0001558370-24-007646 | 10-Q | XBRL Viewer | Iovance Biotherapeutics INC

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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2024	Dec. 31, 2023
Common stock, par or stated value per share	$ 0.000041666	$ 0.000041666
Common stock, shares authorized	500,000,000	500,000,000
Common Stock, Shares, Issued	279,756,339	256,135,715
Common Stock, Shares, Outstanding	279,756,339	256,135,715
Series A Convertible Preferred Stock
Preferred stock, par or stated value per share	$ 0.001	$ 0.001
Preferred stock, shares authorized	17,000	17,000
Preferred Stock, Shares Issued	194	194
Preferred stock, shares outstanding	194	194
Series B Convertible Preferred Stock
Preferred stock, par or stated value per share	$ 0.001	$ 0.001
Preferred stock, shares authorized	11,500,000	11,500,000
Preferred Stock, Shares Issued	2,842,158	2,842,158
Preferred stock, shares outstanding	2,842,158	2,842,158

REVENUE	3 Months Ended
Mar. 31, 2024
REVENUE
REVENUE	NOTE 7. REVENUE Product sales for the three months ended March 31, 2024 was $0.7 million, and represented sales of Proleukin^® made in licensed markets outside of the U.S. To date, there have been no product sales from Proleukin^® in the U.S. market, nor have we recognized any revenue from sales of Amtagvi™ to date.

REVENUE

3 Months Ended

Mar. 31, 2024

REVENUE

REVENUE

NOTE 7. REVENUE

Product sales for the three months ended March 31, 2024 was $0.7 million, and represented sales of Proleukin^® made in licensed markets outside of the U.S. To date, there have been no product sales from Proleukin^® in the U.S. market, nor have we recognized any revenue from sales of Amtagvi™ to date.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

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+ Details

LEASES - Right-of-use asset and lease liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
LEASES
Operating lease right-of-use assets	$ 71,516	$ 62,515
Operating lease liabilities
Current portion included in current liabilities	11,078	7,777
Long-term portion included in non-current liabilities	72,291	67,085
Total operating lease liabilities	$ 83,369	$ 74,862

LEASES

3 Months Ended

Mar. 31, 2024

LEASES

LEASES

NOTE 12. LEASES

Operating Leases

The Company leases corporate office space in California, including 49,918 square feet for its current corporate headquarters’ office space in San Carlos, California, manufacturing, research and development lab facilities and office space in Philadelphia, Pennsylvania, including 136,000 square feet of commercial manufacturing and lab space at the iCTC, and research and development lab facilities in Tampa, Florida. The determination if an arrangement is a lease occurs at inception, and for leases with terms greater than 12 months, the Company records a related right-of-use asset and lease liability at the present value of lease payments over the term. Many leases include fixed rental escalation clauses, renewal options and/or termination options that are factored into the determination of lease payments when appropriate. The Company’s leases do not provide an implicit rate, and thus the Company estimated the incremental borrowing rate in calculating the present value of the lease payments.

The Company’s leases have remaining lease terms that range from less than one year to approximately 20 years. Some of the Company’s leases include one or more options to renew with renewal terms that can extend the lease for additional years, or options to terminate the leases, both at the Company’s discretion. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense for minimum lease payments is recognized on a straight-line basis based on the fixed components of a lease arrangement.

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

The Company also leases certain furniture and equipment that has a lease term of 12 months or less. Since the lease 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.

Manufacturing Contracts

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

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

For contracts with multiple deliverables, Topic 842 requires the Company to first identify a lease deliverable and non-lease deliverable included in the arrangements, and then allocate the fixed contractual consideration to the lease deliverable(s) and the non-lease deliverable(s) on a relative standalone selling price basis to determine the amount of operating lease right-of-use assets and liabilities. The Company identified the use of a dedicated suite as a single lease deliverable, and related labor services as a single non-lease deliverable in each of the CMO arrangements. Judgment is required to determine the relative standalone selling price of each deliverable as the observable standalone selling prices are not readily available. Therefore, management uses estimates and assumptions in determining relative standalone selling price of lease of a suite and labor service using information that includes market and other observable inputs to the extent possible.

During the first quarter of 2024, the BLA approval of Amtagvi™ resulted in a lease modification as a result of a change in the Company’s assumption of its most-likely minimum noncancellable lease term of the manufacturing contract with WuXi. This lease modification extended the lease term by 18 months and resulted in an increase of the Company’s right-of-use assets and liabilities by $11.2 million.

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


	March 31,		December 31,
	2024		2023
Operating lease right-of-use assets	$	71,516	$	62,515
Operating lease liabilities
Current portion included in current liabilities		11,078		7,777
Long-term portion included in non-current liabilities		72,291		67,085
Total operating lease liabilities	$	83,369	$	74,862

The following table summarizes components of lease expenses, which were included in total expenses in the Company’s condensed consolidated statements of operations, and other information related to its operating leases as follows (in thousands except weighted-average remaining lease terms and discount rates):


	Three Months Ended
	March 31,
	2024			2023
Operating lease cost	$	3,797		$	4,524
Variable lease cost		1,608			1,694
Short-term lease cost		56			45
Total lease cost	$	5,461		$	6,263

Other information
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations	$	4,290		$	4,161
Increase in right-of-use assets from lease modifications	$	11,297		$	349
Weighted-average remaining lease terms (years)		11.72			12.90
Weighted-average discount rates		7.8	%		7.5	%

As of March 31, 2024, the maturities of the Company’s operating lease liabilities were as follows (in thousands):


			CMO
	Facility		embedded
Year Ending December 31,	leases		leases		Total
Remainder of 2024	$	6,604	$	6,379	$	12,983
2025		8,432		8,505		16,937
2026		7,989		—		7,989
2027		8,186		—		8,186
2028		8,389		—		8,389
Thereafter		75,438		—		75,438
Total lease payments	$	115,038	$	14,884	$	129,922
Less: Present value adjustment		(45,148)		(1,405)		(46,553)
Operating lease liabilities	$	69,890	$	13,479	$	83,369

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (112,976)	$ (107,370)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

LICENSES AND AGREEMENTS (Details) $ in Thousands					1 Months Ended				3 Months Ended		12 Months Ended		15 Months Ended
LICENSES AND AGREEMENTS (Details) $ in Thousands	May 18, 2023 USD ($) item	May 07, 2018 USD ($)	Apr. 17, 2017 USD ($)	Jun. 28, 2014 USD ($)	Oct. 31, 2022 item	Aug. 31, 2021 USD ($)	Nov. 30, 2016 item	Aug. 31, 2011	Mar. 31, 2024 USD ($)	Mar. 31, 2023 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	Mar. 31, 2024 USD ($)
Research and development									$ 79,783	$ 82,734
Strategic Alliance Agreement
Research and development									400
Research and development arrangement, contract to perform for others, costs incurred, gross									5,300
Manufacturing and Supply Agreement With Boehringer Ingelheim Biopharmaceuticals GmbH
Renewal term of agreement	2 years
Maximum \| Strategic Alliance Agreement
Research and development arrangement, contract to perform for others, costs incurred, gross			$ 14,200
Sponsored research agreement
Research and development									100	100
Second license agreement
Research and development													$ 100
First WuXi Manufacturing and Services Agreement
Agreement term							3 years
Number Of Statements Of Work \| item							1
Number Of Suites Under The Agreement \| item							2
Number of statements of work under the agreement \| item							2
Second WuXi Manufacturing and Services Agreement
Agreement term					3 years
Number Of Suites Under The Agreement \| item					2
Termination notice period					120 days
Period to address issues within receipt of FDA response letter in collaboration arrangement					90 days
Patent license agreement related to the development and manufacture of TIL therapies
Research and development										0
Amount of collaborative arrangement required to be remitted									$ 1,500				1,500
Period of collaborative arrangement required to be remitted									60 days
License agreement									$ 100
Cooperative Research and Development Agreement
Agreement term						3 years		5 years
Research and development						$ 500			500	500
Notification Period To Terminate Agreement						60 days
Research Collaboration And Clinical Grant Agreements With Moffitt
Research and development									0	0
Moffitt License Agreement One
Agreement term				20 years
Research and development									0	0
Moffitt License Agreement One \| Research and development
Payments for upfront licensing fee				$ 100
Moffitt License Agreement Two
Payments for upfront licensing fee		$ 100
Additional milestone payable									400				$ 400
Moffitt License Agreement Two, Amended and Restated
Payments for upfront licensing fee											$ 200
WuXi Apptech, Inc - Manufacturing and Services Agreement
Research and development									5,500	3,900
Cellectis S.A
Research and development									100	100
Novartis Pharma AG and Related Entities - License Agreement
Research and development									0	0		$ 10,000
Number of historical asset purchase agreement. \| item	2
Number of historical master cell bank license and working cell bank transfer agreement \| item	1
Number of historical license agreement \| item	1
Amount of milestone payment made during the period under the license agreement									$ 0	$ 0
Percent of milestone payments reimbursable	25.00%
Novartis Pharma AG and Related Entities - License Agreement \| Maximum \| UNITED STATES
Amount of milestone payments payable under the license agreement	$ 30,000
Novartis Pharma AG and Related Entities - License Agreement \| Maximum \| Non-US
Amount of milestone payments payable under the license agreement	$ 15,000

LEASES - Components of lease expenses (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
LEASES
Operating lease cost	$ 3,797	$ 4,524
Variable lease cost	1,608	1,694
Short-term lease cost	56	45
Total lease cost	5,461	6,263
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations	4,290	4,161
Increase in right-of-use assets from lease modifications	$ 11,297	$ 349
Weighted-average remaining lease terms (years)	11 years 8 months 19 days	12 years 10 months 24 days
Weighted-average discount rates	7.80%	7.50%

PROPERTY AND EQUIPMENT, NET (Tables)

3 Months Ended

Mar. 31, 2024

PROPERTY AND EQUIPMENT, NET

Schedule of Property and equipment

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


	March 31,		December 31,
	2024		2023
Leasehold improvements	$	76,847	$	76,804
Lab, process, and validation equipment		23,197		23,131
Utility equipment		5,990		5,990
Office furniture and equipment		3,298		3,297
Computer software		8,485		7,772
Computer equipment		595		542
Machinery and equipment		306		306
Construction in progress		23,962		24,101
Total property and equipment, cost		142,680		141,943
Less: Accumulated depreciation and amortization		(30,891)		(27,913)
Property and equipment, net	$	111,789	$	114,030

LEASES - Maturities of the Company's operating lease liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Remainder of 2024	$ 12,983
2025	16,937
2026	7,989
2027	8,186
2028	8,389
Thereafter	75,438
Total lease payments	129,922
Less: Present value adjustment	(46,553)
Operating lease liabilities	83,369	$ 74,862
Facility leases
Remainder of 2024	6,604
2025	8,432
2026	7,989
2027	8,186
2028	8,389
Thereafter	75,438
Total lease payments	115,038
Less: Present value adjustment	(45,148)
Operating lease liabilities	69,890
CMO embedded leases
Remainder of 2024	6,379
2025	8,505
Total lease payments	14,884
Less: Present value adjustment	(1,405)
Operating lease liabilities	$ 13,479

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Segment Reporting (Details)	3 Months Ended
	Mar. 31, 2024 segment
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Number of operating segments	1

GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY
Net loss	$ (112,976)	$ (107,370)
Net cash used in operating activities	(122,279)	(99,815)
Cash, cash equivalents, short-term investments, and restricted cash	362,600
Cash and cash equivalents	134,188	543,484	$ 114,888
Short-term investments	222,007		164,979
Restricted cash	$ 6,430	$ 6,430	$ 66,430

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

PROLEUKIN ACQUISITION - Narrative (Details) - PROLEUKIN £ in Millions, $ in Millions			3 Months Ended
	May 18, 2023 USD ($)	May 18, 2023 GBP (£)	Mar. 31, 2024 USD ($)
PROLEUKIN ACQUISITION
Upfront payment	$ 207.2	£ 166.9	$ 210.2
Payment for certain inventory	$ 3.0	£ 2.4

LICENSES AND AGREEMENTS

3 Months Ended

Mar. 31, 2024

LICENSES AND AGREEMENTS

LICENSES AND AGREEMENTS

NOTE 11. LICENSES AND AGREEMENTS

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

Cooperative Research and Development Agreement (the “CRADA”)

In August 2011, the Company signed a five-year CRADA with the NCI to work on the development of adoptive cell immunotherapies in multiple solid tumor types, including unmodified TIL as a stand-alone therapy or in combination, improved methods for the generation and selection of TIL cell therapy with anti-tumor reactivity, and strategies for more potent TILs that are designed to destroy metastatic melanoma cells. 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 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.

In August 2021, the NCI and the Company entered into a third amendment to the CRADA. The third amendment, among other things, extended the term of the CRADA by three years to August 2024. The research plan in this amendment includes the evaluation in clinical trials of strategies for development of more potent TILs, such as selection of CD39/69 double negative cells and the use of certain inhibitors or other reagents in TIL expansion cultures.

Pursuant to the terms of the CRADA, as amended, the Company is required to make quarterly payments of $0.5 million to the NCI for support of research activities. To the extent the Company licenses patent rights relating to a TIL-based product candidate, the Company will be responsible for all patent-related expenses and fees, past and future, relating to the TIL-based product candidate. In addition, the Company may be required to supply certain test articles, including TIL, grown and processed under Current Good Manufacturing Practice (“cGMP”) conditions, suitable for use in clinical trials. The extended CRADA has a three-year term expiring in August 2024. The Company or the NCI may unilaterally terminate the CRADA for any reason or for no reason at any time by providing written notice at least 60 days before the desired termination date. The Company recorded costs associated with the CRADA of $0.5 million for each of the three months ended March 31, 2024 and 2023, respectively, as research and development expenses.

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

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

Effective May 6, 2021, the Company entered into an Amended and Restated Patent License Agreement with NIH, which included the grant of additional exclusive, worldwide patent rights in the indications to interleukin-15 and interleukin-21 cytokine-tethered TIL technology, and expanded the non-exclusive, worldwide field of use to all cancers. Effective August 1, 2022, the Company entered into a Second Amended and Restated Patent License Agreement with NIH to include additional exclusive, worldwide patent rights to TIL products expressing interleukin-12, expanded rights to TIL selection technologies previously licensed under the Exclusive Patent License Agreement below, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.

The Second Amended and Restated Patent License Agreement requires the Company to pay royalties based on a percentage of net sales in jurisdictions where patent rights exist, which percentage can fall into a tier that may be less than one percent to mid-single digits depending upon certain events, including the exclusivity of the rights, and the Company expects lower overall royalty payments as a result. The Company 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. 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. and foreign commercial sales of any of its product candidates covered by the Second Amended and Restated Patent License Agreement. The term of the Second Amended and Restated Patent License Agreement continues until the expiry of the last-to-expire patent rights licensed thereunder, and the agreement contains standard termination provisions. Upon the approval of Amtagvi™, the Company has accrued the required intellectual property license milestone payment of $1.5 million that is payable within 60 days of the approval date in accordance with the requirements of the Second Amended and Restated Patent License Agreement, with such amount being capitalized and recorded as intangible assets on the condensed consolidated balance sheet. During the three months ended March 31, 2024, the Company has recorded $0.1 million as a component of cost of sales related to amortization of the milestone payment. No expenses were recorded for the years ended March 31, 2023.

Exclusive Patent License Agreement Related to TIL Selection

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

H. Lee Moffitt Cancer Center

Research Collaboration and Clinical Grant Agreements with Moffitt

In June 2020, the Company entered into a Sponsored Research Agreement (the “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. 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. In August 2023, this agreement was extended until September 2023, at which point it expired. In December 2023, this agreement was extended until the later of November 30, 2024 or mutually agreed determination of the completion of the Research Agreement. The Company recorded research development costs of $0.1 million for each of the three months ended March 31, 2024 and 2023.

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. 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. 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. No expense was recorded for the three months ended March 31, 2024 and 2023, respectively, in connection with the research collaboration and clinical grant agreements with Moffitt.

Exclusive License Agreements with Moffitt

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.

Pursuant to the First Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million which was recorded as research and development expense. A patent issuance fee will also be payable under the First Moffitt License, upon the issuance of the first U.S. patent covering the subject technology. In addition, the Company agreed to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales (which percentage is in the low single digits) and sublicensing payments, as applicable, and annual minimum royalties beginning with the first sale of products based on the licensed technologies, which minimum royalties will be credited against the percentage royalty payments otherwise payable in that year. 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. No expenses were recorded for the First Moffitt License for the three months ended March 31, 2024 and 2023.

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. Pursuant to the Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million in 2018. An annual license maintenance fee is also payable commencing on the first anniversary of the effective date. 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. The Company recorded expense of $0.1 million for the three months ended March 31, 2024 and a de minimis amount for the three months ended March 31, 2023 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. Pursuant to the Amended & Restated Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.2 million in 2021, which was recorded as research and development expense. In addition, the Company agreed to pay an annual commercial use payment for each indication for which a first sale has occurred for products relating to the use of 4-1BB agonists and for products relating to the use of tumor digests covered by the license.

The University of Texas M.D. Anderson Cancer Center

Strategic Alliance Agreement

On April 17, 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with The University of Texas M.D. Anderson Cancer Center (“MDACC”), under which the Company and MDACC agreed to conduct clinical and preclinical research studies. The Company agreed in the SAA to provide total funding not to exceed approximately $14.2 million for the performance of the multi-year studies under the SAA, of which approximately $5.3 million has been funded cumulatively through March 31, 2024, and has been recorded as research and development expense. In return, the Company acquired all rights to inventions resulting from the studies and has been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of MDACC reasonably necessary to exploit, including the commercialization thereof. The Company has also been granted certain rights in clinical data generated by MDACC outside of the clinical trials to be performed under the SAA. The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by the Company of all deliverables due from MDACC thereunder. On March 28, 2024, the Company entered into the first amendment to the SAA, under which the Company and MDACC agreed to conduct additional preclinical research studies. For the three months ended March 31, 2024, the Company recorded a benefit of $0.4 million as a result of finalization of the cost reconciliation. The Company recorded a de minimis amount for the three months ended March 31, 2023 as research and development expenses associated with this agreement.

WuXi Advanced Therapies, Inc.

First WuXi Manufacturing and Services Agreement

In November 2016, the Company entered into a three-year manufacturing and services agreement (the “First WuXi MSA”) with WuXi Advanced Therapies, Inc. (“WuXi”) pursuant to which WuXi agreed to provide manufacturing and other services, which has since been amended and assigned to its subsidiary Iovance Biotherapeutics Manufacturing LLC. 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. The terms of one of these statements of work expired in December 2022.

Second WuXi Manufacturing and Services Agreement

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. 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. Both suites are expected to be capable of being used for the commercial and clinical manufacture of the Company’s products. The Second WuXi MSA and its related statement of work will supersede the statements of work under the First WuXi MSA with respect to commercial and clinical manufacturing and the two manufacturing suites. Certain other statements of work for related services will also be covered by the Second WuXi MSA. 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. 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. 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. The Company recorded costs associated with agreements with WuXi of $5.5 million and $3.9 million for the three months ended March 31, 2024 and 2023, respectively, as research and development expenses.

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. (“Cellectis”), a clinical-stage biopharmaceutical company, to develop TIL cell therapies that have been genetically edited, including a PD-1 inactivated product that the Company refers to as IOV-4001. Financial terms of the license include annual license payments and development, regulatory and sales milestone payments from the Company to Cellectis, as well as royalty payments based on net sales of TALEN®-modified TIL products. The Company recorded costs associated with the license agreement with Cellectis of $0.1 million for each of the three months ended March 31, 2024 and 2023, respectively as research and development expense.

Novartis Pharma AG and Related Entities

On January 9, 2020, the Company obtained a license from Novartis Pharma AG (“Novartis”) to develop and commercialize an antibody cytokine engrafted protein, which the Company refers to as IOV-3001. Under the agreement, the Company paid an upfront payment to Novartis and may pay future milestones related to initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S., EU and Japan. Novartis is also entitled to low-to-mid single digit percentage royalties from commercial sales of the product. The Company recorded costs associated with the license agreement from Novartis of $10.0 million as research and development expenses during for the year ended December 31, 2020. No expenses were recorded for the three months ended March 31, 2024 and 2023.

On May 18, 2023, as part of the completion of the Acquisition, the Company inherited two historical asset purchase agreements, one historical master cell bank license and working cell bank transfer agreement and one historical license agreement from Clinigen with Novartis AG, Novartis Pharma AG and Novartis Vaccines and Diagnostics, Inc. pursuant to which, among other things, the Company may be required to make future milestone payments based on net sales (as defined in the relevant underlying agreements) in the United States and the rest of world, which includes any and all sales outside of the United States. The maximum amount of these milestone payments payable under these agreements is $30.0 million upon reaching several certain net sales amounts in the United States and $15.0 million upon reaching several certain net sales amounts in the rest of the world, of which 25% of each milestone payment will be reimbursed by Clinigen by deduction from the deferred consideration due under the Option Agreement in the period such milestone payment is made. To date, the net sales milestones have not been achieved, and, therefore, no payments were made under these agreements for the three months ended March 31, 2024 and 2023.

Boehringer Ingelheim Biopharmaceuticals GmbH

On May 18, 2023 as part of the completion of the Acquisition, the Company inherited a manufacturing and supply agreement from Clinigen with Boehringer Ingelheim Biopharmaceuticals GmbH (“BI”) pursuant to which BI will carry out the processing, manufacturing and supply of Proleukin^® in unlabeled vials. The term of this agreement is through October 2025, with automatic renewals for a period of two years unless terminated as permitted by the contract. Under this agreement, the Company must purchase a minimum number of vials each year at fixed prices determined by vial batch size. The total estimated purchase obligations under this agreement for the remaining nine months in the year ending December 31, 2024, and the years ending December 31, 2025, 2026, and 2027 are $8.0 million, $11.2 million, $7.2 million, and $7.2 million, respectively.

Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Condensed Consolidated Statements of Operations
Total revenue	$ 715
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember	us-gaap:ProductMember
Costs and expenses
Cost of sales	$ 7,261
Research and development	79,783	$ 82,734
Selling, general and administrative	31,393	28,122
Total costs and expenses	118,437	110,856
Loss from operations	(117,722)	(110,856)
Other income
Interest income, net	3,338	3,486
Net Loss before income taxes	(114,384)	(107,370)
Income tax benefit	1,408	0
Net Loss	$ (112,976)	$ (107,370)
Net Loss Per Share of Common Stock, Basic	$ (0.42)	$ (0.50)
Net Loss Per Share of Common Stock, Diluted	$ (0.42)	$ (0.50)
Weighted Average Shares of Common Stock Outstanding, Basic	266,220	213,694
Weighted Average Shares of Common Stock Outstanding, Diluted	266,220	213,694

PROLEUKIN ACQUISITION - Cash consideration and allocated fair value of assets acquired and liability assumed (Details) - PROLEUKIN - USD ($) $ in Thousands		3 Months Ended
	May 18, 2023	Mar. 31, 2024
Total cash consideration and allocated acquisition date fair values of assets acquired and liabilities assumed
Cash	$ 35
Inventory	9,688
Deferred tax liability	(20,352)
Total cost of acquisition	222,672	$ 222,700
Developed technology
Total cash consideration and allocated acquisition date fair values of assets acquired and liabilities assumed
Intangible assets	232,665
Assembled workforce
Total cash consideration and allocated acquisition date fair values of assets acquired and liabilities assumed
Intangible assets	$ 636

STOCKHOLDERS' EQUITY - Stock based expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Total stock-based compensation expenses	$ 17,178	$ 15,665
Research and development
Total stock-based compensation expenses	8,915	8,859
Selling, general and administrative
Total stock-based compensation expenses	$ 8,263	$ 6,806

PROPERTY AND EQUIPMENT, NET

3 Months Ended

Mar. 31, 2024

PROPERTY AND EQUIPMENT, NET

PROPERTY AND EQUIPMENT, NET

NOTE 8. PROPERTY AND EQUIPMENT, NET

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


	March 31,		December 31,
	2024		2023
Leasehold improvements	$	76,847	$	76,804
Lab, process, and validation equipment		23,197		23,131
Utility equipment		5,990		5,990
Office furniture and equipment		3,298		3,297
Computer software		8,485		7,772
Computer equipment		595		542
Machinery and equipment		306		306
Construction in progress		23,962		24,101
Total property and equipment, cost		142,680		141,943
Less: Accumulated depreciation and amortization		(30,891)		(27,913)
Property and equipment, net	$	111,789	$	114,030

Depreciation and amortization expense for the three months ended March 31, 2024 and 2023, was $3.0 million and $2.8 million, respectively.

CASH EQUIVALENTS AND INVESTMENTS - Available for sale debt securities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
CASH EQUIVALENTS AND INVESTMENTS
Cash equivalents	$ 45,724	$ 34,053
Short-term investments	222,007	164,979
Total investments	$ 267,731	$ 199,032

Condensed Consolidated Statements of Cash Flows $ in Thousands, £ in Millions	3 Months Ended
	Mar. 31, 2024 USD ($)	Mar. 31, 2023 USD ($)
Cash Flows from Operating Activities
Net Income (Loss)	$ (112,976)	$ (107,370)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	17,178	15,665
Unrealized foreign exchange gains	(96)	0
Amortization of intangible assets	4,633	0
Amortization of right of use asset	2,296	2,933
Depreciation and amortization of property and equipment	2,978	2,764
Deferred tax benefit	(1,408)	0
Accretion of discounts and premiums on investments	(2,335)	(978)
Changes in assets and liabilities:
Prepaid expenses, other assets and long-term assets	5,888	(4,231)
Inventory	(6,735)	0
Trade accounts receivable	(83)	0
Operating lease liabilities	(2,789)	(2,569)
Accounts payable	(5,815)	3,025
Accrued expenses	(23,015)	(9,054)
Net cash used in operating activities	(122,279)	(99,815)
Cash Flows from Investing Activities
Maturities of investments	87,000	164,383
Purchase of investments	(141,762)	(5,323)
Contingent consideration paid for acquisition	(52,573)	0
Purchase of property and equipment	(4,171)	(5,664)
Net cash (used in) provided by investing activities	(111,506)	153,396
Cash Flows from Financing Activities
Tax payments related to shares withheld for vested restricted stock units	(4,701)	(1,929)
Proceeds from the issuance of common stock upon exercise of options	364	0
Proceeds from the issuance of common stock, net	197,913	260,101
Net cash provided by financing activities	193,576	258,172
Effect of foreign exchange rate changes	(491)	0
Net (decrease) increase in cash, cash equivalents and restricted cash	(40,700)	311,753
Cash, Cash Equivalents and Restricted Cash Beginning of Period	181,318	238,161
Cash, Cash Equivalents and Restricted Cash End of Period	140,618	549,914
Supplemental disclosure of non-cash investing and financing activities:
Net unrealized (loss) /gain on investments	(69)	776
Intangible asset and deferred tax liability arising from contingent consideration	17,495	0
Purchase of property and equipment included in accounts payable and accrued expenses	683	7,777
Accrued offering costs in accounts payable and accrued expenses	552	0
Lease liabilities arising from obtaining right-of-use asset from lease modifications	$ 11,297	$ 349

PROPERTY AND EQUIPMENT, NET - Other information (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
PROPERTY AND EQUIPMENT, NET
Depreciation and amortization expense	$ 2,978	$ 2,764

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Investments

The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the condensed consolidated balance sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in the condensed consolidated statements of comprehensive loss. Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest income, net. No impairment losses related to credit losses were recognized for the three months ended March 31, 2024 and 2023. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest income, net in the condensed consolidated statements of operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest income, net in the condensed consolidated statements of operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities and commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government.

Restricted Cash

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. As of March 31, 2024, the Company’s letters of credit were primarily comprised of a letter of credit for the benefit of the landlord for the Iovance Cell Therapy Center (the “iCTC”) used as a security deposit for the lease in the amount of $5.45 million and a letter of credit for $0.6 million for the benefit of the landlord for the Company’s current headquarters’ lease (See Note 12 - Leases). The letter of credit for $5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date. Further, on the expiration of the seventh year of the lease, and

each anniversary date thereafter, the letter of credit may be decreased by $1.0 million, with a minimum security deposit of $1.5 million maintained through the end of the lease term. The letter of credit with the landlord for the Company’s 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.

A letter of credit in the amount of $60.0 million for the regulatory approval milestone payment as required by the terms of the Option Agreement for the Proleukin^® acquisition (See Note 4 – Proleukin^® Acquisition) was cancelled in March 2024 following the milestone payment of $52.6 million (£41.7 million) during the first quarter of 2024. As of March 31, 2024 and December 31, 2023, restricted cash totaled $6.4 million and $66.4 million, respectively. This amount has been classified as a non-current asset in the Company’s condensed consolidated balance sheets.

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


	March 31,
	2024		2023
Cash and cash equivalents	$	134,188	$	543,484
Restricted cash		6,430		6,430
Total cash, cash equivalents and restricted cash	$	140,618	$	549,914

Asset Acquisitions

The Company evaluates acquisitions of assets using the guidance in Accounting Standard Codification (“ASC”) Topic 805, Business Combinations (“ASC 805”), to determine whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further assessment is required to determine whether the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.

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

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

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

Inventory and Cost of Sales

Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis. Cost includes amounts related to materials, internal labor, costs of external manufacturing, and allocable depreciation of manufacturing facilities, equipment and overhead. Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation. Inventoriable costs incurred, such as manufacturing costs incurred prior to regulatory approval that did not qualify for capitalization and clinical manufacturing costs, are expensed as incurred as research and development expenses.

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

Proleukin^® inventories presented in the condensed consolidated balance sheet as of March 31, 2024 include a step-up of the fair value of inventories as a result of the acquisition of the worldwide rights to Proleukin^®.

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

Cost of sales includes the cost of inventories and other costs that are directly associated with the purchase and sales of Proleukin^®. In addition, amortization expense for the fair value step-up of Proleukin^® inventories and the acquired intangible assets related to the developed technology and intellectual property intangible assets, as well as period costs associated with excess overhead and manufacturing costs of Amtagvi™ incurred during a ramp-up period, are included in cost of sales in the Company’s condensed consolidated statement of operations.

Trade Accounts Receivable

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

Intangible Assets

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

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

The Company reviews intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, the Company measures the amount of impairment by comparing the carrying value of the assets to their fair values. The Company determined that no indicators of impairment existed as of March 31, 2024.

Leases

The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its condensed consolidated balance sheets as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2024 and December 31, 2023. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date.

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

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

Revenue Recognition

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

Products are sold principally to distributors and wholesalers and to a lesser extent outside of the U.S. to hospitals and clinics. Contractual performance obligations are usually limited to transfer of control of the product to the customer. The transfer occurs either upon shipment, upon receipt of the product after considering when the customer obtains legal title to the product, or in the case of Amtagvi™, upon infusion. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring it products and is generally based on a list of fixed price less allowances for product returns, rebates and discounts. The Company’s payment terms to customers range from 45 to 105 days; payment terms differ by customer and by product. Discounts, rebates, returns and certain other adjustments are accounted for as variable consideration.

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.

The Company did not recognize any revenue for Amtagvi™ sales during the three months ended March 31, 2024. Product sales for the three months ended March 31, 2024 pertains to the sales of Proleukin^® in licensed markets outside of the U.S. To date, there have been no product sales from Proleukin^®in the U.S. market. Reserves for variable consideration for the market outside of the U.S. were immaterial.

Stock-Based Compensation

The Company periodically grants stock options to employees and non-employees as compensation for services rendered. The Company accounts for all stock-based payment awards made to employees, including the employee stock purchase plans, and non-employees in accordance with the authoritative guidance provided by the Financial Accounting Standards Board (“FASB”) where the value of the award is measured on the date of grant and recognized over the vesting period. Forfeitures are recognized in the period in which they occur. The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair values at each reporting date until the shares underlying the options have vested. The non-employee awards that contain a performance condition that affects the quantity or other terms of the award are measured based on the outcome that is probable.

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

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

compensation cost with respect to PRSUs issued to employees based upon the estimated fair value of the equity instruments at the date of grant, which is recognized as an expense over the period that achievement is determined to be probable through the stated service period associated with the award.

Accrued Research and Development Costs

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

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

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

In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the condensed consolidated balance sheets and subsequently recognized as research and development expense in the condensed consolidated statements of operations when the associated services have been performed. As actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.

Selling, general and administrative expense

Selling, general and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, procurement, legal, investor relations, facilities, business development, marketing, commercial, information technology and human resources functions. Other significant costs include facility costs not otherwise capitalized in inventory or included in research and development expenses. Selling, general and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to such expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.

Net Loss per Share

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

Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalent outstanding during the period. The Company’s potentially

dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) shares issued as a result of 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.

As of March 31, 2024 and 2023, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive:


	March 31,
	2024	2023
Stock options	18,697,395	19,264,017
Restricted stock units	12,080,735	3,910,457
Employee Stock Purchase Plan	296,751	247,284
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	2,842,158	2,842,158
	34,014,039	26,360,916

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

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

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include assumptions made in the fair value of intangible assets, 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.

Principles of Consolidation

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

Foreign Currency Translation

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

Segment Reporting

The Company operates in one segment, focused on innovating, developing and commercializing therapies using autologous TIL for the treatment of metastatic melanoma and other solid tumor cancers.

STOCKHOLDERS' EQUITY (Tables)

3 Months Ended

Mar. 31, 2024

STOCKHOLDERS' EQUITY

Schedule of status of stock options


				Weighted
		Weighted		Average	Aggregate
	Number	Average		Remaining	Intrinsic
	of	Exercise		Contract	Value
	Options	Price		Life	( in thousands)
Outstanding at December 31, 2023	18,899,849	$	18.57
Issued	189,525		12.00
Exercised	(41,753)		8.72
Expired/Cancelled	(350,226)		25.30
Outstanding at March 31, 2024	18,697,395	$	18.40	6.50	$	59,503
Ending vested and expected to vest at March 31, 2024	18,697,395	$	18.40	6.50	$	59,503
Options exercisable at March 31, 2024	13,638,558	$	21.87	5.68	$	28,529

Schedule of summary of RSU activity including PRSUs


		Weighted
	Number	Average
	of	Grant Date
	RSUs and PRSUs	Fair Value
Outstanding as of December 31, 2023	3,453,901	$	8.97
Granted	9,603,736		16.79
Vested/Released	(880,242)		8.89
Canceled/Forfeited	(96,660)		12.71
Outstanding as of March 31, 2024	12,080,735	$	15.16
Ending vested and expected to vest at March 31, 2024	12,080,735	$	15.16

Schedule of stock-based compensation

Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the condensed consolidated statements of operations as follows (in thousands):


	Three Months Ended
	March 31,
	2024		2023
Research and development	$	8,915	$	8,859
Selling, general and administrative		8,263		6,806
Total stock-based compensation expense	$	17,178	$	15,665

Schedule of stock-based compensation by type of award

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


	Three Months Ended
	March 31,
	2024		2023
Stock option expense	$	5,763	$	11,702
Restricted stock expense		11,067		3,660
ESPP expense		348		303
Total stock-based compensation expense	$	17,178	$	15,665

LEGAL PROCEEDINGS

3 Months Ended

Mar. 31, 2024

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS

NOTE 13. LEGAL PROCEEDINGS

Derivative Lawsuit. On December 11, 2020, a purported stockholder derivative complaint was filed by plaintiff Leo Shumacher against the Company, as nominal defendant, and then current directors, as defendants, in the Court of Chancery in the State of Delaware (the “Court of Chancery”). The complaint alleges breach of fiduciary duty and a claim for unjust enrichment in connection with alleged excessive compensation of certain non-executive directors of the Company and seeks unspecified damages on behalf of the Company. The parties have agreed to a proposed settlement, which was submitted to the Court of Chancery on June 15, 2022. After a hearing on November 17, 2022, the Court of Chancery required the parties to take additional steps before it would approve the settlement. The Company, as nominal defendant, and its current directors, as defendants, answered the complaint on February 3, 2023. The parties agreed to a revised proposed settlement, which was submitted to the Court of Chancery on March 12, 2024. Under the terms of the proposed settlement, the Company will cancel certain equity awards made to non-employee directors and make a monetary payment to plaintiff for reasonable legal fees and costs in the amount of $600,000, which have been accrued as of March 31, 2024. The settlement is subject to approval by the Court of Chancery.

Solomon Capital, LLC. On April 8, 2016, a lawsuit (“the First Solomon Suit”) titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. was filed by Solomon Capital, LLC, Solomon Capital 401(k) Trust, Solomon Sharbat and Shelhav Raff (“Solomon Plaintiffs”) against the Company in the Supreme Court of the State of New York, County of New York (index no. 651881/2016) (the “court”). The Solomon Plaintiffs allege that, between June and November 2012, they provided the Company $0.1 million and that they advanced and paid on behalf of the Company an additional $0.2 million.

The complaint further alleges that the Company agreed to (i) provide them with promissory notes totaling $0.2 million, plus interest, (ii) issue a total of 1,110 shares to the Solomon Plaintiffs (after the 1-for-100 reverse split of the Company’s common stock effected in March 2013) (the “Equity Claim”), and (iii) allow the Solomon Plaintiffs to convert the foregoing funds into its securities in the next financing of the Company on the same terms offered to other investors, which Solomon Plaintiffs allege, should have given them the right to convert their advances and payments into shares of the Company’s common stock in the restructuring that took effect in May 2013. Based on the foregoing, the Solomon Plaintiffs allege causes for breach of contract and unjust enrichment and demand judgment against the Company in an unspecified amount exceeding $1.5 million, plus interest. On June 3, 2016, the Company filed an answer and counterclaims in the lawsuits. The Company has asserted counterclaims for fraudulent inducement, fraudulent misrepresentation, fraudulent concealment, breach of fiduciary duty, and breach of contract, alleging principally that the counterclaim defendants misrepresented their qualifications and failed to disclose that Solomon Sharbat was the subject of an investigation by the Financial Industry Regulatory Authority (“FINRA”) that resulted in the loss of his FINRA license.

In its counterclaims, the Company is seeking damages in an amount exceeding $0.5 million and an order rescinding any and all agreements that the Solomon Plaintiffs contend entitled them to obtain shares of Company stock. On May 12, 2020, the court granted the Company’s motion for summary judgment limiting the Solomon Plaintiffs’ damages for the Equity Claim to less than $47,420. The Solomon Plaintiffs filed a notice of appeal of this summary judgment on June 9, 2020. On July 2, 2020, the court granted the Company’s motion to dismiss the First Solomon Suit for want of prosecution. On January 4, 2021, the court granted the Solomon Plaintiffs motion for reconsideration, and reinstituted the case. On January 15, 2021, the Company filed a notice of appeal of the court’s grant of the Solomon Plaintiffs motion for reconsideration. On May 11, 2021, the Appellate Division upheld the court’s grant of the Solomon Plaintiffs’ motion for reconsideration of the dismissal of the First Solomon Suit for want of prosecution.

On September 27, 2019, the Solomon Plaintiffs filed a new lawsuit (through new legal counsel) (“the Second Solomon Suit”) titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Iovance Biotherapeutics, Inc., f/k/a/ Lion Biotechnologies Inc. f/k/a/ Genesis Biopharma Inc., and Manish Singh in the Supreme Court of the State of New York, County of New York (index no. 655668/2019). In the Second Solomon Suit, the Solomon Plaintiffs allege that they are third party beneficiaries of a “finder’s fee agreement” that prior management entered into with a third party unlicensed entity in 2012 in connection with seeking financing, that an agreement or understanding existed between the Company and the plaintiffs that the plaintiffs would be paid fees and commissions (in cash and stock) if they obtained financing for the Company, and that they directly and indirectly introduced investors to the Company who invested in the Company, or were willing to invest in the Company. Finally, the Solomon Plaintiffs allege that they were promised a license to use the Company’s technology in Israel. The plaintiffs claim that the Company breached the foregoing understandings, promises and agreements and, as a result, they are entitled to certain damages. The Solomon Plaintiffs also allege that Manish Singh, the Company’s former Chief Executive Officer, committed fraud and took shares belonging to them. On February 18, 2020, the Company filed a removal petition and removed the Second Solomon Suit to the U.S. District Court for the Southern District of New York (the “District Court”), where the case has been assigned case no. 1:20-cv-1391. On May 22, 2020, the Company moved to dismiss the Second Solomon Suit for lack of personal jurisdiction. On March 26, 2021, the District Court denied the Company’s motion to dismiss for lack of personal jurisdiction. The Company filed a response to the complaint in the Second Solomon Suit on April 30, 2021. On May 26, 2021, the Company and Singh filed motions for judgment on the pleadings with respect to the second and third claims asserted against the Company and all claims asserted against Singh, respectively, in the Second Solomon Suit. On January 5, 2022, the District Court granted the Company’s motions for judgment on the pleadings, dismissing the second and third claims against the Company and dismissing all claims against Singh. On January 4, 2023, the District Court granted in part the Company’s motion for sanctions against the Solomon Plaintiffs for violating Rule 11 of the Federal Rules of Civil Procedure, in a decision and order that dismissed the Solomon Plaintiffs’ first claim against the Company, denied the Solomon Plaintiffs’ motion for leave to amend the complaint, and ordered the Solomon Plaintiffs to pay the Company’s attorneys’ fees incurred in connection with the Rule 11 motion. Following the District Court’s decision and order on the Rule 11 motion, only the Solomon Plaintiffs’ fifth and sixth claims, for unjust enrichment and indemnification, respectively, remain pending against the Company. On October 26, 2023, the District Court granted the Company’s motion for summary judgment and dismissed the Solomon Plaintiffs’ fifth and sixth claims. On October 27, 2023, the District Court entered judgment for the Company and closed the Second Solomon Suit. On November 10, 2023, the Company filed a motion for attorneys’ fees as the prevailing party in the action. On December 1, 2023, the Solomon Plaintiffs filed a notice of appeal to the U.S. Court of Appeals for the Second Circuit, appealing the District Court’s orders (a) granting the motions for judgment on the pleadings filed on behalf of Singh and the Company, (b) granting the Company’s Rule 11 motion, (c) denying the Solomon Plaintiffs’ motions to compel discovery and re-open discovery, and (d) granting the Company’s summary judgment motion. On December 22, 2023, the Company filed a motion for an order requiring the Solomon Plaintiffs to post an appeal bond, to ensure payment of the Company’s appellate fees and costs should the Company prevail on the appeal.

The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable. At the current stage of the litigation, in both the First Solomon Suit and the Second Solomon Suit, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters.

The Company has been and may continue to be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues amounts, to the extent they can be reasonably estimated, that it believes are adequate to address any liabilities related to legal proceedings and other loss contingencies that it believes will result in a probable loss. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on its financial position, results of operations or cash flows.

- Definition

The entire disclosure for loss and gain contingencies. Describes any existing condition, situation, or set of circumstances involving uncertainty as of the balance sheet date (or prior to issuance of the financial statements) as to a probable or reasonably possible loss incurred by an entity that will ultimately be resolved when one or more future events occur or fail to occur, and typically discloses the amount of loss recorded or a range of possible loss, or an assertion that no reasonable estimate can be made.

+ References + Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Investments

Restricted Cash


	March 31,
	2024		2023
Cash and cash equivalents	$	134,188	$	543,484
Restricted cash		6,430		6,430
Total cash, cash equivalents and restricted cash	$	140,618	$	549,914

Asset Acquisitions

Inventory and Cost of Sales

Trade Accounts Receivable

Intangible Assets

Leases

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

Revenue Recognition

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

Stock-Based Compensation

Accrued Research and Development Costs

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

Selling, general and administrative expense

Net Loss per Share

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

As of March 31, 2024 and 2023, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive:


	March 31,
	2024	2023
Stock options	18,697,395	19,264,017
Restricted stock units	12,080,735	3,910,457
Employee Stock Purchase Plan	296,751	247,284
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	2,842,158	2,842,158
	34,014,039	26,360,916

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

Use of Estimates

Principles of Consolidation

Foreign Currency Translation

Segment Reporting

The Company operates in one segment, focused on innovating, developing and commercializing therapies using autologous TIL for the treatment of metastatic melanoma and other solid tumor cancers.

ACCRUED EXPENSES

3 Months Ended

Mar. 31, 2024

ACCRUED EXPENSES

ACCRUED EXPENSES

NOTE 9. ACCRUED EXPENSES

Accrued expenses consist of the following (in thousands):


	March 31,		December 31,
	2024		2023
Accrued payroll and employee related expenses	$	21,363	$	34,814
Clinical related		7,180		10,911
Manufacturing related		8,569		10,893
Facilities related		1,661		2,437
Legal and related services		2,431		1,610
Inventory related		1,253		2,148
Other accrued expenses		3,979		6,593
Total accrued expenses	$	46,436	$	69,406

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of cash and cash equivalents and restricted cash


	March 31,
	2024		2023
Cash and cash equivalents	$	134,188	$	543,484
Restricted cash		6,430		6,430
Total cash, cash equivalents and restricted cash	$	140,618	$	549,914

Schedule of Antidilutive securities excluded from computation of earnings per share


	March 31,
	2024	2023
Stock options	18,697,395	19,264,017
Restricted stock units	12,080,735	3,910,457
Employee Stock Purchase Plan	296,751	247,284
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	2,842,158	2,842,158
	34,014,039	26,360,916

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

LICENSES AND AGREEMENTS - Estimated purchase obligations (Details) $ in Millions	Mar. 31, 2024 USD ($)
Years ending December 31, 2026	$ 7.2
Manufacturing and Supply Agreement With Boehringer Ingelheim Biopharmaceuticals GmbH
Remaining six months ending December 31, 2024	8.0
Years ending December 31, 2025	11.2
Years ending December 31, 2026	$ 7.2

INTANGIBLE ASSETS, NET

3 Months Ended

Mar. 31, 2024

INTANGIBLE ASSETS, NET

INTANGIBLE ASSETS, NET

NOTE 5. INTANGIBLE ASSETS, NET

The gross carrying amounts and net book value of intangible assets as of March 31, 2024 and December 31, 2023, are as follows (in thousands):


	March 31,		December 31,
	2024		2023
Developed technology	$	306,698	$	238,612
Assembled workforce		647		652
Intellectual property license		1,500		—
Total intangible assets		308,845		239,264
Less: accumulated amortization		(14,542)		(10,006)
Intangible assets, net	$	294,303	$	229,258

The Company recognized amortization expense of $4.6 million during the three months ended March 31, 2024. Amortization expense for the developed technology and the intellectual property license is recorded in cost of sales, and amortization expense for the assembled workforce is recorded in selling, general and administrative expense in the condensed consolidated statement of operations for the three months ended March 31, 2024. There was no such expense recorded in the three months ended March 31, 2023.

The total estimated amortization of the Company’s intangible assets for the remaining nine months ending December 31, 2024, and the years ending December 31, 2025, 2026, 2027, and 2028 are $15.8 million, $21.1 million, $20.9 million, $20.8 million, and $20.8 million, respectively.

INVENTORY (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Inventories
Raw materials	$ 5,566
Work in process	5,914	$ 5,749
Finished goods	6,137	4,623
Total inventory	$ 17,617	$ 10,372

LEASES - Additional information (Details) $ in Millions	3 Months Ended
LEASES - Additional information (Details) $ in Millions	Mar. 31, 2024 USD ($) ft²
Term of contract in years	18 months
Option to extend	true
Existence of option	true
Increase in right-of-use assets and liabilities \| $	$ 11.2
Minimum
Term of contract in years	1 year
Maximum
Term of contract in years	20 years
Office Space \| Minimum
Term of contract in years	12 months
Office Space \| Philadelphia, Pennsylvania
Area of land	136,000
Furniture and equipment \| Maximum
Term of contract in years	12 months
New Headquarters Lease \| Office Space \| San Carlos, California
Area of land	49,918

CASH EQUIVALENTS AND INVESTMENTS - Narrative (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)
Cash equivalents total	$ 45,724	$ 34,053
Unrealized losses on available-for-sale	$ 0
Number of investments in debt securities in continuous unrealized loss position for more than 12 months	0
Demand Deposits
Cash equivalents total	$ 88,500	$ 80,800

PROPERTY AND EQUIPMENT, NET - (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 142,680	$ 141,943
Less: Accumulated depreciation and amortization	(30,891)	(27,913)
Property and equipment, net	111,789	114,030
Leasehold improvements
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	76,847	76,804
Lab, process, and validation equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	23,197	23,131
Utility equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	5,990	5,990
Office furniture and equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	3,298	3,297
Computer software
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	8,485	7,772
Computer equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	595	542
Machinery and equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	306	306
Construction in progress
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 23,962	$ 24,101

ACCRUED EXPENSES (Tables)

3 Months Ended

Mar. 31, 2024

ACCRUED EXPENSES

Schedule of accrued expenses

Accrued expenses consist of the following (in thousands):


	March 31,		December 31,
	2024		2023
Accrued payroll and employee related expenses	$	21,363	$	34,814
Clinical related		7,180		10,911
Manufacturing related		8,569		10,893
Facilities related		1,661		2,437
Legal and related services		2,431		1,610
Inventory related		1,253		2,148
Other accrued expenses		3,979		6,593
Total accrued expenses	$	46,436	$	69,406

CASH EQUIVALENTS AND INVESTMENTS (Tables)

3 Months Ended

Mar. 31, 2024

CASH EQUIVALENTS AND INVESTMENTS

Schedule of cost and fair value of cash equivalents and short-term investments

The amortized cost and fair value of cash equivalents and investments as of March 31, 2024 and December 31, 2023 were as follows (in thousands):


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of March 31, 2024	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	222,037	$	—	$	(30)	$	222,007
Money market funds		45,724		—		—		45,724
Total investments	$	267,761	$	—	$	(30)	$	267,731


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of December 31, 2023	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	164,940	$	39	$	—	$	164,979
Money market funds		34,053		—		—		34,053
Total investments	$	198,993	$	39	$	—	$	199,032

Schedule of available-for-sale debt securities

The fair value of cash equivalents and investments as of March 31, 2024 and December 31, 2023, are classified as follows in the Company’s condensed consolidated balance sheets (in thousands):


	March 31,		December 31,
Classified as:	2024		2023
Cash equivalents	$	45,724	$	34,053
Short-term investments		222,007		164,979
Total investments	$	267,731	$	199,032

Schedule of fair value of the company's financial assets

As of March 31, 2024, and December 31, 2023, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):


	Assets at Fair Value as of March 31, 2024
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	222,007	$	—	$	—	$	222,007
Money market funds		45,724		—		—		45,724
Total investments	$	267,731	$	—	$	—	$	267,731


	Assets at Fair Value as of December 31, 2023
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	164,979	$	—	$	—	$	164,979
Money market funds		34,053		—		—		34,053
Total	$	199,032	$	—	$	—	$	199,032

- Definition

Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

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-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

+ Details

INCOME TAXES

3 Months Ended

Mar. 31, 2024

INCOME TAXES

INCOME TAXES

NOTE 14. INCOME TAXES

The Company recorded a tax benefit of $1.4 million for the three months ended March 31, 2024, which resulted in effective tax rates of 1.2%. The effective tax rate is different from U.S. statutory rate of 21% due to the full valuation allowance against tax losses in the U.S. The income tax benefit for the periods presented primarily relates to operations in the United Kingdom and realization of related deferred taxes.

As of March 31, 2024, the Company continued to maintain its full valuation allowance against U.S. federal and state net deferred tax assets as it expected to be in a cumulative loss position and does not have sufficient positive evidence to support the realizability of its U.S. net deferred tax assets. The Company recorded no tax benefit or expense for the three months ended March 31, 2023.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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+ Details

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

INVENTORY

3 Months Ended

Mar. 31, 2024

INVENTORY

INVENTORY

NOTE 6. INVENTORY

As of March 31, 2024 and December 31, 2023, inventory consists of the following (in thousands):


		March 31,		December 31,
		2024		2023
Raw materials	$	5,566	$	—
Work in process		5,914		5,749
Finished goods		6,137		4,623
Total inventory	$	17,617	$	10,372

PROLEUKIN ACQUISITION - Additional information (Details) $ in Thousands, £ in Millions			3 Months Ended
	May 18, 2023 USD ($)	May 18, 2023 GBP (£)	Mar. 31, 2024 USD ($)	Mar. 31, 2024 GBP (£)	Mar. 31, 2023 USD ($)
PROLEUKIN ACQUISITION
Contingent consideration paid for acquisition			$ 52,573	£ 41.7	$ 0
Finite-lived intangible assets			17,500	13.9
Accrued offering costs in accounts payable and accrued expenses			552		$ 0
PROLEUKIN
PROLEUKIN ACQUISITION
Total cost of acquisition	$ 222,672		222,700
Cash payment	207,200	£ 166.9	210,200
Direct transaction costs incurred			12,500
Contingent cash payments, milestone payment	$ 50,000	£ 41.7
Contingent consideration paid for acquisition			$ 52,600	£ 41.7
Deferred consideration term	12 years	12 years
PROLEUKIN \| Assembled workforce
PROLEUKIN ACQUISITION
Expected useful life of intangible assets	15 years	15 years
PROLEUKIN \| Assembled workforce \| Selling, general and administrative
PROLEUKIN ACQUISITION
Expected useful life of intangible assets	3 years	3 years

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash, Cash equivalents and Restricted Cash (Details) $ in Thousands, £ in Millions	3 Months Ended
	Mar. 31, 2024 USD ($)	Mar. 31, 2024 GBP (£)	Mar. 31, 2023 USD ($)	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Restricted security deposit	$ 5,450
Contingent consideration paid for acquisition	52,573	£ 41.7	$ 0
Cash and cash equivalents	134,188		543,484	$ 114,888
Restricted cash	6,430		6,430	66,430
Total cash, cash equivalents and restricted cash	140,618		$ 549,914	$ 181,318	$ 238,161
PROLEUKIN
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Future milestone payment	60,000
Contingent consideration paid for acquisition	$ 52,600	£ 41.7
Minimum
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Customer payment term	45 days	45 days
Maximum
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Customer payment term	105 days	105 days
Commercial manufacturing facility
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Security deposit	$ 5,450
Decrease in letters of credit	1,000
Commercial manufacturing facility \| Minimum
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Security deposit	1,500
Headquarters lease
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Security deposit	$ 600

GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

3 Months Ended

Mar. 31, 2024

GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

General Organization and Business

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

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”). 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.

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.

The Company’s development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings for solid tumor cancers. 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. 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. The Company is also developing next generation therapies using TIL, such as genetically modified TIL cell therapy.

Basis of Presentation of Unaudited Condensed Consolidated Financial Information

The accompanying unaudited condensed consolidated financial statements of the Company for the three months ended March 31, 2024 and 2023 have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for audited financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the Company's financial position and results of operations. Results shown for interim periods are not necessarily indicative of the results that may be expected for the year ended December 31, 2024 or for any other period. The condensed consolidated balance sheet as of December 31, 2023 was derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2024. These interim financial statements should be read in conjunction with that report. Certain prior period amounts reported in the Company’s condensed consolidated financial statements and accompanying notes have been reclassified to conform to the current period presentation.

Liquidity

As of March 31, 2024, the Company had $362.6 million in cash, cash equivalents, short term-investments, and restricted cash ($134.2 million of cash and cash equivalents, $222.0 million in short-term investments, and $6.4 million in restricted cash). The Company has recently launched its first internally developed commercial product and continues to be engaged in the development of therapeutics to fight cancer, specifically solid tumors. With the recent approval of the BLA, the Company expects to generate revenue from the sale of its product Amtagvi™, starting in the second quarter of 2024. Furthermore, following the acquisition of the worldwide rights to Proleukin^® (as discussed below in Note 4 - Proleukin^® Acquisition) in the second quarter of 2023, the Company began to generate revenue from the sales of Proleukin^®. However, such revenues for Amtagvi™ and Proleukin^® may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Form 10-Q is filed. The Company has incurred a net loss of $113.0 million for the three months ended March 31, 2024 and used $122.3 million of cash in its operating activities during the first quarter ended March 31, 2024.

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. Based on the funds the Company has available as of the date these condensed consolidated financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures as planned for at least the next twelve months from the date these condensed consolidated financial statements are issued.

Concentrations of Risk

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

PROLEUKIN ACQUISITION

3 Months Ended

Mar. 31, 2024

PROLEUKIN ACQUISITION

PROLEUKIN ACQUISITION

NOTE 4. PROLEUKIN^® ACQUISITION

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

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

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

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


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

The $222.7 million of total cost of the Acquisition consisted of (i) a $210.2 million of cash payment to Clinigen and (ii) $12.5 million of direct transaction costs incurred by the Company. The Option Agreement additionally provides for contingent cash payments consisting of (i) a milestone payment of £41.7 million, or 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. These contingent payments were determined to be within the scope of ASC 450 and will be recognized when they are both probable and estimable. During the first quarter of 2024, the Company made the required milestone payment of $52.6 million (£41.7 million) upon the approval of our BLA of Amtagvi™, which was capitalized as an intangible asset and is being amortized over the remaining useful life of such asset. Additionally, $17.5 million (£13.9 million) was added to the carrying value of the acquired developed technology intangible asset, which reflects the deferred tax liability recognized on the temporary differences related to the book and tax basis of the acquired intangible assets. The recognition criteria have not been met for the remaining contingent consideration targets as of the acquisition date or as of March 31, 2024.

The net assets acquired in the Acquisition were recorded by allocating the total cost of the Acquisition to the assets acquired on a relative fair value basis based on their estimated fair values as of May 18, 2023, which is the date that the Acquisition was completed.

The fair value of the developed technology was estimated using a multi-period excess earnings income approach that discounts expected cash flows to present value by applying a discount rate that represents the estimated rate that market participants would use to value the intangible assets. 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 condensed consolidated statement of operations.

The fair value of the assembled workforce was estimated using a replacement cost less depreciation method. The fair value of the assembled workforce is being amortized over an expected useful life of 3 years and is recorded as Selling, General and Administrative expense in the Company’s condensed consolidated statement of operations.

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. The inventory fair value adjustment is being amortized as cost of sales as the acquired inventories are sold.

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

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Series A Convertible Preferred Stock Preferred Stock	Series B Convertible Preferred Stock Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	Total
Beginning Balance at Dec. 31, 2022		$ 3	$ 8	$ 2,068,867	$ (902)	$ (1,568,338)	$ 499,638
Beginning Balance (in Shares) at Dec. 31, 2022	194	2,842,158	187,812,072
Stock-based compensation expense				15,665			15,665
Vesting of restricted shares issued for services (in shares)			770,257
Tax payments related to shares retired for vested restricted stock units				(1,929)			(1,929)
Tax payments related to shares retired for vested restricted stock units (in shares)			(303,576)
Common stock sold in public offering, net of offering costs			$ 1	260,100			260,101
Common stock sold in public offering, net of offering costs (in shares)			36,080,226
Unrealized (loss)/gain on investments					776		776
Net Income (Loss)						(107,370)	(107,370)
Ending Balance at Mar. 31, 2023		$ 3	$ 9	2,342,703	(126)	(1,675,708)	666,881
Ending Balance (in Shares) at Mar. 31, 2023	194	2,842,158	224,358,979
Beginning Balance at Dec. 31, 2023		$ 3	$ 11	2,594,448	2,526	(2,012,375)	584,613
Beginning Balance (in Shares) at Dec. 31, 2023	194	2,842,158	256,135,715
Stock-based compensation expense				17,773			17,773
Vesting of restricted shares issued for services (in shares)			880,242
Tax payments related to shares retired for vested restricted stock units				(4,701)			(4,701)
Tax payments related to shares retired for vested restricted stock units (in shares)			(315,371)
Common stock sold in public offering, net of offering costs			$ 1	197,360			197,361
Common stock sold in public offering, net of offering costs (in shares)			23,014,000
Common stock issued upon exercise of stock options				364			364
Common stock issued upon exercise of stock options (in shares)			41,753
Unrealized (loss)/gain on investments					(69)		(69)
Foreign currency cumulative translation adjustment					(2,341)		(2,341)
Net Income (Loss)						(112,976)	(112,976)
Ending Balance at Mar. 31, 2024		$ 3	$ 12	$ 2,805,244	$ 116	$ (2,125,351)	$ 680,024
Ending Balance (in Shares) at Mar. 31, 2024	194	2,842,158	279,756,339

INTANGIBLE ASSETS, NET (Tables)

3 Months Ended

Mar. 31, 2024

INTANGIBLE ASSETS, NET

Summary of gross carrying amounts and net book value of intangible assets

The gross carrying amounts and net book value of intangible assets as of March 31, 2024 and December 31, 2023, are as follows (in thousands):


	March 31,		December 31,
	2024		2023
Developed technology	$	306,698	$	238,612
Assembled workforce		647		652
Intellectual property license		1,500		—
Total intangible assets		308,845		239,264
Less: accumulated amortization		(14,542)		(10,006)
Intangible assets, net	$	294,303	$	229,258

INVENTORY (Tables)

3 Months Ended

Mar. 31, 2024

INVENTORY

Summary of inventories

As of March 31, 2024 and December 31, 2023, inventory consists of the following (in thousands):


		March 31,		December 31,
		2024		2023
Raw materials	$	5,566	$	—
Work in process		5,914		5,749
Finished goods		6,137		4,623
Total inventory	$	17,617	$	10,372

CASH EQUIVALENTS AND INVESTMENTS - Cost and fair value (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Amortized Cost	$ 267,761	$ 198,993
Gross Unrealized Gains		39
Gross Unrealized Losses	(30)
Fair Value	267,731	199,032
U.S. treasury securities
Amortized Cost	222,037	164,940
Gross Unrealized Gains		39
Gross Unrealized Losses	(30)
Fair Value	222,007	164,979
Money market funds
Amortized Cost	45,724	34,053
Fair Value	$ 45,724	$ 34,053

CASH EQUIVALENTS AND INVESTMENTS - Fair value of company's financial assets (Details) - Recurring - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Total	$ 267,731	$ 199,032
U.S. treasury securities
Total	222,007	164,979
Money market funds
Total	45,724	34,053
Level 1
Total	267,731	199,032
Level 1 \| U.S. treasury securities
Total	222,007	164,979
Level 1 \| Money market funds
Total	$ 45,724	$ 34,053

Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Condensed Consolidated Statements of Comprehensive Loss
Net Loss	$ (112,976)	$ (107,370)
Other comprehensive loss:
Unrealized (loss)/gain on investments	(69)	776
Foreign currency translation adjustment	(2,341)
Comprehensive Loss	$ (115,386)	$ (106,594)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

LEASES (Tables)

3 Months Ended

Mar. 31, 2024

LEASES

Schedule of balance sheet classification of the Company's right-of-use asset and lease liabilities

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


	March 31,		December 31,
	2024		2023
Operating lease right-of-use assets	$	71,516	$	62,515
Operating lease liabilities
Current portion included in current liabilities		11,078		7,777
Long-term portion included in non-current liabilities		72,291		67,085
Total operating lease liabilities	$	83,369	$	74,862

Schedule of components of lease expenses


	Three Months Ended
	March 31,
	2024			2023
Operating lease cost	$	3,797		$	4,524
Variable lease cost		1,608			1,694
Short-term lease cost		56			45
Total lease cost	$	5,461		$	6,263

Other information
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations	$	4,290		$	4,161
Increase in right-of-use assets from lease modifications	$	11,297		$	349
Weighted-average remaining lease terms (years)		11.72			12.90
Weighted-average discount rates		7.8	%		7.5	%

Schedule of minimum lease commitments

As of March 31, 2024, the maturities of the Company’s operating lease liabilities were as follows (in thousands):


			CMO
	Facility		embedded
Year Ending December 31,	leases		leases		Total
Remainder of 2024	$	6,604	$	6,379	$	12,983
2025		8,432		8,505		16,937
2026		7,989		—		7,989
2027		8,186		—		8,186
2028		8,389		—		8,389
Thereafter		75,438		—		75,438
Total lease payments	$	115,038	$	14,884	$	129,922
Less: Present value adjustment		(45,148)		(1,405)		(46,553)
Operating lease liabilities	$	69,890	$	13,479	$	83,369

STOCKHOLDERS' EQUITY

3 Months Ended

Mar. 31, 2024

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

NOTE 10. STOCKHOLDERS’ EQUITY

Common Stock

The Company’s certificate of incorporation, as amended, authorizes the issuance of up to 500,000,000 shares of the Company’s common stock, par value $0.000041666. As of March 31, 2024, 279,756,339 shares of the Company’s common stock were issued and outstanding.

Public Offering

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

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

At the Market Offering Program

On November 18, 2022, the Company entered into an Open Market Sale Agreement (the “2022 Sale Agreement”) with Jefferies LLC (“Jefferies”). Under the terms of the 2022 Sale Agreement, the Company was able to, from time to time, at its sole discretion, issue and sell through Jefferies, acting as a sales agent, up to $500.0 million of shares of the Company’s common stock. On June 16, 2023, the Company entered into a new Open Market Sale Agreement (the “2023 Sale Agreement”), which superseded and replaced in its entirety the 2022 Sale Agreement, which was terminated by the Company. Under the terms of the 2023 Sale Agreement, the Company 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. 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.

Pursuant to the 2023 Sale Agreements, Jefferies may sell 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 of common stock from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the 2023 Sale Agreement.

The Company is not obligated to make any sales of Common Shares under the 2023 Sale Agreement. 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.

No sales were made pursuant to the 2023 Sales Agreement during the three months ended March 31, 2024. During the same period in 2023, the Company received $260.1 million in net proceeds, net of offering costs, through the sale of 36,080,226 shares of common stock through the 2021 Sales Agreements at a weighted average price per share of $7.35.

Preferred Stock

The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. As of March 31, 2024, 17,000 shares were designated as Series A Convertible Preferred Stock and 11,500,000 shares were designated as Series B Convertible Preferred Stock.

Series A Convertible Preferred Stock

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

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

During the three months ended March 31, 2024 and 2023, no shares of Series A Convertible Preferred Stock were converted into shares of common stock. As of March 31, 2024 and December 31, 2023, 194 shares of Series A Convertible Preferred Stock (that are convertible into 97,000 shares of common stock) remained outstanding.

Series B Convertible Preferred Stock

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

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

During the three months ended March 31, 2024 and 2023, no shares of Series B Convertible Preferred Stock were converted into shares of common stock. As of March 31, 2024 and December 31, 2023, 2,842,158 shares of Series B Preferred Stock (that are convertible into 2,842,158 shares of common stock) remained outstanding.

Equity Incentive Plans

The Company has multiple equity incentive plans under which it grants awards. As of March 31, 2024, there were 283,314 shares available to grant under the 2014 Equity Incentive Plan (the “2014 Plan”).

On April 22, 2018, the Company’s Board of Directors (the “Board”) adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (the “2018 Plan”), which was approved by the Company’s stockholders in June 2018. The 2018 Plan as approved initially authorized the issuance up to an aggregate of 6,000,000 shares of common stock in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. On June 8, 2020, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 6,000,000 to 14,000,000 shares, which became effective immediately. Additionally on June 10, 2022, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 14,000,000 to 20,700,000 shares, which became effective immediately. On June 6, 2023, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 20,700,000 to 29,700,000, which became effective immediately. As of March 31, 2024, 677,377 shares of common stock were available for grant under the 2018 Plan.

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

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

On March 13, 2023 and February 26, 2024, the Compensation Committee approved additional amendments to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,750,000 shares of the Company’s common stock to 2,250,000 shares of the Company’s common stock in March 2023 and from 2,250,000 to 2,750,000 shares of the Company’s common stock in February 2024 without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Inducement Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). As of March 31, 2024, 724,653 shares of common stock were available for grant under the Inducement Plan.

Stock Options

A summary of the status of stock options as of March 31, 2024, and the changes during the three months ended March 31, 2024, is presented in the following table:


				Weighted
		Weighted		Average	Aggregate
	Number	Average		Remaining	Intrinsic
	of	Exercise		Contract	Value
	Options	Price		Life	( in thousands)
Outstanding at December 31, 2023	18,899,849	$	18.57
Issued	189,525		12.00
Exercised	(41,753)		8.72
Expired/Cancelled	(350,226)		25.30
Outstanding at March 31, 2024	18,697,395	$	18.40	6.50	$	59,503
Ending vested and expected to vest at March 31, 2024	18,697,395	$	18.40	6.50	$	59,503
Options exercisable at March 31, 2024	13,638,558	$	21.87	5.68	$	28,529

As of March 31, 2024, there was $27.0 million of total unrecognized compensation expense related to unvested employee stock options. The unrecognized compensation expense is estimated to be recognized over a period of 1.72 years as of March 31, 2024. The weighted average grant date fair value for employee options granted under the Company’s stock option plans during the three months ended March 31, 2024 was $8.54 per option.

The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the quarter ended March 31, 2024 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on March 31, 2024. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

Employee Stock Purchase Plan

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

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

The compensation expense related to the 2020 ESPP for the three months ended March 31, 2024 and 2023 was $0.4 million and $0.3 million, respectively. As of March 31, 2024, there was $0.3 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over the remaining 2.3 months.

Restricted Stock Units

Activity for RSUs during the three months ended March 31, 2024 is presented in the following table:


		Weighted
	Number	Average
	of	Grant Date
	RSUs and PRSUs	Fair Value
Outstanding as of December 31, 2023	3,453,901	$	8.97
Granted	9,603,736		16.79
Vested/Released	(880,242)		8.89
Canceled/Forfeited	(96,660)		12.71
Outstanding as of March 31, 2024	12,080,735	$	15.16
Ending vested and expected to vest at March 31, 2024	12,080,735	$	15.16

As of March 31, 2024, there was $168.4 million of unrecognized stock-based compensation expense associated with unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of 2.05 years. The aggregate intrinsic value of the unvested RSUs outstanding as of March 31, 2024 was $179.0 million.

Stock-Based Compensation

Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the condensed consolidated statements of operations as follows (in thousands):


	Three Months Ended
	March 31,
	2024		2023
Research and development	$	8,915	$	8,859
Selling, general and administrative		8,263		6,806
Total stock-based compensation expense	$	17,178	$	15,665

The amount included in capitalized inventory and cost of sales were immaterial for the three months ended March 31, 2024.

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


	Three Months Ended
	March 31,
	2024		2023
Stock option expense	$	5,763	$	11,702
Restricted stock expense		11,067		3,660
ESPP expense		348		303
Total stock-based compensation expense	$	17,178	$	15,665

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
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+ Details

INCOME TAXES (Details) - USD ($) $ in Thousands	3 Months Ended
INCOME TAXES (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023
INCOME TAXES
Income tax benefit	$ 1,408	$ 0
Effective tax rates	1.20%
Federal statutory tax rate	21.00%

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

LEGAL PROCEEDINGS (Details)			1 Months Ended		3 Months Ended
LEGAL PROCEEDINGS (Details)	May 12, 2020 USD ($)	Apr. 08, 2016 USD ($) item	Nov. 30, 2012 USD ($)	Jun. 30, 2012 USD ($)	Mar. 31, 2024 USD ($)
Lessee, Operating Lease, Existence of Option to Extend [true false]					true
Equity claim	$ 47,420,000
Accrued Professional fees					$ 600,000
Solomon Capital LLC Litigation
Proceeds from lawsuit filed			$ 200,000	$ 100,000
Face amount		$ 200,000
Debt instrument, convertible, number of equity instruments \| item		1,110
Reverse split ratio		0.01
Estimate of possible loss		$ 1,500,000
Damages claimed		$ 500,000

INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	3 Months Ended
INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	$ 308,845		$ 239,264
Accumulated amortization	(14,542)		(10,006)
Intangible assets, net	294,303		229,258
Amortization expense	4,633	$ 0
Total estimated amortization of the Company's intangible assets:
Remaining nine months ending December 31, 2024	15,800
Year ending December 31, 2025	21,100
Year ending December 31, 2026	20,900
Year ending December 31, 2027	20,800
Year ending December 31, 2028	20,800
Developed technology
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	306,698		238,612
Assembled workforce
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	647		$ 652
Intellectual property license
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	$ 1,500

CASH EQUIVALENTS AND INVESTMENTS

3 Months Ended

Mar. 31, 2024

CASH EQUIVALENTS AND INVESTMENTS

CASH EQUIVALENTS AND INVESTMENTS

NOTE 3. CASH EQUIVALENTS AND INVESTMENTS

The amortized cost and fair value of cash equivalents and investments as of March 31, 2024 and December 31, 2023 were as follows (in thousands):


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of March 31, 2024	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	222,037	$	—	$	(30)	$	222,007
Money market funds		45,724		—		—		45,724
Total investments	$	267,761	$	—	$	(30)	$	267,731


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of December 31, 2023	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	164,940	$	39	$	—	$	164,979
Money market funds		34,053		—		—		34,053
Total investments	$	198,993	$	39	$	—	$	199,032

The fair value of cash equivalents and investments as of March 31, 2024 and December 31, 2023, are classified as follows in the Company’s condensed consolidated balance sheets (in thousands):


	March 31,		December 31,
Classified as:	2024		2023
Cash equivalents	$	45,724	$	34,053
Short-term investments		222,007		164,979
Total investments	$	267,731	$	199,032

Cash equivalents in the tables above exclude cash demand deposits of $88.5 million and $80.8 million as of March 31, 2024 and December 31, 2023, respectively. Unrealized gains and losses are included in accumulated other comprehensive (loss) income, and as of March 31, 2024 and December 31, 2023, no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of March 31, 2024 and December 31, 2023, had contractual maturities of less than one year. No significant available-for-sale securities held as of the periods presented have been in a continuous unrealized loss position for more than 12 months. To date, the Company has not recorded any impairment charges on its investments.

Recurring Fair Value Measurements


	Assets at Fair Value as of March 31, 2024
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	222,007	$	—	$	—	$	222,007
Money market funds		45,724		—		—		45,724
Total investments	$	267,731	$	—	$	—	$	267,731


	Assets at Fair Value as of December 31, 2023
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	164,979	$	—	$	—	$	164,979
Money market funds		34,053		—		—		34,053
Total	$	199,032	$	—	$	—	$	199,032

Level 2 assets consist of commercial paper and government agency securities. 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.

PROLEUKIN ACQUISITION (Tables)

3 Months Ended

Mar. 31, 2024

PROLEUKIN ACQUISITION

Summary of the total cash consideration and allocated acquisition date fair values of assets acquired and liabilities assumed

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


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

Document And Entity Information - shares	3 Months Ended
Document And Entity Information - shares	Mar. 31, 2024	May 02, 2024
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
Document Transition Report	false
Entity File Number	001-36860
Entity Registrant Name	IOVANCE BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	75-3254381
Entity Address, Address Line One	825 Industrial Road, Suite 400
Entity Address, City or Town	San Carlos
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94070
City Area Code	650
Local Phone Number	260-7120
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Title of 12(b) Security	Common Stock, par value $0.000041666
Trading Symbol	IOVA
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		279,832,722
Entity Central Index Key	0001425205
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Amendment Flag	false

STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands					3 Months Ended		15 Months Ended
	Feb. 22, 2024	Jul. 13, 2023	Nov. 18, 2022	Jun. 08, 2020	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Feb. 26, 2024	Feb. 25, 2024	Dec. 31, 2023	Jun. 16, 2023	Jun. 06, 2023	Jun. 05, 2023	Mar. 13, 2023	Mar. 12, 2023	Jun. 10, 2022	Jan. 12, 2022	Jan. 11, 2022	Sep. 22, 2021	Apr. 22, 2018
Common Stock
Common stock, shares authorized					500,000,000		500,000,000			500,000,000
Common stock, par or stated value per share					$ 0.000041666		$ 0.000041666			$ 0.000041666
Common stock, shares issued					279,756,339		279,756,339			256,135,715
Common stock, shares outstanding					279,756,339		279,756,339			256,135,715
Common stock sold in public offering, net of offering costs (in shares)	23,014,000	23,000,000
Proceeds from the issuance of common stock, net					$ 197,913	$ 260,101
Weighted average grant date fair value, options granted					$ 8.54
Common stock issued upon exercise of stock options (in shares)		3,000,000
Share price (in dollars per share)	$ 9.15	$ 7.50
Net proceeds from public offering	$ 197,400	$ 161,500
Common Stock
Common Stock
Common stock issued upon exercise of stock options (in shares)					41,753
At the Market Offering Program
Common Stock
Maximum percentage of commission			3.00%
Common stock sold in public offering, net of offering costs (in shares)					36,080,226
Proceeds from the issuance of common stock, net					$ 0
Weighted average price					$ 7.35
Proceeds from the issuance of common stock					$ 260,100
Second Sales Agreement
Common Stock
Maximum amount of shares to be issued			$ 500,000
2023 Sales Agreement
Common Stock
Maximum amount of shares to be issued											$ 450,000
Series A Convertible Preferred Stock
Common Stock
Preferred stock, shares authorized					17,000		17,000			17,000
Preferred stock, par or stated value per share					$ 0.001		$ 0.001			$ 0.001
Conversion of Stock, shares converted							0
Conversion of stock, shares issued					500
Preferred stock, shares outstanding					194		194			194
Series A Convertible Preferred Stock \| Common Stock
Common Stock
Common stock available in conversion, shares					97,000		97,000			97,000
Series A Convertible Preferred Stock \| Private Placement
Common Stock
Preferred stock, par or stated value per share					$ 1,000		$ 1,000
Convertible price per share					$ 2.00
Series B Convertible Preferred Stock
Common Stock
Preferred stock, shares authorized					11,500,000		11,500,000			11,500,000
Preferred stock, par or stated value per share					$ 0.001		$ 0.001			$ 0.001
Conversion of stock, shares issued					1
Preferred stock, shares outstanding					2,842,158		2,842,158			2,842,158
Series B Convertible Preferred Stock \| Issuance Of Common Stock Upon Conversion Of Preferred Stock
Common Stock
Conversion of stock, shares issued					0	0
Series B Convertible Preferred Stock \| Common Stock
Common Stock
Preferred stock, shares outstanding					2,842,158		2,842,158			2,842,158
Series B Convertible Preferred Stock \| IPO
Common Stock
Preferred stock, par or stated value per share					$ 4.75		$ 4.75
Convertible price per share					$ 4.75
Blank check
Common Stock
Preferred stock, shares authorized					50,000,000		50,000,000
Employee Stock Option [Member]
Common Stock
Unrecognized compensation cost					$ 27,000		$ 27,000
Unrecognized compensation cost recognition period					1 year 8 months 19 days
RSUs and PRSUs
Common Stock
Unrecognized compensation cost					$ 168,400		168,400
Unrecognized compensation cost recognition period					2 years 18 days
Aggregate intrinsic value of outstanding non-vested RSUs & PRSUs					$ 179,000		$ 179,000
Vested					880,242
Granted					9,603,736
2014 Equity Incentive Plan
Common Stock
Number of shares available					283,314		283,314
The 2018 Plan
Common Stock
Number of shares available					677,377		677,377
Shares authorized				14,000,000												20,700,000				6,000,000
Common Stock, Capital Shares Reserved for Future Issuance												29,700,000				20,700,000
2020 ESPP
Common Stock
Shares authorized				500,000								1,400,000	500,000
Percentage of purchase price				85.00%
Stock-based compensation expense					$ 400	$ 300
Unrecognized compensation cost					$ 300		$ 300
Unrecognized compensation cost recognition period					2 months 9 days
2021 Inducement Plan
Common Stock
Number of shares available					724,653		724,653
Shares authorized								2,750,000	2,250,000					2,250,000	1,750,000		1,750,000	1,000,000	1,000,000

STOCKHOLDERS' EQUITY - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended
	Jul. 13, 2023	Mar. 31, 2024
Number of Options
Exercised	(3,000,000)
Employee Stock Option [Member]
Number of Options
Outstanding, beginning balance		18,899,849
Issued		189,525
Exercised		(41,753)
Expired/Cancelled		(350,226)
Outstanding, ending balance		18,697,395
Ending vested and expected to vest		18,697,395
Options exercisable		13,638,558
Weighted Average Exercise Price
Outstanding, beginning balance		$ 18.57
Issued		12.00
Exercised		8.72
Expired/Cancelled		25.30
Outstanding, ending balance		18.40
Ending vested and expected to vest		18.40
Options exercisable		$ 21.87
Weighted Average Remaining Contractual Life
Options outstanding, remaining term		6 years 6 months
Ending vested and expected to vest, remaining term		6 years 6 months
Options exercisable, remaining term		5 years 8 months 4 days
Aggregate Intrinsic Value
Option at ending balance		$ 59,503
Ending vested and expected to vest		59,503
Option exercisable		$ 28,529

STOCKHOLDERS' EQUITY - Stock-based compensation by instrument (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Total stock-based compensation expenses	$ 17,178	$ 15,665
Employee Stock Option [Member]
Total stock-based compensation expenses	5,763	11,702
Restricted stock units
Total stock-based compensation expenses	11,067	3,660
2020 ESPP
Total stock-based compensation expenses	$ 348	$ 303

ACCRUED EXPENSES (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
ACCRUED EXPENSES
Employee and consultant related expenses	$ 21,363	$ 34,814
Clinical related	7,180	10,911
Manufacturing related	8,569	10,893
Facilities related	1,661	2,437
Inventory related	1,253	2,148
Legal and related services	2,431	1,610
Other accrued expenses	3,979	6,593
Total accrued expenses	$ 46,436	$ 69,406

REVENUE (Details) - USD ($) $ in Thousands	3 Months Ended
REVENUE (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023
REVENUE
Total revenue	$ 715
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember	us-gaap:ProductMember
Outside of U.S.
REVENUE
Total revenue	$ 700
In U.S.
REVENUE
Total revenue	$ 0
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 924
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479941/924-10-S99-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479806/606-10-50-5

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 30
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-30

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 42
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-42

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (b)
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
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-Paragraph 41
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
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-Section 50
-Paragraph 4
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479806/606-10-50-4

+ Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Net Loss per Share (Details) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Antidilutive securities excluded from calculation of net loss per share	34,014,039	26,360,916
Employee Stock Option
Antidilutive securities excluded from calculation of net loss per share	18,697,395	19,264,017
Employee Stock Purchase Plan
Antidilutive securities excluded from calculation of net loss per share	296,751	247,284
Restricted stock units
Antidilutive securities excluded from calculation of net loss per share	12,080,735	3,910,457
Series A Convertible Preferred Stock
Antidilutive securities excluded from calculation of net loss per share	97,000	97,000
Series B Convertible Preferred Stock
Antidilutive securities excluded from calculation of net loss per share	2,842,158	2,842,158

STOCKHOLDERS' EQUITY - Restricted Stock Units and Performance Restricted Stock Units (Details) - RSUs and PRSUs	3 Months Ended
	Mar. 31, 2024 $ / shares shares
Number of Shares
Outstanding, Beginning Balance \| shares	3,453,901
Granted \| shares	9,603,736
Vested/Released \| shares	(880,242)
Canceled/forfeited \| shares	(96,660)
Outstanding, Ending balance \| shares	12,080,735
Ending vested and expected to vest \| shares	12,080,735
Weighted Average Grant Date Fair Value
Weighted Average Grant Date Fair Value, Beginning Balance \| $ / shares	$ 8.97
Weighted Average Grant Date Fair Value, Granted \| $ / shares	16.79
Weighted Average Grant Date Fair Value, Vested/Released \| $ / shares	8.89
Weighted Average Grant Date Fair Value, Canceled/forfeited \| $ / shares	12.71
Weighted Average Grant Date Fair Value, Ending Balance \| $ / shares	15.16
Weighted Average Grant Date Fair Value, Ending vested and expected to vest \| $ / shares	$ 15.16

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Current Assets
Cash and cash equivalents	$ 134,188	$ 114,888
Trade accounts receivable	234	151
Short-term investments	222,007	164,979
Inventory	17,617	10,372
Prepaid expenses and other assets	11,487	17,458
Total Current Assets	385,533	307,848
Property and equipment, net	111,789	114,030
Intangible assets, net	294,303	229,258
Operating lease right-of-use assets	71,516	62,515
Restricted cash	6,430	66,430
Long-term assets	259	270
Total Assets	869,830	780,351
Current Liabilities
Accounts payable	25,700	33,123
Accrued expenses	46,436	69,406
Operating lease liabilities	11,078	7,777
Total Current Liabilities	83,214	110,306
Non-Current Liabilities
Operating lease liabilities- non-current	72,291	67,085
Deferred tax liabilities	33,301	17,347
Long-term note payable	1,000	1,000
Total Non-Current Liabilities	106,592	85,432
Total Liabilities	189,806	195,738
Commitments and contingencies
Stockholders' Equity
Common stock, $0.000041666 par value; 500,000,000 shares authorized, 279,756,339 and 256,135,715 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively	12	11
Accumulated other comprehensive loss	116	2,526
Additional paid-in capital	2,805,244	2,594,448
Accumulated deficit	(2,125,351)	(2,012,375)
Total Stockholders' Equity	680,024	584,613
Total Liabilities and Stockholders' Equity	869,830	780,351
Series A Convertible Preferred Stock
Stockholders' Equity
Preferred stock, Value	0	0
Series B Convertible Preferred Stock
Stockholders' Equity
Preferred stock, Value	$ 3	$ 3