the second point. So how we're helping people increase the mapping utilization is we onboarded a reimbursement consultant called Z Health. I don't know if you guys are familiar with this company. The key person who leads this event is an interventional radiologist. He's been in coding for twenty five years. Speaker 200:33:05He actually leads many webinars, and we now have him as our back office support for reimbursement, so he can work with coders directly on how to code specifically for mapping and for treatment. And that's been just an incredible resource. Just to give you a flavor of that, he had a webinar at the July. We had close to 8,000 people on the webinar. So that's kind of the key metric of how we're getting information out to the individuals of how to code for it. Speaker 200:33:34That's really been the biggest barrier on mapping. People are concerned about, will I get reimbursed? How do I do this with this new C code? So that's helped immensely. I will tell you since April, it's really starting to grow. Speaker 200:33:47And we track it through our Veeva data, so it's rep reported. We can't really see the code until we have kind of another quarters of data and we can go into the data. But based on reports from our representatives, we're really starting to see a big acceleration following the reimbursement, and that really began in the May and June timeframe. Speaker 900:34:10Got it. Appreciate that. That's helpful color. Just one last one from our end. You know, I know you guys are focusing a partnership for nalotolimod. Speaker 900:34:19I guess Yep. When could we expect to potentially hear something? You know, What are you looking for in a partner that you're going to bring in? Just any color there. Thank you again for taking our questions. Speaker 200:34:30Yeah, sure. So in nalatolimod, we're kind of winding down to the end. I know we've been talking about it for while, but we hope to roll out the data in Q3. And I think what we're looking for in a partner is someone that can advance that to the next stage and bring it to the market. And that would be a partner that's really focused in the liver and pancreas, that has an understanding of this mechanism, the TLR9 mechanism, that understands the impact of a reduction in myeloid derived suppressor cells. Speaker 200:35:03We actually have a very clear target list, kind of a first tier, second tier, third target list, where strategically this would be a nice addition to their portfolio. And so once we have the final data, and then we're gonna begin those discussions in Q3, so we're really excited to begin those. I think the challenge that we have is just the market right now in biotech is not as robust as I would like. But it's hard to find a phase one asset that has good data. So we're excited to start the discussions and hopefully can move this ahead. Operator00:35:42Thank you. And I'm showing there are no further questions in the queue at this time. I will now turn the call back over to Mary Zella for any closing remarks. Speaker 200:35:53Thank you, everyone. Really appreciate your interest in Trysalis. Operator00:35:59This concludes today's conference call. Thank you for your participation, and you may now disconnect.Read morePowered by