TriSalus Life Sciences, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
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Sep 30, 2025 · Filed Nov 13, 2025
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Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
(Unaudited)
(1)Nature of Business and Basis of Presentation
On August 10, 2023 (the "Closing Date"), TriSalus Life Sciences, Inc., a Delaware corporation (the “Company,” “TriSalus,” “we,” “us”), formerly known as MedTech Acquisition Corporation (“MTAC”), consummated the previously announced merger pursuant to the Agreement and Plan of Merger by and between MTAC Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of MTAC (“Merger Sub”) and TriSalus Operating Life Sciences, Inc. (formerly known as TriSalus Life Sciences, Inc.), a Delaware corporation (“Legacy TriSalus”), whereby Merger Sub merged with and into Legacy TriSalus with the separate corporate existence of Merger Sub ceasing (the “Merger” and, together with the other transactions contemplated by the Merger Agreement, the “Business Combination”). In connection with the consummation of the Business Combination, on August 10, 2023, Legacy TriSalus changed its name from TriSalus Life Sciences, Inc. to TriSalus Operating Life Sciences, Inc., and MTAC changed its name from MedTech Acquisition Corporation to TriSalus Life Sciences, Inc., the surviving company. Legacy TriSalus was deemed to be the accounting acquirer and predecessor company in the Business Combination.
We are a growing, oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies, and with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 (“TLR9”) agonist, for a range of different therapeutic and technology applications. Our ultimate goal is to transform the treatment paradigm for patients battling solid tumors. We have developed an innovative technology designed to overcome two significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) off target delivery. Nelitolimod, specifically, combined with our technology, aims to address the immunosuppressive properties of tumor immune cells in liver, pancreas and other solid tumors. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). In management’s opinion, the accompanying condensed consolidated financial statements include all adjustments, including normal recurring items, considered necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the Securities and Exchange Commission (" SEC"). Certain reclassifications have been made to the 2024 and 2025 condensed consolidated statements of stockholders’ deficit to conform to the presentation as of September 30, 2025. Operating results for the nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2025. The accompanying condensed consolidated financial statements should be read in conjunction with the Annual Report on Form 10-K for the year ended December 31, 2024.
Cash, Cash Equivalents and Restricted Cash
We consider all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. We invest excess cash primarily in money market funds. Restricted cash of $0.35 million is held in a separate account at our bank to support our corporate credit card program and is recorded in other assets on our condensed consolidated balance sheets.
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ significantly from those estimates. The most significant estimates relate to the valuation of the OrbiMed warrant liability and the revenue base redemption liability (see Note 9), the contingent earnout liability (see Note 4), certain of our clinical expense accruals, and the valuation allowance on deferred tax assets.
Accounts Receivable and Allowance for Credit Losses
Accounts receivable are recorded at the invoiced amount and do not bear interest. Our payment terms are typically on net 30 day terms. Our opening accounts receivable balance as of January 1, 2024 was $3.6 million. In accordance with ASC Topic 326, Financial Instruments-Credit Losses, the allowance for credit losses is our best estimate of the amount of probable credit losses in our existing accounts receivable. We review our allowance for credit losses periodically and establish reserves based on management’s expectations of realization based on historical write-off experience, as well as current general economic conditions and expectations regarding collection. Account balances are charged against the allowance after all reasonable means of collection have been exhausted and the potential for recovery is considered remote. We did not incur any credit losses for the nine months ended September 30, 2025 and 2024.
Revenue Recognition
Our revenue is derived from the shipments of our Pressure Enabled Drug Delivery ("PEDD") infusion systems to our customers. Our customers are generally comprised of hospitals, clinics and physicians. Under ASC Topic 606, Revenue Recognition, we evaluate five steps to determine the appropriate timing and amount to recognize revenue. The five steps are:
i. Identify the contract — We do not maintain long-term contracts with our customers. Typically, customers will submit a purchase order to us for delivery of a quantity of our products, which incorporate enforceable rights and obligations constituting the contract with the customer.
ii. Identify the performance obligation — Our performance obligation is to deliver the ordered products in accordance with the terms of the purchase order, which constitutes a single performance obligation. We do not have any on-going service obligation after delivery and only offer our customers an assurance-type warranty, which provides assurance the product will work as intended.
iii. Determine the transaction price — We maintain a single sales price for each of our products, which is fixed. For customers with rebate agreements, the rebates are accounted for within a contra-revenue account at the time the rebate milestone is achieved. We do not have a history of any significant refunds, allowances or other concessions provided to our customers from the agreed-upon sales price after delivery of the product. Refunds, allowances or other concessions are accounted for as a reduction of revenue.
iv. Allocate the transaction price — We do not have multiple performance obligations to complete when we fulfill a purchase order, as such, the transaction price is allocated fully to the units being sold.
v. Recognize revenue — We recognize revenue at the point-in-time when the units for a purchase order have been shipped and control of the units has transferred to the customer, as evidenced by the delivery terms on the shipping documents. Typically, we ship Freight on Board (FOB) Shipping Point. Therefore, we recognize revenue when the shipment leaves our premises. In certain cases, the purchase order specifies alternate shipping terms, usually FOB Destination. In those cases, we defer revenue recognition until the units have been delivered and control has transferred to the customer. Our sales team is able to make in-person sales. When this occurs, the revenue in not recognized until we receive a Purchase Order ("P.O.") from the customers, with the inventory treated as consignment until the time receiving the P.O. Shipping and handling activities are not considered to be a separate performance obligation. The costs are considered to be a fulfillment cost and the expenses are accounted for within cost of goods sold.
We provide certain customers with rebates that are explicitly stated in our contracts and are recorded as a reduction of revenue in the period the conditions for the rebates are achieved. The rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes. Subsequent to a rebate being earned, the customer receives a credit to apply to future purchases. We recognized rebates of $0.2 million and $0.6 million, respectively, in the three and nine months ended September 30, 2025 compared to $0.1 million and $0.3 million, respectively, in the three and nine months ended September 30, 2024.
Research and development (“R&D”) costs include our engineering, regulatory, pre-clinical and clinical activities. R&D costs are expensed as incurred. The costs are related to internal headcount and external services we purchase, such as pre-clinical supplies and materials, clinical study management and supplies, and consulting related to our R&D. There were no development milestone payments to Dynavax for nelitolimod for the three and nine months ended September 30, 2025 and 2024 (see Note 7).
In 2021, we entered into a 5-year Alliance Program (the “MDACC Agreement”) with the University of Texas MD Anderson Cancer Center (“MDACC”) to serve as the lead investigators for the PERIO-01, PERIO-02, and PERIO-03 studies. The term of the agreement was for the later of (i)five years or (ii) until the applicable studies are completed. Prior to the expiration of the term of the MDACC Agreement, either party may terminate the MDACC Agreement if the other party commits a material breach of the agreement and fails to cure such breach within 30 days of receiving notice of such breach. Effective February 25, 2025, we modified our payment terms and extended the MDACC Agreement for an additional year.
We are required to estimate our expenses resulting from our obligations under agreements with vendors, consultants and contract research organizations, in connection with conducting R&D activities. The financial terms of these contracts are subject to negotiations, which vary from agreement to agreement and may result in payment flows that do not match the periods over which goods or services are provided. We reflect R&D expenses in our condensed consolidated financial statements by matching those expenses with the period in which services and efforts are incurred. We account for these expenses according to the progress of the agreements, along with preparation of financial models, taking into account discussions with research and other key personnel as to the progress of studies or other services being performed. Nonrefundable advance payments for goods and services are deferred and recognized as expense in the period that the related goods are consumed or services are performed. With the close out of some of our clinical studies related to nelitolimod, we recorded a charge of approximately $2.1 million during the three and nine months ended September 30, 2025.
Segment reporting
Our Chief Operating Decision Maker (“CODM”), the Chief Executive Officer ("CEO"), reviews our financial information on a consolidated basis for purposes of allocating resources and evaluating its financial performance. The CEO considers recommendations from the Chief Financial Officer ("CFO") and reviews the Monthly Financial Report ("MFR"), including financial information and the Company’s performance highlights, such as revenue, accounts receivable and inventory balances, cash flows and cash on-hand, operational expenditures and headcount. Based on the Company’s condensed consolidated financial information, the CEO makes the key operating decisions and determines how resources should be allocated. Once the CEO has decided, the CEO and CFO are responsible for carrying out the CEO’s decisions. All of our customers and long-lived assets are located in the United States. Since the Company operates as a single reporting segment, all required segment reporting disclosures can be found in the condensed consolidated financial statements. Accordingly, we have determined we operate as a single reportable segment within a single geographic area.
Liquidity and Going Concern
Under ASC 205, Presentation of Financial Statements, we are required to consider and evaluate whether there is substantial doubt that we have the ability to meet our obligation within one year from the issuance of the financial statements. This assessment also includes our consideration of any management plans to alleviate such doubts. We have reported liabilities greater than our assets as of September 30, 2025 and December 31, 2024, and had losses from operations and cash used in operating activities for the nine months ended September 30, 2025 and for the year ended December 31, 2024. We believe our current earnings, projections of future cash flows, financial condition, sources of liquidity and debt obligations raise substantial doubt about our ability to continue as a going concern for at least one year from the date of issuance of these condensed consolidated financial statements. Our ability to fund future operations and to continue the execution of our long-term business plan and strategy will require that we raise additional capital through a combination of collaborations, strategic alliances and licensing arrangements, and issuance of additional equity and/or debt. While we have historically been successful in raising outside capital, there can be no assurance we will be able to continue to obtain outside capital in the future or do so on terms that are acceptable to us. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring clinical trials and capital expenditures, and reducing other operating costs. The accompanying condensed consolidated financial statements have been prepared on the basis that we will continue to operate as a going concern, which contemplates that we will be able to realize assets and settle liabilities and commitments in the normal course of business for the foreseeable future. Accordingly, the accompanying condensed consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
Recently Adopted Accounting Pronouncements
In March 2024, the FASB issued ASU 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, which clarifies the guidance on ASC Topic 718 by illustrating how to apply the scope guidance to determine whether a profit interest award should be accounted for as a shared-based payment arrangement under ASC 718 or another accounting standard (e.g., employee profit-sharing arrangement under ASC 710). The ASU aims to reduce the complexity diversity in practice by adding an example to ASC 718 that describes four fact patterns and illustrates how an entity evaluates common terms and characteristics of profit interests and similar awards to reach a conclusion about whether an award meets the scope conditions in ASC 718-10-15-3. The ASU is effective for all public entities for fiscal years beginning after December 15, 2024 and interim periods within those fiscal years. We adopted ASU 2024-01 on January 1, 2025. The effect of the adoption had no impact on our condensed consolidated financial statements.
In March 2024, the FASB issued ASU 2024-02, Codification Improvements — Amendments to Remove References to the Concept Statements, which removes references to the Board's concepts statement from the FASB Accounting Standards Codification (the "Codification" or ASC). The ASU is part of the Board’s standing project to make “Codification updates for technical corrections such as conforming amendments, clarifications to guidance, simplifications to wording or the structure of guidance, and other minor improvements.” Before establishing the Codification in 2009, the FASB used or referred to the concepts statements as part of its standard setting. However, the Board is now removing those references since “references to the Concepts Statements in the Codification could imply that the Concepts Statements are authoritative." The amendment is effective for all public entities for fiscal years beginning after December 15, 2024. Those who adopt the amendments in an interim period would have to adopt them as of the beginning of the fiscal year that includes that interim period. We adopted ASU 2024-02 on January 1, 2025. The effect of the adoption had no impact on our condensed consolidated financial statements.
Accounting Pronouncements Not Yet Adopted
In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments in ASU 2023-06 update requirements in various disclosure areas, including the statement of cash flows, earnings per share, debt and equity. The amendments in ASU 2023-06 will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC and will no longer be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. Under the ASU, Public Business Entity ("PBE") must annually "(1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate)." This guidance is effective for public companies for annual periods beginning after December 15, 2024. For other companies, the amendments are effective for annual periods beginning after December 15, 2025. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements.
In November 2024, the FASB issues ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, and in January 2025, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. ASU 2024-03 requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement. ASU 2024-03, as clarified by ASU 2025-01. The amendment applies to all public business entities and is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements.
In November 2024, the FASB issues ASU 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, which amends ASC 470-20, Debt: Debt With Conversion and Other Options, to clarify the requirements related to accounting for the settlement of a debt instrument as an induced conversion. Based primarily on the consensus-for-exposure reached on Issue 23-A, Induced Conversion of Convertible Debt Instruments, by the Emerging Issues Task Force on September 14, 2023. The ASU is intended to “improve the relevance and consistency in application of the induced conversion guidance in Subtopic 470-20 for (a) convertible debt instruments with cash conversion features and (b) debt instruments that are not currently convertible.” The amendments are effective for all entities for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those annual reporting periods. Early adoption is permitted as of the beginning of the annual reporting period for all entities that have adopted the amendments in Update 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. We are currently evaluating the impact the adoption of this ASU will have on our condensed consolidated financial statements.
In May 2025, the FASB issued ASU 2025-04, Compensation - Stock Compensation and Revenue from Contracts with Customers, which clarifies the guidance for accounting for share-based payments to customers, including the treatment of vesting conditions tied to customer purchases and the requirement to estimate forfeitures. ASU 2025-04 will become effective for us for annual periods beginning after December 15, 2026, with early adoption permitted. We are currently evaluating the impact the adoption of this Update will have on our condensed consolidated financial statements.
(2)Financial Instruments
Our financial instruments consist of warrant liabilities, the contingent earnout liability, a Standby Equity Purchasing Agreement ( "SEPA"), and the revenue base redemption liability related to the Credit Agreement we entered into with OrbiMed (the "OrbiMed Credit Agreement"). The carrying values of these financial instruments (other than the contingent earnout liability, revenue base redemption liability and warrant liabilities, which are held at fair value) approximate fair value through the use of publicly available market prices as of September 30, 2025, and December 31, 2024. In general, asset and liability fair values are determined using the following categories:
Level 1 — Inputs utilize quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs include quoted prices for similar assets or liabilities in active markets, and inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly.
Level 3 — Inputs are unobservable inputs and include situations where there is little, if any, market activity for the balance sheet items at period end. Pricing inputs are unobservable for the terms and are based on the Company’s own assumptions about the assumptions that a market participant would use.
Our contingent earnout liability, warrant liabilities, SEPA liability and revenue base redemption liability are measured at fair value on a recurring basis (see Notes 4, 5, 8 and 9, respectively).The carrying values of the warrant liabilities represent the remeasurement to fair value each reporting period based on Level 1 inputs for the publicly traded Public Warrants and Level 2 inputs for the Private Placement Warrants and Working Capital Warrants. The carrying amounts of the OrbiMed Warrants (defined in Note 5), contingent earnout liability and SEPA liability represent the remeasurement to fair value each reporting period based on unobservable, or Level 3 inputs, using assumptions made by us, including the market price of our common stock and the observed volatility of a peer group of companies.
The fair value of the Public Warrants has been measured based on the quoted price of such warrants on the Nasdaq Global Market. The Private Placement Warrants and Working Capital Warrants are similar to the Public Warrants and therefore, use the same fair value as the Public Warrants (see Note 5).
We use a Black-Scholes option pricing model to estimate the fair value of the OrbiMed Warrant (defined in Note 9), as warrants give the holders the right, but not the obligation, to purchase the underlying securities at a contractual exercise price. This method utilizes certain unobservable inputs, including the determination of the expected volatility, and is therefore considered a Level 3 fair value measurement. Certain inputs used in this Black-Scholes pricing model may fluctuate in future periods based upon factors that are outside of our control, including potential change in control outside of our control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the warrant liabilities, which could also result in material non-cash gains or losses being reported in the condensed statement of operations. The expected volatility was implied from a blend of the Company's own common shares and the average historical share volatilizes of several unrelated public companies within the Company's industry that the Company considers to be comparable to its own business.
The repayment of the loans under the OrbiMed Credit Agreement is referred to as the “revenue base redemption liability” (see Note 9). We determine the value of the revenue base redemption liability using a Monte Carlo simulation of future revenue and valuing the Term Loan (as defined in Note 9) using the with and without method.
The following tables summarize the changes in fair value of our outstanding warrant liabilities, contingent earnout liability, SEPA liability and revenue base redemption liability for the nine months ended September 30, 2025:
| Warrant Liabilities | Fair Value at December 31,2024 | Change in Unrealized (Gains) Losses | Issuances (Settlements) | Fair Value at September 30,2025 |
|---|---|---|---|---|
| Public Warrants - Level 1 | $1,927 | $1,051 | $— | $2,978 |
| Private Placement Warrants - Level 2 | 4,872 | 2,657 | — | 7,529 |
| Working Capital Warrants - Level 2 | 1,100 | 600 | — | 1,700 |
| Total | $7,899 | $4,308 | $— | $12,207 |
| Level 3Liabilities | Fair Value at December 31,2024 | Change in Unrealized (Gains) Losses | Issuances (Settlements) | Fair Value at September 30,2025 |
|---|---|---|---|---|
| Contingent earnout liability | $7,401 | $(2,404) | $— | $4,997 |
| SEPA liability | $55 | $(55) | $— | $— |
| OrbiMed Warrants liability | $362 | $(151) | $366 | $577 |
| Revenue base redemption liability | $507 | $(5) | $— | $502 |
The following tables summarize the changes in fair value of our outstanding warrant liabilities, contingent earnout liability, SEPA liability, and revenue base redemption liability for the nine months ended September 30, 2024:
| Warrant Liabilities | Fair Value at December 31,2023 | Change in Unrealized (Gains) Losses | Issuances (Settlements) | Fair Value at September 30,2024 |
|---|---|---|---|---|
| Public Warrants - Level 1 | $9,855 | $2,982 | $(11,068) | $1,769 |
| Private Placement Warrants - Level 2 | 5,871 | (542) | (855) | 4,474 |
| Working Capital Warrants - Level 2 | 1,190 | (180) | — | 1,010 |
| Total | $16,916 | $2,260 | $(11,923) | $7,253 |
| Level 3Liabilities | Fair Value at December 31,2023 | Change in Unrealized (Gains) Losses | Issuances (Settlements) | Fair Value at September 30,2024 |
|---|---|---|---|---|
| Contingent earnout liability | $18,632 | $(12,061) | $— | $6,571 |
| SEPA liability | $185 | $51 | $— | $236 |
| Initial OrbiMed Warrant liability | $— | $(488) | $811 | $323 |
| Revenue base redemption liability | $— | $(303) | $729 | $426 |
(3)Inventory
The components of inventory are summarized as follows:
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Raw materials | $1,415 | $1,338 |
| Finished goods | 1,937 | 2,720 |
| Reserve for obsolete inventory | (76) | (10) |
| Inventory, net | $3,276 | $4,048 |
(4)Contingent Earnout Liability
In connection with the Business Combination, MTAC entered into a sponsor support agreement (the "Sponsor Support Agreement"). Pursuant to the Sponsor Support Agreement, the 3,125,000 Sponsor Earnout Shares (the "Sponsor Earnout Shares") became unvested and subject to potential forfeiture if certain triggering events are not achieved prior to the fifth anniversary of the Closing Date. Pursuant to the Sponsor Support Agreement, (i)25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during thefive year period following the Closing Date volume weighted average price of our Common Stock equals or exceeds $15.00 for any 20 trading days within a period of 30 consecutive trading days, (ii)25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during thefive year period following the Closing Date, the volume weighted average price of our Common Stock equals or exceeds $20.00 for any 20 trading days within a period of 30 consecutive trading days, (iii)25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during thefive year period following the Closing Date, the volume weighted average price of our Common Stock equals or exceeds $25.00 for any 20 trading days within a period of 30 consecutive trading days, and (iv)25% of the shares of the unvested Common Stock held by the Sponsor Holders will only vest if, during thefive year period following the Closing Date, the volume weighted average price of our Common Stock equals or exceeds $30.00 for any 20 trading days within a period of 30 consecutive trading days. Additionally, the Sponsor Earnout Shares will vest if there is a change in control of our company on or before the fifth anniversary of the Closing Date that results in the holders of our Common Stock receiving a price per share equal to or in excess of the applicable earnout targets. Any such shares held by the Sponsor Holders that remain unvested after the fifth anniversary of the Closing Date will be forfeited.
The estimated fair value of the contingent earnout liability on the Closing Date, August 10, 2023, was $28.9 million, based on a Monte Carlo simulation valuation model. The liability was remeasured to its fair value of $5.0 million and $7.4 million, respectively, as of September 30, 2025 and December 31, 2024. This remeasurement resulted in the recording of a gain of $2.5 million and $2.4 million, respectively, for the three and nine months ended September 30, 2025 compared to a gain of $2.4 million and $12.1 million, respectively, for the three and nine months ended September 30, 2024, classified as change in fair value of contingent earnout liability in the condensed consolidated statements of operations. Assumptions used in the valuation are described below:
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Current stock price | $4.65 | $5.01 |
| Expected share price volatility | 70.0% | 70.0% |
| Risk-free interest rate | 3.6% | 4.3% |
| Expected term (years) | 2.86 | 3.61 |
| Estimated dividend yield | —% | —% |
The estimated fair value of the liability was determined using a Monte Carlo simulation valuation model using a distribution of potential outcomes. The inputs and assumptions utilized in the calculation require management to apply judgment and make estimates including:
(a)expected volatility, which is based on the historical equity volatility of publicly traded peer companies for a term equal to the expected term of the earnout period;
(b)expected term, which we based on the earnout period per the agreement;
(c)risk-free interest rate, which was determined by reference to the U.S. Treasury yield curve for time periods commensurate with the expected term of the earnout period; and
(d)expected dividend yield, which we estimate to be 0% based on the fact that we have never paid or declared dividends.
These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with exact precision.
(5)Warrants
Warrants that have not been tendered for exchange and outstanding at September 30, 2025, and December 31, 2024, are as follows:
| September 30,2025 | December 31,2024 | |
|---|---|---|
| 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 |
Public, Private Placement and Working Capital Warrant Liabilities
In connection with consummation of the Business Combination, we assumed the warrant liabilities associated with 8,333,272 Public Warrants. Each Public Warrant is exercisable to purchaseone share of common stock at a price of $11.50 per share, subject to adjustment. As of September 30, 2025 and December 31, 2024, there were 1,751,825 Public Warrants outstanding. The Public Warrants expire on August 10, 2028 or earlier upon redemption or liquidation.
The Public Warrants expire five years after the completion of the Business Combination or earlier upon redemption or liquidation. We may redeem for cash the outstanding Public Warrants:
a. in whole and not in part;
b. at a price of $0.01 per Public Warrant;
c. upon not less than 30 days’ prior written notice of redemption to each warrant holder; and
d. if, and only if, the reported closing price of the Common Stock equals or exceeds $18.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading day period ending three business days before we send the notice of redemption to the warrant holders.
If and when the Public Warrants become redeemable, we may exercise its redemption right even if it is unable to register or qualify the underlying securities for sale under all applicable state securities laws.
If we call the Public Warrants for redemption, management will have the option to require all holders that wish to exercise the Public Warrants to do so on a cashless basis. The exercise price and number of shares of common stock issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, recapitalization, reorganization, merger or consolidation. However, except as described below, the warrants will not be adjusted for issuances of common stock at a price below its exercise price. Additionally, in no event will we be required to net cash settle the warrants. Accordingly, the warrants may expire worthless.
In addition to the Public Warrants, we assumed the warrant liabilities associated with 4,933,333 Private Placement Warrants and 1,000,000 Working Capital Warrants. The Private Placement Warrants and Working Capital Warrants are identical to the Public Warrants, except that the Private Placement Warrants and Working Capital Warrants and the common stock issuable upon the exercise of the Private Placement Warrants and Working Capital Warrants, were not transferable, assignable or saleable until 30 days after the completion of the Business Combination, subject to certain limited exceptions. Additionally, the Private Placement Warrants and Working Capital Warrants are exercisable on a cashless basis and are non-redeemable so long as they are held by the initial purchasers or their permitted transferees. If the Private Placement Warrants and Working Capital Warrants are held by someone other than the initial purchasers or their permitted transferees, they will be redeemable by the Company and exercisable by such holders on the same basis as the Public Warrants. As of September 30, 2025 and December 31, 2024, there were 4,428,648 Private Placement Warrants and 1,000,000 Working Capital Warrants outstanding.
We determined that the Public Warrants, Private Placement Warrants, and Working Capital Warrants (collectively, the "Exchange Warrants") do not meet the criteria to be equity classified and should be recorded as liabilities. Our analysis concluded liability classification under ASC 815, Derivatives and Hedging, as these warrants include a provision that could allow cash settlement upon an event outside our control and such event may not result in a change in control of the Company. As a result, the Private and Public Warrants do not meet the criteria for equity classification.
The fair value of the Public Warrants has been measured based on the quoted price of such warrants on the Nasdaq Global Market. The transfer of Private Placement Warrants or Working Capital Warrants to anyone outside of a small group of individuals who are permitted transferees would result in the Private Placement Warrants and Working Capital Warrants having substantially the same terms as the Public Warrants. Therefore, we determined that the fair value of each Private Warrant and Working Capital Warrant is equivalent to that of each Public Warrant. As of September 30, 2025, the fair values of the Public Warrants, Private Placement Warrants and Working Capital Warrants were $3.0 million, $7.5 million, and $1.7 million, respectively. As of December 31, 2024, the fair values of the Public Warrants, Private Placement Warrants and Working Capital Warrants were $1.9 million, $4.9 million, and $1.1 million. We recorded a loss adjustment of $2.9 million and $4.3 million three and nine months ended September 30, 2025, respectively, to the change in fair value of SEPA, warrant and revenue base redemption liabilities on the condensed consolidated statements of operations.
On May 24, 2024, we commenced (i) the Offer and (ii) the solicitation of consent (the “Consent Solicitation”) from holders of the Exchange Warrants to amend the Warrant Agreement, dated as of December 17, 2020 (the “Warrant Agreement” and such amendment, the “Warrant Amendment”), by and between the Company and Continental Stock Transfer & Trust Company, which governs all of the Exchange Warrants.
The Offer and Consent Solicitation expired at one minute after 11:59 p.m., Eastern Standard Time, on June 25, 2024. The Exchange Warrants tendered were comprised of 6,529,954 Public Warrants and 504,685 Private Placement Warrants, which represents approximately 78.8% and 10.2% of the outstanding warrants of each respective class. The Warrants were validly tendered and not validly withdrawn prior to the expiration of the Offer and Consent Solicitation. No Working Capital Warrants were tendered. We determined the Exchange Warrants met the criteria to be equity classified at June 26, 2024, and that their fair value was $11.9 million. Adjusting for issuance costs of $1.7 million, the net fair value of the Exchange Warrants was $10.2 million. Accordingly, we recorded that amount as a reduction of the warrant and SEPA liabilities and an increase to additional paid-in capital on the condensed consolidated balance sheets, partially offset by issuance costs of $1.7 million. On July 1, 2024, we issued 2,110,366 shares of common stock for the Exchange Warrants.
In addition, the Warrant Amendment was entered into with respect to the Public Warrants. As a result all of the outstanding Public Warrants may be exchanged, at the Company's option, at any time while they are exercisable and prior to their expiration, at the office of the warrant agent, upon notice to the holders of the then outstanding Public Warrants, at the exchange ratio of 0.27 shares of Common Stock per Public Warrant (subject to equitable adjustment by us in the event of any stock splits, stock dividends, recapitalizations or similar transaction with respect to the Common Stock).
The following table summarizes activity in the Public Warrants, Private Placement Warrants, and Working Capital Warrants in the nine months ended September 30, 2025 and 2024.
| Series | Balance at December 31, 2024 | Exchanges | Issuances | Retirements / Conversions | Balance at September 30, 2025 |
|---|---|---|---|---|---|
| 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 |
| Series | Balance at December 31, 2023 | Exchanges | Issuances | Retirements / Conversions | Balance at September 30, 2024 |
|---|---|---|---|---|---|
| Public Warrants | 8,281,779 | — | — | (6,529,954) | 1,751,825 |
| Private Placement Warrants | 4,933,333 | — | — | (504,685) | 4,428,648 |
| Working Capital Warrants | 1,000,000 | — | — | — | 1,000,000 |
OrbiMed Warrants
In connection with the closing of the OrbiMed Credit Agreement, we also issued OrbiMed (the "OrbiMed Warrant Holder") a warrant to purchase 130,805 shares of our common stock (the "Warrant Shares"), with the initial exercise price of $9.5562, (the "Exercise Price") per share, or approximately $1.3 million in the aggregate, assuming none of the Initial OrbiMed Warrant is exercised through a cashless exercise. As of September 30, 2025, the exercise price was $8.8398 per share pursuant to the terms of the Initial OrbiMed Warrant, or approximately $1.2 million in the aggregate. The Initial OrbiMed Warrant expires on April 30, 2031 (the "Expiration Date"). On each of the closings of the Delayed Draw Commitment Amounts (see Note 9), if any, we agreed to issue additional warrants to purchase a number of shares of our common stock determined by dividing 5.0% of the applicable Delayed Draw Commitment Amount by the 10-day volume weighted average sale price of our common stock as of the issue date (the “Subsequent OrbiMed Warrants” and collectively, with the Initial OrbiMed Warrant, the “OrbiMed Warrants” and together with the Exchange Warrants, the “Warrants”). The Subsequent OrbiMed Warrants will expire seven years from each applicable issuance date, if any. In connection with the OrbiMed Warrants, we entered into a Registration Rights Agreement with OrbiMed (the “OrbiMed Registration Rights Agreement”), whereby OrbiMed will have certain customary registration rights with respect to the shares of common stock underlying the OrbiMed Warrants. In connection with the First Delayed Draw Term Loan Commitment draw (see Note 9) on February 18, 2025, we issued the OrbiMed operating entities a warrant to purchase 64,748 and 26,515 shares of our common stock (the "Subsequent OrbiMed Warrants"), with the initial exercise price of $5.4787, or approximately $0.5 million. As of September 30, 2025, the Exercise Price was $5.3322 per share pursuant to the terms of the Subsequent OrbiMed Warrant, or approximately $0.5 million in the aggregate. The Subsequent OrbiMed Warrant expires on February 18, 2032 (the "Expiration Date").
The OrbiMed Warrants may be exercised in whole or in part, at any time prior to the Expiration Date (the "Exercise Period"), by either:
a. making a payment to the Company, in an amount in immediately available funds equal to the aggregate Exercise Price to be paid upon the exercise of the OrbiMed Warrants; or
b. instructing the Company to withhold a number of Warrant Shares then issuable upon exercise of the OrbiMed Warrants with an aggregate fair market value as of the exercise date equal to such aggregate Exercise Price to be paid upon the exercise of the OrbiMed Warrants (the “Cashless Exercise”).
If either upon (i) the occurrence of the Expiration Date, or (ii) the date on which a Sale of the Company is consummated pursuant to which the sole consideration payable to the Company or its stockholders in respect of such sale transaction consists of cash, marketable securities or a combination thereof, and the per share fair market value of a Warrant Share is greater than the exercise price, any portion of the OrbiMed Warrants that remains unexercised on such date shall be deemed to have been exercised automatically pursuant to a Cashless Exercise (the “Automatic Cashless Exercise”).
Ownership Cap
The OrbiMed Warrant Holder in any circumstance cannot exercise the OrbiMed Warrants if such exercise would result in the holder and its affiliates to own more than 9.99% of the Company's common stock (the “Ownership Cap”).
Adjustments
The current Exercise Price and the number of Warrant Shares underlying the OrbiMed Warrants are subject to certain anti-dilutive adjustments. These are triggered by events such as stock splits, reclassification of shares, combinations or substitutions. Additionally, the Exercise Price will be adjusted if shares,which include options and convertible securities settled in common stock) are issued at a price per share less than the current Exercise Price. These adjustments are collectively referred to as "Warrant Adjustments.”
If we declare or pay a dividend or distribution on our outstanding common shares payable in cash, capital securities or other property, the OrbiMed Warrant Holder shall be entitled to receive, at the time such dividend or distribution is paid, without additional cost to the OrbiMed Warrant Holder, the total number and kind of cash, capital securities or other property which the OrbiMed Warrant Holder would have received had the OrbiMed Warrant Holder owned the Warrant Shares of record as of the date such dividend or distribution was paid (the “Pro-Rata Distribution”).
Additionally, the OrbiMed Warrants are subject to customary price-based anti-dilution protections, such that, in certain circumstances, if we issue shares of our common stock below the current exercise price of the Initial OrbiMed Warrant, the exercise price of the OrbiMed Warrants will be adjusted downward based on such issuance. As a result of any adjustments, the amount of proceeds we receive from the exercise of the OrbiMed Warrants would be less than the amount we would receive immediately prior to such adjustment.
Transfers of OrbiMed Warrants
The OrbiMed Warrants may be transferred or assigned in whole or in part, subject to compliance with applicable federal and state securities laws.
Allocation of Proceeds and Issuance Costs
The agreement explicitly permits the settlement of the OrbiMed Warrants in a cashless manner (i.e., net share settlement) and not indexed to the Company's own stock. Therefore, it is considered as a derivative instrument under ASC 815 and will be classified as a liability and is subsequently measured at fair value with changes reported within the change in fair value of SEPA, warrant, and revenue base redemption liabilities of the condensed consolidated statement of operations following the proceeds from the issuance of the Initial Term Loan.
The fair value of the Initial OrbiMed Warrant was measured using the Black-Scholes option pricing model. The key inputs used in the valuations were as follows:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Expected term (years) | 5.6 | 6.3 |
| Risk free interest rate | 3.8% | 4.5% |
| Expected volatility | 70.0% | 70.0% |
| Dividend yield | —% | —% |
| Exercise price | $8.8398 | $9.3722 |
| Stock price | $4.65 | $5.01 |
The fair value of the Subsequent OrbiMed Warrant was measured using the Black-Scholes option pricing model. The key inputs used in the valuations were as follows:
| September 30, 2025 | February 18, 2025 | |
|---|---|---|
| Expected term (years) | 6.4 | 7.0 |
| Risk free interest rate | 3.9% | 4.1% |
| Expected volatility | 70.0% | 70.0% |
| Dividend yield | —% | —% |
| Exercise price | $5.3322 | $5.4787 |
| Stock price | $4.65 | $5.69 |
(6)Income Taxes
The Company's full pretax loss for the three and nine months ended September 30, 2025 and 2024 was from U.S. domestic operations. The Company's effective tax rate ("ETR") from continuing operations was (0.16)% and (0.05)% for the three and nine months ended September 30, 2025 (0.12)% and (0.05)% for the three and nine months ended September 30, 2024. There discrete items recorded for the quarter primarily related to the tax impact of the change in the fair value of warrant, SEPA and revenue base redemption liabilities and the change in fair value of contingent earnout liability.
On July 04, 2025, the “One Big Beautiful Bill Act” ("OBBBA") was enacted into law. The Act has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. These changes include the allowance of immediate expensing of qualifying research and development expenses and permanent extension of certain provisions within the Tax Cuts and Jobs Act. We evaluated the impact of OBBBA on our quarterly tax provision as it was enacted in the third quarter of 2025. For the three and nine months ended September 30, 2025, there was no material impact related to the changes of OBBBA.
(7)Dynavax Purchase
We purchased all of the intellectual property and trial drug substance for nelitolimod from Dynavax Technologies (“Dynavax”) in 2020. This was a purchase of in-process research and development. Nelitolimod, an investigational agent in development, is a TLR9 agonist which is believed to bind to the TLR9 receptors found on suppressive immune cells including myeloid-derived suppressor cells and antigen-presenting immune cells. We believe that nelitolimod, when delivered using our PEDD devices, can improve therapeutic distribution to solid tumors and improve outcomes for liver metastases and Locally Advanced Pancreatic Ductal Adenocarcinoma ("LA-PDAC").
Payments under the Dynavax purchase agreement consist of: (a) an upfront payment of $9.0 million, (b) milestone payments upon the achievement of certain development and commercial milestones, and (c) royalty payments based on aggregate annual net sales after nelitolimod receives Food and Drug Administration ("FDA") approval to be sold.
The milestone payments range from $1.0 million to $10.0 million, triggered by development achievements for each of up tofour indications. The development milestone payments cannot exceed $170.0 million. We have made milestone payments of $1.0 million in September 2021, after initiating our clinical study of uveal melanoma liver metastases, June 2022, after initiating our clinical study for primary liver tumors, and August 2023, after initiating our clinical study for LA-PDAC. In aggregate, the commercial milestones shall not exceed $80.0 million. We will also pay annual royalties at the rate of 10.0% for aggregate annual net sales less than or equal to $1.0 billion and 12.0% for aggregate annual net sales above that amount.
We record the milestone payments in R&D expense when they are incurred. The milestone payments and royalty payments are contingent upon future events and therefore will also be recorded as expense when it is probable that a milestone has been achieved or when royalties are due. During the three and nine months ended September 30, 2025 and 2024, we made no payments to Dynavax.
(8)Standby Equity Purchase Agreement
In October 2023, we entered into the SEPA with Yorkville Advisors Global, LP ("Yorkville"). Pursuant to the SEPA, we have the right, but not the obligation, to sell to Yorkville up to $30.0 million of Common Stock, par value $0.0001 per share, at our request any time during the commitment period commencing on October 2, 2023 (the “Effective Date”), and terminating on the first day of the month following the 24-month anniversary of the Effective Date. Each issuance and sale to Yorkville under the SEPA (an “Advance”) is subject to a maximum limit equal to the greater of: (i) an amount equal to 100% of the average of the daily volume of the Common Stock on the Nasdaq Stock Market (“Nasdaq”) for the 10 trading days immediately preceding an Advance notice, or (ii)1,000,000 shares of Common Stock. At our election, the shares will be issued and sold to Yorkville at a per-share price equal to: (i)96.0% of the Market Price (as defined below) for any period commencing on the receipt of the Advance notice by Yorkville and ending on 4:00 p.m. Eastern time on the applicable Advance notice date (the “Option 1 Pricing Period”), or (ii)97.0% of the Market Price for anythree consecutive trading days commencing on the Advance notice date (the “Option 2 Pricing Period,” and each of the Option 1 Pricing Period and the Option 2 Pricing Period, a “Pricing Period”). “Market Price” is defined as, for any Option 1 Pricing Period, the daily volume-weighted average price (“VWAP”) of the Common Stock on Nasdaq, and for any Option 2 Pricing Period, the lowest VWAP of the Common Stock on the Nasdaq during the Option 2 Pricing Period. The Advances are subject to certain limitations, including that Yorkville cannot purchase any shares that would result in it beneficially owning more than 4.99% of the outstanding voting power or Common Stock. Further, Yorkville cannot purchase shares that would result in it acquiring more than 5,260,704 shares of Common Stock, which represents 19.99% of the outstanding Common Stock, as of the Effective Date of SEPA.
The SEPA contract is accounted for as a derivative as it is an equity-linked contract that does not qualify for equity classification under ASC 815. Therefore, SEPA is recognized as a liability measured each period at fair value in accordance with ASC 820, Fair Value Measurement, on the condensed consolidated balance sheets and the change in fair value of the SEPA liability is recorded on the condensed consolidated statements of operations. We did not issue any Advances during three and nine months ended September 30, 2025.
The estimated fair value of the SEPA liability on December 31, 2024, was $0.1 million, which was determined using a scenario-based valuation model. The liability was remeasured to its fair value ofzero as of September 30, 2025 due to not having any intentions to utilize the SEPA prior to expiring on November 1, 2025. This remeasurement resulted in the recognition of an immaterial gain and a gain of $0.06 million for three and nine months ended September 30, 2025, classified as change in fair value of SEPA, tranche and warrant liabilities in the condensed consolidated statement of operations. Assumptions used in the valuation are described below:
| Valuation assumptions: | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Expected draws | None | $2,000 |
| Expected probability of draws | —% | 90% |
| Risk-free interest rate | —% | 4.4% |
The estimated fair value of the liability was determined using a scenario-based valuation model which assigned a probability to a number of different outcomes. The inputs and assumptions utilized in the calculation require management to apply judgment and make estimates including:
(a)no total expected draws as of September 30, 2025, and $2.0 million total expected draws, respectively, December 31, 2024 through the issuance of multiple separate advances under the Option 2 Pricing Period as of December 31, 2024;
(b)the expected probability of the draws on the SEPA, which we estimate based on our expectation of the draws being completed; and
(c)risk-free interest rate, which was determined by reference to the U.S. Treasury yield curve for time periods commensurate with the expected term of the agreement in relation to the date of the expected draw.
These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with exact precision.
(9)Debt
On April 30, 2024 (the "OrbiMed Closing Date"), we entered into the Credit Agreement with OrbiMed ("OrbiMed Credit Agreement"), a healthcare investment firm, and certain of its affiliates to support the execution of strategic expansion plans, fuel continued growth and provide financial flexibility.
Pursuant to the Agreement, OrbiMed agreed to provide a term loan facility to the Company, in an aggregate principal amount of $50.0 million, as follows:
a.$25.0 million funded on the OrbiMed Closing Date (the “Initial Term Loan”).
b.$10.0 million term loan available at the election of the Company, provided that Product Revenue Base for the trailing 12-months ending on the last day of the month immediately prior to the funding of such loan was at least $30.0 million (the “First Delayed Draw Term Loan Commitment”). The First Delayed Draw Term Loan Commitment expired on June 30, 2025.
c. An additional $15.0 million term loan available at the election of the Company, provided that Product Revenue Base for the trailing 12-months ending on the last day of the month immediately prior to the funding of such loan was at least $50.0 million (the “Second Delayed Draw Term Loan Commitment” and together with the First Delayed Draw Term Loan Commitment the “DDTL Commitments”). The Second Delayed Draw Term Loan Commitment expires on December 31, 2025.
The term loan matures on April 30, 2029 (the "Maturity Date"). On April 30, 2024, we borrowed the initial commitment amount, resulting in gross proceeds of $25.0 million. On February 18, 2025, we borrowed the First Delayed Draw Term Loan Commitment resulting in gross proceeds of $10.0 million based on achieving the trailing 12-month Product Revenue Base of $30.0 million in January 2025.
The OrbiMed Credit Agreement includes a subjective acceleration clause whereby an event of default, including a material adverse change in the business, operations, or conditions, could result in the acceleration of the obligations under the OrbiMed Credit Agreement. Under certain circumstances, a default interest rate of an additional 4.0% per annum will apply, at the election of OrbiMed, on all outstanding obligations during the occurrence and continuance of an event of default. OrbiMed can also declare all or a portion of the outstanding principal amount of the loan due and payable, and cancel any unmade draws. OrbiMed has not exercised its right under this clause as there have been no such events.
As part of the First Amendment to the OrbiMed Credit Agreement and Registration Rights Agreement, effective March 20, 2025, we received a waiver for the prior default events related to the Series A Convertible Preferred Stock conversions and the OrbiMed Credit Agreement was amended to allow for these conversions going forward. In addition, we received a waiver on March 31, 2025 to extend the timing for the required audited financial statements to occur on or before April 15, 2025. Effective on April 30, 2025, the Second Amendment to the OrbiMed Credit Agreement allows for the Company to accelerate payment of the Series A Preferred Stock dividends in cash payments in lieu of fractional shares upon conversion of Preferred Stock.
On November 10, 2025, we entered into the Third Amendment to the OrbiMed Credit Agreement ("OrbiMed Third Amendment"), which lowered the the minimum cash requirement for the liquidity covenant from $10.0 million to $5.0 million. In addition, we received a waiver for the prior default related to the 30 days written notice of the change in our Chief Financial Officer.
Repayment
If the Product Revenue Base (i.e., with respect to any period, the net revenues for such period from sales of TriNav) on a trailing 12-month basis does not equal or exceed the specified amount as stipulated in table below, the Company will start repaying the outstanding principal amount of the Term Loans. Such repayments will commence in the calendar month immediately following the applicable Test Date (stipulated in the table below) and occur on the last day of each calendar month ("Amortization Payment Date"). The repayments are made in equal monthly installments, calculated from the first Amortization Payment Date through the Maturity Date and the balance principal amount of the Term Loans shall be repaid on the Maturity Date. The repayments include the applicable Repayment Premium and the Exit Fee (each as defined below). The repayment of the Term Loans as aforementioned, is referred to as the “revenue base redemption liability.”
| Test Dates (fiscal Quarter Ending) | Product Revenue Base for 12 months Period |
|---|---|
| September 30, 2025 | 37,800 |
| December 31, 2025 | 42,700 |
| March 31, 2026 | 46,400 |
| June 30, 2026 and each Fiscal Quarter ending thereafter | 50,000 |
As of September 30, 2025, we were in compliance with the Product Revenue Base requirement and no repayments were required.
Repayment Premium
All payments of the Term Loans (other than on Maturity Date) shall be accompanied by the payment of the premium, which shall be determined based on the timing of the repayment as follows (the “Repayment Premium”):
| Time of Repayment | Premium Rate |
|---|---|
| Within the first 12 months from the funding date of each respective loan. | 3.0% plus the Make-Whole Amount (1) |
| After the first 12 months but before the 24-month anniversary of the funding date of each respective loan. | 3.0% |
| After the 24-month anniversary but before the 36-month anniversary of the funding date of each respective loan. | 2.0% |
| After the 36-month anniversary but before the 48-month anniversary of the funding date of each respective loan. | 1.0% |
| After the 48-month anniversary of the funding date of each respective loan. | 0.0% |
(1)“Make-Whole Amount” is equal to the sum of the remaining scheduled interest payments through the 12-month anniversary
of the closing date of each respective loan.
Interest Rate and Payment
The interest rate is calculated as Secured Overnight Financing Rate for the interest period (which shall not be less than 4.0% (the “Floor”)) plus 8.5% (the “Interest Rate”). Until the first full interest period after the 15 months anniversary of the OrbiMed Closing Date,3.5% of the Interest Rate shall be designated as paid-in-kind interest ("PIK Interest"), which is added to the outstanding principal amount of the Loans. However, the Company upon written notice can elect to pay all interest in cash or to pay a percentage less than 3.5% as PIK Interest.
On and after occurrence of any Event of Default, until such Event of Default is cured, the Company is obligated to pay 4.0% in addition to the otherwise applicable Interest Rate (the “Default Rate”).
Interest payments (except PIK Interest) are due on the last day of the month. Whenever a prepayment is made on the principal of the Term Loans, the accrued interest on the amount prepaid is also due on such date.
Warrant
In connection with the closing of the OrbiMed Credit Agreement, we issued OrbiMed the Initial OrbiMed Warrant. Subsequent to achieving the First Delayed Draw Term Loan Commitment revenue requirement, the Subsequent OrbiMed Warrant was issued (see Note 5) for further discussion.
Debt Related Fees
Exit Fee
The Company on the repayment of the Term Loans is obligated to pay an additional fee equal to 4.0% of the of the principal amount being repaid. This applies whether the repayment is made on the Maturity Date, or under any other conditions specified in the Agreement (the “Exit Fee”). The Exit Fee is amortized over the term of the Term Loans.
Commitment Fee
The Company on the funding date of the Term Loans, shall pay a commitment fee to the Lender, equal to 2.0% of the principal amount drawn (the “Commitment Fee”). The Commitment Fee was recorded as a debt discount and amortized over the life of the Term Loans.
Undrawn Fee
Every month, the Company is obligated to remit a fee to the Lender, calculated as 0.25% per annum of the total undrawn amount under the DDTL Commitments (the "Undrawn Fee"). The Undrawn Fee is accounted for as a service fee, which is expensed as incurred.
Administrative Fee
The Company will pay to the Agent for its own account a quarterly loan administration fee of $0.01 million, payable in advance, with the first payment due and payable upon the OrbiMed Closing Date.
In 2024, we recorded the Initial Term Loan and the First Delay Draw as Long-term debt, and recorded the issuance costs incurred to obtain the loan as contra-debt, in accordance with ASC 470, Debt.
During the three months ended September 30, 2025, we recorded interest expense of $1.5 million related to the Term Loan on the condensed consolidated statements of operations, of which $0.2 million was recorded as PIK Interest $1.0 million was cash interest and $0.3 million was amortization of debt issuance costs and debt discount.
The following table summarizes activity within the Term Loan for the nine months ended September 30, 2025:
| OrbiMed Debt | |
|---|---|
| Initial draw | $25,000 |
| Debt issuance costs | |
| Cash issuance costs | $(2,593) |
| Noncash issuance costs: | |
| Revenue base redemption liability | (729) |
| Warrant liability | (811) |
| Balance at April 30, 2024 | $20,867 |
| Amortization of debt issuance costs | 486 |
| PIK interest | 604 |
| Accretion of exit fee liability | 127 |
| Balance at December 31, 2024 | $22,084 |
| First Delayed Draw Term Loan Commitment | 10,000 |
| Debt issuance costs | |
| Cash issuance costs | (521) |
| Noncash issuance costs: | |
| Warrant liability | (366) |
| Amortization of debt issuance costs | 558 |
| PIK interest | 800 |
| Accretion of exit fee liability | 209 |
| Balance at September 30, 2025 | $32,764 |
(10)Convertible Preferred Stock
As of June 30, 2025, the Company had 3,594,002 shares of Series A Convertible Preferred Stock ("Preferred Stock") outstanding. The original issue price of the Series A Convertible Preferred Stock was $10.00. The Series A Convertible Preferred Stock accrues cumulative dividends at the rate of 8.00% per annum on the original issue price. As of June 30, 2025, total undeclared cumulative dividends were $5.4 million, which were not recorded in our condensed consolidated financial statements, except actual undeclared dividends of $1.4 million as a reconciling item for net loss attributable to common stockholders on the condensed consolidated statements of operations.
On June 23, 2025, the Company commenced an offer (the “Offer”) to all holders of Preferred Stock to exchange their shares of Preferred Stock for Common Stock equal to the sum of the liquidation preference per share price of $10.00 and all accrued and unpaid dividends per share outstanding through August 10, 2027, divided by a $4.00 conversion price per share. The Offer expired at one minute after 11:59 p.m., Eastern Daylight Time, on July 23, 2025. For any Preferred Stock holders that did not participate in the Offer, the Company had the right to call their Preferred Stock shares for conversion into Common Stock shares equal to the sum of the liquidation preference per share price of $10.00 and all accrued and unpaid dividends per share outstanding through the conversion date, divided by a $5.277 conversion price per share.
Approximately 98.8% of the outstanding shares of Preferred Stock shares were tendered through the Offer and were accepted for exchange, resulting in 3,551,502 shares of Preferred Stock converted to 11,719,956 shares of Common Stock. For the holders of Preferred Stock that did not participate in the Offer, the Company called their Preferred Stock and 42,500 shares of Preferred Stock were converted to 93,103 shares of Common Stock. All shares of Preferred Stock were converted for common stock shares on July 31, 2025, resulting in the issuance of 11,813,059 Common Stock shares.
As of September 30, 2025 and subsequent to the Preferred Stock Conversion, there areno outstanding shares of Preferred Stock. The Company is authorized to issue up to 10,000,000 shares of preferred stock with 10,000,000 shares available for issuance.
The following table summarizes activity in Series A Convertible Preferred Stock, as-converted, for the nine months ended September 30, 2025.
| Series | Balance at December 31, 2024 | Issuances | Retirements / Conversions | Balance at September 30, 2025 |
|---|---|---|---|---|
| Series A convertible preferred stock | 3,985,002 | — | (3,985,002) | — |
| Total convertible preferred stock | 3,985,002 | — | (3,985,002) | — |
(11)Net Loss Per Share
Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. During periods where we might earn net income, we would allocate to participating securities a proportional share of net income determined by dividing total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities (the “two-class method”). Our preferred stock participates in any dividends declared by us and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods where we incur net losses, we do not allocate the loss to participating securities because they have no contractual obligation to share in our losses. We computed diluted loss per common share after giving consideration to the dilutive effect of stock options and warrants that are outstanding during the period, except where such nonparticipating securities would be antidilutive. For the three and nine months ended September 30, 2025 and 2024, diluted net loss per common share is the same as basic net loss per common share for those periods.
The following potentially dilutive securities (in common stock equivalent shares) have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported:
| September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Preferred stock | — | 25,048,584 |
| Common stock warrants | 7,402,541 | 7,311,278 |
| RSUs and PSUs | 797,669 | 538,345 |
| Options to purchase common stock | 6,452,581 | 4,909,457 |
| Shares issuable under the SEPA | 3,468,998 | 3,385,837 |
| Total | 18,121,789 | 41,193,501 |
As a result of the Offer related to the Preferred Stock, the Preferred Stock was completely converted to Common Stock before the quarter-end September 30, 2025 and is no longer considered a potentially dilutive security (see Note 10).
(12)Share-Based Compensation
We currently maintain the 2023 Equity Incentive Plan (the “2023 Plan”), which our Board of Directors (the "Board") and stockholders approved in connection with the Business Combination, for purposes of granting equity-based incentive awards to our employees and consultants, including our executive officers and directors. Prior to the Business Combination, TriSalus granted equity incentive awards under the 2009 Amended and Restated Equity Incentive Plan (the “2009 Plan”). The 2009 Plan has not be used following the Business Combination. However, any awards granted under the 2009 Plan remain subject to the terms of the 2009 Plan and the applicable award agreement. Historically, we have used options as an incentive for long-term compensation to our executive officers because options allow our executive officers to realize value from this form of equity compensation only if the value of the underlying equity securities increase relative to the option’s exercise price, which exercise price is set at the fair market value of the underlying equity securities on the grant date. We record the issuance of the shares when they are recorded by the transfer agent and as such, there could be timing differences between when the expense is recorded and shares are transferred.
As of September 30, 2025, the balances under thetwo plans are as follows:
| September 30, 2025 | |||
|---|---|---|---|
| Authorized | Outstanding | Available for Issue | |
| 2009 Plan | 1,179,218 | 1,179,218 | — |
| 2023 Plan | 10,006,900 | 6,071,032 | 3,935,868 |
| Total | 11,186,118 | 7,250,250 | 3,935,868 |
2009 Equity Incentive Plan
As of September 30, 2025, there were in total 1,153,861 stock options and 25,357 Restricted Stock Units ("RSUs") issued and outstanding under the 2009 Plan. Stock options were granted with an exercise price equal to the estimated fair value of the stock at the date of grant. Prior to the Business Combination, the fair value was determined by a third-party valuation performed in accordance with IRS Section 409A. No awards have been granted subsequent to the Business Combination, as the 2009 Plan was frozen and replaced by the 2023 Plan. Options generally have aten-year contractual term and typically have graded vesting overone tofour years.
Options for 67,300 shares of Common Stock were exercised and 19,887 options were forfeited during the nine months ended September 30, 2025. There were 8,322 RSUs released during the nine months ended September 30, 2025.
We recorded compensation expense related to the 2009 Plan of $0.2 million and $0.4 million for the three and nine months ended September 30, 2025, respectively, compared to $0.1 million and $0.4 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had unrecognized compensation expense of $0.2 million and $0.1 million, respectively, for options and RSUs granted under the 2009 Plan. The September 30, 2025 balance will be recognized over a weighted average period of 0.75 years.
2023 Equity Incentive Plan
As of September 30, 2025, there were in total 5,298,720 stock options and 772,312 RSUs and Performance Stock Units ("PSUs") issued and outstanding under the 2023 Plan. Initially,5,585,008 shares were authorized under the 2023 Plan. In addition, the share reserve will automatically increase on January 1 of each year for a period of 10 years, commencing on January 1, 2024, and ending on January 1, 2033, in an amount equal to (1)five percent of the total number of shares of the fully diluted Common Stock determined on December 31 of the preceding year or (2) a lesser number of shares of Common Stock determined by our Board prior to January 1 of a given year. On January 1, 2025, the authorized shares under the 2023 Plan increased by 2,383,545 shares to 10,350,022. Options for 54,906 shares of Common Stock were exercised and 574,641 options were forfeited during the nine months ended September 30, 2025. There were 288,216 RSUs released and 52,375 RSUs forfeited during the nine months ended September 30, 2025. During the nine months ended September 30, 2025, we granted 2,577,713 options with a weighted average fair value of $5.04, and 687,546 RSUs, net of forfeitures, with a weighted average fair value of $4.90.
We recorded compensation expense related to the 2023 Plan of $3.1 million and $6.4 million for the three and nine months ended September 30, 2025, respectively, compared to $1.1 million and $3.2 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had unrecognized compensation expense of $11.1 million and $3.5 million, respectively, for options and RSUs and PSUs granted under the 2023 Plan. The balance at September 30, 2025 will be recognized over a weighted average period of 2.80 years.
Employee Stock Purchase Plan
We maintain an Employee Stock Purchase Plan ("ESPP"), which provides our eligible employees with an opportunity to purchase shares of Common Stock, to assist us in retaining the services of eligible employees, to secure and retain the services of new employees, and to provide incentives for such persons to exert maximum efforts for our success. The ESPP became active in 2024. Initially,2,350,530 shares of Common Stock were reserved for issuance under the ESPP. The number of shares of Common Stock reserved for issuance under the ESPP will automatically increase on January 1 of each year for a period of up toten years, beginning on January 1, 2024, and continuing through and including January 1, 2033, by an amount equal to the lesser of (a) two percent (2%) of the total number of shares of the Fully Diluted Common Stock determined on December 31 of the preceding year, and (b)200% of the Initial Share Reserve. On January 1, 2025, the authorized shares under ESPP increased by 953,418 shares to 3,303,948.
During the nine months ended September 30, 2025,49,939 shares were purchased in an offering under the ESPP.
(13)Commitments And Contingencies
From time to time, we may have certain contingent liabilities, including litigation, which arise in the ordinary course of its business activities. We accrue contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. In the opinion of management, there are no pending claims for which the outcome is expected to result in a material adverse effect on our condensed consolidated balance sheets, statements of operations or statements of cash flows.
As part of the Business Combination, we entered into the Amended and Restated Registration Rights Agreement with certain investors in MedTech and Legacy TriSalus. Subject to certain requirements and customary conditions, we granted piggyback registration rights and demand registration rights to the parties thereto, agreed to pay certain expenses related to such registrations and agreed to indemnify the parties thereto against certain liabilities related to such registrations. Our registration obligations under the Amended and Restated Registration Rights Agreement will terminate with respect to any party thereto on the date that such party no longer holds any Registrable Securities (as defined in the Amended and Restated Registration Rights Agreement). The Amended and Restated Registration Rights Agreement does not contain liquidated damages or other cash settlement provisions resulting from delays in registering the Company’s securities.
We are not a party to any legal proceedings and we are not aware of any claims or actions pending or threatened against us. In the future, we might from time to time become involved in litigation relating to claims arising from our ordinary course of business.
(14) Leases
We havetwo property leases in effect as of September 30, 2025, which we account for as operating leases:
A lease for our principal administrative and production facility at 6272 West 91st Avenue, Westminster, Colorado, which expires on December 31, 2031. This lease includesone option to extend the lease byfive years from the end of the current term.
A lease for office space at 2275 Half Day Road, Bannockburn, Illinois, which expires in January 2028. This lease includes an option to extend the lease bythree years at the end of the current term.
We also haveone finance leases for copier equipment in our Westminster facility.
On July 17, 2024, we exercisedone of thetwo options to extend the current lease for the Westminster facility for an additional period offive years commencing on January 1, 2027 and ending on December 31, 2031 ("Second Extended Lease Term"). All terms and conditions of the lease shall continue to apply during the Second Extended Lease Term. We will pay approximately $1.5 million in rent over the duration of the Second Extended Lease Term.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.