SEC Filing – IOVANCE Biotherapeutics, Inc.

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IOVANCE BIOTHERAPEUTICS, INC._June 30, 2026

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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 June 30, 2026

☐	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 ☐	Accelerated filer þ
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 July 29, 2026, the issuer had 452,971,432 shares of common stock, par value $0.000041666 per share, outstanding.

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IOVANCE BIOTHERAPEUTICS, INC.

FORM 10-Q

For the Quarter Ended June 30, 2026

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	34
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	46
Item 4.	Controls and Procedures	47
PART II OTHER INFORMATION
Item 1.	Legal Proceedings	47
Item 1A.	Risk Factors	47
Item 2.	Unregistered Sales of Securities, Use of Proceeds, and Issuer Purchases of Equity Securities	103
Item 3.	Defaults Upon Senior Securities	103
Item 4.	Mine Safety Disclosure	103
Item 5.	Other Information	103
Item 6.	Exhibits	104
SIGNATURES		105

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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, design, 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 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.

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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.

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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)


		June 30,			December 31,
		2026			2025
ASSETS

Current Assets
Cash and cash equivalents		$	110,768		$	163,078
Trade accounts receivable			102,119			82,448
Short-term investments			186,906			133,902
Inventory			55,590			51,678
Prepaid expenses and other assets			8,874			11,583
Total Current Assets			464,257			442,689

Property and equipment, net			131,464			131,112
Intangible assets, net			263,894			279,324
Operating lease right-of-use assets			43,480			45,899
Restricted cash			6,005			5,980
Long-term assets			6,431			8,166
Total Assets		$	915,531		$	913,170

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current Liabilities
Accounts payable		$	26,211		$	22,159
Accrued expenses and other liabilities			77,964			111,156
Note payable - current			—			1,000
Operating lease liabilities			2,673			4,043
Total Current Liabilities			106,848			138,358

Non-Current Liabilities
Operating lease liabilities – non-current			43,330			44,401
Deferred tax liabilities			29,308			31,828
Total Non-Current Liabilities			72,638			76,229
Total Liabilities			179,486			214,587

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 June 30, 2026 and December 31, 2025			—			—
Series B Convertible Preferred stock, $0.001 par value; 11,500,000 shares designated, 1,932,667 shares issued and outstanding as of June 30, 2026 and December 31, 2025			2			2
Common stock, $0.000041666 par value; 650,000,000 shares authorized, 452,971,016 and 411,938,061 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively			19			17
Accumulated other comprehensive income			13,078			16,440
Additional paid-in capital			3,624,836			3,457,654
Accumulated deficit			(2,901,890)			(2,775,530)
Total Stockholders’ Equity			736,045			698,583
Total Liabilities and Stockholders’ Equity		$	915,531		$	913,170

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

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IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(unaudited; in thousands, except per share information)


	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2026			2025			2026			2025
Revenue
Product revenue, net	$	99,313		$	59,952		$	170,743		$	109,276
Total revenue		99,313			59,952			170,743			109,276

Costs and expenses *
Cost of sales **	$	43,595		$	48,881		$	86,093		$	91,595
Research and development **		58,851			77,928			121,338			153,895
Selling, general, and administrative **		39,272			37,567			78,221			81,366
Depreciation and amortization		9,500			9,350			18,039			17,415
Total costs and expenses	$	151,218		$	173,726		$	303,691		$	344,271
Loss from operations		(51,905)			(113,774)			(132,948)			(234,995)
Other income
Interest and other income, net		3,217			4,104			4,550			7,324
Net Loss before income taxes	$	(48,688)		$	(109,670)		$	(128,398)		$	(227,671)
Income tax benefit (expense)		1,373			(1,988)			2,038			(150)
Net Loss	$	(47,315)		$	(111,658)		$	(126,360)		$	(227,821)
Net Loss Per Share of Common Stock, Basic and Diluted	$	(0.11)		$	(0.33)		$	(0.29)		$	(0.69)
Weighted Average Shares of Common Stock Outstanding, Basic and Diluted		450,189			334,511			434,437			328,721

* Non-cash stock-based compensation included in cost of sales and operating expenses
Cost of sales	$	1,536		$	2,149		$	2,555		$	4,569
Research and development		5,078			6,359			10,195			16,276
Selling, general, and administrative		5,119			6,435			10,252			17,013
	$	11,733		$	14,943		$	23,002		$	37,858
** 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						Six Months Ended
	June 30,						June 30,
	2026			2025			2026			2025
Net Loss	$	(47,315)		$	(111,658)		$	(126,360)		$	(227,821)
Other comprehensive loss:
Unrealized loss on investments		(52)			(30)			(137)			(140)
Foreign currency translation adjustment		480			14,595			(3,225)			22,045
Comprehensive Loss	$	(46,887)		$	(97,093)		$	(129,722)		$	(205,916)

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 June 30, 2026 and 2025

(unaudited; in thousands, except share information)


		Series A					Series B
		Convertible					Convertible										Additional			Accumulated Other						Total
		Preferred Stock					Preferred Stock					Common Stock					Paid-In			Comprehensive			Accumulated			Stockholders’
		Shares		Amount			Shares		Amount			Shares		Amount			Capital			Income			Deficit			Equity
Balance - March 31, 2026		194		$	—		1,932,667		$	2		438,106,537		$	18		$	3,563,659		$	12,650		$	(2,854,575)		$	721,754
Stock-based compensation expense		—			—		—			—		—			—			11,890			—			—			11,890
Common stock issued upon purchase of employee stock purchase plan		—			—		—			—		448,277			—			861			—			—			861
Vesting of restricted shares issued for services		—			—		—			—		691,716			—			—			—			—			—
Tax payments related to shares retired for vested restricted stock units		—			—		—			—		(284,889)			—			(1,166)			—			—			(1,166)
Common stock issued upon exercise of stock options		—			—		—			—		8,632			—			26			—			—			26
Common stock sold in public and/or at the market offering, net of offering costs		—			—		—			—		14,000,743			1			49,566			—			—		<