0001558370-24-002036 | 10-K | XBRL Viewer | Iovance Biotherapeutics INC

LEGAL PROCEEDINGS (Details)			1 Months Ended
LEGAL PROCEEDINGS (Details)	May 12, 2020 USD ($)	Apr. 08, 2016 USD ($) item	Nov. 30, 2012 USD ($)	Jun. 30, 2012 USD ($)
Equity claim	$ 47,420
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

PROPERTY AND EQUIPMENT, NET - Other information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Depreciation and amortization expense	$ 11,568	$ 9,310	$ 3,111
Commercial Manufacturing Facility Agreement
Property, Plant and Equipment [Line Items]
Fixed asset additions	$ 2,600	$ 27,200

PROLEUKIN ACQUISITION

12 Months Ended

Dec. 31, 2023

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 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 (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. The recognition criteria have not been met as of the acquisition date or as of December 31, 2023.

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 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 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.

INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	12 Months Ended
INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	$ 239,264
Accumulated amortization	(10,006)
Intangible assets, net	229,258
Amortization expense	9,849	$ 0
Total estimated amortization of the Company's intangible assets:
Years ending December 31, 2024	16,100
Years ending December 31, 2025	16,100
Years ending December 31, 2026	16,000
Years ending December 31, 2027	15,900
Years ending December 31, 2028	15,900
Developed technology
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	238,612
Accumulated amortization	(9,871)
Intangible assets, net	228,741
Assembled workforce
Gross carrying amounts and net book value of intangible assets
Gross carrying amounts	652
Accumulated amortization	(135)
Intangible assets, net	$ 517

REVENUE (Details) $ in Thousands	12 Months Ended
REVENUE (Details) $ in Thousands	Dec. 31, 2023 USD ($)
REVENUE
Total revenue	$ 1,189
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember
Outside of U.S.
REVENUE
Total revenue	$ 1,200
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
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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
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-22

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 40
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-40

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-22

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-32

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 41
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482810/280-10-50-41

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

+ Details

LEASES - Right-of-use asset and lease liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
LEASES
Operating lease right-of-use assets	$ 62,515	$ 73,015
Operating lease liabilities
Current portion included in current liabilities	7,777	12,587
Long-term portion included in non-current liabilities	67,085	71,859
Total operating lease liabilities	$ 74,862	$ 84,446

SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2023

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 17. SUBSEQUENT EVENTS

FDA Approval of Amtagvi™⁽lifileucel)

On February 16, 2024, the Company announced that the FDA approved Amtagvi™⁽lifileucel), a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on an endpoint of ORR.

Public Offering

On February 22, 2024, the Company closed the sale of an aggregate of 23,014,000 shares of its common stock, pursuant to an underwriting agreement with Jefferies, Barclays Capital Inc., and Goldman Sachs & Co. LLC 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 are expected to be approximately $197.1 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

EMPLOYEE BENEFIT PLAN (Details) - USD ($) $ in Millions	12 Months Ended
EMPLOYEE BENEFIT PLAN (Details) - USD ($) $ in Millions	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
EMPLOYEE BENEFIT PLAN
Defined contribution plan	$ 4.1	$ 3.0	$ 2.2

LEASES - Additional information (Details)	12 Months Ended
LEASES - Additional information (Details)	Dec. 31, 2023 USD ($) ft²	Dec. 31, 2022 USD ($)
Option to extend	true
Tenant improvement allowance	$ 8,200,000
Tenant improvement allowance reimbursed		$ 6,432,000
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 \| ft²	136,000
Furniture and equipment \| Maximum
Term of contract in years	12 months
New Headquarters Lease \| Office Space \| San Carlos, California
Area of land \| ft²	49,918
Tenant improvement allowance reimbursed	$ 0	$ 6,400,000

STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands				12 Months Ended
	Nov. 18, 2023	Jul. 13, 2023	Jun. 08, 2020	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	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	300,000,000
Common stock, par or stated value per share				$ 0.000041666	$ 0.000041666
Common stock, shares issued				256,135,715	187,812,072
Common stock, shares outstanding				256,135,715	187,812,072
Common stock issued, net of offering costs (in shares)		23,000,000
Proceeds from the issuance of common stock, net				$ 463,281	$ 189,502	$ 203,156
Weighted average grant date fair value, options granted				$ 4.91	$ 8.29	$ 22.28
Common stock issued upon exercise of stock options (in shares)		3,000,000
Share price (in dollars per share)		$ 7.50
Net proceeds from public offering		$ 161,500
Intrinsic value of options exercised				$ 10	$ 40	$ 21,300
Common Stock
Common Stock
Common stock issued upon exercise of stock options (in shares)				8,860	203,579	2,822,617
At the Market Offering Program
Common Stock
Maximum percentage of commission	3.00%
Common stock issued, net of offering costs (in shares)				44,080,226	29,788,993
Weighted average price				$ 6.99	$ 6.52
Proceeds from the issuance of common stock				$ 301,700	$ 189,500
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
Preferred stock, par or stated value per share				$ 0.001	$ 0.001
Conversion of Stock, shares converted				0	0
Conversion of stock, shares issued				500
Preferred stock, shares outstanding				194	194
Series A Convertible Preferred Stock \| Common Stock
Common Stock
Common stock available in conversion, shares				97,000	97,000
Series A Convertible Preferred Stock \| Private Placement
Common Stock
Preferred stock, par or stated value per share				$ 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
Preferred stock, par or stated value per share				$ 0.001	$ 0.001
Conversion of Stock, shares converted				1
Convertible price per share				$ 4.75
Preferred stock, shares outstanding				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
Series B Convertible Preferred Stock \| IPO
Common Stock
Preferred stock, shares authorized				11,500,000
Convertible price per share				$ 4.75
Blank check
Common Stock
Preferred stock, shares authorized				50,000,000
Employee Stock Option [Member]
Common Stock
Unrecognized compensation cost				$ 31,700
Unrecognized compensation cost recognition period				1 year 10 months 2 days
RSUs and PRSUs
Common Stock
Unrecognized compensation cost				$ 19,900	$ 20,600
Unrecognized compensation cost recognition period				1 year 7 months 24 days	1 year 8 months 19 days
Aggregate intrinsic value of outstanding non-vested RSUs & PRSUs				$ 28,100	$ 14,500
Vested				1,253,465
Granted				2,729,348
2014 Equity Incentive Plan
Common Stock
Number of shares available				275,625
The 2018 Plan
Common Stock
Number of shares available				9,906,666
Shares authorized			14,000,000					29,700,000				20,700,000				6,000,000
2020 ESPP
Common Stock
Common stock issued, net of offering costs (in shares)				435,459	262,701
Shares authorized			500,000					1,400,000	500,000
Percentage of purchase price			85.00%
Stock-based compensation expense				$ 1,200	$ 1,300	$ 1,200
Unrecognized compensation cost				$ 600
Unrecognized compensation cost recognition period				5 months 12 days
Proceeds from Issuance or Sale of Equity				$ 2,400	$ 1,700
2021 Inducement Plan
Common Stock
Number of shares available				349,428
Shares authorized										2,250,000	1,750,000		1,750,000	1,000,000	1,000,000

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Current Assets
Cash and cash equivalents	$ 114,888	$ 231,731
Trade accounts receivable	151
Short-term investments	164,979	240,114
Inventory	10,372
Prepaid expenses and other assets	17,458	7,271
Total Current Assets	307,848	479,116
Property and equipment, net	114,030	105,232
Intangible assets, net	229,258
Operating lease right-of-use assets	62,515	73,015
Restricted cash	66,430	6,430
Long-term assets	270	189
Total Assets	780,351	663,982
Current Liabilities
Accounts payable	33,123	26,603
Accrued expenses	69,406	52,295
Operating lease liabilities	7,777	12,587
Total Current Liabilities	110,306	91,485
Non-Current Liabilities
Operating lease liabilities - non-current	67,085	71,859
Deferred tax liabilities	17,347
Long-term note payable	1,000	1,000
Total Non-Current Liabilities	85,432	72,859
Total Liabilities	195,738	164,344
Commitments and contingencies
Stockholders' Equity
Common stock, $0.000041666 par value; 500,000,000, and 300,000,000 shares authorized, 256,135,715 and 187,812,072 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively	11	8
Accumulated other comprehensive income (loss)	2,526	(902)
Additional paid-in capital	2,594,448	2,068,867
Accumulated deficit	(2,012,375)	(1,568,338)
Total Stockholders' Equity	584,613	499,638
Total Liabilities and Stockholders' Equity	780,351	663,982
Series A Convertible Preferred Stock
Stockholders' Equity
Preferred stock, Value	0	0
Series B Convertible Preferred Stock
Stockholders' Equity
Preferred stock, Value	$ 3	$ 3

INCOME TAXES - Reconciliation of the effective income tax rate (Details)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
INCOME TAXES
Federal statutory tax rate	21.00%	21.00%	21.00%
Orphan drug and research credits	2.00%	1.00%	2.00%
Permanent and other differences	(1.00%)	(1.00%)	0.00%
Stock Based Compensation	(1.00%)	(1.00%)	0.00%
State tax, net of federal benefit	1.00%	1.00%	0.00%
Effective Income Tax Rate Reconciliation Expected Rate Total	22.00%	21.00%	23.00%
Valuation allowance	(21.00%)	(21.00%)	(23.00%)
Effective tax rate	0.78%	0.00%	0.00%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Net Loss per Share (Details) - shares	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Antidilutive securities excluded from calculation of net loss per share	25,589,659	20,876,978	16,655,260
Employee Stock Option
Antidilutive securities excluded from calculation of net loss per share	18,899,849	15,240,197	12,520,865
Employee Stock Purchase Plan
Antidilutive securities excluded from calculation of net loss per share	296,751	260,859	85,227
Restricted stock units
Antidilutive securities excluded from calculation of net loss per share	3,453,901	2,436,764	1,110,010
Series A Convertible Preferred Stock
Antidilutive securities excluded from calculation of net loss per share	97,000	97,000	97,000
Series B Convertible Preferred Stock \| Restricted stock units
Antidilutive securities excluded from calculation of net loss per share	2,842,158	2,842,158	2,842,158

STOCKHOLDERS' EQUITY - Restricted Stock Units and Performance Restricted Stock Units (Details) - RSUs and PRSUs	12 Months Ended
	Dec. 31, 2023 $ / shares shares
Number of Shares
Outstanding, Beginning Balance \| shares	2,436,764
Granted \| shares	2,729,348
Vested/Released \| shares	(1,253,465)
Canceled/forfeited \| shares	(458,746)
Outstanding, Ending balance \| shares	3,453,901
Ending vested and expected to vest \| shares	3,453,901
Weighted Average Grant Date Fair Value
Weighted Average Grant Date Fair Value, Beginning Balance \| $ / shares	$ 14.74
Weighted Average Grant Date Fair Value, Granted \| $ / shares	7.19
Weighted Average Grant Date Fair Value, Vested/Released \| $ / shares	16.17
Weighted Average Grant Date Fair Value, Canceled/forfeited \| $ / shares	9.35
Weighted Average Grant Date Fair Value, Ending Balance \| $ / shares	8.97
Weighted Average Grant Date Fair Value, Ending vested and expected to vest \| $ / shares	$ 8.97

GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY (Details) - USD ($) $ in Thousands			12 Months Ended
	Feb. 22, 2024	Jul. 13, 2023	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Net Income (Loss)			$ (444,037)	$ (395,893)	$ (342,252)
Net cash used in operating activities			(361,820)	(292,757)	(227,941)
Cash equivalents, short-term investments, and restricted cash			346,300
Cash and cash equivalents			114,888	231,731	78,229
Short-term investments			164,979	240,114
Restricted cash			66,430	6,430	6,084
Net proceeds from public offering		$ 161,500
Proceeds from the issuance of common stock, net			$ 463,281	$ 189,502	$ 203,156
Common Stock \| Public Offering \| Subsequent Event
Proceeds from the issuance of common stock, net	$ 197,100

INVENTORY (Details) $ in Thousands	Dec. 31, 2023 USD ($)
Inventories
Work in process	$ 5,749
Finished goods	4,623
Total inventory	$ 10,372

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Cash Flows from Operating Activities
Net Income (Loss)	$ (444,037)	$ (395,893)	$ (342,252)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	62,625	84,022	69,765
Unrealized exchange gains	70
Amortization of intangible assets	9,849	0
Amortization of right of use asset	11,710	11,825	10,869
Depreciation and amortization of property and equipment	11,568	9,310	3,111
Deferred tax benefit	(3,479)
Accretion of discounts and premiums on investments	(3,605)	474	6,013
Loss on write-off of fixed assets		397
Changes in assets and liabilities:
Prepaid expenses, other assets and long-term assets	(10,062)	(2,130)	2,775
Trade accounts receivable	(149)
Inventory	(10,118)
Operating lease liabilities	(10,794)	(1,942)	(5,882)
Accounts payable	4,828	5,883	6,976
Accrued expenses and other liabilities	19,774	(4,703)	20,684
Net cash used in operating activities	(361,820)	(292,757)	(227,941)
Cash Flows from Investing Activities
Maturities of investments	285,583	522,696	762,914
Purchase of investments	(205,902)	(245,816)	(725,208)
Cash paid for acquisition, net of cash acquired	(212,633)
Purchase of property and equipment	(22,290)	(20,425)	(37,574)
Net cash provided by / (used in) investing activities	(155,242)	256,455	132
Cash Flows from Financing Activities
Tax payments related to shares withheld for vested restricted stock units	(2,795)	(2,649)
Proceeds from the issuance of common stock under employee stock purchase plan	2,410	1,655	1,586
Proceeds from the issuance of common stock upon exercise of options	63	1,642	33,526
Proceeds from the issuance of common stock, net	463,281	189,502	203,156
Proceeds from the issuance of debt			1,000
Net cash provided by financing activities	462,959	190,150	239,268
Effect of exchange rate changes	(2,740)
Net increase in cash, cash equivalents and restricted cash	(56,843)	153,848	11,459
Cash, Cash Equivalents and Restricted Cash Beginning of Period	238,161	84,313	72,854
Cash, Cash Equivalents and Restricted Cash End of Period	181,318	238,161	84,313
Supplemental disclosure of non-cash investing and financing activities:
Fair value of net assets acquired	222,637
Net unrealized gain (loss) on investments	940	(301)	(620)
Acquisition of property and equipment included in accounts payable and accrued expenses	4,062	5,985	12,410
Conversion of convertible preferred stock to common stock			1
Lease liabilities arising from obtaining right-of-use asset from new leases	177	553	17,275
Lease liabilities arising from obtaining right-of-use asset from lease modifications	$ 1,033	$ 15,304	$ 7,800

PROLEUKIN ACQUISITION - Cash consideration and allocated fair value of assets acquired and liability assumed (Details) - PROLEUKIN - USD ($) $ in Thousands		12 Months Ended
	May 18, 2023	Dec. 31, 2023
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

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of cash and cash equivalents and restricted cash

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


	December 31,
	2023		2022		2021
Cash and cash equivalents	$	114,888	$	231,731	$	78,229
Restricted cash		66,430		6,430		6,084
Total cash, cash equivalents and restricted cash	$	181,318	$	238,161	$	84,313

Schedule Of Useful Lives Of Property Plant And Equipment [Table Text Block]

Computer equipment		2 years
Computer software		5 years
Office furniture and equipment		5 years
Lab, process, and validation equipment		5 years
Machinery and equipment		5 – 7 years
Utility equipment		Lesser of the remaining economic life of the asset or the lease-term
Leasehold improvements		Lesser of the remaining economic life of the asset or the lease-term

Schedule of Antidilutive securities excluded from computation of earnings per share

As of December 31, 2023, 2022, and 2021, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.


	As of December 31,
	2023	2022	2021
Stock options	18,899,849	15,240,197	12,520,865
Employee Stock Purchase Plan	296,751	260,859	85,227
Restricted stock units	3,453,901	2,436,764	1,110,010
Series A Convertible Preferred Stock*	97,000	97,000	97,000
Series B Convertible Preferred Stock*	2,842,158	2,842,158	2,842,158
	25,589,659	20,876,978	16,655,260

*on an as-converted basis

GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

12 Months Ended

Dec. 31, 2023

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.

Liquidity

The Company is currently 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™. Furthermore, following the acquisition of the worldwide rights to Proleukin^® (as discussed below in Note 4 - Proleukin^® Acquisition) in the second quarter of 2023, the Company began to generate revenue from the sales of Proleukin^® during the year ended December 31, 2023. However, such revenues for Amtagvi™ and Proleukin^® may not be material during the 12 months from the date the consolidated financial statements are issued and this Annual Report on Form 10-K is filed. The Company has incurred a net loss of $444.0 million for the year ended December 31, 2023 and used $361.8 million of cash in its operating activities during the year ended December 31, 2023. As of December 31, 2023, the Company had $346.3 million in cash, cash equivalents, investments, and restricted cash ($114.9 million of cash and cash equivalents, $165.0 million in short-term investments and $66.4 million in restricted cash).

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 consolidated financial statements are issued, which include estimated net proceeds (after deducting underwriting and other offering expenses) of approximately $197.1 million from the public offering of its common stock completed on February 22, 2024, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures as planned for at least the next twelve months from the date these consolidated financial statements are issued.

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.

Consolidated Statements of Operations - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Consolidated Statements of Operations
Total revenue	$ 1,189
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember
Costs and expenses
Cost of sales	$ 10,755
Research and development	344,077	$ 294,781	$ 259,039
Selling, general and administrative	106,916	104,097	83,664
Total costs and expenses	461,748	398,878	342,703
Loss from operations	(460,559)	(398,878)	(342,703)
Other income
Interest income, net	13,043	2,985	451
Net Loss before income taxes	(447,516)	(395,893)	(342,252)
Income tax benefit	3,479	0	0
Net Loss	$ (444,037)	$ (395,893)	$ (342,252)
Net Loss Per Share of Common Stock, Basic	$ (1.89)	$ (2.49)	$ (2.23)
Net Loss Per Share of Common Stock, Diluted	$ (1.89)	$ (2.49)	$ (2.23)
Weighted Average Shares of Common Stock Outstanding, Basic	235,131	159,259	153,406
Weighted Average Shares of Common Stock Outstanding, Diluted	235,131	159,259	153,406

PROLEUKIN ACQUISITION (Tables)

12 Months Ended

Dec. 31, 2023

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 (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

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES

Cash, Cash Equivalents, and Investments

The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the Consolidated Balance Sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive loss. Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest income, net. No impairment losses related to credit losses were recognized for the years ended December 31, 2023, 2022 and 2021. 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 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 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. Currently, the Company’s letters of credit are primarily comprised of one for the benefit of the landlord for the Iovance Cell Therapy Center (the “iCTC”) used as a security deposit for the lease in the amount $5.45 million (See Note 14 - Leases) and a letter of credit for $0.6 million for the benefit of the landlord for the Company’s current headquarters’ lease (See Note 14 - Leases), as well as a letter of credit for $60.0 million, for the future milestone payment as required by the terms of the Option Agreement for the Proleukin^® acquisition (See Note 4 – Proleukin^® Acquisition). This letter of credit expires on May 5, 2024, however, it will be automatically extended, without written agreement, for one-year periods to May in each succeeding calendar year and the final expiration date will be July 20, 2026. Furthermore, the letter of credit will not be automatically extended if a thirty-day written notice is provided prior to the annual extension. The letter of credit for $5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date. 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. As of December 31, 2023 and December 31, 2022, Restricted cash totaled $66.4 million and $6.4 million, respectively. This amount has been classified as a non-current asset in the Company’s consolidated balance sheets.


	December 31,
	2023		2022		2021
Cash and cash equivalents	$	114,888	$	231,731	$	78,229
Restricted cash		66,430		6,430		6,084
Total cash, cash equivalents and restricted cash	$	181,318	$	238,161	$	84,313

Asset Acquisitions

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

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

Deferred tax liabilities arising from basis differences in assets acquired are calculated using the simultaneous equations method under ASC Topic 740, Income Taxes (“ASC 740”), and based on the effective tax rate. The resulting deferred tax liability is recorded in the consolidated balance sheet as of December 31, 2023.

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, labor 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. Inventories presented in the consolidated balance sheet as of December 31, 2023 pertain solely to Proleukin^® and include a step-up of the fair value of inventories as a result of the acquisition of the worldwide rights to Proleukin^®. Inventoriable costs incurred such as manufacturing costs for the Company’s product candidates, including Amtagvi™, are expensed as incurred as research and development expenses prior to regulatory approval. When regulatory approval of a product is obtained and the approved product is commercially launched, the Company will begin capitalizing manufacturing costs related to the approved product into inventory.

Cost of sales includes the cost of Proleukin^® 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 are included in cost of sales in the Company’s 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 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. The Company amortizes the intangible assets on a straight-line basis over their estimated useful lives.

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

The Company reviews intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, the Company measures the amount of impairment by comparing the carrying value of the assets to their fair values. The Company determined that no indicators of impairment existed as of December 31, 2023.

Leases

The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its consolidated balance sheets as Operating lease right-of-use assets and Operating lease liabilities as of December 31, 2023 and 2022. 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 consolidated statements of operations. The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No. 2016-02 and No. 2018-10 (together “Topic 842”) for short-term leases.

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

Property and Equipment, net

Property and equipment are stated at cost, net of accumulated depreciation and amortization. The cost of property and equipment is depreciated or amortized on the straight-line method over the following estimated useful lives. The depreciation or amortization of capitalized construction in progress costs, a component of property and equipment, net, begins once the underlying asset is placed into service and is recognized over the estimated useful lives:

Computer equipment		2 years
Computer software		5 years
Office furniture and equipment		5 years
Lab, process, and validation equipment		5 years
Machinery and equipment		5 – 7 years
Utility equipment		Lesser of the remaining economic life of the asset or the lease-term
Leasehold improvements		Lesser of the remaining economic life of the asset or the lease-term

Expenditures for maintenance and repairs are charged to operations as incurred while renewals and betterments are capitalized. Gains and losses on disposals are included within operating expenses in the consolidated statements of operations.

Management assesses the carrying value of property and equipment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. If there is an indication of impairment, management prepares an estimate of future undiscounted cash flows expected to result from the use of the asset and its eventual disposition. If these cash flows are less than the carrying amount of the asset, an impairment loss is recognized to write down the asset to its estimated fair value. For the years ended December 31, 2023, 2022, and 2021, the Company did not recognize any impairments for its property and equipment.

Fair Value Measurements

Under ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most

advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied.

Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:

Level 1—These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access.

Level 2—These are investments where values are based on quoted market prices in markets that are not active or model derived valuations in which all significant inputs are observable in active markets.

Level 3—These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable.

The Company’s financial instruments consist of cash, cash equivalents, short-term investments, and long-term notes payable, all of which are reported at their respective fair value or approximate fair value on its consolidated balance sheets.

A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Where quoted prices are available in an active market, securities are classified as Level 1.

When quoted market prices are not available for a specific security, the Company estimates the fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes, and market reference data. Level 2 assets consist of commercial paper, corporate securities 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.

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.

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.

Subsequent to the closing of the acquisition of Proleukin^® in May 2023, the Company began to sell Proleukin^® in licensed markets outside of the U.S. To date, there have been no product sales from Proleukin^® in the U.S. market. Revenue recognized for the year ended December 31, 2023 was not material to the Company’s consolidated financial statements.

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 judgements and estimates in determining the accrual balance in each reporting period.

In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the Consolidated Balance Sheets and subsequently recognized as research and development expense in the consolidated statements of operations when the associated services have been performed. 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 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.

Income Taxes

The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.

ASC Topic 740, Income Taxes (“ASC 740”), clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company will classify as income tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented.

Net Loss per Share

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

Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalent outstanding during the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) purchases 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 December 31, 2023, 2022, and 2021, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.


	As of December 31,
	2023	2022	2021
Stock options	18,899,849	15,240,197	12,520,865
Employee Stock Purchase Plan	296,751	260,859	85,227
Restricted stock units	3,453,901	2,436,764	1,110,010
Series A Convertible Preferred Stock*	97,000	97,000	97,000
Series B Convertible Preferred Stock*	2,842,158	2,842,158	2,842,158
	25,589,659	20,876,978	16,655,260

*on an as-converted basis

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

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include assumptions made in the fair value of intangible assets, 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 consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, Iovance Biotherapeutics GmbH, and Iovance Biotherapeutics B.V., Iovance Biotherapeutics UK Ltd and Iovance Biotherapeutics UK SP Ltd (together, the “UK subsidiaries”), and Iovance Biotherapeutics Canada, Inc. All intercompany accounts and transactions have been eliminated.

Certain prior year amounts in the notes to these consolidated financial statements have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the previously reported consolidated balance sheets, consolidated statements of operations, consolidated statements of other comprehensive loss, consolidated statements of stockholder’s equity or consolidated statements of cash flows.

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 consolidated balance sheets. The subsidiaries’ net loss is translated into U.S. dollars by using the average exchange rate for the applicable period. The 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 developing and commercializing therapies using autologous TIL for the treatment of metastatic melanoma and other solid tumor cancers.

Concentrations

The Company is subject to credit risk from its portfolio of cash, cash equivalents and investments. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The Company maintains cash, cash equivalents and investment balances at four financial institutions. Management believes that the financial institutions which hold its cash are financially sound and, accordingly, minimal credit risk exists. As of December 31, 2023 and 2022, respectively, the Company’s cash balances were in excess of insured limits maintained at the financial institutions.

Recent Accounting Standards Issued But Not Yet Adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances the disclosures of income taxes. ASU 2023-09 is effective for the Company in its annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which enhances the disclosures required for operating segments in annual and interim consolidated financial statements. ASC 2023-07 is effective for the Company in its annual reporting for fiscal year 2024 and for interim period reporting beginning in

fiscal year 2025 on a retrospective basis. Early adoption is permitted. The Company is currently evaluating the impact of ASC 2023-07 on its consolidated financial statements.

INCOME TAXES - Other information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Income Tax Contingency [Line Items]
Operating loss carryovers definite to be expired	$ 142,400
Operating loss carryovers indefinite	1,000,000
Change in valuation allowance	96,400	$ 82,900	$ 78,100
Interest or penalties on unpaid tax	0	$ 0	$ 0
Federal income tax
Income Tax Contingency [Line Items]
Net operating loss carryforwards (NOLs)	1,200,000
State income tax
Income Tax Contingency [Line Items]
Net operating loss carryforwards (NOLs)	$ 180,000

PROPERTY AND EQUIPMENT, NET

12 Months Ended

Dec. 31, 2023

PROPERTY AND EQUIPMENT, NET

PROPERTY AND EQUIPMENT, NET

NOTE 8. PROPERTY AND EQUIPMENT, NET

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


	December 31,		December 31,
	2023		2022
Leasehold improvements	$	76,804	$	74,305
Lab, process, and validation equipment		23,131		22,136
Utility equipment		5,990		5,951
Office furniture and equipment		3,297		2,927
Computer software		7,772		6,736
Computer equipment		542		695
Machinery and equipment		306		82
Construction in progress		24,101		9,118
Total property and equipment, cost		141,943		121,950
Less: Accumulated depreciation and amortization		(27,913)		(16,718)
Property and equipment, net	$	114,030	$	105,232

Depreciation expense for the years ended December 31, 2023, 2022, and 2021 was approximately $11.6 million, $9.3 million and $3.1 million, respectively. During the years ended December 31, 2023 and 2022, the Company placed $2.6 million and $27.2 million of assets related to the iCTC in service, respectively, and initiated depreciation of these assets.

INTANGIBLE ASSETS, NET (Tables)

12 Months Ended

Dec. 31, 2023

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 December 31, 2023 are as follows (in thousands):


	December 31, 2023
	Gross carrying amounts		Accumulated amortization		Intangible assets, net
Intangible assets:
Developed technology	$	238,612	$	(9,871)	$	228,741
Assembled workforce		652		(135)		517
Total Intangible Assets	$	239,264	$	(10,006)	$	229,258
* Amounts are translated using the foreign exchange rate as of 12/31/2023.

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Pay vs Performance Disclosure
Net Income (Loss)	$ (444,037)	$ (395,893)	$ (342,252)

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: 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 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

LEASES (Tables)

12 Months Ended

Dec. 31, 2023

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):


		December 31,	December 31,
		2023		2022
Operating lease right-of-use assets	$	62,515	$	73,015
Operating lease liabilities
Current portion included in current liabilities		7,777		12,587
Long-term portion included in non-current liabilities		67,085		71,859
Total operating lease liabilities	$	74,862	$	84,446

Schedule of components of lease expenses

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


	For the Year			For the Year
	Ended			Ended
	December 31, 2023			December 31, 2022
Operating lease cost	$	17,786		$	17,657
Variable lease cost		7,629			5,447
Short-term lease cost		335			154
Total lease cost	$	25,750		$	23,258

Other information
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations	$	16,871		$	14,209
Tenant improvement allowance received for amounts included in the measurement of lease liabilities included in cash flows from operations		—			6,432
Right-of-use assets obtained from entering new leases	$	177		$	553
Increase in right-of-use assets from lease modifications	$	1,033		$	15,304
Weighted-average remaining lease terms (years)		13.09			12.90
Weighted-average discount rates		7.4	%		7.5	%

Schedule of minimum lease commitments

As of December 31, 2023, maturities of the Company's operating lease liabilities were as follows (in thousands):


			CMO
	Facility		embedded
Year Ending December 31,	leases		leases		Total
2024	$	8,579	$	4,349	$	12,928
2025		8,324		—		8,324
2026		7,989		—		7,989
2027		8,186		—		8,186
2028		8,389		—		8,389
Thereafter		75,438		—		75,438
Total lease payments	$	116,905	$	4,349	$	121,254
Less: Present value adjustment		(46,254)		(138)		(46,392)
Operating lease liabilities	$	70,651	$	4,211	$	74,862

EMPLOYEE BENEFIT PLAN

12 Months Ended

Dec. 31, 2023

EMPLOYEE BENEFIT PLAN

EMPLOYEE BENEFIT PLAN

NOTE 11. EMPLOYEE BENEFIT PLAN

The Company maintains a defined contribution plan covering substantially all U.S. employees under Section 401(k) of the Internal Revenue Code of 1986, as amended (the “IRC”). The Company's matching contribution to the defined contribution plan was $4.1 million, $3.0 million, and $2.2 million for the years ended December 31, 2023, 2022 and 2021, respectively.

CASH EQUIVALENTS AND INVESTMENTS (Tables)

12 Months Ended

Dec. 31, 2023

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 December 31, 2023 and December 31, 2022 were as follows (in thousands):


			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


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of December 31, 2022	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	118,570	$	—	$	(850)	$	117,720
U.S. government agency securities		11,272		—		(7)		11,265
Corporate securities		7,230		—		—		7,230
Commercial paper		148,299		8		(53)		148,254
Money market funds		88,001		—		—		88,001
Total investments	$	373,372	$	8	$	(910)	$	372,470

Schedule of available-for-sale debt securities

The fair value of cash equivalents and investments as of December 31, 2023 and December 31, 2022 are classified as follows in the Company’s consolidated balance sheets (in thousands):


	December 31,		December 31,
Classified as:	2023		2022
Cash equivalents	$	34,053	$	132,356
Short-term investments		164,979		240,114
Total investments	$	199,032	$	372,470

Schedule of fair value of the company's financial assets

As of December 31, 2023 and 2022, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):


	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


	Assets at Fair Value as of December 31, 2022
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	117,720	$	—	$	—	$	117,720
U.S. government agency securities		—		11,265		—		11,265
Corporate securities		—		7,230		—		7,230
Commercial paper		—		148,254		—		148,254
Money market funds		88,001		—		—		88,001
Total	$	205,721	$	166,749	$	—	$	372,470

- 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).

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
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-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

Reference 11: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

Reference 12: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481800/320-10-50-3

+ Details

LICENSES AND AGREEMENTS (Details) $ in Thousands					1 Months Ended					12 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	Nov. 30, 2016 item	Aug. 31, 2016 USD ($)	Aug. 31, 2011	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Research and development										$ 344,077	$ 294,781	$ 259,039
Research and development arrangement, contract to perform for others, costs incurred, gross										5,300
Strategic Alliance Agreement
Research and development										0	200	500
Research Collaboration And Clinical Grant Agreement
Research and development										0
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										200	600	300
First WuXi Manufacturing and Services Agreement
Agreement term							3 years
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										600	0
Amount of collaborative arrangement required to be remitted										$ 1,500
Period of collaborative arrangement required to be remitted										60 days
Cooperative Research and Development Agreement
Agreement term						3 years			5 years
Research and development								$ 500		$ 2,000	2,000	2,000
Notification Period To Terminate Agreement								60 days
Research Collaboration And Clinical Grant Agreements With Moffitt
Research and development											100	100
Moffitt License Agreement One
Agreement term				20 years
Research and development										0	0	0
Payments for upfront licensing fee				$ 100
Moffitt License Agreement Two
Research and development										100	200	100
Payments for upfront licensing fee		$ 100
Additional milestone payable										400
Moffitt License Agreement Two, Amended and Restated
Payments for upfront licensing fee										200
WuXi Apptech, Inc - Manufacturing and Services Agreement
Research and development										17,300	14,200	17,500
Cellectis S.A
Research and development										400	400	$ 400
Novartis Pharma AG and Related Entities - License Agreement
Research and development										0	$ 0		$ 10,000
Number of historical master cell bank license and working cell bank transfer agreement \| item	2
Number of historical license agreement \| item	1
Amount of milestone payment made during the period under the license agreement										$ 0
Percent of milestone payments reimbursable	25.00%
Novartis Pharma AG and Related Entities - License Agreement \| Non-US
Amount of milestone payments payable under the license agreement	$ 15,000
Novartis Pharma AG and Related Entities - License Agreement \| Maximum \| UNITED STATES
Amount of milestone payments payable under the license agreement	$ 30,000

LONG-TERM NOTE PAYABLE

12 Months Ended

Dec. 31, 2023

LONG-TERM NOTE PAYABLE

LONG-TERM NOTE PAYABLE

NOTE 16. LONG-TERM NOTE PAYABLE

On January 26, 2021, the Company entered into a Loan Note and accompanying Economic Stimulus Program Loan Agreement with PIDC – Local Development Corporation, a Pennsylvania nonprofit corporation (the “Lender”), pursuant to which the Lender agreed to make a loan (the “Job Creation Loan”) to the Company in a principal amount of $1.0 million. The Job Creation Loan will be for a term of five years starting on February 18, 2021, the date of the issuance of a final certificate of occupancy for the Company’s leased premises in Philadelphia, Pennsylvania. The Job Creation Loan is unsecured, bears no interest, and will be forgiven by the Lender in the amount of $2,000 per full-time or “full time equivalent” (defined as two or more part time employees whose working hours total at least 35 hours a week) employee with an average salary of at least $80,000 (“FT Employees”), up to a maximum amount equal to the amount of the Job Creation Loan, as calculated based on the average number of FT Employees employed at the Company’s premises during the period of the 5-year term beginning on the date that is nine months prior to the maturity date and ending on the maturity date. If the Job Creation Loan is not forgiven in full by the maturity date, the remaining balance of the loan not forgiven will become payable on the maturity date. The Loan Note includes customary events of default. Upon the occurrence of an event of default, the Lender will have the right to exercise remedies against the Company, including the right to require immediate payment of all amounts due under the Loan Note.

The Company concluded that it is not reasonably assured that all or a portion of the loan will be forgiven as of December 31, 2023, and therefore accounted for the Job Creation Loan as debt in accordance with ASC Topic 470, Debt, as opposed to an in-substance government grant, and classified as a long-term debt in its consolidated balance sheets as of December 31, 2023 and 2022.

SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Thousands			12 Months Ended
	Feb. 22, 2024	Jul. 13, 2023	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
SUBSEQUENT EVENTS
Common stock issued, net of offering costs (in shares)		23,000,000
Public offering price		$ 7.50
Proceeds from the issuance of common stock, net			$ 463,281	$ 189,502	$ 203,156
Subsequent Event \| Public Offering \| Common Stock
SUBSEQUENT EVENTS
Common stock issued, net of offering costs (in shares)	23,014,000
Public offering price	$ 9.15
Proceeds from the issuance of common stock, net	$ 197,100

ACCRUED EXPENSES

12 Months Ended

Dec. 31, 2023

ACCRUED EXPENSES

ACCRUED EXPENSES

NOTE 9. ACCRUED EXPENSES

Accrued expenses consist of the following (in thousands):


	December 31,		December 31,
	2023		2022
Employee and consultant related expenses	$	34,814	$	20,188
Clinical related		10,911		14,812
Manufacturing related		10,893		4,467
Facilities related		2,437		6,510
Legal and related services		1,610		3,015
Inventory related		2,148		—
Other accrued expenses		6,593		3,303
Total accrued expenses	$	69,406	$	52,295

CASH EQUIVALENTS AND INVESTMENTS - Cost and fair value (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Amortized Cost	$ 198,993	$ 373,372
Gross Unrealized Gains	39	8
Gross Unrealized Losses		(910)
Fair Value	199,032	372,470
U.S. treasury securities
Amortized Cost	164,940	118,570
Gross Unrealized Gains	39
Gross Unrealized Losses		(850)
Fair Value	164,979	117,720
U.S. government agency securities
Amortized Cost		11,272
Gross Unrealized Losses		(7)
Fair Value		11,265
Corporate securities
Amortized Cost		7,230
Fair Value		7,230
Commercial paper
Amortized Cost		148,299
Gross Unrealized Gains		8
Gross Unrealized Losses		(53)
Fair Value		148,254
Money market funds
Amortized Cost	34,053	88,001
Fair Value	$ 34,053	$ 88,001

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, 2020		$ 4	$ 6	$ 1,486,662	$ 19	$ (830,193)	$ 656,498
Beginning Balance (in Shares) at Dec. 31, 2020	194	3,581,119	146,874,917
Stock-based compensation expense				69,765			69,765
Common stock issued upon purchase of employee stock purchase plan				1,586			1,586
Common stock issued upon purchase of employee stock purchase plan (in shares)			94,148
Common stock issued upon exercise of stock options				33,526			33,526
Common stock issued upon exercise of stock options (in shares)			2,822,617
Common stock issued from preferred stock conversion		$ (1)	$ 1	1			1
Common stock issued from preferred stock conversion (in Shares)		(738,961)	738,961
Common stock sold in public and/or at the market offerings, net of offering costs				203,155			203,155
Common stock sold in public and/or at the market offerings, net of offering costs (in shares)			6,474,099
Unrealized gain/(loss) on investments					(620)		(620)
Net Loss						(342,252)	(342,252)
Ending Balance at Dec. 31, 2021		$ 3	$ 7	1,794,695	(601)	(1,172,445)	621,659
Ending Balance (in Shares) at Dec. 31, 2021	194	2,842,158	157,004,742
Stock-based compensation expense				84,022			84,022
Common stock issued upon purchase of employee stock purchase plan				1,655			1,655
Common stock issued upon purchase of employee stock purchase plan (in shares)			262,701
Vesting of restricted shares issued for services (in shares)			894,760
Tax payments related to shares retired for vested restricted stock units				(2,649)			(2,649)
Tax payments related to shares retired for vested restricted stock units (in shares)			(342,703)
Common stock issued upon exercise of stock options				1,642			1,642
Common stock issued upon exercise of stock options (in shares)			203,579
Common stock sold in public and/or at the market offerings, net of offering costs			$ 1	189,501			189,502
Common stock sold in public and/or at the market offerings, net of offering costs (in shares)			29,788,993
Unrealized gain/(loss) on investments					(301)		(301)
Net Loss						(395,893)	(395,893)
Ending Balance at Dec. 31, 2022		$ 3	$ 8	2,068,867	(902)	(1,568,338)	499,638
Ending Balance (in Shares) at Dec. 31, 2022	194	2,842,158	187,812,072
Stock-based compensation expense				62,625			62,625
Common stock issued upon purchase of employee stock purchase plan				2,410			2,410
Common stock issued upon purchase of employee stock purchase plan (in shares)			435,459
Vesting of restricted shares issued for services (in shares)			1,253,465
Tax payments related to shares retired for vested restricted stock units				(2,795)			(2,795)
Tax payments related to shares retired for vested restricted stock units (in shares)			(454,367)
Common stock issued upon exercise of stock options				63			63
Common stock issued upon exercise of stock options (in shares)			8,860
Stock issued during period, value, new issues			$ 3	463,278			463,281
Common stock sold in public and/or at the market offerings, net of offering costs (in shares)			67,080,226
Unrealized gain/(loss) on investments					940		940
Foreign currency cumulative translation adjustment					2,488		2,488
Net Loss						(444,037)	(444,037)
Ending Balance at Dec. 31, 2023		$ 3	$ 11	$ 2,594,448	$ 2,526	$ (2,012,375)	$ 584,613
Ending Balance (in Shares) at Dec. 31, 2023	194	2,842,158	256,135,715

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Consolidated Statements of Comprehensive Loss
Net Loss	$ (444,037)	$ (395,893)	$ (342,252)
Other comprehensive loss:
Unrealized gain/(loss) on investments	940	(301)	(620)
Foreign currency translation adjustment	2,488
Comprehensive Loss	$ (440,609)	$ (396,194)	$ (342,872)

- Definition

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

+ References

+ Details

ACCRUED EXPENSES (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
ACCRUED EXPENSES
Employee and consultant related expenses	$ 34,814	$ 20,188
Clinical related	10,911	14,812
Manufacturing related	10,893	4,467
Facilities related	2,437	6,510
Legal and related services	1,610	3,015
Inventory related	2,148
Other accrued expenses	6,593	3,303
Total accrued expenses	$ 69,406	$ 52,295

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2023	Dec. 31, 2022
Common stock, par or stated value per share	$ 0.000041666	$ 0.000041666
Common stock, shares authorized	500,000,000	300,000,000
Common Stock, Shares, Issued	256,135,715	187,812,072
Common Stock, Shares, Outstanding	256,135,715	187,812,072
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

INVENTORY

12 Months Ended

Dec. 31, 2023

INVENTORY

INVENTORY

NOTE 6. INVENTORY

Inventory presented in the consolidated balance sheet as of December 31, 2023 pertains solely to Proleukin^®. Inventory classified as work in process are unlabeled vials of Proleukin^®.

As of December 31, 2023 and December 31, 2022, inventory consists of the following (in thousands):


		December 31,		December 31,
		2023		2022
Work in process	$	5,749	$	—
Finished goods		4,623		—
Total inventory	$	10,372	$	—

LEASES

12 Months Ended

Dec. 31, 2023

LEASES

LEASES

NOTE 14. 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 our 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.

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


		December 31,	December 31,
		2023		2022
Operating lease right-of-use assets	$	62,515	$	73,015
Operating lease liabilities
Current portion included in current liabilities		7,777		12,587
Long-term portion included in non-current liabilities		67,085		71,859
Total operating lease liabilities	$	74,862	$	84,446


	For the Year			For the Year
	Ended			Ended
	December 31, 2023			December 31, 2022
Operating lease cost	$	17,786		$	17,657
Variable lease cost		7,629			5,447
Short-term lease cost		335			154
Total lease cost	$	25,750		$	23,258

Other information
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations	$	16,871		$	14,209
Tenant improvement allowance received for amounts included in the measurement of lease liabilities included in cash flows from operations		—			6,432
Right-of-use assets obtained from entering new leases	$	177		$	553
Increase in right-of-use assets from lease modifications	$	1,033		$	15,304
Weighted-average remaining lease terms (years)		13.09			12.90
Weighted-average discount rates		7.4	%		7.5	%

As of December 31, 2023, maturities of the Company's operating lease liabilities were as follows (in thousands):


			CMO
	Facility		embedded
Year Ending December 31,	leases		leases		Total
2024	$	8,579	$	4,349	$	12,928
2025		8,324		—		8,324
2026		7,989		—		7,989
2027		8,186		—		8,186
2028		8,389		—		8,389
Thereafter		75,438		—		75,438
Total lease payments	$	116,905	$	4,349	$	121,254
Less: Present value adjustment		(46,254)		(138)		(46,392)
Operating lease liabilities	$	70,651	$	4,211	$	74,862

For its corporate headquarters’ office, the lease agreement includes a tenant improvement allowance of $8.2 million. For the years ended December 31, 2023 and 2022, the Company has received reimbursements associated with this tenant improvement allowance of zero and $6.4 million, respectively. The Company does not expect to receive additional reimbursement associated with this tenant improvement allowance.

INCOME TAXES (Details) - USD ($) $ in Thousands	12 Months Ended
INCOME TAXES (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	May 18, 2023
INCOME TAXES
Tax benefit	$ (3,479)	$ 0	$ 0
Deferred tax liability	$ 17,300			$ 20,400
Effective tax rates	0.78%	0.00%	0.00%
Federal statutory tax rate	21.00%	21.00%	21.00%

- Definition

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

+ References + Details

Document And Entity Information - USD ($) $ in Billions	12 Months Ended
Document And Entity Information - USD ($) $ in Billions	Dec. 31, 2023	Feb. 22, 2024	Jun. 30, 2023
Document And Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2023
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
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Title of 12(b) Security	Common Stock, $ 0.000041666 Par Value per Share
Trading Symbol	IOVA
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		279,307,043
Entity Well-known Seasoned Issuer	Yes
Entity Voluntary Filers	No
ICFR Auditor Attestation Flag	true
Entity Public Float			$ 1.4
Auditor Name	Ernst & Young LLP
Auditor Firm ID	42
Auditor Location	San Mateo, California
Entity Central Index Key	0001425205
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	FY
Amendment Flag	false

INCOME TAXES - Net deferred tax assets and liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Deferred income tax asset:
Net operating loss carry forwards	$ 255,639	$ 225,904
Stock-based compensation	28,609	24,920
Tax credit carryforwards	58,565	46,957
Lease liabilities	16,024	18,017
Capitalized R&D	99,107	47,755
Reserves and accruals	6,540	3,997
Deferred tax assets before valuation allowance	464,484	367,550
Less: valuation allowance	(446,853)	(350,418)
Net deferred income tax assets	17,631	17,132
Deferred tax liabilities:
Right-of-use assets	(13,381)	(15,578)
Depreciation and amortization	(21,597)	(1,554)
Net deferred tax assets (liabilities)	$ (17,347)	$ 0

LICENSES AND AGREEMENTS - Estimated purchase obligations (Details) - Manufacturing and Supply Agreement With Boehringer Ingelheim Biopharmaceuticals GmbH $ in Millions	Dec. 31, 2023 USD ($)
Years ending December 31, 2024	$ 8.2
Years ending December 31, 2025	11.4
Years ending December 31, 2026	7.3
Years ending December 31, 2027	$ 7.3

CASH EQUIVALENTS AND INVESTMENTS - Narrative (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Cash equivalents total	$ 34,053	$ 132,356
Unrealized losses on available-for-sale	$ 0	$ 0
Number of investments in debt securities in continuous unrealized loss position for more than 12 months	0	0
Demand Deposits
Cash equivalents total	$ 80,800	$ 99,400

INVENTORY (Tables)

12 Months Ended

Dec. 31, 2023

INVENTORY

Summary of inventories

As of December 31, 2023 and December 31, 2022, inventory consists of the following (in thousands):


		December 31,		December 31,
		2023		2022
Work in process	$	5,749	$	—
Finished goods		4,623		—
Total inventory	$	10,372	$	—

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Segment Reporting (Details)	12 Months Ended
	Dec. 31, 2023 item segment
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Number of operating segments \| segment	1
Number Of Financial Institutions \| item	4

PROLEUKIN ACQUISITION - Narrative (Details) - PROLEUKIN £ in Millions, $ in Millions			12 Months Ended
	May 18, 2023 USD ($)	May 18, 2023 GBP (£)	Dec. 31, 2023 USD ($)
PROLEUKIN ACQUISITION
Upfront payment	$ 207.2	£ 166.9	$ 210.2
Payment for certain inventory	$ 3.0	£ 2.4

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2023

INCOME TAXES

Schedule of Deferred Tax Assets and Liabilities

The significant components of the Company’s net deferred tax assets and liabilities are summarized as follows (in thousands):


	As of December 31,
	2023		2022
Deferred income tax assets:
Net operating loss carryforwards	$	255,639	$	225,904
Stock-based compensation		28,609		24,920
Tax credit carryforwards		58,565		46,957
Lease liabilities		16,024		18,017
Capitalized R&D		99,107		47,755
Reserves and accruals		6,540		3,997
Deferred tax assets before valuation allowance		464,484		367,550
Less: valuation allowance		(446,853)		(350,418)
Net deferred income tax assets		17,631		17,132
Deferred tax liabilities:
Right-of-use assets		(13,381)		(15,578)
Depreciation and amortization		(21,597)		(1,554)
Net deferred tax assets (liabilities)	$	(17,347)	$	—

Schedule of Effective Income Tax Rate Reconciliation


	Years ended December 31,
	2023	2022	2021
Federal statutory tax rate	21%	21%	21%
Orphan drug and research credits	2%	1%	2%
Permanent and other differences	(1)%	(1)%	0%
Stock Based Compensation	(1)%	(1)%	0%
State tax, net of federal benefit	1%	1%	0%
	22%	21%	23%
Valuation allowance	(21)%	(21)%	(23)%
Effective tax rate	1%	0%	0%

Schedule of Unrecognized Tax Benefits


	Years Ended December 31,
	2023		2022		2021
Unrecognized benefit - beginning of period	$	21,645	$	18,171	$	14,432
Gross decreases - prior period tax positions		—		—		(159)
Gross increase current period tax positions		4,462		3,474		3,898
Unrecognized benefit - end of period	$	26,107	$	21,645	$	18,171

PROLEUKIN ACQUISITION - Additional information (Details) - PROLEUKIN $ in Thousands, £ in Millions			12 Months Ended
	May 18, 2023 USD ($)	May 18, 2023 GBP (£)	Dec. 31, 2023 USD ($)
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
Deferred consideration term	12 years	12 years
Assembled workforce
PROLEUKIN ACQUISITION
Expected useful life of intangible assets	15 years	15 years
Assembled workforce \| Selling, general and administrative
PROLEUKIN ACQUISITION
Expected useful life of intangible assets	3 years	3 years

STOCKHOLDERS' EQUITY - Stock-based compensation by instrument (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Total stock-based compensation expenses	$ 62,625	$ 84,022	$ 69,765
Employee Stock Option [Member]
Total stock-based compensation expenses	45,340	58,308	56,305
Restricted stock units
Total stock-based compensation expenses	16,062	24,436	12,247
2020 ESPP
Total stock-based compensation expenses	$ 1,223	$ 1,278	$ 1,213

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2023

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 December 31, 2023, 256,135,715 shares of the Company’s common stock were issued and outstanding.

Public Offerings

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 Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the 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.

For the years ended December 31, 2023 and 2022, the Company received $301.7 million and $189.5 million in net proceeds, net of offering costs, through the sale of 44,080,226 shares and 29,788,993 shares of its common stock through the 2023 Sale Agreement and/or the 2022 Sale Agreement at a weighted average price per share of $6.99 and $6.52, respectively.

Preferred Stock

The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. As of December 31, 2023, 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.

No shares of Series A Convertible Preferred Stock were converted to common stock during the year ended December 31, 2023 and 2022. As of December 31, 2023, and 2022, 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.

No shares of Series B Convertible Preferred Stock were converted to common stock during the year ended December 31, 2023 and 2022. At December 31, 2023 and 2022, 2,842,158 shares of Series B Preferred Stock (that are convertible into 2,842,158 shares of common stock) remained outstanding.

Equity Incentive Plans

The Company has multiple equity incentive plans under which it grants awards. As of December 31, 2023, there are 275,625 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 December 31, 2023, 9,906,666 shares of common stock were available for grant under the Company’s 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, the Compensation Committee approved an additional amendment to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,750,000 shares of the Company’s common stock to 2,250,000 shares of the Company’s common stock without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Inducement Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). As of December 31, 2023, 349,428 shares of common stock were available for grant under the Inducement Plan.

Stock Options

A summary of the status of stock options as of December 31, 2023, and the changes during the three years then ended, 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, 2022	15,240,197	$	22.45
Issued	5,379,670		7.04
Exercised	(8,860)		7.10
Expired/Cancelled	(1,711,158)		17.01
Outstanding at December 31, 2023	18,899,849	$	18.57	6.75	$	7,065
Ending vested and expected to vest at December 31, 2023	18,899,849	$	18.57	6.75	$	7,065
Options exercisable at December 31, 2023	12,160,135	$	23.40	5.54	$	1,337

As of December 31, 2023, there was $31.7 million of total unrecognized compensation expense related to unvested employee stock options, which the Company expects to recognize over a remaining weighted average period of 1.84 years.

The weighted average grant date fair value for employee options granted under the Company's stock option plans during the years ended December 31, 2023, 2022, and 2021 was $4.91, $8.29, and $22.28 per option, respectively.

The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the year ended December 31, 2023 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on December 31, 2023. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

The aggregate intrinsic value of stock options exercised during the year ended December 31, 2023, 2022, and 2021 were $0.01 million, $0.04 million, and $21.3 million, respectively.

Employee Stock Purchase Plan

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

Under the 2020 ESPP, employees of the Company can purchase shares of our common stock based on a percentage of their compensation subject to certain limits. The purchase price per share is equal to the lower of 85% of the fair market value of its common

stock on the offering date or the purchase date with a six-month look-back feature. The 2020 ESPP purchases are settled with common stock from the 2020 ESPP’s previously authorized and available pool of shares.

The compensation expense related to the 2020 ESPP for the years ended December 31, 2023, 2022 and 2021 was $1.2 million, $1.3 million and $1.2 million, respectively. Under the 2020 ESPP, for the years ended December 31, 2023 and 2022, the Company received proceeds of $2.4 million for the issuance of 435,459 shares and $1.7 million for the issuance of 262,701 shares, respectively. As of December 31, 2023, there was $0.6 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over 5.4 months.

Restricted Stock Units and Performance Restricted Stock Units

In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). Compensation expense related to PRSUs is based on the grant date fair value of the award and recorded from the period that achievement is determined to be probable through the stated service period associated with the award.

Activity for RSUs and PRSUs during the years ended December 31, 2023 and 2022 is presented in the following table:


		Weighted
	Number	Average
	of	Grant Date
	RSUs and PRSUs	Fair Value
Outstanding, non-vested as of December 31, 2022	2,436,764	$	14.74
Granted	2,729,348		7.19
Vested/Released	(1,253,465)		16.17
Canceled/Forfeited	(458,746)		9.35
Outstanding as of December 31, 2023	3,453,901	$	8.97
Ending vested and expected to vest at December 31, 2023	3,453,901	$	8.97

As of December 31, 2023 and 2022, there was $19.9 million and $20.6 million of unrecognized stock-based compensation expense associated with unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of 1.65 and 1.72 years, respectively. The aggregate intrinsic value of the unvested RSUs and PRSUs outstanding as of December 31, 2023 and 2022, was $28.1 million and $14.5 million, respectively.

Stock-Based Compensation

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



	Years Ended December 31,
	2023		2022		2021
Research and development	$	34,926	$	50,242	$	40,833
Selling, general and administrative		27,699		33,780		28,932
Total stock-based compensation expense	$	62,625	$	84,022	$	69,765

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



	Years Ended December 31,
	2023		2022		2021
Stock option expense	$	45,340	$	58,308	$	56,305
Restricted stock expense		16,062		24,436		12,247
ESPP expense		1,223		1,278		1,213
Total stock-based compensation expense	$	62,625	$	84,022	$	69,765

The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the years ended December 31, 2023, 2022, and 2021:


	Stock Option			ESPP
	Years Ended December 31,			Years Ended December 31,
Assumptions:	2023	2022	2021	2023	2022	2021
Expected term (years)	5.18 - 5.37	4.94 - 5.12	4.94 - 5.28	0.5	0.50	0.50
Expected volatility	83.63% - 84.21%	73.73% - 83.90%	70.35% - 73.88%	72.96% - 83.36%	73.02% - 137.42%	52.04% - 94.56%
Risk-free interest rate	3.59% - 4.60%	1.25% - 4.05%	0.36% - 0.97%	5.38% - 5.40%	1.98% - 4.78%	0.06% - 0.13%
Expected dividend yield	0%	0%	0%	0%	0%	0%

Expected Term (Years)—The expected term of the stock option grants was calculated based on historical exercises, cancellations, and forfeitures of stock options and outstanding option shares.

Expected Volatility —The expected volatility is based on the historical volatility for the Company's stock over a period equal to the expected terms of the options.

Risk-Free Interest Rate —The risk-free interest rate was based on the market yield currently available on United States Treasury securities with maturities approximately equal to the option’s expected term.

Expected Dividend Yield —The Company has never paid dividends and does not expect to pay dividends in the foreseeable future.

Forfeiture Rate —The Company recognizes forfeitures as they occur.

Each of the inputs discussed above is subjective and generally requires significant management judgment.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

PROPERTY AND EQUIPMENT, NET (Tables)

12 Months Ended

Dec. 31, 2023

PROPERTY AND EQUIPMENT, NET

Schedule of Property and equipment

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


	December 31,		December 31,
	2023		2022
Leasehold improvements	$	76,804	$	74,305
Lab, process, and validation equipment		23,131		22,136
Utility equipment		5,990		5,951
Office furniture and equipment		3,297		2,927
Computer software		7,772		6,736
Computer equipment		542		695
Machinery and equipment		306		82
Construction in progress		24,101		9,118
Total property and equipment, cost		141,943		121,950
Less: Accumulated depreciation and amortization		(27,913)		(16,718)
Property and equipment, net	$	114,030	$	105,232

STOCKHOLDERS' EQUITY - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Jul. 13, 2023	Dec. 31, 2023
Number of Options
Exercised	(3,000,000)
Employee Stock Option [Member]
Number of Options
Outstanding, beginning balance		15,240,197
Issued		5,379,670
Exercised		(8,860)
Expired/Cancelled		(1,711,158)
Outstanding, ending balance		18,899,849
Ending vested and expected to vest		18,899,849
Options exercisable		12,160,135
Weighted Average Exercise Price
Outstanding, beginning balance		$ 22.45
Issued		7.04
Exercised		7.10
Expired/Cancelled		17.01
Outstanding, ending balance		18.57
Ending vested and expected to vest		18.57
Options exercisable		$ 23.40
Weighted Average Remaining Contractual Life
Options outstanding, remaining term		6 years 9 months
Ending vested and expected to vest, remaining term		6 years 9 months
Options exercisable, remaining term		5 years 6 months 14 days
Aggregate Intrinsic Value
Option at ending balance		$ 7,065
Ending vested and expected to vest		7,065
Option exercisable		$ 1,337

REVENUE

12 Months Ended

Dec. 31, 2023

REVENUE

REVENUE

NOTE 7. REVENUE

Product sales for the year ended December 31, 2023 was $1.2 million and represented sales of Proleukin^® made primarily in licensed markets outside of the U.S. To date, there have been no product sales from Proleukin^® in the U.S. market.

- 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
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-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479806/606-10-50-12

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (d)
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-URI https://asc.fasb.org//1943274/2147479806/606-10-50-12

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
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-URI https://asc.fasb.org//1943274/2147479806/606-10-50-12

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
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-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479806/606-10-50-13

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org//606/tableOfContent

+ Details

LEASES - Maturities of the Company's operating lease liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
2024	$ 12,928
2025	8,324
2026	7,989
2027	8,186
2028	8,389
Thereafter	75,438
Total lease payments	121,254
Less: Present value adjustment	(46,392)
Operating lease liabilities	74,862	$ 84,446
Facility leases
2024	8,579
2025	8,324
2026	7,989
2027	8,186
2028	8,389
Thereafter	75,438
Total lease payments	116,905
Less: Present value adjustment	(46,254)
Operating lease liabilities	70,651
CMO embedded leases
2024	4,349
Total lease payments	4,349
Less: Present value adjustment	(138)
Operating lease liabilities	$ 4,211

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Investments

Restricted Cash


	December 31,
	2023		2022		2021
Cash and cash equivalents	$	114,888	$	231,731	$	78,229
Restricted cash		66,430		6,430		6,084
Total cash, cash equivalents and restricted cash	$	181,318	$	238,161	$	84,313

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.

Property and Equipment, net

Computer equipment		2 years
Computer software		5 years
Office furniture and equipment		5 years
Lab, process, and validation equipment		5 years
Machinery and equipment		5 – 7 years
Utility equipment		Lesser of the remaining economic life of the asset or the lease-term
Leasehold improvements		Lesser of the remaining economic life of the asset or the lease-term

Fair Value Measurements

Level 1—These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access.

Level 3—These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable.

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 judgements and estimates in determining the accrual balance in each reporting period.

Selling, general and administrative expense

Income Taxes

Net Loss per Share

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

As of December 31, 2023, 2022, and 2021, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.


	As of December 31,
	2023	2022	2021
Stock options	18,899,849	15,240,197	12,520,865
Employee Stock Purchase Plan	296,751	260,859	85,227
Restricted stock units	3,453,901	2,436,764	1,110,010
Series A Convertible Preferred Stock*	97,000	97,000	97,000
Series B Convertible Preferred Stock*	2,842,158	2,842,158	2,842,158
	25,589,659	20,876,978	16,655,260

*on an as-converted basis

Use of Estimates

Principles of Consolidation

Foreign Currency Translation

Segment Reporting

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

Concentrations

Recent Accounting Standards Issued But Not Yet Adopted

fiscal year 2025 on a retrospective basis. Early adoption is permitted. The Company is currently evaluating the impact of ASC 2023-07 on its consolidated financial statements.

STOCKHOLDERS' EQUITY - Stock based expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Total stock-based compensation expenses	$ 62,625	$ 84,022	$ 69,765
Research and development
Total stock-based compensation expenses	34,926	50,242	40,833
General and administrative
Total stock-based compensation expenses	$ 27,699	$ 33,780	$ 28,932

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash, Cash equivalents and Restricted Cash (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Security deposit	$ 600
Restricted security deposit	5,450
Cash and cash equivalents	114,888	$ 231,731	$ 78,229
Restricted cash	66,430	6,430	6,084
Total cash, cash equivalents and restricted cash	181,318	$ 238,161	$ 84,313	$ 72,854
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
Future milestone payment	$ 60,000

CASH EQUIVALENTS AND INVESTMENTS - Fair value of company's financial assets (Details) - Recurring - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Total	$ 199,032	$ 372,470
U.S. treasury securities
Total	164,979	117,720
U.S. government agency securities
Total		11,265
Corporate securities
Total		7,230
Commercial paper
Total		148,254
Money market funds
Total	34,053	88,001
Level 1
Total	199,032	205,721
Level 1 \| U.S. treasury securities
Total	164,979	117,720
Level 1 \| Money market funds
Total	$ 34,053	88,001
Level 2
Total		166,749
Level 2 \| U.S. government agency securities
Total		11,265
Level 2 \| Corporate securities
Total		7,230
Level 2 \| Commercial paper
Total		$ 148,254

SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES - Useful lives, impairment (Details)	Dec. 31, 2023
Computer equipment
Property, Plant and Equipment, Useful Life	2 years
Computer software
Property, Plant and Equipment, Useful Life	5 years
Office furniture and equipment
Property, Plant and Equipment, Useful Life	5 years
Lab, process, and validation equipment
Property, Plant and Equipment, Useful Life	5 years
Machinery and equipment \| Minimum
Property, Plant and Equipment, Useful Life	5 years
Machinery and equipment \| Maximum
Property, Plant and Equipment, Useful Life	7 years
Utility equipment
Property, Plant and Equipment, Estimated Useful Lives	us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember
Leasehold improvements
Property, Plant and Equipment, Estimated Useful Lives	us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember

LONG-TERM NOTE PAYABLE (Details) - Job Creation Loan	Jan. 26, 2021 USD ($)
LONG-TERM NOTE PAYABLE
Principal amount	$ 1,000,000.0
Loan term	5 years
Interest rate (as percent)	0.00%
Lender amount	$ 2,000
Average salary	$ 80,000
Average number of term	5 years

- 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

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482900/835-30-50-1

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 235
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-Subparagraph (SX 210.4-08(f))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Paragraph 3
-Subparagraph (SX 210.12-04(a))
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-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-3

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 5: http://www.xbrl.org/2003/role/exampleRef
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-Name Accounting Standards Codification
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-Paragraph 69B
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-URI https://asc.fasb.org//1943274/2147481568/470-20-55-69B

Reference 6: http://www.xbrl.org/2003/role/exampleRef
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-URI https://asc.fasb.org//1943274/2147481568/470-20-55-69C

Reference 7: http://www.xbrl.org/2003/role/exampleRef
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Reference 8: http://www.xbrl.org/2003/role/exampleRef
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-URI https://asc.fasb.org//1943274/2147481568/470-20-55-69F

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 1B
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 11: http://www.xbrl.org/2003/role/exampleRef
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-Subparagraph (d)
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1D

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1D
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1D

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1E

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
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Reference 23: http://www.xbrl.org/2003/role/disclosureRef
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1F
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

INCOME TAXES - Unrecognized benefits (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
INCOME TAXES
Unrecognized benefit - beginning of period	$ 21,645	$ 18,171	$ 14,432
Gross decreases - prior period tax positions	0	0	(159)
Gross increase current period tax positions	4,462	3,474	3,898
Unrecognized benefit - end of period	$ 26,107	$ 21,645	$ 18,171

INTANGIBLE ASSETS, NET

12 Months Ended

Dec. 31, 2023

INTANGIBLE ASSETS, NET

INTANGIBLE ASSETS, NET

NOTE 5. INTANGIBLE ASSETS, NET

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


	December 31, 2023
	Gross carrying amounts		Accumulated amortization		Intangible assets, net
Intangible assets:
Developed technology	$	238,612	$	(9,871)	$	228,741
Assembled workforce		652		(135)		517
Total Intangible Assets	$	239,264	$	(10,006)	$	229,258
* Amounts are translated using the foreign exchange rate as of 12/31/2023.

The Company recognized amortization expense of $9.9 million during the year ended December 31, 2023. Amortization expense for the developed technology and assembled workforce is recorded in Cost of sales and Selling, general and administrative expense, respectively, in the consolidated statement of operations for the year ended December 31, 2023. There was no such expense recorded in the year ended December 31, 2022.

The total estimated amortization of the Company’s intangible assets the years ending December 31, 2024, 2025, 2026, 2027 and 2028 are $16.1 million, $16.1 million, $16.0 million, $15.9 million, and $15.9 million, respectively.

LICENSES AND AGREEMENTS

12 Months Ended

Dec. 31, 2023

LICENSES AND AGREEMENTS

LICENSES AND AGREEMENTS

NOTE 13. 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 $2.0 million for each of the years ended December 31, 2023, 2022 and 2021, 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 our 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. The Company recorded milestone costs associated with the Second Amended and Restated Patent License Agreement, specifically for the completion of the first licensee-sponsored Phase 2 trial of $0.6 million for the year ended December 31, 2023. In addition, with the approval of Amtagvi™, we will be required to remit $1.5 million within 60 days of the approval date in accordance with the requirements of the Second Amended and Restated Patent License Agreement. No expenses were recorded for the years ended December 31, 2022 and 2021, respectively.

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 a mutually agreed determination of the completion of the Research Agreement. The Company recorded research and development costs of $0.2 million, $0.6 million and $0.3 million for each of the years ended December 31, 2023, 2022 and 2021, respectively.

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 years ended December 31, 2023, and for the year ended December 31, 2022 and 2021 the Company recorded $0.1 million of research and development costs, in connection with the research collaboration and clinical grant agreements with Moffitt.

Exclusive License Agreements with Moffitt

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 years ended December 31, 2023, 2022, and 2021.

The Company entered into a second license agreement with Moffitt effective as of May 7, 2018 (the “Second Moffitt License”), under which the Company received a license to Moffitt’s rights to patent-pending technologies related to the use of 4-1BB agonists in conjunction with TIL manufacturing processes and therapies. 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 $0.1 million, $0.2 million and $0.1 million for the years ended December 31, 2023, 2022 and 2021, respectively, as research and development expenses in connection with this agreement.

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 December 31, 2023 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. The Company recorded zero, $0.2 million and $0.5 million associated with the SAA for the years ended December 31, 2023, 2022 and 2021 as research and development expenses, respectively.

WuXi Advanced Therapies, Inc.

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 $17.3 million, $14.2 million, and $17.5 million for the years ended December 31, 2023, 2022, and 2021 respectively, as research and development expenses.

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 $0.4 million for each of the years ended December 31, 2023, 2022, and 2021 respectively as research and development expense.

Novartis Pharma AG

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 for the year ended December 31, 2020. No expenses were recorded for the years ended December 31, 2023 and 2022.

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 year ended December 31, 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 years ending December 31, 2024, 2025, 2026 and 2027, are $8.2 million, $11.4 million, $7.3 million, and $7.3 million, respectively.

LEGAL PROCEEDINGS

12 Months Ended

Dec. 31, 2023

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS

NOTE 15. 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 Feb. 3, 2023.

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 $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 judgement 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

LEASES - Components of lease expenses (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
LEASES
Operating lease cost	$ 17,786	$ 17,657
Variable lease cost	7,629	5,447
Short-term lease cost	335	154
Total lease cost	25,750	23,258
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations	16,871	14,209
Tenant improvement allowance received for amounts included in the measurement of lease liabilities included in cash flows from operations		6,432
Right-of-use assets obtained from entering new leases	177	553
Increase in right-of-use assets from lease modifications	$ 1,033	$ 15,304
Weighted-average remaining lease terms (years)	13 years 1 month 2 days	12 years 10 months 24 days
Weighted-average discount rates	7.40%	7.50%

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2023
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

CASH EQUIVALENTS AND INVESTMENTS - Available for sale debt securities (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
CASH EQUIVALENTS AND INVESTMENTS
Cash equivalents	$ 34,053	$ 132,356
Short-term investments	164,979	240,114
Total investments	$ 199,032	$ 372,470

CASH EQUIVALENTS AND INVESTMENTS

12 Months Ended

Dec. 31, 2023

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 December 31, 2023 and December 31, 2022 were as follows (in thousands):


			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


			Gross		Gross
	Amortized		Unrealized		Unrealized
As of December 31, 2022	Cost		Gains		Losses		Fair Value
U.S. treasury securities	$	118,570	$	—	$	(850)	$	117,720
U.S. government agency securities		11,272		—		(7)		11,265
Corporate securities		7,230		—		—		7,230
Commercial paper		148,299		8		(53)		148,254
Money market funds		88,001		—		—		88,001
Total investments	$	373,372	$	8	$	(910)	$	372,470

The fair value of cash equivalents and investments as of December 31, 2023 and December 31, 2022 are classified as follows in the Company’s consolidated balance sheets (in thousands):


	December 31,		December 31,
Classified as:	2023		2022
Cash equivalents	$	34,053	$	132,356
Short-term investments		164,979		240,114
Total investments	$	199,032	$	372,470

Cash equivalents in the tables above exclude cash demand deposits of $80.8 million and $99.4 million as of December 31, 2023 and 2022, respectively. Unrealized gains and losses are included in accumulated other comprehensive (loss) income, and as of December 31, 2023 and 2022 no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of December 31, 2023 and December 31, 2022 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 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


	Assets at Fair Value as of December 31, 2022
	Level 1		Level 2		Level 3		Total
U.S. treasury securities	$	117,720	$	—	$	—	$	117,720
U.S. government agency securities		—		11,265		—		11,265
Corporate securities		—		7,230		—		7,230
Commercial paper		—		148,254		—		148,254
Money market funds		88,001		—		—		88,001
Total	$	205,721	$	166,749	$	—	$	372,470

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.

PROPERTY AND EQUIPMENT, NET - (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 141,943	$ 121,950
Less: Accumulated depreciation and amortization	(27,913)	(16,718)
Property and equipment, net	114,030	105,232
Leasehold improvements
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	76,804	74,305
Lab, process, and validation equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	23,131	22,136
Utility equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	5,990	5,951
Office furniture and equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	3,297	2,927
Computer software
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	7,772	6,736
Computer equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	542	695
Machinery and equipment
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	306	82
Construction in progress
Property, Plant and Equipment [Line Items]
Total property and equipment, cost	$ 24,101	$ 9,118

STOCKHOLDERS' EQUITY (Tables)

12 Months Ended

Dec. 31, 2023

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, 2022	15,240,197	$	22.45
Issued	5,379,670		7.04
Exercised	(8,860)		7.10
Expired/Cancelled	(1,711,158)		17.01
Outstanding at December 31, 2023	18,899,849	$	18.57	6.75	$	7,065
Ending vested and expected to vest at December 31, 2023	18,899,849	$	18.57	6.75	$	7,065
Options exercisable at December 31, 2023	12,160,135	$	23.40	5.54	$	1,337

Schedule of summary of RSU activity including PRSUs


		Weighted
	Number	Average
	of	Grant Date
	RSUs and PRSUs	Fair Value
Outstanding, non-vested as of December 31, 2022	2,436,764	$	14.74
Granted	2,729,348		7.19
Vested/Released	(1,253,465)		16.17
Canceled/Forfeited	(458,746)		9.35
Outstanding as of December 31, 2023	3,453,901	$	8.97
Ending vested and expected to vest at December 31, 2023	3,453,901	$	8.97

Schedule of stock-based compensation



	Years Ended December 31,
	2023		2022		2021
Research and development	$	34,926	$	50,242	$	40,833
Selling, general and administrative		27,699		33,780		28,932
Total stock-based compensation expense	$	62,625	$	84,022	$	69,765

Schedule of stock-based compensation by type of award



	Years Ended December 31,
	2023		2022		2021
Stock option expense	$	45,340	$	58,308	$	56,305
Restricted stock expense		16,062		24,436		12,247
ESPP expense		1,223		1,278		1,213
Total stock-based compensation expense	$	62,625	$	84,022	$	69,765

Schedule of share-based payment award, stock options, valuation assumptions


	Stock Option			ESPP
	Years Ended December 31,			Years Ended December 31,
Assumptions:	2023	2022	2021	2023	2022	2021
Expected term (years)	5.18 - 5.37	4.94 - 5.12	4.94 - 5.28	0.5	0.50	0.50
Expected volatility	83.63% - 84.21%	73.73% - 83.90%	70.35% - 73.88%	72.96% - 83.36%	73.02% - 137.42%	52.04% - 94.56%
Risk-free interest rate	3.59% - 4.60%	1.25% - 4.05%	0.36% - 0.97%	5.38% - 5.40%	1.98% - 4.78%	0.06% - 0.13%
Expected dividend yield	0%	0%	0%	0%	0%	0%

STOCKHOLDERS' EQUITY - Assumptions (Details)	12 Months Ended
STOCKHOLDERS' EQUITY - Assumptions (Details)	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Employee Stock Option [Member]
Expected dividend yield	0.00%	0.00%	0.00%
Employee Stock Option [Member] \| Minimum
Expected term (years)	5 years 2 months 4 days	4 years 11 months 8 days	4 years 11 months 8 days
Expected volatility	83.63%	73.73%	70.35%
Risk-free interest rate	3.59%	1.25%	0.36%
Employee Stock Option [Member] \| Maximum
Expected term (years)	5 years 4 months 13 days	5 years 1 month 13 days	5 years 3 months 10 days
Expected volatility	84.21%	83.90%	73.88%
Risk-free interest rate	4.60%	4.05%	0.97%
2020 ESPP
Expected term (years)	6 months	6 months	6 months
Expected dividend yield	0.00%		0.00%
2020 ESPP \| Minimum
Expected volatility	72.96%	73.02%	52.04%
Risk-free interest rate	5.38%	1.98%	0.06%
2020 ESPP \| Maximum
Expected volatility	83.36%	137.42%	94.56%
Risk-free interest rate	5.40%	4.78%	0.13%

INCOME TAXES

12 Months Ended

Dec. 31, 2023

INCOME TAXES

INCOME TAXES

NOTE 12. INCOME TAXES

The Company recorded an income tax benefit of $3.5 million for the year ended December 31, 2023, but did not record a provision or benefit for income taxes for the years ended December 31, 2022 or 2021.

Upon the completion of the Acquisition on May 18, 2023, a deferred tax liability of $20.4 million was recognized on the temporary differences related to the book and tax basis of the acquired intangible assets. 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.

The Company recorded a tax benefit of $3.5 million for the year ended December 21, 2023, which resulted in an effective tax rate of 0.78%. 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 the movement of deferred tax assets and liabilities.

The significant components of the Company’s net deferred tax assets and liabilities are summarized as follows (in thousands):


	As of December 31,
	2023		2022
Deferred income tax assets:
Net operating loss carryforwards	$	255,639	$	225,904
Stock-based compensation		28,609		24,920
Tax credit carryforwards		58,565		46,957
Lease liabilities		16,024		18,017
Capitalized R&D		99,107		47,755
Reserves and accruals		6,540		3,997
Deferred tax assets before valuation allowance		464,484		367,550
Less: valuation allowance		(446,853)		(350,418)
Net deferred income tax assets		17,631		17,132
Deferred tax liabilities:
Right-of-use assets		(13,381)		(15,578)
Depreciation and amortization		(21,597)		(1,554)
Net deferred tax assets (liabilities)	$	(17,347)	$	—

The reconciliation of the effective income tax rate to the U.S. statutory rate is as follows:


	Years ended December 31,
	2023	2022	2021
Federal statutory tax rate	21%	21%	21%
Orphan drug and research credits	2%	1%	2%
Permanent and other differences	(1)%	(1)%	0%
Stock Based Compensation	(1)%	(1)%	0%
State tax, net of federal benefit	1%	1%	0%
	22%	21%	23%
Valuation allowance	(21)%	(21)%	(23)%
Effective tax rate	1%	0%	0%

The Company had net operating loss carryforwards (“NOLs”) for federal and state income tax purposes of approximately $1.2 billion and $180 million, respectively, as of December 31, 2023. $142.4 million of federal NOLs will expire beginning in 2027, while $1.0 billion generated after the recently enacted tax reform will have an indefinite life under the Tax Cuts and Jobs Act of 2017 (the “Tax Act”). The state NOLs will expire if unused in years 2030 through 2043.

The Company’s utilization of NOLs is subject to an annual limitation due to ownership changes that have occurred previously or that could occur in the future as provided in Section 382 of the Internal Revenue Code (“Section 382”), as well as similar state provisions. Section 382 limits the utilization of NOLs when there is a greater than 50% change of ownership as determined under the regulations. Since its formation, the Company has raised capital through the issuance of capital stock and various convertible instruments which, combined with the purchasing shareholders’ subsequent disposition of these shares, has resulted in multiple ownership changes as defined by Section 382, and could result in ownership change in the future upon subsequent disposition. The Company’s utilization of NOLs may also be adversely affected by future changes in federal and state tax laws and regulations.

In assessing the realization of U.S. deferred tax assets, management considers whether it is more likely than not that some portion or all the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon future generation for taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. After consideration of all the information available, management continues to maintain a full valuation allowance against U.S. federal and state net deferred tax assets 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 For the years ended December 31, 2023, 2022 and 2021, the change in the valuation allowance was approximately $96.4 million, $82.9 million, and $78.1 million, respectively. For the year ended December 31, 2023, the Company recorded approximately $17.3 million of net deferred tax liability from its operation in the United Kingdom. The basis difference resulted from acquisition of Proleukin business.

The Company evaluated the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the Company has taken or expects to take in its tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Differences between tax positions taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant to the interpretation are referred to as “unrecognized benefits.” A liability is recognized (or amount of net operating loss carry forward or amount of tax refundable is reduced) for unrecognized tax benefit because it represents an enterprise’s potential future obligation to the taxing authority for a tax position that was not recognized as a result of applying the provisions of ASC 740.

If applicable, interest costs related to the unrecognized tax benefits are required to be calculated and would be classified as income tax expenses in the consolidated statements of operations. Penalties would be recognized as a component of “General and Administrative Expenses” in the consolidated statements of operations.

A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2023, 2022 and 2021 is as follows (in thousands):


	Years Ended December 31,
	2023		2022		2021
Unrecognized benefit - beginning of period	$	21,645	$	18,171	$	14,432
Gross decreases - prior period tax positions		—		—		(159)
Gross increase current period tax positions		4,462		3,474		3,898
Unrecognized benefit - end of period	$	26,107	$	21,645	$	18,171

No interest or penalties on unpaid tax were recorded during the years ended December 31, 2023, 2022, or 2021. The Company does not anticipate any significant changes within 12 months of this reporting date of its uncertain tax positions.

The Company files tax returns in the U.S. federal and state jurisdictions. The U.S. federal and U.S. state taxing authorities may choose to audit tax returns for tax years beyond the statute of limitation period due to significant tax attribute carryforwards from prior years, making adjustments only to carryforward attributes. The Company is not currently under examination by income tax authorities in federal, state or other foreign jurisdictions.

The Inflation Reduction Act of 2022 (the “Act”), which includes certain new tax measures, was signed into law in August 2022. The Act contains two main tax provisions, a new corporate alternative minimum tax imposed on certain corporations meeting average annual financial statement income of more than $1 billion during a three-year tax period, and an excise tax imposed upon share repurchases by certain publicly traded corporations. The Act is effective for tax years beginning after December 31, 2022; however, the provisions of the Act will not have a material impact on the Company’s consolidated financial statements. The Company will continue to monitor the effect of the Act and its impact on the Company.

- 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-14

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-21

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482526/740-270-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-17

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

ACCRUED EXPENSES (Tables)

12 Months Ended

Dec. 31, 2023

ACCRUED EXPENSES

Schedule of accrued expenses

Accrued expenses consist of the following (in thousands):


	December 31,		December 31,
	2023		2022
Employee and consultant related expenses	$	34,814	$	20,188
Clinical related		10,911		14,812
Manufacturing related		10,893		4,467
Facilities related		2,437		6,510
Legal and related services		1,610		3,015
Inventory related		2,148		—
Other accrued expenses		6,593		3,303
Total accrued expenses	$	69,406	$	52,295