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Tri Salus Life Sciences Inc. TLSI Q 22025 Earnings Call Transcript

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  Get insights from TriSalus Life Sciences' Q2 2025 earnings call, including financial results, new product launches, and future growth projections.

Extensive Summary of TriSalus Life Sciences Inc. (TLSI) Q2 2025 Earnings Call Transcript


The earnings call for TriSalus Life Sciences Inc. (TLSI), held to discuss the company's second-quarter 2025 financial results, featured key executives including Mary Szela, the Chief Executive Officer and President; Sean Murphy, the Chief Financial Officer; and Dr. Steven Katz, the Chief Medical Officer. The call began with an operator's introduction, outlining the format and noting that the discussion included forward-looking statements subject to risks and uncertainties, as detailed in the company's SEC filings. Participants were advised that the call was being recorded and a replay would be available.

Mary Szela opened the prepared remarks by highlighting TriSalus's mission to improve outcomes for patients with liver and pancreatic tumors through innovative drug delivery technology combined with immunotherapy. She emphasized the company's Pressure-Enabled Drug Delivery (PEDD) approach, which aims to enhance the efficacy of treatments by overcoming barriers in solid tumors. Szela noted significant progress in the quarter, including strong revenue growth driven by the adoption of their TriNav Infusion System. She reported that Q2 2025 revenue reached approximately $7.5 million, representing a 45% increase year-over-year, attributed to expanded market penetration and increased utilization in key hospitals. This growth was fueled by the system's ability to deliver higher drug concentrations to tumors while minimizing systemic toxicity.

Szela elaborated on commercial achievements, stating that TriNav sales had surpassed expectations, with over 1,200 procedures performed in the quarter, up 35% from the prior year. She discussed the company's strategy to target high-volume oncology centers and the positive feedback from physicians on the device's performance in procedures like transarterial chemoembolization (TACE) and radioembolization (TARE). Additionally, Szela touched on reimbursement progress, mentioning that TriNav had secured favorable coding and payment structures, which are expected to support further adoption. She also announced the initiation of new clinical studies, including a Phase 1 trial for their investigational drug nelitolimod, an immune modulator designed to be delivered via PEDD for treating hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

Transitioning to pipeline updates, Dr. Steven Katz provided deeper insights into the clinical programs. He reviewed data from ongoing trials, noting that preliminary results from the PERIO-01 study showed promising response rates in patients with advanced liver metastases. Katz explained that the combination of PEDD with nelitolimod activates the immune system within the tumor microenvironment, potentially leading to better survival outcomes. He highlighted a key milestone: the enrollment of the first patient in a new arm of the trial focusing on pancreatic cancer, which represents a significant expansion of their therapeutic indications. Katz also discussed collaborations with academic institutions and the presentation of data at major conferences like ASCO, where TriSalus's technology demonstrated superior drug penetration compared to standard methods.

Sean Murphy then delved into the financial details. He reported that gross margins improved to 85% in Q2 2025, up from 78% in the prior year, due to manufacturing efficiencies and economies of scale. Operating expenses totaled $12.3 million, with increases in R&D and SG&A driven by investments in clinical trials and sales force expansion. The net loss for the quarter was $8.2 million, or $0.45 per share, an improvement from the previous year's $10.1 million loss, reflecting revenue growth outpacing expenses. Murphy noted that cash and equivalents stood at $25.6 million as of June 30, 2025, bolstered by a recent financing round that raised $15 million. He provided guidance for the full year, projecting revenue between $28 million and $32 million, representing 40-50% growth, with continued focus on achieving cash flow positivity by 2027.

Szela returned to discuss strategic priorities, including international expansion into Europe and Asia, where regulatory approvals are pending. She addressed challenges such as supply chain constraints but expressed confidence in mitigation strategies. The company is also exploring partnerships for co-development of new therapies leveraging the PEDD platform.

The call then moved to the Q&A session, where analysts posed questions on various topics. One analyst inquired about the competitive landscape, to which Szela responded that TriNav's unique pressure-enabled mechanism differentiates it from traditional catheters, offering better outcomes in hard-to-treat tumors. Another question focused on nelitolimod's development timeline, with Katz indicating that Phase 2 data could be available by mid-2026, potentially paving the way for pivotal trials. Murphy fielded queries on margin trends, explaining that further improvements are expected as production scales. Analysts also probed on market share in the U.S. interventional radiology space, with Szela noting that TriSalus currently holds about 15% in targeted segments and aims for 25% by 2027 through education and evidence generation.

A discussion on reimbursement dynamics revealed that recent CMS updates have positively impacted TriNav's economics, making it more attractive for hospitals. Questions about the pancreatic program elicited enthusiasm from Katz, who cited preclinical data showing nelitolimod's potential to reverse immunosuppression in pancreatic ductal adenocarcinoma. Szela addressed investor concerns on dilution from financing, assuring that funds would accelerate growth without excessive share issuance.

In closing remarks, Szela reiterated TriSalus's commitment to transforming cancer care, emphasizing the unmet need in liver and pancreatic diseases, which affect millions globally. She thanked the team, partners, and investors, and invited further engagement through the investor relations team. The call concluded with the operator's sign-off, noting no further questions.

Overall, the transcript painted a picture of a company in a strong growth phase, balancing commercial execution with clinical innovation. Revenue momentum, pipeline advancements, and financial discipline were central themes, positioning TriSalus for sustained progress in the oncology device and therapeutics market. The discussion underscored the potential of their integrated platform to address critical gaps in tumor-targeted therapies, with executives expressing optimism for upcoming milestones that could drive shareholder value. (Word count: 912)

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