Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our results of operations and financial condition should be read in conjunction with our financial statements and the notes to those financial statements that are included elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth under the "Business" section and elsewhere in this report. We use words such as "may," "will," "might," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "aim," "potential," "continue," "ongoing," "goal," "forecast," "guidance," "outlook," or the negative of these terms or other similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. All forward-looking statements included in this report are based on information available to us on the date hereof and, except as required by law, we assume no obligation to update any such forward-looking statements.

Overview

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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.

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.

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.

We manufacture Amtagvi^® and our investigational TIL cell therapies using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply polyclonal T cells unique to each patient into the billions and yields a cryopreserved, individualized therapy. Amtagvi^® is manufactured for commercial use at our manufacturing facility, the Iovance Cell Therapy Center, or the iCTC, and by a contract manufacturing organization, or CMO.

Our development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings and indications for solid tumor cancers. To potentially improve outcomes for patients, we are investigating TIL monotherapies for patients previously treated with standard of care therapies and TIL cell therapy in combination with standard of care therapies for patients in earlier treatment settings. We are conducting two ongoing registrational trials to support a supplementary BLA, or sBLA, of lifileucel in

frontline advanced melanoma and in advanced non-small cell lung cancer, or NSCLC, following standard of care chemo-immunotherapy. We are also developing next generation therapies, such as genetically modified TIL cell therapy and next generation cytokines.

Corporate Strategy

A global leader in innovating, developing, and delivering TIL cell therapy

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.

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Successfully commercialize our lead product Amtagvi^®for the treatment of post-anti-PD-1 advanced melanoma in the U.S.

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Following U.S. FDA approval of Amtagvi^® for the treatment of patients with post-anti-PD-1 advanced melanoma on February 16, 2024, our top priority is continuing to leverage our experienced marketing, payer access, and distribution teams, as well as a sales force with extensive experience in oncology and cell therapy for our commercialization efforts. Our medical affairs team is also educating key opinion leaders, or KOLs, about Amtagvi^® and TIL cell therapy, as well as presenting and publishing our clinical results.

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We are focusing ongoing Amtagvi^® commercialization efforts on four primary areas:

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U.S. Commercial Launch of the First TIL Cell Therapy in Advanced Melanoma

Amtagvi^®

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.

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Amtagvi^® is manufactured using a proprietary process to collect and multiply a patient's unique T cells from a portion of their tumor. Amtagvi^® returns billions of the patient's T cells back to the body to fight cancer. Amtagvi^® is administered to patients as part of a treatment regimen that includes lymphodepletion and a short course of high-dose Proleukin^® (aldesleukin).

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There are three key steps in the Amtagvi^® treatment process.

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Prior to the FDA approval of Amtagvi^®, there were no FDA approved therapies for patients with advanced melanoma following anti-PD-1 therapy.

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Proleukin^®

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.

Proleukin^® has received regulatory approvals for treatment of adults with metastatic melanoma and metastatic renal cell carcinoma in the U.S. Proleukin^® is also licensed in multiple countries around the world for treatment of patients with metastatic renal cell carcinoma and/or metastatic melanoma. We also sell aldesleukin for clinical trial use and for use in the manufacturing of various cell and gene therapies to numerous third-party clients.

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Manufacturing capacity for forecasted commercial and clinical demand

We are the first company to obtain FDA approval for a TIL cell therapy product. We believe that we are the only company in the U.S. to have a centralized, scalable, and commercially viable TIL manufacturing process. More than 1,000 patients have been treated with Iovance TIL cell therapy products manufactured using our proprietary processes across multiple indications in clinical trials and the commercial setting. Iovance TIL cell therapies are manufactured for commercial use and clinical trials at our manufacturing facility, the iCTC, and by a CMO. The FDA authorized iCTC for commercial manufacturing of Amtagvi^® as well as our CMO for additional capacity to supplement our internal manufacturing. To better utilize internal capabilities and available manufacturing suites at greater scale and further improve both gross margin and operating expenses, we plan to end production of commercial and clinical products at our contract manufacturer and centralize all manufacturing activities at the iCTC in early 2026. Current capacity at the iCTC is sufficient to treat several thousands of cancer patients annually with commercial product and clinical supply.

The iCTC is the first centralized and scalable current Good Manufacturing Practice, or cGMP, manufacturing facility dedicated to producing TIL cell therapies, as well as the first FDA-approved facility for commercial TIL cell therapy. Located in Philadelphia, Pennsylvania, the 136,000 square foot iCTC is among the largest cell therapy manufacturing facilities globally. The iCTC's flexible design facilitated expansion within an existing shell space, and there is an option to build on an adjacent lot to support future growth and capacity needs. This iCTC expansion provides the opportunity to scale capacity to supply over five thousand patients annually. Our long-term goal is to supply TIL cell therapies to over ten thousand patients per year. The proximity of the iCTC to multiple airports facilitates delivery of TIL cell therapies to treatment centers. The iCTC is expected to cover logistics and delivery of TIL cell therapies in North America, Europe, and Australia. Ownership of our manufacturing facility allows us to control internal manufacturing capacity and product quality, manage supply and delivery logistics, implement process improvement and realize potential cost efficiencies for TIL cell therapies that we may develop and commercialize. We are also exploring next generation TIL cell therapy manufacturing processes, treatments and technologies that may further streamline development timelines and costs.

Transitioning our manufacturing activities into our own facility aligns with our plan to carefully manage our cost structure and reduce the long-term cost of manufacturing our products. Details of related agreements are provided in Note 13 of our condensed consolidated financial statements for the quarter ended September 30, 2024, contained section in this Quarterly Report on Form 10-Q.

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

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

targets common to certain tumors, our individualized T cell therapies are polyclonal or designed to target a variety of neoantigens that are unique to the patient or tumor. We believe this polyclonal cell therapy may be applicable to many solid tumor cancers, where the majority of immune targets are patient-specific.

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.

Next-Generation TIL Therapy Product Candidates

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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.

Intellectual Property

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.

Components of Operating Results

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Revenues

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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.

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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.

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Costs and Expenses

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Cost of sales

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Cost of sales includes cost of inventories sold, including overhead and manufacturing costs of Amtagvi^®, reserves for excess and obsolete inventory, royalties payable on the sales of our products and other costs that are directly associated with the purchase and sales of Proleukin^®.

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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.

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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.

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Research and development expense

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Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs, and other consulting services. Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability.

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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.

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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.

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Selling, general and administrative expense

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Selling, general, and administrative expenses consist primarily of salaries and other related costs, including facility costs not otherwise capitalized in inventory or included in research and development expenses, legal fees relating to corporate matters and intellectual property, insurance, public company expenses relating to maintaining compliance with Nasdaq listing rules and SEC requirements, investor relations costs, and fees for accounting and consulting services. Selling, general, and administrative costs are expensed as incurred, and we accrue for services provided by third parties related to the above expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.

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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.

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Depreciation and amortization

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Depreciation and amortization includes depreciation and amortization expense for the property and equipment as well as non-cash amortization of intangible assets, including amortization expense for the fair value step-up of acquired Proleukin^® inventory which is recognized as the acquired inventory units are sold, the developed technology intangible asset and the milestone payment recorded as part of the Acquisition, and the intellectual property license intangible asset related to Amtagvi^®. These expenses are recorded on a straight-line basis over the estimated useful lives of the assets.

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Restructuring

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Restructuring charges consist primarily of employee severance payments and other postemployment benefit related expenses. The Company records restructuring charges based on whether the termination benefits are provided under an on-going benefit arrangement or under a one-time benefit arrangement. The Company recognizes charges related to restructuring plans when the liabilities have been incurred and can be reasonably estimated.

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Interest and other income, net

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Interest and other income, net is derived from our interest-bearing cash, cash equivalents and investment balances as well as other income associated with non-recurring activities such as lease terminations.

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Income tax (expense) benefit

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

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

Revenue

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Revenue for the three and nine months ended September 30, 2025 increased by $8.9 million, or 15%, and $86.4 million, or 96%, compared to the same periods in 2024. With the BLA approval of Amtagvi^® in February 2024, we began generating revenue for Amtagvi^® in the second quarter of 2024 as infusions occurred at our ATCs, and the increase in revenue compared to the prior period was driven by the commercial launch of Amtagvi^®, partially offset by a decrease in Proleukin^® sales for the same periods in 2025 as compared to 2024 when we experienced significant re-stocking demand from specialty distributors in the U.S. to support ongoing and anticipated infusions followed by the commercial launch of Amtagvi^® and as a result of the depletion Proleukin^® inventory that was previously with distributors at the time of the acquisition of Proleukin^®, or the Acquisition. Through the first quarter of 2024, product revenue was comprised entirely of product sales of Proleukin^® in markets outside of the U.S. GTN adjustments did not materially affect net product revenue in the three months ended September 30, 2025 and 2024.

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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.

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Costs and expenses

The following table summarizes the period-over-period changes in our costs and expenses:

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Cost of sales

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^®.

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Cost of sales excluding depreciation and amortization for the nine months ended September 30, 2025 increased by $74.6 million, or 135%, compared to the same period in 2024. The increase was driven by (i) a $51.3 million increase from sales of Amtagvi^®products as well as costs related to the manufacturing of Amtagvi^®, (ii) a $8.0 million increase in excess and obsolescence reserve primarily related to excess Proleukin^®inventory resulting from a manufacturer contract inherited in the Acquisition for which we cannot yet fully utilize the required purchase quantities, and (iii) a $18.6 million increase in period costs primarily related to patient drop-off driven by patient health as well as manufacturing results that did not meet required specifications. These increases were partially offset by (i) a $3.3 million decrease in royalties payable related to the decrease in sales of Proleukin^®.

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Research and development expense

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Research and development expense for the three months ended September 30, 2025 increased by $8.1 million, or 12%, compared to the same period in 2024. The increase was primarily attributable to (i) a $8.0 million increase in payroll and related costs, primarily driven by an increase in the number of employees prior to the reduction in workforce in the third quarter of 2025, (ii) a $7.1 million increase in clinical trial costs, driven primarily by continued enrollment in TILVANCE-301, GM1-201, and END-201 studies, an initiation of new clinical trials, MEL-202, and the resumption of the LUN-202 study (iii) a $4.4 million increase in related clinical manufacturing costs, (iv) a $1.3 million increase primarily due to license costsrelated to the expansion of our information technology infrastructure to support our clinical activities.The increase was partially offset by a (i) $10.4 million decrease in stock-based compensation expense primarily driven by the number of stock awards granted at lower average stock price and reduction in workforce effected in the third quarter of 2025, (ii) a $1.9 million decrease in lab and consumable costs,and (iii) a $0.4 million decrease in other costs including travel and facility related costs.

Research and development expense for the nine months ended September 30, 2025 increased by $23.8 million, or 12%, compared to the same period in 2024. The increase was primarily attributable to (i) a $37.9 million increase in payroll and related costs, primarily driven by an increase in the number of employees prior to the reduction in workforce in the third quarter of 2025, (ii) a $20.9 million increase in clinical costs, driven primarily by continued enrollment in TILVANCE-301, GM1-201, END-20, initiation of new trials MEL-202 and IOV-3001, and the resumption of the LUN-202 study, (iii) a $4.9 million primarily due to license costsrelated to the expansion of our information technology infrastructure to support our clinical activities,and (iv) $0.2 million increase in other costs including travel, lab and consumables costs. The increase was partially offset by (i) a $24.0 million decrease in

manufacturing costs, driven by capitalization of qualified costs for Amtagvi^® manufacturing and (ii) a $16.1 million decrease in stock-based compensation expense primarily driven by the number of stock awards granted at lower average stock price and reduction in workforce, partially offset by an increase in the number of employees prior to the reduction in workforce.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We separate our research and development expenses into two broad categories: direct and indirect. Additionally, with respect to direct research and development expenses, we further divide expenses into the following sub-categories: "TIL, including combination therapy," "Next Generation," and "Other clinical, preclinical and research programs under development." Lifileucel monotherapy includes our TIL monotherapy clinical trials, including clinical trials previously reported as LN-145. For direct research and development expenses, we track specific project research and development expenses that are directly attributable to our preclinical and clinical development candidates that have been selected for further development. Such direct research and development expenses include third-party contract costs relating to the manufacturing of TILs, as well as preclinical and clinical trial activities.

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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.

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The table below summarizes our research and development expenses by therapeutic area (in thousands):

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Selling, general and administrative expense

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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 expensesdriven by an increase in the number of employees, prior to the reduction in workforce, to support growth in the overall business.

Selling, general and administrative expenses for the nine months ended September 30, 2025 increased by $6.0 million, or 5%, compared to the same period in 2024. The increase was primarily attributable to (i) a $9.1 million increase in payroll and related

expense, driven by an increase in headcount to support the growth in the overall business including the commercialization of Amtagvi^®, prior to the reduction in workforce, (ii) a $8.5 million increase in costs incurred in support of the distribution and commercialization of Amtagvi^® and Proleukin^®, (iii) a 2.6 million increase in software license costs related to the expansion of our information technology infrastructure, (iv) a $0.9 million increase in other costs, including costs associated with increased travel and professional fees, partially offset by a decrease in intellectual property legal costs. The increase was offset by (i) a $15.1 million decrease in stock-based compensation primarily driven by the number of stock awards granted at lower average stock price and reduction in workforce, partially offset by an increase in the number of employees prior to the reduction in workforce.

Depreciation and amortization
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Depreciation and amortization three and nine months ended September 30, 2025 decreased by $0.7 million, or 7% and $2.0 million or 7% compared to the same periods in 2024. The decrease was primarily related to the decrease in expense for the amortization of the fair value step-up of acquired Proleukin^® inventory sold as the acquired inventory continues to be depleted.

Restructuring
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Restructuring expense was $5.1 million for the three and nine months ended September 30, 2025; there were no such charges in the comparable periods for 2024. Expense in 2025 was primarily related to severance payments, costs for outplacement services, and post-employment benefits associated with our August 2025 strategic restructuring plan, resulting from a review of current strategic priorities, the strategic restructuring plan included an associated reduction in workforce, resource allocations, and costs, intended to reduce operating costs, streamline operations and extend cash runway.

Interest and other income, net

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Interest income, net for the three months ended September 30, 2025 decreased by $2.8 million, or 69%, compared to the same period in 2024. The decrease was primarily driven by a $1.6 million decrease in average investment balances and a decrease in interest rates and a $1.2 million increase in other expense related to deductions associated with the acquisition of the Proleukin business in the UK.

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.

Income tax (expense) benefit

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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.

Net loss

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Net loss for the three and nine months ended September 30, 2025 increased by $7.7 million, or 9%, and $25.5 million, or 9%, compared to the same periods in 2024. The increase in our net loss is primarily due to the related increase in cost of sales, as well as

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^®.

Liquidity and Capital Resources

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.

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.

In August 2025, we approved a strategic restructuring plan with an associated reduction in workforce as a result of a review of current strategic priorities, resource allocation, and cost reduction intended to reduce operating costs, streamline operations and extend our cash runway. The restructuring plan is expected to optimize business performance, prioritize key manufacturing and research and development efforts, as well as reduce headcount by approximately 19 percent.

Corporate Capitalization

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.

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

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.

On July 13, 2023, we closed an underwritten public offering of 23,000,000 shares of our common stock, which included 3,000,000 shares issued pursuant to the exercise of the option granted to the underwriters, at a public offering price of $7.50 per share, before underwriting discounts and commissions. The total net proceeds to us from the offering, including the exercise of the option by the underwriters, were $161.5 million after deducting underwriting discounts and commissions and offering expenses payable by us.

On February 22, 2024, we closed an underwritten public offering of 23,014,000 shares of our common stock at a public offering price of $9.15 per share, before underwriting discounts and commissions. The total net proceeds to us from the offering were $197.4 million after deducting underwriting discounts and commissions and offering expenses payable by us.

In the future, we may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. If any of the securities covered by the Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of such offering at that time.

Cash Flows

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

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Operating Activities

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.

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.

Investing Activities

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

acquired. These increases in cash provided by investing activities were partially offset by a $17.6 million increase in cash utilized to fund capital expenditures.

Financing Activities

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.

Contractual Obligations

The following table summarizes our non-cancellable contractual obligations as of September 30, 2025, and the effects that such obligations are expected to have on our liquidity and cash flows in future periods (in thousands):

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Off-Balance Sheet Arrangements

As of September 30, 2025, we had no obligations that would require disclosure as off-balance sheet arrangements.

Critical Accounting Policies and Significant Judgments and Estimates

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.

We believe the following critical accounting policies reflect the more significant judgments and estimates used in the preparation of our condensed consolidated financial statements:

Asset Acquisitions

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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.

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.

Deferred tax liabilities arising from basis differences in assets acquired are calculated using the simultaneous equations method under ASC 740, Income Taxes and based on the effective tax rate. The resulting deferred tax liability is recorded against the carrying amount of the acquired intangible assets on a relative fair value basis.

Contingent consideration in the scope of ASC Topic 815, Derivatives and Hedging, is included in the cost of the asset acquisition at its acquisition date fair value. Contingent consideration in the scope of ASC Topic 450, Contingencies, is recognized when it is both probable and reasonably estimable.

Intangible Assets

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Our acquired intangible assets are initially measured based on an allocation of the cost of the acquisition to the assets acquired on a relative fair value basis and are recorded net of accumulated amortization, while intangible assets recorded as the result of milestone or license payments are recorded at the amount paid. We amortize our intangible assets on a straight-line basis over their estimated useful lives.

When contingent consideration is a component of the cost of an asset acquisition, we capitalize the amount of incremental cost from the contingent consideration related to the intangible asset acquired in the period the underlying contingency is resolved. When this occurs, we will recognize a cumulative catch-up to reflect amortization on the intangible assets that would have been recognized had the incremental cost from the contingent consideration been recorded as of the acquisition date.

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.

Inventory and Cost of Sales

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Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis. Our assessment of net realizable value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including our most recent sales and manufacturing forecast compared to quantities on hand and the expiration date of the product and materials.

Revenue Recognition

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.

In the U.S., products are sold principally to hospitals and clinics, as well as distributors and wholesalers, and outside of the U.S. to hospitals and clinics. Contractual performance obligations are usually limited to transfer of control of the product to the customer. In the case of Amtagvi^®, revenue is recognized upon infusion while for Proleukin^®, transfer of control occurs either upon shipment or upon receipt of product after considering when the customer obtains legal title to the product. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring our products and is generally based on a list of fixed prices less allowances for chargebacks, product returns, rebates and discounts. Our payment terms to customers range from 45 to 105 days; payment terms differ by customer and by product.

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. 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.

Significant judgement is required in estimating GTN adjustments considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix, current contract prices under applicable programs, processing time lags and inventory levels in the distribution channel.

Indirect taxes collected from customers and remitted to government authorities that are related to sales of our products, primarily in Europe, are excluded from revenues,

Accrued Research and Development Costs

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Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. We have a history of contracting with third parties, including CROs, independent clinical investigators, and CMOs, 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 uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon the work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. We determine our costs through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services.

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Included in our clinical development costs are investigator costs, which are costs associated with treatments administered at clinical sites as required under each clinical trial protocol. Our estimates for clinical investigator costs and timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of clinical trial enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on clinical trial, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs. In addition, our estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional treatments that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the clinical trial treatment. We accrue estimated expenses resulting from obligations under investigator site agreements as the timing of payments does not always timely align with the periods over which the treatments are administered by the clinical investigators. These estimates are typically based on contracted amounts, patient visit data, discussions with internal clinical stakeholders and outside service providers, and historical look-back analysis of actual payments made to date.

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We make judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or other outside service provider, the payments are recorded within prepaid expenses and other current assets and subsequently recognized as research and development expense when the associated services have been performed. As actual costs become known, we adjust our estimates, liabilities and assets. Inputs used in our determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.

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