TriSalus Life Sciences, Inc.

Previous wording

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’ 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 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.

Current wording

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’ condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q ("Quarterly Report") and 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 involve risks and uncertainties. You should review the section titled “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.

Previous wording

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 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.

Current wording

We market our cutting edge PEDD infusion systems, which are designed to optimize therapeutic delivery for hepatocellular carcinoma, pancreatic cancer and other solid liver tumors. Additionally, we are studying nelitolimod to determine whether an immunotherapeutic 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 two main barriers in the tumor microenvironment that inhibit 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, 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") 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"). 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.

Current wording

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") to obtain reimbursement for TriNav device. Effective April 1, 2025, TriNav received a second unique and permanent HCPCS code, C8004, from CMS. This new code provides reimbursement clarity for mapping procedures conducted prior to 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.

Previous wording

In 2025, we expanded our portfolio of PEDD devices with the commercial launch of the TriNav® FLX Infusion System and the TriNav XP Infusion System, further broadening the TriNav product family. These systems complement the Company’s existing TriNav Infusion System, TriNav LV Infusion System and TriGuide Guiding Catheter and are designed to support therapeutic delivery across a broader range anatomical complexity. The TriNav FLX Infusion System incorporates a more flexible distal tip, intended to improve trackability and navigation in tortuous vasculature. While the TriNav XP Infusion System also includes the more flexible distal tip, it is also designed to support delivery of larger embolic particles, expanding procedural versatility across embolization applications. Together with TriNav LV, which is suitable for vessels 3.5 mm to 5.0 mm in diameter, these products are intended to increase the addressable embolization market. TriNav FLX and TriNav XP are eligible for the same HCPCS reimbursement codes as previously commercialized TriNav products, allowing for integration into existing reimbursement framework.

Current wording

In 2025, we expanded our portfolio of PEDD devices with the commercial launch of the TriNav FLX Infusion System and the TriNav XP Infusion System, further broadening the TriNav product family. These systems complement the Company’s existing TriNav Infusion System, TriNav LV Infusion System and TriGuide Guiding Catheter and are designed to support therapeutic delivery across a broader range of anatomical complexity. The TriNav FLX Infusion System incorporates a more flexible distal tip, intended to improve trackability and navigation in tortuous vasculature. While the TriNav XP Infusion System also includes the more flexible distal tip, it is also designed to support delivery of larger embolic particles, expanding procedural versatility across embolization applications. Together with TriNav LV, which is suitable for vessels 3.5 mm to 5.0 mm in diameter, these products are intended to increase the addressable embolization market. In September 2026, we obtained FDA 510(k) clearance for TriNav Advance, a device that interventional radiologists can pair with a microcatheter of their choice to match vessel anatomy and treatment goals. TriNav FLX, TriNav XP, and TriNav Advance are eligible for the same HCPCS reimbursement codes as previously commercialized TriNav products, allowing for integration into existing reimbursement framework.

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 conducted two 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. We anticipate releasing a consolidated clinical update in the second half of 2026 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 immuno-oncology drug, nelitolimod, in July 2020, and conducted several Phase I clinical trials to study the potential for nelitolimod, delivered via our PEDD technology, to improve outcomes in areas of high unmet need. We conducted two Phase I dose escalation (UMLM and LA-PDAC) and one 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. We anticipate releasing a consolidated clinical update in the fourth quarter of 2026 and will begin discussions for a 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 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. On November 4, 2026, CMS finalized the calendar year 2027 Hospital Outpatient Prospective Payment System ("OPPS") final rule for the reassignment of HCPCS code C8004 from APC 5193 to APC 5194, aligning it with C9797, which is already assigned to APC 5194. On June 17, 2026, CMS created a G-Code, which became effective on July 1, 2026. On November 4, 2026, CMS published its calendar year 2027 Physician Fee Schedule final rule, establishing national payment for HCPCS code G0577, extending reimbursement for PEDD to OBLs. 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 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.

Current wording

•The success of our clinical trials of nelitolimod. Nelitolimod is in early-stage 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

Sales and marketing expense consists primarily of salaries, commissions, travel and related business expenses for our sales force, which is principally engaged in physician education regarding the features and benefits of TriNav. We also incur expenses for attendance at medical society meetings, product promotions and marketing activities.

Current wording

Sales and marketing expenses consist primarily of salaries, commissions, travel and related business expenses for our sales force, which is principally engaged in physician education regarding the features and benefits of TriNav. We also incur expenses for attendance at medical society meetings, product promotions and marketing activities.

Previous wording

General and administrative expense includes 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.

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 expenses 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 Public Warrants, Private Placement Warrants and Working Capital Warrants (the "Exchange Warrants"), the change in fair value of the OrbiMed Warrants and the change in fair value of the revenue base redemption liability.

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 Public Warrants, Private Placement Warrants and Working Capital Warrants, the change in fair value of the OrbiMed Warrants and the change in fair value of the revenue base redemption liability.

Previous wording

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

Current wording

Other expense, net represents miscellaneous expenses that historically have been immaterial.

Previous wording

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

Current wording

Cost of goods sold decreased by $0.1 million, or 6.5%, for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The decrease in cost of goods sold was primarily due to a reduction in cost per TriNav unit sold.

Previous wording

Gross profit increased by $0.5 million, or 5.2%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, and gross margin increased from 83.9% to 86.8% year over year. The increase in gross profit and gross margin was primarily due to a reduction in cost per TriNav unit.

Current wording

Gross profit increased by $1.4 million, or 14.9%, for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, and gross margin increased from 83.5% to 86.2% year over year. The increase in gross profit and gross margin was primarily due to an increase in TriNav units sold and a reduction in cost per TriNav unit.

Previous wording

R&D expenses decreased by $0.5 million, or 14.5%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease was primarily due to lower professional services costs and clinical trial expenses related to nelitolimod that did not recur during the three months ended June 30, 2026 compared to prior year.

Current wording

R&D expenses decreased by $2.5 million, or 44.1%, for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The decrease was primarily due to clinical trial expenses related to nelitolimod that did not recur during the three months ended September 30, 2026 compared to prior year.

Previous wording

Sales and marketing expenses increased by $4.3 million, or 59.4%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was primarily due to increased investment in marketing and our sales organization expansion during the three months ended June 30, 2026 compared to prior year.

Current wording

Sales and marketing expenses increased by $3.9 million, or 56.9%, for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The increase was primarily due to increased investment in marketing and our sales organization expansion during the three months ended September 30, 2026 compared to prior year.

Previous wording

General and administrative expenses decreased by $0.8 million, or 12.7%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease was primarily due to lower professional services costs related to legal and audit related expenses.

Current wording

General and administrative expenses decreased by $1.2 million, or 20.4%, for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The decrease was primarily due to lower professional services costs related to legal and audit related expenses and lower non-cash stock-based compensation expense driven by the acceleration of an award that did not recur during the three months ended September 30, 2026 compared to prior year.

Previous wording

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

Current wording

Interest income increased by $0.2 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was due to interest earned on a higher cash and cash equivalents balance during the three months ended September 30, 2026 compared to prior year.

Previous wording

Interest expense increased by $0.1 million or 4.7% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was primarily due to a slight increase in the effective interest rate and additional debt discount amortization for the lender fees incurred for the OrbiMed Fourth and Fifth Amendments during the three months ended June 30, 2026.

Current wording

Interest expense increased by $0.1 million or 6.8% for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The increase was primarily due to a slight increase in the effective interest rate and additional debt discount amortization for the lender fees incurred for the OrbiMed Fourth, Fifth, and Sixth Amendments during the three months ended September 30, 2026.

Previous wording

The change in fair value of SEPA, warrant and revenue base redemption liabilities resulted in a gain of $6.5 million in the six months ended June 30, 2026, compared to a loss of $1.2 million in the six months ended June 30, 2025, a difference of $7.6 million. The change was primarily due to the decrease in the Company's warrant stock price during the six months ended June 30, 2026 as compared to prior year.

Current wording

The change in fair value of SEPA, warrant and revenue base redemption liabilities resulted in a loss of $0.7 million in the three months ended September 30, 2026, compared to a loss of $2.9 million in the three months ended September 30, 2025, a difference of approximately $2.3 million. The change was primarily due to less of an increase in the Company's warrant stock price during the three months ended September 30, 2026 as compared to prior year.

Previous wording

The change in fair value of contingent earnout liability resulted in a loss of $1.0 million for the three months ended June 30, 2026 compared to a gain of $0.7 million for the three months ended June 30, 2025. The change in the fair value of the contingent earnout liability during the three months ended June 30, 2026 was primarily driven by the increase in the Company's stock price and increase in stock price volatility.

Current wording

The change in fair value of contingent earnout liability resulted in a gain of $0.7 million for the three months ended September 30, 2026 compared to a gain of $2.5 million for the three months ended September 30, 2025. The change in the fair value of the contingent earnout liability during the three months ended September 30, 2026 was primarily driven by the decrease in the Company's stock price.

Previous wording

Revenue was relatively consistent with the prior comparative period with an increase of $0.2 million, or 1.7%, for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.

Current wording

Other expense, net, for the three months ended September 30, 2026 was relatively consistent with the three months ended September 30, 2025.

Previous wording

Cost of goods sold decreased by $0.6 million, or 17.0%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease in cost of goods sold was primarily due to a reduction in cost per TriNav unit sold.

Current wording

Cost of goods sold decreased by $0.7 million, or 13.1%, for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The decrease in cost of goods sold was primarily due to a reduction in cost per TriNav unit sold.

Previous wording

Gross profit increased by $0.5 million, or 2.8%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, and gross margin increased from 83.8% to 86.5% year over year. The increase in gross profit and gross margin was primarily due to a reduction in cost per TriNav unit.

Current wording

Gross profit increased by $1.9 million, or 7.2%, for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, and gross margin increased from 83.7% to 86.4% year over year. The increase in gross profit and gross margin was primarily due to an increase in TriNav units sold and a reduction in cost per TriNav unit.

Previous wording

R&D expenses decreased by $0.3 million, or 5.1%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease was primarily due to lower professional services costs and clinical trial expenses related to nelitolimod that did not recur during the six months ended June 30, 2026 compared to prior year.

Current wording

R&D expenses decreased by $2.9 million, or 23.0%, for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The decrease was primarily due to clinical trial expenses related to nelitolimod that did not recur during the nine months ended September 30, 2026 compared to prior year.

Previous wording

Sales and marketing expenses increased by $4.9 million, or 35.5%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The increase was primarily due to increased investment in marketing and our sales organization expansion during the six months ended June 30, 2026 compared to prior year.

Current wording

Sales and marketing expenses increased by $8.8 million, or 42.6%, for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The increase was primarily due to increased investment in marketing and our sales organization expansion during the nine months ended September 30, 2026 compared to prior year.

Previous wording

General and administrative expenses decreased by $0.5 million, or 4.9%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease was primarily due to lower professional services costs related to a decrease in legal and audit related expenses, partially offset by an increase in corporate headcount.

Current wording

General and administrative expenses decreased by $1.8 million, or 10.4%, for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The decrease was primarily due to lower professional services costs related to a decrease in legal and audit related expenses, partially offset by an increase in corporate headcount.

Previous wording

Interest income increased by $0.4 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was due to interest earned on a higher cash and cash equivalents balance during the six months ended June 30, 2026 compared to prior year.

Current wording

Interest income increased by $0.6 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was due to interest earned on a higher cash and cash equivalents balance during the nine months ended September 30, 2026 compared to prior year.

Previous wording

Interest expense increased by $0.3 million or 11.2% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The increase was due to interest on borrowings under the First Delayed Draw Term Loan that was only outstanding for a portion of the six months ended June 30, 2025, a slight increase in the effective interest rate and additional debt discount amortization for the lender fees incurred for the OrbiMed Fourth and Fifth Amendments during the six months ended June 30, 2026.

Current wording

Interest expense increased by $0.4 million or 9.6% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The increase was due to interest on borrowings under the First Delayed Draw Term Loan that was only outstanding for a portion of the nine months ended September 30, 2025, and a slight increase in the effective interest rate and additional debt discount amortization for the lender fees incurred for the OrbiMed Fourth, Fifth, and Sixth Amendments during the nine months ended September 30, 2026.

Previous wording

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

Current wording

The change in fair value of SEPA, warrant and revenue base redemption liabilities resulted in a gain of $5.8 million in the nine months ended September 30, 2026, compared to a loss of $4.1 million in the nine months ended September 30, 2025, a difference of $9.9 million. The change was primarily due to the decrease in the Company's warrant stock price during the nine months ended September 30, 2026 as compared to prior year.

Previous wording

The change in fair value of contingent earnout liability resulted in a gain of $6.4 million for the six months ended June 30, 2026 compared to a loss of $0.1 million for the six months ended June 30, 2025. The change in the fair value of the contingent earnout liability during the period was primarily driven by the decrease in the Company's stock price.

Current wording

The change in fair value of contingent earnout liability resulted in a gain of $7.1 million for the nine months ended September 30, 2026 compared to a gain of $2.4 million for the nine months ended September 30, 2025. The change in the fair value of the contingent earnout liability during the period was primarily driven by the decrease in the Company's stock price.

Previous wording

Other income (expense), net, decreased by $0.3 million of expense for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease in expense was primarily driven by the retirement of lease assets that did not recur during the six months ended June 30, 2026.

Current wording

Other expense, net, decreased by $0.3 million of expense for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The decrease in expense was primarily driven by the retirement of lease assets that did not recur during the nine months ended September 30, 2026.

Previous wording

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 $18.2 million and $14.7 million for the six months ended June 30, 2026 and 2025, respectively. We had cash and cash equivalents of approximately $46.3 million and $20.4 million as of June 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.

Current wording

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 expenses we expect to incur as a public company. We incurred operating losses of $25.9 million and $23.7 million for the nine months ended September 30, 2026 and 2025, respectively. We had cash and cash equivalents of approximately $41.1 million and $20.4 million as of September 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.

Previous wording

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). As of June 30, 2026, we were in compliance with the Product Revenue Base requirement and no repayments were required.

Current wording

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, May 28, 2026, and September 29, 2026, we entered into the OrbiMed Fourth Amendment, OrbiMed Fifth Amendment, and OrbiMed Sixth Amendment, respectively, which reduced certain Product Revenue Base thresholds (see Note 9). As of September 30, 2026, we were in compliance with the Product Revenue Base requirement and no repayments were required.

Previous wording

For the six months ended June 30, 2026, net cash used in operating activities was $16.6 million. The net cash used in operating activities consisted of net loss of $7.6 million, adjusted for non-cash activity totaling $6.7 million, primarily related to gains on the change in the fair value of the contingent earnout liability and the fair value of the SEPA, warrant and revenue base redemption liabilities of $6.4 million and $6.5 million, respectively, partially offset by stock-based compensation of $5.1 million, depreciation of $0.3 million and amortization of debt issuance costs of $0.6 million. Net operating assets increased by $2.2 million, primarily due to increases in inventory, net and prepaid expenses and a decrease in accrued liabilities, partially offset by an increase in trade payables.

Current wording

For the nine months ended September 30, 2026, net cash used in operating activities was $21.9 million. The net cash used in operating activities consisted of net loss of $16.5 million, adjusted for non-cash activity totaling $3.5 million, primarily related to gains on the change in the fair value of the contingent earnout liability and the fair value of the SEPA, warrant and revenue base redemption liabilities of $7.1 million and $5.8 million, respectively, partially offset by stock-based compensation of $7.9 million, depreciation of $0.4 million and amortization of debt issuance costs of $1.0 million. Net operating assets increased by $1.9 million, primarily due to increases in inventory, net and prepaid expenses and a decrease in accrued liabilities, partially offset by an increase in trade payables and a decrease in accounts receivable.

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 activity totaling $6.6 million, primarily related to stock-based compensation of $3.5 million, changes in the fair value of the contingent earnout liability and SEPA, warrant and revenue base redemption liabilities of $0.1 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 $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 activity totaling $11.3 million, primarily related to stock-based compensation of $6.9 million, a loss on the change in fair value of the SEPA, warrant and revenue base redemption liabilities of $4.1 million and debt expenses of $1.6 million related to paid-in-kind interest and amortization of debt issuance costs, partially offset by a gain on the change in fair value of the 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

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

Current wording

Net cash used in investing activities of $0.3 million for the nine months ended September 30, 2026 was primarily due to purchases of property and equipment of $0.3 million.

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 $42.3 million for the six months ended June 30, 2026, consisted primarily of $42.6 million of net proceeds raised from the issuance of Common Stock through a public offering and $0.3 million in proceeds from the issuance of Common Stock through ESPP, offset by $0.6 million of debt issuance costs.

Current wording

Net cash provided by financing activities of $42.5 million for the nine months ended September 30, 2026, consisted primarily of $42.6 million of net proceeds raised from the issuance of Common Stock through a public offering, $0.3 million in proceeds from the issuance of Common Stock through ESPP and $0.3 million in proceeds from the exercise of stock options, offset by $0.6 million of debt issuance costs.

Previous wording

Net cash provided by financing activities of $30.4 million for the six months ended June 30, 2025, consisted 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 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

We also expect to continue to incur significant expenses in connection with our ongoing activities related to TriNav, including sales and marketing expenses to support our expected sales growth. Our future capital requirements, both near and long-term, will depend on many factors, including but not limited to: the success of our commercialization of TriNav including, among other things, continued patient and physician adoption of TriNav and our ability to maintain adequate reimbursement for TriNav; the cost of commercialization activities for TriNav, including manufacturing, distribution, marketing and sales; net product revenues received from sales of TriNav; the outcome, timing and cost of the regulatory approval process for nelitolimod by the FDA, including the potential for the FDA to require that we perform more studies and clinical trials than those that we currently expect; the costs involved in preparing, filing and prosecuting patent applications and annuity fees relating to issued patents; the cost of maintaining and enforcing our intellectual property rights, as well as the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us; the initiation, progress, timing, costs and results of clinical trials and other research and development related to our product candidates; and the extent to which we in-license, acquire or otherwise partner in development or commercialization of other products, product candidates or technologies; the achievement of milestones or occurrence of other developments that trigger payments under the Dynavax Agreement or any other collaboration or other agreements; the number of future product candidates that we may pursue and their development requirements; the costs of commercialization activities for any of our product candidates that may receive marketing approval to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities; the amount and timing of future revenue, if any, received from commercial sales of our current and future product candidates upon any marketing approvals; and the costs of operating as a public company.

Current wording

We also expect to continue to incur significant expenses in connection with our ongoing activities related to TriNav, including sales and marketing expenses to support our expected sales growth. Our future capital requirements, both near and long-term, will depend on many factors, including but not limited to: the success of our commercialization of TriNav including, among other things, continued patient and physician adoption of TriNav and our ability to maintain adequate reimbursement for TriNav; the cost of commercialization activities for TriNav, including manufacturing, distribution, marketing and sales; net product revenues received from sales of TriNav; the outcome, timing and cost of the regulatory approval process for nelitolimod by the FDA, including the potential for the FDA to require that we perform more studies and clinical trials than those that we currently expect; the costs involved in preparing, filing and prosecuting patent applications and annuity fees relating to issued patents; the cost of maintaining and enforcing our intellectual property rights, as well as the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us; the initiation, progress, timing, costs and results of clinical trials and other research and development related to our product candidates; the extent to which we in-license, acquire or otherwise partner in development or commercialization of other products, product candidates or technologies; the achievement of milestones or occurrence of other developments that trigger payments under the Dynavax Agreement or any other collaboration or other agreements; the number of future product candidates that we may pursue and their development requirements; the costs of commercialization activities for any of our product candidates that may receive marketing approval to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities; the amount and timing of future revenue, if any, received from commercial sales of our current and future product candidates upon any marketing approvals; and the costs of operating as a public company.