0001558370-22-002567 | 10-K | XBRL Viewer

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
CURRENT ASSETS
Cash and cash equivalents	$ 181,564	$ 114,634
Accounts receivable, net	7,712
Inventories	5,512	0
Other current assets	7,473	7,729
Total current assets	202,261	122,363
Property and equipment, net	1,847	1,825
Operating lease right-of-use assets	3,842	4,569
Intangible assets, net	1,663
Other assets	3,170	3,290
TOTAL ASSETS	212,783	132,047
LIABILITIES
Accounts payable	13,552	9,372
Accrued liabilities	12,540	8,197
Operating lease liabilities, current portion	1,783	1,966
Total current liabilities	27,875	19,535
Accrued milestone and royalty payments	2,100	2,695
Operating lease liabilities, long-term portion	1,851	2,013
Other liabilities	851	1,968
TOTAL LIABILITIES	32,677	26,211
Commitments and contingencies (Note 9)
STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value, 5,500,000 shares authorized and none issued at December 31, 2021 and December 31, 2020
Common stock, $0.0001 par value, 100,000,000 shares authorized at December 31, 2021 and December 31, 2020; 43,694,716 and 40,688,447 shares issued at December 31, 2021 and December 31, 2020, respectively	4	4
Additional paid in capital	519,206	391,558
Accumulated other comprehensive income /(loss)	1,371	(526)
Accumulated deficit	(340,475)	(285,200)
TOTAL STOCKHOLDERS' EQUITY	180,106	105,836
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 212,783	$ 132,047

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Consolidated Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001	$ 0.0001
Preferred stock, authorized shares	5,500,000	5,500,000	5,500,000
Preferred stock, shares issued	0	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001	$ 0.0001
Common stock, authorized shares	100,000,000	100,000,000	100,000,000
Common stock, shares issued	43,694,716	40,688,447	39,728,416

Consolidated Statements of Net Loss and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
REVENUES
Total revenues	$ 34,897	$ 20,750
OPERATING COSTS AND EXPENSES
Cost of goods sold	2,304
Licensing royalties	210	2,203
Research and development	93,245	93,697	$ 63,492
Selling, general, and administrative	54,571	44,785	19,512
Total operating costs and expenses	150,330	140,685	83,004
Loss from operations	(115,433)	(119,935)	(83,004)
OTHER INCOME, NET
Gain from sale of priority review voucher, net	62,010
Interest and other income / (loss)	(1,852)	598	1,976
NET LOSS	(55,275)	(119,337)	(81,028)
Other comprehensive income / (loss)
Foreign currency translation	1,897	(576)	43
COMPREHENSIVE LOSS	$ (53,378)	$ (119,913)	$ (80,985)
Net loss per share attributable to common stockholders, basic (in dollars per share)	$ (1.28)	$ (2.97)	$ (2.30)
Net loss per share attributable to common stockholders, diluted (in dollars per share)	$ (1.28)	$ (2.97)	$ (2.30)
Weighted average common shares outstanding, basic (in shares)	43,181,808	40,118,537	35,183,488
Weighted average common shares outstanding, diluted (in shares)	43,181,808	40,118,537	35,183,488
Product
REVENUES
Total revenues	$ 32,897	$ 0	$ 0
License
REVENUES
Total revenues	$ 2,000	$ 20,750

Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	Total
Balance at the beginning of period at Dec. 31, 2018	$ 3	$ 225,352	$ 7	$ (84,835)	$ 140,527
Balance at the beginning of period (in shares) at Dec. 31, 2018	34,193,666
Increase (Decrease) in Stockholders' Equity
Issuance of common stock to investors, net of issuance costs	$ 1	134,703			134,704
Issuance of common stock to investors, net of issuance costs (in shares)	5,134,750
Issuance of common stock to nonemployees (in shares)	400,000
Stock-based compensation expense		4,657			4,657
Foreign currency translation			43		43
Net loss				(81,028)	(81,028)
Balance at the end of period at Dec. 31, 2019	$ 4	364,712	50	(165,863)	198,903
Balance at the end of period (in shares) at Dec. 31, 2019	39,728,416
Increase (Decrease) in Stockholders' Equity
Exercise of stock options		2,004			2,004
Exercise of stock options (in shares)	299,706
Issuance of common stock to nonemployees		8,707			8,707
Issuance of common stock to nonemployees (in shares)	656,896
Stock-based compensation expense		16,135			16,135
Stock-based compensation expense (in shares)	3,429
Foreign currency translation			(576)		(576)
Net loss				(119,337)	(119,337)
Balance at the end of period at Dec. 31, 2020	$ 4	391,558	(526)	(285,200)	105,836
Balance at the end of period (in shares) at Dec. 31, 2020	40,688,447
Increase (Decrease) in Stockholders' Equity
Issuance of common stock to investors, net of issuance costs		107,725			107,725
Issuance of common stock to investors, net of issuance costs (in shares)	2,804,878
Exercise of stock options		589			$ 589
Exercise of stock options (in shares)	190,492				190,492
Stock-based compensation expense		19,334			$ 19,334
Stock-based compensation expense (in shares)	10,899
Foreign currency translation			1,897		1,897
Net loss				(55,275)	(55,275)
Balance at the end of period at Dec. 31, 2021	$ 4	$ 519,206	$ 1,371	$ (340,475)	$ 180,106
Balance at the end of period (in shares) at Dec. 31, 2021	43,694,716

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (55,275)	$ (119,337)	$ (81,028)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain from sale of priority review voucher, net	(62,010)
Depreciation and amortization	782	396	166
Stock-based compensation	19,334	16,135	4,657
Non-cash expense in connection with equity issuance to MSK/MIT		1,331
Non-cash expense in connection with equity issuance to inventors		7,376
Foreign currency transactions	1,897	(576)	43
Changes in assets and liabilities:
Accounts receivable, net	(7,712)
Inventories	(5,512)
Other current assets	256	(3,848)	(1,158)
Other assets	120	(311)	(182)
Accounts payable	4,180	852	2,617
Accrued liabilities and other	1,384	6,751	1,388
NET CASH USED IN OPERATING ACTIVITIES	(102,556)	(91,231)	(73,497)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment	(667)	(175)	(1,965)
Acquisition of intangible assets	(300)
Loans to inventors		(2,610)
Net proceeds from sale of priority review voucher	62,010
NET CASH PROVIDED BY/ (USED IN) INVESTING ACTIVITIES	61,043	(2,785)	(1,965)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common stock, net of issuance costs	107,725		134,704
Proceeds from exercised stock options	589	2,004
NET CASH PROVIDED BY FINANCING ACTIVITIES	108,314	2,004	134,704
Effect of exchange rates on cash and cash equivalents	129	(490)	23
NET INCREASE / (DECREASE) IN CASH AND CASH EQUIVALENTS	66,930	(92,502)	59,265
Cash and cash equivalents at the beginning of period	114,634	207,136	147,871
Cash and cash equivalents at the end of period	181,564	114,634	207,136
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES
Property and equipment purchases in accounts payable			49
Intangible assets acquisition in accrued milestones and royalty payments	1,500
Right-of-use assets obtained in exchange for lease obligations	$ 1,754	$ 2,679	$ 901

ORGANIZATION AND DESCRIPTION OF BUSINESS

12 Months Ended

Dec. 31, 2021

ORGANIZATION AND DESCRIPTION OF BUSINESS

ORGANIZATION AND DESCRIPTION OF BUSINESS

NOTE 1—ORGANIZATION AND DESCRIPTION OF BUSINESS

Y-mAbs Therapeutics, Inc. (“we,” “us,” “our,” the “Company,” or “Y-mAbs”) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody based therapeutic products for the treatment of cancer. We are leveraging our proprietary antibody platforms and deep expertise in the field of antibodies to develop a broad portfolio of innovative medicines.

The Company is headquartered in New York, New York and was incorporated on April 30, 2015 under the laws of the State of Delaware.

BASIS OF PRESENTATION

12 Months Ended

Dec. 31, 2021

BASIS OF PRESENTATION

BASIS OF PRESENTATION

NOTE 2—BASIS OF PRESENTATION

The Company has incurred annual losses since inception. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of drug candidate development; technological uncertainty; uncertainty regarding patents and proprietary rights; uncertainty in obtaining FDA approval in the United States and regulatory approval in other jurisdictions; marketing or sales capability or experience; uncertainty in obtaining adequate payer coverage and reimbursement; dependence on key personnel; compliance with government regulations and the need to obtain additional financing. The Company’s drug candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance reporting capabilities.

The Company’s drug candidates are in various stages of development. DANYELZA (naxitamab-gqgk) was approved by the U.S. FDA in November 2020, but there can be no assurance that the Company’s other research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies.

The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Company has experienced negative cash flows from operations since inception, and had an accumulated deficit of $340,475,000 as of December 31, 2021 and $285,200,000 as of December 31, 2020. Through December 31, 2021, the Company has funded its operations primarily through proceeds from sales of shares of its common stock, including its initial public offering in September 2018 and its subsequent public offerings in November 2019 and February 2021.

On February 22, 2021, the Company announced the closing of its public offering of 2,804,878 shares of its common stock, at a public offering price of $41.00 per share, which included the exercise in full of the underwriters' option to purchase 365,853 additional shares of common stock. The aggregate gross proceeds to the Company, before deducting underwriting discounts and commissions and offering expenses payable by the Company, were $115,000,000.

As of December 31, 2021, the Company had cash and cash equivalents of $181,564,000, and as of December 31, 2020 the Company had cash and cash equivalents of $114,634,000. As of the issuance date of the financial statements for the year ended December 31, 2021, the Company expects that its cash and cash equivalents at December 31, 2021 will be sufficient to fund its operating expenses and capital expenditure requirements through at least the next twelve months, irrespective of whether any additional product approvals are obtained.

The Company may raise additional capital to fund future operations through the sale of its equity securities, incurring debt, entering into licensing or collaboration agreements with partners, grants or other sources of financing. Sufficient funds may not be available to the Company on attractive terms or at all when needed from equity or debt financing. If FDA approval for omburtamab does not occur or is significantly delayed, and the Company is unable to obtain additional financing from these or other sources when needed, it will likely be necessary to take other actions to enhance its liquidity position which may include significantly reducing the current rate of spending through delaying, scaling back current operations, or suspending certain research and development programs and other operational programs.

The accompanying consolidated financial statements reflect the accounts of the Company and its wholly-owned subsidiary and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, net product revenues, the accrual for research and development expenses, the accrual of milestone and royalty payments, and the valuation of stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.

The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including expenses, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international markets.

Cash and Cash Equivalents

The Company considers all highly liquid instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund which is unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. We maintain cash balances in excess of insured limits. We do not anticipate any losses with respect to such cash balances.

Trade Accounts Receivables

The Company’s trade accounts receivable balance consists of amounts due from sales of our approved product, DANYELZA. Receivables from product sales are recorded net of allowances which generally include chargebacks, doubtful accounts, rebates, returns, and discounts. The Company accrues allowances based on the estimation of each individual sales transaction.

The Company has not experienced any write-offs related to our customers and has not recognized any allowance for doubtful accounts nor reversed any allowances during the years ended December 31, 2021, 2020 or 2019.

Concentration of Credit Risk

The Company product sales are made through arrangements primarily with three national specialty distributors in the United States of America. As of December 31, 2021, the receivables balances from such distributors totaled 99%

of our outstanding accounts receivable. The Company has contractual payment terms with each of its customers and the Company monitors their financial performance, historical payment terms and credit worthiness to timely assess and respond to any changes in their credit profile.

Inventory

The Company values its inventories at the lower of cost or net realizable value on a first-in, first-out basis. The Company’s inventory costs include amounts related to materials, third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process, and indirect overhead costs. Raw and intermediate materials that may be utilized for both commercial and clinical programs are identical and given the alternative future use such amounts are initially classified as inventory. Amounts in inventory associated with clinical development programs are charged to research and development expense when the product enters the research and development process and can no longer be used for commercial purposes and, therefore, does not have an alternative future use.

The Company capitalizes inventory costs related to products to be sold in the ordinary course of business. The Company makes a determination of capitalizing inventory costs for a product based on, among other factors, status of regulatory approval, information regarding safety, efficacy and expectations relating to commercial sales and recoverability of costs. For DANYELZA, the Company commenced capitalization of inventory at the receipt of FDA approval. Prior to FDA approval, the Company expensed such costs as part of research and development expenses.

The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of goods sold. The determination of whether inventory costs will be realizable requires estimates by management. No material inventory write-downs occurred and no reserves were reversed in the years ended December 31, 2021, 2020 or 2019.

Fair Value Measurements

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (i.e. an exit price). The accounting guidance includes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The three levels of the fair value hierarchy are as follows:

• Level 1 — Unadjusted quoted prices for identical assets or liabilities in active markets;

• Level 2 — Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the asset or liability; and

• Level 3 — Unobservable inputs for the asset or liability, which include management's own assumption about the assumptions market participants would use in pricing the asset or liability, including assumptions about risk.

Cash equivalents held in money market funds are valued using other significant observable inputs, which represent a Level 2 measurement within the fair value hierarchy. The Company has no other cash equivalents.

The following tables present the Company’s fair value hierarchy for its cash equivalents, which are measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements at December 31, 2021 Using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	166,729	$	—	$	166,729
Total	$	—	$	166,729	$	—	$	166,729


	Fair Value Measurements at December 31, 2020 Using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	97,302	$	—	$	97,302
Total	$	—	$	97,302	$	—	$	97,302

During the years ended December 31, 2021 and 2020, there were no transfers between Level 1, Level 2 and Level 3.

Operating Leases

As described below, the Company adopted Topic 842 as of January 1, 2019. The Company determines if an arrangement includes a lease at inception. 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 its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement 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 its estimated incremental borrowing rate based on information available at the lease commencement date. Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the estimated rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.

The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. None of the Company’s leases contain any residual value guarantees. Lease expense is recognized on a straight-line basis over the expected lease term. Related variable lease costs incurred are not material to the Company.

Topic 842 also provides practical expedients and certain exemptions for an entity’s ongoing accounting post implementation. The Company currently elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right-of-use assets or liabilities, and this includes not recognizing right-of-use assets or liabilities for existing short-term leases of those assets in transition. We also elected the practical expedient to not separate lease and non-lease components for all of our leases. The Company has made an accounting policy election to account for each separate lease component of a contract and its associated non-lease components as a single lease component. See the Lease Agreements section in NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS for the related disclosures.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset as follows:


		Estimated Useful Life
Furniture and fixtures		5 years
Machinery and equipment		5 years
Leasehold improvements		Shorter of life of lease or 15 years

Depreciation expense on property and equipment was $645,000, $396,000, and $166,000 for the years ended December 31, 2021, 2020, and 2019, respectively.

Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are expensed as incurred.

Impairment of Long-Lived Assets

ASC 360, Property, Plant and Equipment, addresses the financial accounting and reporting for impairment or disposal of long-lived assets. The Company reviews the recorded values of long-lived assets for impairment whenever events or changes in business circumstance indicate that the carrying amount of an asset or group of assets may not be fully recoverable.

Income Taxes

The Company accounts for income taxes under the asset and liability approach for the financial accounting and reporting of income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to net operating loss carry forwards and temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. These assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which the temporary differences are expected to reverse. We maintain a full valuation allowance on our deferred tax assets based on cumulative historical and expected losses. If we achieve profitability, we will consider the continued need for such valuation allowance.

The Company prepares and files tax returns based on its interpretation of tax laws and regulations. In the normal course of business, the Company’s tax returns are subject to examination by various taxing authorities. Such examinations may result in future tax and interest assessments by these taxing authorities. In determining the Company’s tax provision for financial reporting purposes, the Company establishes a reserve for uncertain tax positions unless such positions are determined to be more likely than not of being sustained upon examination based on their technical merits. The Company considers many factors when evaluating and estimating its tax positions and tax benefits, which may require periodic adjustments and which may not accurately anticipate actual outcomes. Accordingly, the Company will report a liability for unrecognized tax benefits resulting from any uncertain tax positions taken or expected to be taken on a tax return.

The Company’s policy is to recognize, when applicable, interest and penalties on uncertain tax positions as part of income tax expense.

In accordance with guidance issued by Financial Accounting Standards Board (“FASB”), companies should make and disclose a policy election as to whether they will recognize deferred taxes for basis differences expected to reverse as Global Intangible Low-Taxed Income (“GILTI”) or whether they will account for GILTI as period costs if and when incurred. The Company has elected to recognize the resulting tax with respect to the GILTI provision as a period cost. No costs were incurred by the Company through December 31, 2021 as a result of GILTI.

Revenue Recognition

To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The company only applies the five-step model to arrangements that meet the definition of a contract with a customer under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the company assesses the goods or services promised within each contract, determines those that are performance obligations, and assess whether each promised good or service is distinct. The company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Under the practical expedient permitted under Topic 606, the Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the assets is one year or less.

If there are multiple distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. In assessing whether a promised good or service is distinct in the evaluation of a license arrangement subject to ASC 606, the Company considers factors such as the research, manufacturing and commercialization capabilities of the licensing partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, the Company combines that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The standalone selling price is generally determined based on the prices charged to customers or using expected cost-plus margin.

Product revenue

We recognize revenue from sales of DANYELZA at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt at the end-user hospital.

The amount of revenue we recognize from sales of DANYELZA varies due to rebates, chargebacks and discounts provided under governmental and other programs, distribution related fees and other sales-related deductions. In order to determine those deductions, we estimate, utilizing the expected value method, the amount of revenue that we will ultimately be entitled to. This estimate is based upon contracts with customers and government agencies, statutorily-defined discounts applicable to government-funded programs, estimated payor mix, and other relevant factors. Calculating these amounts involves estimates and judgments, and we review these estimates quarterly. If actual results vary from our original estimates, we will adjust these estimates quarterly, which would affect net product revenue and earnings in the period such variances become known.

●

Rebates and chargebacks

We contract with United States governmental agencies to ensure that DANYELZA will be eligible for coverage under the various programs administered by the agencies. We estimate the rebates and chargebacks to be provided and deduct these estimated amounts from our gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of accrued liabilities for the rebates and a reduction of accounts receivable for the chargebacks. We develop estimates for rebates and chargebacks based upon (i) the Company’s contracts with these agencies, (ii) the government-mandated discounts applicable to government-funded programs, and (iii) information obtained from hospitals and third party consultants regarding the payor mix. Our liability for these rebates and chargebacks mainly consists of claims for which invoices have not yet been received and paid. We do not maintain material levels of inventory in the wholesale or retail channel.

●

Discounts and distribution-related fees

We provide invoice discounts on DANYELZA sales to our distributors for prompt payment and fees for distribution services and invoice discounts reduce the original accounts receivable balances. The payment terms for sales to distributors generally include a 2% discount for prompt payment or fees for distribution services which are based on contractual rates agreed with the respective distributors. Based on historical data and experiences with the distributors, we expect our distributors to earn these discounts and fees and deducts the full amount of these discounts and fees from our gross product revenue at the time such revenues are recognized.

●

Returns

We offer our customers a limited product return rights for damaged, defective, or expiring products. We estimate returns on sales of DANYELZA mainly based on information provided to the Company from the hospitals and distributors. The return reserves are recorded in the same period the related

revenue is recognized, resulting in a reduction of product revenue and an establishment of an accrued liability.

License revenue

In December 2020, the Company entered into a development and commercialization arrangement with SciClone International Pharmaceuticals Ltd. (“SciClone”) for certain indications of DANYELZA and omburtamab within China. As part of the agreement, we received a nonrefundable up-front fee of $20,000,000 for the transfer of the license and know-how related to the product indications. The Company may receive regulatory-based milestone payments up to $40,000,000 and sales-based milestone payments up to $60,000,000 and is entitled to royalties based upon the net sales generated by SciClone related to the product indications in the territory. We considered the license to be distinct from other promises within the arrangement based on the rights and know-how transferred, late-stage development of the underlying indications and anticipated lack of significant involvement required from the joint steering committee associated with the indications. Accordingly, the full transaction price of $20,000,000 was recognized upon transferring of the license and know-how to SciClone. The future potential regulatory milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606. As part of our evaluation of the regulatory milestones constraint, we determined that the achievement of such milestones are contingent upon regulatory approvals which are not within our control and therefore not deemed probable. We expect that the sales-based milestone payments and royalty arrangements will be recognized when the related sales occur or the milestone is achieved. We reevaluate the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur, we assess whether this resolves the constraint and revenue will be recognized. We also considered that the pricing terms for the cost-plus manufacturing and supply terms, included within the arrangement, did not represent a material right to SciClone at inception as the terms reflected stand-alone selling price for similar goods or services.

In November 2020, we entered into an exclusive license and distribution agreement for DANYELZA and omburtamab with Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited covering the State of Israel, West Bank and Gaza Strip.

In December 2020, we entered into a distribution agreement for DANYELZA and omburtamab with Swixx BioPharma AG for the Eastern European territories Bosnia & Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Serbia, Slovakia and Slovenia.

In May 2021, the Company entered into an exclusive distribution agreement with Adium Pharma S.A. (“Adium”) to be the exclusive distributor in Latin America of the Company’s antibodies DANYELZA and omburtamab. As part of this agreement, we received and recognized a nonrefundable up-front fee of $2,000,000 for the transfer of the license and know-how related to the product indications during twelve-month period ended December 31, 2021. The Company may also receive regulatory-based milestone payments up to $3,000,000 and is entitled to royalties based upon the net sales generated by Adium related to the product indications in the territory. We considered the license to be distinct from other promises within the arrangement based on the rights and know-how transferred, late-stage development of the underlying indications and anticipated lack of significant involvement required from the joint steering committee associated with the indications. The future potential regulatory milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606. As part of our evaluation of the regulatory milestones constraint, we determined that the achievement of such milestones are contingent upon regulatory approvals which are not within our control and therefore not deemed probable. We expect that the sales-based milestone payments and royalty arrangements will be recognized when the related sales occur or the milestone is achieved. We reevaluate the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur, we assess whether this resolves the constraint and revenue will be recognized.

For the year ended December 31, 2021, revenues of $649,000 were recognized related to these arrangements and no milestones were achieved.

Research and Development Costs

Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation cost for our employees and consultants that perform our research activities, the fees paid to maintain our licenses, the payments to third parties for manufacturing of products in development and clinical research organizations and additional product development payments, and consumables and other materials used in research and development. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Actual results could differ from the Company’s estimates. The Company is obligated to make certain milestone and royalty payments in accordance with the contractual terms of its license agreement with MSK based upon the resolution of certain contingencies. The Company records the milestone and royalty payments when the achievement of the milestone or payment of the milestone or royalty is probable and the amount of the payment is reasonably estimable. Research and development costs were $93,245,000, $93,697,000, and $63,492,000 for the years ended December 31, 2021, 2020, and 2019, respectively.

Additionally, the Company is obligated to make certain royalty and clinical, regulatory and sales-based milestone payments in accordance with the contractual terms of the MSK License, CD33 License, MabVax Sublicense, and SADA License based upon the resolution of certain contingencies. We record the clinical and regulatory milestone payments when the achievement of the milestones or payment of the milestones is deemed probable, and the amount of the payment is reasonably estimable. As it relates to clinical and regulatory milestone payments under the SADA agreement, those may become due and payable with the passage of time whether or not the milestones have actually been met. When evaluating whether milestones should be recognized under the SADA agreement, the Company uses its collective clinical experience across the company to determine the likelihood of achievement, as well as the current stage of the compounds under development, and estimates the progress of its preclinical studies and clinical trials, completion of milestone events per underlying agreements, the time expected to complete certain development activities, each party’s termination right under the license agreements, invoices received and contracted costs when evaluating whether the clinical milestones should be recognized in each reporting period. We review our assessment each period and make revisions to such estimates as necessary. We recognized research and development costs in connection with SADA licensing milestones of $605,000 for the year ended December 31, 2020 as we deemed them probable of occuring. The Company determined that the achievement of the regulatory milestones under the SADA agreement were not probable given the current stage of the product development. The remaining total clinical milestones of $4,125,000 were determined to not be probable as of December 31, 2021, as detailed in NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS.

Patent Costs

The Company expenses the costs of obtaining and maintaining patents as selling, general, and administrative expenses.

Advertising and Promotion Costs

Advertising and promotion costs are included in selling, general, and administrative expenses and were immaterial in the years ended December 31, 2021, 2020, and 2019. Advertising and product promotion costs are expensed as incurred.

Stock-Based Compensation

The Company measures stock options granted to employees, directors and consultants based on the fair value on the date of the grant and recognizes compensation expense of those awards, over the requisite service period, which for employees and directors is the vesting period of the respective award. Forfeitures are accounted for as they occur. The Company issues stock options with only service-based or immediate vesting conditions and records the expense for these awards using the straight-line method over the requisite service period.

Following the Company’s adoption of ASU 2018-07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), on January 1, 2019, for stock-based option awards issued to non-employees, the Company no longer revalues non-employee awards at each reporting date and instead calculates the fair value of the awards as of the grant date using the Black-Scholes option-pricing model. The overall fair value measurement for non-employees awards is consistent with the awards issued to employees.

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The Company’s public trading commenced in September 2018, and, as a result, there is only limited available historical volatility experience. Therefore, we estimate our expected share price volatility based on the historical volatility of a group of publicly-traded peer companies. Starting the fourth quarter of 2021, we added a weighting of our own volatility to the estimation with the historical volatility of a group of publicly traded peer companies, and we expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded share price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards as the Company has limited historical data to support the expected term assumption. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield is based on the fact that the Company has never paid cash dividends on common shares and does not expect to pay any cash dividends in the foreseeable future.

Stock-based compensation costs were $19,334,000, $16,135,000, and $4,657,000 for the years ended December 31, 2021, 2020, and 2019, respectively.

Segment Information

The Company is engaged solely in the discovery and development of novel antibody-based therapeutic products for the treatment of cancer. Accordingly, the Company has determined that it operates in one operating segment.

Comprehensive Loss

Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with shareholders. The difference between net loss and comprehensive loss for the period presented in the accompanying financial statements was due to foreign currency translation.

Foreign Currency

The financial statements of our international subsidiaries with a functional currency other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates during the period for operating results. Translation gains and losses are included in accumulated other comprehensive income / (loss), net of tax, in stockholders’ equity. Foreign currency transaction gains and losses are included in the results of operations in other income and expense, and totaled $1,897,000, $(576,000), and $43,000 for the years ended December 31, 2021, 2020, and 2019, respectively.

Recently Issued Accounting Pronouncements - Adopted

In October 2020, the FASB issued Accounting Standards Update No. 2020-10 (“ASU 2020-10”), Codification improvements. The amendments in this Update represent changes to clarify the Codification, correct unintended application of guidance, or make minor improvements to the Codification. The adoption of this standard on December 31, 2020 did not have a material impact on our consolidated financial statements and related disclosures.

In March 2020, the FASB issued Accounting Standards Update No. 2020-04 (“ASU 2020-04”), Reference rate reform (Topic 848)—Facilitation of the effects of reference rate reform on financial reporting. The amendments in this Update provide optional guidance for a limited time to ease the potential burden in accounting for (or recognizing the effects) of reference rate reform on financial reporting. The amendments in this Update provide optional expedients and

exceptions for applying generally accepted accounting principles (GAAP) to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The amendments in this Update are effective for all entities as of March 12, 2020 through December 31, 2022. The adoption of this standard on January 1, 2021 did not have a material impact on our consolidated financial statements and related disclosures.

In December 2019, the FASB issued Accounting Standards Update No. 2019-12 (“ASU 2019-12”), Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in this Update affect entities within the scope of Topic 740, Income Taxes, and are effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The adoption of this standard on January 1, 2021 did not have a material impact on our consolidated financial statements and related disclosures

In August 2018, the FASB issued Accounting Standards Update No. 2018 -13 (“ASU 2018-13”), Fair Value Measurement (Topic 820) Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 allows to remove the reasons for transfer between Level 1 and Level 2 assets, and adds the changes in unrealized gains and losses for recurring level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. The adoption of this standard on January 1, 2020 did not have a material impact on our consolidated financial statements and related disclosures.

In August 2018, the FASB issued Accounting Standards Update No. 2018-15 (“ASU 2018-15”), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 clarifies certain aspects of ASU 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, which was issued in April 2015. Specifically, ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal use software (and hosting arrangements that include an internal-use software license). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. The adoption of this standard on January 1, 2020 did not have a material impact on our consolidated financial statements and related disclosures.

In July 2018, the FASB issued Accounting Standards Update No. 2018-09 (“ASU 2018-09”), Codification Improvements, which clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2018-09 are not expected to have a significant effect on current accounting practices. Some of the amendments in this update do not require transition guidance and will be effective upon this update. However, many of the updates do have transition guidance with effective dates for periods beginning after December 15, 2018. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures.

In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation. ASU 2018-07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures.

In February 2018, the FASB issued Accounting Standards Update No. 2018-02, (“ASU 2018-02”), Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018-02 allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018-07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures.

In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2016-13 (“ASU 2016-13”) Financial Instruments—Credit Losses (Topic 326): Measurement of credit losses on financial instruments. ASU 2016-13 introduces the current expected credit losses methodology (CECL) for estimating allowances

for credit losses. The standard is effective in fiscal years and interim periods beginning after December 15, 2019. The adoption of this standard on January 1, 2020 did not have a material impact on our consolidated financial statements and related disclosures.

In February 2016, the FASB issued Accounting Standards Update No. 2016-02 (“ASU 2016-02”), Leases, which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018 with early adoption permitted. Under ASU 2016-02, lessees will be required to recognize for most leases, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right-to-use asset, which is an asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. Topic 842 was subsequently amended by ASU 2017-13, Revenue and Leases: Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments; ASU 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements and ASU No. 2018-20, Narrow Scope Improvements for Lessors.

The Company adopted the new leasing standards using the modified retrospective transition approach as of January 1, 2019, with no restatement of prior periods or cumulative adjustment to retained earnings. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. The Company used the effective date as our date of initial application. Consequently, financial information was not updated and the disclosures required under the new standard are not provided for dates and periods before January 1, 2019. The new standard also provides a number of optional practical expedients in transition. The Company elected the package of practical expedients, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs.

Upon adoption of the new leasing standards, the Company recognized a lease liability of $1,800,000 and a related right-of-use asset of $1,500,000 with the difference being due to the elimination of previously reported deferred rent. Please refer to NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS for futher details.

PRODUCT REVENUE

12 Months Ended

Dec. 31, 2021

REVENUE RECOGNITION

REVENUE RECOGNITION

NOTE 4—PRODUCT REVENUE

The Company’s net product revenues were generated from sales of DANYELZA and totaled $32,897,000 for the year ended December 31, 2021. There were no product sales for the years ended December 31, 2020 and 2019.

Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, discounts, distribution-related fees and other sales-related deductions. Accruals for chargebacks and discounts are recorded as a direct reduction to accounts receivable. Accruals for rebates, distribution-related fees and other sales-related deductions are recorded within accrued liabilities. As of December 31, 2021, the company had recorded accounts receivable allowances of approximately $486,000 and accrued liabilities of $2,615,000 related to product sales.

An analysis of the change in reserves for discounts and allowances is summarized as follows:


				Contractual
				Allowances and
		Discounts		Government Rebates		Returns		Total
		(in thousands)		(in thousands)		(in thousands)		(in thousands)
Balance, December 31, 2020	$	—	$	—	$	—	$	—
Current provisions relating to sales in current year		64		4,357		428		4,849
Payments/credits relating to sales in current year		(51)		(1,330)		(367)		(1,748)
Balance, December 31, 2021	$	13	$	3,027	$	61	$	3,101

Substantially all of the Company’s product sales were in the United States. The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for year ended December 31, 2021. Two wholesalers accounted for 73.2% and 17.6%, respectively, of our gross product revenue for the year ended December 31, 2021.

- 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
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

+ Details

NET LOSS PER SHARE

12 Months Ended

Dec. 31, 2021

NET LOSS PER SHARE

NET LOSS PER SHARE

NOTE 5—NET LOSS PER SHARE

Basic net loss per share (“EPS”) is calculated by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated by adjusting weighted average common shares outstanding for the dilutive effect of common stock options and restricted stock units. In periods in which a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be antidilutive. Securities that could potentially dilute basic EPS in the future were not included in the computation of diluted EPS because to do so would have been antidilutive. The calculations of basic and diluted net loss per share are as follows (in thousands, except per share amounts):


	Year ended December 31,
	2021		2020		2019


Net loss (numerator)	$	(55,275)	$	(119,337)	$	(81,028)
Weighted-average shares (denominator), basic and diluted		43,182		40,119		35,183
Basic and diluted net loss per share	$	(1.28)	$	(2.97)	$	(2.30)

Potentially dilutive securities excluded from the computation of diluted earnings per share relate to stock options and unvested restricted share units (“RSUs”) outstanding totaled 6,716,035 shares as of December 31, 2021, 5,704,246 shares as of December 31, 2020, and 4,005,873 shares as of December 31, 2019, and were excluded because including them would have an anti-dilutive impact.

INVENTORY

12 Months Ended

Dec. 31, 2021

INVENTORY

INVENTORY

NOTE 6—INVENTORY

Inventories consist of the following (in thousands):


		As of December 31, 2021
	Raw Material		Work In Progress		Finished Goods		Total

Inventories	$	—	$	4,741	$	771	$	5,512

The Company had no inventories as of December 31, 2020 and 2019 and had no inventory amounts written down as a result of excess and obsolescence, lower of cost or net realizable value or other reasons charged to cost of goods sold for the years ending December 31, 2021, 2020 or 2019.

INTANGIBLE ASSETS

12 Months Ended

Dec. 31, 2021

INTANGIBLE ASSETS

INTANGIBLE ASSETS

NOTE 7—INTANGIBLE ASSETS

The company’s intangible assets as of December 31, 2021 totaled $1,663,000 and related to capitalized milestone payments made following FDA approval and commercialization of DANYELZA. The intangible asset net book value as of December 31, 2021 is after $137,000 of accumulated amortization. The Company presented intangible assets as of December 31, 2020 within ‘Other Assets’ in the Consolidated Balance Sheets.

ACCRUED LIABILITIES

12 Months Ended

Dec. 31, 2021

ACCRUED LIABILITIES

ACCRUED LIABILITIES

NOTE 8—ACCRUED LIABILITIES

Accrued short-term liabilities at December 31, 2021 and December 31, 2020 are as follows (in thousands):


	December 31,		December 31,
	2021		2020



Accrued licensing, milestone and royalty payments	$	3,090	$	3,608
Accrued clinical costs		915		678
Accrued compensation and board fees		1,877		2,603
Accrued manufacturing costs		2,622		983
Accrued sales reserves		2,615		—
Other		1,421		325
Total	$	12,540	$	8,197

LICENSE AGREEMENTS AND COMMITMENTS

12 Months Ended

Dec. 31, 2021

LICENSE AGREEMENTS AND COMMITMENTS

LICENSE AGREEMENTS AND COMMITMENTS

NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS

As of December 31, 2021, the Company has entered into two license agreements and certain other agreements with Memorial Sloan Kettering Cancer Center (“MSK”). The license agreements are the MSK License and the CD33 License Agreement. Through a Settlement and Assumption and Assignment of the MSK License and Y-mAbs Sublicense Agreement (“SAAA”) with MabVax, Inc. (“MabVax”) and MSK, the Company has established a direct license with MSK relating to the GD2-GD3 Vaccine, which was originally sublicensed by the Company in 2018 from MabVax.

On April 15, 2020, we entered into a license agreement (the “SADA License Agreement”) with MSK and Massachusetts Institute of Technology (“MIT”) that grants us an exclusive worldwide, sublicensable license to MSK’s and MIT’s rights to certain patent and intellectual property to develop, make, and commercialize licensed products and to perform services for all therapeutic and diagnostic uses in the field of cancer diagnostics and cancer treatments using the SADA BiDE Pre-targeted Radioimmunotherapy Platform (“SADA technology”). We have assessed the licensing and other rights acquired and given the lack of outputs upon acquisition and that no employees were acquired, among other factors, we have concluded that the licensing rights represented an asset acquisition.

The patents and patent applications covered by this agreement are directed, in part, to the SADA technology, as well as a number of SADA constructs developed by MSK. Upon entering into the SADA License Agreement and in exchange for the licenses granted thereunder, we concluded that the technology acquired under the licensing arrangement had no alternative future use. This conclusion was based on consideration of the rights conveyed under the agreement, extent of further development necessary and presence of uncertainty prior to obtaining regulatory approval for any product. Accordingly, we expensed and paid an upfront payment to MSK and MIT of $1,995,000. During the year ended December 31, 2020, we expensed $3,331,000 associated with stock grants available to MSK and MIT. This includes $1,331,000 related to 42,900 shares of common stock issued to the licensors on the effective date of the agreement based on the fair value of the stock on the grant date and $2,000,000 of future stock grants of which $1,000,000 was paid cash in 2021 with the remaining $1,000,000 to be paid in cash or stock grants at our discretion on the anniversary date of the SADA License Agreement in 2022. These awards survive the potential termination of the licensing arrangement, unless a breach by the licensors occurs. During the year ended December 31, 2020, we expensed $7,376,000 related to 213,996 shares issued to two non-employee researchers based on the fair value of the shares on the grant date. The above expenses were all recorded as research and development expenses. Please reference NOTE 10—STOCKHOLDERS’ EQUITY for additional details. The Company did not occur such expenses for the year ended December 31, 2021.

The SADA License Agreement requires us to pay to MSK and MIT mid to high single-digit royalties based on annual net sales of licensed products or the performance of licensed services by us and our affiliates and sublicensees. We are obligated to pay annual minimum royalties of $40,000, increasing to $60,000 once a patent has been issued, over

the royalty term, commencing on the tenth anniversary of the license agreement. These amounts are non-refundable but are creditable against royalty payments otherwise due under the SADA License Agreement.

The Company is also obligated to pay MSK and MIT certain clinical, regulatory and sales-based milestone payments under the SADA License Agreement. Certain of the clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the SADA License Agreement.

In addition, to the extent we enter into sublicense arrangements, we are obligated to pay to MSK and MIT a percentage of certain payments received from sublicensees of the rights licensed to us by MSK and MIT, which percentage will be based upon the achievement of certain clinical milestones. The Company has not entered into any sublicenses related to the SADA License Agreement. For each of the constructs previously generated by MSK using the SADA technology and sold for the Company by a sublicensee, the Company may pay sales milestones up to $60,000,000, in total, based on the achievement of various levels of cumulative net sales made by the sublicensee.

Failure by the Company to meet certain conditions under the arrangement could cause the related license to such licensed products to be canceled and could result in termination of the entire arrangement with MSK and MIT. In addition, the Company may terminate the SADA License Agreement with prior written notice.

Research and development is inherently uncertain and as described above, should such research and development fail, the SADA License Agreement is cancelable at the Company’s option. The Company will also consider the development risk and each party’s termination rights under the agreement when considering whether any clinical or regulatory based milestone payments, certain of which also contain time-based payment requirements, are probable. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. During the twelve months ended December 31, 2020, we expensed $605,000 of milestones under the SADA License Agreement. This includes all time-based milestones coming due within 36 months of the effective date of the agreement as this continues to represent the time period we expect will be required to gather necessary clinical data to determine which patent rights to further pursue, if any, under the SADA License Agreement. The Company does not consider any other milestones under the SADA License Agreement to be probable as of December 31, 2021 and 2020.

Certain of the payments are contingent milestone and royalty payments, as disclosed in the table below. Amounts disclosed for accrued milestone and royalty payments are inclusive of obligations under the MSK License, CD33 License Agreement, MabVax License Agreement, and SADA License Agreement, collectively. We have the following significant license agreements and related commitments which include all obligations that have been paid or are accrued as of and for the period ending December 31, 2021, 2020, and 2019 (in thousands):


													Accrued		Accrued		Accrued		Accrued
	Cash paid		Cash paid		Cash paid		Expense		Expense		Expense		liabilities		liabilities		liabilities		liabilities
	Twelve months		Twelve months		Twelve months		Twelve months		Twelve months		Twelve months		Current		Non-current		Current		Non-current
	ended		ended		ended		ended		ended		ended		as of		as of		as of		as of
	December		December		December		December		December		December		December		December		December		December
Agreements	2021		2020		2019		2021		2020		2019		2021		2021		2020		2020
MSK		$ 1,480		$ 80		$ 725		$ 1,170		$ -		$ 75		$ 1,486		$ 1,650		$ 305		$ 1,640
CD33		100		—		—		—		—		—		—		450		100		450
MabVax		10		—		600		10		—		—		—		—		—		—
SADA		1,000		2,707		—		—		14,019		—		1,605		—		1,000		1,605

Minimum royalties and certain clinical milestones that become due based upon the passage of time under the CD33 License Agreement, the MabVax Agreement, and SADA Agreement are not recorded as a liability as the Company does not consider such obligations to be probable as of December 31, 2021.

The below table represents the maximum clinical, regulatory or sales-based milestones as reflected within the agreements, certain of which have been paid in prior periods or are accrued as presented in the table above (in thousands):


	Maximum		Maximum		Maximum
Agreements	Clinical Milestones		Regulatory Milestones		Sales-based milestones
MSK		$ 2,450		$ 9,000		$ 20,000
CD33		550		500		7,500
MabVax		200		1,200		—
SADA		4,730		18,125		23,750

Other agreements

We have also entered into various other support agreements with MSK including a sponsored research agreement to provide research services related to the intellectual property licensed under the MSK License Agreement; a master data services agreement, for services provided by approximately five full time employees at MSK, who are engaged in transferring clinical data, databases, regulatory files and other know-how included in the MSK License Agreement to the Company; a master clinical trial agreement pursuant to which we committed to fund certain clinical trials at MSK; two separate core facility service agreements pursuant to which we committed to obtaining certain laboratory services from MSK; and a CD33 sponsored research agreement pursuant to which we agreed to pay MSK to provide research services over a period of two years related to the intellectual property licensed under the CD33 License Agreement; and in October 2020 we entered into a SADA sponsored research agreement pursuant to which we agreed to pay MSK to provide research services over a period of three years related to the intellectual property licensed under the SADA License Agreement. During 2021, 2020, and 2019, we incurred research and development expenses of $4,086,000, $4,220,000, and $6,757,000, respectively, under these agreements.

Lease Agreements

In July 2019, the Company entered a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx agreed to establish a manufacturing unit designated for the Company within its existing facilities, at which both clinical and commercial supply of radiolabeled omburtamab can be produced. Since the Company possesses the right to substantially all the economic benefits and directs the use of the production area, the Company accounts for the payments related to the access to the manufacturing space under ASC 842 as an operating lease. The term of the lease is two years from the commencement date of August 31, 2020. Upon the lease commencement date, we recorded $3,617,000 as right-of-use asset and $2,680,000 as lease liability with the difference of $937,000 from certain prepayments and other costs incurred. The Company pays equal monthly installments of approximately $117,000 per month in additional access fees through September 2022 resulting in total payments of $932,000 remaining under the agreement. There are no renewal options in this agreement.

In February 2019, the Company entered into a lease agreement in connection with its 4,548 square feet laboratory in New Jersey. In December 2019, we expanded the space with an additional 235 square feet. The term of the lease is three years from the date the Company occupied the premises, with an option to extend for an additional two years which the Company expects to exercise and has included in the determination of the related lease liability. This lease will be expired on the fourth quarter of 2023. Fixed rent payable under the lease is approximately $144,000 per annum and is payable in equal monthly installments of approximately $12,000.

January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease is five years from the date the Company begins to occupy the premises. Fixed rent payable under the lease is approximately $384,000 per annum and is payable in equal monthly installments of approximately $32,000, which are recognized on a straight-line basis.

The Company entered a three-year lease agreement for the lease of certain office space in Denmark in February 2018, as amended in November 2018 and February 2019. Additionally, on September 26, 2021, the Company entered into a lease agreement in Denmark to expand the size of its current office space to a total of 29,288 square feet. The lease is payable in monthly installments of approximately $41,000, which are recognized on a straight line basis. The new lease is expected to last for 48 months and commenced on November 1, 2021 when we were provided access to the leased space. The Company at its discretion has the ability to terminate a portion of the lease from June 1, 2022.

Total operating lease costs were $2,608,000, $1,324,000 and $676,000 for the year ended December 31, 2021, 2020, and 2019, respectively. During the year ended December 31, 2021, the expenses were recorded as $2,367,000 in research and development expense and $241,000 in selling, general, and administrative expense. During the year ended December 31, 2020, the expenses were recorded as $1,114,000 in research and development expense and $210,000 in selling, general, and administrative expense. During year ended December 31, 2019, the expenses were recorded as $493,000 in research and development expense and $183,000 in selling, general, and administrative expense.

Cash paid for amounts included in the measurement of lease liabilities was $2,216,000, $1,248,000, and $606,000 for year ended December 31, 2021, 2020, and 2019, respectively, and was included in net cash used in operating activities in the Company’s Consolidated Statements of Cash Flows.

Maturities of operating lease liabilities at December 31, 2021 and 2020 were as follows (in thousands):


	Operating Leases
	at December 31, 2021
Years ending December 31,
2022	$	1,953
2023		1,025
2024		550
2025		445
Total lease payments		3,973
Less: Imputed interest		(339)
Total operating lease liabilities at December 31, 2021	$	3,634


	Operating Leases
	at December 31, 2020
2021	$	2,180
2022		1,593
2023		540
2024		64
Total lease payments		4,377
Less: Imputed interest		(398)
Total operating lease liabilities at December 31, 2020	$	3,979

Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its estimate of its incremental borrowing rate based on the information available at the lease commencement date. As of December 31, 2021, the weighted average remaining lease term is 2.62 years and the weighted average discount rate used to determine the operating lease liability was 6.5%. As of December 31, 2020, the weighted average remaining lease term is 2.18 years and the weighted average discount rate used to determine the operating lease liability was 7.6%.

Legal Matters

The Company has been named a nominal defendant in a lawsuit instigated by a stockholder against our Chairman of the Board and President, Mr. Thomas Gad, seeking to compel Mr. Gad to disgorge alleged short swing profits stemming from a certain transaction involving the Company’s common stock undertaken by Mr. Gad on March 10, 2021. The Company is of the opinion that the claim is without merit and intends to maintain this position in the proceedings. In addition, the Company had been informed by Mr. Gad that he also believes the claim is without merit, that he has strong defenses against such claim and that he intends to vigorously defend the action. The Company has assessed the proceedings and does not believe that it is probable that a gain or a liability will be realized by the Company. As a result, the Company did not record any loss or gain contingencies for this matter.

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2021

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

NOTE 10—STOCKHOLDERS’ EQUITY

Authorized Stock

As of December 31, 2021, 2020, and 2019, the Company has authorized a total of 105,500,000 shares, 100,000,000 of which are to be common stock, par value $0.0001 per stock, and 5,500,000 of which are to preferred stock, par value $0.0001 per share.

Common Stock

Each share of common stock is entitled to one vote. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to preferential dividend rights of the preferred stock, none of which have been issued. The Company has issued 43,694,716 shares of its common stock as of December 31, 2021, 40,688,447 shares of its common stock as of December 31, 2020, and 39,728,416 shares of its common stock as of December 31, 2019.

Preferred Stock

Preferred stock may be issued from time to time in one or more series with such designations, preferences and relative participating, optional or other special rights and qualifications, limitations or restrictions as approved by the Company’s Board of Directors. No preferred stock has been issued as of December 31, 2021, 2020, or 2019.

Stock grant agreements with non-employees

In August 2015, we entered into stock grant agreements with certain non-employees of the Company. We agreed to issue a total of 2,800,000 shares to two non-employee researchers who were involved in the development of technology licensed from MSK in consideration for their prior service. The shares are released according to a vesting schedule. A total of 560,000; 448,000; 448,000; 544,000; 400,000 and 400,000 shares, respectively, were issued in each year from 2015 through 2020. The total awards were expensed at its estimated fair value in 2015, as no future service was required to continue to vest in and receive the shares. No future shares will be issued under these awards.

In April 2020, in connection with the SADA License Agreement, we entered into certain stock grant agreements pursuant to which we agreed to issue a total of 213,996 shares to two non-employee researchers who were involved in the development of the SADA technology licensed from MSK and MIT in consideration for their prior service. All 213,996 shares were issued in April 2020 into escrow with 40% of the shares immediately vesting at the time of issuance and the remaining 60% of the shares subject to vesting ratably over the next three years on the anniversary date of the agreement. In accordance with the terms of the agreement, during the twelve months ended December 31, 2021, the non-employee researchers vested in an additional 20% of the awards. Therefore, as of December 31, 2021, the two non-employee researchers have vested in 60% of the total grant with the remaining 40% vesting ratably over the next two years on the anniversary date of the agreement. The shares are subject to forfeiture to the extent the SADA License Agreement is terminated prior to the vesting of the shares. There is no cash settlement feature, and no future service is required for the non-employee researchers to vest and receive the shares. While the shares vest over

time, there is no performance condition for the shares. In April 2020, we recorded an expense within research and development totaling $7,376,000 related to the shares which represented the fair value of the shares on the grant date.

In July 2020, pursuant to the stock grant agreements, we also loaned the two researchers a total of $2,610,000 related to their individual tax payments due in conjunction with the stock grants. Each of the loans are evidenced by a three year Secured Promissory Note. The outstanding principal amounts of the loans, together with all accrued interest thereon at the rate of 1% per annum, is due and payable on the maturity date of the loans. The loans are secured by Pledge and Security Agreements, pursuant to which the researchers have pledged the shares as security for repayment of the loans with interest rates that are at market. The loans are recorded at amortized cost, which approximates fair value due to the short-term nature and minimal changes in market interest rates.

There were no shares were issued to non-employees in 2021.

Issuance of common stock

On February 22, 2021, we completed a third public offering of our common stock pursuant to which we issued and sold 2,804,878 shares of our common stock at a price to the public of $41.00 per share which included the exercise in full of the underwriters’ option to purchase additional shares. We received aggregate gross proceeds from our secondary public offering of $115,000,000, with aggregate net proceeds of approximately $107,725,000 after deducting underwriting discounts and commissions and offering expenses.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

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-Publisher FASB
-Name Accounting Standards Codification
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-Subparagraph (b)
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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+ Details

SHARE-BASED COMPENSATION

12 Months Ended

Dec. 31, 2021

SHARE-BASED COMPENSATION

SHARE-BASED COMPENSATION

NOTE 11—SHARE-BASED COMPENSATION

2015 Equity Incentive Plan

Our board of directors and stockholders have approved and adopted the 2015 Plan, which provided for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 4,500,000 shares of our common stock were reserved for issuance pursuant to the 2015 Plan. Options granted under the 2015 Plan vest according to the schedule specified in the grant agreements, which is generally a four year period and generally become immediately exercisable upon the occurrence of a change in control, as defined. Upon the 2018 Equity Incentive Plan (the “2018 Plan’) becoming effective in September 2018, no further grants were allowed under the 2015 Plan.

2018 Equity Incentive Plan

Our board of directors and stockholders approved and adopted the 2018 Plan, which became effective upon the Company’s initial public offering in September 2018 and which provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 5,500,000 shares of our common stock, inclusive of the awards previously granted under the 2015 Equity Incentive Plan, are reserved for issuance pursuant to the 2018 Plan. In addition, the number of shares available for issuance under the 2018 Plan will also include an annual increase on the first day of each fiscal year beginning in 2019, equal to 4% of the outstanding shares of common stock as of the last day of our immediately preceding fiscal year. The exercise price of options granted under the plans must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. Options granted under the 2018 Plan vest according to the schedule specified in the grant

agreements, which is generally a four-year period and generally become immediately exercisable upon the occurrence of a change in control, as defined.

Stock Option Valuation and Restricted Stock Units

During the years ended December 31, 2021, 2020 and 2019, stock-based compensation expenses for stock option grants were $19,032,000, $15,949,000, and $4,581,000, respectively. During 2021, the expenses were recorded as $7,133,000 in research and development expense and $11,899,000 in selling, general, and administrative expense. During 2020, the expenses were recorded as $7,401,000 in research and development expense and $8,548,000 in selling, general, and administrative expense. During 2019, the expenses were recorded as $933,000 in research and development expense and $3,648,000 in selling, general, and administrative expense.

In addition, $302,000 was expensed for restricted stock units in 2021. A total of $269,000 was recorded in research and development expense and $33,000 in selling, general, and administrative expense. In 2020, $186,000 was expensed for restricted stock units. A total of $169,000 was recorded in research and development expense and $17,000 in selling, general, and administrative expense. In 2019, $76,000 was expensed for restricted stock units. A total of $69,000 was recorded in research and development expense and $7,000 in selling, general, and administrative expense.

The total stock based compensation was $19,334,000 in 2021, $16,135,000 in 2020 and $4,657,000 in 2019, respectively.

Stock Option Valuation Activity

The assumptions that the Company used to determine the fair value of the stock options granted to employees, directors and consultants were as follows, presented on a weighted average basis:


	Year Ended		Year Ended		Year Ended
	December 31, 2021		December 31, 2020		December 31, 2019

Risk-free interest rate	1.31	%	0.64	%	1.78	%
Expected term (in years)	6.3		6.3		6.3
Expected volatility	72.6	%	65.0	%	60.6	%
Expected dividend yield	—	%	—	%	—	%

During the year ended December 31, 2020, the Company recognized $4.8 million in stock-based compensation related to an option grant of 150,000 options to a non-employee consultant for past service and contributions to a development program. No further service is required by the non-employee consultant to obtain the options and therefore the Company recorded the full value of the grant on the date of the grant. During the year ended December 31, 2021, the Company did not occur such expenses for non-employees.

The Company recognizes compensation expense for only the portion of awards that vest.

The following table summarizes common stock options issued and outstanding:


						Weighted
		Weighted		Aggregate		average
		average		intrinsic		remaining
		exercise		value		contractual
	Options	price		(in thousands)		life (years)
Outstanding and expected to vest at December 31, 2020	5,674,100	$	22.55	$	156,726	7.51
Granted	1,309,000		20.41
Exercised	(190,492)		3.09
Forfeited	(105,480)		38.96
Outstanding and expected to vest at December 31, 2021	6,687,128	$	22.43	$	26,412	7.21
Exercisable at December 31, 2021	3,872,356	$	16.18	$	25,802	5.90

The weighted average grant-date fair value of stock options granted during the years ended December 31, 2021, 2020 and 2019 was $13.03, $25.40, and $14.92 per share, respectively.

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The Company’s public trading commenced in September 2018, and, as a result, there is only limited available historical volatility experience. Therefore, we estimate our expected share price volatility based on the historical volatility of a group of publicly-traded peer companies. Starting the fourth quarter of 2021, we added a weighting of our own volatility to the estimation with the historical volatility of a group of publicly traded peer companies, and we expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded share price. The expected term of our stock options has been determined utilizing the “simplified” method for awards as we have limited historical data to support the expected term assumption. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield is based on the fact that we have never paid cash dividends on shares of our common stock and do not expect to pay any cash dividends in the foreseeable future. There were no significant changes to the inputs included in the Black-Scholes option pricing model during the period ended December 31, 2021.

As of December 31, 2021, we had $46,405,000 unrecognized stock-based compensation expense related to employee stock options that are expected to vest over a period of 2.94 years.

Restricted Stock Unit Activity

The following table summarizes restricted stock units issued and outstanding:


				Weighted
		Weighted		average
		average		remaining
		grant		vesting
	Restricted Stock Units	price		life (years)
Outstanding and expected to vest at December 31, 2020	30,146	$	25.45	2.18
Granted	13,919		29.32
Vested	(10,899)		24.82
Forfeited	(4,259)		26.44
Outstanding and expected to vest at December 31, 2021	28,907	$	28.04	1.82

As of December 31, 2021, we had $588,000 of unrecognized compensation related to employee restricted stock units that are expected to vest over a period of 1.82 years.

RELATED PARTY TRANSACTIONS

12 Months Ended

Dec. 31, 2021

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS

NOTE 12—RELATED PARTY TRANSACTIONS

MSK is a shareholder of the Company. Under the MSK License Agreement, SADA License Agreement, the CD33 License Agreement, MabVax Agreement, and various other supporting agreements with MSK, we have expensed costs in the total amount of $5,266,000, $11,556,000 and $6,832,000 in the years ended December 31, 2021, 2020, and 2019, respectively, for milestones, minimum royalties, research and development costs, and patent activities. Please refer to NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS for additional details on our agreements with MSK. As of December 31, 2021, we had a total of $748,000 recorded as accounts payable, $5,443,000 as accrued liabilities, thereby totaling $6,191,000 due to MSK. As of December 31, 2020, we had a total of $833,000 recorded as accounts payable, $7,161,000 as accrued liabilities, thereby totaling $7,994,000 due to MSK.

INCOME TAXES

12 Months Ended

Dec. 31, 2021

INCOME TAXES

INCOME TAXES

NOTE 13—INCOME TAXES

Domestic and foreign loss before income taxes are as follows (thousands):


	For The Year Ended December 31,
	2021		2020		2019
United States	$	(47,275)	$	(119,153)	$	(80,598)
Foreign		(8,000)		(184)		(430)
Total	$	(55,275)	$	(119,337)	$	(81,028)

The Company provided no income tax benefits on net losses of $55,275,000, $119,337,000 and $81,028,000 for years ended December 31, 2021, 2020, and 2019, respectively, and maintains a full valuation allowance against its net deferred tax assets.

Current and deferred income taxes (tax benefits) are as follows (thousands):


	For The Year Ended December 31,
	2021		2020		2019
Current income tax
Domestic	$	—	$	—	$	—
Foreign		304		—		—
Total current income taxes (tax benefits)		304		—		—
Deferred income tax
Domestic		—		—		—
Foreign		(304)		—		—
Total deferred income taxes (tax benefits)		(304)		—		—
Total income taxes (tax benefits)	$	—	$	—	$	—

The difference between income taxes expected at the U.S. federal statutory income tax rate of 21% for tax years ended December 31, 2021, 2020, and December 31, 2019, respectively, and income taxes provided are set forth below (thousands):


	For The Year Ended December 31,
	2021		2020		2019
Taxes on income at U.S. federal statutory rate	$	(11,607)	$	(25,061)	$	(17,016)
State and local taxes, net of federal tax effects		(5,523)		(3,059)		(11,022)
Effect of rate change		(1,734)		1,647		(22)
Foreign tax rate differential		(80)		(2)		(4)
Valuation allowance		20,978		30,986		33,984
Tax credits		(1,904)		(4,734)		(5,924)
Uncertain tax position		304		—		—
Other		(434)		223		4
Total	$	—	$	—	$	—

Significant components of the Company’s net deferred tax assets/(liabilities) are as follows (thousands):


	December 31, 2021		December 31, 2020
Deferred tax assets/(liabilities):
Acquired intangibles	$	4,316	$	4,424
Accrued bonus		—		34
Unrealized foreign exchange loss		38		(448)
Accrued royalty		377		284
Stock based compensation		9,222		3,803
Net operating loss carryforwards		88,968		75,711
Tax credit carryforwards		15,050		13,146
ROU asset		(1,015)		(1,068)
Lease liability		960		931
Other		(479)		(357)
Total deferred tax assets/(liabilities)		117,437		96,460
Valuation allowance		(117,437)		(96,460)
Net deferred tax assets/(liabilities)	$	—	$	—

The Company maintains a full valuation allowance on its U.S. and foreign deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative losses historically and in recent years and its forecasted losses in the near term as significant negative evidence. Based upon review of available positive and negative evidence, the Company determined that the negative evidence outweighed the positive evidence and a full valuation allowance on its U.S. and foreign deferred tax assets will be maintained. The Company will continue to assess the realizability of its deferred tax assets and will adjust the valuation allowance as needed.

As of December 31, 2021, the Company had U.S. federal and various state net operating loss (“NOL”) carryforwards of approximately $290,839,000 and $207,011,000, respectively. The Company also had U.S. federal tax credit carryforwards of $15,050,000 as of December 31, 2021. The federal NOL carryforwards of approximately $29,909,000 will begin to expire from 2035 through 2037. The federal NOL of approximately $260,930,000 can be carried forward indefinitely but limited to offset 80% of taxable income. The State and City NOL and tax credit carryforwards will begin to expire in 2030. The NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986 (“IRC”). The Company has performed an analysis of its Section 382 ownership changes through March 31, 2021. Due to the large annual limitation, the Company believes that it is more likely than not that none of the net operating loss carryforwards

will expire as a result of the limitation from the ownership change under Section 382. The Company also has Danish NOL carryforwards of $59,000, which have an indefinite carryforward period.

The Company recognizes income tax benefits for tax positions determined more likely than not to be sustained upon examination, based on the technical merits of the positions.

Changes in the Company’s unrecognized tax benefits, excluding the related accrual of interest and penalties, from January 1 through December 31 are set forth below (thousands):


	Year Ended
	December 31,
	2021		2020		2019
Beginning balance	$	—	$	—	$	—
Additions for prior year tax positions		304		—		—
Ending balance	$	304	$	—	$	—

It is reasonably possible that the amount of uncertain tax positions will decrease by $304,000 in the next 12 months. If recognized, the total amount of uncertain tax positions of $304,000 would not have an impact on the effective tax rate. The Company’s tax returns for the years 2020, 2019, 2018, and 2017 are open for tax examination by U.S. federal and state, and the Danish tax authorities. During 2021, there is an ongoing review of the Company’s transfer pricing policies by the Danish Tax Authorities for tax years 2016 - 2019.

The Company classifies interest and penalty expense related to income tax expense as components of the tax provision for income taxes. As of December 31, 2021, the Company does not have any interest or penalties accrued related to the total amount of unrecognized tax benefits.

- 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
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI http://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

OTHER BENEFITS

12 Months Ended

Dec. 31, 2021

OTHER BENEFITS

OTHER BENEFITS

NOTE 14—OTHER BENEFITS

The Company has established a retirement program for employees of our Danish subsidiary pursuant to which all such employees can contribute an amount at their election from their base compensation and may receive contributions from our Danish subsidiary. Contributions from our Danish subsidiary were immaterial during the years ended December 31, 2021, 2020, and 2019. In addition, health insurance benefits for our Danish employees are fully paid for by such employees. Our Danish subsidiary does not incur any costs for these health insurance benefits.

On October 1, 2018, the Company adopted a defined contribution 401(k) savings plan (the “401(k) plan”) covering all U.S. employees of the Company. Participants may elect to defer a percentage of their pretax or after-tax compensation to the 401(k) plan, subject to defined limitations. The plan allows for a discretionary match by the Company. The Company made no matching contributions to the plan during the years ended December 31, 2021, December 31, 2020, and December 31, 2019.

GAIN FROM SALE OF PRIORITY REVIEW VOUCHER

12 Months Ended

Dec. 31, 2021

GAIN FROM SALE OF PRIORITY REVIEW VOUCHER

GAIN FROM SALE OF PRIORITY REVIEW VOUCHER

NOTE 15 —GAIN FROM SALE OF PRIORITY REVIEW VOUCHER

On December 28, 2020, the Company announced that it entered into a definitive agreement to sell its DANYELZA Priority Review Voucher to United Therapeutics Corporation for $105,000,000. The PRV was granted in conjunction with the approval by the U.S. Food and Drug Administration (“FDA”) of DANYELZA, for the treatment of refractory/relapsed high-risk neuroblastoma. Under the terms of the Company’s license agreement with MSK, Y-mAbs retained 60% of the net proceeds received from the sale, and the remaining 40% was paid to MSK. The transaction closed on January 21, 2021 and the Company recognized a net gain of $62,010,000 in the year ended December 31, 2021, related to the sale.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

Cash and Cash Equivalents

Trade Accounts Receivables

Concentration of Credit Risk

Inventory

Fair Value Measurements

• Level 1 — Unadjusted quoted prices for identical assets or liabilities in active markets;

The following tables present the Company’s fair value hierarchy for its cash equivalents, which are measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements at December 31, 2021 Using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	166,729	$	—	$	166,729
Total	$	—	$	166,729	$	—	$	166,729


	Fair Value Measurements at December 31, 2020 Using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	97,302	$	—	$	97,302
Total	$	—	$	97,302	$	—	$	97,302

During the years ended December 31, 2021 and 2020, there were no transfers between Level 1, Level 2 and Level 3.

Operating Leases

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset as follows:


		Estimated Useful Life
Furniture and fixtures		5 years
Machinery and equipment		5 years
Leasehold improvements		Shorter of life of lease or 15 years

Depreciation expense on property and equipment was $645,000, $396,000, and $166,000 for the years ended December 31, 2021, 2020, and 2019, respectively.

Impairment of Long-Lived Assets

Income Taxes

The Company’s policy is to recognize, when applicable, interest and penalties on uncertain tax positions as part of income tax expense.

Revenue Recognition

Product revenue

We recognize revenue from sales of DANYELZA at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt at the end-user hospital.

●

Rebates and chargebacks

●

Discounts and distribution-related fees

●

Returns

revenue is recognized, resulting in a reduction of product revenue and an establishment of an accrued liability.

License revenue

For the year ended December 31, 2021, revenues of $649,000 were recognized related to these arrangements and no milestones were achieved.

Research and Development Costs

Patent Costs

The Company expenses the costs of obtaining and maintaining patents as selling, general, and administrative expenses.

Advertising and Promotion Costs

Stock-Based Compensation

Stock-based compensation costs were $19,334,000, $16,135,000, and $4,657,000 for the years ended December 31, 2021, 2020, and 2019, respectively.

Segment Information

Comprehensive Loss

Foreign Currency

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements - Adopted

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of cash equivalents measured at fair value on recurring basis

The following tables present the Company’s fair value hierarchy for its cash equivalents, which are measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements at December 31, 2021 Using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	166,729	$	—	$	166,729
Total	$	—	$	166,729	$	—	$	166,729


	Fair Value Measurements at December 31, 2020 Using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	97,302	$	—	$	97,302
Total	$	—	$	97,302	$	—	$	97,302

Schedule of property and equipment


		Estimated Useful Life
Furniture and fixtures		5 years
Machinery and equipment		5 years
Leasehold improvements		Shorter of life of lease or 15 years

PRODUCT REVENUE (Tables)

12 Months Ended

Dec. 31, 2021

REVENUE RECOGNITION

Change in reserves for discounts and allowances


				Contractual
				Allowances and
		Discounts		Government Rebates		Returns		Total
		(in thousands)		(in thousands)		(in thousands)		(in thousands)
Balance, December 31, 2020	$	—	$	—	$	—	$	—
Current provisions relating to sales in current year		64		4,357		428		4,849
Payments/credits relating to sales in current year		(51)		(1,330)		(367)		(1,748)
Balance, December 31, 2021	$	13	$	3,027	$	61	$	3,101

NET LOSS PER SHARE (Tables)

12 Months Ended

Dec. 31, 2021

NET LOSS PER SHARE

Schedule of basic and diluted net loss per share

The calculations of basic and diluted net loss per share are as follows (in thousands, except per share amounts):


	Year ended December 31,
	2021		2020		2019


Net loss (numerator)	$	(55,275)	$	(119,337)	$	(81,028)
Weighted-average shares (denominator), basic and diluted		43,182		40,119		35,183
Basic and diluted net loss per share	$	(1.28)	$	(2.97)	$	(2.30)

INVENTORY (Tables)

12 Months Ended

Dec. 31, 2021

INVENTORY

Schedule of inventory

Inventories consist of the following (in thousands):


		As of December 31, 2021
	Raw Material		Work In Progress		Finished Goods		Total

Inventories	$	—	$	4,741	$	771	$	5,512

ACCRUED LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2021

ACCRUED LIABILITIES

Summary of accrued short-term liabilities

Accrued short-term liabilities at December 31, 2021 and December 31, 2020 are as follows (in thousands):


	December 31,		December 31,
	2021		2020



Accrued licensing, milestone and royalty payments	$	3,090	$	3,608
Accrued clinical costs		915		678
Accrued compensation and board fees		1,877		2,603
Accrued manufacturing costs		2,622		983
Accrued sales reserves		2,615		—
Other		1,421		325
Total	$	12,540	$	8,197

LICENSE AGREEMENTS AND COMMITMENTS (Tables)

12 Months Ended

Dec. 31, 2021

Agreements

Summary of significant license agreements, related commitments and milestone information


													Accrued		Accrued		Accrued		Accrued
	Cash paid		Cash paid		Cash paid		Expense		Expense		Expense		liabilities		liabilities		liabilities		liabilities
	Twelve months		Twelve months		Twelve months		Twelve months		Twelve months		Twelve months		Current		Non-current		Current		Non-current
	ended		ended		ended		ended		ended		ended		as of		as of		as of		as of
	December		December		December		December		December		December		December		December		December		December
Agreements	2021		2020		2019		2021		2020		2019		2021		2021		2020		2020
MSK		$ 1,480		$ 80		$ 725		$ 1,170		$ -		$ 75		$ 1,486		$ 1,650		$ 305		$ 1,640
CD33		100		—		—		—		—		—		—		450		100		450
MabVax		10		—		600		10		—		—		—		—		—		—
SADA		1,000		2,707		—		—		14,019		—		1,605		—		1,000		1,605


	Maximum		Maximum		Maximum
Agreements	Clinical Milestones		Regulatory Milestones		Sales-based milestones
MSK		$ 2,450		$ 9,000		$ 20,000
CD33		550		500		7,500
MabVax		200		1,200		—
SADA		4,730		18,125		23,750

Maturities of operating lease liabilities

Maturities of operating lease liabilities at December 31, 2021 and 2020 were as follows (in thousands):


	Operating Leases
	at December 31, 2021
Years ending December 31,
2022	$	1,953
2023		1,025
2024		550
2025		445
Total lease payments		3,973
Less: Imputed interest		(339)
Total operating lease liabilities at December 31, 2021	$	3,634


	Operating Leases
	at December 31, 2020
2021	$	2,180
2022		1,593
2023		540
2024		64
Total lease payments		4,377
Less: Imputed interest		(398)
Total operating lease liabilities at December 31, 2020	$	3,979

MSK, CD33, MabVax and SADA License Agreements

Agreements

Summary of significant license agreements, related commitments and milestone information

We have the following significant license agreements and related commitments which include all obligations that have been paid or are accrued as of and for the period ending December 31, 2021, 2020, and 2019 (in thousands):

SHARE-BASED COMPENSATION (Tables)

12 Months Ended

Dec. 31, 2021

SHARE-BASED COMPENSATION

Schedule of assumptions that Company used to determine the fair value of the stock options granted


	Year Ended		Year Ended		Year Ended
	December 31, 2021		December 31, 2020		December 31, 2019

Risk-free interest rate	1.31	%	0.64	%	1.78	%
Expected term (in years)	6.3		6.3		6.3
Expected volatility	72.6	%	65.0	%	60.6	%
Expected dividend yield	—	%	—	%	—	%

Schedule of common stock options issued and outstanding


						Weighted
		Weighted		Aggregate		average
		average		intrinsic		remaining
		exercise		value		contractual
	Options	price		(in thousands)		life (years)
Outstanding and expected to vest at December 31, 2020	5,674,100	$	22.55	$	156,726	7.51
Granted	1,309,000		20.41
Exercised	(190,492)		3.09
Forfeited	(105,480)		38.96
Outstanding and expected to vest at December 31, 2021	6,687,128	$	22.43	$	26,412	7.21
Exercisable at December 31, 2021	3,872,356	$	16.18	$	25,802	5.90

Schedule of restricted stock units issued and outstanding


				Weighted
		Weighted		average
		average		remaining
		grant		vesting
	Restricted Stock Units	price		life (years)
Outstanding and expected to vest at December 31, 2020	30,146	$	25.45	2.18
Granted	13,919		29.32
Vested	(10,899)		24.82
Forfeited	(4,259)		26.44
Outstanding and expected to vest at December 31, 2021	28,907	$	28.04	1.82

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2021

INCOME TAXES

Schedule of domestic and foreign loss before income taxes

Domestic and foreign loss before income taxes are as follows (thousands):


	For The Year Ended December 31,
	2021		2020		2019
United States	$	(47,275)	$	(119,153)	$	(80,598)
Foreign		(8,000)		(184)		(430)
Total	$	(55,275)	$	(119,337)	$	(81,028)

Schedule of components of provision for (benefit from) income taxes

Current and deferred income taxes (tax benefits) are as follows (thousands):


	For The Year Ended December 31,
	2021		2020		2019
Current income tax
Domestic	$	—	$	—	$	—
Foreign		304		—		—
Total current income taxes (tax benefits)		304		—		—
Deferred income tax
Domestic		—		—		—
Foreign		(304)		—		—
Total deferred income taxes (tax benefits)		(304)		—		—
Total income taxes (tax benefits)	$	—	$	—	$	—

Schedule of difference between incomes taxes expected at U.S. federal statutory income tax rate and income taxes


	For The Year Ended December 31,
	2021		2020		2019
Taxes on income at U.S. federal statutory rate	$	(11,607)	$	(25,061)	$	(17,016)
State and local taxes, net of federal tax effects		(5,523)		(3,059)		(11,022)
Effect of rate change		(1,734)		1,647		(22)
Foreign tax rate differential		(80)		(2)		(4)
Valuation allowance		20,978		30,986		33,984
Tax credits		(1,904)		(4,734)		(5,924)
Uncertain tax position		304		—		—
Other		(434)		223		4
Total	$	—	$	—	$	—

Schedule of significant components of net deferred tax assets/(liabilities)

Significant components of the Company’s net deferred tax assets/(liabilities) are as follows (thousands):


	December 31, 2021		December 31, 2020
Deferred tax assets/(liabilities):
Acquired intangibles	$	4,316	$	4,424
Accrued bonus		—		34
Unrealized foreign exchange loss		38		(448)
Accrued royalty		377		284
Stock based compensation		9,222		3,803
Net operating loss carryforwards		88,968		75,711
Tax credit carryforwards		15,050		13,146
ROU asset		(1,015)		(1,068)
Lease liability		960		931
Other		(479)		(357)
Total deferred tax assets/(liabilities)		117,437		96,460
Valuation allowance		(117,437)		(96,460)
Net deferred tax assets/(liabilities)	$	—	$	—

Schedule of uncertain tax positions

Changes in the Company’s unrecognized tax benefits, excluding the related accrual of interest and penalties, from January 1 through December 31 are set forth below (thousands):


	Year Ended
	December 31,
	2021		2020		2019
Beginning balance	$	—	$	—	$	—
Additions for prior year tax positions		304		—		—
Ending balance	$	304	$	—	$	—

BASIS OF PRESENTATION - Accumulated deficit (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
BASIS OF PRESENTATION
Accumulated deficit	$ (340,475)	$ (285,200)

- Definition

The cumulative amount of the reporting entity's undistributed earnings or deficit.

+ References + Details

BASIS OF PRESENTATION - Secondary public offering (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Feb. 22, 2021	Dec. 31, 2021	Dec. 31, 2019
Common Stock
Issuance of stock
Issuance of common stock, Stock offering (in shares)		2,804,878	5,134,750
Secondary public offering, February 22, 2021
Issuance of stock
Aggregate gross proceeds	$ 115,000
Secondary public offering, February 22, 2021 \| Common Stock
Issuance of stock
Issuance of common stock, Stock offering (in shares)	2,804,878
Share price (in dollars per share)	$ 41.00
Secondary public offering, February 22, 2021, Underwriters' option \| Common Stock
Issuance of stock
Issuance of common stock, Stock offering (in shares)	365,853

BASIS OF PRESENTATION - Cash and cash equivalents (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
BASIS OF PRESENTATION
Cash and cash equivalents	$ 181,564	$ 114,634

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Credit Risk (Details) - Credit Concentration Risk - Accounts Receivable - Three customers	12 Months Ended
	Dec. 31, 2021 customer
Concentration risk
Number of customers	3
Concentration risk percentage (as a percent)	99.00%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurement (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Fair value measurements
Level 1 to Level 2 Transfers	$ 0	$ 0
Level 2 to Level 1 Transfers	0	0
Transfers into Level 3	0	0
Transfers out of Level 3	0	0
Recurring
Fair value measurements
Cash equivalents	166,729	97,302
Recurring \| Money market funds
Fair value measurements
Cash equivalents	166,729	97,302
Recurring \| Level 2
Fair value measurements
Cash equivalents	166,729	97,302
Recurring \| Level 2 \| Money market funds
Fair value measurements
Cash equivalents	$ 166,729	$ 97,302

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Operating Leases (Details)	Dec. 31, 2021 USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Residual value guarantees	$ 0

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Property and Equipment
Depreciation expense	$ 645,000	$ 396,000	$ 166,000
Furniture and fixtures
Property and Equipment
Estimated Useful Life	5 years
Machinery and equipment
Property and Equipment
Estimated Useful Life	5 years
Leasehold improvements \| Maximum
Property and Equipment
Estimated Useful Life	15 years

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Income Taxes (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cost incurred as a result of GILTI	$ 0	$ 0	$ 0

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019	May 31, 2021
Agreements
Revenue		$ 34,897	$ 20,750
SciClone and Adium
Agreements
Revenue		649
Amount of milestone achieved		0
Product
Agreements
Revenue		32,897	0	$ 0
License
Agreements
Revenue		2,000	20,750
License \| Development and commercialization arrangement \| SciClone
Agreements
Upfront payment	$ 20,000
Maximum regulatory milestones	40,000		40,000
Maximum sales-based milestones	$ 60,000		60,000
Revenue			$ 20,000
License \| Distribution agreement \| Adium
Agreements
Upfront payment		$ 2,000
Maximum regulatory milestones					$ 3,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Research and development (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Agreements
Research and development	$ 93,245	$ 93,697	$ 63,492
SADA License Agreement
Agreements
Milestone expenses		$ 605
Clinical milestone payments considered not probable	$ 4,125

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Other policies (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) segment	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Stock-based compensation	$ 19,334	$ 16,135	$ 4,657
Number of operating segments \| segment	1
Foreign currency transaction (gain) loss	$ 1,897	$ (576)	$ 43

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recently issued accounting pronouncements (Details) - USD ($) $ in Thousands	Jan. 01, 2019	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2018
New accounting pronouncements
Lease liabilities		$ 3,634	$ 3,979
Operating lease right-of-use assets		$ 3,842	$ 4,569
ASU 2016-02
New accounting pronouncements
Change in Accounting Principle, Accounting Standards Update, Adopted	true
Change in Accounting Principle, Accounting Standards Update, Transition Option Elected	us-gaap:AccountingStandardsUpdate201602CumulativeEffectPeriodOfAdoptionMember
New Accounting Pronouncement or Change in Accounting Principle, Prior Period Not Restated	true
Lease, Practical Expedients, Package	true
ASU 2016-02 \| Cumulative Effect, Period of Adoption, Adjustment
New accounting pronouncements
Lease liabilities				$ 1,800
Operating lease right-of-use assets				$ 1,500

- Definition

Indicates (true false) whether accounting standards update was adopted.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 718
-SubTopic 10
-Section 65
-Paragraph 15
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121322162&loc=SL121327923-165333

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 1
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=124431687&loc=d3e22499-107794

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 815
-SubTopic 20
-Section 65
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=121483254&loc=SL120254523-199619

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 326
-SubTopic 10
-Section 65
-Paragraph 4
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=122640432&loc=SL121648383-210437

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S65
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=124359872&loc=SL124427846-239511

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

PRODUCT REVENUE - Discounts and Allowances (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Revenue
Revenue	$ 34,897	$ 20,750
Change in reserves for discounts and allowances
Discounts, Current provisions relating to sales in current year	64
Discounts, Payments/credits relating to sales in current year	(51)
Discounts, Balance at end of period	13
Contractual Allowances and Government Rebates, Current provisions relating to sales in current year	4,357
Contractual Allowances and Government Rebates, Payments/credits relating to sales in current year	(1,330)
Contractual Allowances and Government Rebates, Balance at end of period	3,027
Returns, Current provisions relating to sales in current year	428
Returns, Payments/credits relating to sales in current year	(367)
Returns, Balance at end of period	61
Reserves for discounts and allowances, Current provisions relating to sales in current year	4,849
Reserves for discounts and allowances, Payments/credits relating to sales in current year	(1,748)
Reserves for discounts and allowances, Balance at end of period	3,101
Accounts receivable
Change in reserves for discounts and allowances
Reserves for discounts and allowances, Balance at end of period	486
Accrued liabilities
Change in reserves for discounts and allowances
Reserves for discounts and allowances, Balance at end of period	2,615
Product
Revenue
Revenue	32,897	0	$ 0
License
Revenue
Revenue	$ 2,000	$ 20,750

PRODUCT REVENUE - Concentrations (Details) - Customer Concentration Risk - Revenue - Product	12 Months Ended
	Dec. 31, 2021 customer
Concentration risk
Number of wholesale customers	2
Wholesaler One
Concentration risk
Concentration risk percentage (as a percent)	73.20%
Wholesaler Two
Concentration risk
Concentration risk percentage (as a percent)	17.60%

NET LOSS PER SHARE - Basic and diluted (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
NET LOSS PER SHARE
Net loss (numerator), Basic (in dollars)	$ (55,275)	$ (119,337)	$ (81,028)
Net loss (numerator), Diluted (in dollars)	$ (55,275)	$ (119,337)	$ (81,028)
Weighted-average shares (denominator), basic (in dollars per share)	43,181,808	40,118,537	35,183,488
Weighted-average shares (denominator), diluted (in dollars per share)	43,181,808	40,118,537	35,183,488
Basic net loss per share (in dollars per share)	$ (1.28)	$ (2.97)	$ (2.30)
Diluted net loss per share (in dollars per share)	$ (1.28)	$ (2.97)	$ (2.30)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities, and addition from assumption of issuance of common shares for dilutive potential common shares; of income (loss) available to common shareholders.

+ References + Details

NET LOSS PER SHARE - Anti-dilutive securities (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
NET LOSS PER SHARE
Potentially dilutive securities outstanding	6,716,035	5,704,246	4,005,873

INVENTORY (Details) - USD ($) $ in Thousands	12 Months Ended
INVENTORY (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
INVENTORY
Work in Process	$ 4,741
Finished Goods	771
Inventory Total	5,512	$ 0	$ 0
Inventory write-downs	$ 0	$ 0	$ 0

INTANGIBLE ASSETS (Details) $ in Thousands	Dec. 31, 2021 USD ($)
INTANGIBLE ASSETS
Intangible assets, net	$ 1,663
Accumulated amortization	$ 137

ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Accrued short-term liabilities
Accrued licensing, milestone and royalty payments	$ 3,090	$ 3,608
Accrued clinical costs	915	678
Accrued compensation and board fees	1,877	2,603
Accrued manufacturing costs	2,622	983
Accrued sales reserves	2,615
Other	1,421	325
Total	$ 12,540	$ 8,197

LICENSE AGREEMENTS AND COMMITMENTS - SADA License Agreement (Details) $ in Thousands		1 Months Ended			12 Months Ended
	Apr. 15, 2020 USD ($) individual	Jul. 31, 2020 individual	Apr. 30, 2020 individual shares	Aug. 31, 2015 individual	Dec. 31, 2021 USD ($) agreement individual shares	Dec. 31, 2020 USD ($) individual shares	Dec. 31, 2019 shares	Dec. 31, 2018 shares	Dec. 31, 2017 shares	Dec. 31, 2016 shares	Dec. 31, 2015 shares
Agreements
Non-cash expense in connection with equity issuance to inventors						$ 7,376
Common Stock
Agreements
Issuance of common stock to non-employees (in shares) \| shares						656,896	400,000
MSK
Agreements
Number of license agreements \| agreement					2
Nonemployees
Agreements
Issuance of common stock to non-employees (in shares) \| shares					0
Nonemployees \| Researchers, Employees of MSK
Agreements
Number of individuals \| individual				2
Nonemployees \| Researchers, Employees of MSK \| Common Stock
Agreements
Issuance of common stock to non-employees (in shares) \| shares						400,000	400,000	544,000	448,000	448,000	560,000
SADA License Agreement
Agreements
Number of employees acquired \| individual	0
Upfront payment	$ 1,995
Stock grant expense						$ 3,331
Issuance of common stock to strategic partner						$ 1,331
Issuance of common stock to strategic partner (in shares) \| shares						42,900
Value of future stock grants						$ 2,000
Payment in cash					$ 1,000
Amount to be paid in cash or stock grants					1,000
Annual minimum royalties payable (non-refundable)	40
Annual minimum royalties payable from tenth anniversary (non-refundable)	60
Maximum sales based milestone payments due for each construct previously generated	$ 60,000
Milestone expenses						605
Milestone period	36 months
SADA License Agreement \| Researchers, Employees of MSK
Agreements
Number of individuals \| individual		2
SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK
Agreements
Non-cash expense in connection with equity issuance to inventors					$ 0	$ 7,376
Number of individuals \| individual			2		2	2
SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK \| Common Stock
Agreements
Issuance of common stock to non-employees (in shares) \| shares			213,996			213,996

LICENSE AGREEMENTS AND COMMITMENTS - MSK, CD33 and MabVax License Agreement (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) agreement	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
Financial statement information
Accrued liabilities, current	$ 12,540	$ 8,197
Accrued liabilities, noncurrent	2,100	2,695
Gross intangible assets related to Danyelza	$ 1,663
MSK
Agreements
Number of license agreements \| agreement	2
MSK License Agreement
Financial statement information
Cash paid	$ 1,480	80	$ 725
Expense	1,170		75
Accrued liabilities, current	1,486	305
Accrued liabilities, noncurrent	1,650	1,640
Milestones
Maximum Clinical Milestones	2,450
Maximum Regulatory Milestones	9,000
Maximums Sales-based Milestones	20,000
CD33 License Agreement
Financial statement information
Cash paid	100
Accrued liabilities, current		100
Accrued liabilities, noncurrent	450	450
Milestones
Maximum Clinical Milestones	550
Maximum Regulatory Milestones	500
Maximums Sales-based Milestones	7,500
MabVax Agreement
Financial statement information
Cash paid	10		$ 600
Expense	10
Milestones
Maximum Clinical Milestones	200
Maximum Regulatory Milestones	1,200
SADA License Agreement
Financial statement information
Cash paid	1,000	2,707
Expense		14,019
Accrued liabilities, current	1,605	1,000
Accrued liabilities, noncurrent		$ 1,605
Milestones
Maximum Clinical Milestones	4,730
Maximum Regulatory Milestones	18,125
Maximums Sales-based Milestones	$ 23,750

LICENSE AGREEMENTS AND COMMITMENTS - Other agreements (Details) $ in Thousands	1 Months Ended	12 Months Ended
	Oct. 31, 2020	Dec. 31, 2021 USD ($) agreement individual	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)	Dec. 31, 2018
Agreements
Research and development		$ 93,245	$ 93,697	$ 63,492
Other Agreements with MSK
Agreements
Research and development		$ 4,086	$ 4,220	$ 6,757
Core Facility Service Agreements
Agreements
Number of service agreements \| agreement		2
CD33 Sponsored Research Agreement
Agreements
Research service period					2 years
Sponsored Research Agreement
Agreements
Research service period	3 years
Researchers, Employees of MSK \| Master Data Services Agreement
Agreements
Number of individuals \| individual		5

LICENSE AGREEMENTS AND COMMITMENTS - Lease agreements (Details) $ in Thousands	1 Months Ended
	Aug. 31, 2020 USD ($)	Feb. 28, 2019 USD ($) ft²	Dec. 31, 2021 USD ($)	Sep. 26, 2021 ft²	Dec. 31, 2020 USD ($)	Dec. 31, 2019 ft²	Jan. 31, 2018 USD ($)
Leases
Operating lease right-of-use assets			$ 3,842		$ 4,569
Lease liabilities			3,634		$ 3,979
Manufacturing facility, Indiana
Leases
Lease term	2 years
Operating lease right-of-use assets	$ 3,617
Lease liabilities	2,680
Difference between right of use asset and lease liability recognized	937
Access fee monthly installment	117
Amount of additional access fees to be paid in monthly installments	$ 932
Option to extend	false
Laboratory, New Jersey
Leases
Leased area (in square feet) \| ft²		4,548
Additional leased area (in square feet) \| ft²						235
Lease term		3 years
Option to extend		true
Option to extend, period		2 years
Fixed rent payable per annum		$ 144
Lease payable per month		$ 12
Corporate headquarters, New York
Leases
Lease term							5 years
Fixed rent payable per annum							$ 384
Lease payable per month							$ 32
Office space, Denmark
Leases
Leased area (in square feet) \| ft²				29,288
Lease term		3 years		48 months
Lease payable per month			$ 41

LICENSE AGREEMENTS AND COMMITMENTS - Lease costs (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Leases
Total operating lease costs	$ 2,608	$ 1,324	$ 676
Cash paid for amounts included in the measurement of lease liabilities	2,216	1,248	606
Research and development expense
Leases
Total operating lease costs	2,367	1,114	493
Selling, general, and administrative
Leases
Total operating lease costs	$ 241	$ 210	$ 183

LICENSE AGREEMENTS AND COMMITMENTS - Lease maturities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Future minimum commitments under all non-cancelable operating leases
First fiscal year	$ 1,953	$ 2,180
Second fiscal year	1,025	1,593
Third fiscal year	550	540
Fourth fiscal year	445	64
Total lease payments	3,973	4,377
Less: Imputed interest	(339)	(398)
Total operating lease liabilities at end of period	$ 3,634	$ 3,979

LICENSE AGREEMENTS AND COMMITMENTS - Lease term and discount rate (Details)	Dec. 31, 2021	Dec. 31, 2020
LICENSE AGREEMENTS AND COMMITMENTS
Weighted average remaining lease term	2 years 7 months 13 days	2 years 2 months 4 days
Weighted average discount rate	6.50%	7.60%

STOCKHOLDERS' EQUITY - Authorized, Common and Preferred Stock (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) Vote $ / shares shares	Dec. 31, 2020 USD ($) $ / shares shares	Dec. 31, 2019 USD ($) $ / shares shares
STOCKHOLDERS' EQUITY
Total shares authorized	105,500,000	105,500,000	105,500,000
Common stock, authorized shares	100,000,000	100,000,000	100,000,000
Common stock, par value (in dollars per share) \| $ / shares	$ 0.0001	$ 0.0001	$ 0.0001
Preferred stock, authorized shares	5,500,000	5,500,000	5,500,000
Preferred stock, par value (in dollars per share) \| $ / shares	$ 0.0001	$ 0.0001	$ 0.0001
Number of votes per common share \| Vote	1
Common stock dividends issued \| $	$ 0	$ 0	$ 0
Common stock, shares issued	43,694,716	40,688,447	39,728,416
Preferred stock, shares issued	0	0	0

STOCKHOLDERS' EQUITY - Stock grant agreements with non-employees (Details) $ in Thousands	1 Months Ended			12 Months Ended							21 Months Ended
	Jul. 31, 2020 USD ($) individual	Apr. 30, 2020 USD ($) individual shares	Aug. 31, 2015 individual shares	Dec. 31, 2021 USD ($) individual shares	Dec. 31, 2020 USD ($) individual shares	Dec. 31, 2019 shares	Dec. 31, 2018 shares	Dec. 31, 2017 shares	Dec. 31, 2016 shares	Dec. 31, 2015 shares	Dec. 31, 2021
Share-Based Compensation Awards
Non-cash expense in connection with equity issuance to inventors \| $					$ 7,376
Nonemployees
Share-Based Compensation Awards
Issuance of common stock to non-employees (in shares)				0
Nonemployees \| Researchers, Employees of MSK
Share-Based Compensation Awards
Number of individuals \| individual			2
SADA License Agreement \| Researchers, Employees of MSK
Share-Based Compensation Awards
Number of individuals \| individual	2
Notes receivable, noncurrent \| $	$ 2,610
Notes receivable term	3 years
Notes receivable interest rate (as a percent)	1.00%
SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK
Share-Based Compensation Awards
Number of individuals \| individual		2		2	2
Vested (as a percent)				20.00%							60.00%
Remaining vesting percentage				40.00%							40.00%
Non-cash expense in connection with equity issuance to inventors \| $				$ 0	$ 7,376
SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK \| Research and development expense
Share-Based Compensation Awards
Non-cash expense in connection with equity issuance to inventors \| $		$ 7,376
SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK \| Tranche one
Share-Based Compensation Awards
Vested (as a percent)		40.00%
SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK \| Tranche two
Share-Based Compensation Awards
Vesting (as a percent)		60.00%
Vesting period		3 years		2 years
Common Stock
Share-Based Compensation Awards
Issuance of common stock to non-employees (in shares)					656,896	400,000
Common Stock \| Nonemployees \| Researchers, Employees of MSK
Share-Based Compensation Awards
Shares agreed to be issued			2,800,000
Issuance of common stock to non-employees (in shares)					400,000	400,000	544,000	448,000	448,000	560,000
Common Stock \| SADA License Agreement \| Nonemployees \| Researchers, Employees of MSK
Share-Based Compensation Awards
Shares agreed to be issued		213,996
Issuance of common stock to non-employees (in shares)		213,996			213,996

STOCKHOLDERS' EQUITY - Issuance of common stock (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Feb. 22, 2021	Dec. 31, 2021	Dec. 31, 2019
Issuance of stock
Proceeds from issuance of common stock, net		$ 107,725	$ 134,704
Secondary public offering, February 22, 2021
Issuance of stock
Aggregate gross proceeds	$ 115,000
Proceeds from issuance of common stock, net	$ 107,725
Common Stock
Issuance of stock
Issuance of common stock, Stock offering (in shares)		2,804,878	5,134,750
Common Stock \| Secondary public offering, February 22, 2021
Issuance of stock
Issuance of common stock, Stock offering (in shares)	2,804,878
Share price (in dollars per share)	$ 41.00

SHARE-BASED COMPENSATION - 2015 Plan (Details) - 2015 Plan - shares	12 Months Ended
	Dec. 31, 2015	Sep. 30, 2018
Share-Based Compensation Awards
Shares reserved for issuance pursuant to the plan	4,500,000
Shares available for grant		0
Stock options
Share-Based Compensation Awards
Vesting period	4 years

SHARE-BASED COMPENSATION - 2018 Plan (Details) - 2018 Plan	12 Months Ended
	Dec. 31, 2021 shares
Share-Based Compensation Awards
Shares reserved for issuance pursuant to the plan	5,500,000
Annual increase on share reserve (as a percent)	4.00%
Stock options
Share-Based Compensation Awards
Vesting period	4 years
Stock options \| Employees and nonemployees owning less than 10% of voting power
Share-Based Compensation Awards
Term of award	10 years
Stock options \| Participants owning more than 10% of voting power
Share-Based Compensation Awards
Term of award	5 years
Stock options \| Participants owning more than 10% of voting power \| Minimum
Share-Based Compensation Awards
Ownership (as a percent)	10.00%
Option price as percentage of fair market value of common stock on the date of grant	110.00%

SHARE-BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share-Based Compensation Awards
Stock-based compensation expenses	$ 19,334	$ 16,135	$ 4,657
Stock options \| Employees
Share-Based Compensation Awards
Stock-based compensation expenses	19,032	15,949	4,581
Stock options \| Employees \| Research and development expense
Share-Based Compensation Awards
Stock-based compensation expenses	7,133	7,401	933
Stock options \| Employees \| Selling, general, and administrative
Share-Based Compensation Awards
Stock-based compensation expenses	11,899	8,548	3,648
RSUs
Share-Based Compensation Awards
Stock-based compensation expenses	302,000	186	76
RSUs \| Research and development expense
Share-Based Compensation Awards
Stock-based compensation expenses	269	169	69
RSUs \| Selling, general, and administrative
Share-Based Compensation Awards
Stock-based compensation expenses	$ 33	$ 17	$ 7

SHARE-BASED COMPENSATION - Stock Option Valuation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Stock Option Valuation
Stock-based compensation expenses	$ 19,334	$ 16,135	$ 4,657
Granted (in shares)	1,309,000
Stock options
Stock Option Valuation
Risk-free interest rate	1.31%	0.64%	1.78%
Expected term (in years)	6 years 3 months 18 days	6 years 3 months 18 days	6 years 3 months 18 days
Expected volatility	72.60%	65.00%	60.60%
Stock options \| Nonemployees
Stock Option Valuation
Stock-based compensation expenses		$ 4,800
Granted (in shares)		150,000
Stock options \| Employees
Stock Option Valuation
Stock-based compensation expenses	$ 19,032	$ 15,949	$ 4,581

SHARE-BASED COMPENSATION - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Options
Outstanding at beginning of period (in shares)	5,674,100
Granted (in shares)	1,309,000
Exercised (in shares)	(190,492)
Forfeited, shares (in shares)	(105,480)
Outstanding at end of period (in shares)	6,687,128	5,674,100
Exercisable at end of period (in shares)	3,872,356
Weighted average exercise price
Outstanding at beginning of period (in dollars per share)	$ 22.55
Granted (in dollars per share)	20.41
Exercised (in dollars per share)	3.09
Forfeited (in dollars per share)	38.96
Outstanding at end of period (in dollars per share)	22.43	$ 22.55
Exercisable at end of period (in dollars per share)	$ 16.18
Aggregate intrinsic value and Weighted average remaining contractual life (years)
Outstanding (in dollars)	$ 26,412	$ 156,726
Exercisable (in dollars)	$ 25,802
Outstanding (in years)	7 years 2 months 15 days	7 years 6 months 3 days
Exercisable (in years)	5 years 10 months 24 days
Weighted average grant-date fair value of stock options granted (in dollars per share)	$ 13.03	$ 25.40	$ 14.92

SHARE-BASED COMPENSATION - Stock option unrecognized compensation (Details) - Stock options - Employees $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($)
Unrecognized compensation related to employee stock options
Unrecognized compensation	$ 46,405
Expected vesting period	2 years 11 months 8 days

SHARE-BASED COMPENSATION - Restricted Stock Unit Activity (Details) - RSUs - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Restricted stock units issued and outstanding
Outstanding and expected to vest at beginning of period (in shares)	30,146
Granted (in shares)	13,919
Vested (in shares)	(10,899)
Forfeited (in shares)	(4,259)
Outstanding and expected to vest at end of period (in shares)	28,907	30,146
Weighted average grant price
Weighted average grant price, Outstanding and expected to vest, Beginning of period (in dollars per share)	$ 25.45
Weighted average grant price, Granted (in dollars per share)	29.32
Weighted average grant price, Vested (in dollars per share)	24.82
Weighted average grant price, Forfeited (in dollars per share)	26.44
Weighted average grant price, Outstanding and expected to vest, End of period (in dollars per share)	$ 28.04	$ 25.45
Weighted average remaining vesting life	1 year 9 months 25 days	2 years 2 months 4 days
Unrecognized compensation	$ 588

RELATED PARTY TRANSACTIONS (Details) - Shareholder, MSK - MSK License Agreement, CD33 License Agreement, CTA, CFAs, SRA and MDSA - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Related party transactions
Expensed costs	$ 5,266,000	$ 11,556,000	$ 6,832,000
Due to related parties, Accounts payable	748,000	833,000
Due to related parties, Accrued liabilities	5,443,000	7,161,000
Due to related parties	$ 6,191,000	$ 7,994,000

- Definition

Carrying amount as of the balance sheet date of obligations due all related parties.

+ References

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- Definition

Portion of the carrying amount as of the balance sheet date of obligations due all related parties that is payable after one year or beyond the normal operating cycle if longer.

+ References

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+ Details

INCOME TAXES - Loss before income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Domestic and foreign loss before income taxes:
United States	$ (47,275)	$ (119,153)	$ (80,598)
Foreign	(8,000)	(184)	(430)
Total losses before taxes	(55,275)	(119,337)	(81,028)
Income tax expense
Total provision for (benefit from) income tax	$ 0	$ 0	$ 0

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

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+ Details

- Definition

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

+ References + Details

INCOME TAXES - Provision for (benefit from) income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Current income tax
Foreign	$ 304
Total current income taxes (tax benefits)	304
Deferred income tax
Foreign	(304)
Total deferred income taxes (tax benefits)	(304)
Total income taxes (tax benefits)	$ 0	$ 0	$ 0

- Definition

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

+ References + Details

INCOME TAXES - Reconciliation of Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
INCOME TAXES
U.S. federal corporate tax rate (as a percent)	21.00%	21.00%	21.00%
Difference between income taxes expected at U.S. federal statutory income tax rate and income taxes provided:
Taxes on income at U.S. federal statutory rate	$ (11,607)	$ (25,061)	$ (17,016)
State and local taxes, net of federal tax effects	(5,523)	(3,059)	(11,022)
Effect of rate change	(1,734)	1,647	(22)
Foreign tax rate differential	(80)	(2)	(4)
Valuation allowance	20,978	30,986	33,984
Tax credits	(1,904)	(4,734)	(5,924)
Uncertain tax position	304
Other	(434)	223	4
Total income taxes (tax benefits)	$ 0	$ 0	$ 0

INCOME TAXES - Deferred assets (liabilities) (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred tax assets/(liabilities)::
Acquired intangibles	$ 4,316	$ 4,424
Accrued bonus		34
Unrealized foreign exchange loss, tax asset	38
Unrealized foreign exchange loss, tax liability		(448)
Accrued royalty	377	284
Stock based compensation	9,222	3,803
Net operating loss carryforwards	88,968	75,711
Tax credit carryforwards	15,050	13,146
ROU asset	(1,015)	(1,068)
Lease liability	960	931
Other liabilities	(479)	(357)
Total deferred tax assets/(liabilities)	117,437	96,460
Valuation allowance	(117,437)	(96,460)
Net deferred tax assets/(liabilities)

INCOME TAXES - Net Operating Loss Carryforwards (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($)
U.S. federal
Operating Loss Carryforwards
Net operating loss carryforwards	$ 290,839
Tax credit carryforwards	15,050
Operating loss carryforward, expiring through 2037	29,909
Operating loss carryforward, indefinite	260,930
State
Operating Loss Carryforwards
Net operating loss carryforwards	207,011
Danish
Operating Loss Carryforwards
Net operating loss carryforwards	$ 59

INCOME TAXES - Uncertain tax positions (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2018
INCOME TAXES
Additions for tax provisions of prior years	$ 304
Unrecognized tax benefits, Balance at end of year	304	$ 0	$ 0
Possible decrease in amount of uncertain tax positions	304
Amount of unrecognized tax benefits that, if recognized, would not affect the effective tax rate	$ 304

OTHER BENEFITS (Details)	12 Months Ended
OTHER BENEFITS (Details)	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
UNITED STATES
Benefit plan
Employer matching contribution to defined contribution plan (as a percent)	0.00%	0.00%	0.00%

GAIN FROM SALE OF PRIORITY REVIEW VOUCHER (Details) - USD ($) $ in Thousands		12 Months Ended
	Jan. 21, 2021	Dec. 31, 2021
Disposal
Net gain recognized		$ 62,010
Priority Review Voucher \| Disposal Group, Disposed of by Sale, Not Discontinued Operations
Disposal
Consideration	$ 105,000
Percentage of net proceeds from monetization entitled to be retained	60.00%
Percentage of net proceeds from monetization to be paid to MSK	40.00%
Net gain recognized	$ 62,010