TriSalus Life Sciences, Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited interim 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, 2024 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”), on April 15, 2025 ("Annual Report"). Information included in this Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. For a complete discussion of forward-looking statements, see the section above entitled “Special Note Regarding Forward Looking Statements.” 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. You should carefully read the “Risk Factors” section of our Annual Report to gain an understanding of the various factors that could cause actual results to differ materially from our forward-looking statements.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our 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, 2024 included in our Annual Report on Form 10-K, filed with the SEC, on April 15, 2025 ("Annual Report"). Information included in this Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. For a complete discussion of forward-looking statements, see the section above entitled “Cautionary Note Regarding Forward Looking Statements.” 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. You should carefully read the “Risk Factors” section of our Annual Report to gain an understanding of the various factors that could cause actual results to differ materially from our forward-looking statements.

Previous wording

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 immune cells in the tumor and tumor microenvironment of the liver, pancreas and other solid tumors. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.

Current wording

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 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 immune cells in the tumor and tumor microenvironment of the liver, pancreas and other solid tumors. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.

Previous wording

We market our cutting-edge Pressure Enabled Drug Delivery (PEDD™) infusion systems, which optimize delivery of embolics and therapeutics for the treatment of various solid tumors. Additionally, we have conducted Phase I clinical trials of nelitolimod to study the ability of an immunotherapeutic--when administered via PEDD in combination with systemic treatment--can enhance the effectiveness of other therapeutics and ultimately lead to better patient responses. Once final data is assembled, we plan to pursue a pharmaceutical partner for future development. We believe the combination of our PEDD technology with nelitolimod has the potential to solve 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.

Current wording

We market our cutting-edge PEDD infusion systems, which optimize delivery of embolics and therapeutics for the treatment of various solid tumors. Additionally, we have conducted Phase I clinical trials of nelitolimod to study the ability of an immunotherapeutic when administered via PEDD in combination with systemic treatment can enhance the effectiveness of other therapeutics and ultimately lead to better patient responses. Once final data is assembled, we plan to pursue a pharmaceutical partner for future development. We believe the combination of our PEDD technology with nelitolimod has the potential to solve 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.

Previous wording

In 2020, we launched TriNav™, our therapeutic and embolic 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 transarterial radioembolization ("TARE").

Current wording

In 2020, we launched TriNav, our therapeutic and embolic delivery device with SmartValve technology for our proprietary PEDD approach. Current sales consist of the TriNav Infusion System. 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 transarterial radioembolization ("TARE").

Previous wording

In 2024, we expanded our portfolio of PEDD devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV is targeted for patients with vessels sized between 3.5 and 5.0mm and is expected to provide a full range of PEDD devices for all vessel sizes and allow us to expand our addressable liver embolization market. The TriGuide Guiding Catheter has a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV, which we believe will enhance procedural efficiency. In June 2025, we launched an additional PEDD device, TriNav

Current wording

In 2024, we expanded our portfolio of PEDD devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV is targeted for patients with vessels sized between 3.5mm and 5.0mm, which is expected to provide a full range of PEDD devices for all vessel sizes and allow us to expand our addressable liver embolization market. The TriGuide Guiding Catheter has a larger inner diameter, lubricious inner lining and reverse curve design to support femoral access for the TriNav LV, which we believe will enhance procedural efficiency. In June 2025, we launched an additional PEDD device, TriNav FLX, designed with a more flexible distal tip to facilitate navigation through tortuous anatomy. These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, enabling seamless integration into current billing structures.

Previous wording

We 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 ten 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 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.

Current wording

We also initiated a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease) and intend to enroll 100 patients across ten leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters. We estimate that this could expand the addressable market by approximately 50,000 procedures, which represents an incremental $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.

Previous wording

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 have completed Phase I dose escalation (UMLM and LA-PDAC) and Phase Ib (ICC/HCC) clinical trials for nelitolimod. Due to physician and investigator interest, we are supporting two IIT studies, one in patients with advanced HCC in combination with durvalumab and tremelimumab and another in patients with resectable colorectal liver metastases. Based on the changing landscape for second line treatment of uveal melanoma, 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 has completed enrollment and we anticipate data from the study will be available sometime in 2025, and will begin discussions for a pharmaceutical partner for further clinical development.

Current wording

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 have completed Phase I dose escalation (UMLM and LA-PDAC) and Phase Ib (ICC/HCC) clinical trials for nelitolimod. 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 has completed enrollment and we anticipate data from the study will be available in late 2025 and will begin discussions for a pharmaceutical partner for further clinical development.

Previous wording

•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; 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, 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.

Current wording

•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 Transitional Pass-Through ("TPT") payment program from CMS. 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 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.

Previous wording

•The success and cost of our clinical trials of nelitolimod. Nelitolimod is in Phase I 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.

Current wording

•The success and cost to close out our clinical trials of nelitolimod. Nelitolimod is in Phase I 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.

Previous wording

We currently operate in one reportable segment and revenue is generated primarily from sales of PEDD infusion systems to our customers, principally related to TriNav. Revenue is recognized when control of the promised goods or services is transferred to the customer in an amount that reflects the consideration to which we expect to be entitled in exchange for those products or services.

Current wording

We currently operate in one reportable segment and revenue is generated primarily from sales of PEDD infusion systems to our customers, principally related to TriNav. Revenue is recognized when control of the promised goods or services is transferred to the customer in an amount that reflects the consideration to which we expect to be entitled in exchange for those products or services.The primary end-user customers for our products are hospitals, clinics and physicians, to which we sell directly.

Previous wording

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 $0.2 million and $0.4 million, respectively, of rebates for three and six months ended June 30, 2025.

Current wording

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.

Previous wording

R&D expenses include engineering, regulatory, pre-clinical and clinical activities, including salaries, travel, materials purchased for R&D activities and patent expense. 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.

Current wording

R&D expenses include engineering, regulatory, pre-clinical and clinical activities, including salaries, travel, materials purchased for R&D 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.

Previous wording

General and administrative expense includes executive management, finance, information technology, human resources, business development, legal, one-time costs associated with the Business Combination, 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, NASDAQ fees, and costs associated with public company financial reporting.

Current wording

General and administrative expenses include executive management, finance, information technology, human resources, business development, 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, NASDAQ fees and costs associated with public company financial reporting.

Previous wording

Change in fair value of SEPA, Warrant, and Revenue Base Redemption liabilities represents the change in fair value at each reporting period of the SEPA, the change in fair value of the SPAC Warrants we assumed in the Business Combination, and the change in fair value of the OrbiMed Warrants issued in connection with the initial and subsequent draw down under the OrbiMed Credit Agreement.

Current wording

Change in fair value of SEPA, warrant, and revenue base redemption liabilities represents the change in fair value at each reporting period of the SEPA, the change in fair value of the Exchange Warrants and the change in fair value of the OrbiMed Warrants.

Previous wording

Revenue increased by $3.8 million, or 52.3% for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase in revenue was due to a 52.5% increase based on the units of TriNav sold and the introduction of a price increase.

Current wording

Revenue increased by $4.2 million, or 57.4% for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increase in revenue was primarily due to an increase in TriNav units sold.

Previous wording

Cost of goods sold increased by $0.9 million, or 97.6% for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase in cost of goods sold was primarily due to higher production volumes to support our increased revenue.

Current wording

Cost of goods sold increased by $0.9 million, or 89.8% for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increase in cost of goods sold was primarily due to more TriNav units sold.

Previous wording

Gross profit increased by $3.0 million, or 45.9% for the three months ended June 30, 2025, and gross margin decreased to 83.9% from 87.6% for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase in gross profit was due primarily to the increase in sales volume. The year-over-year decline in gross margin was primarily driven by lower manufacturing efficiency associated with newly launched products, a dynamic we expect to improve as production scales and processes mature over the course of the year.

Current wording

Gross profit increased by $3.3 million, or 52.2% for the three months ended September 30, 2025, while gross margin decreased to 83.5% from 86.3% for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increase in gross profit was due primarily to the increase in TriNav units sold, while the year-over-year decline in gross margin was primarily driven by lower manufacturing efficiency associated with newly launched products, which is a dynamic we expect to improve as production scales and processes mature.

Previous wording

Sales and marketing expenses increased by $1.2 million, or 19.3% for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The changes was due primarily to a $0.8 million increase in the sales and marketing department headcount and a $0.2 million increase in utilizing consultants during the three months ended June 30, 2025 compared to the same period in the prior year.

Current wording

Sales and marketing expenses increased by $0.7 million, or 11.4% for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increase was primarily due to an increase in performance related compensation driven by the increase in sales during the three months ended September 30, 2025 compared to the same period in the prior year.

Previous wording

Interest expense increased by $0.5 million for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase was due to our usage of the OrbiMed Credit Agreement throughout the three months ended June 30, 2025 compared to the prior year period as we entered into the OrbiMed Credit Agreement on April 30, 2024.

Current wording

Interest expense increased by $0.3 million for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increase was due to interest on the additional funds borrowed under the First Delayed Draw Term Loan in 2025 that was not present for the prior year period.

Previous wording

The fair value of the SEPA, warrant, and revenue base redemption liabilities resulted in a change of $8.7 million as a result of a loss of $0.3 million in the three months ended June 30, 2025, compared to a loss of $9.0 million in the three months ended June 30, 2024. The change was primarily due to the increase of the warrant price on the open market and the additions of the Subsequent OrbiMed Warrant as a result of the First Delayed Draw.

Current wording

The fair value of the SEPA, warrant and revenue base redemption liabilities resulted in a change of $7.9 million as a result of a loss of $2.9 million in the three months ended September 30, 2025, compared to a gain of $5.0 million in the three months ended September 30, 2024. The change was primarily due to changes in our stock price and the addition of the Subsequent OrbiMed Warrant as a result of the First Delayed Draw during the first quarter of 2025.

Previous wording

The fair value of earnout liability resulted in a change of $13.0 million as a result of a gain of $0.7 million in the three months ended June 30, 2025, compared to a gain of $13.7 million for the three months ended June 30, 2024. This is mainly due to the change in the market price of the underlying common stock.

Current wording

The fair value of the contingent earnout liability resulted in a change of approximately $0.2 million as a result of a gain of $2.5 million in the three months ended September 30, 2025, compared to a gain of $2.4 million for the three months ended September 30, 2024. The change in the fair value of the contingent earnout liability during the period is primarily driven by a change in the following inputs into the valuation of the liability: the decrease in stock price, the shortened achievement time frame for the vesting thresholds and the slight decrease in the risk-free rate.

Previous wording

Revenue increased by $6.6 million, or 47.5% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase in revenue was due to a 48.4% increase based on the units of TriNav sold and the introduction of a price increase effective March 1, 2025.

Current wording

Revenue increased by $10.8 million, or 50.9% for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase in revenue was primarily due to an increase in TriNav units sold.

Previous wording

Cost of goods sold increased by $1.4 million, or 75.1% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase in cost of goods sold was primarily due to higher production volumes to support our increased revenue.

Current wording

Cost of goods sold increased by $2.3 million, or 80.2% for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase in cost of goods sold was primarily due to more TriNav units sold.

Previous wording

Gross profit increased by $5.1 million, or 43.1% for the six months ended June 30, 2025, and gross margin decreased to 83.8% from 86.4% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase in gross profit was due primarily to the increase in sales volume. The year-over-year decline in gross margin was primarily driven by lower manufacturing efficiency associated with lower production volumes for a planned shut down during the current period.

Current wording

Gross profit increased by $8.5 million, or 46.3% for the nine months ended September 30, 2025 and gross margin decreased to 83.7% from 86.4% for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase in gross profit was due primarily to the increase in TriNav units sold, while the year-over-year decline in gross margin was primarily driven by lower manufacturing efficiency associated with newly launched products, a dynamic we expect to improve as production scales and processes mature.

Previous wording

R&D expenses decreased by $0.7 million, or 15.9% for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The decrease was primarily driven by a $0.7 million reduction of clinical trial expenses related to nelitolimod.

Current wording

Research and development expenses decreased by $2.3 million, or 15.8% for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The decrease was primarily due to a reduction in clinical trial expenses related to nelitolimod as the Company moved to close the trials in 2025.

Previous wording

Sales and marketing expenses increased by $1.2 million, or 9.5% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The change was due primarily to a $1.2 million increase in the sales and marketing department headcount during the three months ended June 30, 2025 compared to the same period in the prior year.

Current wording

Sales and marketing expenses increased by $1.9 million, or 10.1% for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The change was primarily due to an increase in performance related compensation driven by the increase in sales, during the nine months ended September 30, 2025 compared to the same period in the prior year.

Previous wording

General and administrative expenses increased by $1.7 million, or 43.0%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase was primarily due to professional services as a result of the timing of various filing and audit related expenses.

Current wording

General and administrative expenses increased by $4.0 million, or 29.9%, for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase was primarily due to the acceleration of a non-cash stock-based compensation award of approximately $1.6 million, the revision of certain patent-related expenses from research and development to general and administrative expenses of approximately $0.7 million, and professional services as a result of the timing of various filing and audit related expenses.

Previous wording

The fair value of the SEPA, warrant, and revenue base redemption liabilities resulted in a change of $5.3 million as a result of a loss of $1.2 million in the six months ended June 30, 2025, compared to a loss of $6.5 million in the six months ended June 30, 2024. The change was primarily due to the increase of the warrant price on the open market and the additions of the Subsequent OrbiMed Warrant as a result of the First Delayed Draw.

Current wording

The fair value of the SEPA, warrant and revenue base redemption liabilities resulted in a change of $2.6 million as a result of a loss of $4.1 million in the nine months ended September 30, 2025, compared to a loss of $1.5 million in the nine months ended September 30, 2024. The change was primarily due to changes in the Company's stock price and the addition of the Subsequent OrbiMed Warrant as a result of the First Delayed Draw during the first quarter of 2025.

Previous wording

Since inception, we have incurred significant net losses and expect to continue to incur net 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 net losses of $18.7 million for the six months ended June 30, 2025. We had cash and cash equivalents of approximately $26.5 million at June 30, 2025. Since inception, we have financed operations primarily through the issuance and sales of common and preferred stock, convertible notes, and term loans. 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. There can be no assurance that we will be able to raise such additional capital 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.

Current wording

Since inception, we have incurred significant net losses and expect to continue to incur net 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 net losses of $29.5 million for the nine months ended September 30, 2025. We had cash and cash equivalents of approximately $22.7 million at September 30, 2025. Since inception, we have financed operations primarily through the issuance and sales of common and preferred stock, convertible notes and term loans. 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. There can be no assurance that we will be able to raise such additional capital 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.

Previous wording

During the six months ended June 30, 2025, we achieved the trailing 12-month Product Revenue Base of $30.0 million in January 2025 and were able to borrow the First Delayed Draw Term Loan Commitment resulting in gross proceeds of $10.0 million. As of June 30, 2025, the minimum cash requirement increased from $5.0 million to $10.0 million. On April 30, 2025, we raised gross proceeds of approximately $22.0 million through a Private Placement. Although these events have occurred, our existing cash and cash equivalents may not be sufficient to fund our projected liquidity requirements for at least the next 12 months from the date of this Quarterly Report, as the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024. See also “Funding Requirements” below.

Current wording

During the nine months ended September 30, 2025, we achieved the trailing 12-month Product Revenue Base of $30.0 million in January 2025 and were able to borrow the First Delayed Draw Term Loan Commitment resulting in gross proceeds of $10.0 million. As of September 30, 2025, the minimum cash requirement remained at $10.0 million, following the increase from $5.0 million during the second quarter 2025. On November 10, 2025, we entered into the OrbiMed Third Amendment, which lowered the the minimum cash requirement for the liquidity covenant from $10.0 million to $5.0 million. On April 30, 2025, we raised gross proceeds of approximately $22.0 million through a Private Placement. Although these events have occurred, our existing cash and cash equivalents may not be sufficient to fund our projected liquidity requirements for at least one year from the date of this Quarterly Report, as the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024. See also “Funding Requirements” below.

Previous wording

For the six months ended June 30, 2025, net cash used in operating activities was $11.8 million. The net cash used in operating activities consisted of net loss of $18.7 million, adjusted for non-cash charges totaling $6.6 million, primarily related to a loss on share-based compensation of $3.5 million, warrant and SEPA liabilities of $1.3 million, 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 $0.2 million, due primarily to a decrease in prepaid expenses offset by an increase in accounts receivable.

Current wording

For the nine months ended September 30, 2025, net cash used in operating activities was $15.5 million. The net cash used in operating activities consisted of net loss of $29.5 million, adjusted for non-cash charges totaling $11.3 million, primarily related to share-based compensation expense of $6.9 million, a loss on the fair value recognized on SEPA, warrant and revenue base redemption liabilities of $4.1 million and debt expenses of $1.6 million related to PIK Interest and amortization of debt issuance costs, offset by a gain on the fair value of the change in fair value of contingent earnout liability of $2.4 million. The change in net operating assets and liabilities decreased $2.6 million, due primarily to a decrease in prepaid expenses, inventory, net, and operating lease liabilities offset by an increase in trade payables and accrued liabilities and accounts receivable.

Previous wording

For the six months ended June 30, 2024, net cash used in operating activities was $24.3 million. The net cash used in operating activities consisted of net loss of $17.5 million, adjusted for non-cash charges totaling $0.2 million, primarily related to a loss on the adjustment of the fair value of the warrants to purchase preferred stock of $6.9 million, depreciation and amortization of $0.4 million and stock-based compensation expense of $2.4 million, partially offset a gain from the change in fair value of contingent earnout liability of $9.7 million. In addition, net operating assets and liabilities decreased $6.9 million driven by an increase in accounts payable and accrued liabilities, an increase in prepaid expenses, and an increase in accounts receivable.

Current wording

For the nine months ended September 30, 2024, net cash used in operating activities was $35.1 million. The net cash used in operating activities consisted of net loss of $19.9 million, adjusted for non-cash charges totaling $5.6 million, primarily related to a loss on the adjustment of the fair value of the contingent earnout liability of $12.1 million, stock-based compensation expense of $3.7 million, and depreciation and amortization of $0.6 million, partially offset by a gain from the change in fair value of SEPA, warrant and revenue base redemption liabilities of $1.5 million. In addition, net operating assets and liabilities decreased $10.0 million driven by an increase in accounts receivable and inventory, an increase in prepaid expenses, and an decrease in accounts payable and accrued liabilities.

Previous wording

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

Current wording

Net cash used in investing activities of $0.8 million for the nine months ended September 30, 2025, was primarily due to purchases of property and equipment of $0.9 million.

Previous wording

Net cash provided by financing activities of $30.4 million for the six months ended June 30, 2025, consisted of primarily of $20.5 million, net of expenses, from the April 30, 2025 Private Placement and $9.5 million, net of expenses, from the First Delayed draw under the OrbiMed Credit Agreement.

Current wording

Net cash provided by financing activities of $30.5 million for the nine months ended September 30, 2025, consisted of primarily of $20.5 million, net of expenses, from the April 30, 2025 Private Placement and $9.5 million, net of expenses, from the First Delayed draw under the OrbiMed Credit Agreement.

Previous wording

Net cash provided by financing activities of $29.1 million for the six months ended June 30, 2024, consisted $6.7 million from the sale of 750,000 shares of common stock under the SEPA and $22.4 million, net of expenses, from the initial draw down under the OrbiMed Credit Agreement.

Current wording

Net cash provided by financing activities of $34.9 million for the nine months ended September 30, 2024, consisted of $12.6 million from the sale of 1,874,867 shares of common stock under the SEPA and $22.4 million, net of expenses, from the initial draw down under the OrbiMed Credit Agreement.

Previous wording

We may require additional capital in order to continue to fund our operations through one or a combination of securities offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements which may not be available on a timely basis, on favorable terms, or at all, and such capital, if obtained, may not be sufficient to enable us to continue to implement our long-term business strategy. See factors further described in the sections titled "Risk Factors" in this Quarterly Report.

Current wording

We may require additional capital in order to continue to fund our operations through one or a combination of securities offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements which may not be available on a timely basis, on favorable terms, or at all, and such capital, if obtained, may not be sufficient to enable us to continue to implement our long-term business strategy.

Previous wording

Our continuation as a going concern is dependent on our ability to generate sufficient cash flows from operations and/or obtain additional capital through one or a combination of securities offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements to carry out our long-term business strategy. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than fair value for such assets and less than the value at which such assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investment. As discussed in Note(1) Nature of Business to our unaudited condensed consolidated financial statements accompanying this Quarterly Report, there is substantial doubt regarding our ability to continue as a going concern as of June 30, 2025.

Current wording

Our continuation as a going concern is dependent on our ability to generate sufficient cash flows from operations and/or obtain additional capital through one or a combination of securities offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements to carry out our long-term business strategy. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than fair value for such assets and less than the value at which such assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investment. As discussed in Note 1 to our condensed consolidated financial statements accompanying this Quarterly Report, there is substantial doubt regarding our ability to continue as a going concern as of September 30, 2025.

Previous wording

Our contractual obligations as of June 30, 2025, include lease obligations of $2.1 million, reflecting the minimum commitments for our principal administrative and production facility and other office spaces.

Current wording

Our contractual obligations as of September 30, 2025, include lease obligations of $2.0 million, reflecting the minimum commitments for our principal administrative and production facility and other office spaces.

Previous wording

Pursuant to the Asset Purchase Agreement, dated July 31, 2020, between TriSalus and Dynavax, we have paid Dynavax $12.0 million as of June 30, 2025, and may be required to pay Dynavax up to an additional $158 million upon the achievement of certain development and regulatory milestones with respect to nelitolimod. Subject to obtaining marketing approval for nelitolimod, we will also be required to pay up to $80 million upon achieving certain commercial milestones. 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.

Current wording

Pursuant to the Asset Purchase Agreement, dated July 31, 2020, between TriSalus and Dynavax, we have paid Dynavax $12.0 million as of September 30, 2025, and 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. Subject to obtaining marketing approval for nelitolimod, we will also be required to pay up to $80.0 million upon achieving certain commercial milestones. 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.

Previous wording

Our significant accounting policies are summarized in Note(2) Summary of Significant Accounting Policies in the unaudited condensed consolidated financial statements accompanying this Quarterly Report. There have been no significant changes in our critical accounting policies during the six months ended June 30, 2025, as compared to the critical accounting policies disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 15, 2025. While all of these significant accounting policies affect the reporting of our financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require us to use a greater degree of judgment and/or estimates. Actual results may differ from those estimates. Additionally, changes in accounting estimates could occur in the future from period to period.

Current wording

Our significant accounting policies and estimates are described in Note 2 to our consolidated financial statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations, respectively, in our Annual Report on Form 10-K for the year ended December 31, 2024. Also refer to Note 1, Nature of Business and Basis of Presentation, in this report.There have been no significant changes in our critical accounting policies during the nine months ended September 30, 2025, as compared to the critical accounting policies disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 15, 2025. While all of these significant accounting policies affect the reporting of our financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require us to use a greater degree of judgment and/or estimation. Actual results may differ from those estimates. Additionally, changes in accounting estimates could occur in the future from period to period.