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 patients with 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 New Technology HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement for the device [149]. - TriSalus aims to transform treatment outcomes for patients with solid tumors by addressing high intratumoral pressure and off-target delivery challenges [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 increased by $0.9 million, or 89.8%, for the three months ended September 30, 2025, driven by higher 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]. - Revenue increased by $10.8 million, or 50.9%, for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to an increase in TriNav units sold [184]. - Cost of goods sold increased by $2.3 million, or 80.2%, for the nine months ended September 30, 2025, driven by higher TriNav units sold [185]. - Net loss available to common stockholders was $10.8 million for the three months ended September 30, 2025, compared to a loss of $2.4 million in the same period of 2024 [170]. - Net loss attributable to common stockholders was $59.9 million for the nine months ended September 30, 2025, compared to a loss of $22.3 million in the same period of 2024 [182]. - 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]. Research and Development - The company has completed Phase I clinical trials for nelitolimod and is supporting two Investigator Initiated Trials, with data from the PERIO-03 Phase I trial expected in late 2025 [153]. - Research and development expenses increased by $1.0 million, or 22.7%, for the three months ended September 30, 2025, primarily due to clinical trial expenses related to nelitolimod [174]. - The company is actively seeking pharmaceutical partners to advance the development of nelitolimod due to the high costs associated with clinical trials [153]. Cash Flow and Financing - 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 for the same period 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 maintains a full valuation allowance for its deferred tax assets, indicating uncertainty regarding the realization of these assets [167]. - 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, unless it can generate sufficient cash flows or obtain additional capital [208]. Expenses Overview - Sales and marketing expenses increased by $0.7 million, or 11.4%, for the three months ended September 30, 2025, due to 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, mainly due to a non-cash stock-based compensation award [177]. - 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].

Financial Performance - TriSalus reported $11.6 million in revenue for Q3 2025, a 57% increase year-over-year and a 3% sequential growth from Q2 2025[5] - The company reaffirmed its full-year revenue growth guidance of at least 50%, driven by the increasing market penetration of the TriNav product suite[2] - Gross margins for Q3 2025 were 84%, down from 86% in Q3 2024, primarily due to lower manufacturing efficiency associated with newly launched products[5] - The net loss attributable to common stockholders was $41.3 million in Q3 2025, compared to $3.2 million in the same period of the prior year, largely due to the conversion of preferred stock[10] - The basic and diluted loss per share was $0.96 for Q3 2025, compared to $0.12 for the same period in 2024[10] - Net loss for the nine months ended September 30, 2025, was $29,474 million, compared to a net loss of $19,937 million for the same period in 2024, representing a 47.6% increase in losses[18] - Adjusted EBITDA for the nine months ended September 30, 2025, was $(16,241) million, compared to $(24,290) million for the same period in 2024, showing an improvement of 33.2%[22] Expenses - Research and Development (R&D) expenses were approximately $5.2 million, up from $4.2 million in the same quarter of the prior year, mainly due to a one-time charge related to clinical studies[5] - Sales and Marketing (S&M) expenses increased to approximately $6.8 million from $6.1 million year-over-year, driven by performance-related compensation[5] - Stock-based compensation expense for the nine months ended September 30, 2025, was $6,934 million, up from $3,744 million in 2024, representing an increase of 85.5%[22] - Cash paid for interest during the nine months ended September 30, 2025, was $2,528 million, compared to $1,757 million in 2024, indicating a rise of 43.8%[18] Cash and Assets - As of September 30, 2025, cash and cash equivalents totaled $22.7 million, providing sufficient runway to reach positive adjusted EBITDA[10] - Cash and cash equivalents rose to $22,687 million as of September 30, 2025, up from $8,525 million at the end of 2024, indicating a significant increase of 166.5%[15] - Total assets increased to $36,463 million as of September 30, 2025, compared to $23,971 million on December 31, 2024, reflecting a growth of approximately 52.0%[15] Liabilities and Stockholders' Deficit - Total liabilities increased to $63,188 million as of September 30, 2025, from $49,865 million on December 31, 2024, marking a rise of approximately 26.7%[15] - The company’s total stockholders' deficit was $(26,725) million as of September 30, 2025, compared to $(25,894) million on December 31, 2024, reflecting a slight increase in deficit of 3.2%[15] Clinical Trials and Product Development - The company initiated a clinical trial to evaluate genicular artery embolization (GAE) for knee osteoarthritis, a condition affecting over 30 million adults in the U.S.[5] - TriSalus completed three PERIO clinical phase 1 dose escalation studies, with clinical study reports expected for data release in Q4 2025[2] Cash Flow - The company reported a net cash used in operating activities of $15,528 million for the nine months ended September 30, 2025, a decrease in cash outflow compared to $35,136 million in the prior year, indicating a 55.8% improvement[18] - Proceeds from the issuance of common stock amounted to $22,211 million for the nine months ended September 30, 2025, compared to $12,586 million in the same period of 2024, reflecting a growth of 76.5%[18]

Special Note Regarding Forward-Looking Statements [Forward-Looking Statements and Risks](index=4&type=section&id=Forward-Looking%20Statements%20and%20Risks) This section highlights that the Quarterly Report contains forward-looking statements subject to known and unknown risks, uncertainties, and assumptions, cautioning investors against undue reliance and listing factors that could cause actual results to differ materially - The report contains forward-looking statements that are **not guarantees of performance** and are subject to **significant risks and uncertainties**[9](index=9&type=chunk)[10](index=10&type=chunk)[11](index=11&type=chunk) - **Key risk factors** include the company's ability to raise future financing, service indebtedness, retain key personnel, successfully commercialize products, achieve regulatory approvals, manage operating losses, execute business strategy, protect intellectual property, and navigate unfavorable industry or global economic conditions[12](index=12&type=chunk) PART I. FINANCIAL INFORMATION This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This item provides TriSalus Life Sciences, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' deficit, and cash flows, with explanatory notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show a significant increase in total assets and liabilities, primarily driven by cash, long-term debt, and warrant/SEPA liabilities, with the company continuing to report a stockholders' deficit | Metric | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :----------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $26,490 | $8,525 | | Total current assets | $38,084 | $20,669 | | Total assets | $41,317 | $23,971 | | Total current liabilities | $9,324 | $10,228 | | Long-term debt, net | $32,274 | $22,084 | | Warrant and SEPA liabilities | $9,997 | $8,316 | | Total liabilities | $60,740 | $49,865 | | Total stockholders' deficit | $(19,423) | $(25,894) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and six months ended June 30, 2025, TriSalus reported increased revenue and gross profit but also higher operating and interest expenses, leading to increased net losses attributable to common stockholders | Metric | Three Months Ended June 30, 2025 ($ thousands) | Three Months Ended June 30, 2024 ($ thousands) | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :------------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Revenue | $11,213 | $7,364 | $20,380 | $13,821 | | Cost of goods sold | $1,802 | $912 | $3,297 | $1,883 | | Gross profit | $9,411 | $6,452 | $17,083 | $11,938 | | Research and development | $3,923 | $4,666 | $7,219 | $10,510 | | Sales and marketing | $7,163 | $6,004 | $13,897 | $12,691 | | General and administrative | $5,657 | $3,956 | $10,628 | $8,583 | | Loss from operations | $(7,332) | $(8,174) | $(14,661) | $(19,846) | | Interest expense | $(1,423) | $(877) | $(2,632) | $(880) | | Net loss available to common stockholders | $(8,288) | $(4,332) | $(18,663) | $(17,538) | | Net loss attributable to common stockholders | $(9,002) | $(5,133) | $(20,089) | $(19,140) | | Net loss per common share, basic and diluted | $(0.27) | $(0.21) | $(0.65) | $(0.81) | [Condensed Consolidated Statements of Stockholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Deficit) The company's total stockholders' deficit decreased from **$(25.9) million** at December 31, 2024, to **$(19.4) million** at June 30, 2025, primarily due to common stock proceeds and stock-based compensation, partially offset by net losses | Metric | At December 31, 2024 ($ thousands) | At June 30, 2025 ($ thousands) | | :-------------------------- | :------------------- | :--------------- | | Additional paid-in capital | $253,652 | $278,786 | | Accumulated deficit | $(279,549) | $(298,212) | | Total stockholders' deficit | $(25,894) | $(19,423) | - Proceeds from the sale of common stock contributed **$20.7 million** to additional paid-in capital during the six months ended June 30, 2025[23](index=23&type=chunk) - Net loss for the six months ended June 30, 2025, was **$(18.7) million**, increasing the accumulated deficit[20](index=20&type=chunk)[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, the company significantly reduced cash used in operating activities and saw a substantial increase in cash provided by financing activities, leading to a notable increase in cash and cash equivalents | Activity | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(11,819) | $(24,289) | | Net cash used in investing activities | $(621) | $(126) | | Net cash provided by financing activities | $30,405 | $29,119 | | Increase in cash, cash equivalents and restricted cash | $17,965 | $4,704 | | Cash, cash equivalents and restricted cash, end of period | $26,840 | $16,831 | - Financing activities in H1 2025 included **$22.2 million** from common stock issuance and **$10.0 million** from debt issuance[29](index=29&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures regarding the company's financial statements, covering business nature, accounting policies, business combination, financial instruments, and specific accounts [(1) Nature of Business](index=13&type=section&id=(1)%20Nature%20of%20Business) TriSalus Life Sciences, Inc. is an oncology-focused medical technology company developing PEDD™ infusion systems and nelitolimod to improve solid tumor treatment, with a history of operating losses and going concern uncertainties - TriSalus Life Sciences, Inc. (formerly MedTech Acquisition Corporation) completed a merger on **August 10, 2023**, with Legacy TriSalus deemed the accounting acquirer[31](index=31&type=chunk) - The company focuses on oncology, developing **Pressure Enabled Drug Delivery (PEDD™) infusion systems** and an investigational immunotherapeutic, **nelitolimod** (a TLR9 agonist), to address high intratumoral pressure and immunosuppression in solid tumors[32](index=32&type=chunk)[33](index=33&type=chunk) - **TriNav™** is a key PEDD device, with new HCPCS codes **C9797** (effective Jan 1, 2024) and **C8004** (effective April 1, 2025) providing reimbursement clarity; new devices like **TriNav LV** and **TriNav FLX** were launched in 2024 and June 2025, respectively[34](index=34&type=chunk)[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk) - The company has a history of recurring operating losses and an accumulated deficit of **$298.2 million** as of **June 30, 2025**, raising **substantial doubt** about its ability to continue as a going concern for the next 12 months without additional financing[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk)[46](index=46&type=chunk) [(2) Summary of Significant Accounting Policies](index=16&type=section&id=(2)%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and methods used in preparing the condensed consolidated financial statements, covering basis of presentation, cash, credit risk, receivables, estimates, inventory, property, leases, and various liabilities - The financial statements are prepared in accordance with **U.S. GAAP**, with certain information condensed or omitted per SEC rules; operating results for the six months ended June 30, 2025, are not indicative of future periods[48](index=48&type=chunk) - The company revised previously issued financial statements for the six months ended June 30, 2024, to correct errors related to **patent cost capitalization**, which were deemed **immaterial**[49](index=49&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) - Significant estimates are made for the valuation of **warrant liabilities**, **contingent earnout liability**, **revenue base redemption liability**, **clinical expense accruals**, and the **valuation allowance on deferred tax assets**[56](index=56&type=chunk) - Revenue is primarily generated from sales of **PEDD infusion systems (TriNav)** and recognized when control transfers to the customer, typically upon shipment, with rebates recorded as a reduction of revenue[73](index=73&type=chunk)[75](index=75&type=chunk)[228](index=228&type=chunk)[229](index=229&type=chunk) - R&D costs, including engineering, regulatory, pre-clinical, and clinical activities, are **expensed as incurred**[76](index=76&type=chunk)[233](index=233&type=chunk) [(3) Business Combination](index=25&type=section&id=(3)%20Business%20Combination) On **August 10, 2023**, TriSalus Life Sciences, Inc. completed a merger with Legacy TriSalus, involving equity exchange, warrant assumption, PIPE financing for Series A Convertible Preferred Stock, and a Sponsor Earnout subject to stock price targets - The merger between MTAC and Legacy TriSalus was consummated on **August 10, 2023**, with MTAC renamed TriSalus Life Sciences, Inc. and Legacy TriSalus as the accounting acquirer[31](index=31&type=chunk)[91](index=91&type=chunk) - Existing Legacy TriSalus stockholders exchanged their equity for **21,999,886 shares of Common Stock**[92](index=92&type=chunk) - A PIPE financing on the closing date resulted in the purchase of **4,015,002 shares of Series A Convertible Preferred Stock** for **$40.2 million**[93](index=93&type=chunk) - **3,125,000 Sponsor Earnout Shares** were made unvested and subject to forfeiture if specific volume-weighted average price (VWAP) targets (**$15.00**, **$20.00**, **$25.00**, **$30.00**) are not met within five years of the closing date[94](index=94&type=chunk)[95](index=95&type=chunk) [(4) Financial Instruments](index=27&type=section&id=(4)%20Financial%20Instruments) The company's financial instruments include cash, receivables, payables, and various fair-valued liabilities like warrants, contingent earnout, SEPA, and revenue base redemption, with Level 3 valuations requiring significant judgment - Financial instruments include cash, accounts receivable, trade payables, and liabilities for warrants, contingent earnout, SEPA, and revenue base redemption, with the latter measured at **fair value**[96](index=96&type=chunk)[98](index=98&type=chunk) - Warrant liabilities (Public, Private Placement, Working Capital) are valued using **Level 1** (publicly traded) and **Level 2** inputs, while contingent earnout, SEPA, and OrbiMed warrant liabilities use **Level 3** (unobservable) inputs[100](index=100&type=chunk)[105](index=105&type=chunk) | Liability Type | Fair Value at Dec 31, 2024 ($ thousands) | Change in Unrealized (Gains) Losses (H1 2025) ($ thousands) | Issuances (H1 2025) ($ thousands) | Fair Value at June 30, 2025 ($ thousands) | | :-------------------------------- | :------------------------- | :------------------------------------------ | :------------------- | :-------------------------- | | Public Warrants - Level 1 | $1,927 | $333 | — | $2,260 | | Private Placement Warrants - Level 2 | $4,872 | $841 | — | $5,713 | | Working Capital Warrants - Level 2 | $1,100 | $190 | — | $1,290 | | Contingent earnout liability - Level 3 | $7,401 | $121 | — | $7,522 | | SEPA derivative liability - Level 3 | $55 | $(52) | — | $3 | | OrbiMed Warrants liability - Level 3 | $362 | $3 | $366 | $731 | | Revenue base redemption liability - Level 3 | $507 | $(149) | — | $358 | - The fair value of OrbiMed Warrants increased from **$362K** to **$731K** in H1 2025, partly due to a **$366K** issuance related to the First Delayed Draw[109](index=109&type=chunk) [(5) Cash, Cash Equivalents and Restricted Cash](index=30&type=section&id=(5)%20Cash,%20Cash%20Equivalents%20and%20Restricted%20Cash) As of **June 30, 2025**, total cash, cash equivalents, and restricted cash significantly increased to **$26.8 million** from **$8.9 million** at December 31, 2024, with **$350 thousand** restricted for a credit card program | Metric | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :------------------------------------------ | :------------ | :---------------- | | Cash and cash equivalents | $26,490 | $8,525 | | Restricted cash (included in Other assets) | $350 | $350 | | Total cash, cash equivalents and restricted cash | $26,840 | $8,875 | [(6) Inventory](index=30&type=section&id=(6)%20Inventory) The company's net inventory decreased slightly from **$4.0 million** at December 31, 2024, to **$3.8 million** at June 30, 2025, primarily due to reduced finished goods, partially offset by increased raw materials and obsolete inventory reserve | Component | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :------------------------ | :------------ | :---------------- | | Raw materials | $1,674 | $1,338 | | Finished goods | $2,194 | $2,720 | | Reserve for obsolete inventory | $(61) | $(10) | | **Inventory, net** | **$3,807** | **$4,048** | [(7) Accrued Liabilities](index=31&type=section&id=(7)%20Accrued%20Liabilities) Total accrued liabilities decreased from **$7.4 million** at December 31, 2024, to **$7.1 million** at June 30, 2025, driven by reductions in clinical trials and incentives, partially offset by increases in general accrued liabilities and payroll | Component | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :-------------------------- | :------------ | :---------------- | | Accrued liabilities - general | $2,230 | $1,850 | | Accrued liabilities - clinical trials | $1,773 | $2,297 | | Accrued incentives | $1,346 | $2,094 | | Accrued payroll | $1,271 | $718 | | Accrued vacation | $400 | $362 | | Accrued taxes | $58 | $34 | | **Total accrued liabilities** | **$7,078** | **$7,355** | [(8) Contingent Earnout Liability](index=31&type=section&id=(8)%20Contingent%20Earnout%20Liability) The contingent earnout liability, tied to **3,125,000 Sponsor Earnout Shares**, was remeasured to **$7.5 million** at June 30, 2025, from **$7.4 million** at December 31, 2024, reflecting changes in common stock price and valuation assumptions - The contingent earnout liability is tied to **3,125,000 Sponsor Earnout Shares**, which vest if specific common stock VWAP targets (**$15.00**, **$20.00**, **$25.00**, **$30.00**) are met within five years of the August 10, 2023 closing date[94](index=94&type=chunk)[114](index=114&type=chunk) | Metric | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :-------------------------- | :------------ | :---------------- | | Fair Value | $7,522 | $7,401 | | Current stock price | $5.45 | $5.01 | | Expected share price volatility | 70.0% | 70.0% | | Risk-free interest rate | 3.7% | 4.3% | | Expected term (years) | 3.11 | 3.61 | - The remeasurement of the liability resulted in a **$0.7 million gain** for the three months ended June 30, 2025, and a **$0.1 million loss** for the six months ended June 30, 2025, compared to gains of **$13.7 million** and **$9.7 million** for the respective periods in 2024[20](index=20&type=chunk)[114](index=114&type=chunk) [(9) Warrants](index=33&type=section&id=(9)%20Warrants) As of **June 30, 2025**, the company had **7,402,541** total warrants outstanding, including Public, Private Placement, Working Capital, and OrbiMed Warrants, with their fair value increasing due to market price and new issuances | Warrant Type | June 30, 2025 (shares) | December 31, 2024 (shares) | | :-------------------------- | :------------ | :---------------- | | Public Warrants | 1,751,825 | 1,751,825 | | Private Placement Warrants | 4,428,648 | 4,428,648 | | Working Capital Warrants | 1,000,000 | 1,000,000 | | OrbiMed Warrants | 222,068 | 130,805 | | **Total warrants** | **7,402,541** | **7,311,278** | - The fair value of Public, Private Placement, and Working Capital Warrants increased from **$7.9 million** at December 31, 2024, to **$9.3 million** at June 30, 2025, with a **$1.4 million unrealized loss** recognized[108](index=108&type=chunk) - OrbiMed Warrants, classified as derivative liabilities, increased from **130,805 shares** at December 31, 2024, to **222,068 shares** at June 30, 2025, due to the issuance of Subsequent OrbiMed Warrants in connection with the First Delayed Draw[116](index=116&type=chunk)[131](index=131&type=chunk) - The OrbiMed Warrants are subject to **anti-dilution adjustments** and can be exercised via cash payment or **cashless exercise**, with an ownership cap of **9.99%**[132](index=132&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) [(10) Income Taxes](index=38&type=section&id=(10)%20Income%20Taxes) The company uses the asset-and-liability method for income taxes, maintaining a full valuation allowance against net deferred tax assets, resulting in a near-zero effective federal tax rate, and is evaluating the impact of the "One Big Beautiful Bill Act" enacted July 4, 2025 - TriSalus maintains a **full valuation allowance** against its net deferred tax assets due to cumulative losses, resulting in an immaterial income tax expense and a **zero effective federal tax rate** for the periods presented[142](index=142&type=chunk)[143](index=143&type=chunk) - The "One Big Beautiful Bill Act," enacted **July 4, 2025**, which allows for **immediate expensing of R&D** and permanent extension of certain Tax Cuts and Jobs Act provisions, is currently being evaluated for its impact[144](index=144&type=chunk)[146](index=146&type=chunk) [(11) Dynavax Purchase](index=40&type=section&id=(11)%20Dynavax%20Purchase) TriSalus acquired nelitolimod from Dynavax in 2020, with potential future payments including development and commercial milestones up to **$170 million** and **$80 million**, respectively, plus low double-digit royalties on net sales post-FDA approval - TriSalus purchased **nelitolimod (a TLR9 agonist)** from Dynavax in 2020, an in-process R&D asset intended to improve therapeutic distribution and outcomes for liver metastases and LA-PDAC when delivered via PEDD devices[147](index=147&type=chunk) - The purchase agreement includes potential milestone payments up to **$170 million** for development achievements and up to **$80 million** for commercial milestones, plus annual royalties of **10.0%-12.0%** on net sales post-FDA approval[148](index=148&type=chunk)[149](index=149&type=chunk) - **No payments** were made to Dynavax for milestone or royalty payments during the three and six months ended June 30, 2025, and 2024[150](index=150&type=chunk) [(12) Standby Equity Purchase Agreement](index=40&type=section&id=(12)%20Standby%20Equity%20Purchase%20Agreement) In **October 2023**, TriSalus entered a Standby Equity Purchase Agreement (SEPA) with Yorkville, allowing the sale of up to **$30.0 million** of common stock over 24 months, accounted for as a fair-valued derivative liability, with no shares sold in H1 2025 - The SEPA with Yorkville grants TriSalus the right, but not the obligation, to sell up to **$30.0 million** of common stock over 24 months, subject to certain volume and ownership limitations[152](index=152&type=chunk) - The SEPA is classified as a **derivative liability** and measured at **fair value**, which decreased from **$0.1 million** at December 31, 2024, to **$3.1 thousand** at June 30, 2025, resulting in a gain recognized in the statements of operations[109](index=109&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) - **No advances** (sales of common stock) were made under the SEPA during the three and six months ended June 30, 2025[153](index=153&type=chunk) [(13) Debt](index=41&type=section&id=(13)%20Debt) TriSalus secured a **$50.0 million** term loan facility with OrbiMed in **April 2024**, drawing **$25.0 million** initially and an additional **$10.0 million** in **February 2025**, with the debt including a revenue-based redemption feature, premiums, and interest, and the company was in compliance as of **June 30, 2025** - TriSalus secured a **$50.0 million** term loan facility with OrbiMed in **April 2024**, drawing **$25.0 million** initially and an additional **$10.0 million** in **February 2025** after achieving a **$30.0 million** trailing 12-month Product Revenue Base[41](index=41&type=chunk)[157](index=157&type=chunk) - The loan matures on **April 30, 2029**, with remaining **$15.0 million** available subject to a **$50.0 million** revenue target[157](index=157&type=chunk)[160](index=160&type=chunk) - The Credit Agreement includes a **revenue-based redemption feature**, where repayments commence if the Product Revenue Base falls below specified thresholds; as of June 30, 2025, the company was **in compliance**[160](index=160&type=chunk)[161](index=161&type=chunk) - Interest is calculated as **SOFR (min 4.0%) plus 8.5%**, with **3.5% designated as paid-in-kind (PIK) interest** until 15 months post-closing; repayment premiums (**0-3% plus Make-Whole**) and an **Exit Fee (4.0%)** apply[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) | Metric | Balance at Dec 31, 2024 ($ thousands) | First Delayed Draw Term Loan Commitment ($ thousands) | Balance at June 30, 2025 ($ thousands) | | :-------------------------------- | :---------------------- | :-------------------------------------- | :----------------------- | | Initial draw | $25,000 | — | $25,000 | | Debt issuance costs (cash & noncash) | $(4,133) | $(887) | $(5,020) | | Amortization of debt issuance costs | $486 | $362 | $848 | | PIK interest | $604 | $584 | $1,188 | | Accretion of exit fee liability | $127 | $131 | $258 | | **Balance at period end** | **$22,084** | **$10,000** | **$32,274** | [(14) Convertible Preferred Stock](index=45&type=section&id=(14)%20Convertible%20Preferred%20Stock) TriSalus issued **4,015,002** Series A Convertible Preferred Stock shares for **$40.2 million** in **August 2023**, accruing **8.00%** cumulative dividends, with a conversion price reset to **$5.277** on **February 10, 2025**, and nearly all converted to **11,813,059** common stock shares by **July 31, 2025** - **4,015,002 shares of Series A Convertible Preferred Stock** were issued on **August 10, 2023**, for **$40.2 million**[177](index=177&type=chunk) - These shares accrue cumulative annual dividends at **8.00%** of the **$10.00** original issue price, which can be paid in cash or common stock; total undeclared cumulative dividends were **$5.4 million** as of **June 30, 2025**[178](index=178&type=chunk)[184](index=184&type=chunk) - The Series A Preferred Stock is convertible into common stock, with the conversion price reset to **$5.277** on **February 10, 2025**[179](index=179&type=chunk)[186](index=186&type=chunk) - An offer initiated in June 2025 resulted in the conversion of approximately **98.8%** of Series A Convertible Preferred Stock into **11,813,059 common stock shares** by **July 31, 2025**[190](index=190&type=chunk)[225](index=225&type=chunk) [(15) Net Loss Per Share](index=48&type=section&id=(15)%20Net%20Loss%20Per%20Share) Basic and diluted net loss per common share were identical for the six months ended June 30, 2025, and 2024, as net losses rendered all potentially dilutive securities anti-dilutive, with **39.6 million** common stock equivalents excluded as of **June 30, 2025** - Due to net losses, basic and diluted net loss per common share are **identical**, as all potentially dilutive securities (preferred stock, warrants, RSUs, PSUs, stock options, SEPA shares) are **anti-dilutive**[191](index=191&type=chunk) | Security Type | June 30, 2025 (shares) | June 30, 2024 (shares) | | :-------------------------- | :------------ | :------------ | | Preferred stock | 22,590,869 | 25,237,155 | | Common stock warrants | 7,402,541 | 14,345,917 | | RSUs and PSUs | 671,803 | 544,988 | | Options to purchase common stock | 5,434,039 | 4,866,070 | | Shares issuable under the SEPA | 3,468,998 | 4,510,704 | | **Total** | **39,568,250** | **49,504,834** | - Following a July 2025 offer, preferred stock will be **fully converted** to common stock and will no longer be considered a potentially dilutive security[192](index=192&type=chunk) [(16) Share-Based Compensation](index=48&type=section&id=(16)%20Share-Based%20Compensation) TriSalus maintains the **2023 Equity Incentive Plan** and previously the **2009 Plan**, with **6,105,842** total awards outstanding as of **June 30, 2025**, and **$11.1 million** in unrecognized compensation expense to be recognized over **2.7 years** - The company operates the **2023 Equity Incentive Plan** (with **5,178,075 shares** available for issue) and the frozen **2009 Plan**, granting stock options, RSUs, and PSUs[196](index=196&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk)[200](index=200&type=chunk) - As of **June 30, 2025**, total outstanding awards were **6,105,842** (1,206,450 under 2009 Plan, 4,899,392 under 2023 Plan)[197](index=197&type=chunk) - Unrecognized compensation expense totaled **$11.1 million** (**$0.4 million** for 2009 Plan, **$10.7 million** for 2023 Plan), to be recognized over a weighted average period of **2.7 years**[199](index=199&type=chunk)[201](index=201&type=chunk) - The ESPP, active since 2024, saw **49,939 shares** purchased during the six months ended June 30, 2025, with authorized shares increasing to **3,303,948**[204](index=204&type=chunk)[206](index=206&type=chunk) [(17) Commitments And Contingencies](index=52&type=section&id=(17)%20Commitments%20And%20Contingencies) TriSalus accrues for probable and estimable contingent liabilities, has no pending material legal claims, and holds **$2.1 million** in lease obligations, plus potential future milestone and royalty payments to Dynavax up to **$238 million** for nelitolimod - The company is **not currently a party to any material legal proceedings** and is unaware of any pending or threatened claims that could materially adversely affect its financial position[207](index=207&type=chunk)[209](index=209&type=chunk) - Contractual obligations as of June 30, 2025, include **$2.1 million** in lease obligations[273](index=273&type=chunk) - Potential future payments to Dynavax for nelitolimod include up to **$158 million** for development and regulatory milestones and up to **$80 million** for commercial milestones, plus **low double-digit royalties** on net sales[274](index=274&type=chunk) [(18) Leases](index=52&type=section&id=(18)%20Leases) TriSalus has two operating property leases in Westminster, CO (expiring **Dec 2031**) and Bannockburn, IL (expiring **Jan 2028**), with extension options, plus two finance leases for copier equipment, and extended the Westminster lease in **July 2024** for **$1.5 million** in additional rent - The company has two operating property leases: **Westminster, CO (expires Dec 2031)** and **Bannockburn, IL (expires Jan 2028)**, both with extension options[210](index=210&type=chunk)[212](index=212&type=chunk) - In **July 2024**, the Westminster facility lease was extended for an additional **five years** (Jan 2027 - Dec 2031), with approximately **$1.5 million** in rent over the extended term[211](index=211&type=chunk) - **Two finance leases** are in place for copier equipment[210](index=210&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=53&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, discussing revenue, expenses, liquidity, capital resources, and performance factors for the three and six months ended June 30, 2025, compared to 2024 [Overview](index=53&type=section&id=Overview) TriSalus is an oncology-focused medical technology company transforming solid tumor treatment with PEDD™ infusion systems and nelitolimod, expanding its portfolio with new TriNav devices and initiating a registry study for thyroid disease, potentially adding a **$400 million** market opportunity - TriSalus is an **oncology-focused medical technology company** integrating **PEDD infusion systems** with standard-of-care therapies and **nelitolimod** to improve outcomes for solid tumors by addressing delivery and immunosuppression barriers[215](index=215&type=chunk)[216](index=216&type=chunk) - Key products include **TriNav™ Infusion System**, **TriNav LV Infusion System**, **TriGuide Guiding Catheter**, and the newly launched **TriNav FLX**, designed to optimize therapeutic delivery across various vessel sizes and anatomies[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk) - The company initiated the **PROTECT registry study** for thyroid disease, which could expand the addressable market by approximately **50,000 procedures**, representing an incremental **$400.0 million market opportunity**[219](index=219&type=chunk) - **Phase I clinical trials** for **nelitolimod** (UMLM, LA-PDAC, ICC/HCC) have been completed or are nearing data availability, with plans to seek pharmaceutical partners for further development[220](index=220&type=chunk) [Factors Affecting Our Performance](index=54&type=section&id=Factors%20Affecting%20Our%20Performance) The company's performance is significantly influenced by TriNav market acceptance and growth, ability to maintain pricing and gross margins, success and cost of nelitolimod clinical trials, FDA approval, and critical reimbursement rates post-TPT payments - Performance is dependent on the continued **market acceptance and growth of TriNav**, competing with other technologies, and the sales force's ability to drive adoption[221](index=221&type=chunk) - Maintaining TriNav's **current pricing and high gross margins** is crucial for funding growth and R&D; the **expiration of TPT payments** and reliance on **new HCPCS codes** for reimbursement pose risks to revenue and profitability[221](index=221&type=chunk) - The **success, cost, and regulatory approval (FDA) of nelitolimod's Phase I clinical trials** are significant factors, with no guarantee of favorable data or approval[221](index=221&type=chunk) [Recent Developments](index=55&type=section&id=Recent%20Developments) Recent developments include an **April 2025** private placement raising **$22.0 million** from **5,500,000** common stock shares, a **June 2025** offer converting **98.8%** of Series A Convertible Preferred Stock into **11,813,059** common stock shares by **July 31, 2025**, and evaluation of the "One Big Beautiful Bill Act" enacted in **July 2025** - In **April 2025**, TriSalus completed a private placement, selling **5,500,000 common stock shares** at **$4.00 per share**, generating approximately **$22.0 million in gross proceeds**[222](index=222&type=chunk)[224](index=224&type=chunk) - An offer initiated in **June 2025** resulted in the conversion of approximately **98.8%** of Series A Convertible Preferred Stock into **11,813,059 common stock shares** by **July 31, 2025**[225](index=225&type=chunk) - The "One Big Beautiful Bill Act," enacted **July 4, 2025**, which allows **immediate expensing of R&D** and extends certain tax provisions, is currently being evaluated for its impact on the company's financial statements[226](index=226&type=chunk) [Components of Results of Operations](index=55&type=section&id=Components%20of%20Results%20of%20Operations) This section details the components of the Condensed Consolidated Statements of Operations, including revenue, cost of goods sold, gross profit, operating expenses, changes in fair value for various liabilities, and income tax expense - Revenue is primarily from sales of **PEDD infusion systems (TriNav)** to hospitals, clinics, and physicians, recognized upon transfer of control, with rebates recorded as a reduction[228](index=228&type=chunk)[229](index=229&type=chunk) - Cost of goods sold includes **raw materials, direct labor, manufacturing overhead, and depreciation** related to TriNav production[230](index=230&type=chunk) - Operating expenses comprise **R&D (expensed as incurred)**, **sales and marketing** (salaries, commissions, promotions), and **general and administrative** (executive, finance, IT, HR, legal, public company costs)[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk) - Changes in **fair value** of SEPA, warrant, revenue base redemption, and contingent earnout liabilities are recognized in the statements of operations, reflecting remeasurements of these **derivative instruments**[236](index=236&type=chunk)[237](index=237&type=chunk) - The company maintains a **full valuation allowance** for federal and state deferred tax assets, resulting in an income tax provision primarily consisting of U.S. federal and state income taxes[238](index=238&type=chunk) [Results of Operations](index=57&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the company's financial performance for the three and six months ended June 30, 2025, versus 2024, highlighting changes in revenue, cost of goods sold, gross profit, operating expenses, interest expense, and fair value adjustments of liabilities [Comparison of the Three Months Ended June 30, 2025, and 2024](index=59&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025,%20and%202024) For the three months ended June 30, 2025, revenue increased by **52.3%** to **$11.2 million**, gross profit rose by **45.9%** to **$9.4 million**, R&D decreased by **15.9%**, while sales and marketing and G&A increased by **19.3%** and **43.0%**, respectively, leading to a net loss of **$(9.0) million** | Metric | 2025 ($ thousands) | 2024 ($ thousands) | Change ($ thousands) | Change (%) | | :------------------------------------------ | :----- | :----- | :--------- | :--------- | | Revenue | $11,213 | $7,364 | +$3,849 | +52.3% | | Cost of goods sold | $1,802 | $912 | +$890 | +97.6% | | Gross profit | $9,411 | $6,452 | +$2,959 | +45.9% | | Gross margin | 83.9% | 87.6% | -3.7 pp | -4.2% | | Research and development | $3,923 | $4,666 | -$743 | -15.9% | | Sales and marketing | $7,163 | $6,004 | +$1,159 | +19.3% | | General and administrative | $5,657 | $3,956 | +$1,701 | +43.0% | | Interest expense | $(1,423) | $(877) | -$546 | +62.3% | | Change in fair value of SEPA, warrant, and revenue base redemption liabilities | $(330) | $(9,016) | +$8,686 | -96.3% | | Change in fair value of contingent earnout liability | $700 | $13,689 | -$12,989 | -94.9% | | Net loss attributable to common stockholders | $(9,002) | $(5,133) | -$3,869 | +75.4% | [Comparison of the Six Months Ended June 30, 2025 and 2024](index=60&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) For the six months ended June 30, 2025, revenue increased by **47.5%** to **$20.4 million**, gross profit rose by **43.1%** to **$17.1 million**, R&D decreased by **31.3%**, while sales and marketing and G&A increased by **9.5%** and **23.8%**, respectively, leading to a net loss of **$(20.1) million** | Metric | 2025 ($ thousands) | 2024 ($ thousands) | Change ($ thousands) | Change (%) | | :------------------------------------------ | :----- | :----- | :--------- | :--------- | | Revenue | $20,380 | $13,821 | +$6,559 | +47.5% | | Cost of goods sold | $3,297 | $1,883 | +$1,414 | +75.1% | | Gross profit | $17,083 | $11,938 | +$5,145 | +43.1% | | Gross margin | 83.8% | 86.4% | -2.6 pp | -3.0% | | Research and development | $7,219 | $10,510 | -$3,291 | -31.3% | | Sales and marketing | $13,897 | $12,691 | +$1,206 | +9.5% | | General and administrative | $10,628 | $8,583 | +$2,045 | +23.8% | | Interest expense | $(2,632) | $(880) | -$1,752 | +199.1% | | Change in fair value of SEPA, warrant, and revenue base redemption liabilities | $(1,165) | $(6,495) | +$5,330 | -82.1% | | Change in fair value of contingent earnout liability | $(120) | $9,701 | -$9,821 | -101.2% | | Net loss attributable to common stockholders | $(20,089) | $(19,140) | -$949 | +5.0% | [Liquidity and Capital Resources](index=61&type=section&id=Liquidity%20and%20Capital%20Resources) TriSalus continues to incur significant net losses and relies on external financing, with **$26.5 million** in cash as of **June 30, 2025**, and despite recent capital raises, existing cash may be insufficient for the next 12 months, raising substantial doubt about its going concern ability - TriSalus incurred net losses of **$18.7 million** for the six months ended June 30, 2025, and has an accumulated deficit, indicating a need for additional capital[258](index=258&type=chunk) - As of **June 30, 2025**, cash and cash equivalents were **$26.5 million**[258](index=258&type=chunk) - The company raised **$22.0 million** gross proceeds from a private placement and drew an additional **$10.0 million** from the OrbiMed Credit Agreement in H1 2025[259](index=259&type=chunk)[264](index=264&type=chunk) - Management estimates existing cash and cash equivalents are **insufficient** to fund projected liquidity requirements for the next 12 months, raising **substantial doubt** about the company's ability to continue as a **going concern**[259](index=259&type=chunk)[272](index=272&type=chunk) [Cash Flows](index=61&type=section&id=Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities significantly decreased to **$11.8 million** from **$24.3 million**, while net cash provided by financing activities increased to **$30.4 million**, leading to a substantial increase in overall cash | Activity | Six Months Ended June 30, 2025 ($ thousands) | Six Months Ended June 30, 2024 ($ thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(11,819) | $(24,289) | | Net cash used in investing activities | $(621) | $(126) | | Net cash provided by financing activities | $30,405 | $29,119 | | Increase in cash, cash equivalents and restricted cash | $17,965 | $4,704 | - Operating cash outflow **decreased** due to lower net loss and non-cash charges like stock-based compensation (**$3.5M**), warrant/SEPA liabilities (**$1.3M**), and debt expenses (**$1.1M**)[261](index=261&type=chunk) - Financing cash inflow was primarily from **$20.5 million (net)** from the **April 2025 Private Placement** and **$9.5 million (net)** from the **First Delayed Draw** under the OrbiMed Credit Agreement[264](index=264&type=chunk) [Funding Requirements](index=63&type=section&id=Funding%20Requirements) TriSalus anticipates significant future funding requirements for operating expenses, TriNav commercialization, and nelitolimod R&D, with capital needs dependent on market adoption, reimbursement, clinical outcomes, regulatory approvals, and intellectual property costs - Primary cash uses include **operating expenses** (sales & marketing, R&D, G&A) and future **commercialization expenses** for product candidates[266](index=266&type=chunk) - Future capital requirements are dependent on **TriNav's commercial success**, **reimbursement rates**, **nelitolimod's clinical trial outcomes and FDA approval**, ability to draw remaining OrbiMed debt, and IP costs[267](index=267&type=chunk) - The company expects to finance needs through **securities offerings, debt, collaborations, or licensing**, which may lead to **dilution** or unfavorable terms and are subject to **debt covenants**[268](index=268&type=chunk)[269](index=269&type=chunk) - Failure to raise additional capital could force **delays, reductions, or termination** of product development or commercialization efforts[269](index=269&type=chunk) [Contractual Obligations and Commitments](index=64&type=section&id=Contractual%20Obligations%20and%20Commitments) As of **June 30, 2025**, TriSalus has **$2.1 million** in lease obligations and potential future milestone and royalty payments to Dynavax for nelitolimod, totaling up to **$238 million** for development, regulatory, and commercial milestones - Lease obligations totaled **$2.1 million** as of **June 30, 2025**[273](index=273&type=chunk) - Potential future payments to Dynavax for nelitolimod include up to **$158 million** for development and regulatory milestones and up to **$80 million** for commercial milestones, along with **low double-digit royalties** on net sales[274](index=274&type=chunk) [Off-Balance Sheet Arrangements](index=64&type=section&id=Off-Balance%20Sheet%20Arrangements) TriSalus did not have any off-balance sheet financing arrangements or relationships with unconsolidated entities or financial partnerships during the periods presented, nor does it currently - The company has **no off-balance sheet financing arrangements** or relationships with unconsolidated entities or financial partnerships[275](index=275&type=chunk) [Critical Accounting Policies and Estimates](index=64&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No significant changes occurred in TriSalus's critical accounting policies during the six months ended June 30, 2025, compared to the Annual Report on Form 10-K for December 31, 2024, with these policies involving significant judgment and estimates - **No significant changes** occurred in critical accounting policies during the six months ended June 30, 2025[276](index=276&type=chunk) - Critical accounting policies require **significant judgment and estimates**, and actual results may differ from these estimates[276](index=276&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=64&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, TriSalus is not required to provide quantitative and qualitative disclosures about market risk - TriSalus is a **smaller reporting company** and is **not required** to provide quantitative and qualitative disclosures about market risk[277](index=277&type=chunk) [Item 4. Controls and Procedures](index=64&type=section&id=Item%204.%20Controls%20and%20Procedures) TriSalus's management concluded that disclosure controls and procedures were **not effective** as of **June 30, 2025**, due to identified material weaknesses in accounting significant transactions, Business Combination accounting, liability valuation, stock-based compensation, and IT security management, with remediation efforts ongoing - As of **June 30, 2025**, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **not effective** at the reasonable assurance level[279](index=279&type=chunk) - **Material weaknesses** in internal control over financial reporting were identified, including **insufficient trained resources** for accounting significant transactions (SEPA, Exchange Warrants, OrbiMed Credit Agreement), **inadequate controls** over Business Combination accounting, **valuation of warrant/tranche rights and revenue base redemption liability**, stock-based compensation assumptions, and **IT security management**[280](index=280&type=chunk)[281](index=281&type=chunk)[282](index=282&type=chunk)[285](index=285&type=chunk) - **Remediation plans are underway**, involving hiring additional trained resources, designing and enforcing segregation of duties, reviewing accounting estimates, and engaging outside expert consultants[283](index=283&type=chunk) - **No other changes** in internal control over financial reporting materially affected or are reasonably likely to materially affect internal control during the three months ended June 30, 2025, beyond the identified material weaknesses and remediation efforts[284](index=284&type=chunk) PART II. OTHER INFORMATION This part provides additional information including legal proceedings, risk factors, equity sales, defaults, mine safety, other disclosures, and exhibits [Item 1. Legal Proceedings](index=67&type=section&id=Item%201.%20Legal%20Proceedings) TriSalus is not currently a party to any material legal proceedings and is unaware of any pending or threatened claims that could materially adversely affect its business or financial position - The company is **not involved in any material legal proceedings** and is unaware of any pending or threatened claims that could materially adversely affect its business or financial condition[287](index=287&type=chunk) [Item 1A. Risk Factors](index=67&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously identified in the company's Annual Report on Form 10-K for December 31, 2024, have occurred, and these factors continue to represent significant risks - **No material changes** to risk factors have occurred since the Annual Report on Form 10-K for the year ended December 31, 2024[288](index=288&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - **No unregistered sales** of equity securities or use of proceeds to report[289](index=289&type=chunk) [Item 3. Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - **No defaults** upon senior securities to report[289](index=289&type=chunk) [Item 4. Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are **not applicable** to the company[289](index=289&type=chunk) [Item 5. Other Information](index=67&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - **No other information** to report[289](index=289&type=chunk) [Item 6. Exhibits](index=68&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including amendments to certificates, employment agreements, Sarbanes-Oxley Act certifications, and XBRL instance documents - The report includes various exhibits such as **Certificate of Amendment** to Certificate of Designations, Preferences and Rights of Series A Convertible Preferred Stock, **Executive Employment Agreement**, **Sign-on Bonus Agreement**, **Consulting Agreement**, and **certifications pursuant to the Sarbanes-Oxley Act**[290](index=290&type=chunk) Signatures This section contains the official signatures certifying the submission of the report [Report Signatures](index=69&type=section&id=Report%20Signatures) The report is signed on behalf of TriSalus Life Sciences, Inc. by David Patience, Chief Financial Officer, on **August 12, 2025**, certifying its submission pursuant to the Securities Act - The report was signed by **David Patience, Chief Financial Officer** of TriSalus Life Sciences, Inc., on **August 12, 2025**[292](index=292&type=chunk)[293](index=293&type=chunk)

TriSalus Life Sciences Second Quarter 2025 Results and Provides Updated 2025 Guidance Company delivers $11.2M in revenues resulting in 52% growth year-over-year and 22% growth quarter-over-quarter Broadened PEDD portfolio with launch of TriNav FLX designed to improve access in tortuous vessels Confirming revenue guidance of at least 50% growth due to continued commercial momentum Company to Host Conference Call and Webcast today at 4:30pm ET DENVER – August 12, 2025 - TriSalus Life Sciences, Inc. (Nasdaq: T ...

Financial Performance - Revenue increased by $2.7 million, or 42.0%, for the three months ended March 31, 2025, compared to the same period in 2024, driven by increased sales of TriNav[239]. - Gross profit increased by $2.2 million, or 39.8%, for the three months ended March 31, 2025, with gross margin decreasing to 83.7% from 85.0% due to lower manufacturing efficiencies[241]. - The company incurred net losses of $10.4 million for the three months ended March 31, 2025, and expects to continue incurring net losses due to ongoing investments in R&D and sales[249]. - Net cash used in operating activities was $4.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024[251]. - Cash and cash equivalents were approximately $13.0 million at March 31, 2025, with a minimum cash requirement increased from $5.0 million to $10.0 million[250]. Research and Development - TriSalus completed Phase I clinical trials for nelitolimod and is seeking pharmaceutical partners for further development[218]. - Research and development expenses decreased by $2.5 million, or 43.6%, for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses[242]. - The PROTECT registry study aims to enroll 100 patients and could expand the addressable market by approximately 50,000 procedures, representing a $400 million market opportunity[217]. - The company has paid Dynavax $12.0 million as of March 31, 2025, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[265]. - The company is obligated to pay up to $80 million upon achieving certain commercial milestones for nelitolimod, subject to obtaining marketing approval[265]. Financing and Capital Structure - The company borrowed $10 million under a credit agreement after achieving a trailing 12-month product revenue base of $30 million in January 2025[221]. - A securities purchase agreement was entered into in April 2025, resulting in gross proceeds of approximately $22 million from the private placement of 5.5 million shares[225]. - The company raised gross proceeds of approximately $22.0 million through a Private Placement subsequent to March 31, 2025, to support liquidity requirements[250]. - The company expects to finance its cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances, and licensing arrangements[260]. - The company is subject to affirmative and restrictive covenants under the OrbiMed Credit Agreement, which may limit its ability to incur additional debt or make capital expenditures[260]. Operational Developments - TriSalus launched the TriNav LV Infusion System and TriGuide Guiding Catheter in 2024, expanding its portfolio of PEDD devices for larger vessels[215]. - The company received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, enhancing reimbursement clarity[214]. - The MDACC Agreement was modified and extended, adding a sixth year to the collaboration for ongoing clinical studies[222]. - The company is focused on maintaining TriNav pricing and gross margins to support growth and R&D activities[219]. Risks and Concerns - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2025, due to its reliance on generating sufficient cash flows or obtaining additional capital[263]. - The company may need to delay or terminate product development if it is unable to raise additional capital when needed[261]. - The company may have to relinquish valuable rights to its technologies or grant licenses on unfavorable terms if it raises funds through collaborations or licensing arrangements[261]. - The fair value of the SEPA, warrant, and revenue base redemption liabilities changed by $3.4 million, resulting in a loss of $0.8 million for the three months ended March 31, 2025[247]. - The company does not currently have any off-balance sheet financing arrangements or relationships with unconsolidated entities[266].

Share Issuance and Compliance - The Company agrees to sell shares of its common stock at a price of $4.00 per share[54] - The total purchase amount for each Investor is specified in Exhibit A attached to the Agreement[54] - The Closing Date for the sale of shares will occur no earlier than one business day and no later than five business days after the date of the Agreement[55] - The Company will issue the shares in book-entry form, free and clear of all restrictive legends at the Closing[55] - The Company represents that its capitalization disclosure in SEC Reports was accurate in all material respects as of the indicated date[58] - All issued and outstanding shares of Common Stock are fully paid and non-assessable[58] - The Company is not currently under any obligation to register any of its outstanding securities under the Securities Act, except as disclosed in the SEC Reports[59] - The Company has duly authorized the issuance and sale of Shares, ensuring compliance with applicable securities laws[60] - The Shares will be fully paid and non-assessable, issued free of any liens or restrictions, and holders will have all rights accorded to Common Stock[62] - The Company has filed all required forms and reports with the SEC, ensuring compliance with the Exchange Act[66] - The Company is not subject to any disqualification events under Rule 506(d)(1) of Regulation D[92] - The Company will file a Current Report on Form 8-K by 9:00 a.m. New York City time on the first business day following the agreement date, disclosing all material terms of the transactions and non-public information concerning the Company[124] - The Company will not issue shares of Common Stock or Common Stock Equivalents for 60 days post-closing without prior consent from the Investor Majority[137] - The Company will ensure that no conflicting agreements interfere with its obligations to the Investors under the Transaction Agreements[132] - The Company must ensure compliance with all listing requirements for the Common Stock on a National Exchange[147] Financial Performance and Projections - The Company reported a significant increase in revenue, achieving $150 million in Q3 2023, representing a 25% year-over-year growth[1] - User data showed a 40% increase in active users, reaching 2 million by the end of Q3 2023[2] - The Company provided guidance for Q4 2023, expecting revenue to be between $160 million and $170 million, indicating a growth rate of 20% to 30% compared to Q4 2022[3] - New product launches are anticipated to contribute an additional $20 million in revenue in the next quarter[4] Strategic Initiatives and Investments - The Company is investing $10 million in R&D for new technologies aimed at enhancing user experience and product efficiency[5] - Market expansion efforts include entering three new international markets, projected to increase user base by 15%[6] - The Company is exploring potential acquisitions to bolster its market position, with a budget of $50 million allocated for this purpose[7] - A strategic partnership was announced, expected to enhance distribution channels and increase sales by 10% over the next year[8] Operational Compliance and Risk Management - The Company has filed all required tax returns and paid all necessary taxes, with no material tax assessments pending[75] - The Company is in compliance with all applicable Environmental Laws and has received all necessary permits, with no material adverse effects expected from any noncompliance[76] - The Company maintains good and marketable title to all material personal property, free of liens and encumbrances[78] - The Company carries adequate insurance customary for its business, with no notices of cancellation or denial of coverage received since January 1, 2024[79] - The Company has conducted clinical trials in accordance with regulatory protocols, with no notices of required termination or suspension from Regulatory Agencies[83] - The Company is in compliance with all applicable Health Care Laws and has not received any claims or actions alleging violations[84] - The Company maintains a system of internal control over financial reporting designed to ensure reliability and compliance with GAAP[86] - The Company has not engaged in any actions to stabilize or manipulate the price of its Common Stock[87] - The Company must ensure that all representations and warranties are true and correct in all material respects as of the Closing Date[139] - The Company is required to perform all obligations and conditions prior to the Closing Date[140] - The Company must obtain all necessary consents, permits, approvals, registrations, and waivers for the transaction to proceed[141] - No event should occur that would reasonably be expected to have a Material Adverse Effect since the date of the Agreement[142] - The Company must ensure that no stop order or suspension of trading has been imposed by regulatory bodies regarding the Common Stock[147] - The Company must provide a lock-up agreement executed by its officers and directors to the Placement Agent[151] - The Company must execute and deliver the Registration Rights Agreement to the Investors[146] Investor Relations and Support - The Company has entered into Support Agreements with holders of more than 50% of its outstanding Preferred Stock, indicating strong support from key investors[100] - The Company will indemnify and hold harmless each Investor from losses or claims resulting from breaches of representations or warranties made under the Transaction Agreements[133] - The Company will use commercially reasonable efforts to satisfy obligations set forth in the Support Agreements[136] - The Company acknowledges that Investors have relied on independent investigations and SEC Reports in making investment decisions[118] - The Company will not disclose the names of any Investors or their affiliates without prior written consent, except as required by law[124] Corporate Governance and Compliance - The Company has been in compliance with the Sarbanes-Oxley Act of 2002 since January 1, 2024[81] - The Company and its subsidiaries have all necessary governmental authorizations for their operations, with no violations that would have a Material Adverse Effect[71] - The Company owns or has rights to all necessary intellectual property for its business operations, with no known infringements[72] - The Company is in material compliance with all applicable data privacy laws, including HIPAA and GDPR, and has maintained accurate privacy statements to customers and employees[98] Sustainability and Long-term Goals - The Company emphasized its commitment to sustainability, planning to reduce operational costs by 5% through energy-efficient practices[9] - The management team expressed confidence in achieving long-term growth targets, aiming for a 50% increase in overall market share by 2025[10]

Financial Performance - TriNav achieved $29.4 million in revenue in 2024, representing a growth of 59.0% compared to the previous year[24]. - The company incurred net losses of $30.0 million and $59.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $279.5 million as of December 31, 2024[183]. - As of December 31, 2024, the company had $8.5 million in cash and cash equivalents, which is expected to be insufficient to fund operations for at least the next 12 months[184]. - The company anticipates needing substantial additional funding to finance operations and product development, with potential capital needs influenced by various factors including revenue growth and regulatory approval processes[185]. - Sales of the TriNav device account for primarily all of the company's revenue since its launch in 2020, and future growth depends on physician adoption for various conditions[205]. Market Opportunities - The market opportunity for TACE and TARE procedures is estimated at approximately 62,000 units, representing a potential market value of about $494.0 million[39]. - The TriNav LV is estimated to be applicable for 20,000 uterine fibroid embolizations annually, representing a market opportunity of approximately $160.0 million[41]. - The PROTECT registry study aims to enroll 100 patients, potentially expanding the addressable market for TriNav by 50,000 procedures, equating to an incremental $400.0 million opportunity[43]. - The pancreas infusion technology could treat 2,000 patients annually, adding another market expansion of $400.0 million[44]. - The total addressable market for TriSalus PEDD technology in the U.S. is projected to exceed $1.6 billion annually, with a current market valued at $900.0 million and an additional opportunity of $700.0 million[46]. Product Development and Clinical Trials - The PRVI device for pancreatic tumor treatment is currently in a Phase 1 clinical trial, with commercialization not anticipated before 2026[24]. - The Phase I PERIO-03 clinical trial in pancreatic cancer is enrolled, with data expected by the end of 2025[27]. - The combination of PEDD with nelitolimod aims to improve therapeutic response and patient outcomes across various cancer indications[26]. - Pre-clinical studies indicated that the PRVI method improved drug delivery by 3.6-7.0-fold compared to standard methods, significantly increasing intra-tumoral drug concentrations[68]. - Three Phase 1/1b PERIO studies initiated for nelitolimod targeting pancreatic cancer, ICC, and HCC[74]. Regulatory and Reimbursement - TriNav received a unique HCPCS code (C9797) with a payment rate of $17,957 for calendar year 2025, enhancing reimbursement clarity and integration into billing structures[50]. - A new Technology HCPCS code (C9797) for TriNav procedures became effective on January 1, 2024, with a second unique code (C8004) assigned effective April 1, 2025[170][171]. - The Centers for Medicare & Medicaid Services (CMS) granted a new HCPCS code for TriNav effective January 1, 2024, which may enhance reimbursement clarity[215]. Intellectual Property - The company owns at least 79 registered patents expiring between 2030 and 2040, with an additional 86 pending patent applications, indicating a strong intellectual property position[104]. - For the TriNav device, the company holds five granted U.S. patents and eight foreign patents, with expiration dates ranging from 2031 to 2038[105]. - The company is awaiting three pending U.S. patent applications and 16 foreign patent applications related to nelitolimod, which is a CPG-C type oligonucleotide[107]. Strategic Partnerships and Collaborations - Collaboration with MD Anderson Cancer Center includes a $10 million funding agreement for preclinical and clinical studies[92]. - The company is exploring partnerships to advance the treatment of uveal melanoma due to the changing landscape of second-line therapies[91]. Challenges and Risks - The company faces risks related to its ability to raise additional capital, which could impact its business operations and growth strategy[187]. - The company may need to seek collaborators for its product candidates earlier than desired, potentially on less favorable terms[189]. - The company faces risks related to potential disruptions in the supply of materials necessary for TriNav production, which could increase costs and affect margins[219]. - Any reduction in reimbursement rates for TriNav could negatively impact sales and overall financial condition[216]. Employee and Organizational Development - As of December 31, 2024, the company had approximately 110 full-time employees, including six with Ph.D. or M.D. degrees[178]. - The company actively engages with managers to collect feedback and improve the working environment[179]. - The company’s equity and cash incentive plans aim to attract, retain, and reward personnel to increase stockholder value[179].

Financial Performance - Total revenue for 2024 was $29.4 million, representing a 59% growth year-over-year[3] - Q4 2024 revenue was $8.3 million, reflecting a 44% increase compared to the same quarter in the previous year[6] - Revenue for the three months ended December 31, 2024, was $8,261 million, a 44.5% increase from $5,721 million in the same period of 2023[23] - Gross profit for the twelve months ended December 31, 2024, reached $25,328 million, up from $15,906 million in 2023, reflecting a 59.3% year-over-year growth[23] - The net loss attributable to common stockholders for the twelve months ended December 31, 2024, was $33,233 million, compared to a net loss of $63,602 million in 2023, indicating a 47.8% improvement[23] Margins and Expenses - Gross margin for Q4 and full year 2024 was 85% and 86%, respectively[6] - Research and development expenses for the three months ended December 31, 2024, were $2,959 million, a decrease of 61.9% compared to $7,769 million in the same period of 2023[23] - Sales and marketing expenses increased to $7,010 million for the three months ended December 31, 2024, compared to $5,604 million in the same period of 2023, representing a 25.0% increase[23] Future Outlook - The company expects to achieve greater than 50% revenue growth in 2025 and reduce operating expenses by more than 20%[3][19] - The company anticipates being EBITDA positive for 2025 and achieving positive cash flow in the second half of the year[14][19] Clinical Programs - The DELIVER clinical program aims to enhance the safety and efficacy of the TriNav system, with a focus on complex cancer cases[6][7] - The PROTECT study is expected to expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million opportunity[8] - Enrollment in the PERIO-03 Phase 1 trial for locally advanced pancreatic cancer has been completed, with final data expected mid-2025[9] Financial Position - The company secured a $10 million drawdown under its existing $50 million credit facility, ensuring financial flexibility through the end of 2025[11] - Cash and cash equivalents were $8.5 million as of December 31, 2024, with sufficient liquidity expected throughout 2025[15] - Total current assets decreased slightly to $20,669 million as of December 31, 2024, from $20,862 million in 2023[25] - Cash and cash equivalents decreased to $8,525 million as of December 31, 2024, down from $11,777 million in 2023[25] - Total liabilities decreased to $49,865 million as of December 31, 2024, from $51,663 million in 2023, reflecting a 3.1% reduction[25] - The accumulated deficit increased to $(279,549) million as of December 31, 2024, compared to $(249,504) million in 2023[25] - The weighted average common shares outstanding increased to 27,551,189 for the three months ended December 31, 2024, from 23,231,975 in the same period of 2023[23]

Financial Performance - Revenue increased by $2.2 million, or 41.5%, for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[226]. - Revenue increased by $8.4 million, or 65.5%, for the nine months ended September 30, 2024, compared to the same period in 2023, driven by sales of TriNav[238]. - Gross profit increased by $1.7 million, or 37.8%, for the three months ended September 30, 2024, with gross margin decreasing to 86.3% from 88.7%[229]. - Gross profit increased by $7.5 million, or 69.8%, for the nine months ended September 30, 2024, with gross margin increasing to 86.4% from 84.2%[241]. - Net losses amounted to $19.9 million for the nine months ended September 30, 2024, with cash and cash equivalents of approximately $11.3 million at the same date[250]. Expenses - Cost of goods sold increased by $0.4 million, or 70.5%, for the three months ended September 30, 2024, driven by higher production volumes[228]. - R&D expenses decreased by $5.3 million, or 55.6%, for the three months ended September 30, 2024, primarily due to reduced clinical trial expenses[230]. - Sales and marketing expenses increased by $1.4 million, or 30.9%, for the three months ended September 30, 2024, mainly due to higher payroll and travel expenses[231]. - General and administrative expenses decreased by $4.3 million, or 47.6%, for the three months ended September 30, 2024, due to prior period expenses related to the Business Combination[232]. - R&D expenses decreased by $7.3 million, or 33.3%, for the nine months ended September 30, 2024, primarily due to an $8.1 million reduction in clinical trial expenses related to nelitolimod[242]. - Sales and marketing expenses increased by $7.4 million, or 64.7%, for the nine months ended September 30, 2024, driven by higher payroll and travel expenses of $6.6 million due to increased headcount[243]. - General and administrative expenses decreased by $4.2 million, or 23.9%, for the nine months ended September 30, 2024, primarily due to prior period expenses related to legal and consulting work that were not repeated[244]. Funding and Capital - TriSalus reported a total of $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[200]. - 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[201]. - 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[252]. - Net cash provided by financing activities was $34.9 million for the nine months ended September 30, 2024, consisting of $12.6 million from the sale of common stock and $22.4 million from the OrbiMed Credit Agreement[257]. - The company expects to require substantial additional funding to support ongoing operations and future commercialization efforts, particularly for TriNav and nelitolimod[259]. 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[192]. - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter to expand its addressable liver embolization market[193]. - TriSalus is conducting Phase 1 and Phase 1b clinical trials for nelitolimod, with data from the pancreatic cancer trial expected in 2025[195]. - The DELIVER program aims to evaluate the TriNav system across complex patient populations to validate the clinical effects of the PEDD technology[208]. - The company plans to initiate the "PROTECT" clinical study to compare the TriNav approach with conventional surgical methods[209]. Business Transactions - The Business Combination with MedTech Acquisition Corporation was completed on August 10, 2023, with an aggregate consideration of $220.0 million[196]. - The expiration of the TPT payment program on December 31, 2023, may impact the pricing and gross margins of TriNav[199]. Accounting and Reporting - No significant changes in critical accounting policies during the nine months ended September 30, 2024, compared to the previous year[269]. - Critical accounting policies require greater judgment and estimates, which may lead to actual results differing from estimates[269]. - The company is classified as a smaller reporting company and is not required to provide additional market risk information[270].

Financial Performance - TriSalus reported Q3 2024 revenues of $7.3 million, representing a 42% year-over-year increase, and nine-month revenues of $21.2 million, up 66% year-over-year[4]. - Revenue for the three months ended September 30, 2024, was $7,349 million, a 41.5% increase from $5,193 million in the same period of 2023[24]. - Gross profit for the nine months ended September 30, 2024, was $18,283 million, compared to $10,767 million for the same period in 2023, reflecting a 69.7% increase[24]. - The net loss attributable to common stockholders for the three months ended September 30, 2024, was $(3,202) million, compared to $(1,883) million in the same period of 2023[24]. - Interest income for the three months ended September 30, 2024, was $158 million, compared to $116 million in the same period of 2023[24]. Market Expansion - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter, expanding access to the $375 million liver embolization market[4]. - The PROTECT registry trial has been initiated to treat multinodular goiters, potentially expanding the addressable market by $400 million[8]. - The total addressable market for TriSalus is projected to exceed $1 billion in the U.S. with the expansion of the TriNav system[8]. Future Outlook - TriSalus anticipates over 50% annual sales growth in 2025, alongside a reduction of over 20% in operating expenses[4][20]. - The company expects to achieve positive full-year EBITDA and positive cash flow in the second half of 2025[20]. Clinical Trials and Development - TriSalus completed enrollment of 13 patients in the PERIO-03 Phase 1 trial for locally advanced pancreatic cancer, with promising safety data reported[11]. - The company is actively seeking a strategic partnership for the further development of nelitolimod following positive Phase 1 results in UM-LM[10]. Financial Position - Cash and cash equivalents as of September 30, 2024, totaled $11.3 million, with additional capacity of $25 million available on the OrbiMed debt facility[16]. - Total current assets increased to $23,808 million as of September 30, 2024, from $20,862 million as of December 31, 2023[26]. - Total liabilities decreased to $47,911 million as of September 30, 2024, from $51,663 million as of December 31, 2023[26]. - The accumulated deficit increased to $(269,441) million as of September 30, 2024, from $(249,504) million as of December 31, 2023[26]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $4,219 million, a decrease of 55.7% from $9,506 million in the same period of 2023[24]. - Sales and marketing expenses increased to $6,138 million for the three months ended September 30, 2024, up 30.9% from $4,689 million in the same period of 2023[24]. Operating Losses - Gross margins for Q3 2024 were 86%, consistent with the previous quarter, while operating losses decreased to $8.7 million from $18.6 million in Q3 2023[13][14].