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TriSalus Life SciencesF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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Earnings documents stored for TLSI.

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Investor releaseQuarter not tagged2026-08-07

TriSalus Life Sciences Q2 Earnings Call Highlights

MarketBeat
Interested in TriSalus Life Sciences, Inc.? Here are five stocks we like better. Revenue rose modestly to $11.4 million in Q2, up 1.7% year over year, while TriSalus reiterated its 2026 revenue forecast of $54 million to $57 million. The company more than doubled its commercial footprint during the first half of the year. A new CMS G-code could expand reimbursement for TriNav pressure-enabled drug delivery in physician office-based labs, supporting potential growth in liver, uterine, prostate and genicular artery embolization procedures. Gross margin improved to 86.8%, but higher sales and marketing costs from the expanded sales force widened the adjusted EBITDA loss to approximately $7.1 million. TriSalus ended the quarter with about $46.3 million in cash and said it expects sequential revenue improvement in the second half of 2026. TriSalus Life Sciences (NASDAQ:TLSI) reported second-quarter revenue of $11.4 million, up 1.7% from $11.2 million a year earlier, as demand for its TriNav pressure-enabled drug delivery system increased. The company reiterated its full-year 2026 revenue outlook of $54 million to $57 million, representing projected growth of 19% to 26% over 2025. President and Chief Executive Officer Mary Szela said the quarter reflected progress in expanding the company’s commercial infrastructure, building clinical evidence for pressure-enabled drug delivery, or PEDD, and broadening the potential uses of its technology. TriSalus more than doubled its commercial footprint during the first half of the year, with the hiring initiative beginning in February and all new representatives in place by April. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “We’re already seeing positive results from our commercial evolution in the form of ramping engagement and productivity,” Szela said. During the question-and-answer session, she said a number of the newly hired representatives were exceeding internal metrics and that second-quarter results came in according to the company’s internal operating model. A key development during the quarter was notification from the Centers for Medicare & Medicaid Services regarding a G-code intended to extend reimbursement for TriNav into physician office settings, known as office-based labs, or OBLs. TriSalus already has two HCPCS C codes for complex embolization procedures using pressure-generating cat…Read full document

Interested in TriSalus Life Sciences, Inc.? Here are five stocks we like better. Revenue rose modestly to $11.4 million in Q2, up 1.7% year over year, while TriSalus reiterated its 2026 revenue forecast of $54 million to $57 million. The company more than doubled its commercial footprint during the first half of the year. A new CMS G-code could expand reimbursement for TriNav pressure-enabled drug delivery in physician office-based labs, supporting potential growth in liver, uterine, prostate and genicular artery embolization procedures. Gross margin improved to 86.8%, but higher sales and marketing costs from the expanded sales force widened the adjusted EBITDA loss to approximately $7.1 million. TriSalus ended the quarter with about $46.3 million in cash and said it expects sequential revenue improvement in the second half of 2026. TriSalus Life Sciences (NASDAQ:TLSI) reported second-quarter revenue of $11.4 million, up 1.7% from $11.2 million a year earlier, as demand for its TriNav pressure-enabled drug delivery system increased. The company reiterated its full-year 2026 revenue outlook of $54 million to $57 million, representing projected growth of 19% to 26% over 2025. President and Chief Executive Officer Mary Szela said the quarter reflected progress in expanding the company’s commercial infrastructure, building clinical evidence for pressure-enabled drug delivery, or PEDD, and broadening the potential uses of its technology. TriSalus more than doubled its commercial footprint during the first half of the year, with the hiring initiative beginning in February and all new representatives in place by April. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “We’re already seeing positive results from our commercial evolution in the form of ramping engagement and productivity,” Szela said. During the question-and-answer session, she said a number of the newly hired representatives were exceeding internal metrics and that second-quarter results came in according to the company’s internal operating model. A key development during the quarter was notification from the Centers for Medicare & Medicaid Services regarding a G-code intended to extend reimbursement for TriNav into physician office settings, known as office-based labs, or OBLs. TriSalus already has two HCPCS C codes for complex embolization procedures using pressure-generating catheters in hospital outpatient departments and ambulatory surgery centers. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Szela said the new code could support access to TriNav as some liver cancer treatments migrate from hospitals into office-based settings. She cited shorter wait times and more flexible scheduling as potential advantages for patients receiving treatment in OBLs. The company sees liver embolization as an initial opportunity in the setting, along with uterine, prostate and genicular artery embolization procedures. Szela said TriSalus is still evaluating its plans but initially believes its existing sales representatives can cover most of the opportunity because many interventional radiologists practice across hospital and office-based settings. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Chief Medical Officer Dr. Richard Marshall said most interventional radiologists maintain broad practices and commonly perform a range of procedures, including Y90 radioembolization, transarterial chemoembolization, and uterine artery embolization. He added that physicians familiar with TriNav’s use in liver procedures have begun applying it in uterine artery embolization, helping inform the company’s investment in that indication. TriSalus said it has 11 active clinical studies across 27 sites, involving data from more than 400 patients treated with TriNav. The completed PETER study at Massachusetts General Hospital, a randomized multicenter trial evaluating tumor-to-normal ratio in hepatocellular carcinoma and hypovascular tumors, has been submitted for publication in a peer-reviewed journal. Another completed investigator-initiated study, TRI590 at MD Anderson, remains under data review. The PREDICTT study at MD Anderson began enrolling during the second quarter and is evaluating PEDD in hypovascular tumors. TriSalus expects enrollment to take approximately 12 to 18 months. A separate randomized study called PRESSURE, at Stanford, is expected to open enrollment in the third quarter. That study will compare TriNav and radioembolization treatment with standard delivery for liver metastases. The company also plans to begin additional prospective studies during the second half of 2026, including a radioembolization study comparing TriNav with a microcatheter and a multicenter chemoembolization study in neuroendocrine tumors in collaboration with the University of Pennsylvania. Beyond liver procedures, TriSalus is advancing studies in uterine artery embolization, thyroid artery embolization and genicular artery embolization. The uterine artery embolization study remains on track toward a 50-patient target, while the company’s PROTECT thyroid registry has reached the enrollment cutoff for an interim analysis. TriSalus expects to report initial multicenter U.S. thyroid artery embolization data in the first quarter of 2027. TriSalus also continues to anticipate near-term Food and Drug Administration 510(k) clearance for TriNav Advance. The company said the device is designed to enable PEDD in smaller distal vessels through use of a microcatheter selected by the physician. FDA review has extended beyond its MDUFA goal date, according to Szela. Chief Financial Officer David Patience said gross margin improved to 86.8% from 83.9% in the prior-year quarter, driven by lower average TriNav unit costs and manufacturing improvements. Research and development expense declined to about $3.1 million from $3.7 million, while general and administrative expense fell to about $5.1 million from $5.9 million. Sales and marketing expense increased to $11.4 million from $7.2 million, reflecting costs associated with recruiting, onboarding and training the expanded commercial organization. As a result, adjusted EBITDA loss widened to about $7.1 million from $5.3 million in the year-earlier period. TriSalus ended the quarter with approximately $46.3 million in cash, which Patience said the company believes is sufficient to fund its strategic growth plan. Management expects revenue growth to improve sequentially in the third quarter and strengthen further in the fourth quarter. It also expects sales and marketing expense to decline sequentially in the third and fourth quarters as costs tied to the first-half sales-force expansion recede. The company remains on track to provide consolidated Phase I data from its PERIO study of nelitolimod in the second half of 2026. Szela said TriSalus is also evaluating changes in the pancreatic cancer treatment landscape and will provide an update on its broader pancreatic strategy after completing that assessment. TriSalus Life Sciences, Inc is a clinical-stage biotechnology company focused on the development and commercialization of non-invasive drug–device combination therapies for oncology applications. Leveraging proprietary electroporation and ultrasound platforms, the company aims to enhance the localized delivery and efficacy of established chemotherapeutic agents while reducing systemic toxicity. Its lead programs target hard-to-treat head and neck cancers, where improved tumor control and patient tolerability remain significant unmet needs. The company's pipeline comprises investigational product candidates in early and mid-stage clinical trials, including studies that combine its electrochemotherapy platform with radiation therapy and immuno-oncology agents. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "TriSalus Life Sciences Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-07

TriSalus Life Sciences Inc (TLSI) (Q2 2026) Earnings Call Highlights: New CMS G-code Expands ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. TriSalus Life Sciences Inc (NASDAQ:TLSI) received a new CMS G-code that extends TriNav reimbursement to office-based labs (OBLs), significantly expanding its market access and addressing a growing site-of-care trend. The company is reiterating its full-year 2026 revenue guidance of $54 million to $57 million, reflecting 19% to 26% growth, and expects sequential improvement in Q3 and a stronger Q4. Gross margin improved to 86.8% in Q2 2026, up from 83.9% in the prior year period, driven by lower average unit costs and continuous manufacturing improvements. The company has a robust clinical pipeline with 11 active studies across 27 sites, including the completed PETER study submitted for publication and the PREDICT study actively enrolling, which could serve as future commercial catalysts. The new G-code is expected to be a meaningful accelerant for the uterine artery embolization (UAE) indication, which is increasingly performed in OBL settings, removing a historical reimbursement barrier. The company ended Q2 with approximately $46.3 million in cash, which management believes fully funds its strategic growth plan. Q2 2026 revenue growth was modest at only 1.7% year-over-year ($11.4 million vs. $11.2 million), which is below the pace needed to hit the high end of the annual guidance. Adjusted EBITDA loss widened to approximately $7.1 million in Q2 2026, up from $5.3 million in the prior year period, due to heavy investment in the expanded sales force. Sales and marketing expenses surged to $11.4 million in Q2 2026, up from $7.2 million in the prior year period, reflecting elevated costs from recruiting, onboarding, and training new reps. The FDA's review of the TriNav Advance 510(k) clearance is running past the MDUFA goal date, creating uncertainty about the timing of this key product launch. The company's pancreatic strategy is under review due to significant changes in the treatment landscape, and the nelatolimod Phase I data readout is not expected until the second half of 2026, leaving a key pipeline asset in limbo. The company is still in the early innings of its expanded commercial footprint, and while reps are ramping, the full productivity contribution is not expected until the ba…Read full document

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. TriSalus Life Sciences Inc (NASDAQ:TLSI) received a new CMS G-code that extends TriNav reimbursement to office-based labs (OBLs), significantly expanding its market access and addressing a growing site-of-care trend. The company is reiterating its full-year 2026 revenue guidance of $54 million to $57 million, reflecting 19% to 26% growth, and expects sequential improvement in Q3 and a stronger Q4. Gross margin improved to 86.8% in Q2 2026, up from 83.9% in the prior year period, driven by lower average unit costs and continuous manufacturing improvements. The company has a robust clinical pipeline with 11 active studies across 27 sites, including the completed PETER study submitted for publication and the PREDICT study actively enrolling, which could serve as future commercial catalysts. The new G-code is expected to be a meaningful accelerant for the uterine artery embolization (UAE) indication, which is increasingly performed in OBL settings, removing a historical reimbursement barrier. The company ended Q2 with approximately $46.3 million in cash, which management believes fully funds its strategic growth plan. Q2 2026 revenue growth was modest at only 1.7% year-over-year ($11.4 million vs. $11.2 million), which is below the pace needed to hit the high end of the annual guidance. Adjusted EBITDA loss widened to approximately $7.1 million in Q2 2026, up from $5.3 million in the prior year period, due to heavy investment in the expanded sales force. Sales and marketing expenses surged to $11.4 million in Q2 2026, up from $7.2 million in the prior year period, reflecting elevated costs from recruiting, onboarding, and training new reps. The FDA's review of the TriNav Advance 510(k) clearance is running past the MDUFA goal date, creating uncertainty about the timing of this key product launch. The company's pancreatic strategy is under review due to significant changes in the treatment landscape, and the nelatolimod Phase I data readout is not expected until the second half of 2026, leaving a key pipeline asset in limbo. The company is still in the early innings of its expanded commercial footprint, and while reps are ramping, the full productivity contribution is not expected until the back half of the year, leaving near-term growth dependent on execution. Warning! GuruFocus has detected 4 Warning Signs with TLSI. Is TLSI fairly valued? Test your thesis with our free DCF calculator. Q: Regarding the new office-based lab (OBL) reimbursement, which new indications could be most impactful, and when might you allocate more sales and marketing resources to capitalize on this?A: Mary Zella, President and CEO, explained that the CMS G-code extends TriNav reimbursement into OBLs, a setting where liver embolization procedures are increasingly migrating due to shorter wait times and flexible scheduling. Beyond liver, this opens opportunities in uterine artery embolization (UAE), prostate artery embolization, and genicular artery embolization, which are commonly performed in OBLs. The company is currently planning its strategy, noting the G-code arrived earlier than anticipated, and sees UAE as an early beneficiary by removing historical reimbursement barriers. Q: Can you provide more detail on the productivity metrics and launch trajectory of the new sales representatives hired in the first quarter, and how impactful they can be in Q3 and Q4?A: Mary Zella stated that the sales force expansion began in February, with all new reps hired by April. With two quarters under their belts, their contributions are increasing substantially in the back half of the year. The company is excited about the caliber of talent attracted, with several reps exceeding internal metrics. Q2 results came in exactly on their internal operational model, and they feel confident about the growth trajectory for Q3 and Q4. Q: Where are the overlapping call points between the current liver market and the adjacent markets you are expanding into, and can the current sales force leverage its liver work for these new indications?A: Mary Zella noted that interventional radiologists often work across both hospital settings and OBLs, with the same physicians performing procedures in both. The current sales force can handle the majority of this overlap initially, as the call points are largely the same. Dr. Richard Marshall, Chief Medical Officer, added that most interventional radiologists have broad practice diversity, performing Y90, TACE, and UAE, so the call point is identical. He cited UAE as an example where physicians using TriNav in the liver began using it for UAE, driving the company's investment in that indication. Q: What is the significance of the CMS G-code for TriNav reimbursement in OBLs, and how does it expand the commercial opportunity?A: Mary Zella highlighted that the G-code is a seminal moment for TriSalus, extending reimbursement into the physician office setting (OBL). This expands patient access to pressure-enabled drug delivery (PEDD) regardless of treatment site, addressing the migration of liver cancer treatments from hospitals to OBLs. The company holds two unique HCPCS codes for HOPD and ASC settings, and this new code removes the reimbursement barrier for OBLs, which is particularly impactful for UAE and other embolization procedures. Q: Can you provide an update on the clinical trial progress and evidence generation for TriNav?A: Mary Zella reported 11 active studies across 27 clinical sites, with data from over 400 patients treated with TriNav. The PETER study at Massachusetts General Hospital has been submitted for publication, and the TRIPI 90 study at MD Anderson is in data review. The PREDICT study at MD Anderson is actively enrolling, and the PRESSURE trial at Stanford will launch in Q3. New studies include a prospective trial to prove TriNav superiority over microcatheters in liver metastases and a multicenter neuroendocrine tumor study with the University of Pennsylvania. Q: What is the status of the TriNav Advance 510(k) clearance with the FDA?A: Mary Zella stated that the company continues to anticipate near-term 510(k) clearance for TriNav Advance, which will expand liver market access by extending PEDD to small distal vessels via microcatheters. The review is running past the MAUFA goal, but the company remains in close dialogue with the FDA and hopes to receive clearance soon. Q: What are the financial highlights for Q2 2026, and what is the full-year guidance?A: David Patience, CFO, reported Q2 revenue of $11.4 million, up 1.7% year-over-year, with gross margin improving to 86.8%. R&D expenses decreased to $3.1 million, while sales and marketing expenses increased to $11.4 million due to the commercial expansion. Adjusted EBITDA loss was $7.1 million, and the company ended the quarter with $46.3 million in cash. Full-year 2026 revenue guidance is reiterated at $54 million to $57 million, reflecting 19% to 26% growth, with sequential improvement expected from Q2 to Q3 and a stronger Q4. Q: Can you elaborate on the real-world evidence study and its implications for TriNav adoption?A: Mary Zella highlighted a webinar featuring a real-world outcome study evaluating over 300 million patient lives, including 16,210 embolizations, with 1,200 patients compared using sophisticated matching. The data showed TriNav was used in the most challenging patients with high disease burden and complex anatomy, yet demonstrated clinical benefit. The HEOR data showed average cost savings of $7,700 in certain procedures, which serves to validate the platform and catalyze adoption. Q: What is the progress on the emerging indications of uterine, thyroid, and genicular artery embolization?A: Mary Zella reported that the UAE expanded study is enrolling well toward a 50-patient target, with a prospective trial design in progress. The PROTECT registry for thyroid artery embolization has achieved the enrollment cutoff for interim analysis, with first multicenter US data expected in Q1 2027. For genicular artery embolization, the pilot registry has concluded, and the company is advancing a formal clinical trial design. Q: What is the update on the nelatolimod and pancreatic programs?A: Mary Zella stated that the company remains on track to deliver the consolidated PERIO Phase I data readout for nelatolimod in the second half of 2026. Regarding the broader pancreatic strategy, significant changes in the pancreatic cancer treatment landscape are being evaluated, and an update will be provided after the analysis is complete. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-06

TriSalus Life Sciences Reports Second Quarter 2026 Results

Business Wire
Generated second quarter revenue of $11.4 million and expanded commercial organization to support future growth and broader market penetration Maintains 2026 revenue guidance of $54 million to $57 million Hosting Conference Call and Webcast today at 4:30pm ET DENVER, August 06, 2026--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced financial results for the quarter ended June 30, 2026, and provided an operational update. "We delivered a second quarter marked by year-over-year and strong sequential growth. We continued strengthening our foundation to drive future expansion and adoption of the TriNav platform, and generated clinical evidence that demonstrates and validates the value of our technology," said Mary Szela, President and Chief Executive Officer of TriSalus. "We also wanted to acknowledge the Centers for Medicare and Medicaid Services ("CMS") on the recent establishment of a G-code that extends reimbursement for vascular embolization procedures with the use of a pressure-generating catheter into the physician office-based lab site of service. We look forward to maintaining an active dialogue with CMS as their team finalizes the reimbursement rate in the coming months. We anticipate seeing further growth in the back half of the year and beyond as our sales team continues to ramp their efforts. We believe the long term growth opportunity for our PEDD platform remains substantial, and see an exciting pathway ahead." Highlights for Second Quarter 2026 and Recent Weeks Hosted virtual KOL event featuring a discussion around the new real-world evidence for PEDD in liver cancer. Submitted for publication data from the PEDIR study, a multi-center, randomized trial conducted at Massachusetts General Hospital evaluating tumor-to-normal ratio in hepatocellular carcinoma and hypovascular tumors. Financial Results for Q2 2026 Revenue from the sale of the TriNav system was $11.4 million for the three months ended June 30, 2026, which was relatively consistent with the prior comparative period with an increase of 1.7% compared to the same period in 2025. Gross margins were 86.8% for the three months ended June 30, 2026, compared to 83.9…Read full document

Generated second quarter revenue of $11.4 million and expanded commercial organization to support future growth and broader market penetration Maintains 2026 revenue guidance of $54 million to $57 million Hosting Conference Call and Webcast today at 4:30pm ET DENVER, August 06, 2026--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced financial results for the quarter ended June 30, 2026, and provided an operational update. "We delivered a second quarter marked by year-over-year and strong sequential growth. We continued strengthening our foundation to drive future expansion and adoption of the TriNav platform, and generated clinical evidence that demonstrates and validates the value of our technology," said Mary Szela, President and Chief Executive Officer of TriSalus. "We also wanted to acknowledge the Centers for Medicare and Medicaid Services ("CMS") on the recent establishment of a G-code that extends reimbursement for vascular embolization procedures with the use of a pressure-generating catheter into the physician office-based lab site of service. We look forward to maintaining an active dialogue with CMS as their team finalizes the reimbursement rate in the coming months. We anticipate seeing further growth in the back half of the year and beyond as our sales team continues to ramp their efforts. We believe the long term growth opportunity for our PEDD platform remains substantial, and see an exciting pathway ahead." Highlights for Second Quarter 2026 and Recent Weeks Hosted virtual KOL event featuring a discussion around the new real-world evidence for PEDD in liver cancer. Submitted for publication data from the PEDIR study, a multi-center, randomized trial conducted at Massachusetts General Hospital evaluating tumor-to-normal ratio in hepatocellular carcinoma and hypovascular tumors. Financial Results for Q2 2026 Revenue from the sale of the TriNav system was $11.4 million for the three months ended June 30, 2026, which was relatively consistent with the prior comparative period with an increase of 1.7% compared to the same period in 2025. Gross margins were 86.8% for the three months ended June 30, 2026, compared to 83.9% for the same period in 2025. The year-over-year increase in gross margin was primarily due to a reduction in cost per TriNav unit. Operating losses were $9.8 million for the three months ended June 30, 2026, compared to losses of $7.3 million for the same period in 2025. The increase in operating losses was primarily driven by higher sales and marketing expenses related to our investment in marketing and our sales organization expansion, partially offset by improved gross margins, lower research and development and lower general and administrative expenses. Net loss available to common stockholders was $9.2 million for three months ended June 30, 2026, compared to a net loss of $9.0 million for the same period in 2025. The current period includes $1.6 million of non-cash net gains related to changes in the fair value of various derivatives for the three months ended June 30, 2026, compared to net gains of $0.4 million for the same period in 2025. The basic and diluted loss per share for three months ended June 30, 2026 was $0.16, compared to $0.27 for the same period in 2025. The non-GAAP measure of adjusted EBITDA is shown in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $7.1 million for the three months ended June 30, 2026, compared to losses of $5.3 million for the same period in 2025. The increase in adjusted EBITDA losses were primarily driven by increased sales and marketing expenses, partially offset by improved gross margins, lower research and development and lower general and administrative expenses. On June 30, 2026, cash and cash equivalents totaled $46.3 million. The Company raised $46.0 million in gross proceeds in the first quarter from an equity offering. The Company believes that these proceeds provide sufficient cash runway to fully fund commercial expansion and pipeline development. 2026 Financial Guidance The Company is maintaining its full-year 2026 revenue guidance of $54 million to $57 million, consistent with the range set in the first quarter and representing growth of 19% to 26% compared to full year 2025. Conference Call & Webcast The Company will host a conference call and webcast today at 4:30 PM eastern time to discuss its financial results for the quarter ended June 30, 2026. Parties interested in participating by phone should register using the online form on our investor relations website. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. Forward Looking Statements Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav® system and nelitolimod investigational immunotherapy, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav® system and nelitolimod investigational immunotherapy, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with regulatory approval of the Company's product candidates, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company’s filings with the Securities and Exchange Commission under the heading "Risk Factors." All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. Non-GAAP Financial Measure To supplement the financial results presented in accordance with GAAP, TriSalus has also included in this press release non-GAAP adjusted EBITDA, which excludes from net loss, income tax expense, interest expense, interest income, change in fair value of SEPA, warrant and revenue-base redemption liabilities, change in fair value of contingent earn out liability, stock-based compensation expense and depreciation. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. TriSalus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand TriSalus’ business. TriSalus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, TriSalus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare TriSalus’ results from period to period, and to identify operating trends in TriSalus’ business. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806599396/en/ Contacts For Media Inquiries: Andrea MarassoVice President, [email protected] For Investor Inquiries: David PatienceChief Financial [email protected]

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 41 paragraphs
Operator

Good day, and thank you for standing by. Welcome to the TriSalus Life Sciences second quarter 2026 earnings conference call. At this time, all participants are in listen only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker, Caylene Parrish. Please go ahead.

Caylene Parrish

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 30th, 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.

Caylene Parrish

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 6th, 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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

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 510(k) 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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

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.

Mary Szela

Dr. Alex Misono, Chief of Interventional Radiology at Hoag Health System in California, joined our webinar as a speaker and reinforced a key finding from the study that I think deserves emphasis. Data showed TriNav had historically been employed in procedures with the most challenging patients, those who have the highest disease burden, and those with the most complex anatomy. For those patients, TriNav has proven its clinical benefit, particularly in scenarios where anticipated outcomes were poor. Given the clinical benefits and favorable reimbursement in place, Dr. Misono also discussed his approach to expanding TriNav usage with broader utilization across his practice. Additionally, the HEOR data is extremely compelling, with average cost savings in certain procedures of $7,700. We continue to believe that new evidence serves to validate our platform and catalyze adoption within the clinical community. Moving to our third strategic focus, innovating and expanding our indications and portfolio.

Mary Szela

Our first focus, liver embolization, is an area of significant opportunity for us, and we remain focused first and foremost on driving growth there. Indications outside of liver, including uterine, genicular, and thyroid artery embolization, present a vast additional growth opportunity. We believe that liver embolization and these additional indications collectively represent an addressable market in the U.S. of approximately $2.5 billion. I believe that the continued cultivation of our evidence base to validate our platform as a whole, while executing our clinical strategy across multiple indications and physicians, will expand our footprint materially across liver and non-liver indications alike. Beyond liver, we're building a pipeline of emerging markets for the PEDD platform. Uterine artery embolization, thyroid artery embolization, and genicular artery embolization mark greenfield opportunities for TriSalus, and each one can be a meaningful growth driver going forward.

Mary Szela

We're in the early innings with these three indications, the clinical data we're generating is giving us increased confidence that PEDD can redefine treatment and patient outcomes. On uterine artery embolization, momentum continues to build on the strong SIR data we shared last quarter. The expanded study we approved in Q1 is enrolling well, and we remain on track toward our 50-patient target. We continue to advance the design of a prospective trial to more formally evaluate TriNav's potential to streamline workflow, reduce procedure and fluoroscopy time, and improve outcomes in UAE. One additional note here that I think is worth highlighting is UAE is a procedure that is increasingly being performed in the OBL setting. The G-code I discussed earlier has the potential to be a meaningful accelerant for this indication, specifically by removing the reimbursement barrier that has historically limited TriNav use in the physician office-based labs.

Mary Szela

We see UAE as one of those earlier beneficiaries of that expanded access, and we look forward to updating you on the progress in the coming quarters. On thyroid artery embolization, our PROTECT registry continues to gain momentum across multiple centers, evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for conventional therapy. I'm pleased to report that we have achieved the enrollment cutoff required for the protocol's interim analysis and that we remain on track to deliver the first multi-center U.S. data on TAE in the first quarter of 2027. We believe that data set will position PEDD TAE as the leading approach for this procedure, as it is minimally invasive. On genicular artery embolization, we remain focused on executing our clinical strategy.

Mary Szela

Having concluded our pilot registry, we're actively advancing the formal clinical trial design and look forward to sharing additional updates as that program develops. In total, we view these emerging indications as gateways to significant expansion of our existing addressable market opportunity. We will continue to vigorously propel forward these trials and clinical initiatives as we secure a foothold in these markets. Finally, I'd like to provide a brief update on our nelitolimod and pancreatic programs. First on nelitolimod, we remain on track to deliver our consolidated PERIO phase I data readout in the second half of 2026. Second, on a broader pancreatic strategy, there's been significant changes in the pancreatic cancer treatment landscape that we're currently evaluating. We will provide an update on our go-forward pancreatic strategy after we complete that analysis.

Mary Szela

This last quarter was a period of continued focus and execution for TriSalus as we solidified our foundation for future growth. We have a fully deployed, meaningfully expanded commercial organization that is ramping toward its full productivity potential. We progressed our clinical trials and continued growing our evidence base, including the landmark real-world data study on PEDD. The proposed G-code extending reimbursement into office-based labs represents a key milestone that will contribute meaningfully to TriNav adoption. Driven by our Q2 results and the ongoing progress in the business, we are reiterating our full-year 2026 revenue guidance of $54 million-$57 million, reflecting a 19%-26% growth over full-year 2025. We are excited about our growth trajectory and see a tremendous opportunity ahead for TriSalus. With that, I'll turn the call over to David Patience, our CFO, to provide a review of the second quarter results and 2026 guidance.

David Patience

Thank you, Mary, good afternoon, everyone. Revenue for the second quarter was $11.4 million, up 1.7% compared to $11.2 million in the prior year period, driven by increasing demand for our innovative drug delivery technology, TriNav. Gross margin for the quarter was 86.8% compared to 83.9% in the prior year period. The improvement was driven by lower average unit costs on TriNav and our continuous manufacturing improvements. Research and development expenses were approximately $3.1 million, compared to $3.7 million in the prior year period. The decrease was primarily due to lower professional service costs and clinical trial expenses related to nelitolimod, which did not occur in the current year period. Sales and marketing expenses were $11.4 million, compared to $7.2 million in the prior year period.

David Patience

The increase reflects our deliberate investment in expanding our commercial footprint, which includes elevated expenses related to recruiting, onboarding, and training our expanded organization. General and administrative expenses were approximately $5.1 million, compared to $5.9 million in the prior year period. The decrease was primarily due to lower professional service costs related to legal and audit-related expenses. Adjusted EBITDA loss for the quarter was approximately $7.1 million, compared to $5.3 million in the second quarter of 2025. The increase in adjusted EBITDA loss reflects our deliberate investment in our expanded sales organization to build out our commercial infrastructure for longer-term sustainable growth. We ended the quarter with approximately $46.3 million in cash, which we believe fully funds our strategic growth plan. As Mary mentioned, we are reiterating our full-year 2026 revenue guidance of $54 million-$57 million, reflecting 19%-26% growth over the full-year 2025.

David Patience

We expect sequential improvement in growth from Q2 to Q3, followed by a stronger Q4. We also expect sales and marketing expenses to decline sequentially in the third and fourth quarter as we move past the elevated cost of the first-half sales force expansion. Taken together, we're confident in the path ahead. A ramping growth trajectory paired with disciplined cost control and cash management through the back half of 2026 and into 2027. Thank you all for your continued support. With that, operator, we're ready to open the line for questions.

Operator

Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone. You will hear an automated message advising your hand is raised. We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. First question I have will be coming from the line of Frank Takkinen of Lake Street Capital Markets. Please go ahead.

Frank Takkinen

Great, thank you for taking the questions. Wanted to start with a follow-up on the sales force. Appreciate the comments on the call. Specific to the new reps that you hired in the first quarter, can you maybe talk a little bit more about some of the metrics they're putting up as far as productivity improvement, where they are in their launch trajectory, and how impactful they can be in Q3, Q4?

Mary Szela

Hi, Frank. How are you? Good question. We initiated the expansion in February, and all our reps were hired by April. Now you're seeing our reps in the back half of the year. They have two quarters under their belt, and we're starting to see that contribution increase pretty substantially in the back half of the year. I think we've shared previously with everyone, we're really excited about the talent and the caliber of reps that have come into the organization. Frankly, historically, we've never been able to attract this type of talent to the company, and we're really pleased to see how they're hitting the ground running, a number of our reps are really exceeding our internal metrics.

Mary Szela

We have quite a number of leading indicators and metrics and an internal operational model that we've developed over the years, we have really good understanding of how that progresses throughout the year. Essentially, we're right on track. I think Q2 came in exactly on our internal model exactly as we expected, we feel really good about where we're at.

Frank Takkinen

Got it. Very helpful. I want to follow up on the new office-based lab reimbursement. Maybe talk a little bit more specifically on which new indications that could be most impactful for and when you might start to allocate more sales and marketing resource into those to capitalize on that.

Mary Szela

Oh, thank you, Frank. That's a really good question. We've been talking to CMS for quite some time about extending reimbursement for TriNav into the OBL. It was really intended to cover a number of different dimensions. One of the things we're seeing in the liver embolization market is we are seeing patients migrate out of the hospital into the OBL, primarily just to help reduce some of the congestion in the hospital. IRs in the hospital often get called to other procedures, so patients who are scheduled for these procedures get bumped, and then they have to be rescheduled, and they wait quite a long time, and so their treatment can delay. There's actually a number of publications on it that we shared with CMS.

Mary Szela

We also saw that a lot of big institutions, they'll do some of their mappings in the OBL and then they'll do their treatments in the hospital and vice versa. We shared all that data with CMS. I just wanted to take a moment and say just how appreciative we are about the level of collaboration and engagement from CMS, because they looked at this data, and that's really why they moved forward with the G-code so rapidly. They wanted to make sure that these patients could have, literally, the opportunity to go to any site of care and get TriNav because the benefits were so significant. Number one, we see liver embolization, still small, but growing, moving into that environment.

Mary Szela

There's also a lot of other embolization procedures where uterine artery embolization, prostate artery embolization, genicular artery embolization, uterine artery embolization, these are a lot of those procedures that are done in that site of care. Now we'll have the opportunity to have TriNav. We're obviously very excited about that. We're putting together all our planning on that right now. More to come on that. This actually came a little bit earlier than what we even anticipated, so we were really surprised and excited about this.

Frank Takkinen

Got it. That's very helpful. Thank you.

Operator

Thank you. One moment for the next question. Our next question will be coming from the line of Justin Walsh of JonesTrading. Please go ahead.

Justin Walsh

Hi, thanks for taking the question. I think you alluded to this a little bit in your last answer with the reimbursement, but I'm wondering if you could remind us where there's overlap in call points for the current liver market and the adjacent markets that you're working to expand into?

Mary Szela

Would you overlap within the sales organization? Is that what you're saying, or?

Justin Walsh

Yes. If there's any interventional radiologists who maybe do all of these different procedures and I'm kind of thinking as you're expanding here, how much your current sales force will be able to leverage what's been done in liver as you're looking to get some of these other indications going.

Mary Szela

That's a really good question, Justin. You know what we're seeing in the marketplace right now, in a lot of the large academic centers, like I mentioned in my earlier question, we're seeing them actually establish these OBLs. They surround the hospital, or they're kind of located strategically around the hospital so they can feed patients into those locations. We see interventional radiologists who work in the hospital, but then they also work in the OBL. Some of these OBLs can be owned jointly with the hospital and the physicians, and some can just be physician-owned. You do see a lot of back and forth with the same physician going from one institution to another site of care.

Mary Szela

For example, at Columbia, where TriNav is used pretty aggressively, they map in the OBL and treat in the hospital, but they can't use TriNav in the OBL. This is why the G-code is really going to help facilitate that treatment pattern much more significantly. Right now, based on everything we've seen, and we're still early in terms of assessing this, we think our current reps can handle the majority of it right now just because a lot of those physicians are the same. I think as we expand into some of the newer indications, I think we'll get better clarity on whether any additional sales resources would be required. As we look at it, initially, we don't believe that there's going to be any incremental sales resources required.

Richard Marshall

Mary, I can comment a little bit on some of the specialization of interventional radiologists. In general, most interventional radiologists have a pretty broad practice diversity. There are certainly exceptions to that rule in larger academic centers where, let's say, someone is considered a liver specialist, but in general, they take call, and therefore do perform other procedures. The overlap here is really quite broad. A physician such as myself, and many of the people that I know will perform Y90 TACE uterine artery embolization. The same truth applies to biopsies and drainages. You're there in a hospital-based practice to do everything that comes in. The call point is really the same. There's not a whole lot of difference between physicians. There are certainly physicians who have been able to specialize but still do have some reach into other areas.

Richard Marshall

If physicians understand the value of TriNav in one area, and we have certainly seen this, the best example is uterine artery embolization. We have physicians come to us and say, "We've been using this in the liver, but we've actually started using it in uterine artery embolization, and it's working really well." That kind of drove our investment in uterine artery embolization to see those results. I hope that answers your question.

Justin Walsh

Yes. Thank you guys for taking the question.

Operator

Thank you. There are no more questions in the queue. This does conclude today's programming. Thank you all for joining. You may now disconnect and enjoy your evening.

Investor releaseQuarter not tagged2026-08-05

Earnings To Watch: TriSalus Life Sciences Inc (TLSI) Q2 2026 -- GF Value Sees 20% Upside

GuruFocus.com

This article first appeared on GuruFocus. TriSalus Life Sciences Inc (NASDAQ:TLSI) is set to release its Q2 2026 earnings on Aug 6, 2026. The consensus estimate for Q2 2026 revenue is 10.27 million, and the earnings are expected to come in at -0.16 per share. The full year 2026's revenue is expected to be $52.40 million and the earnings are expected to be $-0.29 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 4 Warning Signs with TLSI. Is TLSI fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for TriSalus Life Sciences Inc (NASDAQ:TLSI) have declined from $60.26 million to $52.40 million for the full year 2026, and from $83.99 million to $81.59 million for 2027. During the same period, earnings estimates have increased from $-0.40 per share to $-0.29 per share for the full year 2026, while declining from $-0.01 per share to $-0.03 per share for 2027. In the previous quarter of 2026-03-31, TriSalus Life Sciences Inc's (NASDAQ:TLSI) actual revenue was $8.90 million, which missed analysts' revenue expectations of $10.44 million by -14.76%. TriSalus Life Sciences Inc's (NASDAQ:TLSI) actual earnings were $0.03 per share, which beat analysts' earnings expectations of $-0.158 per share by 118.99%. After releasing the results, TriSalus Life Sciences Inc (NASDAQ:TLSI) was down by -41.45% in one day. Based on the one-year price targets offered by 4 analysts, the average target price for TriSalus Life Sciences Inc (NASDAQ:TLSI) is $9.00 with a high estimate of $11.00 and a low estimate of $7.00. The average target implies an upside of 89.87% from the current price of $4.74. Based on GuruFocus estimates, the estimated GF Value for TriSalus Life Sciences Inc (NASDAQ:TLSI) in one year is $5.69, suggesting an upside of 20.04% from the current price of $4.74. Based on the consensus recommendation from 4 brokerage firms, TriSalus Life Sciences Inc's (NASDAQ:TLSI) average brokerage recommendation is currently 2.00, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-16

TriSalus Life Sciences to Host Second Quarter 2026 Financial Results Conference Call

Business Wire
WESTMINSTER, Colo., July 16, 2026--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard-of-care therapies and an investigational immunotherapeutic to transform outcomes for patients with solid tumors, today announced that it will host a conference call and webcast on Thursday, August 6, 2026 at 4:30 PM eastern time to discuss its financial results for the quarter ended June 30, 2026. A press release detailing the results will be issued prior to the call. Parties interested in participating by phone should register using this online form. After registering for the call, dial-in details will be provided in an auto-generated email containing a link to the conference phone number along with a PIN. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current…Read full document

WESTMINSTER, Colo., July 16, 2026--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard-of-care therapies and an investigational immunotherapeutic to transform outcomes for patients with solid tumors, today announced that it will host a conference call and webcast on Thursday, August 6, 2026 at 4:30 PM eastern time to discuss its financial results for the quarter ended June 30, 2026. A press release detailing the results will be issued prior to the call. Parties interested in participating by phone should register using this online form. After registering for the call, dial-in details will be provided in an auto-generated email containing a link to the conference phone number along with a PIN. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. View source version on businesswire.com: https://www.businesswire.com/news/home/20260716428515/en/ Contacts For Media Inquiries: Andrea MarassoVice President, [email protected] For Investor Inquiries: David PatienceChief Financial [email protected]

Investor releaseQuarter not tagged2026-05-13

TriSalus Life Sciences Q1 Earnings Call Highlights

MarketBeat
Interested in TriSalus Life Sciences, Inc.? Here are five stocks we like better. TriSalus cut its 2026 revenue outlook to $54 million-$57 million after first-quarter revenue slipped to $8.9 million from $9.2 million a year ago. Management said the miss was driven by a major commercial reorganization, not weaker underlying demand. FDA review for TriNav Advance is delayed by about five months, and the company removed any second-half revenue contribution from the forecast. TriSalus still expects clearance in the second half of 2026 and says the device is key to extending its PEDD platform into smaller vessels. The company is expanding its commercial and clinical strategy, with its sales force now largely rebuilt and more than doubled, while a real-world PEDD study showed lower complications and about $7,700 in per-patient cost avoidance. TriSalus also highlighted multiple active trials and upcoming readouts that could support growth later in the year. TriSalus Life Sciences (NASDAQ:TLSI) reported slightly lower first-quarter revenue and reduced its full-year 2026 revenue outlook, citing disruption from a broad commercial reorganization and a delayed FDA review for its next-generation TriNav Advance device. President and Chief Executive Officer Mary Szela said the company’s first-quarter results reflected the “deliberate cost of a build-out phase” as TriSalus expanded and realigned its sales organization to support growth in liver embolization and new applications for its Pressure-Enabled Drug Delivery, or PEDD, platform. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “Q1 performance was not a function of softer demand or any change in the underlying fundamentals of our business,” Szela said. “It reflects the deliberate cost of a build-out phase, investing now in the commercial engine required to scale this organization for our next phase of growth.” For the quarter ended March 31, 2026, TriSalus reported revenue of $8.9 million, compared with $9.2 million in the prior-year period. Chief Financial Officer David Patience said the decline was due to the transition tied to the expanded commercial organization. → MercadoLibre Boldly Invests in Growth: Discount Deepens Gross margin improved to 86% from 84% a year earlier, driven by lower average unit costs on TriNav and continued manufacturing improvements. Research and development ex…Read full document

Interested in TriSalus Life Sciences, Inc.? Here are five stocks we like better. TriSalus cut its 2026 revenue outlook to $54 million-$57 million after first-quarter revenue slipped to $8.9 million from $9.2 million a year ago. Management said the miss was driven by a major commercial reorganization, not weaker underlying demand. FDA review for TriNav Advance is delayed by about five months, and the company removed any second-half revenue contribution from the forecast. TriSalus still expects clearance in the second half of 2026 and says the device is key to extending its PEDD platform into smaller vessels. The company is expanding its commercial and clinical strategy, with its sales force now largely rebuilt and more than doubled, while a real-world PEDD study showed lower complications and about $7,700 in per-patient cost avoidance. TriSalus also highlighted multiple active trials and upcoming readouts that could support growth later in the year. TriSalus Life Sciences (NASDAQ:TLSI) reported slightly lower first-quarter revenue and reduced its full-year 2026 revenue outlook, citing disruption from a broad commercial reorganization and a delayed FDA review for its next-generation TriNav Advance device. President and Chief Executive Officer Mary Szela said the company’s first-quarter results reflected the “deliberate cost of a build-out phase” as TriSalus expanded and realigned its sales organization to support growth in liver embolization and new applications for its Pressure-Enabled Drug Delivery, or PEDD, platform. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “Q1 performance was not a function of softer demand or any change in the underlying fundamentals of our business,” Szela said. “It reflects the deliberate cost of a build-out phase, investing now in the commercial engine required to scale this organization for our next phase of growth.” For the quarter ended March 31, 2026, TriSalus reported revenue of $8.9 million, compared with $9.2 million in the prior-year period. Chief Financial Officer David Patience said the decline was due to the transition tied to the expanded commercial organization. → MercadoLibre Boldly Invests in Growth: Discount Deepens Gross margin improved to 86% from 84% a year earlier, driven by lower average unit costs on TriNav and continued manufacturing improvements. Research and development expenses rose to $3.2 million from $3 million, while sales and marketing expenses increased to $7.4 million from $6.7 million as the company added headcount, training and territory development costs. General and administrative expenses were $5.4 million, up from $5.2 million. The company reported a net operating loss of $8.4 million, compared with a $7.3 million loss in the prior-year period. Adjusted EBITDA loss was approximately $5.8 million, compared with $5.5 million in the first quarter of 2025. TriSalus ended the quarter with $56.6 million in cash and cash equivalents. → MP Materials Is Quietly Building a Rare Earth Powerhouse Patience said the company’s gross margins remained “durable in the mid-80s” and that its cash position “fully funds” the strategic growth plan. TriSalus revised its full-year 2026 revenue guidance to a range of $54 million to $57 million. Szela said the revision reflected both lower first-quarter revenue from the commercial expansion and delayed FDA clearance timing for TriNav Advance, a next-generation device intended to extend PEDD capability to small distal vessels through a microcatheter. According to Szela, FDA review of TriNav Advance is running about five months beyond the 30-day MDUFA review goal. The company remains in active dialogue with the agency and still expects clearance in the second half of the year, but it removed TriNav Advance revenue expectations from its second-half forecast. Szela said TriNav Advance remains important to the company’s product strategy because it would allow interventional radiologists to access PEDD benefits while using the microcatheter of their choice. TriSalus said its expanded sales organization was largely in place as of May. Szela said the company had added commercial leadership, field management, sales representatives and clinical specialists after territories had grown beyond what existing representatives and managers could effectively cover. Chris Staudt recently joined the company as senior vice president of sales and commercial operations. Szela said Staudt brings more than 20 years of commercial leadership experience from companies including Roche, Ventana, Luminex and Accelerate Diagnostics. During the question-and-answer portion of the call, Szela said roughly 60% of territories where representative-to-physician relationships remained intact performed in line with expectations. In the remaining 40%, the company changed both the representative-to-physician and representative-to-manager relationships, which created disruption. “We are very comfortable that there’s been really no fundamental change in demand,” Szela said. She added that the company is now “a little bit above” its prior plan to double the organization and expects month-over-month growth through the rest of the year as new representatives ramp. Patience said TriSalus expects only a “marginal sequential gain” in the second quarter as representatives come out of training, with more meaningful progress anticipated in the third and fourth quarters. TriSalus also announced publication of what Szela called the largest real-world evidence study of PEDD conducted to date. The study included 603 PEDD patients matched against more than 16,210 non-PEDD patients from a claims database covering 96% of U.S. payers and spanning January 2020 through March 2024. The cohort included 515 TARE patients and 88 TACE patients. Szela said the analysis used a two-stage matching design combining Coarsened Exact Matching and propensity score matching. According to the company, PEDD-treated patients showed statistically significant improvements across several measures, including lower post-procedure fatigue, lower lymphopenia at high-adopter centers and reduced 30-day inpatient admissions in the TACE subgroup. Szela said PEDD procedures delivered about 48% more doxorubicin per procedure and cut 30-day inpatient admissions in TACE patients to 8%, compared with 20.5% without PEDD. The study also found approximately $7,700 in per-patient cost avoidance across the 603-patient PEDD cohort, including roughly $3,100 from fewer inpatient stays and $4,600 from fewer post-procedure complications, according to Szela. Medical Director Dr. Richard Marshall said the real-world nature of the data was important for interventional radiology. “This is actually what’s happening in the U.S.,” Marshall said. He added that the study helps physicians understand the economic value that procedures bring to patient care. TriSalus said it now has 10 active studies underway across 24 clinical sites, generating data on more than 400 TriNav-treated patients. Two prospective investigator-initiated trials are expected to begin enrollment this quarter: PRESSURE at Stanford, evaluating TriNav and TARE for liver metastases, and PREDICT at MD Anderson, evaluating PEDD in hypovascular tumors. The company is also preparing publication submissions for two completed investigator-initiated trials, PETER at Massachusetts General Hospital and TRIFY90 at MD Anderson. Szela said those readouts could support second-half commercial momentum. Beyond liver applications, TriSalus highlighted work in uterine artery embolization, thyroid artery embolization and genicular artery embolization. Szela said these indications collectively represent a U.S. addressable market of approximately $2.5 billion. For nelitolimod, TriSalus said it remains on track to deliver a consolidated PERIO Phase 1 readout in the early second half of 2026. Szela said the timing is not driven by a safety signal, efficacy concern or change in strategic priorities. She said the company intends to advance nelitolimod and its broader pancreatic program through a partnership structure while maintaining capital discipline. TriSalus Life Sciences, Inc is a clinical-stage biotechnology company focused on the development and commercialization of non-invasive drug–device combination therapies for oncology applications. Leveraging proprietary electroporation and ultrasound platforms, the company aims to enhance the localized delivery and efficacy of established chemotherapeutic agents while reducing systemic toxicity. Its lead programs target hard-to-treat head and neck cancers, where improved tumor control and patient tolerability remain significant unmet needs. The company's pipeline comprises investigational product candidates in early and mid-stage clinical trials, including studies that combine its electrochemotherapy platform with radiation therapy and immuno-oncology agents. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "TriSalus Life Sciences Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Investor releaseQuarter not tagged2026-05-13

TriSalus Life Sciences Inc (TLSI) Q1 2026 Earnings Call Highlights: Strategic Expansion and ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. TriSalus Life Sciences Inc (NASDAQ:TLSI) has significantly expanded its commercial organization, positioning itself for multi-year growth. The company published a landmark real-world evidence study demonstrating the clinical and economic benefits of its PEDD technology, including fewer complications and hospitalizations. Gross margins improved to 86% from 84% in the prior-year period, driven by lower average unit costs and continuous manufacturing improvements. The company is actively generating new clinical evidence with 10 active studies across 24 clinical sites, enhancing its data-driven approach. TriSalus Life Sciences Inc (NASDAQ:TLSI) has a strong cash position of $56.6 million, fully funding its strategic growth plan. Revenue for the first quarter decreased to $8.9 million from $9.2 million in the prior-year period due to disruptions from the commercial expansion. The company revised its full-year 2026 revenue guidance to $54 million to $57 million, down from previous expectations, due to lower Q1 revenues and delayed FDA clearance for TriNav Advance. Net operating loss increased to $8.4 million from $7.3 million in the prior-year period, reflecting lower revenue and increased sales and marketing investments. The FDA review of TriNav Advance is running approximately five months past the expected timeline, impacting revenue expectations. The expansion of the sales force caused short-term disruptions, affecting 40% of sales territories and requiring time for new representatives to ramp up. Warning! GuruFocus has detected 5 Warning Signs with TLSI. Is TLSI fairly valued? Test your thesis with our free DCF calculator. Q: Can you quantify the disruption caused by the 40% of the sales force that was affected, and how confident are you in the business's recovery trajectory to achieve the guidance range for the year? A: (Mary Della, CEO) 60% of our sales territories were not disrupted and performed as expected, indicating no fundamental change in demand or growth. The disruption in the remaining 40% was due to changes in rep-to-manager and rep-to-physician dynamics, driven by our growth. We are confident in our recovery as the right talent and territory footprint are now in…Read full document

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. TriSalus Life Sciences Inc (NASDAQ:TLSI) has significantly expanded its commercial organization, positioning itself for multi-year growth. The company published a landmark real-world evidence study demonstrating the clinical and economic benefits of its PEDD technology, including fewer complications and hospitalizations. Gross margins improved to 86% from 84% in the prior-year period, driven by lower average unit costs and continuous manufacturing improvements. The company is actively generating new clinical evidence with 10 active studies across 24 clinical sites, enhancing its data-driven approach. TriSalus Life Sciences Inc (NASDAQ:TLSI) has a strong cash position of $56.6 million, fully funding its strategic growth plan. Revenue for the first quarter decreased to $8.9 million from $9.2 million in the prior-year period due to disruptions from the commercial expansion. The company revised its full-year 2026 revenue guidance to $54 million to $57 million, down from previous expectations, due to lower Q1 revenues and delayed FDA clearance for TriNav Advance. Net operating loss increased to $8.4 million from $7.3 million in the prior-year period, reflecting lower revenue and increased sales and marketing investments. The FDA review of TriNav Advance is running approximately five months past the expected timeline, impacting revenue expectations. The expansion of the sales force caused short-term disruptions, affecting 40% of sales territories and requiring time for new representatives to ramp up. Warning! GuruFocus has detected 5 Warning Signs with TLSI. Is TLSI fairly valued? Test your thesis with our free DCF calculator. Q: Can you quantify the disruption caused by the 40% of the sales force that was affected, and how confident are you in the business's recovery trajectory to achieve the guidance range for the year? A: (Mary Della, CEO) 60% of our sales territories were not disrupted and performed as expected, indicating no fundamental change in demand or growth. The disruption in the remaining 40% was due to changes in rep-to-manager and rep-to-physician dynamics, driven by our growth. We are confident in our recovery as the right talent and territory footprint are now in place, and we expect continuous ramp-up throughout the year. Q: Have you achieved the doubling of the sales organization, and is there more hiring needed to complete this expansion? A: (Mary Della, CEO) We have slightly expanded beyond the initial doubling of the organization due to the unprecedented level of talent attracted. This expansion positions us well to scale the company and capture the $2.5 billion market opportunity across liver and new applications. Q: What was the composition and size of the commercial organization before and after the expansion? A: (Mary Della, CEO) We expanded the number of territories more than double and adjusted the rep-to-manager ratio. We also added an executive level of management to engage with hospital systems and payers, positioning us to pursue 400 accounts in liver and new applications. Q: How should we think about revenue cadence for the year, particularly for Q2? A: (David Patience, CFO) We expect a marginal sequential gain in Q2 as reps come out of training, with meaningful progress in Q3 and Q4 as productivity ramps up. The second half ramp is structurally built, and we are excited to see the contributions from the expanded team. Q: Where do you see the new PEDD data having the most direct impact, and how will it resonate with physicians and institutions? A: (Mary Della, CEO) The real-world data validates our prospective clinical data and highlights both clinical and economic benefits. It strengthens our case for PEDD as a standard of care and inclusion in NCCN guidelines. The data's impact on lymphopenia resonates strongly with oncologists, potentially influencing both interventional radiology and oncology communities. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-13

TriSalus Life Sciences, Inc. Q1 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance in Q1 was impacted by a deliberate, large-scale commercial expansion that disrupted 40% of sales territories through simultaneous changes in representative-to-physician and representative-to-manager relationships. Management attributes the revenue dip to transition costs, including representative onboarding, extensive training time out of the field, and the rebuilding of account relationships within realigned territories. The 60% of territories where relationships remained intact performed in line with expectations, which management cites as evidence that underlying demand and market fundamentals remain strong. The company published a landmark real-world evidence study of 603 PEDD patients, demonstrating that the technology reduces health care utilization and generates approximately $7.7 thousand in per-patient cost avoidance. Clinical data showed PEDD preserved immune function by nearly eliminating lymphopenia at high-adopter centers, a critical factor for maintaining patient eligibility for downstream immunotherapy. Strategic expansion into new applications—including uterine, thyroid, and genicular artery embolization—addresses a combined $2.5 billion US market opportunity beyond the core liver business. Full-year 2026 revenue guidance was revised to $54 million to $57 million, reflecting Q1 expansion disruption and a 5-month delay in FDA clearance for TriNav Advance. The TriNav Advance launch is now expected in the second half of 2026, with guidance assuming a prudent market evaluation period following the delayed clearance. Management expects steady, month-over-month sales productivity improvements throughout the remainder of the year as the newly doubled sales force completes its 6- to 9-month ramp period. The PERIO-1 readout for nalotolimod remains on track for 2026, with the company intending to advance its pancreatic programs through a partnership structure to preserve capital. Upcoming clinical catalysts include the submission of results from the TETHER and TRI-FI 90 studies for publication in the second quarter. FDA review of TriNav Advance is currently running 5 months past the 30-day MDUFA goal, creating uncertainty around the exact timing of second-half revenue con…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance in Q1 was impacted by a deliberate, large-scale commercial expansion that disrupted 40% of sales territories through simultaneous changes in representative-to-physician and representative-to-manager relationships. Management attributes the revenue dip to transition costs, including representative onboarding, extensive training time out of the field, and the rebuilding of account relationships within realigned territories. The 60% of territories where relationships remained intact performed in line with expectations, which management cites as evidence that underlying demand and market fundamentals remain strong. The company published a landmark real-world evidence study of 603 PEDD patients, demonstrating that the technology reduces health care utilization and generates approximately $7.7 thousand in per-patient cost avoidance. Clinical data showed PEDD preserved immune function by nearly eliminating lymphopenia at high-adopter centers, a critical factor for maintaining patient eligibility for downstream immunotherapy. Strategic expansion into new applications—including uterine, thyroid, and genicular artery embolization—addresses a combined $2.5 billion US market opportunity beyond the core liver business. Full-year 2026 revenue guidance was revised to $54 million to $57 million, reflecting Q1 expansion disruption and a 5-month delay in FDA clearance for TriNav Advance. The TriNav Advance launch is now expected in the second half of 2026, with guidance assuming a prudent market evaluation period following the delayed clearance. Management expects steady, month-over-month sales productivity improvements throughout the remainder of the year as the newly doubled sales force completes its 6- to 9-month ramp period. The PERIO-1 readout for nalotolimod remains on track for 2026, with the company intending to advance its pancreatic programs through a partnership structure to preserve capital. Upcoming clinical catalysts include the submission of results from the TETHER and TRI-FI 90 studies for publication in the second quarter. FDA review of TriNav Advance is currently running 5 months past the 30-day MDUFA goal, creating uncertainty around the exact timing of second-half revenue contributions. The company successfully raised growth capital in Q1, which funded the commercial build-out but also contributed to higher non-cash stock-based compensation expenses. Territory realignment was necessary because previous sales footprints had expanded beyond the capacity of individual representatives to cover effectively. Management flagged that Q1 G&A expenses are seasonally higher due to annual public company costs materializing in the first quarter. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that the 60% of territories not disrupted by the expansion serve as a 'control group' confirming steady demand. The sales organization is now largely in place, and management expects a continuous ramp in productivity as new hires exit the training phase. The company more than doubled the number of territories and added executive-level management to engage directly with hospital systems and payers. The expansion was slightly larger than originally planned due to the high caliber of talent attracted following the Q1 capital raise. Management anticipates marginal sequential revenue gains in Q2 as representatives complete training. Meaningful revenue step-ups are projected for Q3 and Q4 as the expanded capacity reaches full productivity. The data validates PEDD as a therapeutic delivery platform rather than just a device, showing improved tumor targeting with less off-target toxicity. Management believes the evidence of preserved immune function will resonate strongly with the oncology community, potentially making PEDD a standard of care for combination therapies.

Investor releaseQuarter not tagged2026-05-12

TriSalus Life Sciences Swings to Q1 Earnings, Revenue Declines

MT Newswires

TriSalus Life Sciences (TLSI) reported late Tuesday Q1 earnings of $0.03 per diluted share, swinging

Investor releaseQuarter not tagged2026-05-12

TriSalus Life Sciences Reports First Quarter 2026 Results Demonstrating Commercial and Clinical Progress for Facilitating Long-Term Growth

Business Wire
Generated first quarter revenue of $8.9 million and expanded commercial organization to support future growth and broader market penetration Published landmark, real-world PEDD® Study of 603 PEDD patients and 16,210 non-PEDD patients found PEDD technology was associated with fewer post-procedure complications, reduced hospitalizations, and approximately $7,700 in per-patient charge avoidance despite greater baseline clinical complexity Presented new clinical and preclinical PEDD data across multiple oncology and embolization applications at the 2026 Society of Interventional Radiology Annual Scientific Meeting Strengthened balance sheet with $46 million equity raise; cash balance of $56.6 million fully funds commercial expansion and pipeline development Revised 2026 revenue guidance to $54 million to $57 million, reflecting impact of commercial expansion and timing of FDA clearance for TriNav® Advance Hosting Conference Call and Webcast today at 4:30pm ET DENVER, May 12, 2026--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced financial results for the quarter ended March 31, 2026, and provided an operational update. "The first quarter marked an important strategic inflection point for TriSalus as we significantly strengthened our commercial infrastructure, expanded the clinical evidence supporting PEDD, and continued advancing our next-generation platform opportunities," said Mary Szela, President and Chief Executive Officer of TriSalus. "We are increasingly demonstrating that PEDD is not simply a device, but a differentiated therapeutic delivery platform capable of improving procedural outcomes, reducing healthcare utilization, and expanding treatment possibilities across multiple indications. During and subsequent to the quarter, we added meaningful new clinical evidence supporting PEDD across liver embolization therapy for liver cancer, and other new embolization applications, including one of the largest real-world analyses ever conducted in interventional oncology. At the same time, we substantially completed the commercial expansion initiatives designed to support our next phase of growth and broader market penetration. Our…Read full document

Generated first quarter revenue of $8.9 million and expanded commercial organization to support future growth and broader market penetration Published landmark, real-world PEDD® Study of 603 PEDD patients and 16,210 non-PEDD patients found PEDD technology was associated with fewer post-procedure complications, reduced hospitalizations, and approximately $7,700 in per-patient charge avoidance despite greater baseline clinical complexity Presented new clinical and preclinical PEDD data across multiple oncology and embolization applications at the 2026 Society of Interventional Radiology Annual Scientific Meeting Strengthened balance sheet with $46 million equity raise; cash balance of $56.6 million fully funds commercial expansion and pipeline development Revised 2026 revenue guidance to $54 million to $57 million, reflecting impact of commercial expansion and timing of FDA clearance for TriNav® Advance Hosting Conference Call and Webcast today at 4:30pm ET DENVER, May 12, 2026--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced financial results for the quarter ended March 31, 2026, and provided an operational update. "The first quarter marked an important strategic inflection point for TriSalus as we significantly strengthened our commercial infrastructure, expanded the clinical evidence supporting PEDD, and continued advancing our next-generation platform opportunities," said Mary Szela, President and Chief Executive Officer of TriSalus. "We are increasingly demonstrating that PEDD is not simply a device, but a differentiated therapeutic delivery platform capable of improving procedural outcomes, reducing healthcare utilization, and expanding treatment possibilities across multiple indications. During and subsequent to the quarter, we added meaningful new clinical evidence supporting PEDD across liver embolization therapy for liver cancer, and other new embolization applications, including one of the largest real-world analyses ever conducted in interventional oncology. At the same time, we substantially completed the commercial expansion initiatives designed to support our next phase of growth and broader market penetration. Our updated revenue outlook reflects the lower Q1 revenue from the commercial expansion and the delayed FDA clearance timing for TriNav Advance, our next-generation device which extends PEDD capability to small distal vessels via microcatheter. We continue to believe the long-term growth opportunity for the PEDD platform remains substantial." Highlights for First Quarter 2026 and Recent Weeks Reported publication of Real World PEDD Study of more than 16,800 patients (603 PEDD patients matched against 16,210 non-PEDD patients) published in Journal of Comparative Effectiveness Research, which found PEDD technology was associated with fewer post-procedure complications, reduced hospitalizations, and approximately $7,700 in per-patient charge avoidance despite PEDD patients having greater baseline clinical complexity. Presented new clinical and preclinical data at the 2026 Society of Interventional Radiology Annual Scientific Meeting including a preclinical study showing enhanced hepatic tumor penetration during embolic sphere delivery, a clinical analysis of embolization in neuroendocrine tumor liver metastases before and after PEDD, and a clinical assessment of safety and efficacy in uterine artery embolization, further expanding the body of evidence supporting PEDD across multiple applications. Reported publication of preclinical research in Frontiers in Oncology demonstrating enhanced delivery and immune activation with nelitolimod delivered with PEDD in liver tumor models. Completed a public offering during the quarter, further strengthening the balance sheet with $46 million in gross proceeds and supporting the Company’s planned commercial expansion initiatives designed to support long-term growth and broader market opportunity. Appointed veteran healthcare investor Michael P. Stansky to the Board of Directors in February 2026. Announced the appointment of Richard Marshall, M.D., as Chief Medical Officer effective June 29, 2026. Financial Results for Q1 2026 Revenue from the sale of the TriNav system, was $8.9 million for the three months ended March 31, 2026, a decrease of 2.9% compared to the same period in 2025. The decrease in revenue was primarily due to the Company's commercial expansion. Gross margins were 86.2% for the three months ended March 31, 2026, compared to 83.7% for the same period in 2025. The year-over-year increase in gross margin was primarily due to lower average cost per TriNav unit. Operating losses were $8.4 million for the three months ended March 31, 2026, compared to losses of $7.3 million for the same period in 2025. The increase in operating losses was primarily driven by higher sales and marketing expenses related to our commercial expansion and an increase in non-cash stock-based compensation expense, partially offset by improved gross margins. Net income available to common stockholders was $1.5 million for three months ended March 31, 2026, compared to a net loss of $11.1 million for the same period in 2025. The current period includes $11.3 million of non-cash gains related to changes in the fair value of various derivatives for the three months ended March 31, 2026, compared to losses of $1.7 million for the same period in 2025. The basic and diluted earnings (loss) per share for three months ended March 31, 2026, was $0.03, compared to $(0.39) for the same period in 2025. The non-GAAP measure of adjusted EBITDA is shown in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.8 million for the three months ended March 31, 2026, compared to losses of $5.5 million for the same period in 2025. The increase in adjusted EBITDA losses were primarily driven by higher stock-based compensation and increased operating expenses. On March 31, 2026, cash and cash equivalents totaled $56.6 million. The Company raised $46.0 million in gross proceeds in the first quarter from an equity offering. The Company believes that these proceeds provide sufficient cash runway to fully fund commercial expansion and pipeline development. Conference Call & Webcast The Company will host a conference call and webcast today at 4:30 PM eastern time to discuss its financial results for the quarter ended March 31, 2026. Parties interested in participating by phone should register using the online form on our investor relations website. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. Forward Looking Statements Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav® system and nelitolimod investigational immunotherapy, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav® system and nelitolimod investigational immunotherapy, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with regulatory approval of the Company's product candidates, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company’s filings with the Securities and Exchange Commission under the heading "Risk Factors." All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. Non-GAAP Financial Measure To supplement the financial results presented in accordance with GAAP, TriSalus has also included in this press release non-GAAP adjusted EBITDA, which excludes from net loss, income tax expense, interest expense, interest income, change in fair value of SEPA, warrant and revenue-base redemption liabilities, change in fair value of contingent earn out liability, stock-based compensation expense and depreciation. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. TriSalus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand TriSalus’ business. TriSalus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, TriSalus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare TriSalus’ results from period to period, and to identify operating trends in TriSalus’ business. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512970102/en/ Contacts For Media Inquiries: Jeremy Feffer, Managing DirectorLifeSci [email protected] For Investor Inquiries: David PatienceChief Financial [email protected]

TranscriptFY2026 Q12026-05-12

FY2026 Q1 earnings call transcript

Earnings source - 56 paragraphs
Operator

Good afternoon, and welcome to the TriSalus Life Sciences First Quarter 2026 Earnings Conference Call. All participants are currently in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. As a reminder, this call is being recorded for replay purposes. I will now turn the call over to Jeremy Feffer, Managing Director with LifeSci Advisors. Please go ahead.

Jeremy Feffer

Thank you, operator, and thank you all for joining us today. With me from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Medical Director. Mary will provide an overview of our first quarter results and our strategy for the balance of the year. David will walk through the financial results in detail. Dr. Marshall will join Mary and David for the Q&A portion of the call. Earlier today, TriSalus released its financial results for the quarter ended March 31st, 2026. A copy of the press release is available on the TriSalus Investor Relations website. Today, TriSalus also announced the publication of a landmark real-world evidence study evaluating the clinical and economic impact of our Pressure-Enabled Drug Delivery, or PEDD technology. Mary will discuss that study in detail.

Jeremy Feffer

Before we begin, I would like to remind you that during today's call, management will make forward-looking statements within the meaning of the federal securities laws. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements other than statements of historical fact, including, without limitation, statements regarding our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals are forward-looking. They are based on current estimates and assumptions and involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results to differ materially from those anticipated. You should not place undue reliance on these statements.

Jeremy Feffer

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. TriSalus disclaims any obligation, except as required by law, to update or revise any forward-looking statement, whether due to new information, future events, or otherwise. This call contains time-sensitive information and is accurate only as of today's live broadcast, May 12, 2026. With that, I'll turn the call over to Mary.

Mary Szela

Thank you, Jeremy, and good afternoon, everyone, and thank you for joining us. I'll cover four topics today. First, our first quarter results. Second, the deliberate realignment and significant expansion of our commercial organization, creating a foundation to capture the multi-year growth that a cadence of new clinical and health economic evidence will unlock over the next 18 months. Third, our updated 2026 guidance and the outlook for the balance of the year. Fourth, in my view, the most important news of the quarter, the publication of landmark real-world evidence on PEDD, the largest study of its kind ever conducted, demonstrating fewer complications, fewer hospitalizations, and roughly $7,700 per patient in cost avoidance. This is meaningful news for TriSalus and, more importantly, for the patients we serve. David will then provide a detailed financial review, and we'll take your questions.

Mary Szela

As we previewed on our 2025 year-end call, our 2026 plan called for a disciplined investment in commercial infrastructure designed to deepen physician engagement, extend our footprint to cover new applications, and lay the foundation for future growth. It's why we raised capital this quarter. After several years of significant growth, our territories were expanding beyond what individual representatives and our sales leaders could cover effectively, and the gap was widening as the new applications began to emerge. Continuing to operate at the prior scale was simply not a path to capturing the full opportunity ahead of us in the liver embolization market or the new applications we are entering. The investment had three core dimensions: new commercial leadership, a meaningful expanded talent base across sales leadership, field management, and clinical specialist roles, a realigned, significantly larger field footprint that scales for future growth.

Mary Szela

Anchoring the expansion is Chris Staudt, who recently joined us as Senior Vice President of Sales and Commercial Operations. Chris brings more than 20 years of commercial leadership in diagnostics and in life sciences, with senior roles at Roche, Ventana, Luminex, and most recently, Accelerate Diagnostics, where he led U.S. commercial. He has a proven track record of building and scaling high-performing field organizations and securing strategic partnerships with leading health systems, an important initiative we want to pursue. Chris is precisely the Operator we need to lead our commercial organization through this next phase of growth, and we're fortunate to have him on our team. As of May, the new significantly expanded sales organization is largely in place.

Mary Szela

As with any expansion of this scale, Q1 revenue reflects the transition of costs of territory realignment, representative onboarding, representative time out of the field for training, and the rebuilding of account relationships. In roughly 60% of our territories, where the rep-to-physician relationship remained intact, sales performed in line with expectations. In the remaining 40%, we deliberately modified two critical relationships at the same time: rep to physician and rep to manager. Both are primary drivers of execution and unit volume. Modifying them simultaneously was the right strategic choice. We expect sales productivity to improve steadily throughout the balance of the year, complemented by growing contributions from new clinical data, new account capture, and penetration into new applications. Q1 performance was not a function of softer demand or any change in the underlying fundamentals of our business.

Mary Szela

It reflects the deliberate cost of a build-out phase, investing now in the commercial engine required to scale this organization for our next phase of growth. We are revising our full year 2026 revenue guidance to a range of $54 million-57 million. The driver of this revision includes both the lower Q1 revenues from the Commercial Expansion and the delayed FDA clearance timing for TriNav Advance, our next-generation device which extends PEDD capability to small distal vessels via microcatheter. FDA review of TriNav Advance is now running approximately five months past the 30-day MDUFA review goal. We've been in active dialogue with the FDA, and while we still expect clearance in the second half of the year, we are taking a prudent approach to forecasting the launch given the inherent unpredictability of clearance timing and the appropriate market evaluation period that follows.

Mary Szela

This timing shift removes our Advance revenue expectations from the second half of the year due to the clearance delay. We remain enthusiastic about the launch. TriNav Advance creates an incremental market opportunity by enabling interventional radiologists to access the benefits of PEDD while using the microcatheter of their choice. Today, physicians who employ our super selective approach prefer to track to the site of delivery with their existing microcatheter. TriNav Advance meets them where they're already in practice. Revising guidance is an adjustment the TriSalus team nor I take lightly. We remain fully committed to our investors and to executing against the goals we set. We believe taking a measured posture on TriNav Advance is the right one. Once Advance is in our hands, we'll have a complete portfolio supporting the full range of liver embolization procedures.

Mary Szela

I want to spend a moment on the development of the quarter that matters most for TriSalus and more importantly, the patients we serve. Today, we published the largest real-world evidence study of PEDD ever conducted. It includes 603 PEDD patients matched against more than 16,210 non-PEDD patients drawn from a 300 million patient population-based claims database covering 96% of U.S. payers, with data spanning January 2020 through March of 2024. The cohort comprises 515 TARE patients and 88 TACE patients, making it the largest TARE PEDD dataset ever published and the most comprehensive PEDD dataset across both embolization modalities. The analysis used a rigorous two-stage matching design, Coarsened Exact Matching paired with propensity score matching applied to both the overall cohort and to each modality subgroup. The headline result is compelling.

Mary Szela

Despite higher baseline disease burden, the data is demonstrating that PEDD is simply not a device, but a highly differentiated Therapeutic Delivery Platform capable of improving liver embolization outcomes, reducing healthcare utilization, and expanding treatment possibilities across multiple indications. PEDD-treated patients achieved statistically significant better outcomes across every measure. Four takeaways stood out. Number one, less fatigue and preserved immune function across the full cohort. Significantly less post-procedure fatigue across the full cohort, 20.9% versus 26.4%. Roughly ninefold reduction in lymphopenia at high adopter centers, 0.6% versus 5.2%. Preserving lymphocyte counts is clinically critical since lymphopenia is a known barrier to downstream immunotherapy. Bottom line, PED patients leave the procedure with their immune systems more intact and remain eligible for follow-on immunotherapy treatment. Number two, lower 30-day readmissions in the TACE subgroup, driven by significantly improved tumor targeting.

Mary Szela

PEDD delivered approximately 48% more doxorubicin per procedure. PEDD procedures had 30-day inpatient admissions cut by more than half, 8% with PEDD versus 20.5% without. Bottom line, direct evidence of improved tumor targeting with less off-target toxicity. Number threethe more a center uses PEDD, the better the outcomes. At top 5% adoption facilities, the lymphopenia gap widens further and further, and liver metastatic outcomes improve sharply across both the TARE and TACE practice patterns. In secondary liver metastases, patients at high adopter centers, fatigue was cut by more than half, 19.2% versus 39.7%. Lymphopenia was nearly eliminated, 0% versus 8.2%. Bottom line, the more a center uses PEDD across either care or case, the better the outcomes get. Early adoption and institutional experience compound the benefit. Number four, downstream cost avoidance.

Mary Szela

Per patient cost avoidance of approximately $7,700 across the full 603 patient PEDD cohort. Roughly $3,100 from fewer inpatient stays and $4,600 from fewer post-procedure complications. Cost avoidance holds across both TARE and TACE and is not isolated to one modality. Higher and more durable response rates may further reduce total procedures per patient, compounding the economic benefit over time. Bottom line, PEDD effectively reduced downstream costs in both TARE and TACE cases. This large landmark publication validates what we've been saying for years about the clinical rationale for PEDD, and it does so in patients representative of everyday clinical practice. For our physician customers, it reinforces that the investment in PEDD competency pays compounding dividends. For our commercial team, it's a peer-reviewed evidence at scale that accelerates institutional adoption. Beyond this publication, we continue to generate new Clinical Evidence on the patient impact of PEDD.

Mary Szela

We now have 10 active studies underway across 24 clinical sites, generating data on more than 400 TriNav-treated patients. Two new prospective investigator-initiated trials are set to begin enrollment this quarter. A study called PRESSURE at Stanford is a randomized study of TriNav and TARE for liver metastases comparing tumor-absorbed dose, response rate, and disease control to the current standard delivery. PREDICT at MD Anderson, a prospective study evaluating PEDD impact in hypovascular tumors. Both are designed to generate exactly the kind of prospective head-to-head data that drives clinical adoption at top academic centers. We're also preparing to publish results from two completed investigator-initiated trials, the PETER study at Massachusetts General Hospital and TRIFY90 at MD Anderson. Both have completed data analyses and are targeting publication submission this quarter. We believe these readouts will be a meaningful catalyst for second-half commercial momentum.

Mary Szela

Lastly, we initiated two large retrospective studies during the quarter examining TriNav-delivered care in HCCs. This will provide cost-efficient evidence on outcomes and target populations and will provide the basis of the clinical trial design of our larger prospective clinical trials we plan to initiate in the second half of 2026. Beyond liver, we continue to build meaningful momentum across our new applications, uterine artery embolization, thyroid artery embolization, and genicular artery embolization, each a significant and independent growth factor. At SIR in 2026, Dr. Francis King of Rutgers Robert Wood Johnson Medical School presented a retrospective analysis of PEDD in uterine artery embolization. The headline is the kind of number you rarely see in interventional medicine. Median dominant thyroid volume reduction of 97.5% versus a historical literature comparator of approximately 50%.

Mary Szela

This is a step change in clinical effect achieved with less embolic material and shorter procedure time, exactly what you would expect from a more targeted delivery mechanism. The study also reported 100% technical success with no device-related complications and sustained reductions in pain and heavy menstrual bleeding at both one and six-month follow-up. In Q1, we approved expanding this study to 50 patients and we're actively designing a prospective trial to further evaluate TriNav's potential to streamline workflow, reduce procedure and fluoroscopy time, and improve outcomes in uterine artery embolization.

Mary Szela

Our PROTECT registry continues to roll across multiple centers, evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for conventional therapies. Preliminary results published in the Journal of the Endocrine Society demonstrate 100% technical and clinical success, a 73% reduction in thyroid size, and normalization of thyroid function in 71% of participants with no neurovascular complications.

Mary Szela

These are remarkable results for a minimally invasive outpatient procedure. In February, Dr. Juan Camacho and his colleagues published a review of thyroid artery embolization in Seminars in Interventional Radiology, highlighting PEDD's unique ability to enhance distal distribution and reduce the need for carotid circulation catheterization. We now have enrolled more than 50% at our 11 sites who are actively recruiting patients. PROTECT is on track to deliver the first multi-center U.S. data on thyroid artery embolization and to position PEDD-TAE as the leading approach for this procedure. We just concluded a pilot registry and now are preparing to launch a formal clinical trial evaluating genicular artery embolization for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. GAE represents a novel, minimally invasive approach to pain management and mobility preservation, with the potential to delay or avoid knee arthroplasty in appropriate patients.

Mary Szela

This is an emerging field, and we believe our PEDD platform is uniquely positioned to drive the clinical rigor needed to establish it as standard of care. Collectively, these indications represent a U.S. addressable market of approximately $2.5 billion, and we're methodically building both the Clinical Evidence base and the commercial infrastructure to address all of them. A brief update on our nelitolimod program. We remain on track to deliver our consolidated PERIO phase I readout in the early second half of 2026. As a reminder, that readout will combine data from three completed dose escalation studies, along with emerging data from an ongoing investigator-initiated study, and deliver them as a single complete data set rather than a series of sequential partial releases. This approach reflects our commitment to a rigorous, internally validated package, one we believe will most clearly demonstrate the program's potential.

Mary Szela

The timing is not driven by any safety signal or by any efficacy concern or by any change in our strategic priorities. In parallel, we continue to advance our broader pancreatic strategy. Pancreatic cancer remains one of the most significant unmet needs in oncology, and we believe our novel pancreatic PEDD device is uniquely suited to overcome the delivery barriers that have long limited therapies in this disease. As we prepare to share the nelitolimod data, we're also building the case for PEDD as an adjunct to current and next generation pancreatic regimens. We expect to have more to share as the year progresses. Our commitment to both nelitolimod and our broader pancreatic program is unchanged.

Mary Szela

Consistent with the strategy we previously communicated, we intend to advance these programs through a partnership structure, one designed to preserve their long-term value while maintaining the capital discipline required to fund our near-term commercial and clinical priorities. Before I turn the call over to David, let me summarize where we stand and what we're building towards. Entering the remainder of 2026, we have a substantially expanded commercial organization in place poised to accelerate multi-year growth. The most significant real-world evidence data set in our history, published in a peer-reviewed journal confirming the statistical significant clinical and economic value of PEDD at scale, and a pipeline of new applications and clinical readouts that build throughout the year.

Mary Szela

Our near-term milestones include generating differentiated clinical data across UAE, TAE, and GAE, releasing a nelitolimod data update in the second half, delivering our full year 2026 revenue of $54 million-57 million, and lastly, subject to FDA clearance, launching TriNav Advance in the second half. We're executing against all of these priorities from a position of financial strength with the growth capital we raised in Q1 fully supporting our strategic roadmap. I remain deeply confident in our team, our platform, and the long-term value we're creating for both patients and shareholders. With that, I'll turn the call over to David.

David Patience

Thank you, Mary, and good afternoon, everyone. Let me walk through the results for the first quarter ended March 31st, 2026. Revenue for the first quarter was $8.9 million compared to $9.2 million in the prior-year period. The lower revenues were due to the transition related to the expanded commercial organization. Gross margin for the quarter was 86% compared with 84% in the prior-year period. The improvement was driven by lower average unit costs on TriNav and our continuous manufacturing improvement. Research and development expenses were approximately $3.2 million compared to $3 million in the prior-year period. The increase was driven by non-cash stock-based compensation expense. The current period includes approximately $500,000 of non-cash stock-based compensation expense.

David Patience

Sales and marketing expenses were approximately $7.4 million compared to $6.7 million in the prior year period. The increase reflects our deliberate investment in expanding our commercial footprint, including headcount, onboarding, expanded training, and territory development costs associated with the sales force expansion. The current period includes approximately $500,000 non-cash stock-based compensation expense. General and administrative expenses were approximately $5.4 million compared with $5.2 million in the prior year period. The increase was driven by higher non-cash stock-based compensation expense. The current period includes approximately $1.3 million of such expense. Consistent with prior years, we expect first quarter G&A expenses to be higher than subsequent quarters as many annual public company expenses materialize in the first quarter. Net operating loss for the quarter was $8.4 million compared to $7.3 million in the prior year period.

David Patience

The increase reflects two factors: lower revenue from the Commercial Expansion and a deliberate increase in sales and marketing investment associated with our Commercial Expansion. Adjusted EBITDA loss for the quarter was approximately $5.8 million, compared to $5.5 million in the first quarter of 2025. As of March 31st, 2026, cash and cash equivalents totaled $56.6 million. In closing, the fundamentals of the business are strong. Gross margins remain durable in the mid-80s, and our cash position fully funds our strategic growth plan. The investment we made in Q1 in our commercial organization and as we continue to make in PEDD Clinical Evidence are foundational and will compound. They allow TriSalus to scale successfully and fully execute for the next phase of growth. We look forward to demonstrating that progress as the year unfolds. Thank you all for your continued support.

David Patience

With that, operator, we will open the line for questions.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from Frank Takkinen with Lake Street Capital Markets. You may proceed.

Frank Takkinen

Great. Thank you for taking my questions. I was hoping to start with one on the quarter and then kind of forward-looking from there. On the quarter, maybe specific to the 40% called out that were disrupted in the sales force, can you help quantify just maybe how much disruption that caused? Maybe more importantly, as you're looking at the business now and as you were exiting the quarter and into second quarter now, what can you tell us to give us a little bit of confidence really in the recovering trajectory of the business to achieve the guidance range for the year?

Mary Szela

Hi, Frank Takkinen. How are you? Let me talk first about the 60%. 60% of our sales or territories were not disrupted, and we saw them perform as expected. Think of that as a control group. We are very comfortable that there's been really no fundamental change in demand, no fundamental change in terms of the adoption and continued growth in the business. Now, in the remaining 40%, we changed two dynamics. We changed rep to, you know, manager and rep to physician. It was largely a result of just our growth. You know, it got to the point where the territories had grown so substantially that it was inadequate for those reps to cover them. That caused some disruption in sales because we disrupted those territories.

Mary Szela

We also had some new reps coming in, which was time out of the field. That was the driver of Q1 performance. We're largely in place today, and we're really happy with what we're seeing. You know, I've been through many different sales expansions in the past. You always have a short-term hit when you make these transitions. If you do it in the right way, which I think we have the right talent and the right territory footprint now, we'll start to see that ramp continuously throughout the rest of the year.

Frank Takkinen

Okay. That's helpful. Maybe as a, my follow-up, I think last call you were talking about effectively doubling the sales organization. Maybe an update related to that. Have you achieved that level of hiring? Is there still a portion that needs to hire to hit that doubling? If that's the case, maybe when will that, is that expected to be complete?

Mary Szela

Yeah. Thank you for asking that question. You know, one of the things that occurred during Q1, this was largely due to the capital we raised, just the level of talent of who we were attracting to the company was really unprecedented for us. That drove us to make the decision to slightly expand even further than what we originally envisioned. You know, we are, you know, a little bit above that, you know, doubling of the organization, we think that was the right decision to make at this point. We have just enormous growth potential. You know, $2.5 billion market, cross liver and all the new applications.

Mary Szela

We now have the right footprint of organization, the right combination of management, clinical specialists, and reps that really allow us to scale this company far beyond where we are today.

Frank Takkinen

Okay, that's helpful. I'll hop back in queue. Thank you.

Operator

Thank you. Our next question comes from William Pavlik with Canaccord Genuity. You may proceed.

William Plovanic

Hey, great. Thanks. Good evening. Thanks for taking our questions. Just like to start out first, I was wondering if you could level set us with, you know, what was the composition and size of the commercial organization prior to the expansion and kind of numbers? Where does that sit now as we look at, you know, managers like, you know, VP, regional managers, territory managers that are quota carrying, and then obviously the clinical. Kinda what were those kind of numbers generally, pre and post this transition?

Mary Szela

Hi, Bill. How are you? We're not giving specific numbers, but let me give it to you in a qualitative standpoint. Over the last three years, we've been adding kind of very marginally two reps at a time. We had really started to stretch the manager to rep relationship where it got above double digits, which was too much. In this new reorganization, we expanded the number of territories, you know, more than double. We also really changed the rep to manager level. We added another executive level of management, which we think is really important because in light of the data that we're producing, we now have the opportunity for them to reach out to hospital systems and payers.

Mary Szela

We think this is gonna be an important catalyst for us as we move forward because the data is so strong. We now have an organization that's sized for the full 400 accounts that we wanna pursue both in the liver and the new applications.

William Plovanic

It sounds like this started in early March, and you feel like you've completed this by May. What is the typical ramp time for a rep? How should we think about revenue cadence for the year? You know, is Q2 up year-over-year? Kinda in my numbers, it's probably gonna be down closer to about $10.5 million. You know, the ramp through the rest of the year, 'cause I think you mentioned the cadence would be pretty linear and consistent at least. I mean, those are my words, not yours, that was my takeaway. Thanks.

Mary Szela

Yep. No, it, you're exactly right. We, we typically see with our reps, now the talent of these reps are just outstanding. We see a six to nine-month ramp. All the reps are largely in place. We anticipate for the remainder of the year just to see month-over-month continual growth. I think we were, you know, we've been really reasonable in our assumptions. However, what we're seeing is some of these reps come out of the gate pretty strongly. I'll hand it over to David to talk about the ramp, but we feel confident about the rest of the year.

Mary Szela

The caliber and the quality of these reps that we were attracting, and just to give you a little bit of color on that, we never were really able to get people away from the big companies who have been there 15, 18 years. That's the type of reps that we were getting here that were coming to us. Just deep, you know, relationships with the interventional radiologists, a lot of interventional radiology knowledge, really excited about the company and where we were going. We think that's gonna bode well in terms of performance throughout the year.

David Patience

Yeah, Bill, this is David. To provide some context on the second half of the year, you know, we're thinking about exactly the expansion and the effect of the doubled size is largely in place, and that includes both reps that carry quotas and specialists that are also in the territory supporting those quotas as well. As that productivity is ramping, you know, we also are bringing online additional capacity, and that's what's gonna drive the step-up, you know, from prior periods in the second half of the year. We're very excited about the capacity that we've built, so we feel that the second half ramp is structurally built, and we're very excited to see those reps start contributing in a meaningful way.

William Plovanic

David, how should we think about Q2? I mean, I think with the reset, we just wanna make sure that we're thinking the same way you are. You know, any comments on the ten and a half million-ish estimate or number I'm thinking of?

David Patience

Yeah, Bill, for the second quarter, we are thinking that would be for, you know, marginal sequential gain quarter-over-quarter as these reps are coming out of training. I think where you are is a fair point, we would see that meaningful progress as they reach productivity, you know, in Q3 and Q4.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone. Our next question comes from Justin Walsh with JonesTrading. You may proceed.

Justin Walsh

Hi. Thanks for taking the question. I would love to hear your thoughts on where you see the new PEDD data having the most direct impact. I'm curious about the balance of clinical versus economic benefit and how that will resonate with physicians and institutions to help drive additional adoption.

Mary Szela

Really good question. I think we're really proud of this data. In fact, right before this call, we just got off a call with one of the physicians who I would characterize as really the father of interventional radiology. I think what we're starting to see in this specialty is really begin to value the real world data. How is this technology, you work, not only in the, you know, expert academic centers, but how does it work across all the community centers? The way he characterized this data, he was just incredibly enthusiastic, and I'll have Dr. Marshall talk about it as well. It just validates a lot of our prospective clinical data.

Mary Szela

Together, this data set with all the other studies that we've conducted, it just strengthens that this delivery platform is really significant, and it has both clinical, you know, both clinical side effect and cost-effective data. We believe by building this database that is so interrelated in this way, that we can begin to create a data set that, you know, really creates this as standard of care and be inclusion in the NCCN guidelines. Dr. Marshall, you wanna comment on it? Because I think as a practicing interventional radiologist, I think you'll have some thoughts on this data as well.

Richard Marshall

I do. I think the most interesting part about this data is that it's real world data. This is from physicians who have been practicing. This is not a prospective study that's designed with tight parameters to ensure good data. This is actually what's happening in the U.S. It does validate a lot of the things that we've been saying, the things that we know about TriNav. It's a different way of thinking about looking at data in interventional radiology. This is something that we see large drug companies do, is use HEOR data to help understand the economic value of their products. We're shining a light on some of the things about interventional radiology that have been ignored, helping physicians understand the value that their procedures bring to patient care.

Mary Szela

I thought I'd comment on one aspect that I thought was really profound and that we've heard from some of the other interventional radiologists who have looked at the data. One of the things in terms of having no effect on lymphopenia, that to oncologists has been resonates really strongly. One of the things that's critical in these treatments, there's always been a question about whether embolization can be used in combination with some of the other immunotherapy regimens. You know, if you have elevation in liver enzymes, if you have lymphopenia, often that can disrupt a patient's treatment. When they saw this data, this is just giving them validation that this type of approach can be really impactful for patients, and they don't have to disrupt the treatment. This is the first time we've had this type of data before.

Mary Szela

We think this could not only impact the interventional radiology community, we think it could have real impact in the oncology community as well.

Justin Walsh

Great. Thanks for taking the question.

Operator

Thank you. I would now like to turn the call back over to Mary for any closing remarks.

Mary Szela

Well, thank you for your time today. I really appreciate it, and thank you again for the support of the company.

Operator

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook