TLSI 10-K & 10-Q changes, risk factors and insider trading

Investing in our securities involves a high degree of risk. Before you make a decision to buy our securities, in addition to the risks and uncertainties discussed above under “SpecialCautionary Note Regarding Forward-Looking Statements,” you should carefully consider the risks and uncertainties described below together with all of the other information contained in this Annual Report, including the accompanying financial statements and related notes, and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any of the following events or developments described as risks were to occur, either alone or taken together, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our securities could decline, and you could lose all or part of your investment. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.

We are a commercial-stage medical device and Phase I clinical-stage pharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We have incurred significant losses since inception, including net losses of $30.0$39.2 million and $59.4$30.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $279.5$330.6 million. We anticipate incurring increased sales and general and administrative expenses related to our operations and transition into a public company for the foreseeable future. Losses will likely continue and may increase in the future as we continue to incur significant expenses related to drug development. We may find that these efforts are more expensive than we currently anticipate or that these efforts may not result in revenues, which would further increase our losses. In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by clinical-stage pharmaceutical companies. If we are unable to achieve and/or sustain profitability, or if we are unable to achieve the growth that we expect from these efforts, it could have a material adverse effect on our business, financial condition or results of operations. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

Our need for additional capital raises substantial doubt about our ability to continue as a going concern. Until we are able to generate significant revenues or achieve profitability through product sales, we willmay require substantial additional capital to finance our operations and continue development of our product candidates. We cannot be certain that such additional financing will be available on terms favorable to us, or at all, which could limit our ability to grow and jeopardize our ability to continue our business operations.

We expect to incur significant expenses and operating losses for the foreseeable future as we continue to invest in the commercialization of TriNav, and clinical trials and other development, manufacturing and regulatory activities for TriNav, nelitolimod, and our other product candidates, and discovery research and development. Until we can generate a sufficient amount of revenue, we willmay need to finance our operations through strategic alliance and licensing arrangements and/or public or private debt and equity financings. We anticipate needing to obtain substantial additional funding in connection with our continuing operations and planned activities to expand our business, to respond to competitive pressure and to make acquisitions. The amount of capital we willmay need may change depending on, among other things, the success of our efforts to grow revenue, our efforts to continue to effectively manage expenses, the results of our research and development and clinical trials for product candidates, and costs arising from seeking regulatory approvals. We may not succeed in raising additional funds in a timely manner. The timing of our need for additional funds will depend on many factors, which are difficult to predict or may be outside of our control, including to continue the clinical development of, and seek regulatory approval for, nelitolimod in any indication. These factors include:

◦•the revenue received from sales of TriNav;

◦•the costs and timing of research and development programs, including for additional Pressure- Enabled Drug Delivery (“PEDD”) devices;

◦•our ability to access the remaining available loan amount under our OrbiMed Credit Agreement if and when needed;

◦•the scope, progress, results, resources, time and costs of preclinical development, laboratory testing and clinical trials for our current and future product candidates;

◦•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

◦•our ability to establish collaborations on favorable terms, if at all;

◦•the costs, timing and outcome of the regulatory review and approval of nelitolimod and any future product candidate;

◦•the timing of any milestone payments or royalties due to Dynavax; and ◦the costs of operating as a public company.

We may also need to seek collaboratorspartners for nelitolimod and any future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to nelitolimod and any future product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves. Any of the above events could significantly harm our business, prospects, financial condition, and results of operations and cause the price of Common Stock to decline. Further, our ability to raise additional capital and the interest rate of our term loans under the OrbiMed Credit Agreement may be adversely impacted by potential worsening global economic conditions, and the continued disruptions to and volatility in the credit and financial markets in the United StatesU.S. and worldwide resulting from geopolitical events, including the wars in Ukraine and the Middle East, and disruptions to the U.S. banking system due to bank failures. Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry, or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems. If we are unable to raise sufficient additional capital, we could be forced to curtail our planned operations and the pursuit of our growth strategy and business development efforts, which could jeopardize our ability to continue our business operations.

We have entered into the OrbiMed Credit Agreement,Agreement pursuantand toborrowed which we may borrow up to $50.0$35.0 million in senior secured term debt. Our obligations under the OrbiMed Credit Agreement are secured by substantially all of our assets.

We are subject to a number of affirmative and restrictive covenants pursuant to the OrbiMed Credit Agreement, which limit or restrict our ability to, among others (subject to certain qualifications and exceptions): create liens and encumbrances; incur additional indebtedness; merge, dissolve, liquidate or consolidate; make acquisitions, investments, advances or loans; dispose of or transfer assets; pay dividends or make other payments in respect of our capital stock; amend certain material documents; redeem or repurchase certain debt; engage in certain transactions with our affiliates; and enter into certain restrictive agreements. In addition, we are required to maintain at least $5.0 million of unrestricted cash and cash equivalents at all times (which requirement will increase to $10.0 million at all times after March 31, 2025).times. Our obligations under the OrbiMed Credit Agreement are subject to acceleration upon the occurrence of an event of default (subject to applicable notice and grace periods). We are currently in compliance with the OrbiMed Credit Agreement covenants; however, we currently expect that we expect that we will need to raise additional capital to remain in compliance with the minimum cash threshold.covenants. If we are unable to achieve certain milestones, generate sufficient revenue and maintain certain minimum cash threshold, we may fall out of compliance with these covenants, which could constitute an event of default. We may also enter into other debt agreements in the future which may contain similar or more restrictive terms.

Our ability to make scheduled monthly payments or to refinance our debt obligations depends on numerous factors, including the amount of our cash reserves and our actual and projected financial and operating performance. These amounts and our performance are subject to certain financial and business factors, as well as prevailing economic and competitive conditions, some of which may be beyond our control. We cannot assure you that we will maintain a level of cash reserves or cash flows from operating activities sufficient to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness. If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our indebtedness. We cannot assure you that we would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt service obligations. Failure to comply with the conditions of or covenants in the OrbiMed Credit Agreement could result in an event of default, which could result in an acceleration of amounts due under the OrbiMed Credit Agreement. We may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments,payments and OrbiMed could seek to enforce security interests in the collateral securing such indebtedness, which would materially harm our business and our stock price.

Pursuant to the Dynavax Agreement, as of the date of this Annual Report on Form 10-K,Report, we have paid Dynavax $12.0 million to date and we may be required to pay Dynavax up to an additional $158.0 million upon the achievement of certain development and regulatory milestones with respect to nelitolimod. We will also be required to pay up to $80.0 million upon achieving certain commercial milestones once sales of nelitolimod have begun. The Dynavax Agreement also obligates us to pay royalties based on potential future net sales of products containing nelitolimod compound on a product-by-product and country-by-country basis during the applicable royalty term. Such royalties are subject to reduction by up to 50% in certain circumstances. Our failure to satisfy these payment obligations or other obligations under the Dynavax Agreement could result in penalties or litigation, which could have a material adverse effect on our business, financial condition,condition and results of operations.

We began selling TriNav in 2020 in the United States,U.S., and sales of TriNav account for primarily all of our revenue and will continue to account for primarily all of our revenue going forward. Our ability to execute our growth strategy and become profitable will therefore depend upon the adoption of TriNav by physicians and hospitals, among others, and for various conditions where PEDD may be applicable, including liver cancer, multinodular goiters, locally advanced pancreatic cancer, UFEs and prostate embolization.

We are in the early stages of our development efforts and have only one product candidate, nelitolimod, in early clinical development. We have initiatedcompleted nelitolimod dosing in Phase 1 and Phase 1b clinical trials for nelitolimod, each of which are focused on a different target indication, specifically UMLM, ICC and HCC, and locally- advanced pancreatic cancer. We expect that any continued investigation for ICC and HCC will only continue through IITs. Based on physician and investigator interest, we are supporting two Investigator Initiated Trials with nelitolimod, one in patients with advanced HCC in combination with cryoablation, durvalumab and tremelimumab another in patients with resectable colorectal liver metastases. Due to the changingexcessive landscape for second line treatmentcosts of uveal melanoma, we do not intend to proceed to Phase II trials for that indication on our own, butcapital, we are looking for potential partners for funding to advance thatnelitolimod indication.development Ourin Phase III PERIO-03 clinical trialtrials in pancreaticone canceror ismore enrolledchosen andindications webased anticipate data fromon the studyresults of these early studies. Results will be available byin the2026, endand ofwe 2025,will dependingbegin discussions on whenfurther treatmentclinical isdevelopment. completed.Phase WeII studies will need to progress the pancreatic carcinoma indication through IND-enabling studies and submit Investigational New Drug applications (“INDs”) to therequire FDA authorization prior to initiating their clinical development.initiation. Our ability to generate product revenues from our product candidate, which we do not expect will occur for several years, if ever, will depend heavily on the successful development and eventual commercialization of our product candidate. The success of this product candidate will depend on several factors, including the following:

◦•successful enrollment in clinical trials and completion of clinical trials and preclinical studies with favorable results;

◦•clearance of INDs by the FDA or similar regulatory filings by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidate and our proposed design of future clinical trials;

◦•demonstrating the safety and efficacy in the proposed indications for use of our product candidate to the satisfaction of applicable regulatory authorities;

◦•receipt of marketing approvals from applicable regulatory authorities, including New Drug Applications (“NDAs”) from the FDA and maintaining such approvals;

◦•making arrangements with third-party manufacturers for, or establishing, clinical and commercial manufacturing capabilities;

◦•establishing sales, marketing and distribution capabilities and launching commercial sales of our product candidate, if and when approved, whether alone or in collaboration with others;

◦•establishing and maintaining patent and trade secret protection or regulatory exclusivity for our product candidate;

◦•maintaining an acceptable safety profile of our products following approval; and ◦building and maintaining an organization of people who can successfully develop our product candidate.

The success of our business depends in part on the successful development, regulatory approval, and commercialization of our product candidate, nelitolimod, as well as any other future product candidates, which may never occur. We have not yet succeeded in, and we may not succeed in, obtaining marketing approval for nelitolimod. If we are unable to develop,develop or obtain regulatory approval for,for or,nelitolimod, or if approved, successfully commercialize our product candidates, we may not be able to generate any revenue from our pharmaceutical development efforts and this may have a material adverse effect on our business, results of operations, financial condition and prospects.

Nelitolimod, an investigational agent in development, is a toll-like receptor 9 (TLR9) agonist which is believed to bind to the TLR9 receptors found on suppressive immune cells including myeloid-derived suppressor cells, antigen-presenting immune cells and other immune cells. TLRs play a key role in the innate immune system and create a bridge to adaptive immunity. It is believed that activating TLR9 primes immune cells to promote anti-tumor T-cells. If nelitolimod or any of our future product candidates in clinical trials or similar products from competitors produce serious adverse event data, we may be required to delay, discontinue,discontinue or modify many of our clinical trials or our clinical trial strategy. If a safety risk based on mechanism of action or the molecular structure were identified, it may hinder our ability to develop our product candidates or enter into potential collaboration or commercial arrangements. Rare diseases and a numerical imbalance in cardiac adverse events have been observed in patients in our clinical trials. If adverse event data are found to apply to our TLR agonist and/or inhibitor technology as a whole, we may be required to significantly reduce the scope of or discontinue certain of our pre-clinical or clinical activities.

In addition, although nelitolimod differs in certain ways from other approaches, serious adverse events or deaths in other clinical trials involving precision medicines, even if not ultimately attributable to our product candidates, could result in increased government regulation, unfavorable public perception and publicity, potential regulatory delays in the testing or licensing of our product candidates, stricter labeling requirements for those product candidates that are licensed,licensed and a decrease in demand for any such product candidates.

Moreover, the reimbursement by third-party payors for our product and the amount that we may receive in payment for our products may be materially and adversely affected by factors we do not control, including federal or state regulatory or legislative changes, and cost-containment decisions and changes in reimbursement schedules of third-party payors or product purchasers (such as hospitals). Lack of reimbursement or any reduction or elimination of these payments could have a material adverse effect on our business, prospects, results of operations and financial condition. Furthermore, the healthcare industry in the United StatesU.S. has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore, we cannot be certain that the procedures using our products will be reimbursed at a cost-effective level. Additionally, we cannot be certain that third-party payors using a methodology that sets amounts based on the type of procedure performed, such as those utilized by government programs and in many privately managed care systems, will view the cost of our products to be justified so as to incorporate such costs into the overall cost of the procedure. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to achieve profitability. Moreover, we are unable to predict what changes will be made to the reimbursement methodologies used by third-party payors in the future.

The biopharmaceutical and medical device industries are characterized by intense competition and rapid innovation. Our competitors may be able to develop other devices or drugs that are able to achieve similar or better results. Potential competitors for TriNav and nelitolimod include major multinational medical device and pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions. Many of these competitors have substantially greater financial, technical, and other resources than we do, such as larger research and development staff, experienced marketing and manufacturing organizations, well-established sales forces, and name recognition. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors.

The availability and price, and in the case of nelitolimod, if approved, its FDA-approved labeling versus that of our competitors’ products could limit the demand and the price we are able to charge for TriNav and nelitolimod, if approved. We may not be able to implement our business plan if the acceptance of TriNav or nelitolimod is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment, or if physicians switch to other new drug or biologic products or drug delivery systems or choose to reserve TriNav and/or nelitolimod for use in limited circumstances. For additional information regarding our competition, see the section title " Industry and Competition.Competition" within the Item 1. Business.

We generally do not have long-term contractual commitments with our customers. Our TriNav customers can terminate many of our consignment agreements with or without cause, in some cases subject only to 30 days’days prior notice in the case of termination without cause. Although a substantial majority of our revenue is typically generated from existing customers, our engagements with our customers are typically for orders that are singular in nature. Large consignment orders may involve multiple deliveries or stages, and a customer may choose not to replace inventory with TriNav devices or may cancel or delay additional planned orders.

Our future performance depends to a large extent on the continued services of members of our current management including, in particular, our Chief Executive Officer and Chief Financial Officer. If any of these key executive officers were to leave us, we would be forced to expend significant time and money in the pursuit of a replacement, which would result in both a delay in the implementation of our business plan and the diversion of limited working capital. The unique knowledge and expertise of these individuals would be difficult to replace. In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse effect on our business, operations and prospects. In addition, we will be required over the longer-term to hire highly skilled managerial, scientific and administrative personnel to fully implement our business plan and growth strategies. Due to the specialized scientific nature of our business, we are highly dependent upon our ability to attract and retain qualified scientific, technical and managerial personnel. If we cannot attract and retain such personnel, we will be unable to develop our product candidates and achieve regulatory clearance for them, which would have a material adverse effect on our business, financial condition,condition and results of operations.

As of December 31, 2024,2025, we had approximately 110102 full-time employees, six of whom hold advanced degrees.employees. We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the area of sales and marketing. Competition for skilled personnel in our industry is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, in a timely manner or at all. In particular, we have experienced a very competitive hiring environment. Many of the other biotechnology and medical device companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we have to offer. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided equity incentive awards that vest over time. The value to employees of stock options or other equity awards that vest over time may be significantly affected by movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers from other companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams are at-will employees and may terminate their employment with us on short notice. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. Given the stage of our programs and our plans to expand operations, our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior personnel across the organization.

The following discussion and analysis of the financial condition and results of operations of TriSalus Life Sciences, Inc. (for purposes of this section, the “Company,” “TriSalus” “we,” “us” and “our”) should be read together with TriSalus’ audited consolidated financial statements as of and for the fiscal years ended December 31, 20242025 and 2023,2024, together with the related notes thereto, included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis includes forward-looking statements that involves risks and uncertainties. You should review the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” for a discussion of forward-looking statements and important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

We are dedicated to the research, development,development and commercialization of an innovative drug delivery technology platform and an immuno-oncology therapeutic, aimed at improving outcomes for patients with difficult-to-treat liver and pancreatic cancers. Our advanced technology is designed for use by interventional radiologists to enhance the delivery of therapeutics and improve patient outcomes.

We market our cutting-edge Pressure Enabled Drug Delivery (PEDD™) infusion systems, which optimize therapeutic delivery for hepatocellular carcinoma, pancreatic cancer,cancer and other solid liver tumors. Additionally, we are pursuing the development of nelitolimod to illustrate how an immunotherapeutic--when administered via PEDD in combination with systemic treatment--cantreatment can enhance the effectiveness of other therapeutics, ultimately leading to better patient responses. The combination of our PEDD technology with nelitolimod is focused on solving the two main barriers in the tumor microenvironment that inhibits the success of immunotherapy. The first barrier (mechanical) is comprised of high intratumoral pressure within tumors that limits drug uptake and the second barrier (biological) is the reversal of intratumoral immunosuppression.

In 2020, we launched TriNav™,TriNav, which is our newest liver therapy delivery device with SmartValve technology for our proprietary PEDD approach. Current sales consist of the TriNav Infusion System, introduced in 2020. In 2020, we gained transitional pass-through payments (“TPT”) approval from the Centers for Medicare & Medicaid Services (“CMS”), which allows hospitals to cover the cost of using TriNav. The approval began in January 2020 and expired at the end of 2023. On December 14, 2023, CMS created a permanent New Technology Healthcare Common Procedure Coding System ("HCPCS") code for procedures involving the TriNav® Infusion System. This code became effective on January 1, 2024, and may be reported by hospital outpatient departments ("HOPDs") and ambulatory surgical centers ("ASCs") for the Company to obtain reimbursement for TriNav device. Effective April 1, 2025, TriNav received a second unique and permanent HCPCS code from CMS. This new code provides reimbursement clarity for mapping procedures conducted prior to TARE.

TriSalus also initiated a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease) and intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters, and the prevalence in adults over 50 is estimated to be up to 50%. We estimate that this could expand the addressable market by approximately 50,000 procedures, representing an incremental $400.0$400 million market opportunity. This new procedure utilizing the TriNav system is also eligible for the same Healthcare Common Procedure Coding System (HCPCS) reimbursement code allowing for seamless integration into current billing approaches.

We are currentlya inhigh ourgrowth, earlyhigh stagemargin company approaching a level of developmentrevenues andthat havecan yetgenerate sufficient cash flow to generatesustain revenues sufficient to drive positive cash flows fromour operations. Beginning in 2020, weour beganmission was to improve the delivery of therapeutics to solid tumors across a strategic transformation from a company focused solely on the salerange of ourdifferent infusion systems to a therapeutic company whereby our medical devices are marketed alongside the pharmaceutical drugsdiseases and othertumor treatmentstypes. thatAdditionally, thewe devicesacquired deliver to patients. This transformation led us to acquire our firstan immune-oncology drug, nelitolimod, in July 2020, and toconducted beginseveral Phase I clinical developmenttrials to study the ability and value of nelitolimodour forPEDD the treatment of liver and pancreatic cancerstechnology. We have initiatedcompleted Phase 1I dose escalation (UMLM and LA-PDAC) and Phase 1bIb (ICC/HCC) clinical trials for nelitolimod,nelitolimod. eachDue to physician and investigator interest, we are supporting two Investigator Initiated Trials of whichnelitolimod, areone focusedin onpatients awith differentadvanced targetHCC indication,in specificallycombination UMLM,with ICCcryoablation, durvalumab and HCC,tremelimumab and pancreaticanother cancer.in Continuedpatients investigationwith forresectable ICCcolorectal andliver HCCmetastases. mayDue continue through IITs. Based onto the changingexcessive landscape for second line treatmentcost of uveal melanoma,capital, we do not intend to proceed to Phase II trials for that indication on our own, but we are looking for potential partners to advance that indication. Our PERIO-03 Phase I PERIO-03dose clinical trialescalation in pancreaticLA-PDAC cancerhas iscompleted enrolledenrollment and we anticipate data from the study will be available in sometimeearly in2026 2025,and dependingwill onbegin whendiscussions treatmentfor isa completed.pharmaceutical partner for further clinical development.

•Our ability to maintain our current TriNav pricing and gross margins to help fund the rest of our activities. Our current pricing allows us to generate a substantial gross margin, which provides funds to support our growth and our research and development (“R&D”) for both TriNav and nelitolimod. TriNav sells at a significant premium to competitive products. Our higher price was previously supported by the TPT payment program from CMS;CMS. however,However, the TPT authorization expired on December 31, 2023. In December 2023, CMS granted a New Technology HCPCS for both mapping and therapeutic procedures involving TriNav. This code, HCPCS C9797, has been assigned to the Ambulatory Payment Classification ("APC") 5194 - Level 4 Endovascular Procedures. The code became effective on January 1, 2024,2024 and may be reported by hospital outpatient departments and ambulatory surgical centers, but there can be no assurance that continuing reimbursement will be available at similar reimbursement rates or at all. Effective April 1, 2025, TriNav received a second unique and permanent HCPCS code from CMS, C8004, which has been assigned to APC 5193 (Level 3 Endovascular Procedures). This new code provides reimbursement clarity for mapping procedures conducted prior to TARE. Any reduction in the amount of the reimbursement for TriNav will negatively impact the revenue we are able to generate from the sale of TriNav and may hinder our ability to recoup our total investment in TriNav notwithstanding regulatory approval of the product. If we are unable to promptly obtain coverage and profitable payment rates from hospital budgets or government-funded and private purchasers for TriNav or any future products, we may sell fewer units or need to sell them at a lower price. Such changes in revenues would have a material adverse effect on our operating results and our overall financial condition.

•The success and cost of our clinical trials of nelitolimod. Nelitolimod is in Phase 1 human trials to determine if, when delivered via TriNav, it is safe and effective in treating certain cancers. As with all drug candidates, the cost of operating clinical trials can be substantial, with no guarantee that the trials will result in favorable data.

The primary end-user customers for our products are hospitals, clinics,hospitals and physicians,clinics, to which we sell directly.

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. We recognized $0.3 million of rebates in the 12 months ended December 31, 2024.

Our operating expenses consist of R&D, sales and marketingmarketing, and general and administrative expenses.

R&D expenses include engineering, regulatory, pre-clinical and clinical activities, including salaries, travel,travel and materials purchased for R&D activities and patent expense.activities. We expense R&D costs as incurred. We recognize expenses for certain development activities, such as preclinical studies and manufacturing, based on an evaluation of the progress to completion of specific tasks using data or other information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of expenses incurred. Non-refundable advance payments for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses. These amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered.

General and administrative expense includes executive management, finance, information technology, human resources, business development, legal, one-time costs associated with the Business Combination,legal and the administrative and professional costs associated with those activities. General and administrative costs also include corporate facility costs, including rent, utilities, depreciation and maintenance, not otherwise included in production or R&D expenses, as well as regulatory and professional fees for legal, patent, accounting and other consulting services. We also record public company costs in general and administrative, including board expenses, insurance, audit fees, NASDAQNasdaq fees, and costs associated with public company financial reporting.

Change in Fair Value of SEPA, Warrant,Warrant and Revenue Base Redemption Liabilities

Change in fair value of SEPA, Warrant,warrant and Revenuerevenue Basebase Redemptionredemption liabilities represents the change in fair value at each reporting period of the SEPA, the Series B-2 tranche liabilities (with accompanying warrants to purchase Series B-3 preferred stock) that were issuedchange in Octoberfair 2022,value of the Public Warrants, Private Placement Warrants, and Working Capital Warrants (the "Exchange Warrants"), the change in fair value of the SPACOrbiMed Warrants we assumed in the Business Combination, and the change in fair value of the Initialrevenue OrbiMedbase Warrantredemption and Based Redemption Liability issued in connection with the Initial Term Loan under the OrbiMed Credit Agreement entered into in April 2024.liability.

Income Tax Benefit (Expense)

Revenue increased $10.9$15.7 million, or 59.0%,53.4%, for the year ended December 31, 2024,2025, as compared to the year ended December 31, 2023.2024. The increase in revenue was primarily due to an increase of TriNav salesunits volumes.sold.

Cost of goods sold increased by $1.5$2.9 million, or 57.5%,69.8%, for the year ended December 31, 2024,2025, as compared to the year ended December 31, 2023.2024. The increase in cost of goods sold was due to the higher volume ofmore TriNav producedunits in the period to support the increase in revenue.sold.

Gross profit increased by $9.4$12.9 million, or 59.2%,50.8%, for the year ended December 31, 2024,2025, as compared to the year ended December 31, 2023,2024, andwhile gross margin increaseddecreased from 85.9%86.1% to 86.1%.84.6% year over year. The increase in gross profit was drivendue primarily byto higher sales volume. Thethe increase in TriNav units sold, while the year-over-year decline in gross margin was primarily driven primarily by higherlower manufacturing efficiency associated with newly launched products, which is a dynamic we expect to improve as production scales and yieldprocesses efficiencies.mature.

The following discussion and analysis of the financial condition and results of operations of TriSalus Life Sciences, Inc. (for purposes of this section, the “Company,” “TriSalusTriSalus,” “we,” “us” and “our”) should be read together with TriSalus’ condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q ("Quarterly Report") and for our audited financial statements and related notes thereto as of and for the year ended December 31, 2025 included in our Annual Report on Form 10-K, filed with the SEC, on March 5, 2026 ("Annual Report"). Some of the information contained in this discussion and analysis includes forward-looking statements that involves risks and uncertainties. You should review the section titled “Cautionary Note Regarding Forward-Looking StatementsStatements.”. As a result of many factors, including those factors set forth in the section captioned "Item 1A. Risk Factors" of our Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

We market our cutting-edge PEDD infusion systems, which optimize therapeutic delivery for hepatocellular carcinoma, pancreatic cancer and other solid liver tumors. Additionally, we are pursuing the development of nelitolimod to illustrate how an immunotherapeutic--whenimmunotherapeutic when administered via PEDD in combination with systemic treatment can enhance the effectiveness of other therapeutics, ultimately leading to better patient responses. The combination of our PEDD technology with nelitolimod is focused on solving the two main barriers in the tumor microenvironment that inhibits the success of immunotherapy. The first barrier (mechanical) is comprised of high intratumoral pressure within tumors that limits drug uptake and the second barrier (biological) is the reversal of intratumoral immunosuppression.

In 2020, we launched TriNav, which is our newest liver therapy delivery device with SmartValve technology for our proprietary PEDD approach. In 2020, we gained transitional pass-through payments (“TPT”) approval from the Centers for Medicare & Medicaid Services (“CMS”), which allows hospitals to cover the cost of using TriNav. The approval began in January 2020 and expired at the end of 2023. On December 14, 2023, CMS created a permanent New Technology Healthcare Common Procedure Coding System ("HCPCS") code for procedures involving the TriNav Infusion System. This code became effective on January 1, 2024, and may be reported by hospital outpatient departments ("HOPDs") and ambulatory surgical centers ("ASCs") for the Company to obtain reimbursement for TriNav device. Effective April 1, 2025, TriNav received a second unique and permanent HCPCS code from CMS. This new code provides reimbursement clarity for mapping procedures conducted prior to TARE.transarterial radioembolization ("TARE"). On June 17, 2026, CMS created a permanent HCPCS G Code ("G-code") for vascular embolization or occlusion procedure with use of a pressure-generating catheter, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention for tumors, organ ischemia or infarction performed in the non-facility setting. This code became effective on July 1, 2026, and may be reported by outpatient-based labs ("OBLs") to obtain reimbursement for the TriNav device.

We also initiated a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease) and intendsintend to enroll 100 patients acrossat fiveapproximately leading academic10 sites. It is estimated that approximately 5% of adults have multinodular goiters, and the prevalence in adults over 50 is estimated to be up to 50%. We estimate that this could expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity. This new procedure utilizing the TriNav system is also eligible for the same HCPCS reimbursement code allowing for seamless integration into current billing approaches.

We are a high growth, high margin company approaching a level of revenues that can generate sufficient cash flow to sustain our operations. Beginning in 2020, our mission was to improve the delivery of therapeutics to solid tumors across a range of different diseases and tumor types. Additionally, we acquired an immune-oncology drug, nelitolimod, in July 2020, and conducted several Phase I clinical trials to study the ability and value of our PEDD technology. We haveconducted completedtwo Phase I dose escalation (UMLM and LA-PDAC) and Phase Ib (ICC/HCC) clinical trials for nelitolimod. These trials have now concluded. Due to physician and investigator interest, we are supporting two Investigator Initiated Trials of nelitolimod, one in patients with advanced HCC in combination with cryoablation, durvalumab and tremelimumab and another in patients with resectable colorectal liver metastases. Due to the excessive cost of capital, we do not intend to proceed to Phase II trials for that indication on our own, but we are looking for potential partners to advance that indication. Our PERIO-03 Phase I dose escalation in LA-PDAC is complete and weWe anticipate releasing a consolidated clinical update in the second half of 2026 and will begin discussions for a pharmaceutical partner for further clinical development.

Other Expense,Income (Expense), Net

Other expense,income (expense), net represents miscellaneous income and expenses that historically have been immaterial.

Income Tax Benefit (Expense)

The following tabletables setsset forth our condensed consolidated statements of operations data for each of the periods indicated (in thousands):

Comparison of the Three Months Ended MarchJune 31,30, 2026, and 2025

Revenue decreasedwas $0.3relatively consistent with the prior comparative period with an increase of $0.2 million, or 2.9%,1.7%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The decrease in revenue was primarily due to the Company's commercial expansion.

Cost of goods sold decreased by $0.3 million, or 17.7%,16.3%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The decrease in cost of goods sold was primarily due to both lower unit volume and a reduction in cost per TriNav unit sold.

Gross profit wasincreased relativelyby consistent$0.5 million, or 5.2%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025, whileand gross margin increased from 83.7%83.9% to 86.2%86.8% year over year. The increase in gross profit and gross margin was primarily drivendue byto lowera averagereduction in cost per TriNav unit.

R&D expenses increaseddecreased by $0.2$0.5 million, or 6.5%,14.5%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The increasedecrease was primarily due to anlower increaseprofessional inservices non-cashcosts stock-basedand compensationclinical expensetrial expenses related to nelitolimod that did not recur during the three months ended MarchJune 31,30, 2026 compared to prior year.

Sales and marketing expenses increased by $0.7$4.3 million, or 10.1%,59.4%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to increased investment within marketing and our sales organization expansion and non-cash stock-based compensation expense during the three months ended MarchJune 31,30, 2026 compared to prior year.

General and administrative expenses increaseddecreased by $0.2$0.8 million, or 3.9%,12.7%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The increasedecrease was primarily due to non-cash stock-based compensation expense, partially offset by lower professional services costs related to legal and audit related expenses.

Interest income increased by $0.1$0.3 million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was due to interest earned on a higher cash and cash equivalents balance during the three months ended MarchJune 31,30, 2026 compared to prior year.

Interest expense increased by $0.2$0.1 million or 18.8%4.7% for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to interesta onslight borrowingsincrease underin the Firsteffective Delayedinterest Drawrate Termand Loanadditional thatdebt wasdiscount only outstandingamortization for a portion of the three months ended March 31, 2025, and the lender feefees incurred for the OrbiMed Fourth Amendment,and offsetFifth byAmendments no PIK interest forduring the three months ended MarchJune 31,30, 2026.

The change in fair value of SEPA, warrant and revenue base redemption liabilities resulted in a gain of $3.9$2.6 million in the three months ended MarchJune 31,30, 2026, compared to a loss of $0.8$0.3 million in the three months ended MarchJune 31,30, 2025, a difference of $4.7$2.9 million. The change was primarily due to athe decrease in the Company's warrant stock price during the three months ended MarchJune 31,30, 2026 as compared to prior year.

The change in fair value of contingent earnout liability resulted in a gainloss of $7.4$1.0 million for the three months ended MarchJune 31,30, 2026 compared to a lossgain of $0.8$0.7 million for the three months ended MarchJune 31,30, 2025. The change in the fair value of the contingent earnout liability during the periodthree ismonths ended June 30, 2026 was primarily driven by athe changeincrease ofin the followingCompany's inputsstock intoprice theand valuation of the liability: the decreaseincrease in stock price,price the shortened achievement time frame for the vesting thresholds and the slight decrease in the risk-free rate.volatility.

Other Expense,Income (Expense), Net

Other expense,income (expense), net, decreasedincreased by $0.2$0.1 million,million orof 69.7%,income for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The decreaseincrease in other income is primarily driven by thea retirementone-time ofcredit lease assets that did not recurreceived during the three months ended MarchJune 31,30, 2026.

Since inception, we have incurred significant operating losses and expect to continue to incur operating losses for the foreseeable future due to the investments we will continue to make in R&D and sales and marketing, and due to additional general and administrative costs we expect to incur as a public company. We incurred operating losses of $8.4$18.2 million and $7.3$14.7 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We had cash and cash equivalents of approximately $56.6$46.3 million and $20.4 million as of MarchJune 31,30, 2026 and December 31, 2025, respectively. Since inception, we have financed operations primarily through the issuance of and sales of common and preferred stock, convertible notes, term loans and proceeds from the exercise of warrants. We are still in our early stages of development and have yet to generate revenues sufficient to fund cash flows from operations. Our ability to fund future operations and execute our long-term business plan and strategy will require that we raise additional capital through the issuance of additional equity and/or debt. There can be no assurance that we will be able to raise such additional financing on satisfactory terms, if at all. If additional capital is not secured when required, we may need to delay or curtail our operations until such funding is received.

On February 23, 2026 and February 25, 2026, we raised net proceeds of $42.6 million through a public offering of shares of our Common Stock, including the purchase of optional shares as per the Underwriting Agreement. On March 26, 2026 and May 28, 2026, we entered into the OrbiMed Fourth Amendment and OrbiMed Fifth Amendment, respectively, which reduced two of the Product Revenue Base thresholds (see Note 9) thresholds.. As of MarchJune 31,30, 2026, we were in compliance with the Product Revenue Base requirement and no repayments were required.

Comparison of the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025.

For the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $6.5$16.6 million. The net cash used in operating activities consisted of net incomeloss of $1.5$7.6 million, adjusted for non-cash activity totaling $8.3$6.7 million, primarily related to a gaingains on the adjustmentchange ofin the fair value of the contingent earnout liability and the fair value of the SEPA, warrant and revenue base redemption liabilities of $7.4$6.4 million and $3.9$6.5 million, respectively, partially offset by stock-based compensation of $2.5$5.1 million, depreciation of $0.1$0.3 million and amortization of debt issuance costs of $0.3$0.6 million. Net operating assets decreasedincreased by $0.3$2.2 million, primarily due to a decrease in accounts receivable partially offset by increases in inventory, net and prepaid expenses.expenses and a decrease in accrued liabilities, partially offset by an increase in trade payables.

For the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities was $4.5$11.8 million. The net cash used in operating activities consisted of net loss of $10.4$18.7 million adjusted for non-cash activity totaling $4.3$6.6 million, primarily related to stock-based compensation of $1.6$3.5 million, thechanges adjustments ofin the fair value of the contingent earnout liability of $0.8 million and SEPA, warrant and revenue base redemption liabilities of $0.8$0.1 million.million and $1.2 million, respectively, and debt expenses of $1.1 million related to paid-in-kind interest and amortization of debt issuance costs. The change in net operating assets and liabilities decreased $1.6$0.2 million, due primarily to a decrease in prepaid expenses offset by an increase in tradeaccounts payables and accrued liabilities.receivable.

Net cash used in investing activities of $0.1$0.2 million for the threesix months ended MarchJune 31,30, 2026 was primarily due to purchases of property and equipment of $0.1$0.2 million.

Net cash used in investing activities of $0.7$0.6 million for the threesix months ended MarchJune 31,30, 2025 was primarily due to purchases of property and equipment of $0.8$0.7 million.

Net cash provided by financing activities of $42.4$42.3 million for the threesix months ended MarchJune 31,30, 2026, consisted primarily of $42.6 million of net proceeds raised from the issuance of Common Stock through a public offering.offering and $0.3 million in proceeds from the issuance of Common Stock through ESPP, offset by $0.6 million of debt issuance costs.

Net cash provided by financing activities of $9.7$30.4 million for the threesix months ended MarchJune 31,30, 2025, consisted primarily of $20.5 million, net of expenses, from the April 30, 2025 wasPrivate duePlacement toand $9.5 million, net of expenses, from the First Delayed draw under the OrbiMed Credit Agreement.

Our primary use of cash is to fund our operating expenses, which consist of sales and marketing expenses related to the growth of our sole commercial product TriNav, research, development and clinical expenses related to both TriNav and nelitolimod,nelitolimod as well as general and administrative expenses. If we obtain approval for our product candidates, we expect to incur commercialization expenses, which may be significant, related to establishing or expanding sales, marketing, manufacturing capabilities, distribution and other commercial infrastructure to commercialize such products. Accordingly, we may need to obtain substantial additional funding in connection with our continuing operations. Inflation and rising interest rates may result in an economic recession globally or in the U.S., which could lead to a reduction in product demand, a decrease in corporate capital expenditures, prolonged unemployment, labor shortages, reduction in consumer confidence, adverse geopolitical and macroeconomic events, or any similar negative economic condition. Economic conditions in some parts of the world have been worsening, with disruptions to, and volatility and uncertainty in, the credit and financial markets in the U.S. and worldwide resulting from the effects of inflation and rising interest rates. These conditions have been further exacerbated by recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures. It is not possible at this time to estimate the long-term impact that these and related events could have on our business, as the impact will depend on future developments, which are highly uncertain and cannot be predicted. If these conditions persist and deepen, we could experience an inability to access additional capital, or our liquidity could otherwise be impacted. If we are unable to raise capital when needed and on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or other efforts.

Our contractual obligations as of MarchJune 31,30, 2026, include lease obligations of $2.0$1.9 million, reflecting the minimum commitments for our principal administrative and production facility, other office spaces and computers.

Pursuant to the Asset Purchase Agreement, dated July 31, 2020, between TriSalus and Dynavax, we have paid Dynavax $12.0 million as of MarchJune 31,30, 2026, and may be required to pay Dynavax up to an additional $170.0 million upon the achievement of certain development and regulatory milestones with respect to nelitolimod. We will also be required to pay up to $80.0 million upon achieving certain commercial milestones for nelitolimod. The Dynavax Agreement also obligates us to pay low double-digit royalties based on potential future net sales of product containing nelitolimod compound on a product-by-product and country-by-country basis during the applicable royalty term. Such royalties are subject to reduction by up to 50% in certain circumstances.