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 the European Union, or EU, United Kingdom, or UK, Canada, Switzerland, and Australia. In June 2024, we submitted a centralized marketing authorization application, or MAA, to the European Medicines Agency, or the EMA, for lifileucel. In August 2024, the MAA was validated and accepted for review by the EMA. In October 2024, an MAA was submitted to the Medicines and Healthcare products Regulatory Agency in the UK. A new drug submission, or NDS, was deemed eligible for Notice of Compliance with Conditions or NOC/c by Health Canada and submitted in December 2024 and then accepted in January 2025. The NOC/c policy includes a prioritized 200-day review process for potential NDS approval in mid-2025. If approved, lifileucel is expected to be the first and only approved therapy in this treatment setting in these markets. 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 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.

Previous wording

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.

Current wording

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

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. In clinical trials, more than 700 patients have been treated with Iovance TIL cell therapy products manufactured using our proprietary processes across multiple indications. 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. As built, the two facilities together have capacity to treat several thousands of cancer patients annually with commercial product and clinical supply.

Previous wording

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

Current wording

We have investigated TIL cell therapy in global, multicenter 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.

Previous wording

We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 75 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; 11,141,438; 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 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.

Previous wording

Revenues for the three months ended March 31, 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. Prior to May 2023, we had not recognized any revenue.

Current 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.

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 destroyed and the costs associated with manufacturing and inventory associated with the product is generally required to be expensed as cost of sales. However, if the out-of-specifications product can be administered as part of a clinical trial, in an expanded or early access program, or single-patient IND, as requested by the treating physician, the costs of the product are recorded as research and development expense based on the fact that we receive clinical data related to these infusions.

Current wording

In the event that the manufactured product does not meet specifications, or a patient is unable to receive the infusion, the Amtagvi® product is generally destroyed and the costs associated with manufacturing and inventory associated with the product is generally required to be expensed as cost of sales. However, if the out-of-specifications product can be administered as part of a

Previous wording

Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in an uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites. The duration, costs, and timing of our clinical trials and development of our product candidates will depend on a number of factors that include, but are not limited to, the number of patients that enroll in the trial, per patient trial

Current wording

Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in an uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites. The duration, costs, and timing of our clinical trials and development of our product candidates will depend on a number of factors that include, but are not limited to, the number of patients that enroll in the trial, per patient trial costs, number of sites included in the trial, discontinuation rates of patients, duration of patient follow-up, efficacy and safety profile of the product candidate, and the length of time required to enroll eligible patients.

Previous wording

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

Current wording

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

Previous wording

Results of Operations for the Three Months Ended March 31, 2025 and 2024

Current wording

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

Previous wording

Revenue for the three months ended March 31, 2025 increased by $48.6 million, or 6,798%, compared to the same period in 2024. The increase was driven by the completion of the acquisition of worldwide rights to Proleukin® in May 2023, or the Acquisition, as well as the commercial launch of Amtagvi® in February 2024. Through the first quarter of 2024, product revenue was comprised entirely of product sales of Proleukin® in markets outside of the U.S. 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. Furthermore, in the second quarter of 2024, we began selling Proleukin® in the U.S. market. The Proleukin® inventory that was previously with distributors at the time of the Acquisition to support the U.S. market has been substantially sold, and as a result we experienced significant re-stocking demand from specialty distributors in the second half of 2024 to support ongoing and anticipated infusions related to the strong commercial launch of Amtagvi®. GTN adjustments did not materially affect net product revenue in the three months ended March 31, 2025 and 2024.

Current 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.

Previous wording

Research and development expense for the three months ended March 31, 2025 decreased by $2.9 million, or 4%, compared to the same period in 2024. The decrease was primarily attributable to a $30.5 million decrease in manufacturing costs, driven by capitalization of qualified costs for Amtagvi® manufacturing resulting from our BLA approval and the transition to commercial manufacturing to support the commercial launch of Amtagvi®. This decrease was partially offset by (i) a $16.3 million increase in payroll and related costs, including stock-based compensation, primarily driven by an increase in the number of employees (ii) a $7.5 million increase in clinical costs, driven primarily by continued enrollment in TILVANCE-301 and the resumption the LUN-202 study, and (iii) a $3.8 million increase in lab and consumable costs to develop next generation candidates.

Current 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.

Previous wording

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.

Current wording

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.

Previous wording

Selling, general and administrative expenses for the three months ended March 31, 2025 increased by $12.5 million, or 40%, compared to the same period in 2024. The increase was primarily attributable to (i) a $7.8 million increase in payroll and related expense, including stock-based compensation, driven by an increase in headcount to support the growth in the overall business including the commercialization of Amtagvi® (ii) a $1.7 million increase in costs incurred in support of the distribution and commercialization of Amtagvi® and Proleukin®, and (iii) a $3.0 million increase in other costs, including costs associated with increased travel, software license costs related to the expansion of our information technology infrastructure and legal and professional fees.

Current 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.

Previous wording

Interest income, net for the three months ended March 31, 2025 decreased by $0.1 million, or 4%, compared to the same period in 2024. The decrease was primarily driven by a slightly lower rate of return on our investments, partially offset by an increase in average investment balances, resulting from net proceeds from recent public and at-the-market financings.

Current 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.

Previous wording

Net loss for the three months ended March 31, 2025 increased by $3.2 million, or 1%, compared to the same period 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 execution of the launch of Amtagvi®.

Current 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®.

Previous wording

As of March 31, 2025, we had $366.1 million in cash, cash equivalents, short term-investments, and restricted cash ($171.7 million of cash and cash equivalents, $188.0 million in short-term investments, and $6.4 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 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.

Previous wording

We expect to continue to incur significant expenses to support our execution of the commercial launch of Amtagvi®, fund ongoing clinical programs, including our NSCLC registrational study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the three months ended March 31, 2025 are issued, we believe that we have sufficient capital to fund our anticipated operating expenses and capital

Current wording

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

As of March 31, 2025, we had outstanding 333,934,387 shares of our $0.000041666 par value common stock, 194 shares of our $0.001 par value Series A Convertible Preferred Stock, and 1,932,667 shares of our $0.001 par value Series B Convertible Preferred Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 1,932,667 shares of our common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.

Current wording

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. We received $301.7 million in proceeds, net of offering costs, through the sale of 44,080,226 shares of our common stock for the nine months ended September 30, 2023 through the 2022 Sale Agreement and 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 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.

Previous wording

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 2020 Shelf 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.

Current wording

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.

Previous wording

Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the three months ended March 31, 2025 was $103.7 million as compared to $122.3 million for the same period in 2024. The $18.6 million increase in cash used in operating activities was driven by a $3.2 million increase in net loss resulting from increased cost of sales and overall growth in our workforce to support our expansion, partially offset by an increase in revenues generated by sales of Amtagvi® and sales of Proleukin® in the US market, as well as a net increase in non-cash charges of $6.9 million, primarily driven by higher stock-based compensation expense and amortization of intangible assets, the latter of which is driven primarily by amortization of the developed technology intangible asset recorded as part of the Acquisition and intellectual property license intangible assets associated with Amtagvi®. The increase in non-cash charges was partially offset by an increase in deferred tax benefits resulting from the realization of the related deferred taxes for operations in the UK. Further, net cash used in operating activities related to changes in operating assets and liabilities decreased by $33.1 million, driven by an increase in accounts payable and accrued expenses, resulting from timing of vendor invoicing and related payments. These decreases in the use of cash were partially offset by a $18.2 million increase driven primarily by the cash used for purchases of raw material inventory in support of the commercial demand of Amtagvi®, an increase in trade accounts receivable resulting from the sale of our products, 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

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.

Previous wording

Net cash provided by (used in) investing activities for the periods presented primarily relates to the cash utilized to fund the Acquisition, the purchase and maturity of investments, and capital expenditures. Net cash provided by investing activities for the three months ended March 31, 2025 was $15.9 million, compared to net cash used by investing activities of $111.5 million for the same period in 2024. The decrease in cash used of $127.4 million was driven by a $76.8 million decrease associated with changes in the timing of maturities and purchases of investments, a $52.6 million decrease in cash used for the Acquisition, net of cash acquired. These decreases were offset by a $2.0 million increase in 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 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.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 was $143.3 million compared to net cash provided of $193.6 million for the same period in 2024. The decrease in net cash provided by financing activities of $50.3 million was primarily driven by a decrease in net proceeds of $49.0 million received through the sales of common stock through our “at the market” offering program during the three months ended March 31, 2025, as compared to the net proceeds received from our public offering in February 2024 in the first quarter of 2024. In addition, a $0.9 million increase in tax payments related to shares withheld for vested restricted stock units and a $0.4 million decrease in proceeds from the issuance of common stock upon the exercise of stock options and from our employee stock purchase plan program contributed to the overall decrease in cash provided by financing activities.

Current wording

Net cash provided by financing activities for the six months ended June 30, 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.

Previous wording

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

Current wording

We make certain judgments to determine whether transactions should be accounted for acquisitions of assets or business combinations using the guidance in Accounting 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.

Previous wording

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 an estimate of recent sales forecast compared to quantities on hand and the expiration date of the product and materials.

Current wording

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