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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☑	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission File Number 001-36860

IOVANCE BIOTHERAPEUTICS, INC.

(Exact name of issuer as specified in its charter)


Delaware	75-3254381
(State or other jurisdiction of	(I.R.S. employer
incorporation or organization)	identification number)

825 Industrial Road, Suite 100, San Carlos, CA 94070

(Address of principal executive offices and zip code)

(650) 260-7120

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ◻

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes þ No ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer þ	Accelerated filer ☐
Non-accelerated filer ☐	Smaller reporting company ☐
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No þ

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.000041666		IOVA		The Nasdaq Global Market

As of October 15, 2025, the issuer had 396,967,970 shares of common stock, par value $0.000041666 per share, outstanding.

Table of Contents

IOVANCE BIOTHERAPEUTICS, INC.

FORM 10-Q

For the Quarter Ended September 30, 2025

Table of Contents


		Page
PART I FINANCIAL INFORMATION
Item 1.	Condensed Consolidated Financial Statements (Unaudited)	4
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	37
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	52
Item 4.	Controls and Procedures	52
PART II OTHER INFORMATION
Item 1.	Legal Proceedings	53
Item 1A.	Risk Factors	53
Item 2.	Unregistered Sales of Securities, Use of Proceeds, and Issuer Purchases of Equity Securities	107
Item 3.	Defaults Upon Senior Securities	107
Item 4.	Mine Safety Disclosure	107
Item 5.	Other Information	107
Item 6.	Exhibits	108
SIGNATURES		109

Table of Contents

Forward-Looking Statements and Market Data

This Quarterly Report on Form 10-Q contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “might,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “aim,” “potential,” “continue,” “ongoing,” “goal,” “forecast,” “guidance,” “outlook,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

●

the success, cost, enrollment, and timing of our clinical trials;

●

the success, cost, and timing of our product development activities;

●

the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process;

●

our ability to design, construct, and staff our own manufacturing facility on a timely basis and within the estimated expenses;

●

the success of competing therapies that are or may become available;

●

regulatory developments in the United States of America, or U.S., and foreign countries;

●

the timing of and our ability to obtain and maintain U.S. Food and Drug Administration, or the FDA, European Commission, or other regulatory authority approval of, or other action with respect to, our products and/or product candidates;

●

our ability to attract and retain key scientific or management personnel;

●

the timing, execution and expected benefits of our restructuring plan announced in August 2025;

●

the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;

●

our ability to obtain funding for our operations, including funding necessary to complete further development of our product candidates and commercialization of our products;

●

our ability to successfully commercialize Amtagvi^® (lifileucel) and Proleukin^® (aldesleukin), and any other products and/or product candidates for which we obtain or have obtained FDA or other regulatory approvals, including by the European Commission in the European Union, or the EU;

●

the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates;

●

the potential of our other research and development and strategic collaborations;

●

our expectations regarding our ability to obtain and maintain intellectual property protection for our manufacturing methods and products and/or product candidates;

●

our plans to research, develop, and commercialize our products and/or product candidates;

●

the size and growth potential of the markets for our products and/or product candidates, and our ability to serve those markets;

●

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

●

fluctuations in the trading price of our common stock; and

●

our use of cash and other resources.

Table of Contents

Actual results may differ from those set forth in this Quarterly Report on Form 10-Q due to the risks and uncertainties inherent in our business, including those provided in the foregoing list of forward-looking statements and also including, without limitation: the FDA may not agree with our interpretation of the results of our clinical trials; later developments with the FDA that may be inconsistent with already completed FDA meetings; the preliminary clinical results, including efficacy and safety results, from ongoing Phase 2 and Phase 3 clinical trials may not be reflected in the final analyses of these clinical trials including new cohorts within these clinical trials; the results obtained in our ongoing clinical trials, such as the studies and clinical trials referred to in this Quarterly Report on Form 10-Q, may not be indicative of results obtained in future clinical trials or supportive of product approval; regulatory authorities may potentially delay the timing of FDA or other regulatory authority approval of, or other action with respect to, our product candidates, specifically, our description of FDA interactions are subject to the FDA’s interpretation, as well as the FDA’s authority to request new or additional information; we may not be able to obtain or maintain FDA or other regulatory authority approval of our product candidates; our ability to address FDA or other regulatory authority requirements relating to our clinical programs and registrational plans, such requirements including, but not limited to, clinical and safety requirements, as well as manufacturing and control requirements; risks related to our accelerated FDA review designations; our ability to obtain and maintain intellectual property rights relating to our product pipeline; and the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved.

We caution you that the risks, uncertainties and other factors referenced above may not contain all the risks, uncertainties and other factors that are important to you. In addition, we cannot guarantee future results, level of activity, performance or achievements. Any forward-looking statement made by us in this Quarterly Report on Form 10-Q speaks only as of the date of this Quarterly Report on Form 10-Q or as of the date on which it is made. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise, after the date of this Quarterly Report on Form 10-Q.

Unless the context requires otherwise, in this report the terms “Iovance,” the “Company,” “we,” “us” and “our” refer to Iovance Biotherapeutics, Inc.

Table of Contents

PART I. FINANCIAL INFORMATION

Item 1.Condensed Consolidated Financial Statements (Unaudited)

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(unaudited; in thousands, except share and per share information)


	September 30,		December 31,
	2025		2024
ASSETS

Current Assets
Cash and cash equivalents	$	158,134	$	115,694
Trade accounts receivable		66,761		69,340
Short-term investments		142,669		208,087
Inventory		51,710		51,520
Prepaid expenses and other assets		9,817		12,377
Total Current Assets		429,091		457,018

Property and equipment, net		126,650		109,081
Intangible assets, net		285,208		282,398
Operating lease right-of-use assets		48,763		55,201
Restricted cash		5,965		6,359
Long-term assets		9,271		369
Total Assets	$	904,948	$	910,426

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current Liabilities
Accounts payable	$	31,237	$	27,509
Accrued expenses and other liabilities		87,267		81,936
Note payable - current		1,000		—
Operating lease liabilities		6,281		12,896
Total Current Liabilities		125,785		122,341

Non-Current Liabilities
Operating lease liabilities – non-current		45,211		44,365
Deferred tax liabilities		31,665		32,315
Long-term note payable		—		1,000
Total Non-Current Liabilities		76,876		77,680
Total Liabilities		202,661		200,021

Commitments and contingencies

Stockholders’ Equity
Series A Convertible Preferred stock, $0.001 par value; 17,000 shares designated, 194 shares issued and outstanding as of September 30, 2025 and December 31, 2024		—		—
Series B Convertible Preferred stock, $0.001 par value; 11,500,000 shares designated, 1,932,667 and 2,842,158 shares issued and outstanding as of September 30, 2025 and December 31, 2024 respectively		2		3
Common stock, $0.000041666 par value; 500,000,000 shares authorized, 385,461,728 and 305,252,194 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		16		13
Accumulated other comprehensive loss (income)		16,103		(1,046)
Additional paid-in capital		3,389,792		3,095,987
Accumulated deficit		(2,703,626)		(2,384,552)
Total Stockholders’ Equity		702,287		710,405
Total Liabilities and Stockholders’ Equity	$	904,948	$	910,426

The accompanying notes are an integral part of these condensed consolidated financial statements.

Table of Contents

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(unaudited; in thousands, except per share information)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024
Revenue
Product revenue, net	$	67,455	$	58,555	$	176,731	$	90,376
Total revenue		67,455		58,555		176,731		90,376

Costs and expenses *
Cost of sales **	$	38,477	$	31,518	$	130,073	$	55,459
Research and development **		75,174		67,036		229,067		205,221
Selling, general, and administrative **		34,555		39,336		115,922		109,948
Depreciation and amortization		9,007		9,731		26,422		28,450
Restructuring charges		5,143		—		5,143		—
Total costs and expenses	$	162,356	$	147,621	$	506,627	$	399,078
Loss from operations		(94,901)		(89,066)		(329,896)		(308,702)
Other income
Interest and other income, net		1,243		4,005		8,567		10,698
Net Loss before income taxes	$	(93,658)	$	(85,061)	$	(321,329)	$	(298,004)
Income tax (expense) benefit		2,405		1,520		2,255		4,386
Net Loss	$	(91,253)	$	(83,541)	$	(319,074)	$	(293,618)
Net Loss Per Share of Common Stock, Basic and Diluted	$	(0.25)	$	(0.28)	$	(0.94)	$	(1.03)
Weighted Average Shares of Common Stock Outstanding, Basic and Diluted		364,037		303,269		340,623		284,836

* Non-cash stock-based compensation included in cost of sales and operating expenses
Cost of sales	$	1,408	$	3,065	$	5,977	$	5,362
Research and development		5,011		13,803		21,287		35,825
Selling, general and administrative		5,481		14,138		22,494		37,463
	$	11,900	$	31,006	$	49,758	$	78,650
** Excludes depreciation and amortization

The accompanying notes are an integral part of these condensed consolidated financial statements.

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IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Comprehensive Loss

(unaudited; in thousands)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024
Net Loss	$	(91,253)	$	(83,541)	$	(319,074)	$	(293,618)
Other comprehensive loss:
Unrealized gain (loss) on investments		100		269		(40)		220
Foreign currency translation adjustment		(4,856)		15,447		17,189		13,496
Comprehensive Loss	$	(96,009)	$	(67,825)	$	(301,925)	$	(279,902)

The accompanying notes are an integral part of these condensed consolidated financial statements.

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IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

For the Three Months Ended September 30, 2025 and 2024

(unaudited; in thousands, except share information)


	Series A			Series B
	Convertible			Convertible						Additional		Accumulated other				Total
	Preferred Sock			Preferred Stock			Common Stock			Paid-In		Comprehensive		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Shares	Amount		Capital		Income (Loss)		Deficit		Equity
Balance - June 30, 2025	194	$	—	1,932,667	$	2	341,919,364	$	14	$	3,289,986	$	20,859	$	(2,612,373)	$	698,488
Stock-based compensation expense	—		—	—		—	—		—		11,751		—		—		11,751
Common stock issued upon purchase of employee stock purchase plan	—		—	—		—	1,455		—		3		—		—		3
Vesting of restricted shares issued for services	—		—	—		—	509,742		0		—		—		—		0
Tax payments related to shares retired for vested restricted stock units	—		—	—		—	(211,322)		(0)		(464)		—		—		(464)
Common stock sold in public and/or at the market offering, net of offering costs	—		—	—		—	43,242,489		2		88,516		—		—		88,518
Unrealized loss on investments	—		—	—		—	—		—		—		100		—		100
Foreign currency cumulative translation adjustment	—		—	—		—	—		—		—		(4,856)		—		(4,856)
Net loss	—		—	—		—	—		—		—		—		(91,253)		(91,253)
Balance - September 30, 2025	194	$	—	1,932,667	$	2	385,461,728	$	16	$	3,389,792	$	16,103	$	(2,703,626)	$	702,287

Balance - June 30, 2024	194	$	—	2,842,158	$	3	297,305,999	$	12	$	2,990,451	$	526	$	(2,222,452)	$	768,540
Stock-based compensation expense	—		—	—		—	—		—		30,786		—		—		30,786
Common stock issued upon purchase of employee stock purchase plan	—		—	—		—	—		—		—		—		—		—
Vesting of restricted shares issued for services	—		—	—		—	1,707,198		—		—		—		—		—
Tax payments related to shares retired for vested restricted stock units	—		—	—		—	(587,244)		—		(6,277)		—		—		(6,277)
Common stock sold in public and/or at the market offerings, net of offering costs	—		—	—		—	6,110,234		1		47,517		—		—		47,518
Common stock issued upon exercise of stock options	—		—	—		—	84,283		—		713		—		—		713
Unrealized gain on investments	—		—	—		—	—		—		—		269		—		269
Foreign currency cumulative translation adjustment	—		—	—		—	—		—		—		15,447		—		15,447
Net loss	—		—	—		—	—		—		—		—		(83,541)		(83,541)
Balance - September 30, 2024	194	$	—	2,842,158	$	3	304,620,470	$	13	$	3,063,190	$	16,242	$	(2,305,993)	$	773,455

The accompanying notes are an integral part of these condensed consolidated financial statements.

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IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

For the Nine Months Ended September 30, 2025 and 2024

(unaudited; in thousands, except share information)


	Series A			Series B
	Convertible			Convertible						Additional		Accumulated other				Total
	Preferred Sock			Preferred Stock			Common Stock			Paid-In		Comprehensive		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Shares	Amount		Capital		Income		Deficit		Equity
Balance - December 31, 2024	194	$	—	2,842,158	$	3	305,252,194	$	13	$	3,095,987	$	(1,046)	$	(2,384,552)	$	710,405
Stock-based compensation expense	—		—	—		—	—		—		49,206		—		—		49,206
Common stock issued upon purchase of employee stock purchase plan	—		—	—		—	357,163		0		671		—		—		671
Vesting of restricted shares issued for services	—		—	—		—	4,651,490		0		—		—		—		0
Tax payments related to shares retired for vested restricted stock units	—		—	—		—	(1,856,719)		(0)		(6,614)		—		—		(6,614)
Common stock issued upon exercise of stock options	—		—	—		—	2,586		0		15		—		—		15
Common stock sold in public and/or at the market offering, net of offering costs	—		—	—		—	76,145,523		3		250,526		—		—		250,529
Common stock issued from preferred stock conversion	—		—	(909,491)		(1)	909,491		0		1						—
Unrealized loss on investments	—		—	—		—	—		—		—		(40)		—		(40)
Foreign currency cumulative translation adjustment	—		—	—		—	—		—		—		17,189				17,189
Net loss	—		—	—		—	—		—		—		—		(319,074)		(319,074)
Balance - September 30, 2025	194	$	—	1,932,667	$	2	385,461,728	$	16	$	3,389,792	$	16,103	$	(2,703,626)	$	702,287

Balance - December 31, 2023	194	$	—	2,842,158	$	3	256,135,715	$	11	$	2,594,448	$	2,526	$	(2,012,375)	$	584,613
Stock-based compensation expense	—		—	—		—	—		—		80,389		—		—		80,389
Common stock issued upon purchase of employee stock purchase plan	—		—	—		—	294,222		—		1,562		—		—		1,562
Vesting of restricted shares issued for services	—		—	—		—	2,877,028		—		—		—		—		—
Tax payments related to shares retired for vested restricted stock units	—		—	—		—	(1,003,755)		—		(11,978)		—		—		(11,978)
Common stock issued upon exercise of stock options	—		—	—		—	175,534		—		1,467		—		—		1,467
Common stock sold in public and/or at the market offering, net of offering costs	—		—	—		—	46,141,726		2		397,302		—		—		397,304
Unrealized loss on investments	—		—	—		—	—		—		—		220		—		220
Foreign currency cumulative translation adjustment	—		—	—		—	—		—		—		13,496	—	—		13,496
Net loss	—		—	—		—	—		—		—		—		(293,618)		(293,618)
Balance - September 30, 2024	194	$	—	2,842,158	$	3	304,620,470	$	13	$	3,063,190	$	16,242	$	(2,305,993)	$	773,455

The accompanying notes are an integral part of these condensed consolidated financial statements.

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IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(unaudited; in thousands)


	Nine Months Ended
	September 30,
	2025		2024
Cash Flows from Operating Activities
Net loss	$	(319,074)	$	(293,618)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		49,758		78,650
Unrealized foreign exchange loss		135		(179)
Amortization of intangible assets		16,873		15,656
Amortization of right of use asset		8,669		7,271
Depreciation and amortization of property and equipment		9,138		7,980
Deferred tax (benefit) expense		(2,255)		(4,387)
Excess and obsolescence reserve		9,702		—
Accretion of discounts and premiums on investments		(5,860)		(7,489)
Loss on asset disposals		44		—
Changes in assets and liabilities:
Prepaid expenses, other assets and long-term assets		(7,362)		3,205
Trade accounts receivable		2,579		(55,617)
Inventory		(10,210)		(25,455)
Operating lease liabilities		(8,000)		(8,423)
Accounts payable		(1,448)		(1,769)
Accrued expenses and other liabilities		7,468		4,494
Net cash used in operating activities		(249,843)		(279,681)

Cash Flows from Investing Activities
Maturities of investments		330,000		312,000
Purchase of investments		(258,763)		(372,614)
Cash paid for acquisition, including contingent consideration, net of cash acquired		—		(52,573)
Purchase of property and equipment		(24,516)		(6,901)
Net cash provided by (used) in investing activities		46,721		(120,088)

Cash Flows from Financing Activities
Tax payments related to shares withheld for vested restricted stock units		(6,614)		(11,978)
Proceeds from the issuance of common stock under employee stock purchase plan		671		1,562
Proceeds from the issuance of common stock upon exercise of options		15		1,467
Proceeds from the issuance of common stock, net		250,529		397,304
Net cash provided by financing activities		244,601		388,355
Effect of foreign exchange rate changes		567		637
Net increase in cash, cash equivalents and restricted cash		42,046		(10,777)
Cash, Cash Equivalents and Restricted Cash Beginning of Period		122,053		181,318
Cash, Cash Equivalents and Restricted Cash End of Period	$	164,099	$	170,541

Supplemental disclosure of non-cash investing and financing activities:
Net unrealized loss on investments		40		220
Acquisition of property and equipment included in accounts payable and accrued expenses		9,834		4,613
Intangible asset and deferred tax liability arising from contingent consideration		—		17,495
Conversion of convertible preferred stock to common stock		1		—
Increase / (decrease) in lease liabilities due to obtaining/(reduction) in right-of-use assets from lease modifications		2,231		11,500

The accompanying notes are an integral part of these condensed consolidated financial statements.

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IOVANCE BIOTHERAPEUTICS, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

General Organization and Business

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

Beyond the U.S., the Company plans to launch Amtagvi^® into additional markets with a high prevalence of advanced melanoma, including Canada, the United Kingdom (“UK”), Australia, Switzerland, and the European Union (“EU”). In August 2025, Health Canada issued a Notice of Compliance with Conditions (“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, the Company submitted a centralized marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for lifileucel which was accepted for review in August 2024. Following interactions with EMA’s Committee for Medicinal Products for Human Use (“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.

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

The Company manufactures Amtagvi^® and its investigational TIL cell therapies using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply polyclonal T cells unique to each patient into the billions and yields a cryopreserved, individualized therapy. Amtagvi^® is manufactured for commercial use at the Company’s manufacturing facility, the Iovance Cell Therapy Center (the “iCTC”), and by a contract manufacturing organization (“CMO”).

The Company’s 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, the Company is 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. The Company is conducting two ongoing registrational trials to support a supplementary BLA (“sBLA”), of lifileucel in frontline advanced melanoma and in advanced non-small cell lung cancer (“NSCLC”) following standard of care chemo-immunotherapy. The Company is also developing next generation therapies, such as genetically modified TIL cell therapy and next generation cytokines for use in the TIL cell therapy regimen.

Basis of Presentation of Unaudited Condensed Consolidated Financial Information

The accompanying unaudited condensed consolidated financial statements of the Company for the three and nine months ended September 30, 2025 and 2024 have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”)

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for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for audited financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the Company's financial position and results of operations. Results shown for interim periods are not necessarily indicative of the results that may be expected for the year ended December 31, 2025 or for any other period. The condensed consolidated balance sheet as of December 31, 2024 was derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 27, 2025. Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the condensed consolidated statement of operations. Certain prior period amounts reported in the Company’s condensed consolidated financial statements and accompanying notes have been reclassified to conform to the current period’s presentation. These reclassifications did not have an impact on the Company’s previously presented net results of operations, financial position, or cash flows.

Liquidity

As of September 30, 2025, the Company 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). The Company has launched its first internally developed commercial product and continues to be engaged in the development of therapeutics to fight cancer, specifically solid tumors. With the approval of the Biologics License Application (“BLA”), the Company began to generate revenue from the sale of its product Amtagvi^® in the second quarter of 2024. Furthermore, following the acquisition of the worldwide rights to Proleukin^® (as discussed below in Note 4 - Proleukin^® Acquisition) in 2023, the Company began to generate revenue from the sales of Proleukin^®. However, such revenues 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 Form 10-Q is filed. The Company has incurred a net loss of $319.1 million for the nine months ended September 30, 2025 and used $249.8 million of cash in its operating activities during the nine months ended September 30, 2025.

The Company expects to continue to incur significant expenses to support its ongoing execution of the commercial launch of Amtagvi^®, fund ongoing clinical programs, including its NSCLC registrational study, IOV-LUN-202, and its frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of its pipeline candidates, and for other general corporate purposes. Based on the funds the Company has available as of the date these condensed consolidated financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures as planned for at least the next twelve months from the date these condensed consolidated financial statements are issued.

Concentrations of Risk

The Company is subject to credit risk from its portfolio of cash, cash equivalents, trade accounts receivable and investments. Under its investment policy, the Company limits amounts invested in securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The goals of its investment policy are safety and preservation of principal, diversification of risk, and liquidity of investments sufficient to meet cash flow requirements.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Investments

The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the condensed consolidated balance sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive loss. Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest and other income, net. No impairment losses related to credit losses were recognized for the three and nine months ended September 30, 2025 and 2024. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest and other income, net in the condensed consolidated statements of operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest and other income, net in the condensed consolidated statements of operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments

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such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities and commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government.

Restricted Cash

As of September 30, 2025 and December 31, 2024, restricted cash totaled $6.0 million and $6.4 million, respectively. These amounts have been classified as either current or non-current assets in the Company’s condensed consolidated balance sheet based on the maturity date of the underlying letter of credit agreement.

The Company maintains a required minimum balance in segregated bank accounts in connection with its letters of credit for which amounts are restricted as to their use by the Company. As of September 30, 2025, the Company’s letters of credit were primarily comprised of a letter of credit for the benefit of the iCTC used as a security deposit for the lease in the amount of $5.45 million. The letter of credit for $5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $1.0 million, with a minimum security deposit of $1.5 million maintained through the end of the lease term.

The following table provides a reconciliation of cash, cash equivalents, and restricted cash, reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):


	September 30,
	2025		2024
Cash and cash equivalents	$	158,134	$	164,186
Restricted cash		5,965		6,355
Total cash, cash equivalents and restricted cash	$	164,099	$	170,541

Asset Acquisitions

The Company evaluates acquisitions of assets using the guidance in Accounting Standard Codification (“ASC”) Topic 805, Business Combinations (“ASC 805”), to determine whether the transaction should be accounted for as a business combination or asset acquisition 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 the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.

If the assets acquired do not constitute a business, the Company accounts for asset acquisitions using the cost accumulation and allocation method. Under this method, the cost of the acquisition, including direct acquisition-related costs, is allocated to the assets acquired on a relative fair value basis. Goodwill is not recognized in an asset acquisition and any difference between consideration transferred and the fair value of the net assets acquired is allocated to the identifiable assets acquired based on their relative fair values.

Deferred tax liabilities arising from basis differences in assets acquired are calculated using the simultaneous equations method under ASC Topic 740, Income Taxes (“ASC 740”), and based on the effective tax rate. The resulting deferred tax liability is recorded in the condensed consolidated balance sheet as of September 30, 2025 and December 31, 2024.

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

Inventory and Cost of Sales

Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis. Cost includes amounts related to materials, internal labor, costs of external manufacturing, and allocable overhead. Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation. Inventoriable costs

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incurred, such as manufacturing costs incurred prior to regulatory approval that do not qualify for capitalization and clinical manufacturing costs, are expensed as incurred as research and development expenses.

Upon the February 2024 approval of Amtagvi^®, the Company began capitalizing inventory and manufacturing costs for the commercial manufacturing of Amtagvi^®. Additionally, inventory that initially qualifies for capitalization but that may ultimately be used for the production of clinical drug product or utilized in research and development programs is expensed as research and development expense when it has been designated for the manufacture of clinical drug product or use in research and development activities.

Proleukin^® inventories presented in the condensed consolidated balance sheet as of September 30, 2025 include a step-up of the fair value of inventories as a result of the acquisition of the worldwide rights to Proleukin^®.

The Company periodically reviews inventory for excess and obsolescence, considering factors such as its most recent sales and manufacturing forecast compared to quantities on hand and the expiration date of the product and materials. The Company adjusts its inventory that is obsolete or otherwise unmarketable to its estimated net realizable value in the period in which the impairment is first identified. Any such adjustments are included as a component of cost of sales within the Company’s condensed consolidated statements of operations.

Cost of sales includes inventory and period costs related to overhead and manufacturing costs of Amtagvi^® during the three and nine month period ended September 30, 2025 and during the period from approval through September 30, 2024, as well as the cost of inventories and other costs that are directly associated with the purchase and sales of Proleukin^®. In addition, cost of sales in the Company’s condensed consolidated statements of operations includes royalties payable on sales of its products.

During the Company’s commercial manufacturing process, certain Amtagvi^® product may become out-of-specification, meaning they fall outside commercial specifications. This out-of-specification product can still be utilized by patients in a clinical trial, an expanded or early access program, or single-patient investigational new drug, at which point the costs associated with these batches are classified as research and development expense based on the fact that the Company receives clinical data related to these infusions.

Trade Accounts Receivable

Trade accounts receivable are recorded net of allowances for product returns and estimated credit losses. The estimate of allowance for credit losses considers factors, including existing contractual payment and the aging of receivable from its customers. To date, the Company has determined that an allowance for credit losses is not required.

Intangible Assets

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

When contingent consideration is a component of the cost of an asset acquisition, the Company capitalizes the amount of incremental cost from the contingent consideration related to the intangible asset acquired in the period the underlying contingency is resolved. When this occurs, the Company will recognize amortization expense on the incremental cost prospectively from the date the incremental costs are capitalized.

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

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Leases

The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its condensed consolidated balance sheets as operating lease right-of-use assets and operating lease liabilities as of September 30, 2025 and December 31, 2024. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date.

The operating lease right-of-use assets also include any lease payments made less lease incentives. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term and recorded in costs and expenses in the condensed consolidated statements of operations. The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No. 2016-02 and No. 2018-10 (together “Topic 842”) for short-term leases.

For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately.

Revenue Recognition

The Company recognizes revenue from product sales in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience, as well as applicable information currently available.

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

Revenue is reduced at the time of recognition for expected chargebacks, product returns, discounts, rebates, and sales allowances, collectively referred to as gross to net adjustments (“GTN adjustments”). In the U.S., these GTN adjustments are attributable to various commercial arrangements and government programs. In addition, non-U.S. government programs include different pricing schemes such as cost caps and volume discounts. Cash discounts are recorded as a reduction to receivables and settled through the issuance of credits, typically within one month. All other GTN adjustments are recorded as a liability and settled through cash payments to the customer.

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

Indirect taxes collected from customers and remitted to government authorities that are related to sales of the Company’s products, primarily in Europe, are excluded from revenues.

Stock-Based Compensation

The Company periodically grants stock options to employees and non-employees as compensation for services rendered. The Company accounts for all stock-based payment awards made to employees, including the employee stock purchase plans, and non-employees in accordance with the authoritative guidance provided by the Financial Accounting Standards Board (“FASB”) where the value of the award is measured on the date of grant and recognized over the vesting period. Forfeitures are recognized in the period in

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which they occur. The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair values at each reporting date until the shares underlying the options have vested. The non-employee awards that contain a performance condition that affects the quantity or other terms of the award are measured based on the outcome that is probable.

The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected term of the common stock options, and future dividends. The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option pricing model could affect compensation expense recorded in future periods.

The Company issues restricted stock units (“RSUs”) from time to time as part of its equity incentive plans. The Company measures the compensation cost with respect to RSUs issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the awards. The fair value of RSUs is based on the closing price of the Company’s common stock on the grant date. In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). The Company measures the compensation cost with respect to PRSUs issued to employees based upon the estimated fair value of the equity instruments at the date of grant, which is recognized as an expense over the period that achievement is determined to be probable through the stated service period associated with the award.

Accrued Research and Development Costs

Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. The Company has a history of contracting with third parties, including contract research organizations (“CROs”), independent clinical investigators, and contract manufacturing organizations (“CMOs”) that perform various clinical trial activities on the Company’s behalf in connection with the ongoing development of the Company’s product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon the work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. The Company determines its costs through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services.

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

The Company makes judgements and estimates in determining the accrual balance in each reporting period.

In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the condensed consolidated balance sheets and subsequently recognized as research and development expense in the condensed consolidated statements of operations when the associated services have been performed. As

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actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.

Selling, general, and administrative expense

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. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to such expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.

Restructuring Charges

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

Net Loss per Share

Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period.

Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalent outstanding during the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) purchases through the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), (iii) vesting of restricted stock units, and (iv) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.

As of September 30, 2025 and 2024, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive:


	September 30,
	2025	2024
Stock options	18,612,136	18,852,682
Restricted stock units	9,884,377	9,915,563
Employee Stock Purchase Plan	570,824	250,400
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	1,932,667	2,842,158
	31,097,004	31,957,803

* on an as-converted basis. (See Note 10 – Stockholders’ Equity)

The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of the Company’s common stock could result in a greater dilutive effect from potentially dilutive securities.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include assumptions made in the fair value of intangible assets, equity awards and related stock-based compensation, assumptions used in measuring operating right-of-use assets and operating lease liabilities, accounting for potential liabilities, including estimates inherent in accruals related to clinical trials, and the realizability of the Company’s deferred tax assets.

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Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, Iovance Biotherapeutics GmbH, Iovance Biotherapeutics B.V., Iovance Biotherapeutics UK Ltd, Iovance Biotherapeutics UK SP Ltd, Iovance Biotherapeutics Canada, Inc., and Iovance Australia Pty Ltd. All intercompany accounts and transactions have been eliminated.

Foreign Currency Translation

The condensed consolidated financial statements are presented in U.S. dollars, which is the Company’s reporting currency. The assets and liabilities of the Company’s subsidiaries whose functional currencies are not in U.S. dollars are translated into U.S. dollars at the related period-end exchange rate. The U.S. dollar effects that arise from translation of net assets of these subsidiaries at changing rates are recognized in accumulated other comprehensive loss in the condensed consolidated balance sheets. The subsidiaries’ net loss is translated into U.S. dollars by using the average exchange rate for the applicable period.

Segment Reporting

The Company operates in one segment, focused on innovating, developing and commercializing therapies using autologous TIL for patients with solid tumor cancers. See Note 12 – Segment Information.

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis. Early adoption and retrospective reporting are permitted. The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires the disaggregation of certain expense captions into specified categories in disclosures within the notes to the financial statements to provide enhanced transparency into the expense captions presented on the face of the income statement. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively to financial statements issued for reporting periods after the effective date of ASU 2024-03 or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact of adopting ASU 2024-03.

In July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326) Measurement of Credit Losses for Accounts Receivable and Contract Assets, which amends ASC 326 and provides a practical expedient to assume that current conditions as of the balance sheet date will persist through a reasonable and supportable forecast period when estimating credit losses for current accounts receivable and current contract assets. Entities will still be required to adjust historical data used in the estimation to reflect current conditions. ASU 2025-05 is effective for all entities for annual reporting periods beginning after December 15, 2025, and interim periods within those annual reporting periods. The Company is currently evaluating the impact of adopting ASU 2025-05 on its consolidated financial statements.

NOTE 3. CASH EQUIVALENTS AND INVESTMENTS

The amortized cost and fair value of cash equivalents and investments as of September 30, 2025 and December 31, 2024 were as follows (in thousands):


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of September 30, 2025	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	142,593	$	76	$	—	$	142,669
Money market funds		49,837		—		—		49,837
Total investments	$	192,430	$	76	$	—	$	192,506

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			Gross		Gross
	Amortized		Unrealized		Unrealized
As of December 31, 2024	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	207,970	$	117	$	—	$	208,087
Money market funds		61,432		—		—		61,432
Total investments	$	269,402	$	117	$	—	$	269,519

The fair value of cash equivalents and investments as of September 30, 2025 and December 31, 2024, are classified as follows in the Company’s condensed consolidated balance sheets (in thousands):


	September 30,		December 31,
Classified as:	2025		2024
Cash equivalents	$	49,837	$	61,432
Short-term investments		142,669		208,087
Total investments	$	192,506	$	269,519

Cash equivalents in the tables above exclude cash demand deposits of $108.3 million and $54.3 million as of September 30, 2025 and December 31, 2024, respectively. Unrealized gains and losses are included in accumulated other comprehensive loss, and as of September 30, 2025 and December 31, 2024, no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of September 30, 2025 and December 31, 2024 had contractual maturities of less than one year. No significant available-for-sale securities held as of the periods presented have been in a continuous unrealized loss position for more than 12 months. To date, the Company has not recorded any impairment charges on its investments.

Recurring Fair Value Measurements

As of September 30, 2025, and December 31, 2024, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):


	Assets at Fair Value as of September 30, 2025
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	142,669	$	—	$	—	$	142,669
Money market funds		49,837		—		—		49,837
Total investments	$	192,506	$	—	$	—	$	192,506


	Assets at Fair Value as of December 31, 2024
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	208,087	$	—	$	—	$	208,087
Money market funds		61,432		—		—		61,432
Total	$	269,519	$	—	$	—	$	269,519

NOTE 4. PROLEUKIN^® ACQUISITION

On January 23, 2023, the Company and its wholly owned subsidiary, Iovance Biotherapeutics UK Ltd (the “Purchaser”) entered into an Option Agreement (the “Option Agreement”) with Clinigen Holdings Limited, Clinigen Healthcare Limited, and Clinigen, Inc. (collectively, “Clinigen”), a global pharmaceutical services company, pursuant to which the Purchaser would acquire the worldwide rights for the manufacturing, supply, commercialization and sale of Proleukin^® (aldesleukin) (the “Acquisition”).

On May 18, 2023, the Company completed the Acquisition and specifically acquired (i) all issued and outstanding shares of Clinigen SP Limited (the “Target”), (ii) the business of the Target and Clinigen (the “Proleukin^® Business”) comprising the manufacturing, supply, commercialization and the generation of income from the Product rights and the undertaking of an active role in the development, maintenance and exploitation of those rights, and (iii) certain specified assets identified in the Option Agreement. Pursuant to the Option Agreement, the Company paid to Clinigen (i) an upfront payment of £166.9 million (or approximately $207.2 million), including the applicable stamp-tax payment, and (ii) a payment for certain inventory of £2.4 million (or approximately $3.0 million) using existing cash on hand. The Option Agreement includes potential future contingent payments, as discussed below.

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The Acquisition was accounted for as an asset acquisition because substantially all of the fair value of the acquired assets was concentrated in the acquired developed technology related to the intellectual property rights of Proleukin^® and therefore the Acquisition does not meet the definition of a business in accordance with ASC 805. The Proleukin^® Business operations have been included in the Company’s condensed consolidated financial statements commencing from the acquisition date.

The following table summarizes the total cash consideration and allocated acquisition date fair values of assets acquired and liabilities assumed at the time of the acquisition (in thousands):


		Amounts
Cash	$	35
Inventory		9,688
Developed technology		232,665
Assembled workforce		636
Deferred tax liability		(20,352)
Total Cost of Acquisition	$	222,672

The $222.7 million of total cost of the Acquisition consisted of (i) a $210.2 million of cash payment to Clinigen and (ii) $12.5 million of direct transaction costs incurred by the Company. The Option Agreement additionally provides for contingent cash payments consisting of (i) a milestone payment of £41.7 million, or $52.6 million, upon first approval of lifileucel in advanced melanoma, (ii) deferred consideration based on double digit rates on global net sales (as defined in the Option Agreement) payable from the Company to the sellers following the completion of the Acquisition over a deferred consideration term of twelve years, and (iii) after the deferred consideration term, earnout payments payable from the Company to sellers following the completion of the transaction if deferred consideration payments are equal or greater than the deferred consideration amount provided for in the Option Agreement. These contingent payments were determined to be within the scope of ASC 450 and will be recognized when they are both probable and estimable. During the first quarter of 2024, the Company made the required milestone payment of $52.6 million (£41.7 million) upon the approval of the Company’s BLA of Amtagvi^®, which was capitalized as an intangible asset and is being amortized over the remaining useful life of such asset. Additionally, $17.5 million (£13.9 million) was added to the carrying value of the acquired developed technology intangible asset, which reflects the deferred tax liability recognized on the temporary differences related to the book and tax basis of the acquired intangible assets.

The fair value of the developed technology was estimated using a multi-period excess earnings income approach that discounts expected cash flows to present value by applying a discount rate that represents the estimated rate that market participants would use to value the intangible assets. The fair value of the developed technology is being amortized over an expected useful life of 15 years.

The fair value of the assembled workforce was estimated using a replacement cost less depreciation method. The fair value of the assembled workforce is being amortized over an expected useful life of 3 years.

The weighted average amortization period the developed technology and assembled workforce is 14.8 years.

A deferred tax liability was recognized on the temporary differences related to the book and tax basis of the acquired intangible assets. The deferred tax liability and resulting adjustment to the carrying amount of the acquired intangibles was calculated using the simultaneous equations method under ASC 740. The tax rate used is based on the estimated statutory rates in the UK as this is where the intangible assets are domiciled.

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NOTE 5. INTANGIBLE ASSETS, NET

The gross carrying amounts and net book value of intangible assets as of September 30, 2025 and December 31, 2024, are as follows (in thousands):


	September 30,		December 31,
	2025		2024

Developed technology	$	326,643	$	304,939
Assembled workforce		689		643
Intellectual property license		7,500		7,500
Patents		475		—
Total intangible assets	$	335,307	$	313,082
Less: accumulated amortization		(50,099)		(30,684)
Intangible assets, net	$	285,208	$	282,398

The Company recognized amortization expense of $5.8 million and $16.9 million during the three and nine months ended September 30, 2025, and $5.5 million and $15.7 million during the three and nine months ended September 30, 2024, respectively.

The total estimated amortization of the Company’s intangible assets for the remainder of the year ending December 31, 2025, and the years ending December 31, 2026, 2027, 2028, and 2029 are $5.8 million, $22.9 million, $22.8 million, $22.8 million, and $22.8 million, respectively.

NOTE 6. INVENTORY

As of September 30, 2025 and December 31, 2024, inventory consists of the following (in thousands):


		September 30,		December 31,
		2025		2024
Raw materials	$	35,701	$	27,743
Work in process		6,450		8,765
Finished goods		18,361		15,012
Total inventory	$	60,512	$	51,520

Inventory includes $9.7 million for excess and obsolescence reserves recorded for the nine months ended September 30, 2025, such reserve being 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 while we scale the Amtagvi^® commercial launch.

Inventory expected to be used or sold more than twelve months from the balance sheet date is classified as long-term other assets on the condensed consolidated balance sheet. As of September 30, 2025 the Company recorded $8.8 million of inventory as long-term other assets. There was no long-term inventory recorded as of December 31, 2024.

NOTE 7. REVENUE

Net revenue for the periods presented represents sales of Amtagvi^® and Proleukin^®as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024
Amtagvi^®	$	57,482	$	42,038	$	155,127	$	54,857
Proleukin^®		9,973		16,517		21,604		35,519
Total net revenue	$	67,455	$	58,555	$	176,731	$	90,376

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Revenue from Proleukin^® was primarily related to sales made to specialty distributors and authorized treatment centers (“ATCs”) in the U.S. market to support the commercialization of Amtagvi^®. Amtagvi^® revenue is recognized upon patient infusion, while Proleukin^® revenue is recognized upon transfer of control, either upon shipment or upon delivery to customers, which include specialty distributors, clinical manufacturers, research organizations, and ATCs.

Revenue from product sales was recorded net of GTN adjustments. The following table summarizes GTN adjustments for the periods presented (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024
Gross revenue	$	68,521	$	59,840	$	179,040	$	93,192
GTN adjustments:
Government rebates and chargebacks		(58)		51		(355)		—
Wholesaler fees and cash discounts		(741)		(958)		(1,528)		(1,893)
Other rebates, returns, discounts and adjustments		(267)		(379)		(426)		(923)
Total GTN adjustments		(1,066)		(1,285)		(2,309)		(2,816)
Net revenue	$	67,455	$	58,555	$	176,731	$	90,376

Consolidated net product revenue by geographic area for the periods presented is as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024
United States	$	66,402	$	57,815	$	173,527	$	87,849
Rest of world		1,053		740		3,204		2,527
Net revenue	$	67,455	$	58,555	$	176,731	$	90,376

Net product revenue in the U.S. is comprised of Amtagvi^® revenue, as well as Proleukin^® sales to support the ongoing commercialization of Amtagvi^®. Net product revenue to date for the rest of world is comprised of sales of Proleukin^® into markets outside of the U.S., primarily into European markets.

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The following table summarizes the amount and percentage of gross revenue attributable to customers that represented more than 10% of the Company’s gross revenue and all other customers as a group for the three and nine months ended September 30, 2025 and 2024, respectively (in thousands, except percentages):


	Three Months Ended				Nine Months Ended
	September 30, 2025				September 30, 2025
	$		%		$		%
Customer A	$	*		0%	$	*		0%
Other customers		68,521		100%		179,040		100%
Gross revenue	$	68,521		100%	$	179,040		100%
GTN adjustments		(1,066)				(2,309)
Net revenue	$	67,455			$	176,731

* Represents customer below 10%

	Three Months Ended				Nine Months Ended
	September 30, 2024				September 30, 2024
	$		%		$		%
Customer A	$	12,474		21%	$	16,916		18%
Customer B		—		0%		12,213		13%
Other customers		47,366		79%		64,064		69%
Gross revenue	$	59,840		100%	$	93,192		100%
GTN adjustments		(1,285)				(2,816)
Net revenue	$	58,555			$	90,376

NOTE 8. PROPERTY AND EQUIPMENT, NET

Property and equipment, net consists of the following (in thousands):


	September 30,		December 31,
	2025		2024
Leasehold improvements	$	90,398	$	67,375
Lab, process, and validation equipment		27,704		25,477
Utility equipment		7,306		5,990
Office furniture and equipment		2,586		1,998
Computer software		8,512		8,512
Computer equipment		2,135		448
Machinery and equipment		504		363
Construction in progress		32,829		34,938
Total property and equipment, cost	$	171,974	$	145,101
Less: Accumulated depreciation and amortization		(45,324)		(36,020)
Property and equipment, net	$	126,650	$	109,081

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NOTE 9. ACCRUED EXPENSES

Accrued expenses consist of the following (in thousands):


	September 30,		December 31,
	2025		2024
Accrued payroll and employee related expenses	$	28,141	$	31,910
Clinical related		27,870		13,017
Manufacturing related		10,141		10,084
Facilities related		4,362		6,748
Legal and related services		1,402		2,466
Inventory and distribution related		10,261		12,471
Other accrued expenses		5,090		5,240
Total accrued expenses	$	87,267	$	81,936

NOTE 10. STOCKHOLDERS’ EQUITY

Common Stock

The Company’s certificate of incorporation, as amended, authorizes the issuance of up to 500,000,000 shares of the Company’s common stock, par value $0.000041666. As of September 30, 2025, 385,461,728 shares of the Company’s common stock were issued and outstanding.

Public Offerings

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

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

At the Market Offering Program

On November 18, 2022 , the Company entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies LLC (“Jefferies”). Under the terms of the 2022 Sale Agreement, the Company was able to, from time to time, at its sole discretion, issue and sell through Jefferies, acting as a sales agent, up to $500.0 million of shares of the Company’s common stock. On June 16, 2023, the Company entered into a new Open Market Sale Agreement (the “2023 Sale Agreement”), which superseded and replaced in its entirety the 2022 Sale Agreement, which was terminated by the Company. Under the terms of the 2023 Sale Agreement, the Company was able to, from time to time, in its sole discretion, issue and sell through Jefferies, acting as a sales agent, up to $450.0 million of shares of the Company’s common stock. On August 22, 2025, the Company entered into an Amended and Restated Open Market Sale Agreement (the “2025 Sale Agreement”) with Jefferies. Under the terms of the 2025 Sale Agreement, the Company may, from time to time, in its sole discretion, issue and sell through Jefferies, acting as a sales agent, up to $350.0 million of shares of the Company’s common stock (the “Common Shares”). The issuance and sale, if any, of the shares of common stock by the Company under the 2025 Sale Agreement was or will be made pursuant to a prospectus supplement dated August 22, 2025 to the Company’s Registration Statement on Form S-3ASR, originally filed with the Securities and Exchange Commission on June 16, 2023, which became effective immediately upon filing.

Pursuant to the 2025 Sale Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose). The

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Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the 2025 Sale Agreement.

The Company is not obligated to make any sales of Common Shares under the 2025 Sale Agreement. The offering of Common Shares pursuant to the 2025 Sale Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the 2025 Sale Agreement and (ii) termination of the 2025 Sale Agreement in accordance with its terms.

For the nine months ended September 30, 2025, the Company raised approximately $250.5 million in net proceeds, through the sale of 76,145,523 shares of common stock pursuant to the 2023 and 2025 Sale Agreements at a weighted average price per share of $3.36. For the nine months ended September 30, 2024, the Company raised approximately $200.0 million in net proceeds, after offering costs, through the sale of 23,127,726 shares of common stock pursuant to the 2023 Sale Agreement at a weighted average price per share of $8.82.

Preferred Stock

The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. As of September 30, 2025, 17,000 shares were designated as Series A Convertible Preferred Stock and 11,500,000 shares were designated as Series B Convertible Preferred Stock.

Series A Convertible Preferred Stock

A total of 17,000 shares of Series A Convertible Preferred Stock have been authorized for issuance under the Company’s Certificate of Designation of Preferences and Rights of Series A Convertible Preferred Stock. The shares of Series A Convertible Preferred Stock have a stated value of $1,000 per share and are initially convertible into shares of common stock at a price of $2.00 per share, subject to adjustment. Each share of Series A Preferred Stock is initially convertible into 500 shares of common stock.

The Series A Convertible Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of common stock. The holders of shares of Series A Convertible Preferred Stock do not have the right to vote on matters that come before the Company’s stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of common stock and preferred stock, pro rata based on the number of shares held by each holder. The Company may not declare, pay, or set aside any dividends on shares of capital stock of the Company (other than dividends on shares of common stock payable in shares of common stock) unless the holders of the Series A Convertible Preferred Stock shall first receive an equal dividend on each outstanding share of Series A Convertible Preferred Stock.

During nine months ended September 30, 2025 and 2024, no shares of Series A Convertible Preferred Stock were converted into shares of common stock. As of September 30, 2025 and December 31, 2024, 194 shares of Series A Convertible Preferred Stock (that are convertible into 97,000 shares of common stock) remained outstanding.

Series B Convertible Preferred Stock

A total of 11,500,000 shares of Series B Convertible Preferred Stock are authorized for issuance under the Company’s Series B Certificate of Designation of Rights, Preferences and Privileges of Series B Convertible Preferred Stock. The shares of Series B Convertible Preferred Stock have a stated value of $4.75 per share and are convertible into shares of the Company’s common stock at an initial conversion price of $4.75 per share. Each share of Series B Preferred Stock is initially convertible into 1 share of common stock.

The Series B Convertible Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of common stock. The holders of Series B Convertible Preferred Stock do not have the right to vote on matters that come before the Company’s stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of common stock and preferred stock, pro rata based on the number of shares held by each holder. Holders of Series B Convertible Preferred Stock are entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of the Series A Convertible Preferred Stock or the Company’s common stock. So long as any Series B Convertible Preferred Stock remains outstanding, the Company may not redeem, purchase, or otherwise acquire any material amount of the Series A Convertible Preferred Stock or any securities junior to the Series B Convertible Preferred Stock.

During the nine months ended September 30, 2025, 909,491 shares of Series B Convertible Preferred Stock were converted into 909,491 shares of common stock. No shares of Series B Convertible Preferred Stock were converted into shares of common stock for

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the nine months ended September 30, 2024. As of September 30, 2025 and December 31, 2024, 1,932,667 and 2,842,158 shares of Series B Preferred Stock (that are convertible into 1,932,667, and 2,842,158 shares of common stock) remained outstanding, respectively.

Equity Incentive Plans

The Company has multiple equity incentive plans under which it grants awards.

As of June 11, 2024, the Company’s stockholders approved the termination of the 2014 Equity Incentive Plan (the “2014 Plan”). In addition, the Company’s stockholders approved the recapture by the 2018 Equity Incentive Plan (the “2018 Plan”) of awards granted under the 2014 Plan that expire, terminate, or are cancelled or forfeited without being settled, vested, or exercised after the stockholders’ approval.

On April 22, 2018, the Company’s Board of Directors (the “Board”) adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan, (the “2018 Plan”), which was approved by the Company’s stockholders in June 2018. The 2018 Plan as approved initially authorized the issuance up to an aggregate of 6,000,000 shares of the common stock in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. On June 8, 2020, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 6,000,000 to 14,000,000 shares, which became effective immediately. Additionally on June 10, 2022, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 14,000,000 to 20,700,000 shares, which became effective immediately. On June 6, 2023, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 20,700,000 to 29,700,000 shares, which became effective immediately. On June 11, 2024, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 29,700,000 to 36,700,000 shares and permit share recapture from the 2014 Plan, which became effective immediately. On June 10, 2025, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 36,700,000 to 49,200,000 shares and permit share recapture from the 2014 Plan, which became effective immediately. As of September 30, 2025, 4,997,998 shares of the Company’s common stock were available for grant under the 2018 Plan, including shares recaptured from the 2014 Plan.

On September 22, 2021, the Board adopted the Iovance Biotherapeutics, Inc. 2021 Inducement Plan (the “2021 Inducement Plan”). The 2021 Inducement Plan provides for the grant of non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards, or any combination of the foregoing. The 2021 Inducement Plan was recommended for approval by the Compensation Committee of the Board (the “Compensation Committee”), and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the rules and regulations of The Nasdaq Stock Market LLC (the “Nasdaq Listing Rules”).

The Board initially reserved 1,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the 2021 Inducement Plan, and the 2021 Inducement Plan is administered by the Compensation Committee. On January 12, 2022, the Compensation Committee approved an amendment to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,000,000 shares of the Company’s common stock to 1,750,000 shares of the Company’s common stock without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The Compensation Committee approved additional amendments to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,750,000 to 2,250,000 shares of the Company’s common stock on March 13, 2023 from 2,250,000 to 2,750,000 shares of the Company’s common stock on February 26, 2024, and from 2,750,000 shares to 4,750,000 shares on November 22, 2024 without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Inducement Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). As of September 30, 2025, 71,644 shares of the Company’s common stock were available for grant under the Inducement Plan.

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Stock Options

A summary of the status of stock options as of September 30, 2025 and the changes during the nine months ended September 30, 2025 are presented in the following table:


				Weighted
		Weighted		Average
	Number	Average		Remaining	Aggregate
	of	Exercise		Contract	Intrinsic
	Options	Price		Life (Years)	Value
Outstanding at December 31, 2024	18,218,126	$	17.41		$
Issued	2,796,340		3.21
Exercised	(2,586)		5.80
Expired/Cancelled	(2,399,744)		16.11
Outstanding at September 30, 2025	18,612,136	$	15.45	5.69	$	156,556
Ending vested and expected to vest at September 30, 2025	18,612,136	$	15.45	5.69	$	156,556
Options exercisable at September 30, 2025	14,335,734	$	18.48	4.70	$	—

As of September 30, 2025, there was $13.7 million of total unrecognized compensation expense related to unvested employee stock options. The unrecognized compensation expense is estimated to be recognized over a period of 2.08 years as of September 30, 2025. The weighted average grant date fair value for employee options granted under the Company’s stock option plans during the nine months ended September 30, 2025 was $2.33 per option.

The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the quarter ended September 30, 2025 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on September 30, 2025. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

Employee Stock Purchase Plan

In June 2020, the Company adopted the 2020 ESPP upon its approval by the Company’s shareholders at its Annual Stockholders Meeting on June 8, 2020. The Company reserved 500,000 shares of its common stock for issuance under the 2020 ESPP. On June 6, 2023, the Company's stockholders approved an amendment to the 2020 ESPP to increase the number of shares reserved for issuance under the 2020 ESPP from 500,000 shares of the Company’s common stock to 1,400,000 shares of the Company’s common stock, which became effective immediately. On June 11, 2024, the Company's stockholders approved an amendment to the 2020 ESPP, to increase the number of shares reserved for issuance under the 2020 ESPP from 1,400,000 to 1,900,000 shares of the Company’s common stock, which became effective immediately. On June 10, 2025, the Company’s stockholders approved an amendment to the 2020 ESPP, to increase the number of shares reserved for issuance under the 2020 ESPP from 1,900,000 to 2,900,000 shares of the Company’s common stock, which became effective immediately.

Under the 2020 ESPP, employees of the Company can purchase shares of its common stock based on a percentage of their compensation subject to certain limits. The purchase price per share is equal to the lower of 85% of the fair market value of its common stock on the offering date or the purchase date with a six-month look-back feature. The 2020 ESPP purchases are settled with common stock from the 2020 ESPP’s previously authorized and available pool of shares.

The compensation expense related to the 2020 ESPP for the three and nine months ended September 30, 2025 was $0.3 million, and $1.0 million, respectively. The compensation expense related to the 2020 ESPP for the three and nine months ended September 30, 2024 was $0.4 million, and $1.1 million, respectively. As of September 30, 2025, there was $0.3 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over the remaining 2.33 months.

Restricted Stock Units and Performance Restricted Stock Units

In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). Compensation expense related to

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PRSUs is based on the grant date fair value of the award and recorded from the period that achievement is determined to be probable through the stated service period associated with the award.

A summary of the status of RSUs and PRSUs as of September 30, 2025 and the changes during the nine months ended September 30, 2025 are presented in the following table:


		Weighted
	Number	Average
	of	Grant Date
	RSUs and PRSUs	Fair Value
Outstanding at December 31, 2024	9,547,643	$	15.08
Granted	7,069,396		3.96
Vested/Released	(4,651,490)		15.91
Canceled/Forfeited	(2,081,172)		8.91
Outstanding at September 30, 2025	9,884,377	$	8.04
Ending vested and expected to vest at September 30, 2025	9,588,558	$	8.02

As of September 30, 2025, there was $55.8 million of unrecognized stock-based compensation expense associated with unvested RSUs and PRSUs, which the Company expects to recognize over a remaining weighted-average period of 1.99 years. The aggregate intrinsic value of the unvested RSUs and PRSUs outstanding as of September 30, 2025 was $21.4 million.

Stock-Based Compensation

Total stock-based compensation expense by type of award was as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024
Stock option expense	$	2,810	$	5,050	$	10,088	$	16,080
Restricted stock expense		8,808		25,528		38,688		61,470
ESPP expense		282		428		982		1,100
Total stock-based compensation expense	$	11,900	$	31,006	$	49,758	$	78,650

The amount included in capitalized inventory for stock-based compensation expense for personnel engaged with manufacturing activities was $0.7 million as of September 30, 2025, and $1.2 million as of December 31, 2024.

NOTE 11. RESTRUCTURING

In August 2025, the Company announced a strategic restructuring plan with an associated reduction in workforce as a result of a review of current strategic priorities, resource allocation, and cost reduction intended to reduce operating costs, streamline operations and extend its cash runway. In connection with the restructuring plan, the Company recognized severance and other charges of $5.1 million for the three and nine months ended September 30, 2025, primarily related to severance payments, costs for outplacement services, and post-employment benefits. The workforce reduction was substantially complete by end of September 30, 2025 and cash payments for severance and other charges of $3.8 million were made during the third quarter of 2025.

NOTE 12. SEGMENT INFORMATION

The Company operates in one segment, focusing on innovating, developing, and commercializing therapies using its autologous TIL cell therapies for patients with solid tumor cancers. The Company is executing the U.S. launch of Amtagvi^®, the first product within its autologous TIL cell therapy platform, while also marketing and distributing its Proleukin^® product used in the Amtagvi^® treatment regimen.

The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer, who uses net loss as measurement of segment loss and monitors results against budget to evaluate and assess performance of the Company and resource allocation within the Company. The measure of segment assets is reported on the balance sheet as total consolidated assets.

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Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the condensed consolidated statement of operations as well as in its internal reporting to the CODM. As a result, the Company has recast prior period amounts to align with the information that is used by the CODM.

The table below highlights the Company’s revenue, expenses and net loss for the segment and is reconciled to net loss on a consolidated basis for the three and nine months ended September 30, 2025 and 2024.


	Three Months Ended				Nine Months Ended
	September 30,					September 30,
(in thousands)	2025		2024		2025		2024
Net sales	$	67,455	$	58,555	$	176,731	$	90,376

Cost of sales
Cost of goods sold (excluding depreciation and amortization) (a)	$	34,734	$	24,507	$	119,206	$	41,941
Stock-based Compensation		1,408		3,065		5,977		5,362
Royalties		2,335		3,946		4,890		8,156
Total cost of sales	$	38,477	$	31,518	$	130,073	$	55,459

Expenses
Research and development	$	70,163	$	53,233	$	207,780	$	169,396
General and administrative		17,865		19,010		61,286		54,476
Sales and marketing		11,209		6,188		32,141		18,009
Depreciation and amortization		9,007		9,731		26,422		28,450
Restructuring charges		5,143		-		5,143		-
Other segment items (b)		6,844		22,416		32,960		58,204
Total expenses	$	120,231	$	110,578	$	365,732	$	328,535

Net loss	$	(91,253)	$	(83,541)	$	(319,074)	$	(293,618)


a)	Cost of goods sold represents inventory and period costs related to overhead, manufacturing costs of Amtagvi^®, and reserves associated with excess and obsolete inventory, as well as costs associated with the purchases and sales of Proleukin^®. Also included are manufacturing and period costs incurred for Amtagvi^® that do not meet specifications or a patient is unable to receive the infusion unless they can be administered as part of a clinical trial in an expanded or early access program, or single-patient IND, in which cases related costs are recorded as research and development expenses based on the fact the Company receives clinical data related to these infusions. This category is provided to the CODM on a quarterly basis in comparison to that of previous quarters for review as these costs are controllable costs that indicate operating performance of the Company.
b)	Other segment items include costs that are not considered significant expense segments nor reviewed by the CODM on a regular basis. Such amount includes stock-based compensation expenses (excluding stock-based compensation included in cost of sales), interest income, other income and expenses, and income tax benefits.

NOTE 13. LICENSES AND AGREEMENTS

National Institutes of Health (the “NIH”) and the National Cancer Institute (the “NCI”)

Cooperative Research and Development Agreement (the “CRADA”)

In August 2011, the Company signed a five-year CRADA with the NCI to work on the development of adoptive cell immunotherapies in multiple solid tumor types, including unmodified TIL as a stand-alone therapy or in combination, improved methods for the generation and selection of TIL cell therapy with anti-tumor reactivity, and strategies for more potent TILs. The CRADA has been amended since then to, among other things, extend the term of the CRADA, include new indications such as bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers, and modify the focus on the

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development of unmodified TIL as a stand-alone therapy or in combination and the evaluation in clinical trials of strategies for development of more potent TILs.

In July 2024, the NCI and the Company entered into a fourth amendment to the CRADA to extend its term by an additional five years to August 2029. The fourth amendment includes collaboration on preclinical and clinical development of enhanced tumor reactive TIL products for the treatment of a broad range of common epithelial cancers.

Pursuant to the terms of the CRADA, as amended, the Company is required to make quarterly payments to the NCI for support of research activities through the end of the CRADA’s term. To the extent the Company licenses patent rights relating to a TIL-based product candidate, the Company will be responsible for all patent-related expenses and fees, past and future, relating to the TIL-based product candidate. In addition, the Company may be required to supply certain test articles, including TIL, grown and processed under Current Good Manufacturing Practice (“cGMP”) conditions, suitable for use in clinical trials. The Company or the NCI may unilaterally terminate the CRADA for any reason or for no reason at any time by providing written notice at least 60 days before the desired termination date. The Company recorded costs associated with the CRADA of $0.9 million and $2.6 million, for the three and nine months ended September 30, 2025 and $0.5 million and $1.5 million for the three and nine months ended September 30, 2024, respectively, as research and development expenses.

Patent License Agreement Related to the Development and Manufacture of TIL Cell Therapies

The Company entered into an Exclusive Patent License Agreement (the “Patent License Agreement”) with the NIH, an agency of the U.S. Public Health Service within the Department of Health and Human Services, in 2011, as amended in 2015. Pursuant to the Patent License Agreement, as amended, the NIH granted the Company licenses, including exclusive, co-exclusive, and non-exclusive licenses, to certain technologies relating to autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, lung, breast, bladder, and HPV-positive cancers.

In May 2021, the Company entered into an Amended and Restated Patent License Agreement with NIH, which included the grant of additional exclusive, worldwide patent rights in the indications to interleukin-15 and interleukin-21 cytokine-tethered TIL technology, and expanded the non-exclusive, worldwide field of use to all cancers. In August 2022, the Company entered into a Second Amended and Restated Patent License Agreement with NIH to include additional exclusive, worldwide patent rights to TIL products expressing interleukin-12, expanded rights to TIL selection technologies previously licensed under the Exclusive Patent License Agreement below, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.

The Second Amended and Restated Patent License Agreement requires the Company to pay royalties based on a percentage of net sales in jurisdictions where patent rights exist, which percentage can fall into a tier that may be less than one percent to mid-single digits depending upon certain events, including the exclusivity of the rights, and the Company expects lower overall royalty payments as a result. The Company is also required to pay potential milestone payments on the achievement of certain clinical, regulatory, and commercial sales milestones for each of the indications and other direct costs incurred by the NIH pursuant to the Second Amended and Restated Patent License Agreement. The Company has made and anticipates making additional payments that could range from several hundred thousand dollars to the mid-single-digit millions of dollars in conjunction with certain development milestones, the approval of a BLA or its foreign equivalent, or the first U.S. and foreign commercial sales of any of its product candidates covered by the Second Amended and Restated Patent License Agreement. The term of the Second Amended and Restated Patent License Agreement continues until the expiry of the last-to-expire patent rights licensed thereunder, and the agreement contains standard termination provisions. The Company paid and recorded a $0.6 million milestone payment for an intellectual property license that was payable within 60 days of successful completion of the first Company sponsored Phase 2 clinical study in melanoma, as research and development expenses, for the year ended December 31, 2023. The Company also paid a $1.5 million milestone payment for an intellectual property license that was payable within 60 days of the approval of Amtagvi^® for use in the treatment of melanoma, and a $6.0 million milestone payment for an intellectual property license that was payable within 60 days of the approval of the first commercial sale of Amtagvi^® for use in the treatment of melanoma in the U.S. in accordance with the requirements of the Second Amended and Restated Patent License Agreement. Both aforementioned milestone payments have been capitalized and recorded as intangible assets on the condensed consolidated balance sheet. The Company recorded $0.2 million and $0.6 million, for the three and nine months ended September 30, 2025, and $0.2 million and $0.5 million for the three and nine months ended September 30, 2024, respectively.

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Exclusive Patent License Agreement Related to TIL Selection

On February 10, 2015, the Company entered into an exclusive patent license agreement (the “Exclusive Patent License Agreement”) with the NIH under which the Company received an exclusive, worldwide license under the selected TIL patents. This license was superseded and replaced by the Second Amended and Restated Patent License Agreement.

H. Lee Moffitt Cancer Center

Research Collaboration and Clinical Grant Agreements with Moffitt

In June 2020, the Company entered into a Sponsored Research Agreement (the “SRA”) with the H. Lee Moffitt Cancer Center (“Moffitt”), with a term that ended either upon completion of the research thereunder or on July 1, 2022, whichever is sooner. The SRA has been extended multiple times and has expired as of May 31, 2025. For the three and nine months ended September 30, 2025, the Company recorded a de minimus amount, as research and development costs. For the three and nine months ended September 30, 2024, the Company recorded $0.1 million and $0.2 million, respectively, as research and development costs.

The University of Texas M.D. Anderson Cancer Center

Strategic Alliance Agreement

In April 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with The University of Texas M.D. Anderson Cancer Center (“MDACC”), under which the Company and MDACC agreed to conduct clinical and preclinical research studies. The Company agreed in the SAA to provide total funding not to exceed approximately $14.2 million for the performance of the multi-year studies under the SAA, of which approximately $5.3 million has been funded to date and has been recorded as research and development expense. In return, the Company acquired all rights to inventions resulting from the studies and has been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of MDACC reasonably necessary to exploit, including the commercialization thereof. The Company has also been granted certain rights in clinical data generated by MDACC outside of the clinical trials to be performed under the SAA. The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by the Company of all deliverables due from MDACC thereunder. On March 28, 2024, the Company and MDACC entered into the first amendment to the SAA, under which both parties agreed to conduct additional preclinical research studies. There was no activity for the three and nine months ended September 30, 2025 under this agreement. For the three months ended September 30, 2024, the Company recorded a de minimis cost as a research and development cost, and a benefit of $0.4 million for the nine months ended September 30, 2024 as a result of finalization of the cost reconciliation.

Minaris Advanced Therapies

In November 2016, the Company entered into a manufacturing services agreement (the “First MSA”) with WuXi Apptec, Inc. (“WuXi Apptec”) pursuant to which WuXi Apptec agreed to provide manufacturing and other services for two cGMP manufacturing suites for clinical manufacturing and related testing services. The First MSA was amended and restated in December 2017, further amended and restated and assigned to the Company’s subsidiary Iovance Biotherapeutics Manufacturing LLC (“Iovance Manufacturing LLC”), and Wuxi Advanced Therapies, Inc. in January 2020, and further amended in November 2020 and December 2021. The First MSA expired in November 2022.

In October 2022, Iovance Manufacturing LLC entered into an additional three-year manufacturing and services agreement (the “Second MSA”) with WuXi Advance Therapies, Inc. and its parent company, WuXi Apptec Co., Ltd (collectively, “WuXi”), which, following the acquisition of WuXi, was amended in May 2025 to replace WuXi as party to the Second MSA with Advanced Therapies, LLC (operating under a trade name of Minaris Advanced Therapies, or “Minaris”). Under the Second MSA, Iovance Manufacturing LLC entered into a statement of work for two cGMP manufacturing suites to be operated by Minaris for Iovance Manufacturing LLC to support clinical and commercial manufacturing and related testing services. The Second MSA and its related statement of work superseded the statements of work under the First MSA with respect to manufacturing in the two suites and had an original expiration date of December 31, 2025, which was extended through the end of January 2026. Iovance Manufacturing LLC may unilaterally terminate the statement of work for clinical and commercial manufacturing with written notice of written notice of 6 months in year 3 of the term. The Company recorded costs associated with agreements with Minaris of $5.6 million and $6.8 million for the three months ended September 30, 2025 and 2024, respectively, and $20.1 million and $16.4 million for the nine months ended September 30, 2025 and 2024, respectively, as costs and expenses included in the condensed consolidated statement of operations or as inventory in the condensed consolidated balance sheets.

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Cellectis S.A.

In December 2019, the Company entered into a research collaboration and exclusive worldwide license agreement whereby the Company will license gene-editing technology from Cellectis S.A. (“Cellectis”), a clinical-stage biopharmaceutical company, to develop TIL cell therapies that have been genetically edited, including a PD-1 inactivated product that the Company refers to as IOV-4001. Financial terms of the license include annual license payments and development, regulatory and sales milestone payments from the Company to Cellectis, as well as royalty payments based on net sales of TALEN^®-modified TIL products. The Company recorded costs associated with the license agreement with Cellectis of $0.1 million and $0.3 million for each of the three and nine months ended September 30, 2025 and 2024, respectively, as research and development expense.

Novartis Pharma AG and Related Entities

In January 2020, the Company obtained a license from Novartis Pharma AG (“Novartis”) to develop and commercialize an antibody cytokine engrafted protein, which the Company refers to as IOV-3001. Under the agreement, the Company paid an upfront payment to Novartis and may pay future milestones related to initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S., EU and Japan. Novartis is also entitled to low-to-mid single digit percentage royalties from commercial sales of the product. The Company recorded costs associated with the license agreement from Novartis of $10.0 million as research and development expenses for the year ended December 31, 2020. The Company recorded zero and $2.5 million related to the initiation of patient dosing for the three and nine months ended September 30, 2025. No expenses were recorded for the three and nine months ended September 30, 2024.

On May 18, 2023, as part of the completion of the Acquisition, the Company inherited two historical asset purchase agreements, one historical master cell bank license and working cell bank transfer agreement and one historical license agreement from Clinigen with Novartis AG, Novartis Pharma AG and Novartis Vaccines and Diagnostics, Inc. pursuant to which, among other things, the Company may be required to make future milestone payments based on net sales (as defined in the relevant underlying agreements) in the U.S. and the rest of world, which includes any and all sales outside of the U.S. The maximum amount of these milestone payments payable under these agreements is $30.0 million upon reaching several certain net sales amounts in the U.S. and $15.0 million upon reaching several certain net sales amounts in the rest of the world, of which 25% of each milestone payment will be reimbursed by Clinigen by deduction from the deferred consideration due under the Option Agreement in the period such milestone payment is made. To date, the net sales milestones have not been achieved, and, therefore, no payments were made under these agreements for either the three and nine months ended September 30, 2025 and 2024.

Boehringer Ingelheim Biopharmaceuticals GmbH

On May 18, 2023 as part of the completion of the Acquisition, the Company inherited a manufacturing and supply agreement from Clinigen with Boehringer Ingelheim Biopharmaceuticals GmbH (“BI”) pursuant to which BI will carry out the processing, manufacturing and supply of Proleukin^® in unlabeled vials. The term of this agreement is through October 2025, with automatic renewals for a period of two years unless terminated as permitted by the contract. In September 2025, the agreement was amended and extended through December 31, 2028. Under this amended agreement, the Company must purchase a minimum number of vials each year at fixed prices. The total estimated purchase obligations under this agreement for the remainder of the year ending December 31, 2025, and the years ending December 31, 2026, 2027 and 2028 are nil, $32.2 million, $8.5 million and $25.3 million, respectively.

NOTE 14. LEASES

Operating Leases

The Company leases corporate office space in San Carlos, California, manufacturing, research and development lab facilities and office space in Philadelphia, Pennsylvania, including 136,000 square feet of commercial manufacturing and lab space at the iCTC, and research and development lab facilities in Tampa, Florida. The determination whether an arrangement is a lease occurs at inception, and for leases with terms greater than 12 months, the Company records a related right-of-use asset and lease liability at the present value of lease payments over the term. Many leases include fixed rental escalation clauses, renewal options and/or termination options that are factored into the determination of lease payments when appropriate. The Company’s leases do not provide an implicit rate, and thus the Company estimated the incremental borrowing rate in calculating the present value of the lease payments.

The Company’s leases have remaining lease terms that range from less than one year to approximately 16 years. Some of the Company’s leases include one or more options to renew with renewal terms that can extend the lease for additional years, or options to terminate the leases, both at the Company’s discretion. The Company’s leases may include options to extend or terminate the lease,

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which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense for minimum lease payments is recognized on a straight-line basis based on the fixed components of a lease arrangement.

Variable lease cost is determined based on performance or usage in accordance with the contractual agreements, and not based on an index or rate. Such costs that are not fixed in nature are recognized as incurred.

The Company also leases certain furniture and equipment that has a lease term of 12 months or less. Since the lease agreements do not include an option to purchase the underlying asset, the Company elected not to apply the recognition requirements of Topic 842 for short-term leases, however, the lease costs that pertain to the short-term leases are disclosed in the components of lease costs table below.

Relocation of the Headquarters Office Lease

On November 15, 2024, the Company entered into a sublease agreement (the “New Headquarters Lease”) to relocate its office within the same building of its former San Carlos headquarters to lease approximately 16,731 square feet office space with the lease term of 24 months. The New Headquarters Lease commenced on December 15, 2024 and includes two options to extend the terms of the lease for 12 months each, exercisable under certain conditions and at a rate increase by 3% from the applicable monthly base rent of approximately $0.1 million. Upon the commencement date, the Company recognized operating lease liabilities and right-of-use assets of $2.3 million.

Simultaneously, the Company entered into an Agreement for Termination of Lease and Voluntary Surrender of Premises with its landlord related to its lease for its then existing and now former headquarters location to surrender 49,918 square feet office and laboratory space and paid an early lease termination payment to its landlord of $0.6 million and $2.5 million of related brokerage fees. In accordance with ASC 842, the termination of this lease resulted in derecognition of right-of-use assets and corresponding lease liabilities of $13.7 million and $22.3 million, respectively, which resulted in a $8.6 million gain, partially offset by the aforementioned lease termination related fees, recorded as interest and other income, net in the consolidated statement of operations for the year ended December 31, 2024.

In addition, as a result of the early termination of the former headquarters lease, the Company impaired approximately $7.4 million of long-lived assets, which included leasehold improvements, and furniture and fixtures, previously funded by the landlord through a tenant improvement allowance for the former corporate headquarters office lease (as discussed further below), and is included in the research and development expenses and selling, general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2024.

Manufacturing Contracts

The Company uses contract manufacturing organizations (collectively, the “CMOs” and each a “CMO”) to manufacture and supply TILs for clinical and commercial purposes. The CMO contractual obligations consist of the use of manufacturing facilities and minimum fixed commitment fees, such as personnel, general support fees, and minimum production or material fees. In addition to the minimum fixed commitment fees, the CMO contractual obligations include variable costs such as production and material costs in excess of the minimum quantity specified in each CMO agreement. During the term of each CMO agreement, the Company has access to and control of the use of a dedicated suite in each of the CMOs’ facilities for manufacturing activities. The contracts with CMOs generally contain embedded operating leases based on the fact that the suites are used for the Company’s production are implicitly identified, are used exclusively by the Company during the contractual term of the arrangements, and the CMOs have no substantive contractual rights to substitute the facilities used by the Company.

Further, the Company controls the use of the facilities by obtaining all of the economic benefits from the use of the facilities and directs the use of the facilities throughout the period of use. The terms of the CMO contracts include options to terminate the lease with advance notice of five to nine months. The termination clauses and extension clauses are included in the calculation of the lease term for each of the CMOs when it is reasonably certain that it will not exercise such options.

For contracts with multiple deliverables, Topic 842 requires the Company to first identify a lease deliverable and non-lease deliverable included in the arrangements, and then allocate the fixed contractual consideration to the lease deliverable(s) and the non-lease deliverable(s) on a relative standalone selling price basis to determine the amount of operating lease right-of-use assets and liabilities. The Company identified the use of a dedicated suite as a single lease deliverable, and related labor services as a single non-lease deliverable in each of the CMO arrangements. Judgment is required to determine the relative standalone selling price of each

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deliverable as the observable standalone selling prices are not readily available. Therefore, management uses estimates and assumptions in determining relative standalone selling price of lease of a suite and labor service using information that includes market and other observable inputs to the extent possible.

The balance sheet classification of the Company’s right-of-use asset and lease liabilities was as follows (in thousands):


	September 30,		December 31,
	2025		2024
Operating lease right-of-use assets	$	48,763	$	55,201
Operating lease liabilities
Current portion included in current liabilities	$	6,281	$	12,896
Long-term portion included in non-current liabilities		45,211		44,365
Total operating lease liabilities	$	51,492

IOVANCE BIOTHERAPEUTICS, INC. 10-Q