TriSalus Life Sciences(TLSI) - 2024 Q3 - Quarterly Report

Financial Performance - Revenue increased by $2.2 million, or 41.5$8.4 million, or 65.5%, for the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[209]. - Gross profit increased by $1.7 million, or 37.8$7.5 million, or 69.8%, for the nine months ended September 30, 2024, with gross margin percentage rising to 86.4% from 84.2%[211]. - The company reported a net loss available to common stockholders of $2.4 million for the three months ended September 30, 2024[199]. - Net cash used in operating activities was$35.1 million for the nine months ended September 30, 2024, compared to $41.4 million for the same period in 2023[223]. - Cash and cash equivalents were approximately$11.3 million at September 30, 2024, with significant net losses expected to continue due to ongoing investments in R&D and marketing[221]. Expenses - Cost of goods sold rose by $0.4 million, or 70.5$5.3 million, or 55.6%, for the three months ended September 30, 2024, mainly due to reduced clinical trial expenses[203]. - Sales and marketing expenses increased by $1.4 million, or 30.9$4.3 million, or 47.6%, for the three months ended September 30, 2024, primarily due to prior period expenses related to the Business Combination[205]. - Research and Development expenses decreased by $7.3 million, or 33.3$7.4 million, or 64.7%, for the nine months ended September 30, 2024, driven by higher payroll and travel expenses[213]. - General and administrative expenses decreased by $4.2 million, or 23.9$12.4 million raised from the sale of 1,874,867 shares of common stock under the SEPA during the nine months ended September 30, 2024[172]. - The OrbiMed Credit Agreement provides for up to $50.0 million in senior secured term debt, with an initial commitment of$25.0 million made available on April 30, 2024[173]. - The Warrant Exchange Offering resulted in the issuance of 2,110,366 shares of common stock in exchange for tendered warrants[177]. - The company anticipates needing to raise additional capital to fund operations and execute its long-term business strategy[221]. - The company may require additional capital in the near term through securities offerings, debt financings, collaborations, or licensing arrangements[233]. Clinical and Product Development - The TriNav Infusion System received a permanent HCPCS code effective January 1, 2024, allowing for reimbursement for procedures involving the device[164]. - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter to expand its addressable liver embolization market[165]. - TriSalus is currently conducting Phase 1 and Phase 1b clinical trials for nelitolimod, with data from the pancreatic cancer trial expected in 2025[167]. - The company initiated the DELIVER program to evaluate the TriNav system in complex patient populations, aiming to validate previous clinical studies[180]. - The TPT payment program from CMS expired on December 31, 2023, but a new HCPCS code was granted for TriNav, which may affect future revenue[171]. Internal Controls and Compliance - The company has identified material weaknesses in internal control over financial reporting, which could affect the accuracy and timeliness of financial results[242]. - A remediation plan has been developed, including hiring four additional trained resources to address the identified weaknesses[244]. - As of September 30, 2024, the company's disclosure controls and procedures were deemed not effective at the reasonable assurance level[241]. - The company intends to monitor the effectiveness of its remediation plan but cannot estimate the timeline for completion[245]. Legal and Regulatory Matters - The company is not currently a party to any material legal proceedings that could adversely affect its business[249]. - As of September 30, 2024, there is substantial doubt regarding the company's ability to continue as a going concern[234]. - The company's contractual obligations include lease obligations of $2.5 million as of September 30, 2024[235]. - The company has paid Dynavax$12 million and may owe up to an additional $158 million upon achieving certain milestones related to nelitolimod[236].