Product Development and Market Expansion - TriSalus reported a significant expansion in its PEDD device portfolio with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter, aimed at optimizing therapeutic delivery for larger vessels [150]. - The company estimates that the new PROTECT registry study could expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity [152]. - TriSalus received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement prospects for hospitals [149]. - The company is actively seeking pharmaceutical partners to advance the development of nelitolimod due to the high costs associated with clinical trials [153]. - TriSalus's innovative technology aims to address high intratumoral pressure and off-target delivery challenges in solid tumor treatments [147]. - The company is focused on transforming treatment paradigms for patients with solid tumors through its integrated delivery technology and investigational therapies [147]. Financial Performance - Revenue increased by $4.2 million, or 57.4%, for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to an increase in TriNav units sold [170]. - Cost of goods sold rose by $0.9 million, or 89.8%, for the three months ended September 30, 2025, attributed to more TriNav units sold [171]. - Gross profit increased by $3.3 million, or 52.2%, for the three months ended September 30, 2025, while gross margin decreased to 83.5% from 86.3% [172]. - Research and development expenses increased by $1.0 million, or 22.7%, for the three months ended September 30, 2025, mainly due to clinical trial expenses related to nelitolimod [174]. - Sales and marketing expenses rose by $0.7 million, or 11.4%, for the three months ended September 30, 2025, driven by increased performance-related compensation [176]. - General and administrative expenses increased by $1.9 million, or 40.9%, for the three months ended September 30, 2025, primarily due to a non-cash stock-based compensation award [177]. - For the nine months ended September 30, 2025, revenue increased by $10.8 million, or 50.9%, compared to the same period in 2024, driven by higher TriNav unit sales [184]. - Cost of goods sold for the nine months ended September 30, 2025, increased by $2.3 million, or 80.2%, due to more TriNav units sold [185]. - Net loss attributable to common stockholders for the nine months ended September 30, 2025, was $59.9 million, compared to $22.3 million in the same period of 2024, reflecting a significant increase in losses [182]. - Interest expense increased by $2.1 million for the nine months ended September 30, 2025, due to additional funds borrowed under the First Delayed Draw Term Loan [190]. - The company incurred a net loss of $29.5 million for the nine months ended September 30, 2025, compared to a net loss of $19.9 million for the same period in 2024 [196][197]. Cash Flow and Funding - Cash and cash equivalents were approximately $22.7 million as of September 30, 2025, with a minimum cash requirement of $10.0 million, which was later reduced to $5.0 million [194]. - Net cash used in operating activities was $15.5 million for the nine months ended September 30, 2025, a decrease from $35.1 million in the same period of 2024 [195][197]. - The company raised gross proceeds of approximately $22.0 million through a Private Placement on April 30, 2025, and $10.0 million from the First Delayed Draw Term Loan Commitment [194][199]. - Net cash provided by financing activities was $30.5 million for the nine months ended September 30, 2025, compared to $34.9 million in 2024 [199][200]. - The company expects to incur significant expenses related to the commercialization of its product TriNav, which will require substantial additional funding [201][204]. Risks and Concerns - The expiration of the Transitional Pass-Through payment program on December 31, 2023, poses a risk to maintaining current pricing and gross margins for TriNav [154]. - The company is subject to significant risks related to inflation, rising interest rates, and potential disruptions in access to capital, which could impact its liquidity [203][204]. - There is substantial doubt regarding the company's ability to continue as a going concern as of September 30, 2025, due to its reliance on additional capital [208]. - The company has contractual obligations of $2.0 million in lease obligations as of September 30, 2025 [209]. - The company has paid $12.0 million to Dynavax and may owe up to an additional $158.0 million upon achieving certain milestones related to nelitolimod [210][212].
TriSalus Life Sciences(TLSI) - 2025 Q3 - Quarterly Report