IOVANCE BIOTHERAPEUTICS, INC.

Previous wording

Beyond the U.S., we plan to launch Amtagvi® into additional markets with a high prevalence of advanced melanoma, including United Kingdom, or UK, Canada, Australia, Switzerland, and European Union, or EU. In June 2024, we submitted a centralized marketing authorization application, or MAA, to the European Medicines Agency, or the EMA, for lifileucel which was validated and accepted for review by the EMA 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 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. Australia’s Therapeutic Goods Administration granted Priority Review to Amtagvi® with a decision anticipated by early 2026, and the Swiss Medic recommended Priority Review ahead of the Swiss regulatory submission planned in the fourth quarter of 2025. A new drug submission, or NDS, was deemed eligible for Notice of Compliance with Conditions, or NOC/c, by Health Canada and submitted in 2024 and approval is expected in the third quarter of 2025, which would make lifileucel the first and only approved therapy in this treatment setting in Canada. Across the U.S. and other targeted global markets, Amtagvi® has the potential to address more than 20,000 previously treated advanced melanoma patients annually.

Current 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.

Previous wording

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, theiCTC, and by a CMO. The FDA authorizediCTC for commercial manufacturing of Amtagvi® as well as our CMO for additional capacity to supplement our internal manufacturing. As built, the two facilities together have capacity to treat several thousands of cancer patients annually with commercial product and clinical supply.

Current wording

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, theiCTC, and by a CMO. The FDA authorizediCTC 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 theiCTC in early 2026. Current capacity at theiCTC is sufficient to treat several thousands of cancer patients annually with commercial product and clinical supply.

Previous wording

TheiCTC 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 footiCTC is among the largest cell therapy manufacturing facilities globally.iCTC expansion is underway which is expected to increase capacity to supply over five thousand patients annually. Our long-term goal is to establish a manufacturing network that can supply TIL cell therapies to over ten thousand patients per year. The proximity of theiCTC to multiple airports facilitates delivery of TIL cell therapies to treatment centers. TheiCTC 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. TheiCTC has a flexible design that facilitates our expansion within the existing shell space and an option to build on an adjacent lot to support future growth and capacity needs.

Current wording

TheiCTC 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 footiCTC is among the largest cell therapy manufacturing facilities globally. TheiCTC’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. ThisiCTC 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 theiCTC to multiple airports facilitates delivery of TIL cell therapies to treatment centers. TheiCTC 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.

Previous wording

We 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 12. Licenses and Agreements section of this Quarterly Report on Form 10-Q.

Current wording

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.

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 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.

Current 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

Previous wording

We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 80 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; 11,304,979; 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; 11,433,097; 11,517,592; 11,529,372; 11,541,077; 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; 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; and 12,226,434. More than 40 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 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.

Previous wording

Revenues for the three and six months ended June 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

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.

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

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 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.

Previous wording

Selling, general, and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, procurement, legal, investor relations, facilities, business development, marketing, commercial, information technology and human resources functions. Other significant costs include 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.

Current wording

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.

Previous wording

Cost of sales includes inventory and period costs, as well as non-cash expenses, related to overhead and manufacturing costs of Amtagvi®, as well as the cost of inventories and other costs, and non-cash expenses that are directly associated with the purchase and sales of Proleukin®. In addition, cost of sales includes royalties payable on sales of our products, as well as non-cash expenses including amortization of the fair value step-up of acquired Proleukin® inventory which is recognized as the acquired inventory units are sold, amortization expense for the developed technology intangible asset and the milestone payment recorded as part of the Acquisition, and the intellectual property license intangible assets.

Current wording

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.

Previous wording

Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024

Current wording

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

Previous wording

Revenue for the three and six months ended June 30, 2025 increased by $28.8 million, or 93%, and $77.5 million, or 243%, 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 June 30, 2025 and 2024.

Current wording

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.

Previous wording

Cost of sales for the three months ended June 30, 2025 increased by $25.3 million, or 81%, compared to the same period in 2024. The increase was driven by (i) a $20.6 million increase in sales of products as well as costs related to the manufacturing of Amtagvi®, (ii) a $7.0 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, (iii) a $3.3 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, and (iv) a $0.2 million increase in non-cash amortization expense for the developed technology intangible assets driven by additional milestone payment paid made in the second quarter of 2024. These increases were partially offset by (i) a $3.0 million decrease in royalties payable related to the decrease in sales of Proleukin®, and a (ii) $2.8 million decrease in non-cash amortization expense for the amortization of the fair value step-up of acquired Proleukin® inventory sold as the acquired inventory continues to be depleted.

Current 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®.

Previous wording

Cost of sales for the six months ended June 30, 2025 increased by $67.8 million, or 175%, compared to the same period in 2024. The increase was driven by (i) a $46.4 million increase in sales of products as well as costs related to the manufacturing of Amtagvi®, (ii) a $7.0 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, (iii) a $18.1 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, and (iv) a $1.0 million increase in non-cash amortization expense for the developed technology intangible assets driven by additional milestone payment paid made in the second quarter of 2024. These increases were partially offset by (i) a $1.6 million decrease in royalties payable related to the decrease in sales of Proleukin®, and (ii) a $3.1 million decrease in non-cash amortization expense for the amortization of the fair value step-up of acquired Proleukin® inventory sold as the acquired inventory continues to be depleted.

Current wording

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®.

Previous wording

Research and development expense for the six months ended June 30, 2025 increased by $14.4 million, or 10%, compared to the same period in 2024. The increase was primarily attributable to (i) a $29.9 million increase in payroll and related costs, primarily driven by an increase in the number of employees (ii) a $13.9 million increase in clinical costs, driven primarily by continued enrollment in TILVANCE-301 and the resumption of the LUN-202 study, (iii) a $3.6 million primarily due to license costs related to the expansion of our information technology infrastructure to support our clinical activities, (iv) a $2.6 million increase in lab and consumable costs to develop next generation candidates and (v) $0.2 million increase in other costs including travel and facility related costs. The increase was partially offset by (i) a $30.1 million decrease in manufacturing costs, driven by capitalization of qualified costs for Amtagvi® manufacturing and (ii) a $5.7 million decrease in stock-based compensation expense primarily driven by the number of stock awards granted at lower average stock price, partially offset by an increase in the number of employees.

Current wording

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 costs related 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 inother costs including travel and facility related costs.

Previous wording

Research and development expense for the three months ended June 30, 2025 increased by $17.3 million, or 28%, compared to the same period in 2024. The increase was primarily attributable to (i) a $16.0 million increase in payroll and related costs, primarily driven by an increase in the number of employees (ii) a $6.7 million increase in clinical costs, driven primarily by continued enrollment in TILVANCE-301 and the resumption of the LUN-202 study (iii) $1.8 million increase primarily due to license costs related to the expansion of our information technology infrastructure to support our clinical activities, (iv) a $1.1 million increase in lab and consumable costs to develop next generation candidates, and (v) a $0.3 million increase other costs including travel and facility related costs. The increase was partially offset by a $8.6 million decrease in stock-based compensation expense primarily driven by the number of stock awards granted at lower average stock price.

Current wording

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 costs related 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

Previous wording

Selling, general and administrative expenses for the three months ended June 30, 2025 decreased by $1.9 million, or 5%, compared to the same period in 2024. The decrease was primarily attributable to a $8.8 million decrease in stock-based compensation driven by the number of stock awards granted at lower average stock price. This decrease was partially offset by (i) a $2.8 million increase in costs incurred in support of the marketing and advertising of Amtagvi®, (ii) a $2.6 million increase in payroll and related expenses driven by an increase in the number of employees to support the growth in the overall business, and (iii) a $1.5 million increase in other costs, including costs associated with increased travel, software license costs related to the expansion of our information technology infrastructure.

Current 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.

Previous wording

Selling, general and administrative expenses for the six months ended June 30, 2025 increased by $10.7 million, or 15%, compared to the same period in 2024. The increase was primarily attributable to (i) a $6.7 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®, (ii) a $6.0 million increase in costs incurred in support of the distribution and commercialization of Amtagvi® and Proleukin®, (iii) a $1.9 million increase in software license costs related to the expansion of our information technology infrastructure, (iv) a $1.2 million increase in professional services fees, and (v) a $1.3 million increase in other costs, including costs associated with increased travel and legal fees. The increase was offset by a $6.5 million decrease in stock-based compensation primarily driven by the number of stock awards granted at lower average stock price, partially offset by an increase in the number of employees.

Current wording

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.

Previous wording

Interest income, net for the three and six months ended June 30, 2025 increased by $0.7 million, or 22%, and $0.6 million, or 9%, compared to the same periods in 2024. The increase was primarily driven by an increase in average investment balances, resulting from net proceeds from recent public and at-the-market financings, partially offset by a slight decrease in interest rates.

Current 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.

Previous wording

Net loss for the three and six months ended June 30, 2025 increased by $14.6 million, or 15%, and $17.7 million, or 8%, 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®.

Current 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®.

Previous wording

As of June 30, 2025, we had $307.1 million in cash, cash equivalents, short-term investments, and restricted cash ($132.5 million of cash and cash equivalents, $168.7 million in short-term investments, and $5.9 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 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.

Previous wording

We expect to continue to incur significant expenses to support our ongoing execution of the commercial launch of Amtagvi®, fund ongoing clinical programs, including our NSCLC registrational study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the three and six months ended June 30, 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 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.

Previous wording

Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 1,932,667 shares of our common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.

Current wording

As of September 30, 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.

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 may, 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. We received $403.7 million in proceeds, net of offering costs, through the sale of 64,030,760 shares of our common stock cumulatively through June 30, 2025 under the 2023 Sale Agreement.

Current 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

Previous wording

Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the six months ended June 30, 2025 was $171.1 million as compared to $220.7 million for the same period in 2024. The $49.6 million decrease in cash used in operating activities was driven by a $17.7 million increase in net loss resulting from increased cost of sales and overall growth in our workforce to support our business, partially offset by an increase in revenues generated by sales of Amtagvi® and Proleukin® in the U.S. This increase in net loss was fully offset by a net increase in non-cash charges of $4.5 million and a $62.8 million decrease in net cash used in operating activities related to changes in operating assets and liabilities. The net increase in non-cash charge was primarily driven by excess and obsolescence costs, a decrease in deferred tax benefits related to the operations in the UK, and amortization of intangible assets and right-of-use assets, which were partially offset by lower-stock based compensation expense.

Current wording

Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the nine months ended September 30, 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.

Previous wording

The $62.8 million decrease in net cash used in operating activities related to changes in operating assets and liabilities was driven by a $40.9 million decrease in trade accounts receivable resulting from collection of cash from the sale of our products and a $29.3 million increase in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments, partially offset by a $7.4 million increase in net cash used driven primarily by purchases of raw material 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 $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.

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 six months ended June 30, 2025 was $29.7 million, compared to net cash used by investing activities of $71.3 million for the same period in 2024. The increase in cash provided of $101.0 million was driven by a $57.5 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 $9.1 million increase in cash utilized to fund capital expenditures.

Current 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

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $156.5 million compared to net cash provided of $346.4 million for the same period in 2024. The decrease in net cash provided by financing activities of $189.9 million was primarily driven by a decrease in net proceeds of $187.8 million received through the sales of common stock through our “at the market” offering program during the three and six months ended June 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 three and six months ended June 30, 2024. In addition, a $1.6 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 $0.5 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 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.

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 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.

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