Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures:
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As of the end of the period covered by this Annual Report on Form 10-K, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
(b) Management’s Annual Report on Internal Control Over Financial Reporting:
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024, based on the framework in Internal Control—Integrated Framework 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO. Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2025.
The independent registered public accounting firm, Ernst and Young LLP, has issued an audit report on our internal control over financial reporting. The report on the audit of internal control over financial reporting is included in this Annual Report on Form 10-K.
(c) Changes in Internal Control Over Financial Reporting:
There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
During the fourth quarter of 2025, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) for the purchase or sale of securities of the Company, whether or not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
During the fourth quarter of 2025, the Company did no t adopt or terminate a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) for the purchase or sale of securities of the Company, whether or not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
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PART III
Certain information required by Part III is omitted from this Annual Report on Form 10-K because we will file a definitive Proxy Statement for the Annual Meeting of Stockholders pursuant to Regulation 14A of the Securities Exchange Act of 1934 (the Proxy Statement), not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and the applicable information included in the Proxy Statement is incorporated herein by reference.
Item 10. Directors, Executive Officers, and Corporate Governance
Information required by this Item 10 will be presented in the Proxy Statement “Election of Directors,” “Management Executive Officers,” “Section 16(a) Beneficial Ownership Reporting Compliance” and “Board of Directors and Corporate Governance,” and is incorporated herein by reference.
Item 11. Executive Compensation
The information required by this Item 11 is incorporated herein by reference to the sections entitled “Executive Compensation,” “Executive Compensation—Compensation Discussion and Analysis” and “Directors’ Compensation” in the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item 12 is incorporated herein by reference to the sections entitled “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in the Proxy Statement.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item 13 is incorporated herein by reference to the section entitled “Certain Relationships and Related Transactions” in the Proxy Statement.
Item 14. Principal Accountant’s Fees and Services
Information required by this Item 14 is incorporated herein by reference to the section of the Proxy Statement entitled “Principal Accountant Fees and Services.”
PART IV
Item 15. Exhibits, Financial Statements Schedules
The Company’s consolidated financial statements and related notes thereto are listed and included in this Annual Report on Form 10-K beginning on page F-1. The following exhibits are filed with, or are incorporated by reference into, this Annual Report on Form 10-K.
EXHIBIT INDEX
Exhibit
Description
2.1
Plan of Conversion (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 2, 2017).
3.1
Articles of Conversion (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 2, 2017).
3.2
Certificate of Conversion (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 2, 2017).
3.3
Certificate of Incorporation (incorporated herein by reference to Exhibit 3.3 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 2, 2017).
3.4
Certificate of Designations of Rights, Preferences and Privileges of Series A Convertible Preferred Stock (incorporated herein by reference to Exhibit 3.4 to the Registrant’s Post-Effective Amendment No. 1 to the Registration Statement on Form S-3 (file no. 333-214073) filed with the Commission on July 31, 2017).
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3.5
Certificate of Designations of Rights, Preferences and Privileges of Series B Preferred Stock (incorporated herein by reference to Exhibit 3.5 to the Registrant’s Post-Effective Amendment No. 1 to the Registration Statement on Form S-3 (file no. 333-214073 incorporated by reference into file no. 333-212373) filed with the Commission on July 31, 2017).
3.6
Certificate of Amendment of Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 27, 2017).
3.7
Certificate of Amendment of Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8 K filed with the Commission on June 11, 2019).
3.8
Fourth Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on March 29, 2024).
4.1
Specimen of Stock Certificate (incorporated herein by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 12, 2018).
4.2
Description of Securities (incorporated herein by reference to Exhibit 4.3 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 6, 2019).
10.1
Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan, as amended (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 7, 2025).#
10.2
Form of Incentive Stock Option Agreement under the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 of Registrant’s Annual Report on Form 10-K filed with the Commission on February 25, 2020).#
10.3
Form of Non-Qualified Stock Option Agreement under the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.11 of Registrant’s Annual report on Form 10-K filed with the Commission on February 25, 2020).#
10.4
Form of Stock Unit Notice and Stock Unit Agreement under the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan, as amended (June 2021 Retention Equity Awards) (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 5, 2021).#
10.5
Form of Nonqualified Stock Option Award Agreement under the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan, as amended (June 2021 Retention Equity Awards) (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 10-Q filed with the Commission on August 5, 2021).#
10.6
Iovance Biotherapeutics, Inc. 2020 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 7, 2025).#
10.7
Iovance Biotherapeutics, Inc. Amended and Restated 2021 Inducement Plan (incorporated herein by reference to Exhibit 10.13 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 24, 2022).#
10.8
Form of Stock Option Grant Notice and Stock Option Agreement under the 2021 Inducement Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the Commission on September 23, 2021).#
10.9
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under the 2021 Inducement Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed with the Commission on September 23, 2021).#
10.10
Form of Deferred Stock Unit Notice and Deferred Stock Unit Agreement under the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 4, 2022).#
10.11
Patent License Agreement by and between Genesis Biopharma, Inc. and the National Institutes of Health effective October 5, 2011 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K/A filed with the Commission on December 13, 2011).*
10.12
Cooperative Research and Development Agreement for Intramural-PHS Clinical Research, dated August 5, 2011, by and between the U.S. Department of Health and Human Services, as represented by the National Cancer Institute, and Genesis Biopharma, Inc. (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K/A (Amendment No. 2) filed with the Commission on November 29, 2011).
10.13
Form of Director Stock Award Agreement (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the Commission on July 25, 2013).#
10.14
Form of Registration Rights Agreement by and among Lion Biotechnologies, Inc. and the Investors thereunder (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the Commission on October 31, 2013).
10.15
Cooperative Research and Development Agreement for the Development and Evaluation of the NCI Proprietary Adoptive Cell Transfer Immunotherapy Using Tumor Infiltrating Lymphocytes in Patients with Metastatic Melanoma, Bladder, Lung, Triple-negative Breast, and HPV-associated Cancers, Utilizing Lion Biotechnologies, Inc.’s Business Development
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Expertise in Adoptive Cell Transfer Immunotherapy, executed by Lion Biotechnologies, Inc. on January 22, 2015 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on January 27, 2015).*
10.16
Patent License Agreement, dated February 9, 2015, by and between Lion Biotechnologies, Inc. and the National Institutes of Health (incorporated herein by reference to Exhibit 10.47 to the Registrant’s Annual Report on Form 10 K filed with the Commission on March 16, 2015).*
10.17
Patent License Agreement, dated February 10, 2015, by and between Lion Biotechnologies, Inc. and the National Institutes of Health (incorporated herein by reference to Exhibit 10.46 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 16, 2015).*
10.18
First Amendment to Patent License Agreement, effective October 2, 2015, by and between Lion Biotechnologies, Inc. and the National Institutes of Health (incorporated herein by reference to Exhibit 10.47 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on November 6, 2015).*
10.19
Amended and Restated Patent License Agreement, by and between Iovance Biotherapeutics, Inc. and the National Institutes of Health (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10 Q filed with the Commission on August 5, 2021).*
10.20
Form of Securities Purchase Agreement, dated June 2, 2016, by and among Lion Biotechnologies, Inc. and the Investors thereunder (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 3, 2016).
10.21
Form of Registration Rights Agreement, dated June 2, 2016, by and among Lion Biotechnologies, Inc. and the Investors thereunder (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 3, 2016).
10.22
Amendment #1 to the Cooperative Research and Development Agreement #02734, dated January 22, 2015, by and between the National Cancer Institute and Lion Biotechnologies, Inc. (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current report on Form 8-K filed with the Commission on January 27, 2015).
10.23
Amendment #2 to the Cooperative Research and Development Agreement #02734, dated August 18, 2016, by and between the National Cancer Institute and Lion Biotechnologies, Inc. (incorporated herein by reference to Exhibit 10.3 to Amendment No. 2 to Registrant’s Registration Statement on Form S-1 filed with the Commission on August 31, 2016).
10.24
Amendment #3 to the Cooperative Research and Development Agreement #02734, dated September 7, 2021, by and between the National Cancer Institute and Iovance Biotechnologies, Inc. (incorporated herein by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025).+
10.25
Amendment #4 to the Cooperative Research and Development Agreement #02734, dated August 26, 2024, by and between the National Cancer Institute and Iovance Biotherapeutics, Inc. (incorporated herein by reference to Exhibit 10.31 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025).+
10.26
Manufacturing Services Agreement, dated November 23, 2015, by and between WuXi Advanced Therapies, Inc. and Lion Biotechnologies, Inc. (incorporated herein by reference to Exhibit 10.36 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 9, 2017).*
10.27
Executive Employment Agreement, effective as of September 30, 2016, by and between Frederick G. Vogt and Lion Biotechnologies, Inc. (incorporated herein by reference to Exhibit 10.32 to the Registrant’s Annual Report on Form 10 K filed with the Commission on March 12, 2018).#
10.28
Executive Employment Agreement effective as of July 18, 2019, by and between Friedrich-Reinhard Graf Finck von Finckenstein, M.D. and Iovance Biotherapeutics, Inc. (incorporated herein by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 1, 2019).
10.29
Executive Employment Agreement, effective as of March 15, 2021, by and between Igor Bilinsky, Ph.D. and Iovance Biotherapeutics, Inc. (incorporated herein by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 10-K filed with the Commission on May 6, 2021).#+
10.30
Executive Employment Agreement, effective as of January 10, 2022, by and between Raj K. Puri, M.D., Ph.D. and Iovance Biotherapeutics, Inc. (incorporated herein by reference to Exhibit 10.42 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025).#+
10.31
Executive Employment Agreement, effective as of January 25, 2025, by and between Daniel Gordon Kirby and Iovance Biotherapeutics, Inc. (incorporated herein by reference to Exhibit 10.43 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025).#+
10.32
First Amendment to Executive Employment Agreement, effective as of December 3, 2025, by and between Daniel Gordon Kirby and Iovance Biotherapeutics, Inc.**#+
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10.33
Executive Employment Agreement, effective as of August 6, 2025, by and between Corleen Roche and Iovance Biotherapeutics, Inc. (incorporated herein by reference to Exhibit 10.1 to the Registrant's Current Report on Form 10-Q filed with the Commission on November 6, 2025).#+
10.34
Lease Agreement, effective as of May 28, 2019, by and between Iovance Biotherapeutics, Inc. and 300 Rouse Boulevard, LLC (incorporated herein by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Commission on June 3, 2019).
10.35
First Amendment to the Lease Agreement, effective as of August 20, 2019, between Iovance Biotherapeutics, Inc. and 300 Rouse Boulevard, LLC (incorporated herein by reference to Exhibit 10.2 of the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on November 4, 2019).
10.36
Second Amendment to the Lease Agreement, effective as of June 30, 2020, between Iovance Biotherapeutics, Inc. and 300 Rouse Boulevard, LLC (incorporated herein by reference to Exhibit 10.3 of the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 6, 2020).
10.37
Third Amendment to the Lease Agreement, effective as of November 1, 2021, between Iovance Biotherapeutics, Inc. and 300 Rouse Boulevard, LLC (incorporated herein by reference to Exhibit 10.46 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 24, 2022).
10.38
Sublease, effective as of November 15, 2024, by and between Iovance Biotherapeutics, Inc. and Vaxcyte, Inc. (incorporated herein by reference to Exhibit 10.54 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025).+
10.39
Option Agreement, dated January 23, 2023, by and among Iovance Biotherapeutics, Inc., Iovance Biotherapeutics UK Ltd, Clinigen Holdings Limited, Clinigen Healthcare Limited, and Clinigen, Inc. (incorporated herein by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K/A filed with the Commission on January 27, 2023).
10.40
Amended and Restated Open Market Sale Agreement, dated August 22, 2025, by and between Iovance Biotherapeutics, Inc. and Jefferies LLC (incorporated herein by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed with the Commission on August 22, 2025).
19.1
Iovance Biotherapeutics, Inc. Insider Trading Policy. (incorporated herein by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025)
21.1
Subsidiaries of the Company. (incorporated herein by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025)
23.1
Consent of Independent Registered Public Accounting Firm. **
24.1
Power of Attorney (included on the signature page of this Annual Report).
31.1
Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer. **
31.2
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer. **
32.1
Section 1350 Certification of Chief Executive Officer (furnished herewith). **
32.2
Section 1350 Certification of Chief Financial Officer (furnished herewith). **
97.1
Iovance Biotherapeutics, Inc. Dodd-Frank Clawback Policy. (incorporated herein by reference to Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 27, 2025)
101
The following financial information from the Annual Report on Form 10-K of Iovance Biotherapeutics, Inc. for the year ended December 31, 2025, formatted inline XBRL (eXtensible Business Reporting Language): (1) Balance Sheets as of December 31, 2025 and 2024 (2) Statements of Operations for the years ended December 31, 2025, 2024, and 2023; (3) Statements of Stockholders’ Equity for the years ended December 31, 2025, 2024, and 2023; (4) Statements of Cash Flows for the years ended December 31, 2025, 2024, and 2023; and (5) Notes to Financial Statements.
104
Cover Page Interactive Data File – the cover page interactive date file does not appear in the Interactive Date File because its XBRL tags are embedded within the Inline XBRL document.
*
Certain portions of the Exhibit have been omitted based upon a request for confidential treatment filed by us with the Commission. The omitted portions of the Exhibit have been separately filed by us with the Commission.
** Filed herewith.
#
Indicates a management contract or compensatory plan or arrangement.
+ Certain portions of the Exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
Item 16. Form 10-K Summary
We may voluntarily include a summary of information required by Form 10-K under this Item 16. We have elected not to include such summary information.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
IOVANCE BIOTHERAPEUTICS, INC.
Date: February 24, 2026
By:
/s/ Frederick G. Vogt
Name:
Frederick G. Vogt, Ph.D., J.D.
Title:
Interim Chief Executive Officer and President, and General Counsel
POWER OF ATTORNEY
Know all persons by these presents, that each person whose signature appears below constitutes and appoints Frederick G. Vogt, and Corleen Roche, and each of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities, to sign any and all amendments to this Annual Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his or her substitute or substituted, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Frederick G. Vogt
Interim Chief Executive Officer and President, and
February 24, 2026
Frederick G. Vogt, Ph.D., J.D.
General Counsel (Principal Executive Officer) and Director
/s/ Corleen Roche
Chief Financial Officer
February 24, 2026
Corleen Roche
(Principal Financial Officer and Accounting Officer)
/s/ Michael Weiser
Director
February 24, 2026
Michael Weiser, M.D., Ph.D.
/s/ Ryan D. Maynard
Director
February 24, 2026
Ryan D. Maynard
/s/ Iain Dukes
Director
February 24, 2026
Iain Dukes, D.Phil.
/s/ Wayne Rothbaum
Director
February 24, 2026
Wayne Rothbaum
/s/ Athena Countouriotis
Director
February 24, 2026
Athena Countouriotis, M.D.
/s/ Wendy L. Yarno
Director
February 24, 2026
Wendy L. Yarno
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IOVANCE BIOTHERAPEUTICS, INC.
Index to Financial Statements
Contents
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
F-1
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42)
F-3
Consolidated Financial Statements
Consolidated Balance Sheets
F-4
Consolidated Statements of Operations
F-5
Consolidated Statements of Comprehensive Loss
F-6
Consolidated Statements of Stockholders’ Equity
F-7
Consolidated Statements of Cash Flows
F-8
Notes to Consolidated Financial Statements
F-9
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Iovance Biotherapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Iovance Biotherapeutics, Inc. (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 24, 2026 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Revenue Recognition
Description of the Matter
For the year ended December 31, 2025, the Company recognized product revenue of $264 million related to the sales of Amtagvi ® and Proleukin ® . As described in Note 2 to the Financial Statements, the Company recognizes revenue when a customer obtains control of promised goods. In the case of Amtagvi ® , revenue is recognized upon infusion while for Proleukin ® , transfer of control occurs upon customer receipt of the product, based on the transfer of legal title.
The principal consideration for our determination that performing procedures relating to product revenue is a critical audit matter is a high degree of auditor effort in performing procedures related to revenue recognition cut-off given the magnitude of revenue transactions near the end of the fiscal year.
F-1
Table of Contents
How We Addressed the Matter in Our Audit
We evaluated the design and tested the operating effectiveness of the Company’s internal controls related to the Company’s revenue recognition processes.
To test the cut off of revenue recognition, our audit procedures included, among others, (i) testing the completeness, accuracy and occurrence of revenue recognized for a sample of revenue transactions that took place near the end of fiscal year by obtaining and inspecting source documents, such as sales contracts, purchase orders, customer invoices, proof of delivery, and infusion confirmations and (ii) confirming a sample of outstanding customer invoice balances as of December 31, 2025 and, for confirmations not returned, obtaining and inspecting source documents, such as invoices, records supporting infusion date, proof of delivery, and subsequent cash receipts.
Accounting for Amtagvi Inventory
Description of the Matter
At December 31, 2025, the Company’s net inventory balance was $60 million, and for the year ended December 31, 2025, the Company incurred $173 million in cost of sales. As discussed in Note 2 to the consolidated financial statements, inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis, and includes amounts related to materials, internal labor, external manufacturing costs, and allocable overhead.
Auditing the Company's accounting for inventory valuation and cost of sales measurement related to Amtagvi was challenging primarily due to the manual nature of the process and the high number of inputs involved in the calculation of overhead and labor allocation.
How We Addressed the Matter in Our Audit
We evaluated the design and tested the operating effectiveness of the Company’s internal controls related to the Company’s accounting for inventory valuation and measurement of cost of sales.
To test the valuation of inventory and measurement of cost of sales related to Amtagvi, our substantive audit procedures included, among others, testing a sample of expenses for the accuracy of department coding against source documentation, tracing selected Amtagvi lot information to manufacturing records, testing the allocation methodology and percentages, including recalculating for clerical accuracy for certain manual calculations, and performing corroborative inquiries with manufacturing personnel.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2021.
San Mateo, California
February 24, 2026
F-2
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Iovance Biotherapeutics, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Iovance Biotherapeutics, Inc.’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Iovance Biotherapeutics, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes and our report dated February 24, 2026 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
San Mateo, California
February 24, 2026
F-3
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Consolidated Balance Sheets
(In thousands, except share and per share information)
December 31,
December 31,
2025
2024
ASSETS
Current Assets
Cash and cash equivalents
$
163,078
$
115,694
Trade accounts receivable
82,448
69,340
Short-term investments
133,902
208,087
Inventory
51,678
51,520
Prepaid expenses and other assets
11,583
12,377
Total Current Assets
442,689
457,018
Property and equipment, net
131,112
109,081
Intangible assets, net
279,324
282,398
Operating lease right-of-use assets
45,899
55,201
Restricted cash
5,980
6,359
Long-term assets
8,166
369
Total Assets
$
913,170
$
910,426
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
$
22,159
$
27,509
Accrued expenses and other liabilities
111,156
81,936
Note payable - current
1,000
—
Operating lease liabilities
4,043
12,896
Total Current Liabilities
138,358
122,341
Non-Current Liabilities
Operating lease liabilities – non-current
44,401
44,365
Deferred tax liabilities
31,828
32,315
Long-term note payable
—
1,000
Total Non-Current Liabilities
76,229
77,680
Total Liabilities
214,587
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 December 31, 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 December 31, 2025 and December 31, 2024 respectively
2
3
Common stock, $ 0.000041666 par value; 500,000,000 shares authorized, 411,938,061 and 305,252,194 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
17
13
Accumulated other comprehensive income (loss)
16,440
( 1,046 )
Additional paid-in capital
3,457,654
3,095,987
Accumulated deficit
( 2,775,530 )
( 2,384,552 )
Total Stockholders’ Equity
698,583
710,405
Total Liabilities and Stockholders’ Equity
$
913,170
$
910,426
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Consolidated Statements of Operations
(In thousands, except per share information)
Years Ended December 31,
2025
2024
2023
Revenue
Product revenue, net
$
263,502
$
164,070
$
1,189
Total revenue
263,502
164,070
1,189
Costs and expenses *
Cost of sales **
173,184
93,248
1,033
Research and development **
300,270
276,228
333,194
Selling, general, and administrative **
152,322
152,269
106,098
Depreciation and amortization
35,939
37,603
21,423
Restructuring charges
5,143
—
—
Total costs and expenses
666,858
559,348
461,748
Loss from operations
( 403,356 )
( 395,278 )
( 460,559 )
Other income
Interest and other income, net
10,307
20,273
13,043
Net Loss before income taxes
( 393,049 )
( 375,005 )
( 447,516 )
Income tax (expense) benefit
2,071
2,828
3,479
Net Loss
$
( 390,978 )
$
( 372,177 )
$
( 444,037 )
Net Loss Per Share of Common Stock, Basic and Diluted
$
( 1.09 )
$
( 1.28 )
$
( 1.89 )
Weighted Average Shares of Common Stock Outstanding, Basic and Diluted
357,345
289,877
235,131
* Non-cash stock-based compensation included in cost of sales and operating expenses
Cost of sales
$
7,286
$
8,554
$
—
Research and development
26,959
49,270
34,926
Selling, general and administrative
27,330
51,799
27,699
$
61,575
$
109,623
$
62,625
** Excludes depreciation and amortization
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Consolidated Statements of Comprehensive Loss
(in thousands)
Years Ended December 31,
2025
2024
2023
Net Loss
$
( 390,978 )
$
( 372,177 )
$
( 444,037 )
Other comprehensive loss:
Unrealized gain (loss) on investments
( 54 )
78
940
Foreign currency translation adjustment
17,540
( 3,650 )
2,488
Comprehensive Loss
$
( 373,492 )
$
( 375,749 )
$
( 440,609 )
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Consolidated Statements of Stockholders' Equity
(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, 2022
194
$
—
2,842,158
$
3
187,812,072
$
8
$
2,068,867
$
( 902 )
$
( 1,568,338 )
$
499,638
Stock-based compensation expense
—
—
—
—
—
—
62,625
—
—
62,625
Vesting of restricted shares issued for services
—
—
—
—
1,253,465
—
—
—
—
—
Tax payments related to shares retired for vested restricted stock units
—
—
—
—
( 454,367 )
—
( 2,795 )
—
—
( 2,795 )
Common stock issued upon purchase of employee stock purchase plan
—
—
—
—
435,459
—
2,410
—
—
2,410
Common stock issued upon exercise of stock options
—
—
—
—
8,860
—
63
—
—
63
Common stock sold in public and/or at the market offering, net of offering costs
—
—
—
—
67,080,226
3
463,278
—
—
463,281
Unrealized gain on investments
—
—
—
—
—
—
—
940
—
940
Foreign currency cumulative translation adjustment
—
—
—
—
—
—
—
2,488
2,488
Net loss
—
—
—
—
—
—
—
—
( 444,037 )
( 444,037 )
Balance - December 31, 2023
194
$
—
2,842,158
$
3
256,135,715
$
11
$
2,594,448
$
2,526
$
( 2,012,375 )
$
584,613
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
—
—
—
—
—
—
110,877
—
—
110,877
Vesting of restricted shares issued for services
—
—
—
—
3,150,172
—
—
—
—
—
Tax payments related to shares retired for vested restricted stock units
—
—
—
—
( 1,098,388 )
—
( 12,858 )
—
—
( 12,858 )
Common stock issued upon purchase of employee stock purchase plan
—
—
—
—
497,044
—
2,952
—
—
2,952
Common stock issued upon exercise of stock options
—
—
—
—
425,925
—
3,266
—
—
3,266
Common stock sold in public and/or at the market offering, net of offering costs
—
—
—
—
46,141,726
2
397,302
—
—
397,304
Unrealized gain on investments
—
—
—
—
—
—
—
78
—
78
Foreign currency cumulative translation adjustment
—
—
—
—
—
—
—
( 3,650 )
—
—
( 3,650 )
Net loss
—
—
—
—
—
—
—
—
( 372,177 )
( 372,177 )
Balance - December 31, 2024
194
$
—
2,842,158
$
3
305,252,194
$
13
$
3,095,987
$
( 1,046 )
$
( 2,384,552 )
$
710,405
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
—
—
—
—
—
—
60,897
—
—
60,897
Vesting of restricted shares issued for services
—
—
—
—
5,136,198
—
—
—
—
—
Tax payments related to shares retired for vested restricted stock units
—
—
—
—
( 2,058,144 )
—
( 7,059 )
—
—
( 7,059 )
Common stock issued upon purchase of employee stock purchase plan
—
—
—
—
796,402
—
1,510
—
—
1,510
Common stock issued upon exercise of stock options
—
—
—
—
2,586
—
15
—
—
15
Common stock sold in public and/or at the market offering, net of offering costs
—
—
—
—
101,899,334
4
306,303
—
—
306,307
Common stock issued from preferred stock conversion
—
—
( 909,491 )
( 1 )
909,491
—
1
—
Unrealized loss on investments
—
—
—
—
—
—
—
( 54 )
—
( 54 )
Foreign currency cumulative adjustments
—
—
—
—
—
—
—
17,540
—
17,540
Net loss
—
—
—
—
—
—
—
—
( 390,978 )
( 390,978 )
Balance - December 31, 2025
194
$
—
1,932,667
$
2
411,938,061
$
17
$
3,457,654
$
16,440
$
( 2,775,530 )
$
698,583
The accompanying notes are an integral part of these consolidated financial statements.
F-7
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
Consolidated Statements of Cash Flows
(In thousands)
Years Ended December 31,
2025
2024
2023
Cash Flows from Operating Activities
Net loss
$
( 390,978 )
$
( 372,177 )
$
( 444,037 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
61,575
109,627
62,625
Unrealized foreign exchange loss
( 238 )
( 175 )
70
Amortization of intangible assets
23,077
26,379
9,849
Amortization of right of use asset
11,385
10,437
11,710
Depreciation and amortization of property and equipment
12,862
11,255
11,568
Deferred tax (benefit) expense
( 2,071 )
( 2,828 )
( 3,479 )
Excess and obsolescence reserve
13,404
Accretion of discounts and premiums on investments
( 7,202 )
( 10,261 )
( 3,605 )
Loss on asset disposals
44
7,355
—
Gain on derecognition of lease assets and liabilities
—
( 5,568 )
—
Changes in assets and liabilities:
Prepaid expenses, other assets and long-term assets
( 8,023 )
( 2,113 )
( 10,062 )
Trade accounts receivable
( 13,108 )
( 69,189 )
( 149 )
Inventory
( 14,211 )
( 44,382 )
( 10,118 )
Operating lease liabilities
( 10,900 )
( 12,074 )
( 10,794 )
Accounts payable
( 6,661 )
( 7,841 )
4,828
Accrued expenses and other liabilities
28,637
8,578
19,774
Net cash used in operating activities
( 302,408 )
( 352,977 )
( 361,820 )
Cash Flows from Investing Activities
Maturities of investments
400,000
428,000
285,583
Purchase of investments
( 318,668 )
( 460,769 )
( 205,902 )
Cash paid for acquisition, including contingent consideration, net of cash acquired
—
( 52,573 )
( 212,633 )
Purchase of property and equipment
( 33,836 )
( 11,069 )
( 22,290 )
Net cash provided by (used in) investing activities
47,496
( 96,411 )
( 155,242 )
Cash Flows from Financing Activities
Tax payments related to shares withheld for vested restricted stock units
( 7,059 )
( 12,858 )
( 2,795 )
Proceeds from the issuance of common stock under employee stock purchase plan
1,510
2,952
2,410
Proceeds from the issuance of common stock upon exercise of options
15
3,266
63
Proceeds from the issuance of common stock, net
306,307
397,304
463,281
Net cash provided by financing activities
300,773
390,664
462,959
Effect of foreign exchange rate changes
1,144
( 541 )
( 2,740 )
Net increase (decrease) in cash, cash equivalents and restricted cash
47,005
( 59,265 )
( 56,843 )
Cash, Cash Equivalents and Restricted Cash Beginning of Period
122,053
181,318
238,161
Cash, Cash Equivalents and Restricted Cash End of Period
$
169,058
$
122,053
$
181,318
Supplemental disclosure of non-cash investing and financing activities:
Fair value of net assets acquired
$
—
$
—
$
222,637
Net unrealized loss on investments
54
78
940
Acquisition of property and equipment included in accounts payable and accrued expenses
8,501
7,365
4,062
Intangible asset and deferred tax liability arising from contingent consideration
—
17,495
—
Conversion of convertible preferred stock to common stock
1
—
—
Lease liabilities arising from obtaining right-of-use asset from new leases
—
2,306
177
Increase / (decrease) in lease liabilities due to obtaining/(reduction in) right-of-use assets from lease modifications
2,084
( 7,833 )
1,033
The accompanying notes are an integral part of these consolidated financial statements.
F-8
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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. 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. TIL cell therapies harness the individual immune system’s ability to recognize and destroy cancer cells that are unique to each patient. These individualized therapies are manufactured using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply each patient’s polyclonal T cells into the billions.
The Company was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute (“NCI”). The Company’s multi-center trials, scalable manufacturing, regulatory approvals, and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients, into a commercially viable treatment that is accessible for thousands of cancer patients.
The Company’s two commercial products include Amtagvi ® (lifileucel), and Proleukin ® (aldesleukin), an interleukin-2 (“IL-2”) product used in the Amtagvi ® treatment regimen and in other applications.
Amtagvi ® is the first one-time, individualized T cell therapy for a solid tumor cancer and for the treatment of adult patients with previously treated advanced, or unresectable or metastatic melanoma. Amtagvi ® is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin ® .
Globally, Amtagvi ® has the potential to address tens of thousands of previously treated advanced melanoma patients annually. Amtagvi ® is approved in the U.S. and Canada, and the Company plans to launch Amtagvi ® into additional markets with a high prevalence of advanced melanoma. Potential approvals are pending in the United Kingdom (“UK”) and Australia in the first half of 2026, and Switzerland in 2027. In the European Union (“EU”), the Company withdrew its initial marketing authorization application (“MAA”) in July 2025. The Company is working with the European Medicines Agency (“EMA”) to resubmit a centralized MAA in 2026.
The Company’s development pipeline consists of TIL cell therapies and next generation approaches in additional solid tumor cancers, including one-time TIL monotherapies for previously treated patients and TIL cell therapy combined with standard of care in earlier treatment settings. The Company is conducting two ongoing registrational trials in frontline advanced melanoma and previously treated advanced non-small cell lung cancer (“NSCLC”). The Company plans to commence a registrational trial in previously treated advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma in the second quarter of 2026 and engage with the Food and Drug Administration on a path to expedited approval.
Liquidity
As of December 31, 2025, the Company had $ 303.0 million in cash, cash equivalents, short-term investments, and restricted cash ($ 163.1 million of cash and cash equivalents, $ 133.9 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 the second quarter of 2023, the Company began to generate revenue from the sales of Proleukin ® . However, such revenues for Amtagvi ® and Proleukin ® may not be material enough to generate positive operational cash flows during the 12 months from the date the consolidated financial statements are issued, and this Form 10-K is filed. The Company incurred a net loss of $ 391.0 million for the year ended December 31, 2025, and used $ 302.4 million of cash in its operating activities during the year ended December 31, 2025.
The Company expects to continue to incur significant expenses to support commercial activities for 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 consolidated financial statements for December 31, 2025 are
F-9
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 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 PRACTICES
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 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 years ended December 31, 2025, 2024 and 2023. 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 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 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 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 December 31, 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 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 December 31, 2025, the Company’s letters of credit were primarily comprised of a letter of credit for the benefit of the i CTC used as a security deposit for the lease in the amount of $ 5.45 million and a letter of credit for $ 0.6 million for the benefit of the landlord for the Company’s headquarters lease (See Note 16 - Leases). 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 letter of credit with the landlord for the Company’s headquarters lease expires on February 1, 2032, however, it will be automatically extended, without written agreement, for one-year periods to February in each succeeding calendar year.
F-10
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows (in thousands):
December 31,
2025
2024
2023
Cash and cash equivalents
$
163,078
$
115,694
$
114,888
Restricted cash
5,980
6,359
66,430
Total cash, cash equivalents and restricted cash
$
169,058
$
122,053
$
181,318
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 consolidated balance sheet as of December 31, 2025.
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 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 c osts incurred, such as manufacturing costs incurred prior to regulatory approval that did 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 consolidated balance sheet as of December 31, 2025, and 2024 include a step-up of the fair value of inventories as a result of the acquisition of the worldwide rights to Proleukin ® . The non-cash amortization expense of the fair value step-of acquired inventory is recognized as the acquired inventory units are sold and recorded in depreciation and amortization on our consolidated statement of operations.
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
F-11
Table of Contents
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
identified. Any such adjustments are included as a component of cost of sales within the Company’s consolidated statements of operations.
Cost of sales includes inventory and period costs related to overhead and manufacturing costs of Amtagvi ® during the period from approval through December 31, 2025, 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 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 acquired intangible assets are initially measured based on an allocation of the cost of the acquisition to the assets acquired on a relative fair value basis and are recorded net of accumulated amortization, while intangible assets recorded as the result of milestone or license payments are recorded at the amount paid. 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 December 31, 2025 or December 31, 2024.
Leases
The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its consolidated balance sheets as operating lease right-of-use assets and operating lease liabilities as of December 31, 2025 and 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
and expenses in the 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.
Property and Equipment, net
Property and equipment are stated at cost, net of accumulated depreciation and amortization. The cost of property and equipment is depreciated or amortized on the straight-line method over the following estimated useful lives. The depreciation or amortization of capitalized construction in progress costs, a component of property and equipment, net, begins once the underlying asset is placed into service and is recognized over the estimated useful lives:
Computer equipment
2 years
Computer software
5 years
Office furniture and equipment
5 years
Lab, process, and validation equipment
5 years
Machinery and equipment
5 – 7 years
Utility equipment
Lesser of the remaining economic life of the asset or the lease-term
Leasehold improvements
Lesser of the remaining economic life of the asset or the lease-term
Expenditures for maintenance and repairs are charged to operations as incurred while renewals and betterments are capitalized. Gains and losses on disposals are included within operating expenses in the consolidated statements of operations.
Management assesses the carrying value of property and equipment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. If there is an indication of impairment, management prepares an estimate of future undiscounted cash flows expected to result from the use of the asset and its eventual disposition. If these cash flows are less than the carrying amount of the asset, an impairment loss is recognized to write down the asset to its estimated fair value.
Fair Value Measurements
Under ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied.
Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:
- Level 1—These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access.
- Level 2—These are investments where values are based on quoted market prices in markets that are not active or model derived valuations in which all significant inputs are observable in active markets.
- Level 3—These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable.
The Company’s financial instruments consist of cash, cash equivalents, short-term investments, and long-term notes payable, all of which are reported at their respective fair value or approximate fair value on its consolidated balance sheets.
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Where quoted prices are available in an active market, securities are classified as Level 1.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
When quoted market prices are not available for a specific security, the Company estimates the fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes, and market reference data.
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 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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.
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 consolidated balance sheets and subsequently recognized as research and development expense in the consolidated statements of operations when the associated services have been performed. As 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
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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.
Income Taxes
The Company accounts for income taxes using the asset and liability method whereby deferred tax assets and liabilities are recognized for the differences between the carrying amounts of existing assets and liabilities for financial reporting purposes and their respective tax bases. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of changes in tax laws and rates on deferred tax assets and liabilities is recognized in income in the period of enactment.
Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company is required to use significant judgment in determining any valuation allowance recorded against its deferred tax assets. In assessing the need for a valuation allowance, the Company considers all available evidence, including scheduled reversal of deferred tax liabilities, past operating results, the feasibility of tax planning strategies and estimates of future taxable income. The Company bases its estimates of future taxable income on assumptions that are consistent with its operating plans, and such assumptions represent its best estimates and involve inherent uncertainties and the application of judgment. Should actual amounts differ from estimates, the amount of tax expense and liabilities recognized could be materially impacted. The Company recognizes the tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained upon examination by the tax authorities, based on the merits of the position. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties incurred in relation to the unrecognized tax benefits.
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.
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of December 31, 2025, 2024, and 2023, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.
As of December 31,
2025
2024
2023
Stock options
18,025,891
18,218,126
18,899,849
Restricted stock units
9,080,465
9,547,643
296,751
Employee Stock Purchase Plan
533,510
239,366
3,453,901
Series A Convertible Preferred Stock*
97,000
97,000
97,000
Series B Convertible Preferred Stock*
1,932,667
2,842,158
2,842,158
29,669,533
30,944,293
25,589,659
*on an as-converted basis
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 .
Principles of Consolidation
The accompanying 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.
Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the consolidated statement of operations. Certain prior period amounts reported in the Company’s 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.
Foreign Currency Translation
The 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 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. Refer to Note 12 to the consolidated financial statements included in this Annual Report on Form 10-K for details.
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Concentrations
The Company is subject to credit risk from its portfolio of cash, cash equivalents, and investments. Under its investment policy, the Company limits amounts invested in such 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 Company maintains cash, cash equivalents, and investment balances at three financial institutions. Management believes that the financial institutions which hold its cash are financially sound and, accordingly, minimal credit risk exists. As of December 31, 2025 and 2024, respectively, the Company’s cash balances were in excess of insured limits maintained at the financial institutions.
Recent Accounting Standards
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 has adopted ASU 2023-09 in its December 31, 2025, consolidated financial statements on a prospective basis.
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 December 31, 2025 and December 31, 2024 were as follows (in thousands):
Gross
Gross
Amortized
Unrealized
Unrealized
As of December 31, 2025
Cost
Gains
Losses
Fair Value
U.S. treasury securities
$
133,839
$
63
$
—
$
133,902
Money market funds
60,468
—
—
60,468
Total investments
$
194,307
$
63
$
—
$
194,370
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
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The fair value of cash equivalents and investments as of December 31, 2025 and December 31, 2024 are classified as follows in the Company’s consolidated balance sheets (in thousands):
December 31,
December 31,
Classified as:
2025
2024
Cash equivalents
$
60,468
$
61,432
Short-term investments
133,902
208,087
Total investments
$
194,370
$
269,519
Cash equivalents in the tables above exclude cash demand deposits of $ 102.6 million and $ 54.3 million as of December 31, 2025 and 2024, respectively. Unrealized gains and losses are included in accumulated other comprehensive loss, and as of December 31, 2025 and 2024 no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of December 31, 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 December 31, 2025 and 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 December 31, 2025
Level 1
Level 2
Level 3
Total
U.S. treasury securities
$
133,902
$
—
$
—
$
133,902
Money market funds
60,468
—
—
60,468
Total investments
$
194,370
$
—
$
—
$
194,370
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 newly formed, 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.
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 consolidated financial statements commencing from the acquisition date.
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 United Kingdom as this is where the intangible assets are domiciled.
NOTE 5. INTANGIBLE ASSETS, NET
The gross carrying amounts and net book value of intangible assets as of December 31, 2025 and December 31, 2024 are as follows (in thousands):
December 31,
December 31,
2025
2024
Developed technology
$
326,497
$
304,939
Assembled workforce
688
643
Intellectual property license
7,500
7,500
Patents
475
—
Total intangible assets
$
335,160
$
313,082
Less: accumulated amortization
( 55,836 )
( 30,684 )
Intangible assets, net
$
279,324
$
282,398
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company recognized amortization expense of $ 22.6 million and $ 21.2 million during the years ended December 31, 2025 and December 31, 2024, respectively, excluding non-cash amortization expense of the fair value step-of acquired inventory.
The total estimated amortization of the Company’s intangible assets for the years ending December 31, 2026, 2027, 2028, 2029 and 2030 are $ 22.9 million, $ 22.8 million, $ 22.8 million, $ 22.8 million, and $ 22.8 million, respectively.
NOTE 6. INVENTORY
As of December 31, 2025 and December 31, 2024, inventory consists of the following (in thousands):
December 31,
December 31,
2025
2024
Raw materials
$
31,682
$
27,743
Work in process
5,044
8,765
Finished goods
22,827
15,012
Total inventory
$
59,553
$
51,520
Inventory includes $ 14.3 million for excess and obsolescence reserves recorded for the year ended December 31, 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. The reserve includes $ 7.0 million for a non-cancellable purchase commitment of Proleukin ® as of December 31, 2025 that was delivered in the first quarter of 2026.
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 consolidated balance sheet. As of December 31, 2025 the Company recorded $ 7.9 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):
Years Ended December 31,
2025
2024
2023
Amtagvi ®
$
220,024
$
103,567
$
—
Proleukin ®
43,478
60,503
1,189
Total net revenue
$
263,502
$
164,070
$
1,189
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.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Revenue from product sales was recorded net of GTN adjustments. The following table summarizes GTN adjustments for the periods presented (in thousands):
Years Ended December 31,
2025
2024
2023
Gross revenue
$
268,005
$
169,170
$
1,192
GTN adjustments:
Government rebates and chargebacks
( 600 )
( 172 )
—
Wholesaler fees and cash discounts
( 2,819 )
( 3,226 )
( 3 )
Other rebates, returns, discounts and adjustments
( 1,084 )
( 1,702 )
—
Total GTN adjustments
( 4,503 )
( 5,100 )
( 3 )
Net revenue
$
263,502
$
164,070
$
1,189
Consolidated net product revenue by geographic area for the periods presented is as follows (in thousands):
Years Ended December 31,
2025
2024
2023
United States
$
259,013
$
161,043
$
—
Rest of world
4,489
3,027
1,189
Net revenue
$
263,502
$
164,070
$
1,189
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.
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 years ended December 31, 2025, December 31, 2024, and December 31, 2023, respectively (in thousands, except percentages):
Year Ended December 31, 2025
Year Ended December 31, 2024
Year Ended December 31, 2023
$
%
$
%
$
%
Customer A
$
*
0 %
$
28,395
17 %
$
*
0 %
Other customers
268,005
100 %
140,775
83 %
1,192
100 %
Gross revenue
$
268,005
100 %
$
169,170
100 %
$
1,192
100 %
GTN adjustments
( 4,503 )
( 5,100 )
( 3 )
Net revenue
$
263,502
$
164,070
$
1,189
* Represents customer below 10%
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8. PROPERTY AND EQUIPMENT, NET
Property and equipment, net consists of the following (in thousands):
December 31,
December 31,
2025
2024
Leasehold improvements
$
90,385
$
67,375
Lab, process, and validation equipment
31,499
25,477
Utility equipment
7,306
5,990
Office furniture and equipment
2,573
1,998
Computer software
8,512
8,512
Computer equipment
2,144
448
Machinery and equipment
1,814
363
Construction in progress
35,649
34,938
Total property and equipment, cost
$
179,882
$
145,101
Less: Accumulated depreciation and amortization
( 48,770 )
( 36,020 )
Property and equipment, net
$
131,112
$
109,081
Depreciation and amortization expense, excluding depreciation capitalized in inventory, for the years ended December 31, 2025, 2024, and 2023 was approximately $ 12.9 million, $ 12.0 million, and $ 11.6 million, respectively.
NOTE 9. ACCRUED EXPENSES
Accrued expenses consist of the following (in thousands):
December 31,
December 31,
2025
2024
Accrued payroll and employee related expenses
$
33,780
$
31,910
Clinical related
32,788
13,017
Manufacturing related
18,018
10,084
Facilities related
6,447
6,748
Legal and related services
1,416
2,466
Inventory and distribution related
13,574
12,471
Other accrued expenses
5,133
5,240
Total accrued expenses
$
111,156
$
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 December 31, 2025, 411,938,061 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
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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. The 2023 Sale Agreement was terminated in July 2025 upon the issuance and sale, through Jefferies, of all Common Shares subject to the 2023 Sale Agreement. 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 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 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 years ended December 31, 2025, 2024 and 2023, the Company received $ 306.3 million, $ 200.0 million, and $ 301.7 million in net proceeds, net of offering costs, through the sale of 101,899,334 shares, 23,127,726 shares and 44,080,226 shares of its common stock through the 2025 Sale Agreement, the 2023 Sale Agreement and/or the 2022 Sale Agreement at a weighted average price per share of $ 3.07 , $ 8.82 and $ 6.99 , respectively.
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 December 31, 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
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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.
No shares of Series A Convertible Preferred Stock were converted to common stock during the year ended December 31, 2025 and 2024. As of December 31, 2025, and 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 year ended December 31, 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 to common stock during the year ended December 31, 2024. At December 31, 2025 and 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 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 , 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 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
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2025, 18,896,530 shares of common stock were available for grant under the Company’s 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 December 31, 2025, 91,598 shares of common stock were available for grant under the Inducement Plan.
Stock Options
A summary of the status of stock options as of December 31, 2025, and the changes during the year then ended, is 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
3,269,680
3.07
Exercised
( 2,586 )
5.80
Expired/Cancelled
( 3,459,329 )
16.20
Outstanding at December 31, 2025
18,025,891
$
15.05
5.75
$
893,005
Ending vested and expected to vest at December 31, 2025
18,025,891
$
15.05
5.75
$
893,005
Options exercisable at December 31, 2025
14,010,505
$
18.04
4.79
$
—
As of December 31, 2025, there was $ 11.0 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 2.07 years as of December 31, 2025.
The weighted average grant date fair value for employee options granted under the Company's stock option plans during the years ended December 31, 2025, 2024, and 2023 was $ 2.24 , $ 6.97 , and $ 4.91 per option, respectively.
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 year ended December 31, 2025 and the exercise price of the options, multiplied by the
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on December 31, 2025. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.
The aggregate intrinsic value of stock options exercised during the year ended December 31, 2025, 2024 and 2023, was de minimis, $ 1.1 million, and $ 0.01 million, respectively.
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 years ended December 31, 2025, 2024 and 2023 was $ 1.2 million, $ 1.5 million, and $ 1.2 million, respectively. Under the 2020 ESPP, for the years ended December 31, 2025 and 2024, the Company received proceeds of $ 1.5 million for the issuance of 796,402 shares and $ 3.0 million for the issuance of 497,044 shares, respectively. As of December 31, 2025, there was $ 0.5 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over 5.3 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 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. There were no unvested PRSUs outstanding as of December 31, 2025 and 2024.
Activity for RSUs and PRSUs during the year ended December 31, 2025 is 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
( 5,136,198 )
15.78
Canceled/Forfeited
( 2,400,376 )
8.73
Outstanding at December 31, 2025
9,080,465
$
7.71
Ending vested and expected to vest at December 31, 2025
8,784,646
$
7.68
As of December 31, 2025, there was $ 43.8 million of unrecognized stock-based compensation expense associated with unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of 1.78 years. The aggregate
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
intrinsic value of the unvested RSUs outstanding as of December 31, 2025 was $ 24.8 million and the aggregate intrinsic value of the unvested RSUs and PRSUs as of December 31, 2024 was $ 70.7 million.
Stock-Based Compensation
Total stock-based compensation expense by type of award was as follows (in thousands):
Years Ended December 31,
2025
2024
2023
Stock option expense
$
12,840
$
21,112
$
45,340
Restricted stock expense
47,489
87,025
16,062
ESPP expense
1,246
1,486
1,223
Total stock-based compensation expense
$
61,575
$
109,623
$
62,625
The amount included in capitalized inventory for stock-based compensation expense for personnel engaged with manufacturing activities was $ 0.6 million and $ 1.2 million as of December 31, 2025 and 2024, respectively.
The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the years ended December 31, 2025, 2024, and 2023:
Stock Options
ESPP
Years Ended December 31,
Years Ended December 31,
Assumptions:
2025
2024
2023
2025
2024
2023
Expected term (years)
5.56 - 5.64
5.41 - 5.56
5.18 - 5.37
0.50
0.50
0.50
Expected volatility
84.57 % - 92.28 %
85.03 % - 85.85 %
83.63 % - 84.21 %
73.85 % - 116.86 %
73.85 % - 98.85 %
72.96 % - 83.36 %
Risk-free interest rate
3.80 % - 4.41 %
3.61 % - 4.33 %
3.59 % - 4.60 %
3.66 % - 4.35 %
4.35 % - 5.40 %
5.38 % - 5.40 %
Expected dividend yield
0 %
0 %
0 %
0 %
0 %
0 %
- Expected Term (Years) —The expected term of the stock option grants was calculated based on historical exercises, cancellations, and forfeitures of stock options and outstanding option shares.
- Expected Volatility —The expected volatility is based on the historical volatility for the Company's stock over a period equal to the expected terms of the options.
- Risk-Free Interest Rate —The risk-free interest rate was based on the market yield currently available on United States Treasury securities with maturities approximately equal to the option’s expected term.
- Expected Dividend Yield —The Company has never paid dividends and does not expect to pay dividends in the foreseeable future.
- Forfeiture Rate —The Company recognizes forfeitures as they occur.
Each of the inputs discussed above is subjective and generally requires significant management judgment.
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 year ended December 31, 2025, primarily related to severance payments, costs for outplacement services, and post-employment benefits. As of December 31, 2025, there were no material remaining obligations related to the strategic restructuring plan.
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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.
Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the 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 years ended December 31, 2025, 2024, and 2023, respectively.
Year Ended December 31, 2025
(in thousands)
2025
2024
2023
Net sales
$
263,502
$
164,070
$
1,189
Cost of sales
Cost of goods sold ( excluding depreciation and amortization ) (a)
$
155,809
$
70,497
$
1,033
Stock-based compensation
7,286
8,554
—
Royalties
10,089
14,197
-
Total cost of sales
$
173,184
$
93,248
$
1,033
Expenses
Research and development
$
273,311
$
226,958
$
298,268
General and administrative
73,537
62,443
78,399
Sales and marketing
51,455
38,027
-
Depreciation and amortization
35,939
37,603
21,423
Restructuring charges
5,143
-
—
Other segment items (b)
41,911
77,968
46,103
Total expenses
$
481,296
$
442,999
$
444,193
Net loss
$
( 390,978 )
$
( 372,177 )
$
( 444,037 )
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. For patients that can be administered Amtagvi ® as part of a clinical trial in an expanded or early access program, or single-patient investigational new drug submission, 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.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 13. EMPLOYEE BENEFIT PLAN
The Company maintains a defined contribution plan covering substantially all U.S. employees under Section 401(k) of the Internal Revenue Code of 1986, as amended (the “IRC”). The Company's matching contribution to the defined contribution plan was $ 6.4 million, $ 4.7 million, and $ 4.1 million for the years ended December 31, 2025, 2024 and 2023, respectively.
NOTE 14. INCOME TAXES
Loss before provision of income taxes consisted of U.S. losses of $ 350.2 million, $ 359.9 million, and $ 433.5 million, and foreign losses of $ 42.9 million, $ 15.1 million, and $ 14.0 million for the years ended December 31, 2025, December 31, 2024, and December 31, 2023, respectively. The Company recorded a tax benefit of $ 2.1 million, $ 2.8 million, and $ 3.5 million for the years ended December 31, 2025, December 31, 2024, and December 31, 2023, respectively, which resulted in an effective tax rate of 0.53 %, 0.75 %, and 0.78 %, respectively. The income tax benefit for the periods presented primarily relates to operations in the United Kingdom and the change in deferred tax assets and liabilities.
The significant components of the Company’s net deferred tax assets and liabilities are summarized as follows (in thousands):
As of December 31,
2025
2024
Deferred income tax assets
Net operating loss carryforwards
$
416,152
$
302,875
Stock-based compensation
41,275
40,909
Tax credit carryforwards
65,184
66,874
Lease liabilities
14,911
14,759
Capitalized R&D
147,823
137,577
Reserves and accruals
18,916
11,523
Other
2,217
—
Deferred tax assets before valuation allowance
706,478
574,517
Less: valuation allowance
( 687,503 )
( 557,587 )
Net deferred income tax assets
18,975
16,930
Deferred tax liabilities
Right-of-use assets
( 14,128 )
( 14,228 )
Depreciation and amortization
( 36,496 )
( 35,017 )
Other
( 179 )
—
Net deferred tax liabilities
$
( 31,828 )
$
( 32,315 )
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The reconciliation of the effective income tax rate to the U.S. statutory rate is as follows (in thousands):
As of December 31, 2025
U.S. Federal statutory tax rate
$
( 82,541 )
21
%
Foreign tax effects
United Kingdom
Nontaxable or nondeductible items
4,225
( 1 )
%
Other
1,310
( 0 )
%
Other foreign jurisdictions
1,392
( 0 )
%
Tax credits
Research and development and orphan drug credit
( 1,743 )
0
%
Changes in valuation allowances
58,543
( 15 )
%
Nontaxable or nondeductible items
Share based compensation
19,035
( 5 )
%
Nondeductible officers' compensation
( 4,598 )
1
%
Other nontaxable or nondeductible items
1,782
( 0 )
%
Others
524
( 0 )
%
Effective tax rate
$
( 2,071 )
1
%
The following table presents the required disclosures prior to our adoption of ASU 2023-09 and reconciles the U.S. federal statutory income tax rate to the actual global effective income tax rate for the years ended December 31, 2024, and December 31, 2023:
2024
2023
Federal statutory tax rate
21
%
21
%
Orphan drug and research credits
2
2
Foreign tax effects
Permanent and other differences
( 2 )
( 1 )
Stock-based compensation
( 1 )
( 1 )
State tax, net of federal benefit
10
1
30
%
22
%
Valuation allowance
( 29 )
%
( 21 )
%
Effective tax rate
1
%
1
%
The Company had net operating loss carryforwards (“NOLs”) for federal, state and local, and foreign income tax purposes of approximately $ 1.7 billion, $ 928.8 million, and $ 21.0 million, respectively, as of December 31, 2025. $ 142.4 million of federal NOLs will expire beginning in 2027, while $ 1.6 billion generated after the recently enacted tax reform will have an indefinite life under the Tax Cuts and Jobs Act of 2017 (the “Tax Act”). The state NOLs will expire if unused in years 2030 through 2045. The foreign NOLs do not expire. The Company had $ 82.3 million of federal and $ 13.7 million of California research and development tax credit and other tax credit carryforwards available to offset future taxable income. The federal credits begin to expire in 2033, and the California research credits have no expiration dates.
The Company’s utilization of NOLs and tax credits is subject to an annual limitation due to ownership changes that have occurred previously or that could occur in the future as provided in Section 382 of the Internal Revenue Code (“Section 382”), as well as similar state provisions. Section 382 limits the utilization of NOLs and tax credits when there is a greater than 50% change of ownership as determined under the regulations. Since its formation, the Company has raised capital through the issuance of capital stock and various convertible instruments which, combined with the purchasing shareholders’ subsequent disposition of these shares, has resulted in multiple ownership changes as defined by Section 382, and could result in ownership change in the future upon subsequent disposition. The Company’s utilization of NOLs and Tax Credits may also be adversely affected by future changes in federal and state tax laws and regulations.
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon future generation for
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. After consideration of all the information available, management continues to maintain a full valuation allowance against U.S. federal and state net deferred tax assets due to the Company’s cumulative loss position and lack of sufficient positive evidence to support the realizability of its U.S. net deferred tax assets. For the years ended December 31, 2025, 2024 and 2023, the change in the valuation allowance was approximately $ 129.9 million, $ 110.7 million, and $ 96.4 million, respectively.
The Company evaluated the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the Company has taken or expects to take in its tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Differences between tax positions taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant to the interpretation are referred to as “unrecognized benefits.” A liability is recognized (or amount of NOL carry-forward or amount of tax refundable is reduced) for unrecognized tax benefits because it represents an enterprise’s potential future obligation to the taxing authority for a tax position that was not recognized as a result of applying the provisions of ASC 740.
If applicable, interest costs related to the unrecognized tax benefits are required to be calculated and would be classified as income tax expenses in the consolidated statements of operations. Penalties would be recognized as a component of selling, general and administrative expenses in the consolidated statements of operations.
A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2025, 2024 and 2023 is as follows (in thousands):
Years Ended December 31,
2025
2024
2023
Unrecognized benefit - beginning of period
$
29,854
$
26,107
$
21,645
Gross decreases - prior period tax positions
( 4,231 )
—
—
Gross increases - current period tax positions
3,175
3,747
4,462
Unrecognized benefit - end of period
$
28,798
$
29,854
$
26,107
No interest or penalties on unpaid tax were recorded during the years ended December 31, 2025, 2024, or 2023. If the balance of unrecognized tax benefits were recognized in a future period, there would be no impact to the effective tax rate due to the valuation allowance on deferred tax assets.
The Company files tax returns in U.S. federal and state jurisdictions, as well as foreign jurisdictions. The U.S. federal and U.S. state taxing authorities may choose to audit tax returns for tax years beyond the statute of limitation period due to significant tax attribute carryforwards from prior years, making adjustments only to carryforward attributes. The Company is not currently under examination by income tax authorities in federal, state, or other foreign jurisdictions.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The aggregate impact of the OBBBA is immaterial as the impact to the Company’s deferred tax assets will be offset entirely by a full valuation allowance in the U.S.
The Company did no t have any significant income taxes paid, or refunds received from any jurisdiction for the years ended December 31, 2025, 2024, or 2023.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 15. 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 development of unmodified TIL as a stand-alone therapy or in combination, the evaluation in clinical trials of strategies for development of more potent TILs, such as selection of CD39/69 double negative cells and the use of certain inhibitors or other reagents in TIL expansion cultures.
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 also 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 $ 3.0 million, $ 2.0 million, and $ 2.0 million for each of the years ended December 31, 2025, 2024 and 2023, respectively, as research and development expenses.
Patent License Agreements Related to TIL Cell Therapies
The Company entered into a 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. The Patent License Agreement was amended multiple times to include exclusive, co-exclusive, and non-exclusive licenses to certain NIH technologies relating to autologous tumor infiltrating lymphocyte adoptive cell therapy.
The Patent License Agreement, as amended, 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. 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 Patent License Agreement, as amended. 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 Patent License Agreement, as amended. The term of the Patent License Agreement, as amended, 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 Patent License Agreement, as amended. Both aforementioned milestone payments have been capitalized and recorded as intangible assets on the consolidated balance sheet. During the year ended December 31, 2025 and December 31, 2024, the Company recorded $ 0.8 million and $ 0.7 million, respectively, as a component of cost of sales related to amortization of the milestone payments. No expenses were recorded for the year ended December 31, 2023.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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. Minaris has concluded production of Amtagvi ® and clinical supply of lifileucel and its agreement terminated in the first quarter of 2026. The Company recorded costs associated with agreements with Minaris of $ 24.7 million, $ 25.0 million, and $ 17.3 million for the years ended December 31, 2025, 2024, and 2023, respectively, as costs and expenses included in the consolidated statement of operations or as inventory in the consolidated balance sheets.
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 $ 0.4 million for each of the years ended December 31, 2025, 2024, and 2023, 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 $ 2.5 million during the year ended December 31, 2025 related to a milestone payment for the initiation of patient dosing for IOV-3001. No expenses were recorded for the years ended December 31, 2024, and 2023, respectively.
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 United States 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 the years ended December 31, 2025, 2024, and 2023, respectively.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 original term of this agreement was 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 years ending December 31, 2026, 2027 and 2028 are $ 16.7 million, $ 24.0 million, and $ 21.3 million, respectively.
NOTE 16. 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 i CTC, 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, 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.
Headquarters Office Lease
On November 15, 2024, the Company entered into a sublease agreement (the “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 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 six 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 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):
December 31,
December 31,
2025
2024
Operating lease right-of-use assets
$
45,899
$
55,201
Operating lease liabilities
Current portion included in current liabilities
$
4,043
$
12,896
Long-term portion included in non-current liabilities
44,401
44,365
Total operating lease liabilities
$
48,444
$
57,261
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IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The following table summarizes components of lease expenses, which were included in total expenses in the Company’s consolidated statements of operations and in inventory in the consolidated balance sheets, and other information related to the Company’s operating leases as follows (in thousands, except weighted-average remaining lease terms and discount rates):
Year Ended
December 31,
2025
2024
Operating lease cost
$
15,516
$
16,484
Variable lease cost
2,622
3,995
Short-term lease cost
335
431
Total lease cost
$
18,473
$
20,910
Other information
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations
$
15,125
$
18,120
Right-of-use assets obtained from entering new leases
$
—
$
2,306
Increase in right-of-use assets from lease modifications
$
2,084
$
818
Weighted-average remaining lease terms (years)
13.98
12.83
Weighted-average discount rates
7.5
%
7.9
%
As of December 31, 2025, maturities of the Company's operating lease liabilities were as follows (in thousands):
CMO
Facility
embedded
Year Ending December 31,
leases
leases
Total
2026
$
6,577
$
932
$
7,509
2027
5,469
—
5,469
2028
5,016
—
5,016
2029
4,838
—
4,838
2030
4,610
—
4,610
Thereafter
53,393
—
53,393
Total lease payments
$
79,903
$
932
$
80,835
Less: Present value adjustment
( 32,382 )
( 9 )
( 32,391 )
Operating lease liabilities
$
47,521
$
923
$
48,444
NOTE 17. LEGAL PROCEEDINGS
Shumacher Derivative Lawsuit. On December 11, 2020, a purported stockholder derivative complaint was filed by plaintiff Leo Shumacher against the Company, as nominal defendant, and then current directors, as defendants, in the Court of Chancery in the State of Delaware (the “Court of Chancery”). The complaint alleges breach of fiduciary duty and a claim for unjust enrichment in connection with alleged excessive compensation of certain non-executive directors of the Company and seeks unspecified damages on behalf of the Company. The parties agreed to a proposed settlement, which was submitted to the Court of Chancery on June 15, 2022. After a hearing on November 17, 2022, the Court of Chancery required the parties to take additional steps before it would approve the settlement. The Company, as nominal defendant, and its current directors, as defendants, answered the complaint on February 3, 2023. The parties agreed to a revised proposed settlement, which was submitted to the Court of Chancery on March 12, 2024. On January 17, 2025, a non-party stockholder (The Paul Berger Revocable Trust), which objected to the revised proposed settlement, filed a derivative complaint and letter with the Court suggesting consolidation. On May 29, 2025, the Court issued an order consolidating the cases and appointing the Paul Berger Revocable Trust as lead plaintiff and its counsel as lead counsel. On September 2, 2025, the plaintiff filed a consolidated complaint in the matter, now captioned In re: Iovance Biotherapeutics, Inc. Stockholder Litigation . The defendants filed a motion to dismiss certain claims in the consolidated complaint on November 24, 2025. The Company intends to vigorously defend against this matter.
Ohio Laborers Derivative Lawsuit. On September 11, 2024, a purported stockholder derivative complaint was filed by plaintiff Northern California Pipe Trades Trust Fund against the Company, as nominal defendant, and certain directors, as defendants, in the
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Court of Chancery. The complaint alleges breach of fiduciary duty in connection with the February 2024 underwritten public offering of 23,014,000 shares of the Company’s common stock. On November 22, 2024, the defendants filed a motion to dismiss the complaint. On December 5, 2024, the plaintiff filed an amended complaint adding an additional director defendant. On January 10, 2025, defendants filed a motion to dismiss the amended complaint. On February 3, 2025, the Court approved substitution of Laborers’ District Council and Contractors’ Pension Fund of Ohio (“Ohio Laborers”) as representative plaintiff. The plaintiff filed a motion for leave to file a second amended complaint on October 2, 2025. On October 21, 2025, the Court granted the parties’ stipulation allowing the plaintiff to file its second amended complaint, which it filed on October 22, 2025. The defendants filed a motion to dismiss the second amended complaint on December 12, 2025. The Company intends to vigorously defend against this complaint.
Solomon Capital, LLC. On April 8, 2016, a lawsuit (the “First Solomon Suit”) titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. was filed by Solomon Capital, LLC, Solomon Capital 401(k) Trust, Solomon Sharbat and Shelhav Raff (“Solomon Plaintiffs”) against the Company in the Supreme Court of the State of New York, County of New York (index no. 651881/2016) (the “court”). The Solomon Plaintiffs allege that, between June and November 2012, they provided the Company $ 0.1 million and that they advanced and paid on behalf of the Company an additional $ 0.2 million.
The complaint further alleges that the Company agreed to (i) provide them with promissory notes totaling $ 0.2 million, plus interest, (ii) issue a total of 1,110 shares to the Solomon Plaintiffs (after the 1-for-100 reverse split of the Company’s common stock effected in March 2013) (the “Equity Claim”), and (iii) allow the Solomon Plaintiffs to convert the foregoing funds into its securities in the next financing of the Company on the same terms offered to other investors, which Solomon Plaintiffs allege, should have given them the right to convert their advances and payments into shares of the Company's common stock in the restructuring that took effect in May 2013. Based on the foregoing, the Solomon Plaintiffs allege causes for breach of contract and unjust enrichment and demand judgment against the Company in an unspecified amount exceeding $ 1.5 million, plus interest. On June 3, 2016, the Company filed an answer and counterclaims. The Company asserted counterclaims for fraudulent inducement, fraudulent misrepresentation, fraudulent concealment, breach of fiduciary duty, and breach of contract, alleging principally that the counterclaim defendants misrepresented their qualifications and failed to disclose that Solomon Sharbat was the subject of an investigation by the Financial Industry Regulatory Authority (“FINRA”) that resulted in the loss of his FINRA license.
In its counterclaims, the Company seeks damages in an amount exceeding $ 0.5 million and an order rescinding any and all agreements that the Solomon Plaintiffs contend entitled them to obtain shares of Company stock. On May 12, 2020, the court granted the Company’s motion for summary judgment limiting the Solomon Plaintiffs’ damages for the Equity Claim to $ 47,420 . The Solomon Plaintiffs filed a notice of appeal of this summary judgment on June 9, 2020. On July 2, 2020, the court granted the Company’s motion to dismiss the First Solomon Suit for want of prosecution. On January 4, 2021, the court granted the Solomon Plaintiffs motion for reconsideration and reinstituted the case. On January 15, 2021, the Company filed a notice of appeal of the court’s grant of the Solomon Plaintiffs motion for reconsideration. On May 11, 2021, the Appellate Division upheld the court’s grant of the Solomon Plaintiffs’ motion for reconsideration of the dismissal of the First Solomon Suit for want of prosecution. On January 22, 2025, Solomon Sharbat and Shelhav Raff (through new legal counsel) filed a motion for leave to file an amended complaint in the First Solomon Suit, which the Company opposed. On March 10, 2025, the Company filed a motion for summary judgment in the First Solomon Suit. Following oral argument on December 3, 2025, the court denied the Solomon Plaintiffs’ motion for leave to amend and granted the Company’s motion for summary judgment.
On September 27, 2019, the Solomon Plaintiffs filed a new lawsuit (through new legal counsel) (the “Second Solomon Suit”) titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Iovance Biotherapeutics, Inc., f/k/a/ Lion Biotechnologies Inc. f/k/a/ Genesis Biopharma Inc., and Manish Singh in the Supreme Court of the State of New York, County of New York (index no. 655668/2019). In the Second Solomon Suit, the Solomon Plaintiffs allege that they are third party beneficiaries of a “finder’s fee agreement” that prior management entered into with a third party unlicensed entity in 2012 in connection with seeking financing, that an agreement or understanding existed between the Company and the plaintiffs that the plaintiffs would be paid fees and commissions (in cash and stock) if they obtained financing for the Company, and that they directly and indirectly introduced investors to the Company who invested in the Company, or were willing to invest in the Company. Finally, the Solomon Plaintiffs allege that they were promised a license to use the Company’s technology in Israel. The plaintiffs claim that the Company breached the foregoing understandings, promises and agreements and, as a result, they are entitled to certain damages. The Solomon Plaintiffs also allege that Manish Singh, the Company’s former Chief Executive Officer, committed fraud and took shares belonging to them. On February 18, 2020, the Company filed a removal petition and removed the Second Solomon Suit to the U.S. District Court for the Southern District of New York (the “District Court”), where the case has been assigned case no. 1:20-cv-1391.
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On May 22, 2020, the Company moved to dismiss the Second Solomon Suit for lack of personal jurisdiction. On March 26, 2021, the District Court denied the Company’s motion to dismiss for lack of personal jurisdiction. The Company filed a response to the complaint in the Second Solomon Suit on April 30, 2021. On May 26, 2021, the Company and Singh filed motions for judgment on the pleadings with respect to the second and third claims asserted against the Company and all claims asserted against Singh, respectively, in the Second Solomon Suit. On January 5, 2022, the District Court granted the Company’s motions for judgment on the pleadings, dismissing the second and third claims against the Company and dismissing all claims against Singh. On January 4, 2023, the District Court granted in part the Company’s motion for sanctions against the Solomon Plaintiffs for violating Rule 11 of the Federal Rules of Civil Procedure, in a decision and order that dismissed the Solomon Plaintiffs’ first claim against the Company, denied the Solomon Plaintiffs’ motion for leave to amend the complaint, and ordered the Solomon Plaintiffs to pay the Company’s attorneys’ fees incurred in connection with the Rule 11 motion. Following the District Court’s decision and order on the Rule 11 motion, only the Solomon Plaintiffs’ fifth and sixth claims, for unjust enrichment and indemnification, respectively, remained pending against the Company. On October 26, 2023, the District Court granted the Company’s motion for summary judgment and dismissed the Solomon Plaintiffs’ fifth and sixth claims. On October 27, 2023, the District Court entered judgment for the Company and closed the Second Solomon Suit. On November 10, 2023, the Company filed a motion for attorneys’ fees as the prevailing party in the action. On December 1, 2023, the Solomon Plaintiffs filed a notice of appeal to the U.S. Court of Appeals for the Second Circuit, appealing the District Court’s orders (a) granting the motions for judgment on the pleadings filed on behalf of Singh and the Company, (b) granting the Company’s Rule 11 motion, (c) denying the Solomon Plaintiffs’ motions to compel discovery and re-open discovery, and (d) granting the Company’s summary judgment motion. On December 22, 2023, the Company filed a motion for an order requiring the Solomon Plaintiffs to post an appeal bond, to ensure payment of the Company’s appellate fees and costs should the Company prevail on the appeal. On May 9, 2024, the District Court issued an order granting the Company’s motions for attorneys’ fees and for an appeal bond. On June 28, 2024, the Company filed motions to dismiss the appeal on the grounds that the Solomon Plaintiffs (a) do not have an opening brief on file, which the Second Circuit Court denied, and (b) have not filed an appeal bond. The District Court entered judgment in favor of the Company on September 23, 2024, including a monetary award pursuant to the District Court’s Rule 11 order and orders for attorneys’ fees and costs. On October 9, 2024, the Second Circuit Court stated that it will dismiss the appeal unless the Solomon Plaintiffs post the appeal bond by October 23, 2024. The Solomon Plaintiffs then moved for an extension of time until November 23, 2024 to post the appeal bond. The Company filed an opposition to the motion. The Second Circuit Court denied the Solomon Plaintiffs’ motion for an extension of time on November 7, 2024, and dismissed the appeal on November 8, 2024. On August 15, 2025, the Solomon Plaintiffs filed a motion to vacate or modify the Rule 11 sanctions order, which the District Court denied on September 4, 2025. On January 29, 2026, the Solomon Plaintiffs filed a motion for extension of time to appeal the District Court’s September 4, 2025 order and for a stay of collection efforts, which the Company opposed on February 4, 2026.
The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable. At the current stage of the litigation, in both the First Solomon Suit and the Second Solomon Suit, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters.
Securities Class Actions and Shareholder Derivative Cases. On May 15, 2025, two putative securities class actions were filed in the United States District Court for the Northern District of California (“Northern District of California”), captioned Sundaram v. Iovance Biotherapeutics, Inc., et al ., No. 25-cv-04177 (“ Sundaram ”) and Farberov v. Iovance Biotherapeutics, Inc., et al ., No. 25-cv-04199 (“ Farberov ”), naming the Company and certain of the Company’s officers as defendants. The complaints purport to assert claims against the defendants under Section 10(b) of the Securities Exchange Act of 1934 (the “1934 Act”), SEC Rule 10b-5, and Section 20(a) of the 1934 Act. The Sundaram action is on behalf of persons or entities who acquired the Company’s common stock between August 8, 2024 and May 8, 2025, and the Farberov action is on behalf of persons or entities who acquired the Company’s common stock between May 9, 2024 and May 8, 2025. Each putative class action arises out of the Company’s quarterly disclosure of financial results on May 8, 2025, and the decline in the price of the Company’s common stock the following day, and involve allegations that during the respective class periods, defendants made materially false and misleading statements regarding the Company’s expected revenue for fiscal year 2025, which the plaintiffs claim artificially inflated the price of the Company’s common stock. The actions seek compensatory damages and costs and expenses incurred in the actions, including attorneys’ fees. On December 15, 2025, the court consolidated the class actions, now captioned In re Iovance Biotherapeutics, Inc. Securities Litigation , No. 25-cv-04177, and appointed lead plaintiff and plaintiffs’ counsel.
On June 5, 2025, two putative shareholder derivative lawsuits were filed in the Northern District of California, captioned Hollin v. Vogt, et al ., 3:25-cv-04740 and Gera, et al. v. Vogt, et al ., 3:25-cv-04794, purportedly brought on behalf of Iovance against certain current and former officers and directors of the Company. A third putative shareholder derivative lawsuit, captioned Bitton v. Bellemin, et. al ., 3:25-cv-09701, was filed in the Northern District of California on November 12, 2025. Iovance is named as a
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nominal defendant in the complaints. The lawsuits contain allegations based on or similar to those in the putative securities class actions and claim, among other things, that the named individual defendants breached their fiduciary duties and violated Section 14(a) of the 1934 Act by issuing or causing the Company to issue false and misleading disclosures concerning the Company’s financial forecasts for fiscal year 2025. Before filing the complaints, the plaintiffs did not make a demand that the Company’s Board of Directors consider the claims therein. The lawsuits seek money damages, corporate governance reforms, restitution, punitive damages, and costs and expenses of the lawsuits, including attorneys’ fees. On December 15, 2025, the court consolidated the derivative lawsuits, now captioned In re Iovance Biotherapeutics, Inc. Derivative Litigation , No. 5:25-cv-04740, and appointed co-lead plaintiff and plaintiffs’ counsel.
Based on the preliminary nature of the proceedings in these actions, the outcomes remain uncertain and we cannot estimate the potential impact, if any, on the Company’s business or financial statements at this time.
The Company has been and may continue to be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues amounts, to the extent they can be reasonably estimated, that it believes are adequate to address any liabilities related to legal proceedings and other loss contingencies that it believes will result in a probable loss. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on its financial position, results of operations or cash flows.
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