44 unchanged sentences
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).
−Removed: Third 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 April 29, 2022).
+Added: 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).
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).
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).
−Removed: Genesis Biopharma, Inc.
−Removed: 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8 K filed with the Commission on October 20, 2011).#
−Removed: Form of Incentive Stock Option Agreement under the Genesis Biopharma Inc.
−Removed: 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 25, 2020).#
−Removed: Form of Non-Qualified Stock Option Agreement under the Genesis Biopharma Inc.
−Removed: 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 25, 2020).#
−Removed: Lion Biotechnologies, Inc.
−Removed: 2014 Equity Incentive Plan, as amended (incorporated herein by reference to Appendix A to the Registrant’s Definitive Proxy Statement on Schedule 14A filed with the Commission on July 7, 2016).#
−Removed: Form of Incentive Stock Option Agreement under the Lion Biotechnologies, Inc.
−Removed: 2014 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 25, 2020).#
−Removed: Form of Non-Qualified Stock Option Agreement under the Lion Biotechnologies, Inc.
−Removed: 2014 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 25, 2020).#
Iovance Biotherapeutics, Inc.
−Removed: 2018 Equity Incentive Plan, as amended (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on November 7, 2023).#
+Added: 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).#
Form of Incentive Stock Option Agreement under the Iovance Biotherapeutics, Inc.
7 unchanged sentences
Iovance Biotherapeutics, Inc.
−Removed: 2020 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on November 7, 2023).#
+Added: 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).#
Iovance Biotherapeutics, Inc.
7 unchanged sentences
Cooperative Research and Development Agreement for Intramural-PHS Clinical Research, dated August 5, 2011, by and between the U.S.
−Removed: Department of Health and Human Services, as represented by the National Cancer Institute, and Genesis
−Removed: Biopharma, Inc.
+Added: 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.
3 unchanged sentences
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).
−Removed: 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 Expertise in Adoptive Cell Transfer Immunotherapy, executed by Lion Biotechnologies, Inc.
+Added: 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
+Added: 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).*
17 unchanged sentences
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.
+Added: (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).+
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.
+Added: (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).+
Manufacturing Services Agreement, dated November 23, 2015, by and between WuXi Advanced Therapies, Inc.
1 unchanged sentence
(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).*
−Removed: Strategic Alliance Agreement, effective as of April 17, 2017, between Lion Biotechnologies, Inc.
−Removed: and The University of Texas M.D.
−Removed: Anderson Cancer Center (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10 Q filed with the Commission on August 3, 2017).*
−Removed: First Amendment to the Strategic Alliance Agreement by and between Iovance Biotherapeutics, Inc.
−Removed: and The University of Texas M.D.
−Removed: Anderson Cancer Center, effective as of August 2, 2017 (incorporated herein by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 12, 2018).
−Removed: Second Amendment to the Strategic Alliance Agreement by and between Iovance Biotherapeutics, Inc.
−Removed: and The University of Texas M.D.
−Removed: Anderson Cancer Center, effective February 16, 2018 (incorporated herein by reference to Exhibit 10.35 to the Registrant’s Annual Report on Form 10-K filed with the Commission on March 12, 2018).
−Removed: Executive Employment Agreement, effective as of June 1, 2016, by and between Maria Fardis and Lion Biotechnologies, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.3 of the Registrant’s Quarterly Report on Form 10 Q filed with the Commission on August 9, 2016).*#
−Removed: Severance Agreement and General Release, effective as of July 8, 2020, between Iovance Biotherapeutics, Inc.
−Removed: and Timothy Morris (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on August 6, 2020).*#
Executive Employment Agreement, effective as of September 30, 2016, by and between Frederick G.
4 unchanged sentences
(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).
−Removed: Executive Employment Agreement, effective as of December 14, 2020, by and between Jean-Marc Bellemin and Iovance Biotherapeutics, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.30 of the Registrant’s Annual Report on Form 10-K filed with the Commission on February 25, 2021).#+
Executive Employment Agreement, effective as of March 15, 2021, by and between Igor Bilinsky, Ph.D.
4 unchanged sentences
and Iovance Biotherapeutics, Inc.
+Added: (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).#+
Executive Employment Agreement, effective as of January 25, 2025, by and between Daniel Gordon Kirby and Iovance Biotherapeutics, Inc.
−Removed: Office Lease, effective as of August 4, 2016, by and between Lion Biotechnologies, Inc.
−Removed: and Hudson Skyway Landing, LLC (incorporated herein by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8 K filed with the Commission on August 8, 2016).
−Removed: Office Lease, effective as of October 19, 2018, by and between Iovance Biotechnologies, Inc.
−Removed: and Hudson Skyway Landing, LLC (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8 K filed with the Commission on October 25, 2018).
−Removed: First Amendment to the Office Lease, effective as of June 19, 2019, between Iovance Biotherapeutics, Inc.
−Removed: and Hudson Skyway Landing, LLC (incorporated herein by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed with the Commission on November 4, 2019).
−Removed: Second Amendment to the Office Lease, effective as of February 8, 2021, by and between Iovance Biotherapeutics, Inc.
−Removed: and Hudson Skyway Landing, LLC (incorporated herein by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the Commission on February 9, 2021).
−Removed: First Amendment to the Office Lease, effective as of February 8, 2021, by and between Iovance Biotherapeutics, Inc.
−Removed: and Hudson Skyway Landing, LLC (incorporated herein by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed with the Commission on February 9, 2021).
+Added: (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).#+
+Added: First Amendment to Executive Employment Agreement, effective as of December 3, 2025, by and between Daniel Gordon Kirby and Iovance Biotherapeutics, Inc.**#+
+Added: Executive Employment Agreement, effective as of August 6, 2025, by and between Corleen Roche and Iovance Biotherapeutics, Inc.
+Added: (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).#+
Lease Agreement, effective as of May 28, 2019, by and between Iovance Biotherapeutics, Inc.
6 unchanged sentences
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).
−Removed: Lease Agreement, effective as of February 8, 2021, by and between Iovance Biotherapeutics, Inc.
−Removed: and ARE-San Francisco No.
−Removed: 63, LLC (incorporated herein by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the Commission on February 9, 2021).
Sublease, effective as of November 15, 2024, by and between Iovance Biotherapeutics, Inc.
and Vaxcyte, Inc.
−Removed: Termination Agreement, effective as of November 15, 2024, by and between Iovance Biotherapeutics, Inc.
−Removed: and ARE – San Francisco No.
+Added: (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).+
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).
+Added: Amended and Restated Open Market Sale Agreement, dated August 22, 2025, by and between Iovance Biotherapeutics, Inc.
+Added: 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).
Iovance Biotherapeutics, Inc.
Insider Trading Policy.
+Added: (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)
Subsidiaries of the Company.
+Added: (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)
Consent of Independent Registered Public Accounting Firm.
6 unchanged sentences
Dodd-Frank Clawback Policy.
+Added: (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)
The following financial information from the Annual Report on Form 10-K of Iovance Biotherapeutics, Inc.
21 unchanged sentences
Know all persons by these presents, that each person whose signature appears below constitutes and appoints Frederick G.
−Removed: Vogt, and Jean-Marc Bellemin, 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.
+Added: 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.
4 unchanged sentences
General Counsel (Principal Executive Officer) and Director
−Removed: /s/ Jean-Marc Bellemin
−Removed: Chief Financial Officer and Treasurer
+Added: /s/ Corleen Roche
+Added: Chief Financial Officer
February 24, 2026
−Removed: Jean-Marc Bellemin
+Added: Corleen Roche
(Principal Financial Officer and Accounting Officer)
43 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matter 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 matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Critical Audit Matters
+Added: 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:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: 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
2 unchanged sentences
As described in Note 2 to the Financial Statements, the Company recognizes revenue when a customer obtains control of promised goods.
−Removed: 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.
+Added: 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.
How We Addressed the Matter in Our Audit
−Removed: We evaluated the design and tested the operating effectiveness of the Company’s internal control related to the Company’s revenue recognition processes.
−Removed: 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, 2024 and, for confirmations not returned, obtaining and inspecting source documents, such as invoices, proof of delivery, and subsequent cash receipts.
+Added: We evaluated the design and tested the operating effectiveness of the Company’s internal controls related to the Company’s revenue recognition processes.
+Added: 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.
+Added: Accounting for Amtagvi Inventory
+Added: Description of the Matter
+Added: 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.
+Added: 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.
+Added: 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.
+Added: How We Addressed the Matter in Our Audit
+Added: 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.
+Added: 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
46 unchanged sentences
Accrued expenses and other liabilities
+Added: Note payable - current
Operating lease liabilities
11 unchanged sentences
Series B Convertible Preferred stock, $ 0.001 par value;
−Removed: 11,500,000 shares designated, 2,842,158 shares issued and outstanding as of December 31, 2024 and December 31, 2023
+Added: 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
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
−Removed: Accumulated other comprehensive loss (income)
+Added: Accumulated other comprehensive income (loss)
Additional paid-in capital
9 unchanged sentences
Years Ended December 31,
−Removed: Product revenue
+Added: Product revenue, net
Total revenue
3 unchanged sentences
Selling, general, and administrative **
+Added: Depreciation and amortization
+Added: Restructuring charges
Total costs and expenses
2 unchanged sentences
Net Loss before income taxes
−Removed: Income tax benefit
+Added: Income tax (expense) benefit
Net Loss Per Share of Common Stock, Basic and Diluted
Weighted Average Shares of Common Stock Outstanding, Basic and Diluted
+Added: * Non-cash stock-based compensation included in cost of sales and operating expenses
+Added: Cost of sales
+Added: Research and development
+Added: Selling, general and administrative
+Added: ** Excludes depreciation and amortization
The accompanying notes are an integral part of these consolidated financial statements.
4 unchanged sentences
Other comprehensive loss:
−Removed: Unrealized gain on investments
+Added: Unrealized gain (loss) on investments
Foreign currency translation adjustment
16 unchanged sentences
Common stock issued upon exercise of stock options
−Removed: Common stock sold in public offering, net of offering costs
+Added: Common stock sold in public and/or at the market offering, net of offering costs
Unrealized gain on investments
+Added: Foreign currency cumulative translation adjustment
Balance - December 31, 2023
( 2,012,375 )
+Added: Balance - December 31, 2023
+Added: ( 2,012,375 )
Stock-based compensation expense
1 unchanged sentence
Tax payments related to shares retired for vested restricted stock units
+Added: ( 1,098,388 )
Common stock issued upon purchase of employee stock purchase plan
Common stock issued upon exercise of stock options
−Removed: Common stock sold in public and/or at the market offerings, net of offering costs
+Added: Common stock sold in public and/or at the market offering, net of offering costs
Unrealized gain on investments
2 unchanged sentences
( 2,384,552 )
+Added: Balance - December 31, 2024
+Added: ( 2,384,552 )
Stock-based compensation expense
5 unchanged sentences
Common stock sold in public and/or at the market offering, net of offering costs
−Removed: Unrealized gain on investments
+Added: Common stock issued from preferred stock conversion
+Added: Unrealized loss on investments
Foreign currency cumulative adjustments
9 unchanged sentences
Stock-based compensation expense
−Removed: Unrealized foreign exchange gains
+Added: Unrealized foreign exchange loss
Amortization of intangible assets
1 unchanged sentence
Depreciation and amortization of property and equipment
−Removed: Deferred tax benefit
+Added: Deferred tax (benefit) expense
+Added: Excess and obsolescence reserve
Accretion of discounts and premiums on investments
−Removed: Impairment of long-lived assets
+Added: Loss on asset disposals
Gain on derecognition of lease assets and liabilities
11 unchanged sentences
Purchase of property and equipment
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
Cash Flows from Financing Activities
2 unchanged sentences
Proceeds from the issuance of common stock upon exercise of options
−Removed: Vesting of restricted shares issued for services
Proceeds from the issuance of common stock, net
1 unchanged sentence
Effect of foreign exchange rate changes
−Removed: Net increase in cash, cash equivalents and restricted cash
+Added: Net increase (decrease) in cash, cash equivalents and restricted cash
Cash, Cash Equivalents and Restricted Cash Beginning of Period
2 unchanged sentences
Fair value of net assets acquired
−Removed: Net unrealized gain on investments
+Added: Net unrealized loss on investments
Acquisition of property and equipment included in accounts payable and accrued expenses
Intangible asset and deferred tax liability arising from contingent consideration
+Added: Conversion of convertible preferred stock to common stock
Lease liabilities arising from obtaining right-of-use asset from new leases
−Removed: Lease liabilities arising from obtaining right-of-use asset from lease modifications
+Added: Increase / (decrease) in lease liabilities due to obtaining/(reduction in) right-of-use assets from lease modifications
The accompanying notes are an integral part of these consolidated financial statements.
4 unchanged sentences
Iovance Biotherapeutics, Inc.
−Removed: (the “Company”) is a commercial-stage biopharmaceutical company pioneering a transformational approach to treating cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells using therapies personalized for each patient.
+Added: (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.
−Removed: The Company is executing the U.S.
−Removed: launch of Amtagvi ® (lifileucel), the first product within its autologous TIL cell therapy platform, while also marketing Proleukin ® (aldesleukin), an interleukin-2 (“IL-2”) product used in the Amtagvi ® treatment regimen and in other applications.
−Removed: Amtagvi ® is the first and the only one-time, individualized T cell therapy to receive U.S.
−Removed: Food and Drug Administration (“FDA”) approval for a solid tumor cancer.
−Removed: Amtagvi ® is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
−Removed: This indication was approved under accelerated approval based on overall response rate (“ORR”).
−Removed: Continued approval for this indication may be contingent upon verification and description of clinical benefit in future confirmatory trials.
−Removed: Amtagvi ® and Proleukin ® are part of a treatment regimen that includes lymphodepletion.
−Removed: Beyond the U.S., the Company plans to launch Amtagvi ® into additional markets with a high prevalence of advanced melanoma, including the European Union, United Kingdom, Canada, Switzerland, and Australia.
−Removed: In June 2024, the Company submitted a centralized marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for lifileucel.
−Removed: In August 2024, the MAA was validated and accepted for review by the EMA.
−Removed: In October 2024, an MAA was submitted to the Medicines and Healthcare products Regulatory Agency in the United Kingdom.
−Removed: A new drug submission (“NDS”) was deemed eligible for Notice of Compliance with Conditions (“NOC/c”) by Health Canada and submitted in December 2024 and then accepted in January 2025.
−Removed: The NOC/c policy includes a prioritized 200-day review process for potential NDS approval in mid-2025.
−Removed: If approved, lifileucel is expected to be the first and only approved therapy in this treatment setting in these markets.
−Removed: Across the U.S.
−Removed: and other targeted global markets, Amtagvi ® has the potential to address more than 20,000 previously treated advanced melanoma patients annually.
−Removed: The Company was founded to build upon the promise of TIL cell therapy that was previously demonstrated in single-center clinical trials at academic research centers, including the National Cancer Institute (“NCI”).
−Removed: The Company’s multi-center trials, novel TIL products, manufacturing processes, facilities, and bioanalytical platforms have transformed TIL cell therapy into a commercially viable treatment which thousands of patients with cancer can access.
−Removed: The Company manufactures Amtagvi ® and its investigational TIL cell therapies using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply polyclonal T cells unique to each patient into the billions and yields a cryopreserved, individualized therapy.
−Removed: Amtagvi ® is manufactured for commercial use at the Company’s manufacturing facility, the Iovance Cell Therapy Center (the “ i CTC”), and by a contract manufacturing organization (“CMO”).
−Removed: The Company’s development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings and indications for solid tumor cancers.
−Removed: To potentially improve outcomes for patients, the Company is investigating TIL monotherapies for patients previously treated with standard of care therapies and TIL cell therapy in combination with standard of care therapies for patients in earlier treatment settings.
−Removed: The Company is conducting two ongoing registrational trials to support a supplementary BLA (“sBLA”), of lifileucel in frontline advanced melanoma and in advanced non-small cell lung cancer (“NSCLC”) following standard of care chemo-immunotherapy.
−Removed: The Company is also developing next generation therapies, such as genetically modified TIL cell therapy and next generation cytokines for use in the TIL cell therapy regimen.
+Added: TIL cell therapies harness the individual immune system’s ability to recognize and destroy cancer cells that are unique to each patient.
+Added: 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.
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Amtagvi ® is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin ® .
+Added: Globally, Amtagvi ® has the potential to address tens of thousands of previously treated advanced melanoma patients annually.
+Added: Amtagvi ® is approved in the U.S.
+Added: and Canada, and the Company plans to launch Amtagvi ® into additional markets with a high prevalence of advanced melanoma.
+Added: Potential approvals are pending in the United Kingdom (“UK”) and Australia in the first half of 2026, and Switzerland in 2027.
+Added: In the European Union (“EU”), the Company withdrew its initial marketing authorization application (“MAA”) in July 2025.
+Added: The Company is working with the European Medicines Agency (“EMA”) to resubmit a centralized MAA in 2026.
+Added: 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.
+Added: The Company is conducting two ongoing registrational trials in frontline advanced melanoma and previously treated advanced non-small cell lung cancer (“NSCLC”).
+Added: 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.
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).
−Removed: The Company has recently launched its first internally developed commercial product and continues to be engaged in the development of therapeutics to fight cancer, specifically solid tumors.
−Removed: With the recent approval of the BLA, the Company began to generate revenue from the sale of its product Amtagvi ® in the second quarter of 2024.
+Added: 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.
+Added: 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 ® .
−Removed: However, such revenues for Amtagvi ® and Proleukin ® may not be material enough to generate
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Based on the funds the Company has available as of the date these consolidated financial statements for December 31, 2025 are
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: positive operational cash flows during the 12 months from the date the consolidated financial statements are issued and this Form 10-K is filed.
−Removed: The Company has incurred a net loss of $ 372.2 million for the year ended December 31, 2024 and used $ 353.0 million of cash in its operating activities during the year ended December 31, 2024.
−Removed: The Company expects to continue to incur significant expenses to support its execution of the commercial launch of Amtagvi ® , fund ongoing clinical programs, including its NSCLC registrational study, IOV-LUN-202, and its frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of its pipeline candidates, and for other general corporate purposes.
−Removed: Based on the funds the Company has available as of the date these consolidated financial statements for December 31, 2024 are issued, which includes net proceeds of approximately $ 122.3 million raised through the open market sales agreement through February 14, 2025, 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.
+Added: 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
8 unchanged sentences
Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive loss.
−Removed: Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest income, net.
+Added: 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.
−Removed: Such amortization and accretion are included in Interest income, net in the consolidated statements of operations.
−Removed: Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest income, net in the consolidated statements of operations.
+Added: Such amortization and accretion are included in Interest and other income, net in the consolidated statements of operations.
+Added: 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.
12 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: A letter of credit in the amount of $ 60.0 million for the regulatory approval milestone payment as required by the terms of the Option Agreement for the Proleukin ® acquisition (See Note 4 – Proleukin ® Acquisition) was cancelled in March 2024 following the milestone payment of $ 52.6 million (£ 41.7 million) during the first quarter of 2024.
−Removed: 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 such amounts shown in the consolidated statements of cash flows (in thousands):
+Added: 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):
Cash and cash equivalents
14 unchanged sentences
Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis.
−Removed: Cost includes amounts related to materials, internal labor, costs of external manufacturing, and allocable depreciation of manufacturing facilities, equipment and overhead.
+Added: 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.
3 unchanged sentences
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 ® .
−Removed: The Company periodically reviews inventory for excess and obsolescence, considering factors such as its most recent sales forecast compared to quantities on hand and the expiration date of the product and materials.
−Removed: The Company adjusts its inventory that is obsolete or otherwise unmarketable to its estimated net realizable value in the period in which the impairment is first identified.
−Removed: Any such adjustments are included as a component of cost of sales within the Company’s consolidated statements of operations.
+Added: 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.
+Added: 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.
+Added: 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
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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 ® .
−Removed: In addition, cost of sales in the Company’s consolidated statements of operations includes royalties payable on sales of its products, as well as non-cash expenses including amortization of the fair value step-up of acquired Proleukin ® inventory which is recognized as the acquired inventory units are sold, the acquired intangible asset related to developed technology, and the intellectual property license intangible assets.
+Added: 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.
5 unchanged sentences
Intangible Assets
−Removed: The Company’s intangible assets are initially measured based on an allocation of the cost of the acquisition to the assets acquired on a relative fair value basis and are recorded net of accumulated amortization.
+Added: 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.
4 unchanged sentences
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.
−Removed: The Company determined that no indicators of impairment existed as of December 31, 2024.
+Added: The Company determined that no indicators of impairment existed as of December 31, 2025 or December 31, 2024.
The Company determines if an arrangement includes a lease at inception and thereafter, if modified.
5 unchanged sentences
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.
−Removed: Lease expense is recognized on a straight-line basis over the expected lease term and recorded in costs and expenses in the consolidated statements of operations.
+Added: Lease expense is recognized on a straight-line basis over the expected lease term and recorded in costs
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: and expenses in the consolidated statements of operations.
The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No.
2 unchanged sentences
For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Property and Equipment, net
16 unchanged sentences
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.
−Removed: For the years ended December 31, 2024, 2023, and 2022, the Company did not recognize any impairments for its property and equipment.
Fair Value Measurements
10 unchanged sentences
Where quoted prices are available in an active market, securities are classified as Level 1.
−Removed: 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.
−Removed: Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
+Added: 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.
+Added: 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
24 unchanged sentences
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.
−Removed: The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model.
+Added: The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The assumptions used in the Black-Scholes option pricing model could affect compensation expense recorded in future periods.
3 unchanged sentences
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”).
−Removed: The Company measures the compensation cost
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
+Added: 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
11 unchanged sentences
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.
−Removed: The Company makes judgements and estimates in determining the accrual balance in each reporting period.
In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the consolidated balance sheets and subsequently recognized as research and development expense in the consolidated statements of operations when the associated services have been performed.
3 unchanged sentences
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.
−Removed: Other significant costs include facility costs not otherwise included in research and development expenses.
−Removed: Selling, general, and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to such expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.
−Removed: 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.
−Removed: In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and
+Added: Other significant costs include facility costs not otherwise capitalized in inventory or included in research and development expenses.
+Added: Selling, general, and administrative costs are expensed as
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: development credit carryforwards.
+Added: 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.
+Added: 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.
+Added: 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.
8 unchanged sentences
To date, there have been no interest or penalties incurred in relation to the unrecognized tax benefits.
+Added: Restructuring Charges
+Added: Restructuring charges consist primarily of employee severance payments and other postemployment benefit related expenses.
+Added: 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.
+Added: The Company recognizes charges related to restructuring plans when the liabilities have been incurred and can be reasonably estimated.
Net Loss per Share
1 unchanged sentence
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.
−Removed: 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 (vi) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.
+Added: 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.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: 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.
11 unchanged sentences
Actual results could differ from those estimates.
−Removed: Significant items subject to such estimates and assumptions include assumptions made in the fair value of intangible assets, inventories acquired as part of the acquisition of Proleukin ® , equity awards and related stock-based compensation, assumptions used in measuring operating right-
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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 .
+Added: 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
2 unchanged sentences
All intercompany accounts and transactions have been eliminated.
+Added: Beginning in the third quarter of 2025, the Company began separately presenting depreciation and amortization expense on the consolidated statement of operations.
+Added: 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.
+Added: 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
10 unchanged sentences
Refer to Note 12 to the consolidated financial statements included in this Annual Report on Form 10-K for details.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Concentrations
6 unchanged sentences
Recent Accounting Standards
−Removed: In November 2023, FASB issued Accounting Standard Update (“ASU”) ASU 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures, which enhances the disclosures required for operating segments in annual and interim consolidated financial statements.
−Removed: ASU 2023-07 was effective for us in our annual reporting starting in fiscal year 2024 and for interim period reporting beginning in fiscal year 2025 on a retrospective basis.
−Removed: The Company adopted ASU 2023-07 as of December 31, 2024, and the enhanced disclosures as required are included in Note 11 – Segments.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
2 unchanged sentences
Early adoption and retrospective reporting are permitted.
−Removed: The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements.
+Added: 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.
−Removed: 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
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 2024-03 or retrospectively to any or all prior periods presented in the financial statements.
+Added: 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.
+Added: 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.
+Added: Entities will still be required to adjust historical data used in the estimation to reflect current conditions.
+Added: 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.
+Added: The Company is currently evaluating the impact of adopting ASU 2025-05 on its consolidated financial statements.
CASH EQUIVALENTS AND INVESTMENTS
8 unchanged sentences
Total investments
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: 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):
17 unchanged sentences
Money market funds
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
PROLEUKIN ® ACQUISITION
6 unchanged sentences
The Proleukin ® Business operations have been included in the Company’s consolidated financial statements commencing from the acquisition date.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: 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):
4 unchanged sentences
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.
−Removed: The Option Agreement additionally provides for contingent cash payments consisting of (i) a milestone payment of £ 41.7 million, or approximately $ 50.0 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.
+Added: 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.
1 unchanged sentence
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.
−Removed: The net assets acquired in the Acquisition were recorded by allocating the total cost of the Acquisition to the assets acquired on a relative fair value basis based on their estimated fair values as of May 18, 2023, which is the date that the Acquisition was completed.
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.
−Removed: The fair value of the developed technology is being amortized over an expected useful life of 15 years and is recorded as Cost of Sales in the Company’s consolidated statement of operations.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
−Removed: The fair value of the assembled workforce is being amortized over an expected useful life of 3 years and is recorded as selling, general, and administrative expense in the Company’s consolidated statement of operations.
+Added: 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.
−Removed: The fair value of the acquired inventory was determined using the comparative sales method of the market approach, which uses historical and expected average selling prices of inventory as the base amount to which adjustment for costs to complete for work-in-process, cost of disposal and reasonable profit allowance are applied.
−Removed: The inventory fair value adjustment is being amortized as cost of sales as the acquired inventories are sold.
A deferred tax liability was recognized on the temporary differences related to the book and tax basis of the acquired intangible assets.
2 unchanged sentences
INTANGIBLE ASSETS, NET
−Removed: The gross carrying amounts and net book value of intangible assets as of December 31, 2024 are as follows (in thousands):
+Added: 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):
Developed technology
4 unchanged sentences
Intangible assets, net
−Removed: The Company recognized amortization expense of $ 21.2 million and $ 9.8 million during the years ended December 31, 2024 and December 31, 2023, respectively.
−Removed: Amortization expense for the developed technology and assembled workforce is recorded in cost of sales and selling, general, and administrative expense, respectively, in the consolidated statement of operations for the year ended December 31, 2024.
−Removed: The total estimated amortization of the Company’s intangible assets the years ending December 31, 2025, 2026, 2027, 2028 and 2029 are $ 21.5 million, $ 21.4 million, $ 21.3 million, $ 21.3 million, and $ 21.3 million, respectively.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
+Added: 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.
As of December 31, 2025 and December 31, 2024, inventory consists of the following (in thousands):
3 unchanged sentences
Total inventory
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
+Added: 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.
+Added: 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.
+Added: As of December 31, 2025 the Company recorded $ 7.9 million of inventory as long-term other assets.
+Added: There was no long-term inventory recorded as of December 31, 2024.
Net revenue for the periods presented represents sales of Amtagvi ® and Proleukin ® as follows (in thousands):
4 unchanged sentences
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.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Revenue from product sales was recorded net of GTN adjustments.
14 unchanged sentences
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.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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, 2024 and December 31, 2023, respectively (in thousands, except percentages):
+Added: 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
+Added: Year Ended December 31, 2023
Other customers
1 unchanged sentence
GTN adjustments
+Added: * Represents customer below 10%
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
PROPERTY AND EQUIPMENT, NET
11 unchanged sentences
Property and equipment, net
−Removed: Depreciation and amortization expense for the years ended December 31, 2024, 2023, and 2022 was approximately $ 12.0 million, $ 11.6 million and $ 9.3 million, respectively.
−Removed: As a result of the early termination of the former headquarters lease for the Company’s prior offices, the Company impaired approximately $ 7.4 million of long-lived assets, which included leasehold improvements, computer equipment and furniture and fixtures (See Note 15 – Leases).
+Added: 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.
ACCRUED EXPENSES
8 unchanged sentences
Total accrued expenses
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
STOCKHOLDERS’ EQUITY
5 unchanged sentences
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.
−Removed: The total net proceeds to the Company from the offering, including the exercise of the option by the underwriters, were $ 161.5 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.
+Added: The total net proceeds to the Company from the
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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
2 unchanged sentences
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.
−Removed: Under the terms of the 2023 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 $ 450.0 million of shares of the Company’s common stock.
−Removed: The issuance and sale, if any, of the shares of common stock by the Company under the 2023 Sale Agreement was or will be made pursuant to a prospectus supplement dated June 16, 2023 to the Company’s Registration Statement on Form S-3ASR, which became effective immediately upon filing with the SEC on June 16, 2023.
+Added: 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.
+Added: 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.
+Added: On August 22, 2025, the Company entered into an Amended and Restated Open Market Sale Agreement (the “2025 Sale Agreement”) with Jefferies.
+Added: 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”).
+Added: 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.
3 unchanged sentences
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.
−Removed: For the years ended December 31, 2024, 2023 and 2022, the Company received $ 200.0 million, $ 301.7 million, and $ 189.5 million in net proceeds, net of offering costs, through the sale of 23,127,726 shares, 44,080,226 shares and 29,788,993 shares of its common stock through the 2023 Sale Agreement and/or the 2022 Sale Agreement at a weighted average price per share of $ 8.82 , $ 6.99 and $ 6.52 , respectively.
+Added: 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
1 unchanged sentence
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.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Series A Convertible Preferred Stock
5 unchanged sentences
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.
−Removed: The Company may not declare, pay or set aside any dividends on shares of capital stock of the Company (other than dividends on shares of common stock payable in shares of common stock) unless the holders of the Series A Convertible Preferred Stock shall first receive an equal dividend on each outstanding share of Series A Convertible Preferred Stock.
+Added: 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
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
9 unchanged sentences
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.
−Removed: No shares of Series B Convertible Preferred Stock were converted to common stock during the year ended December 31, 2024 and 2023.
−Removed: At December 31, 2024 and 2023, 2,842,158 shares of Series B Preferred Stock (that are convertible into 2,842,158 shares of common stock) remained outstanding.
+Added: 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.
+Added: No shares of Series B Convertible Preferred Stock were converted to common stock during the year ended December 31, 2024.
+Added: 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
5 unchanged sentences
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.
−Removed: 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
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 6,000,000 to 14,000,000 shares, which became effective immediately.
+Added: 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.
1 unchanged sentence
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.
−Removed: As of December 31, 2024, 8,917,507 shares of common stock were available for grant under the Company’s 2018 Plan, including shares recaptured from the 2014 Plan.
+Added: 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.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
9 unchanged sentences
Stock Options
−Removed: A summary of the status of stock options as of December 31, 2024, and the changes during the three years then ended, is presented in the following table:
−Removed: ( in thousands)
+Added: 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:
Outstanding at December 31, 2024
4 unchanged sentences
Options exercisable at December 31, 2025
−Removed: As of December 31, 2024, there was $ 20.8 million of total unrecognized compensation expense related to unvested employee stock options, which the Company expects to recognize over a remaining weighted average period of 1.71 years.
+Added: As of December 31, 2025, there was $ 11.0 million of total unrecognized compensation expense related to unvested employee stock options.
+Added: The unrecognized compensation expense is estimated to be recognized over a period of 2.07 years as of December 31, 2025.
+Added: 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.
+Added: 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
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The weighted average grant date fair value for employee options granted under the Company's stock option plans during the years ended December 31, 2024, 2023, and 2022 was $ 6.97 , $ 4.91 , and $ 8.29 per option, respectively.
−Removed: 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, 2024 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on December 31, 2024.
+Added: 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.
−Removed: The aggregate intrinsic value of stock options exercised during the year ended December 31, 2024, 2023, and 2022 were $ 1.1 million, $ 0.01 million, and $ 0.04 million, respectively.
+Added: 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
3 unchanged sentences
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.
+Added: 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.
7 unchanged sentences
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.
−Removed: There were no unvested PRSUs outstanding as of December 31, 2024.
−Removed: Activity for RSUs and PRSUs during the years ended December 31, 2024 and 2023 is presented in the following table:
+Added: There were no unvested PRSUs outstanding as of December 31, 2025 and 2024.
+Added: Activity for RSUs and PRSUs during the year ended December 31, 2025 is presented in the following table:
RSUs and PRSUs
3 unchanged sentences
Canceled/Forfeited
+Added: ( 2,400,376 )
Outstanding at December 31, 2025
Ending vested and expected to vest at December 31, 2025
−Removed: As of December 31, 2024 and 2023, there was $ 84.3 million and $ 19.9 million of unrecognized stock-based compensation expense associated with unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of 1.61
+Added: 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.
+Added: The aggregate
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: and 1.65 years, respectively.
−Removed: The aggregate intrinsic value of the unvested RSUs outstanding as of December 31, 2024 was $ 70.7 million and the aggregate intrinsic value of the unvested RSUs and PRSUs as of December 31, 2023 was $ 28.1 million.
+Added: 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
−Removed: Total stock-based compensation expense related to the Company’s stock-based awards was recorded on the consolidated statements of operations as follows (in thousands):
−Removed: Years Ended December 31,
−Removed: Cost of sales
−Removed: Research and development
−Removed: Selling, general, and administrative
−Removed: Total stock-based compensation expense
−Removed: The amount included in capitalized inventory for stock-based compensation expense for personnel engaged with manufacturing activities was $ 1.2 million as of December 31, 2024.
−Removed: No such cost was included in inventory as of December 31, 2023.
Total stock-based compensation expense by type of award was as follows (in thousands):
3 unchanged sentences
Total stock-based compensation expense
+Added: 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:
24 unchanged sentences
Each of the inputs discussed above is subjective and generally requires significant management judgment.
+Added: RESTRUCTURING
+Added: 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.
+Added: 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.
+Added: As of December 31, 2025, there were no material remaining obligations related to the strategic restructuring plan.
IOVANCE BIOTHERAPEUTICS, INC.
6 unchanged sentences
The measure of segment assets is reported on the balance sheet as total consolidated assets.
−Removed: 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 year ended December 31, 2024 and 2023.
−Removed: Years Ended December 31,
−Removed: Increase (Decrease)
+Added: 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.
+Added: As a result, the Company has recast prior period amounts to align with the information that is used by the CODM.
+Added: 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.
+Added: Year Ended December 31, 2025
(in thousands)
−Removed: Direct cost of goods sold (a)
−Removed: Acquisition related cost of sales (b)
+Added: Cost of sales
+Added: Cost of goods sold ( excluding depreciation and amortization ) (a)
+Added: Stock-based compensation
Total cost of sales
2 unchanged sentences
Sales and marketing
−Removed: Other segment items (c)
+Added: Depreciation and amortization
+Added: Restructuring charges
+Added: Other segment items (b)
Total expenses
−Removed: Direct cost of goods sold represents inventory and period costs related to overhead and manufacturing costs of Amtagvi® as well as costs associated with the purchases and sales of Proleukin ® .
−Removed: Also included are manufacturing and period costs incurred for Amtagvi ® that do not meet specifications or a patient is unable to receive the infusion (i.e., scrap) unless they can be administered as part of a clinical trial in an expanded or early access program, or single-patient IND, in which cases related costs are recorded as research and development expenses based on the fact the Company receives clinical data related to these infusions.
+Added: 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 ® .
+Added: Also included are manufacturing and period costs incurred for Amtagvi ® that do not meet specifications or a patient is unable to receive the infusion.
+Added: 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.
−Removed: Acquisition related cost of sales represents amortization expenses for the developed technology intangible assets and the milestone payment recorded as part of the acquisition of Proleukin ® and the fair value step-up of acquired Proleukin® inventory which is recognized as the acquired inventory units are sold.
−Removed: This category is provided to the CODM on a quarterly basis as costs in this category are often reviewed separately in evaluating the performance of the Company because these costs are fixed and uncontrollable costs in nature, and do not affect cashflows of the Company.
Other segment items include costs that are not considered significant expense segments nor reviewed by the CODM on a regular basis.
−Removed: Such amount includes stock-based compensation expenses, interest income, other income and expenses, and income tax benefits .
+Added: 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.
IOVANCE BIOTHERAPEUTICS, INC.
6 unchanged sentences
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.
−Removed: The Company recorded a tax benefit of $ 2.8 million and $ 3.5 million for the years ended December 31, 2024 and December 31, 2023, respectively, which resulted in an effective tax rate of 0.75 % and 0.78 % respectively.
−Removed: The income tax benefit for the periods presented primarily relates to operations in the United Kingdom and the movement of deferred tax assets and liabilities.
−Removed: No income tax benefit was recorded for the year ended December 31, 2022.
+Added: 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.
+Added: 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):
13 unchanged sentences
Depreciation and amortization
−Removed: Net deferred tax assets (liabilities)
+Added: Net deferred tax liabilities
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The reconciliation of the effective income tax rate to the U.S.
−Removed: statutory rate is as follows:
−Removed: Years ended December 31,
+Added: statutory rate is as follows (in thousands):
+Added: As of December 31, 2025
Federal statutory tax rate
+Added: Foreign tax effects
+Added: United Kingdom
+Added: Nontaxable or nondeductible items
+Added: Other foreign jurisdictions
+Added: Research and development and orphan drug credit
+Added: Changes in valuation allowances
+Added: Nontaxable or nondeductible items
+Added: Share based compensation
+Added: Nondeductible officers' compensation
+Added: Other nontaxable or nondeductible items
+Added: Effective tax rate
+Added: The following table presents the required disclosures prior to our adoption of ASU 2023-09 and reconciles the U.S.
+Added: federal statutory income tax rate to the actual global effective income tax rate for the years ended December 31, 2024, and December 31, 2023:
+Added: Federal statutory tax rate
Orphan drug and research credits
+Added: Foreign tax effects
Permanent and other differences
3 unchanged sentences
Effective tax rate
−Removed: The Company had net operating loss carryforwards (“NOLs”) for federal, state, and foreign income tax purposes of approximately $ 1.3 billion, $ 331.9 million, and $ 15.2 million, respectively, as of December 31, 2024.
+Added: 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”).
3 unchanged sentences
The federal credits begin to expire in 2033, and the California research credits have no expiration dates.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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.
3 unchanged sentences
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.
−Removed: The ultimate realization of deferred tax assets is dependent upon future generation for taxable income during the periods in which temporary differences representing net future deductible amounts become deductible.
+Added: The ultimate realization of deferred tax assets is dependent upon future generation for
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
16 unchanged sentences
No interest or penalties on unpaid tax were recorded during the years ended December 31, 2025, 2024, or 2023.
−Removed: The Company does not anticipate any significant changes within 12 months of this reporting date of its uncertain tax positions.
+Added: 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.
3 unchanged sentences
The Company is not currently under examination by income tax authorities in federal, state, or other foreign jurisdictions.
−Removed: The Inflation Reduction Act of 2022 (the “Act”), which includes certain new tax measures, was signed into law in August 2022.
−Removed: The Act contains two main tax provisions, a new corporate alternative minimum tax imposed on certain corporations meeting average annual financial statement income of more than $1 billion during a three-year tax period, and an excise tax imposed upon share repurchases by certain publicly traded corporations.
−Removed: The Act is effective for tax years beginning after December 31, 2022;
+Added: On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S.
+Added: 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.
+Added: The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.
+Added: 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.
+Added: 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.
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: provisions of the Act will not have an impact on the Company’s consolidated financial statements.
−Removed: The Company will continue to monitor the effect of the Act and its impact on the Company.
LICENSES AND AGREEMENTS
5 unchanged sentences
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.
−Removed: Pursuant to the terms of the CRADA, as amended, the Company was required to make quarterly payments of $ 0.5 million to the NCI for support of research activities through the end of 2024.
−Removed: Commencing in 2025, the Company is required to make quarterly payments of $ 0.9 million to the NCI for support of research activities through the end of the CRADA’s term.
+Added: 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.
1 unchanged sentence
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.
−Removed: The Company recorded costs associated with the CRADA of $ 2.0 million for each of the years ended December 31, 2024, 2023 and 2022, respectively, as research and development expenses.
−Removed: Patent License Agreement Related to the Development and Manufacture of TIL Cell Therapies
−Removed: The Company entered into an Exclusive Patent License Agreement (the “Patent License Agreement”) with the NIH, an agency of the U.S.
−Removed: Public Health Service within the Department of Health and Human Services, in 2011, as amended in 2015.
−Removed: Pursuant to the Patent License Agreement, as amended, the NIH granted the Company licenses, including exclusive, co-exclusive, and non-exclusive licenses, to certain technologies relating to autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, lung, breast, bladder and HPV-positive cancers.
−Removed: In May 2021, the Company entered into an Amended and Restated Patent License Agreement with NIH, which included the grant of additional exclusive, worldwide patent rights in the indications to interleukin-15 and interleukin-21 cytokine-tethered TIL technology, and expanded the non-exclusive, worldwide field of use to all cancers.
−Removed: In August 2022, the Company entered into a Second Amended and Restated Patent License Agreement with NIH to include additional exclusive, worldwide patent rights to TIL products expressing interleukin-12, expanded rights to TIL selection technologies previously licensed under the Exclusive Patent License Agreement below, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.
−Removed: The Second Amended and Restated Patent License Agreement requires the Company to pay royalties based on a percentage of net sales in jurisdictions where patent rights exist, which percentage can fall into a tier that may be less than one percent to mid-single digits depending upon certain events, including the exclusivity of the rights, and the Company expects lower overall royalty payments as a result.
−Removed: The Company is also required to pay potential milestone payments on the achievement of certain clinical, regulatory, and commercial sales milestones for each of the indications and other direct costs incurred by the NIH pursuant to the Second Amended and Restated Patent License Agreement.
+Added: 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.
+Added: Patent License Agreements Related to TIL Cell Therapies
+Added: The Company entered into a patent license agreement (the “Patent License Agreement”) with the NIH, an agency of the U.S.
+Added: Public Health Service within the Department of Health and Human Services, in 2011.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: and foreign commercial sales of any of its product candidates covered by the Second
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Amended and Restated Patent License Agreement.
−Removed: The term of the Second Amended and Restated Patent License Agreement continues until the expiry of the last-to-expire patent rights licensed thereunder, and the agreement contains standard termination provisions.
+Added: and foreign commercial sales of any of its product candidates covered by the Patent License Agreement, as amended.
+Added: 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.
−Removed: in accordance with the requirements of the Second Amended and Restated Patent License Agreement.
+Added: 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.
−Removed: During the year ended December 31, 2024, the Company recorded $ 0.7 million, as a component of cost of sales related to amortization of the milestone payments.
−Removed: No expenses were recorded for the years ended December 31, 2023 and 2022.
−Removed: Exclusive Patent License Agreement Related to TIL Selection
−Removed: On February 10, 2015, the Company entered into an exclusive patent license agreement (the “Exclusive Patent License Agreement”) with the NIH under which the Company received an exclusive, worldwide license under the selected TIL patents.
−Removed: This license was superseded and replaced by the Second Amended and Restated Patent License Agreement.
−Removed: Lee Moffitt Cancer Center
−Removed: Research Collaboration and Clinical Grant Agreements with Moffitt
−Removed: In June 2020, the Company entered into a Sponsored Research Agreement (the “SRA”) with the H.
−Removed: Lee Moffitt Cancer Center (“Moffitt”), with a term that ended either upon completion of the research thereunder or on July 1, 2022, whichever is sooner.
−Removed: The SRA has been extended multiple times and currently has an expiration date of May 31, 2025.
−Removed: The Company recorded research and development costs of $ 0.2 million, $ 0.2 million and $ 0.6 million for each of the years ended December 31, 2024, 2023 and 2022, respectively.
−Removed: The University of Texas M.D.
−Removed: Anderson Cancer Center
−Removed: Strategic Alliance Agreement
−Removed: In April 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with The University of Texas M.D.
−Removed: Anderson Cancer Center (“MDACC”) under which the Company and MDACC agreed to conduct clinical and preclinical research studies.
−Removed: The Company agreed in the SAA to provide total funding not to exceed approximately $ 14.2 million for the performance of the multi-year studies under the SAA, of which approximately $ 5.3 million has been funded to date and has been recorded as research and development expense.
−Removed: In return, the Company acquired all rights to inventions resulting from the studies and has been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of MDACC reasonably necessary to exploit, including the commercialization thereof.
−Removed: The Company has also been granted certain rights in clinical data generated by MDACC outside of the clinical trials to be performed under the SAA.
−Removed: The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by the Company of all deliverables due from MDACC thereunder.
−Removed: On March 28, 2024, the Company and MDACC entered into the first amendment to the SAA, under which both parties agreed to conduct additional preclinical research studies.
−Removed: The Company recorded a benefit of $ 0.4 million, for the year ended December 31, 2024, as a result of finalization of the cost reconciliation.
−Removed: For the years ended December 31, 2023 and 2022, the Company recorded $ 0.0 and $ 0.2 million associated with the SAA as research and development expenses, respectively.
−Removed: WuXi Advanced Therapies, Inc.
−Removed: In November 2016, the Company entered into a manufacturing services agreement (the “First Wuxi MSA”) with WuXi Apptec, Inc.
−Removed: (“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.
−Removed: The First WuXi 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.
−Removed: in January 2020, and further amended in November 2020 and December 2021.
−Removed: The First WuXi MSA expired in November 2022.
+Added: 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.
+Added: No expenses were recorded for the year ended December 31, 2023.
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: In October 2022, Iovance Manufacturing LLC entered into an additional three-year manufacturing and services agreement (the “Second Wuxi MSA”) with WuXi Advance Therapies, Inc.
−Removed: and its parent company, WuXi Apptec Co., Ltd (collectively, “WuXi”).
−Removed: Under the Second WuXi MSA, Iovance Manufacturing LLC entered into a statement of work for two cGMP manufacturing suites to be operated by WuXI for Iovance Manufacturing LLC to support clinical and commercial manufacturing and related testing services.
−Removed: The Second WuXi MSA and its related statement of work superseded the statements of work under the First WuXi MSA with respect to manufacturing in the two suites and expire on December 31, 2025.
−Removed: Iovance Manufacturing LLC may unilaterally terminate the statement of work for clinical and commercial manufacturing with written notice of written notice of 6 months in year 3 of the term.
−Removed: The Company recorded costs associated with agreements with WuXi of $ 25 .0 million, $ 17.3 million, and $ 14.2 million for the years ended December 31, 2024, 2023, and 2022, respectively, as costs and expenses included in the consolidated statement of operations or as inventory in the consolidated balance sheets.
+Added: Minaris Advanced Therapies
+Added: In November 2016, the Company entered into a manufacturing services agreement (the “First MSA”) with WuXi Apptec, Inc.
+Added: (“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.
+Added: 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.
+Added: in January 2020, and further amended in November 2020 and December 2021.
+Added: The First MSA expired in November 2022.
+Added: In October 2022, Iovance Manufacturing LLC entered into an additional three-year manufacturing and services agreement (the “Second MSA”) with WuXi Advance Therapies, Inc.
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: Minaris has concluded production of Amtagvi ® and clinical supply of lifileucel and its agreement terminated in the first quarter of 2026.
+Added: 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 .
8 unchanged sentences
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.
+Added: 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.
4 unchanged sentences
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.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: 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.
−Removed: The term of this agreement is through October 2025, with automatic renewals for a period of two years unless terminated as permitted by the contract.
−Removed: Under this agreement, the Company must purchase a minimum number of vials each year at fixed prices determined by vial batch size.
+Added: 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.
+Added: In September 2025, the agreement was amended and extended through December 31, 2028.
+Added: 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.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Operating Leases
11 unchanged sentences
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.
−Removed: Relocation of the Headquarters Office Lease
−Removed: On November 15, 2024, the Company entered into a sublease agreement (the “New Headquarters Lease”) to relocate its office within the same building of its former San Carlos headquarters to lease approximately 16,731 square feet office space with the lease term of 24 months .
−Removed: The New Headquarters Lease commenced on December 15, 2024 and includes two options to extend the terms of the lease for 12 months each, exercisable under certain conditions and at a rate increase by 3 % from the applicable monthly base rent of approximately $ 0.1 million.
+Added: Headquarters Office Lease
+Added: 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 .
+Added: 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.
1 unchanged sentence
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.
−Removed: In addition, as a result of the early termination of the former headquarters lease, the Company impaired approximately $ 7.4 million of long-lived assets, which included leasehold improvements, and furniture and fixtures, previously funded by the landlord through a tenant improvement allowance for the former corporate headquarters office lease (as discussed further below), and is included in the research and development expenses and selling, general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2024.
+Added: 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
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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
1 unchanged sentence
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.
−Removed: In addition to the minimum fixed commitment fees, the CMO contractual obligations include variable costs such as production and material costs in
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: excess of the minimum quantity specified in each CMO agreement.
+Added: 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.
13 unchanged sentences
Total operating lease liabilities
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: 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):
−Removed: December 31, 2024
−Removed: December 31, 2023
Operating lease cost
8 unchanged sentences
Weighted-average discount rates
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of December 31, 2025, maturities of the Company's operating lease liabilities were as follows (in thousands):
3 unchanged sentences
Operating lease liabilities
−Removed: For its former corporate headquarters office, the lease agreement included a tenant improvement allowance of up to $ 8.2 million that was utilized to fund the acquisition of certain assets in the former corporate headquarters.
−Removed: In the years ended December 31, 2022, and 2021, the Company received reimbursements associated with this tenant improvement allowance of $ 6.4 million and $ 1.6 million, respectively.
−Removed: As the tenant improvement allowance was fully utilized, no additional reimbursements were received subsequent to December 31, 2022.
LEGAL PROCEEDINGS
6 unchanged sentences
The parties agreed to a revised proposed settlement, which was submitted to the Court of Chancery on March 12, 2024.
−Removed: On July 17, 2024, the Court of Chancery declined to approve the settlement.
−Removed: The case will proceed to discovery.
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.
−Removed: The Company intends to vigorously defend against these complaints.
+Added: 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.
+Added: On September 2, 2025, the plaintiff filed a consolidated complaint in the matter, now captioned In re:
+Added: Iovance Biotherapeutics, Inc.
+Added: Stockholder Litigation .
+Added: The defendants filed a motion to dismiss certain claims in the consolidated complaint on November 24, 2025.
+Added: The Company intends to vigorously defend against this matter.
Ohio Laborers Derivative Lawsuit.
−Removed: 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 Court of Chancery.
+Added: 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
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
3 unchanged sentences
On February 3, 2025, the Court approved substitution of Laborers’ District Council and Contractors’ Pension Fund of Ohio (“Ohio Laborers”) as representative plaintiff.
+Added: The plaintiff filed a motion for leave to file a second amended complaint on October 2, 2025.
+Added: 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.
+Added: The defendants filed a motion to dismiss the second amended complaint on December 12, 2025.
The Company intends to vigorously defend against this complaint.
5 unchanged sentences
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.
−Removed: 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
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
+Added: 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.
−Removed: On June 3, 2016, the Company filed an answer and counterclaims in the lawsuits.
−Removed: The Company has 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.
−Removed: In its counterclaims, the Company is seeking 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.
+Added: On June 3, 2016, the Company filed an answer and counterclaims.
+Added: 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.
+Added: 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 .
4 unchanged sentences
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.
−Removed: 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.
+Added: 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.
+Added: On March 10, 2025, the Company filed a motion for summary judgment in the First Solomon Suit.
+Added: 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.
9 unchanged sentences
1:20-cv-1391.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
On May 22, 2020, the Company moved to dismiss the Second Solomon Suit for lack of personal jurisdiction.
13 unchanged sentences
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.
−Removed: The District Court entered judgment in favor of the Company on September 23, 2024, including
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: a monetary award pursuant to the District Court’s Rule 11 order and orders for attorneys’ fees and costs.
+Added: 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.
2 unchanged sentences
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.
+Added: 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.
+Added: 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.
+Added: Securities Class Actions and Shareholder Derivative Cases.
+Added: 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.
+Added: Iovance Biotherapeutics, Inc., et al ., No.
+Added: 25-cv-04177 (“ Sundaram ”) and Farberov v.
+Added: Iovance Biotherapeutics, Inc., et al ., No.
+Added: 25-cv-04199 (“ Farberov ”), naming the Company and certain of the Company’s officers as defendants.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The actions seek compensatory damages and costs and expenses incurred in the actions, including attorneys’ fees.
+Added: On December 15, 2025, the court consolidated the class actions, now captioned In re Iovance Biotherapeutics, Inc.
+Added: Securities Litigation , No.
+Added: 25-cv-04177, and appointed lead plaintiff and plaintiffs’ counsel.
+Added: On June 5, 2025, two putative shareholder derivative lawsuits were filed in the Northern District of California, captioned Hollin v.
+Added: Vogt, et al ., 3:25-cv-04740 and Gera, et al.
+Added: Vogt, et al ., 3:25-cv-04794, purportedly brought on behalf of Iovance against certain current and former officers and directors of the Company.
+Added: A third putative shareholder derivative lawsuit, captioned Bitton v.
+Added: Bellemin, et.
+Added: al ., 3:25-cv-09701, was filed in the Northern District of California on November 12, 2025.
+Added: Iovance is named as a
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: nominal defendant in the complaints.
+Added: 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.
+Added: Before filing the complaints, the plaintiffs did not make a demand that the Company’s Board of Directors consider the claims therein.
+Added: The lawsuits seek money damages, corporate governance reforms, restitution, punitive damages, and costs and expenses of the lawsuits, including attorneys’ fees.
+Added: On December 15, 2025, the court consolidated the derivative lawsuits, now captioned In re Iovance Biotherapeutics, Inc.
+Added: Derivative Litigation , No.
+Added: 5:25-cv-04740, and appointed co-lead plaintiff and plaintiffs’ counsel.
+Added: 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.
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.