IOVANCE BIOTHERAPEUTICS, INC.

Previous wording

We are a commercial-stage biopharmaceutical company pioneering a transformational approach to treating cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells using therapies personalized for each patient. Our mission is to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte, or TIL, cell therapies for patients with solid tumor cancers. We are executing the U.S. launch of Amtagvi® (lifileucel), the first product within our autologous TIL cell therapy platform, while also marketing Proleukin® (aldesleukin), an interleukin-2, or IL-2, product used in the Amtagvi® treatment regimen and in other applications. Amtagvi® is the first and the only one-time, individualized T cell therapy to receive U.S. Food and Drug Administration, or the FDA, approval for a solid tumor cancer. Amtagvi® is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication was approved in February 2024 under accelerated approval based on an endpoint of overall response rate, or ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in future confirmatory trials. Amtagvi® and Proleukin® are part of a treatment regimen that also includes lymphodepletion.

Current wording

We are a commercial-stage biopharmaceutical company pioneering a transformational approach to treating cancer. Our mission is to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte, or TIL, cell therapies for patients with solid tumor cancers. TIL cell therapies harness the individual immune system’s ability to recognize and destroy diverse cancer cells that are unique to each patient. These individualized therapies are manufactured using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply each patient’s polyclonal T cells into the billions.

Previous wording

Iovance was founded to build upon the promise of TIL cell therapy that was previously demonstrated in single-center clinical trials at academic research centers, including the National Cancer Institute, or the NCI. Our multi-center trials, novel TIL cell therapy products, manufacturing processes, facilities, and bioanalytical platforms have transformed TIL cell therapy into a commercially viable treatment which thousands of patients with cancer can access.

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.

Previous wording

Beyond the U.S., we plan to launch Amtagvi® into additional markets with a high prevalence of advanced melanoma, including Canada, the United Kingdom, or UK, Australia, Switzerland, and the European Union, or EU. In August 2025, Health Canada issued a Notice of Compliance with Conditions, or NOC/c, authorizing Amtagvi® for the treatment of advanced melanoma after anti-PD-1 and targeted therapy. Australia’s Therapeutic Goods Administration granted Priority Review to Amtagvi® with a decision anticipated in the first half of 2026, and a submission is planned to Swiss Medic in the fourth quarter of 2025, with potential approval in Switzerland anticipated in 2027. In June 2024, we submitted a centralized marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for lifileucel which was accepted for review in August 2024. Following interactions with EMA’s Committee for Medicinal Products for Human Use, or CHMP, Iovance notified EMA of its decision to withdraw the MAA in July 2025 and is working to determine a resubmission strategy. An MAA was submitted to the Medicines and Healthcare Products Regulatory Agency in the UK and is on track for potential approval and launch in the first half of 2026. Across the U.S. and other targeted global markets, Amtagvi® has the potential to address more than 30,000 previously treated advanced melanoma patients annually.

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. 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.

Previous wording

Our mission is to be the global leader in innovating, developing, and delivering TIL cell therapy for patients with solid tumor cancers. We are pioneering this transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. As we continue to execute the U.S. launch of Amtagvi® and advance our pipeline, we are committed to continuous innovation to develop TIL cell therapies and optimize TIL treatment regimens that may extend and improve life for patients with cancer.

Current wording

Our mission is to be the global leader in innovating, developing, and delivering TIL cell therapy. Our vision is to pioneer this transformational approach to cure solid tumor cancers. We are committed to continuous innovation to develop TIL cell therapies and optimize TIL treatment regimens that may extend and improve life for patients with cancer.

Previous wording

Amtagvi® (lifileucel) was approved by the FDA on February 16, 2024, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The approval is based on safety and efficacy results from the C-144-01 clinical trial, a global, multicenter trial investigating Amtagvi® in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable.

Current wording

Amtagvi®is indicated for the treatment of adult patients with advanced melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The U.S. accelerated approval of Amtagvi®is based on safety and efficacy results from the C-144-01 global, multicenter clinical trial. A global, randomized Phase 3 confirmatory trial, TILVANCE-301, is investigating Amtagvi®in combination with pembrolizumab in frontline advanced melanoma.

Previous wording

Proleukin® (aldesleukin) is an IL-2 product used in the Amtagvi® treatment regimen and manufacturing process, as well as other commercial, clinical, manufacturing, and research settings, which provides additional revenue. In May 2023, we acquired the worldwide rights to Proleukin® as well as the manufacturing, supply, and commercialization income generated from such rights and associated operations from Clinigen Holdings Limited, Clinigen Healthcare Limited, and Clinigen, Inc, which we refer to collectively as Clinigen. Ownership of Proleukin® provides an additional revenue source, secures our Proleukin® supply chain, lowers cost of goods, and reduces clinical trial expenses for Proleukin® used with our TIL cell therapies.

Current wording

In May 2023, we acquired the worldwide rights to Proleukin®from Clinigen Holdings Limited, Clinigen Healthcare Limited, and Clinigen, Inc., which we refer to collectively as Clinigen.

Previous wording

Manufacturing capacity for forecasted commercial and clinical demand

Current wording

Scalable TIL manufacturing for commercial and clinical demand

Previous wording

TIL** Cell **Therapy Clinical Development in Advanced, Metastatic or Unresectable Solid Tumor Cancers

Current wording

TIL** Cell **Therapy Platforms for Advanced, or Metastatic or Unresectable, Solid Tumor Cancers

Previous wording

Our TIL cell therapy platform and manufacturing process have been initially validated through the FDA approval of Amtagvi®. TIL cell therapy is a T cell-based immunotherapy technology platform that leverages patient-specific cells to recognize and attack diverse cancer cells that are unique to each patient. Unlike other cell therapies that act on a single or small number of shared antigen

Current wording

Our T cell-based immunotherapy technology platform of TIL cell therapies leverages patient-specific cells to recognize and attack diverse cancer cells that are unique to each patient. We believe this approach is the emerging backbone for immuno-oncology approaches to treat solid tumor cancers.

Previous wording

We have investigated TIL cell therapy in global, multicenter clinical trials in advanced melanoma, cervical cancer, endometrial cancer, non-small cell lung cancer, or NSCLC, and head and neck squamous cell carcinoma, or HNSCC. Through ongoing academic collaborations, as well as government and other partners, we are investigating the next frontier for TIL cell therapy in other tumor types and treatment settings.

Current wording

We have investigated TIL cell therapy in global, multicenter Iovance-sponsored clinical trials in various treatment settings for patients with advanced melanoma, NSCLC, cervical cancer, endometrial cancer, and head and neck squamous cell carcinoma, or HNSCC. Through ongoing academic collaborations, as well as government and other partners, we are investigating additional solid tumor types and treatment settings. We have provided prior or ongoing support for investigator-sponsored clinical trials for patients with soft tissue sarcoma, osteosarcoma, pancreatic and colorectal cancer, platinum resistant ovarian cancer, anaplastic thyroid cancer, and triple negative breast cancer.

Previous wording

Our next-generation technology platforms are designed to optimize outcomes with TIL cell therapy across three key initiatives: genetic modifications, potency, and new treatment regimens.

Current wording

Applying our expertise in TIL cell therapy, our next-generation technology platforms are designed to optimize outcomes with TIL cell therapy across three key initiatives: genetic modifications, potency, and new treatment regimens using an improved IL-2.

Previous wording

We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 90 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; and 12,343,380. More than 45 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; 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.

Previous wording

Revenues for the three and nine months ended September 30, 2025 represent 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

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.

Previous wording

Amtagvi® revenue is recognized upon patient infusion, while Proleukin® revenue is recognized upon shipment or delivery to customers, which include specialty distributors, clinical manufacturers, research organizations, and ATCs. 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 include different pricing schemes such as cost caps and volume discounts.

Current wording

Amtagvi® revenue is recognized upon patient infusion, while Proleukin® revenue is recognized upon shipment or delivery to customers, which include specialty distributors, clinical manufacturers, research organizations, and ATCs. 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.

Previous wording

In the event that the manufactured product does not meet specifications, or a patient is unable to receive the infusion, the Amtagvi® product is generally destroyed and the costs associated with manufacturing and inventory associated with the product is generally required to be expensed as cost of sales. However, if the out-of-specifications product can be administered as part of a clinical trial, in an expanded or early access program, or single-patient IND, as requested by the treating physician, the costs of the product are recorded as research and development expense based on the fact that we receive clinical data related to these infusions.

Current wording

In the event that the manufactured product does not meet specifications, or a patient is unable to receive the infusion, the Amtagvi® product is generally destroyed and the costs associated with manufacturing and inventory associated with the product is generally required to be expensed as cost of sales. However, if the out-of-specifications product can be administered as part of a clinical trial, in an expanded or early access program, or single-patient investigational new drug submission, as requested by the treating physician, the costs of the product are recorded as research and development expense based on the fact that we receive clinical data related to these infusions.

Previous wording

The manufacturing process for Amtagvi® is highly complex and subject to stringent FDA guidelines and requirements, as well as internal specifications and quality guidelines. Our ability to successfully manufacture Amtagvi® and deliver finished product to ATCs for infusion into patients is dependent on several factors, including patient selection and quality of tumors provided by the treatment centers for use in the manufacturing of Amtagvi®. We focus significant effort and attention on working with the treatment centers during the onboarding process regarding these matters, as well as on our internal manufacturing processes.

Current wording

The manufacturing process for Amtagvi® is highly complex and subject to stringent FDA guidelines and requirements, as well as internal specifications and quality guidelines. Our ability to successfully manufacture Amtagvi® and deliver finished product to ATCs for infusion into patients is dependent on several factors, including patient selection and quality of tumors provided by the treatment centers for use in the manufacturing of Amtagvi®. We focus significant effort and attention on working with the treatment centers regarding these matters, as well as on our internal manufacturing processes.

Previous wording

We expect to continue to incur research and development expenses for the foreseeable future as we continue to conduct our clinical trials for our various product candidates. We expect our research and development expenses to decrease in conjunction with an expected increase in commercial activities and selling, general, and administrative expense due to the approval of Amtagvi®. However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates.

Current wording

We expect to continue to incur research and development expenses for the foreseeable future as we continue to conduct our clinical trials for our various product candidates. However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates.

Previous wording

We anticipate selling, general, and administrative expenses will increase as we execute the launch of Amtagvi® and market Proleukin®, as well as execute an expected expansion in the U.S. market and outside of the U.S. of the internal general and administrative team to support the overall growth in our business.

Current wording

We anticipate selling, general, and administrative expenses will increase as we expand the use of Amtagvi® and market Proleukin®, as well as expected growth in the internal general and administrative team to align with the overall growth in the business as we execute an expected expansion in both the U.S. market and outside of the U.S.

Previous wording

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

Current wording

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

Previous wording

Results of Operations for the Three and Nine Months Ended September 30, 2025 and 2024

Current wording

Results of Operations for the Three Months Ended March 31, 2026 and 2025

Previous wording

As it relates to revenue timing for our products, Amtagvi® infusions are expected to lag behind Amtagvi® related Proleukin®sales by 2-3 months, and we expect ATCs to utilize 15-18 Proleukin® vials per Amtagvi® infusion. While such Proleukin® sales are not directly indicative of future Amtagvi® revenues because of the timing of stocking activities by specialty distributors and because of sales that are not related to Amtagvi® infusions, such as sales of Proleukin®utilized in clinical manufacturing or clinical trials, such sales are one indicator of future Amtagvi® revenues.

Current wording

As it relates to revenue timing for our products, Amtagvi® infusions are expected to lag behind Amtagvi® related Proleukin® sales by 2-3 months, and we expect ATCs to utilize approximately 15 Proleukin®vials per Amtagvi® infusion. While such Proleukin® sales are not directly indicative of future Amtagvi® revenues because of the timing of stocking activities by specialty distributors and because of sales that are not related to Amtagvi® infusions, such as sales of Proleukin® utilized in clinical manufacturing or clinical trials, such sales are one indicator of future Amtagvi® revenues.

Previous wording

Cost of sales excluding depreciation and amortization for the three months ended September 30, 2025 increased by $7.0 million, or 22%, compared to the same period in 2024. The increase was driven by (i) a $7.1 million increase from sales of Amtagvi® products as well as costs related to the manufacturing of Amtagvi®, (ii) a $0.9 million increase in excess and obsolescence reserve primarily related to excess Amtagvi® inventory, and (iii) a $0.6 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. These increases were partially offset by (i) a $1.6 million decrease in royalties payable related to the decrease in sales of Proleukin®.

Current 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.

Previous 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.

Current 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.

Previous wording

Selling, general and administrative expenses for the three months ended September 30, 2025 decreased by $4.8 million, or 12%, compared to the same period in 2024. The decrease was primarily attributable to (i) a $8.7 million decrease in stock-based compensation driven by the number of stock awards granted at lower average stock price and reduction in workforce effected in the third quarter of 2025, and (ii) a $1.0 million decrease in other costs, including costs associated with intellectual property legal costs, partially offset by increased travel, software license costs related to the expansion of our information technology infrastructure. This decrease was partially offset by (i) a $2.5 million increase in costs incurred in support of the marketing, advertising, and market research in rest of world of Amtagvi®, (ii) a $2.4 million increase in payroll and related expenses driven by an increase in the number of employees, prior to the reduction in workforce, to support growth in the overall business.

Current 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.

Previous wording

Interest income, net, for the nine months ended September 30, 2025 decreased by $2.1 million, or 20%, compared to the same period in 2024. The decrease was primarily driven by a decrease in average investment balances and interest rates.

Current 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.

Previous wording

Income tax benefit for the three months ended September 30, 2025 increased by $0.9 million or 58%, compared to the same period in 2024. The increase was mainly driven by the mix of income across jurisdictions that have varying effective tax rates. Income tax benefit for the nine months ended September 30, 2025 decreased by $2.1 million, or 49%, compared to the same period in 2024. 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 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.

Previous wording

the overall growth in our workforce and corporate infrastructure to support the ongoing launch of Amtagvi® in the U.S., along with anticipated expansion in additional markets, continued growth in sales of Proleukin®, and ongoing and newly initiated clinical trials. 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 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®.

Previous wording

As of September 30, 2025, we had $306.8 million in cash, cash equivalents, short-term investments, and restricted cash ($158.1 million of cash and cash equivalents, $142.7 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

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.

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 nine months ended September 30, 2025 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 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.

Previous wording

As of September 30, 2025, we had outstanding 385,461,728 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 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

Previous wording

On June 16, 2023, we entered into a new Open Market Sale Agreement, or the 2023 Sale Agreement, with Jefferies with respect to an “at the market” offering program. Under the terms of the 2023 Sale Agreement, we were able to, from time to time, in our sole discretion, issue and sell up to $450.0 million of shares of our common stock pursuant to the “at the market” offering program. The 2023 Sale Agreement superseded and replaced in its entirety the 2022 Sale Agreement, which was terminated by the Company. The issuance and sale, if any, of shares of our common stock under the 2023 Sale Agreement was or will be made pursuant to a prospectus supplement dated June 16, 2023 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. 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

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 U.S. Securities and Exchange Commission on June 16, 2023, or the Registration Statement.

Previous wording

June 16, 2023, or the Registration Statement. We received $250.5 million in proceeds, net of offering costs, through the sale of 76,145,523 shares of our common stock cumulatively through September 30, 2025 under the 2023 and 2025 Sale Agreements.

Current 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.

Previous wording

The following table summarizes our cash flows for the periods indicated (in thousands):

Current wording

The following table summarizes our cash flows from operating, investing and financing activities for the periods indicated (in thousands):

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 nine months ended September 30, 2025 was $249.8 million as compared to $279.7 million for the same period in 2024. The $29.9 million decrease in cash used in operating activities was driven by a $25.5 million increase in net loss resulting from increased cost of sales to support our business, partially offset by an increase in revenues generated by sales of Amtagvi® and Proleukin®. The increase in net loss was offset by a net decrease in non-cash charges of $11.3 million. The net decrease in non-cash was primarily driven by lower stock-based compensation expenses, offset by excess and obsolescence costs, a decrease in deferred tax benefits related to the operations in the UK, amortization of intangible assets and right-of-use assets related to operating leases, and accretion of discounts and amortization of premiums on investments, net. In addition, net cash used in operating activities decreased by $66.6 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 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.

Previous wording

The $66.6 million decrease in net cash used in operating activities related to changes in operating assets and liabilities was driven by a $58.2 million decrease in trade accounts receivable, resulting from the collection of cash from the sale of our products, a $3.3 million increase in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments, and a $5.1 million decrease in net cash driven primarily by purchases of inventory in support of the commercial demand of Amtagvi®, and an increase in prepaid expenses and other assets in the current period compared to the corresponding period in 2024 that resulted from the timing of related payments, as well as the receipt of cash for other miscellaneous receivables.

Current 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.

Previous wording

Net cash provided by (used in) 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 nine months ended September 30, 2025 was $46.7 million, compared to net cash used by investing activities of $120.1 million for the same period in 2024. The increase in cash provided of $166.8 million was driven by a $131.8 million increase associated with changes in the timing of maturities and purchases of investments, and a $52.6 million decrease in cash used for the Acquisition, net of cash

Current 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

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $244.6 million compared to net cash provided of $388.4 million for the same period in 2024. The decrease in net cash provided by financing activities of $143.8 million was primarily driven by a decrease in net proceeds of $146.8 million received through the sales of common stock through our “at the market” offering program during the nine months ended September 30, 2025, as compared to the net proceeds received from our public offering in February 2024 in the first quarter of 2024 and “at the market” offering program for the nine months ended September 30, 2024. In addition, a $2.4 million decrease in proceeds from the issuance of common stock upon the exercise of stock options and from our employee stock purchase plan program and a $5.4 million increase in 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 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.

Previous wording

Our accounting policies are more fully described in Note 2 of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. As described in Note 2, the preparation of our condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be

Current wording

Our accounting policies are more fully described in Note 2 of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. As described in Note 2, the preparation of our condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

We review intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, we measure the amount of impairment by comparing the carrying value of the assets to their fair values. We determined that no indicators of impairment existed as of September 30, 2025. No impairment of intangible assets existed as of September 30, 2025.

Current wording

We review intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, we assess the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, we measure the amount of impairment by comparing the carrying value of the assets to their fair values. We determined that no indicators of impairment or impaired intangible assets existed as of March 31, 2026.

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 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.

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