1 unchanged sentence
(a) Evaluation of Disclosure Controls and Procedures:
−Removed: We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.
+Added: We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
10 unchanged sentences
Other Information
−Removed: Subsequent Event – Acquisition of Proleukin®
−Removed: Pursuant to that certain Option Agreement entered into on January 23, 2023 or the Option Agreement, between Iovance and Clinigen Holdings Limited, Clinigen Healthcare Limited and Clinigen, Inc., collectively, Clinigen, we will acquire worldwide rights to Proleukin®, aldesleukin, an IL-2 product used to promote T-cell activity following TIL infusion.
−Removed: Material terms of the Option Agreement include an upfront payment of £167.7 million, or approximately $200 million, a £41.7 million, or approximately $50 million, milestone payment upon first approval of lifileucel in advanced melanoma, and deferred consideration based on double-digit rates on Proleukin® global net sales payable from Iovance to Clinigen following the completion of the transaction for the applicable deferred consideration term.
−Removed: Subject to the terms and conditions of the Option Agreement, Clinigen granted us a call option to purchase (i) all issued and outstanding shares of Clinigen SP Limited, the Target, (ii) the business of the Target and Clinigen comprising the manufacturing, supply, commercialization and the generation of income from Proleukin® rights and the undertaking of an active role in the development, maintenance and exploitation of those rights, and (iii) certain specified assets identified in the Option Agreement and we granted Clinigen a put option to sell them.
−Removed: The Option Agreement is subject to customary termination provisions, and we would be required to pay to Clinigen a reverse termination fee, less certain transaction fees and expenses incurred by us, upon certain events as described in the Option Agreement.
−Removed: We have provided Clinigen with a parent guarantee in favor of Clinigen, which guarantees that we will promptly fulfill all its obligations under the Option Agreement, subject to the conditions set forth in the Option Agreement.
−Removed: The closing of the transaction is subject to required regulatory approvals and clearances and other customary closing conditions.
+Added: During the fourth quarter of 2023, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) for the purchase or sale of securities of the Company, whether or not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
+Added: During the fourth quarter of 2023, the Company did no t adopt or terminate a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) for the purchase or sale of securities of the Company, whether or not intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
+Added: On February 16, 2024, we received approval from the FDA for Amtagvi™, 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.
+Added: This indication is approved under accelerated approval based on an endpoint of overall response rate.
+Added: On February 22, 2024, we announced the closing of the sale of an aggregate of 23,014,000 shares of our common stock, pursuant to an underwriting agreement with Jefferies, Barclays Capital Inc., and Goldman Sachs & Co.
+Added: LLC at a public offering price of $9.15 per share, before underwriting discounts and commissions.
+Added: The total estimated net proceeds to us from the offering are expected to be approximately $197.1 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us.
Certain information required by Part III is omitted from this Annual Report on Form 10-K because we will file a definitive Proxy Statement for the Annual Meeting of Stockholders pursuant to Regulation 14A of the Securities Exchange Act of 1934 (the Proxy Statement), not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and the applicable information included in the Proxy Statement is incorporated herein by reference.
42 unchanged sentences
Iovance Biotherapeutics, Inc.
−Removed: 2018 Equity Incentive Plan, as amended (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Quarterly Report on Form 10-Q filed with the Commission on August 4, 2022).#
+Added: 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).#
Form of Incentive Stock Option Agreement under the Iovance Biotherapeutics, Inc.
6 unchanged sentences
2018 Equity Incentive Plan, as amended (June 2021 Retention Equity Awards) (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 10-Q filed with the Commission on August 5, 2021).#
−Removed: Iovance Biotherapeutics, Inc, 2020 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 9, 2020).#
Iovance Biotherapeutics, Inc.
+Added: 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: Iovance Biotherapeutics, Inc.
Amended and Restated 2021 Inducement Plan (incorporated herein by reference to Exhibit 10.13 to the Registrant’s Annual Report on Form 10-K filed with the Commission on February 24, 2022).#**
79 unchanged sentences
(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: Iovance Biotherapeutics, Inc.
+Added: Insider Trading Policy.**
Subsidiaries of the Company.**
−Removed: Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
−Removed: Consent of Marcum, LLP, Independent Registered Public Accounting Firm.**
+Added: Consent of Independent Registered Public Accounting Firm.
Power of Attorney (included on the signature page of this Annual Report).
3 unchanged sentences
Section 1350 Certification of Chief Financial Officer (furnished herewith).
+Added: Iovance Biotherapeutics, Inc.
+Added: Dodd-Frank Clawback Policy.**
The following financial information from the Annual Report on Form 10-K of Iovance Biotherapeutics, Inc.
for the year ended December 31, 2023, formatted inline XBRL (eXtensible Business Reporting Language):
−Removed: (1) Balance Sheets as of December 31, 2022 and 2021 (2) Statements of Income for the years ended December 31, 2022 and 2021;
−Removed: (3) Statements of Shareholders’ Equity for the years ended December 31, 2022 and 2021;
+Added: (1) Balance Sheets as of December 31, 2023 and 2022 (2) Statements of Operations for the years ended December 31, 2023, 2022, and 2021;
+Added: (3) Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022, and 2021;
(4) Statements of Cash Flows for the years ended December 31, 2023, 2022, and 2021;
47 unchanged sentences
Index to Financial Statements
−Removed: Report of Ernst & Young LLP, Independent Registered Public Accounting Firm (PCAOB ID:
−Removed: Report of Ernst & Young LLP, Independent Registered Public Accounting Firm (PCAOB ID:
−Removed: Report of Marcum LLP, Independent Registered Public Accounting Firm (PCAOB ID:
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID:
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID:
Consolidated Financial Statements
5 unchanged sentences
Notes to Consolidated Financial Statements
−Removed: REPORT OF ERNST & YOUNG LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Iovance Biotherapeutics, Inc.
1 unchanged sentence
We have audited the accompanying consolidated balance sheets of Iovance Biotherapeutics, Inc.
−Removed: (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with U.S.
+Added: (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S.
generally accepted accounting principles.
11 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 the 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 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.
Accrued clinical development costs
9 unchanged sentences
How We Addressed the Matter in Our Audit
+Added: We evaluated the design and tested the operating effectiveness of the Company’s internal control related to the Company’s accrued clinical development costs processes.
To test accrued clinical development costs, our audit procedures included, among others, testing the accuracy and completeness of the inputs used in management’s analysis to determine costs incurred.
1 unchanged sentence
We met with internal clinical personnel to understand the status of significant clinical activities.
−Removed: We evaluated services provided by third parties by understanding the terms and timeline of significant projects, evaluated management’s determination of work performed, subjects enrolled, sites activated and costs incurred, and obtained external confirmation of the direct cost, and contracts and change orders executed by the Company for selected CROs as well as key terms and conditions of those contracts.
+Added: We evaluated services provided by third parties by understanding the terms and timeline of significant projects, evaluated management’s determination of work performed, subjects enrolled, sites activated and costs incurred, and obtained external confirmation of direct costs incurred, and contracts and change orders executed by the Company for selected CROs as well as key terms and conditions of those contracts.
Further, we inspected selected invoices received from third parties after the balance sheet date and evaluated whether services performed prior to the balance sheet date had been properly included in costs accrued.
+Added: Asset acquisition accounting
+Added: Description of the Matter
+Added: As described in Note 4 to the Financial Statements, on May 18, 2023, the Company acquired the worldwide rights for the manufacturing, supply, commercialization and sale of Proleukin® (aldesleukin) (the “Acquisition”).
+Added: The Company determined substantially all the fair value of the acquired assets was concentrated in the acquired developed technology related to the intellectual property rights of Proleukin ® .
+Added: Therefore, the Company concluded the Acquisition did not meet the definition of a business in accordance with ASC 805 and was accounted for as an asset acquisition.
+Added: Total Acquisition consideration was $222.7 million, which was allocated among the liabilities assumed and assets acquired, including $232.7 million of the acquired developed technology intangible asset.
+Added: The prospective financial information used in the fair value of the acquired developed technology intangible asset was derived using internal management estimates.
+Added: The Company’s most significant assumptions related to projected revenues.
+Added: Auditing management’s accounting for the Acquisition was especially challenging because of the judgement involved in developing the prospective financial information used to estimate the fair value of the Proleukin ® acquired intangible asset, which required the use of subjective inputs.
+Added: The considerations included assessing whether substantially all the fair value of the gross assets acquired was concentrated in a single identifiable asset or group of similar identifiable assets.
+Added: In particular, the fair value of the acquired developed technology intangible asset.
+Added: This required a high degree of auditor judgement, subjectivity, and effort, including the use of professionals with specialized skill and knowledge, in performing procedures to assess the reasonableness of management’s assumptions of projected revenues used in estimating the fair value of the acquired developed technology intangible asset.
+Added: How We Addressed the Matter in Our Audit
+Added: We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the Company’s processes for estimating the prospective financial information used in determining the fair value of the acquired developed technology intangible asset.
+Added: Our audit procedures also included, but was not limited to, evaluating the methodology used and significant assumptions discussed above, and testing the completeness and accuracy of the underlying data used by the Company.
+Added: We involved our strategy and valuation specialists to assist in assessing the reasonableness of the methodologies used by management and certain significant assumptions related to projected revenue.
+Added: Evaluating the reasonableness of management’s assumptions included, among others, consideration of (i) relevant industry forecasts, (ii) consistency with external market research and industry data, and (iii) inquiries of individuals outside the finance function who are knowledgeable about the revenue forecast.
+Added: Our procedures also included testing the completeness and accuracy of the data underlying these estimates and projections.
/s/ Ernst & Young LLP
2 unchanged sentences
February 28, 2024
−Removed: REPORT OF ERNST & YOUNG LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Iovance Biotherapeutics, Inc.
3 unchanged sentences
(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the balance sheets of the Company as of December 31, 2022 and 2021, the related statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022, and the related notes, and our report dated February 28, 2023 expressed an unqualified opinion thereon.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 28, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
17 unchanged sentences
February 28, 2024
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: To the Shareholders and Board of Directors of
IOVANCE BIOTHERAPEUTICS, INC.
−Removed: Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheet of Iovance Biotherapeutics, Inc.
−Removed: (the “Company”) as of December 31, 2020, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for the year ended December 31, 2020, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020, and the results of its operations and its cash flows for the year ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility of the Company's management.
−Removed: Our responsibility is to express an opinion on the Company's financial statements based on our audit.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audit in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audit provides a reasonable basis for our opinion.
−Removed: Critical Audit Matters
−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 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 matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Incremental Borrowing Rate (Leases)
−Removed: Description of the Matter
−Removed: As discussed in Note 10 to the 2020 consolidated financial statements, the Company’s reported right-of-use assets, current lease liabilities and long-term lease liabilities, utilize discount rates to calculate the estimated present value of future lease payments.
−Removed: Since the Company’s leases do not provide an implicit rate, management utilized a third-party valuation specialist to assist in estimating the incremental borrowing rates used in its present value calculation, which required subjectivity.
−Removed: The incremental borrowing rate is the rate of interest that a lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
−Removed: As of December 31, 2020, the weighted average incremental borrowing rate used to determine the operating lease liability is 8.3%.
−Removed: Auditing management’s assessment of its incremental borrowing rate is highly subjective and judgmental as the Company has no outstanding debt nor committed credit facilities, secured or otherwise, that would have comparable collateral or similar terms as their underlying leases.
−Removed: Further, changes in the incremental borrowing rate may have a material impact on the measurement of the Company’s right-of-use assets, current lease liabilities and long-term lease liabilities.
−Removed: Based on the level of management judgment, we have determined the incremental borrowing rate to be a critical audit matter.
−Removed: This required a high degree of auditor judgment and an increased extent of effort, including the need to involve our valuation specialists, when performing audit procedures to evaluate the reasonableness of management’s estimation of the incremental borrowing rate.
−Removed: How We Addressed the Matter in Our Audit
−Removed: Our audit procedures included, amongst others:
−Removed: ● We obtained an understanding, evaluated the design, and tested the operating effectiveness of management’s controls with
−Removed: regards to the methodology, inputs, and assumptions used to determine the incremental borrowing rate, including those over management’s review of its third-party specialist valuation report.
−Removed: ● We obtained an understanding of the factors considered and assumptions made by management and the valuation specialists in developing the estimate of the incremental borrowing rate, the sources of data relevant to these factors and assumptions and the procedures used to obtain the data, and the methods used to calculate the estimate.
−Removed: ● We reviewed the contractual terms of the lease agreements to ensure the commencement dates, any lease term extensions and/or early termination clauses were properly considered in determining the appropriate lease term for calculating the incremental borrowing rates.
−Removed: ● With the assistance of our valuation specialists, we performed an independent estimate of the incremental borrowing rate and compared the results to the Company’s estimate.
−Removed: ● We evaluated the reasonableness of the valuation methods and assumptions used by management and the Company’s valuation specialist to estimate the incremental borrowing rates for borrowing amounts and terms comparable to their outstanding leases by:
−Removed: o Developing an independent estimate of the incremental borrowing rates with the assistance of our valuation specialists by utilizing third party data related to comparable company borrowings with comparable payment terms.
−Removed: o Performing a sensitivity analysis on incremental borrowing rates used to determine the impact rate changes could have on the present value calculation of the Company’s operating lease right-of-use assets and operating lease liabilities.
−Removed: /s/ Marcum LLP
−Removed: We served as the Company’s auditor from 2016 to 2021.
−Removed: February 25, 2021
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
Consolidated Balance Sheets
2 unchanged sentences
Cash and cash equivalents
+Added: Trade accounts receivable
Short-term investments
2 unchanged sentences
Property and equipment, net
+Added: Intangible assets, net
Operating lease right-of-use assets
−Removed: Long-term investments
Restricted cash
8 unchanged sentences
Operating lease liabilities – non-current
+Added: Deferred tax liabilities
Long-term note payable
8 unchanged sentences
Common stock, $ 0.000041666 par value;
−Removed: 300,000,000 shares authorized, 187,812,072 and 157,004,742 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively
−Removed: Accumulated other comprehensive loss
+Added: 500,000,000 , and 300,000,000 shares authorized , 256,135,715 and 187,812,072 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
+Added: Accumulated other comprehensive income (loss)
Additional paid-in capital
9 unchanged sentences
Years Ended December 31,
+Added: Product revenue
+Added: Total revenue
Costs and expenses
+Added: Cost of sales
Research and development
−Removed: General and administrative
+Added: Selling, general and administrative
Total costs and expenses
1 unchanged sentence
Interest income, net
+Added: Net Loss before income taxes
+Added: Income tax benefit
Net Loss Per Share of Common Stock, Basic and Diluted
6 unchanged sentences
Other comprehensive loss:
−Removed: Unrealized loss on investments
+Added: Unrealized gain/(loss) on investments
+Added: Foreign currency translation adjustment
Comprehensive Loss
10 unchanged sentences
Stock-based compensation expense
−Removed: Vesting of restricted stock shares issued for services
−Removed: Tax payments related to shares withheld for vested restricted stock units
+Added: Common stock issued upon purchase through employee stock purchase plan
Common stock issued upon exercise of stock options
Common stock sold in public offering, net of offering costs
+Added: Common stock issued from preferred stock conversion
Unrealized loss on investments
Balance - December 31, 2021
+Added: ( 1,172,445 )
Stock-based compensation expense
Common stock issued upon purchase through employee stock purchase plan
+Added: Vesting of restricted shares issued for services
+Added: Tax payments related to shares retired for vested restricted stock units
Common stock issued upon exercise of stock options
−Removed: Common stock sold in public offering, net of offering costs
−Removed: Common stock issued from preferred stock conversion
Unrealized loss on investments
+Added: Common stock sold in public offering, net of offering costs
Balance - December 31, 2022
4 unchanged sentences
Tax payments related to shares retired for vested restricted stock units
+Added: Common stock sold in public and/or at the market offerings, net of offering costs
Common stock issued upon exercise of stock options
−Removed: Unrealized loss on investments
−Removed: Common stock sold in public offering, net of offering costs
+Added: Unrealized gain on investments
+Added: Foreign currency cumulative translation adjustments
Balance - December 31, 2023
8 unchanged sentences
Stock-based compensation expense
+Added: Unrealized exchange gains
+Added: Amortization of intangible assets
Amortization of right of use asset
−Removed: Depreciation and amortization
+Added: Depreciation and amortization of property and equipment
+Added: Deferred tax benefit
Accretion of discounts and premiums on investments
2 unchanged sentences
Prepaid expenses, other assets and long-term assets
−Removed: Operating lease liabilities, net of tenant improvement allowance received
+Added: Trade accounts receivable
+Added: Operating lease liabilities
Accounts payable
4 unchanged sentences
Purchase of investments
+Added: Cash paid for acquisition, net of cash acquired
Purchase of property and equipment
7 unchanged sentences
Net cash provided by financing activities
+Added: Effect of exchange rate changes
Net increase in cash, cash equivalents and restricted cash
2 unchanged sentences
Supplemental disclosure of non-cash investing and financing activities:
−Removed: Net unrealized loss on investments
+Added: Fair value of net assets acquired
+Added: Net unrealized gain (loss) on investments
Acquisition of property and equipment included in accounts payable and accrued expenses
8 unchanged sentences
Iovance Biotherapeutics, Inc.
−Removed: (the “Company”) is a clinical-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.
−Removed: The Company’s mission is to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with solid tumor cancers.
−Removed: The Company’s autologous TIL therapy platform uses a centralized, scalable, and proprietary 22-day manufacturing process to grow polyclonal T-cells unique to each patient and yields a cryopreserved, individualized therapy.
−Removed: The Company is currently conducting clinical trials to investigate multiple TIL therapies for multiple indications, including its lead product candidate, lifileucel, for advanced, or metastatic or unresectable melanoma.
−Removed: The Company initiated a rolling Biologics License Application (“BLA”) submission to the U.S.
−Removed: Food and Drug Administration (“FDA”) for lifileucel in August 2022 and expects to complete the rolling BLA submission in the first quarter of 2023.
−Removed: The Company is also pursuing registrational strategies for lifileucel in advanced cervical cancer and for its TIL therapy LN-145 in metastatic non-small cell lung cancer (“NSCLC”).
−Removed: In addition, the Company is investigating next generation approaches to optimize TIL products, manufacturing processes and treatment regimens, including a first-in-human clinical trial of its lead genetically modified TIL therapy, IOV-4001.
−Removed: The Company is also exploring a 16-day manufacturing process, tumor tissue procurement via core biopsy, additional genetically modified TIL therapies including multiple immune checkpoint gene edits and cytokine-tethered TIL therapies, as well as, a novel interleukin-2 (“IL-2”) analog, designated IOV-3001, as potential avenues to improve manufacturing timelines, sample collection and supportive treatments involved in the overall TIL therapy process and treatment regimen.
+Added: (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’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.
+Added: With the recent approval of the biologics license application (the “BLA”), the Company is executing the U.S.
+Added: launch of Amtagvi™ (lifileucel), the first product within its autologous TIL cell therapy platform, and Proleukin ® (aldesleukin), an interleukin-2 (“IL-2”) product used in the Amtagvi™ treatment regimen.
+Added: 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.
+Added: This indication is approved under accelerated approval based on overall response rate (“ORR”).
+Added: Continued approval for this indication may be contingent upon verification and description of clinical benefit in future confirmatory trials.
+Added: Amtagvi™ is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
+Added: Amtagvi™ and Proleukin ® are part of a treatment regimen that includes lymphodepletion.
+Added: The Company was founded to build upon the promise of TIL cell therapy that was previously demonstrated in single-center clinical trials at academic centers, including the National Cancer Institute (“NCI”).
+Added: 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 many more patients with cancer can access.
+Added: The Company manufactures Amtagvi™ and its investigational TIL cell therapies using a centralized, scalable and proprietary 22-day manufacturing process which rejuvenates and multiplies polyclonal T cells unique to each patient into the billions and yields a cryopreserved, individualized therapy.
+Added: The Company’s development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings for solid tumor cancers.
+Added: The Company is investigating TIL monotherapies for patients with later stage disease who were previously treated with standard of care therapies and TIL combinations with standard of care therapies to potentially improve outcomes in patients who are earlier in their disease.
+Added: These trials two ongoing registrational trials to support a supplementary BLA (“sBLA”), of its TIL cell therapies in frontline advanced melanoma and in advanced non-small cell lung cancer following standard of care chemo-immunotherapy.
+Added: The Company is also developing next generation therapies using TIL, such as genetically modified TIL cell therapy.
The Company is currently engaged in the development of therapeutics to fight cancer, specifically solid tumors.
−Removed: The Company currently does not have any commercial products and has not yet generated any revenues from its business, nor does the Company currently anticipate that it will generate any significant revenues from the sale or licensing of any of its product candidates during the twelve months from the date these consolidated financial statements are issued.
+Added: With the recent approval of the BLA, the Company expects to generate revenue from the sale of its product Amtagvi™.
+Added: 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 ® during the year ended December 31, 2023.
+Added: However, such revenues for Amtagvi™ and Proleukin ® may not be material during the 12 months from the date the consolidated financial statements are issued and this Annual Report on Form 10-K is filed.
The Company has incurred a net loss of $444.0 million for the year ended December 31, 2023 and used $ 361.8 million of cash in its operating activities during the year ended December 31, 2023.
As of December 31, 2023, the Company had $ 346.3 million in cash, cash equivalents, investments, and restricted cash ($ 114.9 million of cash and cash equivalents, $ 165.0 million in short-term investments and $ 66.4 million in restricted cash).
−Removed: The Company expects to continue to incur significant expenses to support its research and development activities, on-going pre-commercial activities and completion of the construction of tenant improvements for the Iovance Cell Therapy Center (the “ i CTC”) facility during 2023 and beyond.
−Removed: Specifically, the Company expects continued spending on its current and planned clinical trials, continued expansion of manufacturing activities, higher payroll expenses as the Company increases its professional and scientific staff and continuation of pre-commercial activities.
−Removed: Based on the funds the Company has available as of the date these consolidated financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures as planned for at least the next twelve months from the date these consolidated financial statements are issued.
+Added: 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 registration 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 are issued, which include estimated net proceeds (after deducting underwriting and other offering expenses) of approximately $ 197.1 million from the public offering of its common stock completed on February 22, 2024, 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: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Concentrations of Risk
−Removed: The Company is subject to credit risk from its portfolio of cash, cash equivalents and investments.
+Added: The Company is subject to credit risk from its portfolio of cash, cash equivalents, trade accounts receivable and investments.
Under its investment policy, the Company limits amounts invested in securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S.
1 unchanged sentence
The goals of its investment policy are safety and preservation of principal, diversification of risk, and liquidity of investments sufficient to meet cash flow requirements.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES
14 unchanged sentences
The Company maintains a required minimum balance in a segregated bank account in connection with its letters of credit for which amounts are restricted as to their use by the Company.
−Removed: Currently, the Company’s letters of credit are primarily comprised of one for the benefit of the landlord for the i CTC used as a security deposit for the lease in the amount $ 5.45 million (See Note 10 - Leases) and one for $ 0.6 million for the benefit of the landlord for the Company’s current headquarters’ lease.
−Removed: The total amount of the Company’s letters of credit is classified as Restricted Cash on the Consolidated Balance Sheets.
+Added: Currently, the Company’s letters of credit are primarily comprised of one for the benefit of the landlord for the Iovance Cell Therapy Center (the “ i CTC”) used as a security deposit for the lease in the amount $ 5.45 million (See Note 14 - Leases) and a letter of credit for $ 0.6 million for the benefit of the landlord for the Company’s current headquarters’ lease (See Note 14 - Leases), as well as a letter of credit for $ 60.0 million, for the future milestone payment as required by the terms of the Option Agreement for the Proleukin ® acquisition (See Note 4 – Proleukin ® Acquisition).
+Added: This letter of credit expires on May 5, 2024, however, it will be automatically extended, without written agreement, for one-year periods to May in each succeeding calendar year and the final expiration date will be July 20, 2026.
+Added: Furthermore, the letter of credit will not be automatically extended if a thirty-day written notice is provided prior to the annual extension.
The letter of credit for $ 5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date.
1 unchanged sentence
The letter of credit with the landlord for the Company’s current headquarters’ lease expires on February 1, 2032, however, it will be automatically extended, without written agreement, for one-year periods to February in each succeeding calendar year.
−Removed: As of December 31, 2022 and December 31, 2021, restricted cash consisted of $ 6.4 million and $ 6.1 million, respectively.
+Added: As of December 31, 2023 and December 31, 2022, Restricted cash totaled $ 66.4 million and $ 6.4 million, respectively.
This amount has been classified as a non-current asset in the Company’s consolidated balance sheets.
−Removed: The following table provides a reconciliation of cash and 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 such amounts shown in the consolidated statements of cash flows (in thousands):
Cash and cash equivalents
3 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Asset Acquisitions
+Added: The Company evaluates acquisitions of assets using the guidance in Accounting Standard Codification (“ASC”) Topic 805, Business Combinations (“ASC 805”), to determine whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of assets.
+Added: If the screen test is met, the transaction is accounted for as an asset acquisition.
+Added: If the screen test is not met, further assessment is required to determine whether the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.
+Added: If the assets acquired do not constitute a business, the Company accounts for asset acquisitions using the cost accumulation and allocation method.
+Added: Under this method, the cost of the acquisition, including direct acquisition-related costs, is allocated to the assets acquired on a relative fair value basis.
+Added: Goodwill is not recognized in an asset acquisition and any difference between consideration transferred and the fair value of the net assets acquired is allocated to the identifiable assets acquired based on their relative fair values.
+Added: Deferred tax liabilities arising from basis differences in assets acquired are calculated using the simultaneous equations method under ASC Topic 740, Income Taxes (“ASC 740”), and based on the effective tax rate.
+Added: The resulting deferred tax liability is recorded in the consolidated balance sheet as of December 31, 2023.
+Added: Contingent consideration in the scope of ASC Topic 815, Derivatives and Hedging (“ASC 815”), is included in the cost of the asset acquisition at its acquisition date fair value.
+Added: Contingent consideration in the scope of ASC Topic 450, Contingencies (“ASC 450”), is recognized when it is both probable and reasonably estimable.
+Added: Inventory and Cost of Sales
+Added: Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis.
+Added: Cost includes amounts related to materials, labor and overhead.
+Added: Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation.
+Added: Inventories presented in the consolidated balance sheet as of December 31, 2023 pertain solely to Proleukin ® and include a step-up of the fair value of inventories as a result of the acquisition of the worldwide rights to Proleukin ® .
+Added: Inventoriable costs incurred such as manufacturing costs for the Company’s product candidates, including Amtagvi™, are expensed as incurred as research and development expenses prior to regulatory approval.
+Added: When regulatory approval of a product is obtained and the approved product is commercially launched, the Company will begin capitalizing manufacturing costs related to the approved product into inventory.
+Added: Cost of sales includes the cost of Proleukin ® inventories and other costs that are directly associated with the purchase and sales of Proleukin ® .
+Added: In addition, amortization expense for the fair value step up of Proleukin ® inventories and the acquired intangible assets related to the developed technology are included in cost of sales in the Company’s consolidated statement of operations.
+Added: Trade Accounts Receivable
+Added: Trade accounts receivable are recorded net of allowances for product returns and estimated credit losses.
+Added: The estimate of allowance for credit losses considers factors, including existing contractual payment and the aging of receivable from its customers.
+Added: To date, the Company has determined that an allowance for doubtful accounts is not required.
+Added: Intangible Assets
+Added: 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 amortizes the intangible assets on a straight-line basis over their estimated useful lives.
+Added: When contingent consideration is a component of the cost of an asset acquisition, the Company capitalizes the amount of incremental cost from the contingent consideration related to the intangible asset acquired in the period the underlying contingency is resolved.
+Added: When this occurs, the Company will recognize amortization expense on the incremental cost prospectively from the date the incremental costs are capitalized.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company reviews intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable.
+Added: If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets.
+Added: 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.
+Added: The Company determined that no indicators of impairment existed as of December 31, 2023.
+Added: The Company determines if an arrangement includes a lease at inception and thereafter, if modified.
+Added: Operating leases are included in its consolidated balance sheets as Operating lease right-of-use assets and Operating lease liabilities as of December 31, 2023 and 2022.
+Added: Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease.
+Added: Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term.
+Added: In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date.
+Added: The operating lease right-of-use assets also include any lease payments made less lease incentives.
+Added: 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.
+Added: 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: The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No.
+Added: 2016-02 and No.
+Added: 2018-10 (together “Topic 842”) for short-term leases.
+Added: For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately.
Property and Equipment, net
17 unchanged sentences
For the years ended December 31, 2023, 2022, and 2021, the Company did not recognize any impairments for its property and equipment.
−Removed: Net Loss per Share
−Removed: Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period.
−Removed: 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 though 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.
−Removed: As of December 31, 2022, 2021, and 2020, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.
−Removed: As of December 31,
−Removed: Stock options
−Removed: Employee Stock Purchase Plan
−Removed: Restricted stock units
−Removed: Series A Convertible Preferred Stock*
−Removed: Series B Convertible Preferred Stock*
−Removed: *on an as-converted basis
−Removed: The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method.
−Removed: Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities.
+Added: Fair Value Measurements
+Added: Under ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Fair Value Measurements
−Removed: Under Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures , fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability.
+Added: advantageous market for the asset or liability.
Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters.
5 unchanged sentences
- Level 3—These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable.
−Removed: The Company’s financial instruments consist of cash, cash equivalents, short and long-term investments, and long-term notes payable, all of which are reported at their respective fair value or approximate fair value on its Consolidated Balance Sheets.
+Added: The Company’s financial instruments consist of cash, cash equivalents, short-term investments, and long-term notes payable, all of which are reported at their respective fair value or approximate fair value on its consolidated balance sheets.
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
4 unchanged sentences
Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset.
−Removed: The Company’s financial instruments consist of Level 1 and Level 2 assets.
−Removed: Use of Estimates
−Removed: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
−Removed: Actual results could differ from those estimates.
−Removed: Significant items subject to such estimates and assumptions include assumptions made in the fair value of 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 .
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Principles of Consolidation
−Removed: The accompanying consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc.
−Removed: and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, Iovance Biotherapeutics GmbH, and Iovance Biotherapeutics B.V.
−Removed: All intercompany accounts and transactions have been eliminated.
−Removed: dollar is the functional currency for all the Company's consolidated operations.
−Removed: The Company determines if an arrangement includes a lease at inception and thereafter, if modified.
−Removed: Operating leases are included in its Consolidated Balance Sheets as Operating lease right-of-use assets and Operating lease liabilities as of December 31, 2022 and 2021.
−Removed: Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease.
−Removed: Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term.
−Removed: In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date.
−Removed: The operating lease right-of-use assets also include any lease payments made less lease incentives.
−Removed: 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.
−Removed: The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No.
−Removed: 2016-02 and No.
−Removed: 2018-10 (together “Topic 842”) for short-term leases.
−Removed: For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately.
+Added: Revenue Recognition
+Added: The Company recognizes revenue from product sales in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).
+Added: Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services.
+Added: To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience as well as applicable information currently available.
+Added: Indirect taxes collected from customers and remitted to government authorities that are related to sales of the Company’s products, primarily in Europe, are excluded from revenues.
+Added: Subsequent to the closing of the acquisition of Proleukin ® in May 2023, the Company began to sell Proleukin ® in licensed markets outside of the U.S.
+Added: To date, there have been no product sales from Proleukin ® in the U.S.
+Added: Revenue recognized for the year ended December 31, 2023 was not material to the Company’s consolidated financial statements.
Stock-Based Compensation
2 unchanged sentences
Forfeitures are recognized in the period in which they occur.
−Removed: The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair values at each reporting date until the shares underlying the options have vested.
+Added: The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: values at each reporting date until the shares underlying the options have vested.
The non-employee awards that contain a performance condition that affects the quantity or other terms of the award are measured based on the outcome that is probable.
7 unchanged sentences
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.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Accrued Research and Development Costs
7 unchanged sentences
Included in the Company’s clinical development costs are investigator costs, which are costs associated with treatments administered at clinical sites as required under each clinical trial protocol.
−Removed: The Company’s estimates for clinical investigator costs and timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of clinical trial enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on clinical trial, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs.
−Removed: In addition, the Company’s estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional treatments that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the clinical trial treatment.
+Added: The Company’s determination of clinical investigator costs and related timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of clinical trial enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on clinical trial, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs.
+Added: In addition, the Company’s estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional procedures that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the clinical trial treatment.
The Company accrues estimated expenses resulting from obligations under investigator site agreements as the timing of payments does not always timely align with the periods over which the treatments are administered by the clinical investigators.
4 unchanged sentences
Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.
−Removed: General and Administrative Expenses
−Removed: 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 and human resources functions.
−Removed: Other significant costs include facility costs not otherwise included in research and development expenses, sublicense royalty expenses, legal fees relating to corporate matters, insurance, public company expenses relating to maintaining compliance with Nasdaq listing rules and Securities and Exchange Commission (“SEC”) requirements, investor relations costs, and fees for accounting and consulting services.
−Removed: General and administrative costs are expensed as incurred.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Selling, general and administrative expense
+Added: 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.
+Added: Other significant costs include facility costs not otherwise included in research and development expenses.
+Added: 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.
The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences.
2 unchanged sentences
Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: ASC Topic 740, Income Taxes , clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
−Removed: ASC Topic 740 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.
+Added: ASC Topic 740, Income Taxes (“ASC 740”), clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
+Added: ASC 740 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.
The Company will classify as income tax expense any interest and penalties.
The Company has no material uncertain tax positions for any of the reporting periods presented.
+Added: Net Loss per Share
+Added: Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period.
+Added: 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.
+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 though 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: As of December 31, 2023, 2022, and 2021, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.
+Added: As of December 31,
+Added: Stock options
+Added: Employee Stock Purchase Plan
+Added: Restricted stock units
+Added: Series A Convertible Preferred Stock*
+Added: Series B Convertible Preferred Stock*
+Added: *on an as-converted basis
+Added: The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method.
+Added: Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Use of Estimates
+Added: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
+Added: Actual results could differ from those estimates.
+Added: 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-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: Principles of Consolidation
+Added: The accompanying consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc.
+Added: and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, Iovance Biotherapeutics GmbH, and Iovance Biotherapeutics B.V., Iovance Biotherapeutics UK Ltd and Iovance Biotherapeutics UK SP Ltd (together, the “UK subsidiaries”), and Iovance Biotherapeutics Canada, Inc.
+Added: All intercompany accounts and transactions have been eliminated.
+Added: Certain prior year amounts in the notes to these consolidated financial statements have been reclassified for consistency with the current year presentation.
+Added: These reclassifications had no effect on the previously reported consolidated balance sheets, consolidated statements of operations, consolidated statements of other comprehensive loss, consolidated statements of stockholder’s equity or consolidated statements of cash flows.
+Added: Foreign Currency Translation
+Added: The assets and liabilities of the Company’s subsidiaries whose functional currencies are not in U.S.
+Added: dollars are translated into U.S.
+Added: dollars at the related period-end exchange rate.
+Added: dollar effects that arise from translation of net assets of these subsidiaries at changing rates are recognized in Accumulated Other Comprehensive Income (Loss) in the consolidated balance sheets.
+Added: The subsidiaries’ net loss is translated into U.S.
+Added: dollars by using the average exchange rate for the applicable period.
+Added: The consolidated financial statements are presented in U.S.
+Added: dollars, which is the Company’s reporting currency.
+Added: Segment Reporting
+Added: The Company operates in one segment, focused on developing and commercializing therapies using autologous TIL for the treatment of metastatic melanoma and other solid tumor cancers.
Concentrations
5 unchanged sentences
As of December 31, 2023 and 2022, respectively, the Company’s cash balances were in excess of insured limits maintained at the financial institutions.
−Removed: Segment Reporting
−Removed: The Company operates in one segment, focused on developing and commercializing therapies using autologous TIL for the treatment of metastatic melanoma and other solid tumor cancers.
+Added: Recent Accounting Standards Issued But Not Yet Adopted
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures, which enhances the disclosures of income taxes.
+Added: ASU 2023-09 is effective for the Company in its annual reporting for fiscal 2025 on a prospective basis.
+Added: Early adoption and retrospective reporting are permitted.
+Added: The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements.
+Added: In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures, which enhances the disclosures required for operating segments in annual and interim consolidated financial statements.
+Added: ASC 2023-07 is effective for the Company in its annual reporting for fiscal year 2024 and for interim period reporting beginning in
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: fiscal year 2025 on a retrospective basis.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of ASC 2023-07 on its consolidated financial statements.
CASH EQUIVALENTS AND INVESTMENTS
2 unchanged sentences
treasury securities
−Removed: government agency securities
−Removed: Corporate securities
−Removed: Commercial paper
Money market funds
7 unchanged sentences
Total investments
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The fair value of cash equivalents and investments as of December 31, 2023 and December 31, 2022 are classified as follows in the Company’s consolidated balance sheets (in thousands):
2 unchanged sentences
Short-term investments
−Removed: Long-term investments
Total investments
3 unchanged sentences
No significant available-for-sale securities held as of the periods presented have been in a continuous unrealized loss position for more than 12 months.
−Removed: The Company determined that it has the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery.
−Removed: To date, the Company has not recorded any impairment charges on its marketable securities.
+Added: To date, the Company has not recorded any impairment charges on its investments.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Recurring Fair Value Measurements
−Removed: The following table summarizes the Company’s available-for-sale investments by contractual maturity (in thousands):
−Removed: December 31, 2022
−Removed: Amortized Cost
−Removed: Within one year
−Removed: Total investments
As of December 31, 2023 and 2022, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):
1 unchanged sentence
treasury securities
−Removed: government agency securities
−Removed: Corporate securities
−Removed: Commercial paper
Money market funds
7 unchanged sentences
Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset.
+Added: PROLEUKIN ® ACQUISITION
+Added: On January 23, 2023, the Company and its newly formed, wholly owned subsidiary, Iovance Biotherapeutics UK Ltd (the “Purchaser”) entered into an Option Agreement (the “Option Agreement”) with Clinigen Holdings Limited, Clinigen Healthcare Limited, and Clinigen, Inc.
+Added: (collectively “Clinigen”), a global pharmaceutical services company, pursuant to which the Purchaser would acquire the worldwide rights for the manufacturing, supply, commercialization and sale of Proleukin ® (aldesleukin) (the “Acquisition”).
+Added: On May 18, 2023, the Company completed the Acquisition and specifically acquired (i) all issued and outstanding shares of Clinigen SP Limited (the “Target”), (ii) the business of the Target and Clinigen (the “Proleukin ® Business”) comprising the manufacturing, supply, commercialization and the generation of income from the Product rights and the undertaking of an active role in the development, maintenance and exploitation of those rights, and (iii) certain specified assets identified in the Option Agreement.
+Added: Pursuant to the Option Agreement, the Company paid to Clinigen (i) an upfront payment of £ 166.9 million (or approximately $ 207.2 million), including the applicable stamp-tax payment, and (ii) a payment for certain inventory of £ 2.4 million (or approximately $ 3.0 million) using existing cash on hand.
+Added: The Option Agreement includes potential future contingent payments, as discussed below.
+Added: The Acquisition was accounted for as an asset acquisition because substantially all of the fair value of the acquired assets was concentrated in the acquired developed technology related to the intellectual property rights of Proleukin ® and therefore the Acquisition does not meet the definition of a business in accordance with ASC 805.
+Added: The Proleukin ® Business operations have been included in the Company’s consolidated financial statements commencing from the acquisition date.
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: The following table summarizes the total cash consideration and allocated acquisition date fair values of assets acquired and liabilities assumed (in thousands):
+Added: Developed technology
+Added: Assembled workforce
+Added: Deferred tax liability
+Added: Total cost of acquisition
+Added: 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.
+Added: 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: These contingent payments were determined to be within the scope of ASC 450 and will be recognized when they are both probable and estimable.
+Added: The recognition criteria have not been met as of the acquisition date or as of December 31, 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The fair value of the assembled workforce was estimated using a replacement cost less depreciation method.
+Added: 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 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.
+Added: The inventory fair value adjustment is being amortized as cost of sales as the acquired inventories are sold.
+Added: A deferred tax liability was recognized on the temporary differences related to the book and tax basis of the acquired intangible assets.
+Added: The deferred tax liability and resulting adjustment to the carrying amount of the acquired intangibles was calculated using the simultaneous equations method under ASC 740.
+Added: The tax rate used is based on the estimated statutory rates in the United Kingdom as this is where the intangible assets are domiciled.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: INTANGIBLE ASSETS, NET
+Added: The gross carrying amounts and net book value of intangible assets as of December 31, 2023 are as follows (in thousands):
+Added: December 31, 2023
+Added: Gross carrying amounts
+Added: Accumulated amortization
+Added: Intangible assets, net
+Added: Intangible assets:
+Added: Developed technology
+Added: Assembled workforce
+Added: Total Intangible Assets
+Added: * Amounts are translated using the foreign exchange rate as of 12/31/2023.
+Added: The Company recognized amortization expense of $9.9 million during the year ended December 31, 2023.
+Added: 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, 2023.
+Added: There was no such expense recorded in the year ended December 31, 2022.
+Added: The total estimated amortization of the Company’s intangible assets the years ending December 31, 2024, 2025, 2026, 2027 and 2028 are $ 16.1 million, $ 16.1 million, $ 16.0 million, $ 15.9 million, and $ 15.9 million, respectively.
+Added: Inventory presented in the consolidated balance sheet as of December 31, 2023 pertains solely to Proleukin ® .
+Added: Inventory classified as work in process are unlabeled vials of Proleukin ® .
+Added: As of December 31, 2023 and December 31, 2022, inventory consists of the following (in thousands):
+Added: Work in process
+Added: Finished goods
+Added: Total inventory
+Added: Product sales for the year ended December 31, 2023 was $ 1.2 million and represented sales of Proleukin ® made primarily in licensed markets outside of the U.S.
+Added: To date, there have been no product sales from Proleukin ® in the U.S.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
PROPERTY AND EQUIPMENT, NET
12 unchanged sentences
Depreciation expense for the years ended December 31, 2023, 2022, and 2021 was approximately $ 11.6 million, $ 9.3 million and $ 3.1 million, respectively.
−Removed: During the years ended December 31, 2022 and 2021, the Company placed $ 27.2 million and $ 62.4 million of assets related to the i CTC in service and initiated depreciation of these assets.
−Removed: The depreciation expense related to these assets for the years ended December 31, 2022 and 2021 was $ 2.7 million and $ 1.6 million, respectively.
+Added: During the years ended December 31, 2023 and 2022, the Company placed $ 2.6 million and $ 27.2 million of assets related to the i CTC in service, respectively, and initiated depreciation of these assets.
ACCRUED EXPENSES
Accrued expenses consist of the following (in thousands):
−Removed: Accrued payroll and employee related expenses
+Added: Employee and consultant related expenses
Clinical related
2 unchanged sentences
Legal and related services
+Added: Inventory related
Other accrued expenses
4 unchanged sentences
Public Offerings
−Removed: In June 2020, the Company closed an underwritten public offering of 16,935,484 shares of the Company’s common stock at a public offering price of $ 31.00 per share, before underwriting discounts, which included 2,540,322 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount (the "June 2020 Public Offering").
−Removed: The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $ 603.7 million, with net proceeds to the Company of $ 567.0 million.
+Added: 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.
+Added: 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.
IOVANCE BIOTHERAPEUTICS, INC.
1 unchanged sentence
At the Market Offering Program
−Removed: On February 8, 2021, the Company entered into an Open Market Sale Agreement (the “First Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an “at the market” offering program, under which the Company may, from time to time, in its sole discretion, issue and sell through Jefferies, acting as sales agent, up to $ 350.0 million of shares of the Company’s common stock (the “Common Shares”).
−Removed: On November 18, 2022, the Company entered into a new Open Market Sales Agreement (the “Second Sales Agreement”), which superseded and replaced the First Sales Agreement dated February 8, 2021.
−Removed: Under the terms of the Second Sales Agreement, the Company may, from time to time, in its sole discretion, issue and sell up to $ 500.0 million of shares of the Company’s Common Shares.
−Removed: The issuance and sale, if any, of the Common Shares by the Company under the First Sales Agreement and Second Sales Agreement (together, the “Sales Agreements”) will be made pursuant to a prospectus supplement, dated February 8, 2021 and November 18, 2022, to the Company’s Registration Statement on Form S-3ASR, which became effective immediately upon filing with the Securities and Exchange Commission on May 27, 2020.
−Removed: Pursuant to the Sales Agreements, 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.
+Added: On November 18, 2022, the Company entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies LLC (“Jefferies”).
+Added: Under the terms of the 2022 Sale Agreement, the Company was able to, from time to time, at its sole discretion, issue and sell through Jefferies, acting as a sales agent, up to $ 500.0 million of shares of the Company’s common stock.
+Added: 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.
+Added: 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.
+Added: 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: Pursuant to the 2023 Sale Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended.
Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose).
−Removed: The Company will pay Jefferies a commission of up to 3.0 % of the gross sales proceeds of any Common Shares sold through Jefferies under the Sales Agreements.
−Removed: The Company is not obligated to make any sales of Common Shares under the Sales Agreements.
−Removed: The offering of Common Shares pursuant to the Sales Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the Sales Agreement and (ii) termination of the Sales Agreements in accordance with its terms.
−Removed: For the years ended December 31, 2022 and 2021, the Company received $ 189.5 million and $ 203.2 million in net proceeds, net of offering costs, through the sale of 29,788,993 shares and 6,474,099 shares of its common stock through the Sales Agreements at a weighted average price per share of $ 6.52 and $ 32.12 , respectively.
+Added: The Company will pay Jefferies a commission of up to 3.0 % of the gross sales proceeds of any Common Shares sold through Jefferies under the 2023 Sale Agreement.
+Added: The Company is not obligated to make any sales of Common Shares under the 2023 Sale Agreement.
+Added: The offering of Common Shares pursuant to the 2023 Sale Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the 2023 Sale Agreement and (ii) termination of the 2023 Sale Agreement in accordance with its terms.
+Added: For the years ended December 31, 2023 and 2022, the Company received $ 301.7 million and $ 189.5 million in net proceeds, net of offering costs, through the sale of 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 $ 6.99 and $ 6.52 , respectively.
Preferred Stock
22 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, 2022.
−Removed: During the year ended December 31, 2021, 738,961 shares of Series B Convertible Preferred Stock were converted to common stock.
+Added: No shares of Series B Convertible Preferred Stock were converted to common stock during the year ended December 31, 2023 and 2022.
At December 31, 2023 and 2022, 2,842,158 shares of Series B Preferred Stock (that are convertible into 2,842,158 shares of common stock) remained outstanding.
7 unchanged sentences
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.
+Added: On June 6, 2023, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 20,700,000 to 29,700,000 , which became effective immediately.
As of December 31, 2023, 9,906,666 shares of common stock were available for grant under the Company’s 2018 Plan.
7 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: On March 13, 2023, the Compensation Committee approved an additional amendment to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,750,000 shares of the Company’s common stock to 2,250,000 shares of the Company’s common stock without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary.
4 unchanged sentences
(in thousands)
−Removed: Outstanding at January 1, 2020
−Removed: Expired/Cancelled
Outstanding at December 31, 2022
−Removed: ( 2,822,617 )
Expired/Cancelled
1 unchanged sentence
Outstanding at December 31, 2023
−Removed: Expired/Cancelled
−Removed: Outstanding at December 31, 2022
Ending vested and expected to vest at December 31, 2023
8 unchanged sentences
The Company reserved 500,000 shares of its common stock for issuance under the 2020 ESPP.
+Added: On June 6, 2023, the Company's stockholders approved an amendment to the 2020 ESPP to increase the number of shares reserved for issuance under the 2020 ESPP from 500,000 shares of the Company’s common stock to 1,400,000 shares of the Company’s common stock, which became effective immediately.
+Added: Under the 2020 ESPP, employees of the Company can purchase shares of our common stock based on a percentage of their compensation subject to certain limits.
+Added: The purchase price per share is equal to the lower of 85 % of the fair market value of its common
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Under the 2020 ESPP, employees of the Company can purchase shares of our common stock based on a percentage of their compensation subject to certain limits.
−Removed: The purchase price per share is equal to the lower of 85 % of the fair market value of its common stock on the offering date or the purchase date with a six-month look-back feature.
+Added: stock on the offering date or the purchase date with a six-month look-back feature.
The 2020 ESPP purchases are settled with common stock from the 2020 ESPP’s previously authorized and available pool of shares.
1 unchanged sentence
Under the 2020 ESPP, for the years ended December 31, 2023 and 2022, the Company received proceeds of $ 2.4 million for the issuance of 435,459 shares and $ 1.7 million for the issuance of 262,701 shares, respectively.
−Removed: As of December 31, 2020, no shares were issued un the 2020 ESPP.
As of December 31, 2023, there was $ 0.6 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over 5.4 months.
2 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: A summary of the RSU and PRSU activity during the years ended December 31, 2022, and 2021 is presented in the following table:
+Added: Activity for RSUs and PRSUs during the years ended December 31, 2023 and 2022 is presented in the following table:
RSUs and PRSUs
Outstanding, non-vested as of December 31, 2022
−Removed: Canceled/Forfeited
−Removed: Outstanding, non-vested as of December 31, 2021
Vested/Released
+Added: ( 1,253,465 )
Canceled/Forfeited
1 unchanged sentence
Ending vested and expected to vest at December 31, 2023
−Removed: During the year ended December 31, 2022, 2.4 million restricted units were granted, of which only 100,000 were PRSUs.
−Removed: No PRSUs were granted during the year ended December 31, 2021.
−Removed: As of December 31, 2022, there was $ 20.6 million of unrecognized stock-based compensation expense associated with unvested RSUs and PRSUs, which the Company expects to recognize over a remaining weighted-average period of 1.72 years.
+Added: As of December 31, 2023 and 2022, there was $ 19.9 million and $ 20.6 million of unrecognized stock-based compensation expense associated with unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of 1.65 and 1.72 years, respectively.
The aggregate intrinsic value of the unvested RSUs and PRSUs outstanding as of December 31, 2023 and 2022, was $ 28.1 million and $ 14.5 million, respectively.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Stock-Based Compensation
2 unchanged sentences
Research and development
−Removed: General and administrative
+Added: Selling, general and administrative
Total stock-based compensation expense
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Total stock-based compensation expense by type of award was as follows (in thousands):
13 unchanged sentences
73.02 % - 137.42 %
+Added: 52.04 % - 94.56 %
Risk-free interest rate
4 unchanged sentences
1.98 % - 4.78 %
+Added: 0.06 % - 0.13 %
Expected dividend yield
5 unchanged sentences
Each of the inputs discussed above is subjective and generally requires significant management judgment.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
EMPLOYEE BENEFIT PLAN
2 unchanged sentences
The Company's matching contribution to the defined contribution plan was $ 4.1 million, $ 3.0 million, and $ 2.2 million for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: The Company did not record a provision or benefit for income taxes for the years ended December 31, 2022, 2021 or 2020.
+Added: The Company recorded an income tax benefit of $ 3.5 million for the year ended December 31, 2023, but did no t record a provision or benefit for income taxes for the years ended December 31, 2022 or 2021.
+Added: Upon the completion of the Acquisition on May 18, 2023, a deferred tax liability of $ 20.4 million was recognized on the temporary differences related to the book and tax basis of the acquired intangible assets.
+Added: The deferred tax liability and resulting adjustment to the carrying amount of the acquired intangibles was calculated using the simultaneous equations method under ASC 740.
+Added: The tax rate used is based on the estimated statutory rates in the United Kingdom as this is where the intangible assets are domiciled.
+Added: The Company recorded a tax benefit of $ 3.5 million for the year ended December 21, 2023, which resulted in an effective tax rate of 0.78 %.
+Added: The effective tax rate is different from U.S.
+Added: statutory rate of 21 % due to the full valuation allowance against tax losses in
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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.
The significant components of the Company’s net deferred tax assets and liabilities are summarized as follows (in thousands):
6 unchanged sentences
Capitalized R&D
−Removed: Depreciation and amortization
Reserves and accruals
3 unchanged sentences
Deferred tax liabilities:
+Added: Right-of-use assets
Depreciation and amortization
11 unchanged sentences
The Company had net operating loss carryforwards (“NOLs”) for federal and state income tax purposes of approximately $ 1.2 billion and $ 180 million, respectively, as of December 31, 2023.
−Removed: $ 142.4 million of federal NOLs will expire beginning in 2027, while $ 898.9 million generated after the recently enacted tax reform will have an indefinite life under the Tax Cuts and Jobs Act of 2017 (the “Tax Act”).
+Added: $ 142.4 million of federal NOLs will expire beginning in 2027, while $ 1.0 billion generated after the recently enacted tax reform will have an indefinite life under the Tax Cuts and Jobs Act of 2017 (the “Tax Act”).
The state NOLs will expire if unused in years 2030 through 2043.
3 unchanged sentences
The Company’s utilization of NOLs may also be adversely affected by future changes in federal and state tax laws and regulations.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
+Added: In assessing the realization of U.S.
+Added: deferred tax assets, management considers whether it is more likely than not that some portion or all the deferred tax assets will not be realized.
The ultimate realization of deferred tax assets is dependent upon future generation for 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.
−Removed: After consideration of all the information available, management believes that significant uncertainty exists with respect to future realization of the deferred tax assets and has therefore established a full valuation allowance.
−Removed: For the years ended December 31, 2022, 2021 and 2020, the change in the valuation allowance was approximately $ 82.9 million, $ 78.1 million, and $ 60.7 million, respectively.
+Added: After consideration of all the information available, management continues to maintain a full valuation allowance against U.S.
+Added: federal and state net deferred tax assets as it expected to be in a cumulative loss position and does not have
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: sufficient positive evidence to support the realizability of its U.S.
+Added: net deferred tax assets For the years ended December 31, 2023, 2022 and 2021, the change in the valuation allowance was approximately $ 96.4 million, $ 82.9 million, and $ 78.1 million, respectively.
+Added: For the year ended December 31, 2023, the Company recorded approximately $ 17.3 million of net deferred tax liability from its operation in the United Kingdom.
+Added: The basis difference resulted from acquisition of Proleukin business.
The Company evaluated the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements.
17 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.
+Added: The Inflation Reduction Act of 2022 (the “Act”), which includes certain new tax measures, was signed into law in August 2022.
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.
The Act is effective for tax years beginning after December 31, 2022;
−Removed: the Company is evaluating the provisions of the Act but currently does not believe these provisions will have a material impact on its consolidated financial statements.
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: however, the provisions of the Act will not have a material impact on the Company’s consolidated financial statements.
+Added: The Company will continue to monitor the effect of the Act and its impact on the Company.
LICENSES AND AGREEMENTS
1 unchanged sentence
Cooperative Research and Development Agreement (the “CRADA”)
−Removed: In August 2011, the Company signed a five-year CRADA with the NCI to work on the development of adoptive cell immunotherapies that are designed to destroy metastatic melanoma cells.
−Removed: The CRADA was amended in 2015 and 2016 to, among other things, extend the term of the CRADA through August 2021, include new indications such as the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers, and modify the focus on the development of unmodified TIL as a stand-alone therapy or in combination.
+Added: In August 2011, the Company signed a five-year CRADA with the NCI to work on the development of adoptive cell immunotherapies in multiple solid tumor types, including unmodified TIL as a stand-alone therapy or in combination, improved methods for the generation and selection of TIL cell therapy with anti-tumor reactivity, and strategies for more potent TILs that are designed to destroy metastatic melanoma cells.
+Added: The CRADA was amended in 2015 and 2016 to, among other things, extend the term of the CRADA through August 2021, include new indications such as the development of TIL cell therapy for the treatment of patients
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers, and modify the focus on the development of unmodified TIL as a stand-alone therapy or in combination.
The parties have continued the development of improved methods for the generation and selection of TIL with anti-tumor reactivity in metastatic melanoma, bladder, lung, breast, and HPV-associated cancers.
8 unchanged sentences
The Company recorded costs associated with the CRADA of $ 2.0 million for each of the years ended December 31, 2023, 2022 and 2021, respectively, as research and development expenses.
−Removed: Patent License Agreement Related to the Development and Manufacture of TIL Therapies
+Added: Patent License Agreement Related to the Development and Manufacture of TIL Cell Therapies
The Company entered into an Exclusive Patent License Agreement (the “Patent License Agreement”) with the NIH, an agency of the U.S.
5 unchanged sentences
The Company also agreed to 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.
−Removed: The Company anticipates making 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 our product candidates covered by the Second Amended
+Added: The Company 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.
+Added: and foreign commercial sales of any of our product candidates covered by the Second Amended and Restated Patent License Agreement.
+Added: 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: The Company recorded milestone costs associated with the Second Amended and Restated Patent License Agreement, specifically for the completion of the first licensee-sponsored Phase 2 trial of $ 0.6 million for the year ended December 31, 2023.
+Added: In addition, with the approval of Amtagvi™, we will be required to remit $ 1.5 million within 60 days of the approval date in accordance with the requirements of the Second Amended and Restated Patent License Agreement.
+Added: No expenses were recorded for the years ended December 31, 2022 and 2021, respectively.
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
Exclusive Patent License Agreement Related to TIL Selection
3 unchanged sentences
Research Collaboration and Clinical Grant Agreements with Moffitt
−Removed: In June 2020, the Company entered into a Sponsored Research Agreement with the H.
+Added: In June 2020, the Company entered into a Sponsored Research Agreement (the “Research Agreement”) with the H.
Lee Moffitt Cancer Center (“Moffitt”), with a term that ends either upon completion of the research thereunder or on July 1, 2022, whichever is sooner.
−Removed: In June 2022, this agreement was extended until the later of December 19, 2022, or a mutually acceptable completion of the Research Agreement, which is expected in mid-2023.
+Added: In June 2022, this agreement was extended until the later of December 19, 2022 or a mutually acceptable completion of the Research Agreement, which was expected in mid-2023.
+Added: In August 2023, this agreement was extended until September 2023, at which point it expired.
+Added: In December 2023, this agreement was extended until the later of November 30, 2024 or a mutually agreed determination of the completion of the Research Agreement.
The Company recorded research and development costs of $ 0.2 million, $ 0.6 million and $ 0.3 million for each of the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: In December 2016, the Company entered into a clinical grant agreement with Moffitt to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma.
−Removed: In June 2017, the Company entered into a second clinical grant agreement with Moffitt to support a new clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with non-small cell lung cancer, under which the Company obtained a non-exclusive, royalty-free license to any new Moffitt inventions made in the performance of the agreement.
−Removed: Under both clinical grant agreements with Moffit, the Company has non-exclusive rights to clinical data arising from the respective clinical trials.
−Removed: For the years ended December 31, 2022 and 2021 the Company recorded research and development costs of $ 0.1 million, and for the year ended December 31, 2020 the company recorded $ 0.4 million of research and development costs, in connection with the research collaboration and clinical grant agreements with Moffitt.
+Added: In December 2016, the Company entered into a clinical grant agreement with Moffitt to support an ongoing clinical trial at Moffitt that combines TIL cell therapy with nivolumab for the treatment of patients with metastatic melanoma.
+Added: In June 2017, the Company entered into a second clinical grant agreement with Moffitt to support a new clinical trial at Moffitt that combines TIL cell therapy with nivolumab for the treatment of patients with non-small cell lung cancer, under which the Company obtained a non-exclusive, royalty-free license to any new Moffitt inventions made in the performance of the agreement.
+Added: Under both clinical grant agreements with Moffit, the Company has non-exclusive rights to clinical data arising from the respective clinical trials, which are now closed.
+Added: No expense was recorded for the years ended December 31, 2023, and for the year ended December 31, 2022 and 2021 the Company recorded $ 0.1 million of research and development costs, in connection with the research collaboration and clinical grant agreements with Moffitt.
Exclusive License Agreements with Moffitt
−Removed: The Company entered into a license agreement with Moffitt (the “First Moffitt License”), effective as of June 28, 2014, under which the Company received a worldwide license to Moffitt’s rights to patent-pending technologies related to methods for improving TIL for adoptive cell therapy using toll-like receptor agonists.
+Added: The Company entered into a license agreement with Moffitt (the “First Moffitt License”), effective as of June 28, 2014, under which the Company received a worldwide license to Moffitt’s rights to patent-pending and patented technologies related to methods for improving TIL for adoptive cell therapy using toll-like receptor agonists.
Unless earlier terminated, the term of the license extends until the earlier of the expiration of the last issued patent related to the licensed technology or 20 years after the effective date of the license agreement.
4 unchanged sentences
The Company will also be responsible for all costs associated with the preparation, filing, maintenance and prosecution of the patent applications and patents covered by the First Moffitt License related to the treatment of any cancers in the U.S., Europe and Japan and in other countries designated by the Company in agreement with Moffitt.
−Removed: No expenses were recorded for the First Moffitt License for the year ended December 31, 2022, 2021, and 2020.
+Added: No expenses were recorded for the First Moffitt License for the years ended December 31, 2023, 2022, and 2021.
The Company entered into a second license agreement with Moffitt effective as of May 7, 2018 (the “Second Moffitt License”), under which the Company received a license to Moffitt’s rights to patent-pending technologies related to the use of 4-1BB agonists in conjunction with TIL manufacturing processes and therapies.
2 unchanged sentences
The Company agreed to pay an annual commercial use payment for each indication for which a first sale has occurred, which in the aggregate amounts to up to $ 0.4 million a year.
−Removed: The Company recorded $ 0.2 million for the year ended
+Added: The Company recorded $ 0.1 million, $ 0.2 million and $ 0.1 million for the years ended December 31, 2023, 2022 and 2021, respectively, as research and development expenses in connection with this agreement.
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: December 31, 2022, and $ 0.1 million for each of the years ended December 31, 2021 and 2020, respectively, as research and development expenses in connection with this agreement.
The Company subsequently exercised an option to exclusively license Moffitt’s rights to patent pending technologies related to the use of tumor digests in conjunction with TIL manufacturing processes and therapies and entered into an amended and restated Second Moffitt License in October 2021 (the “Amended & Restated Second Moffit License”), to include these rights.
10 unchanged sentences
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: The Company recorded $ 0.2 million, $ 0.5 million and $ 1.1 million associated with the SAA for the year ended December 31, 2022, 2021 and 2020 as research and development expenses, respectively.
+Added: The Company recorded zero , $ 0.2 million and $ 0.5 million associated with the SAA for the years ended December 31, 2023, 2022 and 2021 as research and development expenses, respectively.
WuXi Advanced Therapies, Inc.
3 unchanged sentences
Under the First WuXi MSA, the Company entered into two statements of work for two cGMP manufacturing suites to be operated by WuXi for the Company.
−Removed: Both of the suites are expected to be capable of being used for the commercial manufacture of the Company’s products.
−Removed: The terms of one of these statements of work was extended to December 2022.
−Removed: The Company recorded costs associated with agreements with WuXi of $ 14.2 million, $ 17.5 million, and $ 20.6 million for the years ended December 31, 2022, 2021, and 2020 respectively, as research and development expenses.
+Added: The terms of one of these statements of work expired in December 2022.
Second WuXi Manufacturing and Services Agreement
−Removed: In October 2022, the Company’s subsidiary Iovance Biotherapeutics Manufacturing LLC entered into an additional three-year manufacturing and services agreement (the “Second WuXi MSA”) with WuXi and its parent company WuXi Apptec, Co, Ltd pursuant to which WuXi agreed to provide commercial and clinical manufacturing services and related testing services.
+Added: In October 2022, the Company’s subsidiary Iovance Biotherapeutics Manufacturing LLC entered into an additional three-year manufacturing and services agreement (the “Second WuXi MSA”) with WuXi and its parent company WuXi Apptec, Co.
+Added: Ltd pursuant to which WuXi agreed to provide commercial and clinical manufacturing services and related testing services.
Under the Second WuXi MSA, the Company entered into a statement of work for the two cGMP manufacturing suites to be operated by WuXi for the Company.
2 unchanged sentences
Certain other statements of work for related services will also be covered by the Second WuXi MSA.
−Removed: The First WuXi MSA will continue to address development services provided by WuXi to the Company.
+Added: The First WuXi MSA addressed development services provided by WuXi to the Company.
Prior to regulatory approval, or if the Company experiences a material adverse event, the Company may unilaterally terminate the statement of work for commercial and clinical manufacturing under the Second WuXi MSA at any time by providing written notice of at least 120 days .
−Removed: Post regulatory approval, the Company may unilaterally terminate the statement of work for commercial and clinical manufacturing with written notice of 15 month in year 1 of the term, written notice of 9
+Added: Post regulatory approval, the Company may unilaterally terminate the statement of work for commercial and clinical manufacturing with written notice of 15 month in year 1 of the term, written notice of 9 months in year 2 of the term, and written notice of 6 months in year 3 of the term.
+Added: If WuXi fails a pre-licensing inspection and does not address any related issues within 90 days of receipt of the FDA response letter, the Company may either terminate the statement of work for commercial and clinical manufacturing under the Second WuXi MSA immediately or shorten the term of this statement of work to June 30, 2024.
+Added: The Company recorded costs associated with agreements with WuXi of $ 17.3 million, $ 14.2 million, and $ 17.5 million for the years ended December 31, 2023, 2022, and 2021 respectively, as research and development expenses.
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: months in year 2 of the term, and written notice of 6 months in year 3 of the term.
−Removed: If WuXi fails a Pre-Licensing Inspection and does not address any related issues within 90 days of receipt of the FDA response letter, the Company may either terminate the statement of work for commercial and clinical manufacturing under the Second WuXi MSA immediately or shorten the term of this statement of work to June 30, 2024.
Cellectis S.A .
On December 31, 2019, the Company entered into a research collaboration and exclusive worldwide license agreement whereby the Company will license gene-editing technology from Cellectis S.A.
−Removed: (“Cellectis”), a clinical-stage biopharmaceutical company, to develop TIL therapies that have been genetically edited, including a PD-1 inactivated product that the Company refers to as IOV-4001.
+Added: (“Cellectis”), a clinical-stage biopharmaceutical company, to develop TIL cell therapies that have been genetically edited, including a PD-1 inactivated product that the Company refers to as IOV-4001.
Financial terms of the license include annual license payments and development, regulatory and sales milestone payments from the Company to Cellectis, as well as royalty payments based on net sales of TALEN®-modified TIL products.
6 unchanged sentences
No expenses were recorded for the years ended December 31, 2023 and 2022.
+Added: On May 18, 2023, as part of the completion of the Acquisition, the Company inherited two historical asset purchase agreements, one historical master cell bank license and working cell bank transfer agreement and one historical license agreement from Clinigen with Novartis AG, Novartis Pharma AG and Novartis Vaccines and Diagnostics, Inc.
+Added: pursuant to which, among other things, the Company may be required to make future milestone payments based on net sales (as defined in the relevant underlying agreements) in the United States and the rest of world, which includes any and all sales outside of the United States.
+Added: The maximum amount of these milestone payments payable under these agreements is $ 30.0 million upon reaching several certain net sales amounts in the United States and $ 15.0 million upon reaching several certain net sales amounts in the rest of the world, of which 25 % of each milestone payment will be reimbursed by Clinigen by deduction from the deferred consideration due under the Option Agreement in the period such milestone payment is made.
+Added: To date, the net sales milestones have not been achieved, and, therefore, no payments were made under these agreements for the year ended December 31, 2023.
+Added: Boehringer Ingelheim Biopharmaceuticals GmbH
+Added: 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.
+Added: 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.
+Added: Under this agreement, the Company must purchase a minimum number of vials each year at fixed prices determined by vial batch size.
+Added: The total estimated purchase obligations under this agreement for the years ending December 31, 2024, 2025, 2026 and 2027, are $ 8.2 million, $ 11.4 million, $ 7.3 million, and $ 7.3 million, respectively.
Operating Leases
3 unchanged sentences
The Company’s leases do not provide an implicit rate, and thus the Company estimated the incremental borrowing rate in calculating the present value of the lease payments.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The Company’s leases have remaining lease terms that range from less than one year to approximately 20 years .
6 unchanged sentences
Since the lease agreement 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: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Manufacturing Contracts
39 unchanged sentences
For its corporate headquarters’ office, the lease agreement includes a tenant improvement allowance of $ 8.2 million.
−Removed: For the years ended December 31, 2022, and 2021, the Company has received reimbursement associated with this tenant improvement allowance of $ 6.4 million and $ 1.6 million, respectively.
−Removed: The Company does not expect to receive additional reimbursements associated with this tenant improvement allowance.
+Added: For the years ended December 31, 2023 and 2022, the Company has received reimbursements associated with this tenant improvement allowance of zero and $ 6.4 million, respectively.
+Added: The Company does not expect to receive additional reimbursement associated with this tenant improvement allowance.
LEGAL PROCEEDINGS
Derivative Lawsuit.
−Removed: On December 11, 2020, a purported stockholder derivative complaint was filed by plaintiff Leo Shumacher against the Company, as nominal defendant, and then current directors, as defendants, in the Court of Chancery in the State of Delaware (the “Court”).
+Added: On December 11, 2020, a purported stockholder derivative complaint was filed by plaintiff Leo Shumacher against the Company, as nominal defendant, and then current directors, as defendants, in the Court of Chancery in the State of Delaware (the “Court of Chancery”).
The complaint alleges breach of fiduciary duty and a claim for unjust enrichment in connection with alleged excessive compensation of certain non-executive directors of the Company and seeks unspecified damages on behalf of the Company.
−Removed: The parties have agreed to a proposed settlement, which was submitted to the Court on June 15, 2022.
−Removed: After a hearing on November 17, 2022, the Court required the parties to take additional steps before it would approve the settlement.
+Added: The parties have agreed to a proposed settlement, which was submitted to the Court of Chancery on June 15, 2022.
+Added: After a hearing on November 17, 2022, the Court of Chancery required the parties to take additional steps before it would approve the settlement.
The Company, as nominal defendant, and its current directors, as defendants, answered the complaint on Feb.
+Added: IOVANCE BIOTHERAPEUTICS, INC.
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Solomon Capital, LLC.
1 unchanged sentence
Lion Biotechnologies, Inc.
−Removed: was filed by Solomon Capital, LLC, Solomon Capital
−Removed: IOVANCE BIOTHERAPEUTICS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 401(k) Trust, Solomon Sharbat and Shelhav Raff (“Solomon Plaintiffs”) against the Company in the Supreme Court of the State of New York, County of New York (index no.
−Removed: 651881/2016).
+Added: was filed by Solomon Capital, LLC, Solomon Capital 401(k) Trust, Solomon Sharbat and Shelhav Raff (“Solomon Plaintiffs”) against the Company in the Supreme Court of the State of New York, County of New York (index no.
+Added: 651881/2016) (the “court”).
The Solomon Plaintiffs allege that, between June and November 2012, they provided the Company $ 0.1 million and that they advanced and paid on behalf of the Company an additional $ 0.2 million.
19 unchanged sentences
On February 18, 2020, the Company filed a removal petition and removed the Second Solomon Suit to the U.S.
−Removed: District Court for the Southern District of New York, where the case has been assigned case no.
+Added: District Court for the Southern District of New York (the “District Court”), where the case has been assigned case no.
1:20-cv-1391.
On May 22, 2020, the Company moved to dismiss the Second Solomon Suit for lack of personal jurisdiction.
−Removed: On March 26, 2021, the Court denied the Company’s motion to dismiss for lack of personal jurisdiction.
+Added: On March 26, 2021, the District Court denied the Company’s motion to dismiss for lack of personal jurisdiction.
The Company filed a response to the complaint in the Second Solomon Suit on April 30, 2021.
On May 26, 2021, the Company and Singh filed motions for judgment on the pleadings with respect to the second and third claims asserted against the Company and all claims asserted against Singh, respectively, in the Second Solomon Suit.
−Removed: On January 5, 2022, the Court granted the Company’s motions for judgement on the pleadings, dismissing the second and third claims against the Company and dismissing all claims against Singh.
−Removed: On January 4, 2023, the Court granted in part the Company’s motion for sanctions against Plaintiffs for violating Rule 11 of the Federal Rules of Civil Procedure, in a decision and order that dismissed Plaintiffs’ first claim against the Company, denied Plaintiffs’ motion for leave to amend the complaint, and ordered Plaintiffs to pay the Company’s attorneys’ fees incurred in connection with the Rule 11 motion.
−Removed: Following the Court’s decision and order on the Rule 11 motion, only Plaintiffs’ fifth and sixth claims, for unjust enrichment and indemnification, respectively, remain pending against the Company.
−Removed: The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable.
−Removed: 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: On January 5, 2022, the District Court granted the Company’s motions for judgement on the pleadings, dismissing the second and third claims against the Company and dismissing all claims against Singh.
+Added: On January 4, 2023, the District Court granted in part the Company’s motion for sanctions against the Solomon Plaintiffs for violating Rule 11 of the Federal Rules of Civil Procedure, in a decision and order that dismissed the Solomon Plaintiffs’ first claim against the Company, denied the Solomon Plaintiffs’ motion for leave to amend the complaint, and ordered the Solomon Plaintiffs to pay the Company’s attorneys’ fees incurred in connection with the Rule 11 motion.
+Added: Following the District Court’s decision and order on the Rule 11 motion, only the Solomon Plaintiffs’ fifth and sixth claims, for unjust enrichment and indemnification, respectively, remain pending against the Company.
+Added: On October 26, 2023, the District Court granted the Company’s motion for summary judgment and dismissed the Solomon Plaintiffs’ fifth and sixth claims.
+Added: On October 27, 2023, the District Court entered judgment for the Company and closed the Second Solomon Suit.
+Added: On November 10, 2023, the Company filed a motion for attorneys’ fees as the prevailing party in the action.
+Added: On December 1, 2023, the Solomon Plaintiffs filed a notice of appeal to
IOVANCE BIOTHERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business.
+Added: Court of Appeals for the Second Circuit, appealing the District Court’s orders (a) granting the motions for judgment on the pleadings filed on behalf of Singh and the Company, (b) granting the Company’s Rule 11 motion, (c) denying the Solomon Plaintiffs’ motions to compel discovery and re-open discovery, and (d) granting the Company’s summary judgment motion.
+Added: On December 22, 2023, the Company filed a motion for an order requiring the Solomon Plaintiffs to post an appeal bond, to ensure payment of the Company’s appellate fees and costs should the Company prevail on the appeal.
+Added: The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable.
+Added: 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: The Company has been and may continue to be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business.
Such matters are subject to many uncertainties and outcomes are not predictable with assurance.
10 unchanged sentences
SUBSEQUENT EVENTS
−Removed: Acquisition of Proleukin ®
−Removed: Pursuant to that certain Option Agreement entered into on January 23, 2023 (the “Option Agreement”) between the Company and Clinigen Holdings Limited, Clinigen Healthcare Limited and Clinigen, Inc.
−Removed: (collectively, “Clinigen”), the Company will acquire worldwide rights to Proleukin® (aldesleukin) (the “Product”), an interleukin-2 product used to promote T-cell activity following TIL infusion.
−Removed: Material terms of the Option Agreement include an upfront payment of £ 167.7 million, or approximately $ 200 million, a £ 41.7 million, or approximately $ 50 million, milestone payment upon first approval of lifileucel in advanced melanoma, and deferred consideration based on double-digit rates on global net sales of the Product payable from the Company to Clinigen following the completion of the transaction for the applicable deferred consideration term.
−Removed: Subject to the terms and conditions of the Option Agreement, the Company will purchase (i) all issued and outstanding shares of Clinigen SP Limited (the “Target”), (ii) the business of the Target and Clinigen comprising the manufacturing, supply, commercialization and the generation of income from the Product rights and the undertaking of an active role in the development, maintenance and exploitation of those rights (the “Operations”), and (iii) certain specified assets identified in the Option Agreement.
−Removed: The Option Agreement is subject to customary termination provisions, and the Company would be required to pay to Clinigen a reverse termination fee (less certain transaction fees and expenses incurred by the Company) upon certain events as described in the Option Agreement.
−Removed: The closing of the transaction is subject to required regulatory approvals and clearances and other customary closing conditions.
+Added: FDA Approval of Amtagvi™ ( lifileucel)
+Added: On February 16, 2024, the Company announced that the FDA approved Amtagvi™ ( lifileucel), 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.
+Added: This indication is approved under accelerated approval based on an endpoint of ORR.
+Added: Public Offering
+Added: On February 22, 2024, the Company closed the sale of an aggregate of 23,014,000 shares of its common stock, pursuant to an underwriting agreement with Jefferies, Barclays Capital Inc., and Goldman Sachs & Co.
+Added: LLC at a public offering price of $ 9.15 per share, before underwriting discounts and commissions.
+Added: The total estimated net proceeds to the Company from the offering are expected to be approximately $ 197.1 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.
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.