IOVANCE BIOTHERAPEUTICS, INC.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001104659-26-056778
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001104659-26-091716
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 129 previous paragraphs and 130 current paragraphs.
89 unchanged; 30 reworded; 1 added; 4 removed; 6 previous and 10 current paragraphs rearranged.
Tables are not compared: 17 previous and 17 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (1)
Current report
Income tax benefit (expense)
Removed paragraphs (4)
Previous report
Selling, general and administrative expense
Previous report
Income tax benefit
Previous report
Selling, general and administrative expense
Previous report
In August 2025, we approved a strategic restructuring plan with an associated reduction in workforce as a result of a review of current strategic priorities, resource allocation, and cost reduction intended to reduce operating costs, streamline operations and extend our cash runway. The restructuring plan is expected to optimize business performance, prioritize key manufacturing and research and development efforts, as well as reduce headcount by approximately 19 percent.
Reworded paragraphs (30)
Previous wording
Amtagvi® is the first one-time, individualized T cell therapy for a solid tumor cancer and for the treatment of adult patients with previously treated advanced, or unresectable or metastatic melanoma, approved for use in the U.S. and Canada. Amtagvi® is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin®.
Current wording
Amtagvi® is the first one-time, individualized T cell therapy for a solid tumor cancer and for the treatment of adult patients with previously treated advanced melanoma, defined as unresectable or metastatic melanoma, approved for use in the U.S., Canada, and Australia. Amtagvi® is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin®.
Previous wording
Globally, Amtagvi® has the potential to address more than 30,000 previously treated advanced melanoma patients annually. We plan to launch into additional markets with a high prevalence of advanced melanoma. Potential approvals are pending in Australia in the first half of 2026 and Switzerland in 2027. In the European Union, or EU, we withdrew our initial marketing authorization application, or MAA, in July 2025. We are working with the European Medicines Agency, or EMA, to resubmit a centralized MAA in 2026. In the United Kingdom, or UK, we withdrew our initial MAA in May 2026 and will resubmit the MAA with additional information for expedited review in 2026.
Current wording
Globally, Amtagvi® has the potential to address more than 30,000 previously treated advanced melanoma patients annually. We plan to launch into additional markets with a high prevalence of advanced melanoma. On June 4, 2026, we received marketing authorization with conditions from the Therapeutic Goods Administration of Australia for Amtagvi® for previously treated advanced (metastatic or unresectable) melanoma. In the United Kingdom, or UK, we resubmitted the marketing authorization application, or MAA, with additional information in July 2026. The Medicines and Healthcare products Regulatory Agency, or MHRA, is conducting an expedited review, with potential approval expected later in 2026. Potential approval is pending in Switzerland in 2027. In the European Union, or EU, we are working with the European Medicines Agency, or EMA, to resubmit a centralized MAA in 2026 or 2027.
Previous wording
manufacturing for clinical and commercial Iovance TIL cell therapies to theiCTC and terminated an agreement with a contract manufacturer in the first quarter of 2026 to manage and reduce long-term product manufacturing costs. We have full control of manufacturing capacity and product quality, supply and delivery logistics, cost efficiencies and process improvements, such as automation and next generation approaches that may further streamline timelines and costs. Certain clinical trials for our next-generation investigational TIL cell therapies will continue to be supported by contract manufacturing organizations, or CMOs. Details of related agreements are provided in Note 12 Licenses and Agreements section of this Quarterly Report on Form 10-Q of our condensed consolidated financial statements for the quarter ended March 31, 2026.
Current wording
The currentiCTC facility has the potential capacity to supply TIL cell therapies for more than 5,000 cancer patients annually. To utilize our internal manufacturing suites at greater scale, improve gross margin and reduce operating expenses, we transitioned all manufacturing for clinical and commercial Iovance TIL cell therapies to theiCTC and terminated an agreement with a contract manufacturer in the first quarter of 2026 to manage and reduce long-term product manufacturing costs. We have full control of manufacturing capacity and product quality, supply and delivery logistics, cost efficiencies and process improvements, such as automation and next generation approaches that may further streamline timelines and costs. Certain clinical trials for our next-generation investigational TIL cell therapies will continue to be supported by contract manufacturing organizations, or CMOs. Details of related agreements are provided in Note 11 Licenses and Agreements section of this Quarterly Report on Form 10-Q of our condensed consolidated financial statements for the quarter ended June 30, 2026.
Previous wording
We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 100 U.S. patents related to TIL cell therapy, including patents directed to compositions and methods of treatment in a broad range of cancers, such as U.S. Patent Nos. 10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,398,734; 10,420,799; 10,463,697; 10,517,894; 10,537,595; 10,639,330; 10,646,517; 10,653,723; 10,695,372; 10,894,063; 10,905,718; 10,918,666; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,007,226; 11,013,770; 11,026,974; 11,040,070; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,434; 11,141,438; 11,168,303; 11,168,304; 11,179,419; 11,202,803; 11,202,804; 11,220,670; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,293,009; 11,304,979; 11,304,980; 11,311,578; 11,337,998; 11,344,579; 11,344,580; 11,344,581; 11,351,197; 11,351,198; 11,351,199; 11,364,266; 11,369,637; 11,384,337; 11,401,507; 11,433,097; 11,517,592; 11,529,372; 11,541,077; 11,631,483; 11,713,446; 11,819,517; 11,857,573; 11,865,140; 11,866,688; 11,939,596; 11,969,444; 11,975,028; 11,981,921; 11,998,568; 12,023,355; 12,024,718; 12,031,157; 12,104,172; 12,121,541; 12,159,700; 12,170,134; 12,188,048; 12,194,061; 12,226,434; 12,226,522; 12,230,378; 12,230,379; 12,233,075; 12,280,140; 12,343,380; 12,453,697; 12,473,532; 12,485,145; 12,495,791; 12,553,029; 12,553,031; 12,558,375; 12,570,959; 12,570,961; 12,611,427; 12,611,428; and 12,611,429. More than 50 of these patents are related to our Gen 2 TIL manufacturing processes and have terms that we anticipate will extend to October 2037 or January 2038, not including any patent term extensions or adjustments that may be available. Our owned and licensed intellectual property portfolio also includes patents and patent applications relating to TIL, marrow-infiltrating lymphocytes, or MIL, and peripheral blood lymphocyte, or PBL, therapies; frozen tumor-based TIL technologies; remnant TIL and digest TIL compositions, methods, and processes; methods of manufacturing TIL, MIL, and PBL therapies; the use of costimulatory and T cell modulating molecules in TIL cell therapy and manufacturing; stable and transient genetically-modified TIL cell therapies, including genetic knockouts of immune checkpoints; cytokine-tethered TIL cell therapies; methods of using immune checkpoint inhibitor, or ICIs, in combination with TIL cell therapies; TIL selection technologies; and methods of treating patient subpopulations.
Current wording
We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 100 U.S. patents related to TIL cell therapy, including patents directed to compositions and methods of treatment in a broad range of cancers, such as U.S. Patent Nos. 10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,398,734; 10,420,799; 10,463,697; 10,517,894; 10,537,595; 10,639,330; 10,646,517; 10,653,723; 10,695,372; 10,894,063; 10,905,718; 10,918,666; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,007,226; 11,013,770; 11,026,974; 11,040,070; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,434; 11,141,438; 11,168,303; 11,168,304; 11,179,419; 11,202,803; 11,202,804; 11,220,670; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,293,009; 11,304,979; 11,304,980; 11,311,578; 11,337,998; 11,344,579; 11,344,580; 11,344,581; 11,351,197; 11,351,198; 11,351,199; 11,364,266; 11,369,637; 11,384,337; 11,401,507; 11,433,097; 11,517,592; 11,529,372; 11,541,077; 11,631,483; 11,713,446; 11,819,517; 11,857,573; 11,865,140; 11,866,688; 11,939,596; 11,969,444; 11,975,028; 11,981,921; 11,998,568; 12,023,355; 12,024,718; 12,031,157; 12,104,172; 12,121,541; 12,159,700; 12,170,134; 12,188,048; 12,194,061; 12,226,434; 12,226,522; 12,230,378; 12,230,379; 12,233,075; 12,280,140; 12,343,380; 12,453,697; 12,473,532; 12,485,145; 12,495,791; 12,553,029; 12,553,031; 12,558,375; 12,570,959; 12,570,961; 12,611,427; 12,611,428; 12,611,429; 12,617,833; 12,622,927; 12,636,318; 12,642,268; 12,642,816; 12,642,832; 12,648,962; 12,655,389; and 12,678,499. More than 50 of these patents are related to our Gen 2 TIL manufacturing processes and have terms that we anticipate will extend to October 2037 or January 2038, not including any patent term extensions or adjustments that may be available. Our owned and licensed intellectual property portfolio also includes patents and patent applications relating to TIL, marrow-infiltrating lymphocytes, or MIL, and peripheral blood lymphocyte, or PBL, therapies; TIL cell expansion from core biopsy, small biopsy or fine needle aspirate; assays for evaluating potency and/or functionality of TIL products; frozen tumor-based TIL technologies; remnant TIL and digest TIL compositions, methods, and processes; methods of manufacturing TIL, MIL, and PBL therapies; the use of costimulatory and T cell modulating molecules in TIL
Previous wording
Revenue for the three months ended March 31, 2026 represents product sales of Amtagvi®, as well as Proleukin®, primarily driven from sales in the U.S. to support the ongoing commercial launch of Amtagvi®, which received FDA approval in February 2024. Proleukin®, which we acquired the worldwide rights to in May 2023, is also sold in markets outside the U.S., primarily in the EU and UK.
Current wording
Revenues for the three and six months ended June 30, 2026 represents product sales of Amtagvi®, as well as Proleukin®, primarily driven from sales in the U.S. to support the ongoing commercial launch of Amtagvi®, which received FDA approval in February 2024. Proleukin®, which we acquired the worldwide rights to in May 2023, is also sold in markets outside the U.S., primarily in the EU and UK.
Previous wording
Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in an uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites. The duration, costs, and timing of our clinical trials and development of our product candidates will depend on a number of factors that include, but are not limited to, the number of patients that enroll in the trial, per patient trial costs, number of sites included in the trial, discontinuation rates of patients, duration of patient follow-up, efficacy and safety profile of the product candidate, and the length of time required to enroll eligible patients.
Current wording
Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in an uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites. The duration, costs, and timing of our clinical trials and development of our product candidates will depend on a number of factors that include, but are not limited to, the number of patients that enroll in the trial, per patient trial
Previous wording
Results of Operations for the Three Months Ended March 31, 2026 and 2025
Current wording
Results of Operations for the Three and Six Months Ended June 30, 2026 and 2025
Previous wording
Revenue for the three months ended March 31, 2026 increased by $22.1 million, or 45%, compared to the same period in 2025. The increase in revenue as compared to the prior period was driven by an increase in Amtagvi® infusions, correspondent increase in Proleukin®, and price increases for both products.
Current wording
Revenue for the three and six months ended June 30, 2026 increased by $39.4 million, or 66%, and by $61.5million, or 56%, compared to the same periods in 2025. The increase in revenue as compared to the prior period was driven by an increase in Amtagvi® infusions, correspondent increase in Proleukin®, and price increases for both products.
Previous wording
Cost of sales, excluding depreciation and amortization, for the three months ended March 31, 2026 decreased by $0.2 million, or 1%, compared to the same period in 2025. The decrease was driven by a $5.3 million decrease in period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi® treatment, as well as manufacturing results that did not meet required specifications, and were not otherwise utilized under an expanded access program or single-patient IND to generate clinical data. This decrease was partially offset by (i) a $3.8 million increase from sales of Amtagvi® and Proleukin® products as well as costs related to the manufacturing of Amtagvi® and (ii) a $1.3 million increase in royalties payable related to the increase in sales of Proleukin.
Current wording
Cost of sales, excluding depreciation and amortization, for the three months ended June 30, 2026 decreased by $5.3 million, or 11%, compared to the same period in 2025. The decrease was driven by a (i) a $5.3 million decrease in excess and obsolescence reserve supported by the increased demand and (ii) $3.9 million decrease in period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi® treatment, as well as manufacturing results that did not meet required specifications, and were not otherwise utilized under an expanded access program or single-patient IND to generate clinical data. This decrease was partially offset by (i) a $2.9 million increase from sales of Amtagvi® and Proleukin® products as well as costs related to the manufacturing of Amtagvi® and (ii) a $1.0 million increase in royalties payable related to the increase in sales of Proleukin.
Previous wording
Research and development expense for the three months ended March 31, 2026 decreased by $13.5 million, or 18%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $4.9 million decrease in outside services cost driven by a decrease in the number of consultants, (ii) a $4.8 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, (iii) a $5.5 million decrease in clinical trial costs, driven primarily by completion of 144-01 and 144-05 clinical trials as well as other ongoing studies advancing into a late-stage of clinical trials, and (iv) a $0.7 million decrease in other costs, including travel and license cost. These decreases were partially offset by a $2.4 million increase in clinical manufacturing costs primarily driven by increased clinical production.
Current wording
Research and development expenses for the three months ended June 30, 2026 decreased by $19.1 million, or 24%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $7.3 million decrease in consultant costs, primarily driven by a decrease in outside services cost driven by the number of consultants, (ii) a $5.0 million decrease in manufacturing fees, primarily due to the contract termination with our external contract manufacturer, (iii) a $3.9 million decrease in clinical trial costs, driven primarily by completion of melanoma and cervical clinical trials as well as other ongoing studies advancing into a late-stage of clinical trials, (iv) a $1.6 million decrease in other costs, including lab consumables, travel and license cost, and (v) a $1.3 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price.
Previous wording
services to supplement our in-house activities, and costs associated with our facilities. These expenses are not directly tied to any individual project and are generally deployed across multiple projects. As such, we do not maintain information regarding those costs incurred on a project specific basis.
Current wording
All remaining research and development expenses are categorized as indirect research and development expenses. Such indirect research and development expenses include employee salaries and benefits, stock-based compensation, consulting and contracted services to supplement our in-house activities, and costs associated with our facilities. These expenses are not directly tied to any individual project and are generally deployed across multiple projects. As such, we do not maintain information regarding those costs incurred on a project specific basis.
Previous wording
Selling, general and administrative expenses for the three months ended March 31, 2026 decreased by $4.9 million, or 11%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $5.4 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, and (ii) a $1.4 million decrease in other costs, including costs associated with intellectual property legal costs, and software license costs related to our information technology infrastructure. This decrease was partially offset by (i) a $1.2 million increase in costs incurred in support of the marketing, advertising, and market research in rest of world of Amtagvi®, and (ii) a $0.7 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business.
Current wording
Selling, general, and administrative expenses for the three months ended June 30, 2026 increased by $1.7 million, or 5%, compared to the same period in 2025. The increase was primarily attributable to (i) a $3.9 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business. This increases was partially offset by and (i) a $1.3 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, and (ii) a $0.9 million decrease in other costs, including costs associated with intellectual property legal costs, outside service costs, and software license costs related to our information technology infrastructure.
Previous wording
Depreciation and amortization expense for the three months ended March 31, 2026 increased by $0.5 million, or 6% compared to the same period in 2025. The increase was primarily driven by the expansion of ouriCTC manufacturing facility.
Current wording
Depreciation and amortization expense for the three and six months ended June 30, 2026 increased by $0.2 million, or 2% and increased by $0.6 million, or 4%, compared to the same period in 2025. The increase was primarily driven by the expansion of ouriCTC manufacturing facility.
Previous wording
Interest and other income, net for the three months ended March 31, 2026 decreased by $1.9 million, or 59%, compared to the same period in 2025. The decrease was primarily driven by a decrease in average investment balances and slightly lower rate of return on our investments.
Current wording
Interest and other income, net for the three months ended June 30, 2026 decreased by $0.9 million, or 22%, compared to the same period in 2025. The decrease was primarily driven by a decrease in average investment balances and slightly lower rate of return on our investments.
Previous wording
Income tax benefit for the three months ended March 31, 2026 decreased by $1.2 million or 64%, compared to the same period in 2025. The decrease was mainly driven by the mix of income across jurisdictions that have varying effective tax rates.
Current wording
Income tax benefit for the three and six months ended June 30, 2026 increased by $3.4 million, or 169%, and $2.2 million, or 1459%, respectively, compared to the same periods in 2025. The increase was primarily driven by the mix of income across jurisdictions that with varying effective tax rates and an adjustment in the prior year in transfer pricing, true-up to tax attributes and deductions associated with the Proleukin® business in the U.K.
Previous wording
Net loss for the three months ended March 31, 2026 decreased by $37.1 million, or 32%, compared to the same period in 2025. The decrease in our net loss is primarily due to the increase in sales of Amtagvi® and Proleukin® products. We anticipate that we will continue to incur net losses in the future as we further invest in our clinical and internal research and development programs, as well as ongoing execution of the launch of Amtagvi®.
Current wording
Net loss for the three and six months ended June 30, 2026 decreased by $64.3 million, or 58%, and $101.5 million, or 45%, compared to the same periods in 2025. The decrease in our net loss is primarily due to the increase in sales of Amtagvi® and Proleukin® products. We anticipate that we will continue to incur net losses in the future as we further invest in our clinical and internal research and development programs, as well as ongoing execution of the launch of Amtagvi®.
Previous wording
As of March 31, 2026, we had $319.4 million in cash, cash equivalents, short-term investments, and restricted cash ($196.5 million of cash and cash equivalents, $116.9 million in short-term investments, and $6.0 million in restricted cash). We have incurred losses and generated negative cash flows from operations since inception. Historically, we have funded our operations from various public and private offerings of our equity securities, both common stock and preferred stock, from option and warrant exercises, and from interest income. Since 2017, our primary source of funds has been from the public sale of our common stock. With the recent approval of our BLA, we expect to continue to generate revenue from the sale of our first internally developed product, Amtagvi®. Furthermore, as Proleukin®inventory that was previously with distributors in the U.S. market at the time of the acquisition of the worldwide rights to Proleukin®in May 2023 has been substantially depleted, we also began to sell Proleukin®into the U.S. market, where product margins are substantially higher than in other markets, to support ongoing and anticipated infusions related to the continued strong commercial launch of Amtagvi®. However, such revenues for Amtagvi® and Proleukin® may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Quarterly Report on Form 10-Q is filed.
Current wording
losses and generated negative cash flows from operations since inception. Historically, we have funded our operations from various public and private offerings of our equity securities, both common stock and preferred stock, from option and warrant exercises, and from interest income. Since 2017, our primary source of funds has been from the public sale of our common stock. With the approval of our BLA, we expect to continue to generate revenue from the sale of our first internally developed product, Amtagvi®. Furthermore, as Proleukin®inventory that was previously with distributors in the U.S. market at the time of the acquisition of the worldwide rights to Proleukin®in May 2023 has been substantially depleted, we also began to sell Proleukin®into the U.S. market, where product margins are substantially higher than in other markets, to support ongoing and anticipated infusions related to the continued strong commercial launch of Amtagvi®. However, such revenues for Amtagvi® and Proleukin® may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Quarterly Report on Form 10-Q is filed.
Previous wording
We expect to continue to incur significant expenses to support our ongoing execution of the commercial launch of Amtagvi®, fund ongoing clinical programs, including our NSCLC registrational study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the three months ended March 31, 2026 are issued, we believe that we have sufficient capital to fund our anticipated operating expenses and capital expenditures as planned for at least the twelve months following the issuance of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Current wording
We expect to continue to incur significant expenses to support our ongoing execution of the commercial launch of Amtagvi®, fund ongoing clinical programs, including our NSCLC registrational study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the three and six months ended June 30, 2026 are issued, we believe that we have sufficient capital to fund our anticipated operating expenses and capital expenditures as planned for at least the twelve months following the issuance of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Previous wording
As of March 31, 2026, we had outstanding 438,106,537 shares of our $0.000041666 par value common stock, 194 shares of our $0.001 par value Series A Convertible Preferred Stock, and 1,932,667 shares of our $0.001 par value Series B Convertible Preferred Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 1,932,667 shares of our
Current wording
As of June 30, 2026, we had outstanding 452,971,016 shares of our $0.000041666 par value common stock, 194 shares of our $0.001 par value Series A Convertible Preferred Stock, and 1,932,667 shares of our $0.001 par value Series B Convertible Preferred Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 1,932,667 shares of our common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.
Previous wording
On August 22, 2025, we entered into an Amended and Restated Open Market Sale Agreement, or the 2025 Sale Agreement, with Jefferies with respect to an “at the market” offering program. Under the terms of the 2025 Sale Agreement, we may, from time to time, in our sole discretion, issue and sell up to $350.0 million of shares of our common stock pursuant to the “at the market” offering program. The 2025 Sale Agreement superseded and replaced in its entirety the 2023 Sale Agreement. The issuance and sale, if any, of shares of our common stock under the Sale Agreement was or will be made pursuant to a prospectus supplement dated August 22, 2025 to our Registration Statement on Form S-3ASR, which became effective immediately upon filing with the U.S. Securities and Exchange Commission on June 16, 2023, or the Registration Statement.
Current wording
On August 22, 2025, we entered into an Amended and Restated Open Market Sale Agreement, or the 2025 Sale Agreement, with Jefferies with respect to an “at the market” offering program. Under the terms of the 2025 Sale Agreement, we may, from time to time, in our sole discretion, issue and sell up to $350.0 million of shares of our common stock pursuant to the “at the market” offering program. The 2025 Sale Agreement superseded and replaced in its entirety the 2023 Sale Agreement. The issuance and sale, if any, of shares of our common stock under the Sale Agreement was or will be made pursuant to a prospectus supplement dated August 22, 2025 to our Registration Statement on Form S-3ASR, which became effective immediately upon filing with the SEC on June 16, 2023, or the Registration Statement.
Previous wording
Through the three months ended March 31, 2026, we received $98.5 million in proceeds, net of offering costs, through the sale of 24,918,834 shares of our common stock under the 2025 Sale Agreement.
Current wording
For the quarter ended June 30, 2026, we received $49.6 million in proceeds, net of offering costs, through the sale of 14,000,743 shares of our common stock under the 2025 Sale Agreement.
Previous wording
Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the three months ended March 31, 2026 was $72.1 million as compared to $103.7 million for the same period in 2025. The $31.6 million decrease in cash used in operating activities was driven by a $37.1 million decrease in net loss resulting from an increase in revenues generated by sales of Amtagvi® and Proleukin®. The overall decrease in cash used in operating activities also includes a net decrease in non-cash charges of $10.1 million. The net decrease in non-cash charges was primarily driven by lower stock-based compensation expenses, and lower amortization of right-of-use assets related to operating leases, partially offset by a decrease in deferred tax benefits related to the operations in the UK, amortization of intangible assets and accretion of discounts and amortization of premiums on investments, net. In addition, net cash used in operating activities decreased by $4.6 million, primarily related to changes in operating assets and liabilities.
Current wording
Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the six months ended June 30, 2026 was $132.9 million as compared to $171.1 million for the same period in 2025. The $38.2 million decrease in cash used in operating activities was driven by a $101.5 million decrease in net loss resulting from an increase in revenues generated by sales of Amtagvi® and Proleukin®. The overall decrease in cash used in operating activities also includes a net decrease in non-cash charges of $23.2 million. The net decrease in non-cash charges was primarily driven by lower stock-based compensation expenses, and lower amortization of right-of-use assets related to operating leases, an increase in deferred tax benefits related to the operations in the UK and excess and obsolescence costs, offset by amortization of intangible assets, and accretion of discounts and amortization of premiums on investments, net. In addition, net cash used in operating activities increased by $40.1 million, primarily related to changes in operating assets and liabilities.
Previous wording
The $4.6 million decrease in net cash used in operating activities related to changes in operating assets and liabilities was driven by a $2.3 million decrease in trade accounts receivable, resulting from the collection of cash from the sale of our products, a net $9.5 million decrease in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments, and a $11.8 million decrease in net cash used driven primarily by purchases of inventory and an increase in prepaid expenses and other assets that resulted from the timing of related payments.
Current wording
The $40.1 million increase in net cash used in operating activities related to changes in operating assets and liabilities was driven by a $29.1 million increase in trade accounts receivable, resulting from the sale of our products, a net $30.5 million decrease in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments, offset by a $19.5 million decrease in net cash used driven primarily by purchases of inventory and an decrease in prepaid expenses and other assets that resulted from the timing of related payments.
Previous wording
Net cash provided by investing activities for the periods presented primarily relates to the cash utilized to fund the purchase and maturity of investments, capital expenditures as well as the Acquisition. Net cash provided by investing activities for the three months ended March 31, 2026 was $11.4 million, compared to net cash provided by investing activities of $15.9 million for the same period in
Current wording
Net cash used or provided by investing activities for the periods presented primarily relates to the cash utilized to fund the purchase and maturity of investments, and capital expenditures. Net cash used by investing activities for the six months ended June 30, 2026 was $62.7 million, compared to net cash provided by investing activities of $29.7 million for the same period in 2025. The increase in cash used of $92.4 million was primarily driven by a $94.0 million increase associated with changes in the timing of maturities and purchases of investments, offset by a decrease in capital expenditures of $1.6 million.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2026, was $94.3 million compared to net cash provided of $143.3 million for the same period in 2025. The decrease in net cash provided by financing activities of $49.0 million was primarily driven by a decrease in net proceeds of $50.5 million received through the sales of common stock through our “at the market” offering program during the three months ended March 31, 2026, as compared to the net proceeds received from our “at the market” offering program for the same period in 2025. In addition, a $1.5 million increase from tax payments related to shares withheld for vested restricted stock units contributed to the overall decrease in cash provided by financing activities.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2026, was $143.6 million compared to net cash provided of $156.5 million for the same period in 2025. The decrease in net cash provided by financing activities of $12.9 million was primarily driven by a decrease in net proceeds of $13.9 million received through the sales of common stock through our “at the market” offering program during the six months ended June 30, 2026, as compared to the net proceeds received from our “at the market” offering program for the same period in 2025. This was offset by a $0.8 million decrease in tax payments related to shares withheld for vested restricted stock units, and a $0.2 million increase in proceeds from the issuance of common stock upon the exercise of stock options and from our employee stock purchase plan program.
Previous wording
If the assets acquired do not constitute a business, we account for asset acquisitions using the cost accumulation and allocation method. Under this method, the cost of the acquisition, including direct acquisition-related costs, is allocated to the assets acquired on a relative fair value basis. Goodwill is not recognized in an asset acquisition and any difference between consideration transferred and the fair value of the net assets acquired is allocated to the identifiable assets acquired based on their relative fair values.
Current wording
If the assets acquired do not constitute a business, we account for asset acquisitions using the cost accumulation and allocation method. Under this method, the cost of the acquisition, including direct acquisition-related costs, is allocated to the assets acquired on
Previous wording
We recognize revenue from product sales in accordance with ASC 606,Revenue from Contracts with Customers. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable
Current wording
We recognize revenue from product sales in accordance with ASC 606,Revenue from Contracts with Customers. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience, as well as applicable information currently available.
Previous wording
Revenue is reduced at the time of recognition for expected chargebacks, discounts, rebates, and sales allowances, collectively referred to as gross to net adjustments, or GTN adjustments. In the U.S., these GTN adjustments are attributable to various commercial arrangements and government programs. In addition, non-U.S. government programs may include different pricing schemes such as cost caps and volume discounts. Cash discounts are recorded as a reduction to receivables and settled through the issuance of credits, typically within one month. All other GTN adjustments are recorded as a liability and settled through cash payments to the customer.
Current wording
Revenue is reduced at the time of recognition for expected chargebacks, discounts, rebates, and sales allowances, collectively referred to as gross to net adjustments, or GTN adjustments. In the U.S., these GTN adjustments are attributable to various commercial arrangements and government programs. In addition, non-U.S. government programs may include different pricing schemes such as cost caps and volume discounts. Cash discounts are recorded as a reduction to receivables and settled through the
Previous wording
Significant judgment is required in estimating GTN adjustments considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix, current contract prices under applicable programs, processing time lags and inventory levels in the distribution channel.
Current wording
Judgment is required in estimating GTN adjustments considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix, current contract prices under applicable programs, processing time lags and inventory levels in the distribution channel.
Previous wording
We make judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or other outside service provider, the payments are recorded within prepaid expenses and other current assets and subsequently recognized as research and development expense when the associated services have been performed. As
Current wording
We make judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or other outside service provider, the payments are recorded within prepaid expenses and other current assets and subsequently recognized as research and development expense when the associated services have been performed. As actual costs become known, we adjust our estimates, liabilities and assets. Inputs used in our determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.
Rearranged current paragraphs (10)
Current report — wording carried from elsewhere
cell therapy and manufacturing; stable and transient genetically-modified TIL cell therapies, including genetic knockouts of immune checkpoints; cytokine-tethered TIL cell therapies; methods of using immune checkpoint inhibitor, or ICIs, in combination with TIL cell therapies; TIL selection technologies; and methods of treating patient subpopulations.
Current report — wording carried from elsewhere
costs, number of sites included in the trial, discontinuation rates of patients, duration of patient follow-up, efficacy and safety profile of the product candidate, and the length of time required to enroll eligible patients.
Current report — wording carried from elsewhere
Cost of sales, excluding depreciation and amortization, for the six months ended June 30, 2026 decreased by $5.5 million, or 6%, compared to the same period in 2025. The decrease was driven by (i) a $9.2 million decrease in period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi® treatment, as well as manufacturing results that did not meet required specifications, and were not otherwise utilized under an expanded access program or single-patient IND to generate clinical data and (ii) a $5.3 million decrease in excess and obsolescence reserve supported by the increased demand. These decreases were partially offset by (i) a $6.6 million increase from sales of Amtagvi® and Proleukin® products as well as costs related to the manufacturing of Amtagvi® and (ii) a $2.4 million increase in royalties payable related to the increase in sales of Proleukin.
Current report — wording carried from elsewhere
Research and development expenses for the six months ended June 30, 2026 decreased by $32.6 million, or 21%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $12.1 million decrease in outside services cost driven by a decrease in the number of consultants, (ii) a $9.4 million decrease in clinical trial costs, driven primarily by completion of 144-01 and
Current report — wording carried from elsewhere
144-05 clinical trials as well as other ongoing studies advancing into a late-stage of clinical trials, (iii) a $7.1 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, (iv) a $2.4 million decrease in other costs, including travel and license cost, and (v) a $1.6 million decrease in manufacturing fees, primarily due to the contract termination with our external contract manufacturer.
Current report — wording carried from elsewhere
Selling, general, and administrative expenses for the six months ended June 30, 2026 decreased by $3.1 million, or 4%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $6.8 million decrease in stock-based compensation expense primarily driven by a lower number of stock awards granted at lower average stock price, and (ii) a $2.2 million decrease in intellectual property legal costs. These decreases were partially offset by (i) a $4.6 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business, (ii) a $1.0 million increase in costs incurred in support of the marketing, advertising, and market research in rest of world of Amtagvi®, and (iii) a $0.3 million increase in other costs, including travel, facility fees and licensing costs.
Current report — wording carried from elsewhere
Interest and other income, net for the six months ended June 30, 2026 decreased by $2.8 million, or 38%, compared to the same period in 2025. The decrease was primarily driven by a decrease in average investment balances and slightly lower rate of return on our investments.
Current report — wording carried from elsewhere
As of June 30, 2026, we had $303.7 million in cash, cash equivalents, short-term investments, and restricted cash ($110.8 million of cash and cash equivalents, $186.9 million in short-term investments, and $6.0 million in restricted cash). We have incurred
Current report — wording carried from elsewhere
a relative fair value basis. Goodwill is not recognized in an asset acquisition and any difference between consideration transferred and the fair value of the net assets acquired is allocated to the identifiable assets acquired based on their relative fair values.
Current report — wording carried from elsewhere
issuance of credits, typically within one month. All other GTN adjustments are recorded as a liability and settled through cash payments to the customer.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
The currentiCTC facility has the potential capacity to supply TIL cell therapies for more than 5,000 cancer patients annually. To utilize our internal manufacturing suites at greater scale, improve gross margin and reduce operating expenses, we transitioned all
Previous report — wording carried elsewhere
All remaining research and development expenses are categorized as indirect research and development expenses. Such indirect research and development expenses include employee salaries and benefits, stock-based compensation, consulting and contracted
Previous report — wording carried elsewhere
common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.
Previous report — wording carried elsewhere
The decrease in cash provided of $4.5 million was primarily driven by a $4.1 million decrease associated with changes in the timing of maturities and purchases of investments.
Previous report — wording carried elsewhere
consideration, we estimate the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience, as well as applicable information currently available.
Previous report — wording carried elsewhere
actual costs become known, we adjust our estimates, liabilities and assets. Inputs used in our determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.