IOVANCE BIOTHERAPEUTICS, INC.

Previous wording

Iovance was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute, or the NCI. Our multi-center trials, scalable manufacturing, regulatory approvals and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients into a commercially viable treatment that is accessible for thousands of cancer patients.

Current wording

Iovance was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute, or the NCI. Our multi-center trials, scalable manufacturing, regulatory approvals and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients into a commercially viable treatment that is accessible for thousands of cancer patients globally.

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. 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.

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 in the first quarter of 2027. Potential approval is pending in Switzerland in the first quarter of 2027. In the European Union, or EU, we are working with the European Medicines Agency, or EMA, to resubmit a centralized MAA in 2027.

Previous wording

To date, more than 1,500 patients have been treated with commercial and investigational TIL cell therapies manufactured using Iovance processes. The Iovance Cell Therapy Center, oriCTC, in Philadelphia, Pennsylvania is the first FDA-approved facility to manufacture commercial TIL cell therapy. We believe that theiCTC is the only current Good Manufacturing Practice, or cGMP, facility with a centralized, scalable TIL manufacturing process. Facilitated by its proximity to multiple airports, theiCTC covers logistics and delivery of TIL cell therapies to treatment centers in North America, Europe, and Asia Pacific.

Current wording

To date, more than 2,000 patients have been treated with commercial and investigational TIL cell therapies manufactured using Iovance processes. The Iovance Cell Therapy Center, ori CTC, in Philadelphia, Pennsylvania is the first FDA-approved facility to manufacture commercial TIL cell therapy. We believe that thei CTC is the only current Good Manufacturing Practice, or cGMP, facility with a centralized, scalable TIL manufacturing process. Facilitated by its proximity to multiple airports, thei CTC covers logistics and delivery of TIL cell therapies to treatment centers in North America, Europe, and Asia Pacific.

Previous 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.

Current wording

The currenti CTC 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 thei CTC 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 September 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; 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

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; 12,678,499; and 12,767,928. 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 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.

Previous 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.

Current wording

Revenues for the three and nine months ended September 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

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 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.

Previous wording

Income tax benefit pertains to the operations in the UK and realization of related deferred taxes.

Current wording

Income tax (expense) benefit pertains to the operations in the UK and realization of related deferred taxes.

Previous 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.

Current wording

Revenue for the three and nine months ended September 30, 2026 increased by $54.0 million, or 80%, and by $115.5 million, or 65%, 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 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.

Current wording

Cost of sales, excluding depreciation and amortization, for the three months ended September 30, 2026 increased by $9.6 million, or 25%, compared to the same period in 2025. The increase was driven by (i) a $6.7 million increase from sales of Amtagvi® and Proleukin® products as well as costs related to the manufacturing of Amtagvi®, (ii) a $2.4 million increase in royalties payable related to the increase in sales of Proleukin, and (iii) a $1.4 million increase 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 increase was partially offset by a $0.9 million decrease in excess and obsolescence charges recorded in the three months ended September 30, 2025, with no comparable charges recorded during the three month period ended September 30, 2026.

Previous wording

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 wording

Cost of sales, excluding depreciation and amortization, for the nine months ended September 30, 2026 increased by $4.0 million, or 3%, compared to the same period in 2025. The increase was driven by (i) a $13.3 million increase from sales of Amtagvi® and Proleukin® products as well as costs related to the manufacturing of Amtagvi®, and (ii) a $4.7 million increase in royalties payable related to the increase in sales of Proleukin. These increases were partially offset by (i) a $7.8 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 $6.2 million decrease in excess and obsolescence charges as compared to the same period in 2025.

Previous 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.

Current wording

Research and development expenses for the nine months ended September 30, 2026 decreased by $58.4 million, or 25%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $19.6 million decrease in clinical trial costs, driven primarily due to the completion of melanoma and cervical clinical trials and the progression of other ongoing studies advancing into later stages of development, (ii) a $16.1 million decrease in manufacturing fees, primarily driven by lower clinical manufacturing volume resulting from reduced clinical activity, and lower external contract manufacturing costs, (iii) a $16.0 million decrease in outside services cost, driven by a reduction in the number of consultants, and (iv) a $6.3 million net decrease in stock-based compensation expense primarily due to the non-recurrence of expense related to special awards granted in March 2024, and (v) a $0.4 million decrease in other costs.

Previous 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.

Current wording

Selling, general, and administrative expenses for the three months ended September 30, 2026 increased by $4.0 million, or 12%, compared to the same period in 2025. The increase was primarily attributable to (i) a $3.7 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business, and (ii) a $0.4 million increase in other costs. This increases were partially offset by a $0.1 million decrease in stock-based compensation expense primarily due to fewer equity awards granted at a lower average stock price.

Previous wording

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 wording

Selling, general, and administrative expenses for the nine months ended September 30, 2026 increased by $0.9 million, or 1%, compared to the same period in 2025. The increase was primarily attributable to (i) a $8.3 million increase in payroll and related expenses driven by an increase in the number of employees to support growth in the overall business and (ii) a $1.8 million increase in costs incurred in support of the marketing, advertising, and market research to support Amtagvi®in markets outside of the United States. These increases were partially offset by (i) a $6.9 million decrease in stock-based compensation expense primarily due to fewer equity awards granted at a lower average stock price, (ii) a $1.9 million decrease in intellectual property legal costs and (iii) a $0.4 million decrease in other costs.

Previous 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.

Current wording

Depreciation and amortization expense for the three and nine months ended September 30, 2026 increased by $0.5 million, or 5% and increased by $1.1 million, or 4%, compared to the same period in 2025. The increase was primarily driven by the expansion of ouri CTC manufacturing facility.

Previous wording

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 wording

Interest and other income, net for the three months ended September 30, 2026 increased by $1.1 million, or 86%, compared to the same period in 2025. The increase was primarily driven by an increase in average investment balances and a slightly higher rate of return on our investments.

Previous 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.

Current wording

Interest and other income, net for the nine months ended September 30, 2026 decreased by $1.7 million, or 20%, 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

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®.

Current wording

Net loss for the three and nine months ended September 30, 2026 decreased by $69.0 million, or 76%, and $170.4 million, or 53%, 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 and a decrease in our overall spend, as we continue to streamline our operations. 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

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.

Current wording

As of September 30, 2026, we had $382.3 million in cash, cash equivalents, short-term investments, and restricted cash ($57.9 million of cash and cash equivalents, $318.4 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 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 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.

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 nine months ended September 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 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.

Current wording

As of September 30, 2026, we had outstanding 462,543,386 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 SEC 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 were able to issue and sell, from time to time in our sole discretion, up to $350.0 million of shares of our common stock pursuant to the “at the market” offering program.

Previous 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.

Current wording

For the quarter ended September 30, 2026, we received $87.9 million in proceeds, net of offering costs, through the sale of 8,666,654 shares of our common stock under the 2025 Sale Agreement. As of September 30, 2026, the 2025 Sale Agreement terminated upon the issuance and sale of all Common Shares subject to 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 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.

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 nine months ended September 30, 2026 was $137.4 million as compared to $249.8 million for the same period in 2025. The $112.4 million decrease in cash used in operating activities was driven by a $170.4 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 $22.9 million. The net decrease in non-cash charges was primarily driven by lower stock-based compensation expenses, lower amortization of right-of-use assets related to operating leases, a decrease 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 $35.1 million, primarily related to changes in operating assets and liabilities.

Previous 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.

Current wording

The $35.1 million increase in net cash used in operating activities related to changes in operating assets and liabilities was driven by a $27.1 million increase in trade accounts receivable, resulting from the sale of our products, a net $29.6 million decrease in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments, offset by a $21.6 million decrease in net cash used driven primarily by purchases of inventory and a decrease in prepaid expenses and other assets that resulted from the timing of related payments.

Previous 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.

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 nine months ended September 30, 2026 was $197.3 million, compared to net cash provided by investing activities of $46.7 million for the same period in 2025. The increase in cash used of $244.0 million was primarily driven by a $251.6 million increase associated with changes in the timing of maturities and purchases of investments, and a $0.1 million associated to an increase in the purchase of intangible assets, offset by a decrease in capital expenditures of $7.7 million.

Previous 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.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026, was $229.9 million compared to net cash provided of $244.6 million for the same period in 2025. The decrease in net cash provided by financing activities of $14.7 million was primarily driven by a decrease in net proceeds of $14.6 million received through the sales of common stock through our “at the market” offering program during the nine months ended September 30, 2026, as compared to the net proceeds received from our “at the market” offering program for the same period in 2025, and a $1.1 million increase in tax payments related to shares withheld for vested restricted stock units, offset by a $1.0 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

We make certain judgments to determine whether transactions should be accounted for acquisitions of assets or business combinations using the guidance in Accounting Standard Codification, or ASC, Topic 805,Business Combinations, by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further assessment is required to determine whether we have acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.

Current wording

We make certain judgments to determine whether transactions should be accounted for acquisitions of assets or business combinations using the guidance in Accounting Standards Codification, or ASC, Topic 805, Business Combinations, by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further assessment is required to determine whether we have acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.

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

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 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.

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

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 issuance of credits, typically within one month. All other GTN adjustments are recorded as a liability and settled through cash payments to the customer.