0001558370-24-007056 | 10-Q | XBRL Viewer

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BASIS OF PRESENTATION - Accumulated deficit (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
BASIS OF PRESENTATION
Accumulated deficit	$ (464,099)	$ (457,470)

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

ACCRUED LIABILITIES

3 Months Ended

Mar. 31, 2024

ACCRUED LIABILITIES

ACCRUED LIABILITIES

NOTE 8—ACCRUED LIABILITIES

Accrued liabilities as of March 31, 2024 and December 31, 2023 are as follows (in thousands):


	March 31,		December 31,
	2024		2023

Accrued licensing, milestone and royalty payments	$	2,459	$	3,452
Accrued clinical costs		794		597
Accrued compensation and board fees		2,165		3,858
Accrued manufacturing costs		1,948		2,531
Accrued sales reserves		1,910		2,309
Other		713		419
Total	$	9,989	$	13,166

PRODUCT REVENUE NET - Disaggregation (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Revenue
Revenue	$ 19,931	$ 20,251
Product
Revenue
Revenue	19,431	20,251
Product, Royalty \| Distribution partner
Revenue
Revenue	462	658
United States \| Product
Revenue
Revenue	18,610	16,833
Other countries \| Product
Revenue
Revenue	821	3,418
Other countries \| Product \| WEP \| Distribution partner
Revenue
Revenue	$ 0	$ 2,516

- Definition

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

+ References + Details

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 924
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
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-Topic 606
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+ Details

RESTRUCTURING CHARGE	3 Months Ended
Mar. 31, 2024
RESTRUCTURING CHARGE
RESTRUCTURING CHARGE	NOTE 14—RESTRUCTURING CHARGE On January 4, 2023, following Board approval, the Company announced a strategic restructuring plan designed to extend cash resources and prioritize resources for the commercialization and potential label extension of DANYELZA and the development of the SADA PRIT Technology platform. The Company completed the restructuring in May 2023, which resulted in an approximately 35% reduction to the Company’s workforce. Affected employees were offered separation benefits, including severance and outplacement services along with temporary healthcare coverage assistance. As a result, during the three months ended March 31, 2023, the Company recognized restructuring expenses of $4,482,000 based on the currency rate for the period. For the three months ended March 31, 2023, the Company recorded $3,346,000 and $1,136,000, respectively, within research and development and selling, general, and administrative, on the Consolidated Statements of Net Loss and Comprehensive Loss. The restructuring expenses primarily related to severance benefits of $2,776,000, and acceleration of stock-based compensation of $1,706,000, which was recognized in the three months ended March 31, 2023 as there was no longer a service condition related to such awards.

RESTRUCTURING CHARGE

3 Months Ended

Mar. 31, 2024

RESTRUCTURING CHARGE

RESTRUCTURING CHARGE

NOTE 14—RESTRUCTURING CHARGE

On January 4, 2023, following Board approval, the Company announced a strategic restructuring plan designed to extend cash resources and prioritize resources for the commercialization and potential label extension of DANYELZA and the development of the SADA PRIT Technology platform. The Company completed the restructuring in May 2023, which resulted in an approximately 35% reduction to the Company’s workforce. Affected employees were offered separation benefits, including severance and outplacement services along with temporary healthcare coverage assistance. As a result, during the three months ended March 31, 2023, the Company recognized restructuring expenses of $4,482,000 based on the currency rate for the period. For the three months ended March 31, 2023, the Company recorded $3,346,000 and $1,136,000, respectively, within research and development and selling, general, and administrative, on the Consolidated Statements of Net Loss and Comprehensive Loss. The restructuring expenses primarily related to severance benefits of $2,776,000, and acceleration of stock-based compensation of $1,706,000, which was recognized in the three months ended March 31, 2023 as there was no longer a service condition related to such awards.

STOCK-BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2024

Share-Based Compensation Awards

Schedule of stock-based compensation expense

During the three months ended March 31, 2024 and 2023, the Company recognized the following stock-based compensation expense (in thousands):


	Three months ended March 31,
	2024		2023
Stock-based compensation by type of award
Restricted stock units (excluding PRSUs)	$	421	$	187
PRSUs		53		—
Stock options		3,372		5,117
Total stock-based compensation expense	$	3,846	$	5,304

Stock-based compensation by type of expense
Research and development expenses	$	1,872	$	2,306
Selling, general and administrative expenses		1,974		2,998
Total stock-based compensation expense	$	3,846	$	5,304

Schedule of unrecognized stock-based compensation expense and weighted-average period that the Company expects to recognize expense

The following table sets forth the Company’s unrecognized stock-based compensation expense as of March 31, 2024, by type of award and the weighted-average period over which the Company expects to recognize the expense (in thousands):


	March 31, 2024
	Unrecognized		Weighted average
	compensation expense		recognition period (years)
Type of award
Restricted stock units (excluding PRSUs)	$	4,872		2.4
PRSUs		605		1.9
Stock options		23,991		3.0
Total unrecognized stock-based compensation expense	$	29,468

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 as of December 31, 2023	9,307,330	$	17.26	$	10,012	6.44
Granted	1,450,790		11.23
Exercised	(71,550)		8.22
Forfeited	(116,605)		6.34
Outstanding and expected to vest as of March 31, 2024	10,569,965	$	16.61	$	60,339	6.63
Exercisable as of March 31, 2024	6,453,371	$	20.29	$	31,312	5.06

Schedule of assumptions used to determine fair value of stock options granted


	Three months ended March 31,
	2024		2023


Risk-free interest rate	4.1	%	3.60	%
Expected term (in years)	6.3		6.3
Expected volatility	84.0	%	82.6	%
Expected dividend yield	—	%	—	%

Restricted Stock Units (RSUs), Excluding PRSUs

Share-Based Compensation Awards

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 as of December 31, 2023	351,407	$	5.06	1.99
Granted	400,277		10.96
Vested	(108,976)		4.82
Forfeited	(39,934)		7.35
Outstanding and expected to vest as of March 31, 2024	602,774	$	8.87	2.41

Performance-based Restricted Stock Unit (PRSUs)

Share-Based Compensation Awards

Schedule of restricted stock units issued and outstanding


				Weighted
		Weighted		average
		average		remaining
	Performance	grant		vesting
	Restricted Stock Units	price		life (years)
Outstanding and expected to vest as of December 31, 2023	—	$	—	—
Granted	54,000		12.19
Vested	—		—
Forfeited	—		—
Outstanding and expected to vest as of March 31, 2024	54,000	$	12.19	1.87

Schedule of assumptions used to determine fair value of stock awards


	Three months ended March 31,
	2024

Risk-free interest rate	4.2	%
Expected volatility	101.0	%
Expected dividend yield	—	%

- Definition

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

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+ Details

NET LOSS PER SHARE - Basic and diluted (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
NET LOSS PER SHARE
Net loss (numerator), Basic (in dollars)	$ (6,629)	$ (6,390)
Net loss (numerator), Diluted (in dollars)	$ (6,629)	$ (6,390)
Weighted-average shares (denominator), basic (in shares)	43,779,456	43,671,589
Weighted-average shares (denominator), diluted (in shares)	43,779,456	43,671,589
Basic net loss per share (in dollars per share)	$ (0.15)	$ (0.15)
Diluted net loss per share (in dollars per share)	$ (0.15)	$ (0.15)

- 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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+ Details

- Definition

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.

+ References

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

- Definition

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

Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2024	Dec. 31, 2023
Consolidated Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, authorized shares	5,500,000	5,500,000
Preferred stock, shares issued	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, authorized shares	100,000,000	100,000,000
Common stock, shares issued	43,852,638	43,672,112
Common stock, shares outstanding	43,852,638	43,672,112

INVENTORIES (Tables)

3 Months Ended

Mar. 31, 2024

INVENTORIES

Schedule of inventories

Inventories consist of the following (in thousands):


	March 31, 2024		December 31, 2023

Raw Material	$	261	$	—
Work In Progress		16,550		14,021
Finished Goods		2,378		2,992
Total Inventories	$	19,189	$	17,013

Inventories are classified on the Consolidated Balance Sheets in each respective period (in thousands):


	March 31, 2024		December 31, 2023
CURRENT ASSETS
Inventories	$	8,448	$	5,065
Total recorded in Current Assets		8,448		5,065

NONCURRENT ASSETS
Other assets		10,741		11,948
Total recorded in Noncurrent Assets		10,741		11,948
Total Inventories	$	19,189	$	17,013

INVENTORIES

3 Months Ended

Mar. 31, 2024

INVENTORIES

INVENTORIES

NOTE 6—INVENTORIES

Inventories consist of the following (in thousands):


	March 31, 2024		December 31, 2023

Raw Material	$	261	$	—
Work In Progress		16,550		14,021
Finished Goods		2,378		2,992
Total Inventories	$	19,189	$	17,013

Inventories are classified on the Consolidated Balance Sheets in each respective period (in thousands):


	March 31, 2024		December 31, 2023
CURRENT ASSETS
Inventories	$	8,448	$	5,065
Total recorded in Current Assets		8,448		5,065

NONCURRENT ASSETS
Other assets		10,741		11,948
Total recorded in Noncurrent Assets		10,741		11,948
Total Inventories	$	19,189	$	17,013

As of March 31, 2024 and December 31, 2023, the Company has classified $10,741,000 and $11,948,000, respectively, of work-in-progress inventories as noncurrent assets based on the Company’s current demand schedule and expectation that such inventories will be utilized after one year from the balance sheet date. Changes in noncurrent assets are reflected on the Consolidated Statements of Cash Flows within the caption of other assets.

During the three months ended March 31, 2024 and 2023, the Company did not record any material charges to write off inventories.

STOCK-BASED COMPENSATION - Stock option valuation (Details) - Employee Stock Option	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Stock Award Valuation
Risk-free interest rate (as a percent)	4.10%	3.60%
Expected term (in years)	6 years 3 months 18 days	6 years 3 months 18 days
Expected volatility (as a percent)	84.00%	82.60%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2024

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 cash equivalents, which are measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements as of March 31, 2024
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	71,466	$	—	$	71,466
Total	$	—	$	71,466	$	—	$	71,466


	Fair Value Measurements as of December 31, 2023
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	75,501	$	—	$	75,501
Total	$	—	$	75,501	$	—	$	75,501

BASIS OF PRESENTATION - Cash and cash equivalents (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
BASIS OF PRESENTATION
Cash and cash equivalents	$ 75,749	$ 78,637

STOCK-BASED COMPENSATION - 2018 Plan (Details) - shares	3 Months Ended
STOCK-BASED COMPENSATION - 2018 Plan (Details) - shares	Mar. 31, 2024	Sep. 30, 2018
Employee Stock Option \| Maximum
Share-Based Compensation Awards
Term of award	10 years
2018 Plan
Share-Based Compensation Awards
Shares reserved for issuance (in shares)		5,500,000
Shares available for grant (in shares)	3,106,029
2018 Plan \| Maximum
Share-Based Compensation Awards
Annual increase on share reserve (as a percent)	4.00%
2018 Plan \| Employee Stock Option \| Minimum
Share-Based Compensation Awards
Vesting period	1 year
2018 Plan \| Employee Stock Option \| Maximum
Share-Based Compensation Awards
Vesting period	4 years
2018 Plan \| Employee Stock Option \| Employees and nonemployees owning less than 10% of voting power \| Maximum
Share-Based Compensation Awards
Term of award	10 years
2018 Plan \| Employee Stock Option \| 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%
2018 Plan \| Employee Stock Option \| Participants owning more than 10% of voting power \| Maximum
Share-Based Compensation Awards
Term of award	5 years

PRODUCT REVENUE, NET

3 Months Ended

Mar. 31, 2024

PRODUCT REVENUE, NET

PRODUCT REVENUE, NET

NOTE 4—PRODUCT REVENUE, NET

The Company’s product revenue, net was generated from sales of DANYELZA and consists of the following (in thousands):


	Three months ended March 31,
	2024		2023

United States	$	18,610	$	16,833
Other countries		821		3,418
Total product revenue, net	$	19,431	$	20,251

The majority of the Company’s product sales were in the United States with additional sales in China, Europe, Latin America, and Israel through sublicenses and distribution agreements. The Company’s product revenue, net from other countries for the three months ended March 31, 2023 included $2,516,000 of product revenue, net from the Company’s distribution partner, WEP, in connection with the Company’s early access program for DANYELZA in Europe. There is no product revenue, net from WEP in the three months ended March 31, 2024. The Company

recognized royalty revenue from the distribution partners of $462,000 and $658,000 in the three months ended March 31, 2024 and 2023, respectively.

The Company had product sales to certain customers that accounted for more than 10% of total product revenue, net for the three months ended March 31, 2024 and 2023. McKesson, AmerisourceBergen and Cardinal Health, accounted for 51%, 25%, and 22%, respectively, of the Company’s product revenue, net for the three months ended March 31, 2024. McKesson, AmerisourceBergen, Cardinal Health and WEP accounted for 45%, 29%, 13% and 12%, respectively, of the Company’s product revenue, net for the three months ended March 31, 2023.

As of March 31, 2024, the Company had recorded on the Consolidated Balance Sheets accounts receivable of approximately $20,588,000, of which $2,241,000 represents an unbilled portion to which the Company has unconditional rights to collect the consideration, and accrued liabilities of $198,000 related to product sales to WEP during the year ended December 31, 2023.

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 without contractual right of offset and other sales-related deductions are recorded within accrued liabilities. As of March 31, 2024, the Company had recorded accounts receivable allowances of approximately $617,000 and accrued liabilities of $1,910,000 related to product sales. As of December 31, 2023, the Company had recorded accounts receivable allowances of approximately $492,000 and accrued liabilities of $2,309,000 related to product sales.

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


			Contractual
			Allowances and
	Discounts		Government Rebates		Returns		Total


Balance December 31, 2023	$	41	$	2,694	$	66	$	2,801
Current provisions relating to sales in current year		94		2,667		3		2,764
Payments/credits relating to sales in current year		(54)		(2,690)		—		(2,744)
Change in estimate related to sales in the prior year		—		(294)		—		(294)
Balance March 31, 2024	$	81	$	2,377	$	69	$	2,527

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
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-URI https://asc.fasb.org//1943274/2147479806/606-10-50-9

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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org//606/tableOfContent

+ Details

ORGANIZATION AND DESCRIPTION OF BUSINESS

3 Months Ended

Mar. 31, 2024

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. Y-mAbs is leveraging the Company’s 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 and was incorporated on April 30, 2015 under the laws of the State of Delaware.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurements (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
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	71,466		$ 75,501
Recurring \| Money market funds
Fair value measurements
Cash equivalents	71,466		75,501
Recurring \| Level 2
Fair value measurements
Cash equivalents	71,466		75,501
Recurring \| Level 2 \| Money market funds
Fair value measurements
Cash equivalents	$ 71,466		$ 75,501

STOCK-BASED COMPENSATION - PRSUs Activity (Details) - Performance-based Restricted Stock Unit (PRSUs)	3 Months Ended
	Mar. 31, 2024 tranche $ / shares shares	Mar. 31, 2023 shares
Restricted stock units issued and outstanding
Granted (in shares) \| shares	54,000	0
Outstanding and expected to vest at end of period (in shares) \| shares	54,000
Weighted average grant price
Weighted average grant price, Granted (in dollars per share) \| $ / shares	$ 12.19
Weighted average grant price, Outstanding and expected to vest, End of period (in dollars per share) \| $ / shares	$ 12.19
Weighted average remaining vesting life	1 year 10 months 13 days
Number of equal tranches over which awards vest \| tranche	3
Vesting period	3 years

Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
CURRENT ASSETS
Cash and cash equivalents	$ 75,749	$ 78,637
Accounts receivable, net	20,588	22,454
Inventories	8,448	5,065
Other current assets	3,482	4,955
Total current assets	108,267	111,111
Property and equipment, net	153	224
Operating lease right-of-use assets	1,179	1,412
Intangible assets, net	2,543	2,631
Other assets	11,173	12,491
TOTAL ASSETS	123,315	127,869
LIABILITIES
Accounts payable	6,728	6,060
Accrued liabilities	9,989	13,166
Operating lease liabilities, current portion	888	902
Total current liabilities	17,605	20,128
Accrued milestone and royalty payments	5,375	5,375
Operating lease liabilities, long-term portion	293	517
Other liabilities	853	864
TOTAL LIABILITIES	24,126	26,884
Commitments and contingencies (Note 9)
STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value, 5,500,000 shares authorized and none issued at March 31, 2024 and December 31, 2023
Common stock, $0.0001 par value, 100,000,000 shares authorized at March 31, 2024 and December 31, 2023; 43,852,638 and 43,672,112 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	4	4
Additional paid-in capital	562,436	558,002
Accumulated other comprehensive income	848	449
Accumulated deficit	(464,099)	(457,470)
TOTAL STOCKHOLDERS' EQUITY	99,189	100,985
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 123,315	$ 127,869

RESTRUCTURING CHARGE (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended
RESTRUCTURING CHARGE (Details) - USD ($) $ in Thousands	May 31, 2023	Mar. 31, 2023
RESTRUCTURING CHARGE
Reduction in workforce (as a percent)	35.00%
Restructuring charges		$ 4,482
Share based compensation acceleration cost		1,706
Research and development expense
RESTRUCTURING CHARGE
Restructuring charges		3,346
Selling, general, and administrative
RESTRUCTURING CHARGE
Restructuring charges		1,136
Employee severance
RESTRUCTURING CHARGE
Severance termination benefits		2,776
Share based compensation acceleration cost		$ 1,706

- Definition

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

+ References + Details

Consolidated Statements of Net Loss and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
REVENUES
Total revenues	$ 19,931	$ 20,251
OPERATING COSTS AND EXPENSES
Cost of goods sold	2,097	2,083
License royalties	50
Research and development	13,267	13,418
Selling, general, and administrative	11,425	12,251
Total operating costs and expenses	26,839	27,752
Loss from operations	(6,908)	(7,501)
OTHER INCOME, NET
Interest and other income	439	1,111
LOSS BEFORE INCOME TAXES	(6,469)	(6,390)
Provision for income taxes	160
NET LOSS	(6,629)	(6,390)
Other comprehensive income/(loss)
Foreign currency translation	399	(306)
COMPREHENSIVE LOSS	$ (6,230)	$ (6,696)
Net loss per share attributable to common stockholders, basic (in dollars per share)	$ (0.15)	$ (0.15)
Net loss per share attributable to common stockholders, diluted (in dollars per share)	$ (0.15)	$ (0.15)
Weighted average common shares outstanding, basic (in shares)	43,779,456	43,671,589
Weighted average common shares outstanding, diluted (in shares)	43,779,456	43,671,589
Product
REVENUES
Total revenues	$ 19,431	$ 20,251
License
REVENUES
Total revenues	$ 500

LICENSE AGREEMENTS AND COMMITMENTS - Lease term and discount rate (Details)	Mar. 31, 2024	Dec. 31, 2023
LICENSE AGREEMENTS AND COMMITMENTS
Weighted average remaining lease term	1 year 4 months 13 days	1 year 7 months 9 days
Weighted average discount rate	8.30%	8.30%

OTHER BENEFITS

3 Months Ended

Mar. 31, 2024

OTHER BENEFITS

OTHER BENEFITS

NOTE 13—OTHER BENEFITS

The Company has adopted a defined contribution 401(k) savings plan (the “401(k) plan”) covering all U.S. employees. 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 three months ended March 31, 2024 and 2023.

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. The Danish subsidiary made no contributions during the three months ended March 31, 2024 and 2023. 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.

LICENSE AGREEMENTS AND COMMITMENTS - Legal matters (Details)	Feb. 05, 2024 defendant category	Aug. 25, 2021 stockholder
Lawsuit filed in the U.S. District Court, Southern District of New York, on August 25, 2021
Legal Matters
Number of stockholders that filed lawsuit \| stockholder		1
Class-action lawsuit filed in the U.S. District Court, Southern District of New York, on January 18, 2023
Legal Matters
Number of categories of challenged statements related to plaintiff claims dismissed by court	3
Number of categories of challenged statements related to plaintiff claims	4
Number of individual defendants the court dismissed \| defendant	1

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company’s significant accounting policies are detailed in our Annual Report on Form 10-K for the year ended December 31, 2023.

Use of Estimates

The preparation of consolidated 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 consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated 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, the valuation of stock options and asset impairments. 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.

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 a loss on cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. The Company’s cash and cash equivalents are held at a large major federal, national bank. The Company maintains cash balances in excess of insured limits. The Company monitors the financial performance, credit ratings and liquidity of the money market fund to timely assess and respond to any changes in the asset values of the fund. The Company does not anticipate any loss with respect to such cash balances.

Accounts Receivable, Net

The Company’s accounts receivable, net 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 allowance is based primarily on assessment of specific identifiable customer accounts considered at risk or uncollectible, as well as an analysis of current receivables aging and

expected future write-offs. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed, and no losses are currently expected.

The Company has not experienced any write-offs related to customer accounts receivable and has not recognized any allowance for doubtful accounts nor reversed any allowances in the three months ended March 31, 2024 and 2023.

Concentration of Credit Risk

The Company’s product sales are made through arrangements primarily with three national United States (“U.S.”) specialty distributors. As of March 31, 2024, the accounts receivable balances from such distributors totaled 76% of the Company’s outstanding accounts receivable. See NOTE 4 – PRODUCT REVENUE, NET, for details of product sales to certain customers that accounted for more than 10% of total product revenue, net. The remainder of the Company’s accounts receivable as of March 31, 2024 represented balances from international distribution partners. The Company has contractual payment terms with each customer and monitors their financial performance, historical payment terms and credit worthiness to timely assess and respond to any changes in their credit profile.

Inventories

The Company values inventories at the lower of cost or net realizable value on a first-in, first-out basis. The Company’s inventory cost includes 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 inventories. Amounts in inventories 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 inventories at the receipt of FDA approval.

The Company performs an assessment of the recoverability of capitalized inventories during each reporting period and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment occurs. 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 in the three months ended March 31, 2024 and 2023.

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 cash equivalents, which are measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements as of March 31, 2024
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	71,466	$	—	$	71,466
Total	$	—	$	71,466	$	—	$	71,466


	Fair Value Measurements as of December 31, 2023
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	75,501	$	—	$	75,501
Total	$	—	$	75,501	$	—	$	75,501

During the quarter ended March 31, 2024 and 2023, there were no transfers between Level 1, Level 2, and Level 3.

Operating Lease Right-of-Use Assets and Operating Lease Liabilities

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 the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate 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 the Company 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 a lease which is included in the lease term when it is reasonably certain that the Company 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.

The Company currently elects the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize right-of-use assets or liabilities. The Company also elects 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.

Revenue Recognition

To determine revenue recognition for product revenue and license revenue 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 Company will collect the consideration the Company 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 assesses 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, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. 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 the Company identifies a bundle of goods or services that is distinct. The standalone selling price is generally determined based on the prices charged to customers.

Product revenue, net

The Company recognizes revenue from sales of DANYELZA at a point in time when the Company’s customer is deemed to have obtained control of the product, which generally occurs upon receipt at the end-user hospital for sales in the United States, and upon delivery to the distributors for sales in the international territories.

The amount of revenue the Company recognizes 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, the Company estimates, utilizing the expected value method, the amount of revenue that the Company 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 the Company reviews these estimates quarterly. If actual results vary from the Company’s original estimates, the Company will adjust these estimates quarterly, which would affect net product revenue and earnings in the period such variances occur.

●

Rebates and chargebacks

The Company contracts with United States governmental agencies to ensure that DANYELZA will be eligible for coverage under the various programs administered by the agencies. The Company estimates the rebates and chargebacks to be provided and deducts these estimated amounts from gross product revenues. 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. The Company develops 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. The Company’s liability for these rebates and chargebacks mainly consists of claims for which invoices have not yet been received and paid. The Company does not maintain material levels of inventories in the wholesale or retail channel.

●

Discounts and distribution-related fees

The Company provides invoice discounts on DANYELZA sales to 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, the Company expects the distributors to earn these discounts and fees and deduct the full amount of these discounts and fees from the Company’s gross product revenue at the time such revenues are recognized.

●

Returns

The Company offers customers limited product return rights for damaged, defective, or expiring products. The Company estimates 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 accounts receivable.

In December 2022, the Company announced a distribution agreement with WEP Clinical Ltd., or WEP, in connection with an early access program for DANYELZA in Europe. There are no regulatory-based or sales-based milestone payments or royalty arrangements under this distribution agreement. The Company recognizes revenue when WEP obtains control of the product upon delivery. The Company invoices WEP based on the terms of the distribution agreement, where a portion is billed upon shipment of product and the unbilled portion is billed at a later date based on terms of the distribution agreement. The Company has an unconditional right to the unbilled portion of the receivable and the Company estimates that the receivable will be collected within one year and therefore has recorded the balance at March 31, 2024, within accounts receivable on the Consolidated Balance Sheets.

License revenue

The Company’s license agreements include regulatory-based milestone payments and sales-based milestone payments, in addition to royalties. The Company determines whether the achievement of each regulatory-based milestone is constrained as they are contingent upon regulatory approvals, which are not within the control of the Company and therefore not deemed probable. The Company expects that the sales-based milestones and royalty payments will be recognized when the milestone is achieved or the related sales occur. The Company re-evaluates the transaction price each quarter and as uncertain events are resolved or other changes in circumstances occur, the Company assesses whether this resolves the constraint and when it is appropriate to recognize revenue.

In December 2020, the Company entered into a development and commercialization arrangement with SciClone International Pharmaceuticals Ltd., or SciClone, for certain indications of DANYELZA and omburtamab for Greater China, including Mainland China, Taiwan, Hong Kong and Macau. Based on the terms of the agreement, the Company may receive regulatory-based milestone payments up to $40,000,000, of which $15,000,000 has already been recognized and received in December 2022 for the conditional approval of DANYELZA in China, 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. The Company expects that the remaining regulatory-based and sales-based milestones will be recognized when each milestone is achieved.

In November 2020, the Company 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, the West Bank and the Gaza Strip. Based on the terms of the arrangement, the Company may receive regulatory-based milestone payments up to $750,000, of which $250,000 has already been recognized, and sales-based milestone payments up to $500,000 and is entitled to royalties based upon the net sales generated by Takeda related to the product in the territory. The Company expects that the remaining regulatory-based and sales-based milestones will be recognized when the milestone is achieved, or the related sales occur.

In December 2020, the Company 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. There are no regulatory-based or sales-based milestone payments or royalty arrangements under this distribution agreement.

In May 2021, the Company entered into an exclusive distribution agreement with Adium Pharma S.A. (“Adium”) for Adium to be the exclusive distributor of DANYELZA in Latin America. Under the terms of the agreement, the Company may receive regulatory-based milestone payments up to $3,000,000, of which $2,000,000 has already been recognized, and is entitled to royalties based upon DANYELZA net sales generated by Adium in Latin America. In April 2022, the Company received $1,000,000 upon the submission of the updated FDA Biologics License Applications (“BLA”) dossier for DANYELZA. In addition, during third quarter of 2023, the Company recognized $500,000 in regulatory-based license revenue from Adium pursuant to the distribution agreement in connection with the September 2023 achievement of marketing authorization for DANYELZA in Mexico. Lastly, in January 2024, the Company accepted the price approval for the first product in Brazil from the Brazilian Medicines Market Regulation Chamber, or CMED. The Company received $500,000 regulatory-based payment from Adium in connection with the price approval from CMED in the three months ended March 31, 2024. The Company expects that the sales-based milestones and royalty payments will be recognized when and if the milestones are achieved or the related sales occur.

Stock-Based Compensation

The Company measures stock options granted to employees and directors 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 and records the expense for these awards using the straight-line method over the requisite service period.

The fair value of each stock option grant is estimated on the grant date using the Black Scholes option pricing model. The Company’s public trading commenced in September 2018, and, as a result, there is limited available historical volatility experience. Therefore, the Company estimates expected stock volatility based on the weighting of the Company’s historical volatility with the historical volatility of a group of publicly traded peer companies, and the Company expects to continue to do so until there is adequate historical data regarding the volatility of the Company’s traded stock prices. 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.

The fair value of restricted stock units is determined at the grant-date price of the Company’s common stock.

The fair value of performance-based restricted stock units (“PRSU”) is determined using a Monte-Carlo simulation model. The vesting of each tranche of the award depends on the fulfillment of both a service condition and the achievement of a stock price hurdle at the end of each tranche’s performance period, based on an average of the closing stock price over the 30 consecutive trading days immediately preceding each tranche’s vesting date. The stock price volatility is simulated using the Company’s historical volatility calculated from daily stock returns over a lookback term which equals the remaining service period from the grant date. The risk-free rate is determined using the zero-coupon risk-free interest rate derived from the Treasury Constant Maturities yield curve on the grant date. 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.

Earnings Per Share

The Company reports net earnings per share in accordance with ASC 260, Earnings 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. Similarly, securities that could potentially dilute basic EPS in the future are not included in the computation of diluted EPS because to do so would have been antidilutive.

Segment Information

The Company is engaged solely in operations related to the discovery, development, distribution and commercialization of novel antibody-based therapeutic products for the treatment of cancer, which the Company defines as one operating segment.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are adopted by the Company as of the specific effective date. The Company adopted ASU 2021-01 (as amended by ASU 2022-06), ASU 2020-06, ASU 2022-03, ASU 2022-04, ASU 2023-01, ASU 2023-02 and ASU 2023-07 effective January 1, 2024, and the adoption of these new standards did not have a material impact on the Company’s consolidated financial statements or disclosures.

In December 2023, the FASB issued ASU 2023-09, Improvement to income tax disclosures (Topic 740). ASU 2023-09 addresses annual disclosures related to the income tax rate reconciliation and the income taxes paid within the tax note. ASU 2023-09 requires consistent categories and greater disaggregation of information in the income tax rate reconciliation as well as a disaggregation of taxes paid by jurisdiction for the income taxes paid. ASU 2023-09 is required to be adopted by the Company for annual periods beginning after December 15, 2024. Early adoption is permitted for annual consolidated financial statements that have not yet been issued or made available for issuance. The Company is evaluating the impact of this update on the Company’s disclosures.

The Company has evaluated all other accounting pronouncements recently issued but not yet adopted and believes that these pronouncements will not have a material impact on the Company’s consolidated financial statements or disclosures.

LICENSE AGREEMENTS AND COMMITMENTS (Tables)

3 Months Ended

Mar. 31, 2024

LICENSE AGREEMENTS AND COMMITMENTS

Schedules of maximum clinical, regulatory or sales-based milestones and obligations pertaining to the significant license agreements that have been paid, expensed or accrued

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


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

The below table represents all obligations pertaining to the significant license agreements that have been paid, expensed, or accrued for during the three months ended March 31, 2024 and 2023, and as of March 31, 2024 and December 31, 2023 (in thousands):

Cash paid

Expense

Accrued

three

liabilities

months

current

non-current

current

non-current

ended

as of

March 31,

December 31,

Agreements

2024

2023

2024

2023

2024

2023

MSK

2,377

3,245

1,348

1,223

1,459

1,950

2,452

1,950

CD33

—

300

—

300

SADA

—

1,000

3,125

1,000

3,125

Maturities of operating lease liabilities

Maturities of operating lease liabilities as of March 31, 2024 and December 31, 2023 were as follows (in thousands):



	March 31, 2024		December 31, 2023
Remainder of 2024	$	730	$	—
Years ending December 31,
2024		—		996
2025		525		526
Total lease payments		1,255		1,522
Less: Imputed interest		(74)		(103)
Total operating lease liabilities as of period end	$	1,181	$	1,419

INCOME TAXES

3 Months Ended

Mar. 31, 2024

INCOME TAXES

INCOME TAXES

NOTE 12—INCOME TAXES

During the three months ended March 31, 2024 and 2023, the Company experienced pre-tax net losses of $6,469,000 and $6,390,000. The Company’s current income tax provision was $160,000 during the three months ended March 31, 2024, and the Company did not have a current income tax provision during the three months ended March 31, 2023. There were no deferred income tax provisions during the three months ended March 31, 2024 and 2023.

The Company’s tax returns for the years 2017 to 2022 are open for tax examination by U.S. federal and state, and the Danish tax authorities.

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.

- Definition

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

+ References

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

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

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

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

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

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

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

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

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

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

+ Details

PRODUCT REVENUE, NET - Concentrations (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Concentration risk
Revenue	$ 19,931	$ 20,251
Product
Concentration risk
Revenue	19,431	20,251
Product, Royalty \| Distribution partner
Concentration risk
Revenue	$ 462	$ 658
McKesson \| Customer Concentration Risk \| Revenue \| Product
Concentration risk
Concentration risk percentage (as a percent)	51.00%	45.00%
AmerisourceBergen \| Customer Concentration Risk \| Revenue \| Product
Concentration risk
Concentration risk percentage (as a percent)	25.00%	29.00%
Cardinal Health \| Customer Concentration Risk \| Revenue \| Product
Concentration risk
Concentration risk percentage (as a percent)	22.00%	13.00%
WEP \| Customer Concentration Risk \| Revenue \| Product
Concentration risk
Concentration risk percentage (as a percent)		12.00%

STOCK-BASED COMPENSATION - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Options
Outstanding and expected to vest at beginning of period (in shares)	9,307,330
Granted (in shares)	1,450,790
Exercised (in shares)	(71,550)
Forfeited, shares (in shares)	(116,605)
Outstanding and expected to vest at end of period (in shares)	10,569,965	9,307,330
Exercisable at end of period (in shares)	6,453,371
Weighted average exercise price
Outstanding and expected to vest at beginning of period (in dollars per share)	$ 17.26
Granted (in dollars per share)	11.23
Exercised (in dollars per share)	8.22
Forfeited (in dollars per share)	6.34
Outstanding and expected to vest at end of period (in dollars per share)	16.61	$ 17.26
Exercisable at end of period (in dollars per share)	$ 20.29
Aggregate intrinsic value
Outstanding and expected to vest (in dollars)	$ 60,339	$ 10,012
Exercisable (in dollars)	$ 31,312
Weighted average remaining contractual life (years)
Outstanding and expected to vest (in years)	6 years 7 months 17 days	6 years 5 months 8 days
Exercisable (in years)	5 years 21 days

LICENSE AGREEMENTS AND COMMITMENTS - Summary of Significant Agreements and Commitments (Details) - USD ($) $ in Thousands	3 Months Ended		12 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Financial statement information
Accrued liabilities, current	$ 9,989		$ 13,166
Accrued liabilities, noncurrent	5,375		5,375
License Agreement \| MSK
Milestones
Maximum Clinical Milestones	2,450
Maximum Regulatory Milestones	9,000
Maximum Sales-based Milestones	20,000
Financial statement information
Cash paid	2,377	$ 3,245
Expense	1,348	1,223
Accrued liabilities, current	1,459		2,452
Accrued liabilities, noncurrent	1,950		1,950
License Agreement \| MabVax
Milestones
Maximum Clinical Milestones	200
Maximum Regulatory Milestones	1,200
CD33 License Agreement \| MSK
Milestones
Maximum Clinical Milestones	550
Maximum Regulatory Milestones	500
Maximum Sales-based Milestones	7,500
Financial statement information
Accrued liabilities, noncurrent	300		300
SADA License Agreement \| MSK and MIT
Milestones
Maximum Clinical Milestones	4,730
Maximum Regulatory Milestones	18,125
Maximum Sales-based Milestones	23,750
Financial statement information
Cash paid			605
Expense	0	$ 0	4,125
Accrued liabilities, current	1,000		1,000
Accrued liabilities, noncurrent	3,125		3,125
Accrued liabilities	$ 4,125		$ 4,125

PRODUCT REVENUE, NET - Receivables, allowances and accrued liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Revenue
Accounts receivable	$ 20,588	$ 22,454
Accrued liabilities	9,989	13,166
Product \| WEP \| Distribution agreement
Revenue
Accounts receivable	20,588
Accounts receivable, unbilled portion	$ 2,241
Accrued liabilities		$ 198

- Definition

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

+ References + Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Credit Risk (Details) - Credit Concentration Risk - Accounts Receivable - Three Customers	3 Months Ended
	Mar. 31, 2024 customer
Concentration risk
Number of customers	3
Concentration risk percentage (as a percent)	76.00%

INTANGIBLE ASSETS, NET (Tables)

3 Months Ended

Mar. 31, 2024

INTANGIBLE ASSETS, NET

Schedule of intangible assets, net

The Company’s intangible assets, net related to capitalized milestone payments made following FDA and other regulatory approvals, and commercialization of DANYELZA. The Company’s intangible assets, net as of March 31, 2024 and December 31, 2023 are as follows (in thousands):

March 31, 2024

December 31, 2023

Gross

Net

Gross

Net

Carrying

Accumulated

Carrying

Accumulated

Carrying

Amount

Amortization

Amount

Amortization

Amount

DANYELZA

3,300

757

2,543

3,300

669

2,631

OTHER BENEFITS (Details) - USD ($) $ in Thousands	3 Months Ended		15 Months Ended
OTHER BENEFITS (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024
United States
Benefit plan
Employer matching contribution to defined contribution plan (as a percent)	0.00%	0.00%
Denmark
Benefit plan
Employer matching contribution to defined contribution plan (as a percent)	0.00%	0.00%
Costs for employee health insurance benefits			$ 0

LICENSE AGREEMENTS AND COMMITMENTS - SADA License Agreement (Details) - USD ($) $ in Thousands	3 Months Ended		12 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Agreements
Accrued milestone and royalty payments	$ 5,375		$ 5,375
SADA License Agreement \| MSK and MIT
Agreements
Annual minimum royalties payable from tenth anniversary	40
Annual minimum royalties payable once patent has been issued	60
Expense	0	$ 0	4,125
Accrued liabilities	4,125		4,125
Accrued milestone and royalty payments	$ 3,125		3,125
Cash paid			$ 605

PRODUCT REVENUE, NET - Reserves for discounts and allowances (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Revenue
Revenue	$ 19,931	$ 20,251
Change in reserves for discounts and allowances
Discounts, Balance at beginning of period	41
Discounts, Current provisions relating to sales in current year	94
Discounts, Payments/credits relating to sales in current year	(54)
Discounts, Balance at end of period	81
Contractual Allowances and Government Rebates, Balance at beginning of period	2,694
Contractual Allowances and Government Rebates, Current provisions relating to sales in current year	2,667
Contractual Allowances and Government Rebates, Payments/credits relating to sales in current year	(2,690)
Contractual Allowances and Government Rebates, Change in estimate related to sales in the prior year	(294)
Contractual Allowances and Government Rebates, Balance at end of period	2,377
Returns, Balance at beginning of period	66
Returns, Current provisions relating to sales in current year	3
Returns, Balance at end of period	69
Reserves for discounts and allowances, Balance at beginning of period	2,801
Reserves for discounts and allowances, Current provisions relating to sales in current year	2,764
Reserves for discounts and allowances, Payments/credits relating to sales in current year	(2,744)
Reserves for discounts and allowances, Change in estimate related to sales in the prior year	(294)
Reserves for discounts and allowances, Balance at end of period	2,527
Accounts receivable
Change in reserves for discounts and allowances
Reserves for discounts and allowances, Balance at beginning of period	492
Reserves for discounts and allowances, Balance at end of period	617
Accrued liabilities
Change in reserves for discounts and allowances
Reserves for discounts and allowances, Balance at beginning of period	2,309
Reserves for discounts and allowances, Balance at end of period	$ 1,910

LICENSE AGREEMENTS AND COMMITMENTS

3 Months Ended

Mar. 31, 2024

LICENSE AGREEMENTS AND COMMITMENTS

LICENSE AGREEMENTS AND COMMITMENTS

NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS

The Company has entered into three license agreements and certain other agreements with Memorial Sloan Kettering Cancer Center (“MSK”). The license agreements include the MSK License Agreement, dated August 20, 2015, between the Company and MSK (the “MSK License”), and the CD33 License Agreement, dated November 13, 2017, between the Company and MSK (the “CD33 License”). Through the Settlement and Assumption and Assignment of the MSK License and Y-mAbs Sublicense Agreement, dated December 2, 2019, among MabVax Therapeutics Holdings, Inc. and MabVax Therapeutics, Inc., (together “MabVax”), the Company and MSK (the “SAAA”), 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.

In addition, the Company entered into a license agreement, dated April 15, 2020, with MSK and Massachusetts Institute of Technology (“MIT”) (the “SADA License Agreement”). These license agreements with MSK and MIT grant the Company certain patent rights and intellectual property rights, and in consideration thereof, the Company agreed to make certain payments and issue shares of the Company’s common stock to MSK and MIT. Certain payments are contingent milestone and royalty payments, as disclosed in the table below. Amounts disclosed in NOTE 8—ACCRUED LIABILITIES for accrued licensing, milestone and royalty payments are inclusive of obligations under the MSK License Agreement, CD33 License Agreement, MabVax License Agreement and SADA License Agreement, collectively.

The Company’s material license agreements are detailed in NOTE 9— LICENSE AGREEMENTS AND COMMITMENTS to the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

MSK License Agreement

The MSK License Agreement relates to intellectual property for DANYELZA and requires the Company to pay to MSK mid to high single-digit royalties based on annual net sales of licensed products or the performance of licensed services by the Company and the Company’s affiliates and sublicensees. The Company is required to pay annual minimum royalties of $80,000 over the royalty term, which amounts are non-refundable but are creditable against royalty payments otherwise due thereunder. The Company is also obligated to pay to MSK certain clinical, regulatory and sales-based milestone payments under the MSK License, which payments become due at the earlier of completion of the related milestone activity or the date indicated in the MSK License.

SADA License Agreement

Pursuant to the SADA License Agreement, the Company was granted 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 PRIT Technology.

The SADA License Agreement requires the Company to pay MSK and MIT mid to high single-digit royalties based on annual net sales of licensed products or the performance of licensed services by the Company and its affiliates and sublicensees. The Company is obligated to pay non-refundable 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, which are creditable against royalty payments otherwise due under the SADA License Agreement. Pursuant to the SADA License Agreement, the Company is also obligated to pay MSK and MIT certain clinical, regulatory and sales-based milestone payments, which become due at the earlier of completion of the related milestone activity or the date indicated in the SADA License Agreement. The Company may terminate the SADA License Agreement with prior written notice.

The Company did not recognize any expense related to milestones under the SADA License Agreement during the three months ended March 31, 2024 and 2023, respectively. The Company recognized an expense of $4,125,000 related to clinical milestones under the SADA License Agreement during the year ended December 31, 2023, as the Company determined certain time-based clinical milestones within the agreement are probable based on the availability of necessary data and the assessment of clinical progress during the year ended December 31, 2023. The Company had $4,125,000 in accrued liabilities as of March 31, 2024 and December 31, 2023. The Company made a payment of $605,000 in the year ended December 31, 2023 related to achievement of the milestone for dosing the first patient in the Phase 1 trial of GD2-SADA in April 2023. The Company did not make any payments under SADA License Agreement in the three months ended March 31, 2024.

For the MSK License Agreement and the SADA License Agreement, in addition to any milestone payments, to the extent the Company enters into sublicense arrangements, it is obligated to pay to MSK, as indicated in MSK License Agreement, and MSK and MIT, as indicated in SADA License Agreement, a percentage of certain payments received from sublicensees of the rights licensed to it by MSK, or MSK and MIT, which percentage will be based upon the achievement of certain clinical milestones. See NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES for sublicense agreements related to MSK License Agreements by the Company.

Failure by the Company to meet certain conditions under each arrangement could cause the related licenses to such licensed products to be canceled and could result in termination of the respective arrangement with MSK, or MSK and MIT.

Summary of Significant License Agreements and Related Commitments


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

Cash paid

Expense

Accrued

three

liabilities

months

current

non-current

current

non-current

ended

as of

March 31,

December 31,

Agreements

2024

2023

2024

2023

2024

2023

MSK

2,377

3,245

1,348

1,223

1,459

1,950

2,452

1,950

CD33

—

300

—

300

SADA

—

1,000

3,125

1,000

3,125

Minimum royalties and certain clinical, regulatory and sales milestones that become due based upon the passage of time under the MSK License Agreement, CD33 License Agreement, the MabVax Agreement, and the SADA License Agreement are excluded from the above table as the Company does not consider such obligations to be probable as of March 31, 2024 and December 31, 2023.

Research and development is inherently uncertain and should such research and development fail, the MSK License Agreement, the CD33 License Agreement, the SADA License Agreement and the MabVax License Agreement as well as the MabVax/Y-mAbs Sublicense are cancelable at the Company’s option. The Company will also consider the development risk and each party’s termination rights under the respective 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.

Lease Agreements

In February 2019, the Company entered into a lease agreement in connection with the Company’s 4,548 square feet laboratory in New Jersey. In December 2019, the Company expanded the space with an additional 235 square feet. The original term of the lease was three years from the date the Company occupied the premises, with an option to extend for an additional two years which was to expire in January 2024, which the Company exercised and had included in the determination of the related lease liability. In July 2023, the Company entered into a lease amendment to extend the term to February 2025. Fixed rent payable under the lease is approximately $177,000 per annum and is payable in equal monthly installments of approximately $15,000 per month.

In January 2018, the Company entered into a lease agreement in connection with the Company’s corporate headquarters in New York. The term of the lease was six years from the date the Company began to occupy the premises and the lease was to expire in April 2024. In August 2023, the Company entered into a lease amendment to extend the

term to April 2025. Fixed rent payable under the lease is approximately $408,000 per annum and is payable in equal monthly installments of approximately $34,000.

In February 2018, the Company entered into a lease agreement for certain office space in Denmark, which has been amended several times. The lease was renewed on November 1, 2021 with a four-year term that expires in November 2025. The lease is payable in monthly installments of approximately $41,000. In January 2023, the Company notified the landlord of the intention to reduce the leased premise as a result of the Company’s strategic restructuring. The lease modification resulted in an immaterial charge in the year ended December 31, 2023.

Total operating lease costs were $246,000 and $340,000 for the three months ended March 31, 2024 and 2023, respectively.

During the three months ended March 31, 2024, the expenses were recorded as $168,000 in research and development expense and $78,000 in selling, general, and administrative expense. During the three months ended March 31, 2023, the expenses were recorded as $283,000 in research and development expense and $57,000 in selling, general, and administrative expense. Cash paid for amounts included in the measurement of lease liabilities for the three months ended March 31, 2024 and 2023 was $251,000 and $259,000, 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 as of March 31, 2024 and December 31, 2023 were as follows (in thousands):



	March 31, 2024		December 31, 2023
Remainder of 2024	$	730	$	—
Years ending December 31,
2024		—		996
2025		525		526
Total lease payments		1,255		1,522
Less: Imputed interest		(74)		(103)
Total operating lease liabilities as of period end	$	1,181	$	1,419

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 estimates the incremental borrowing rate based on the information available at the lease commencement date. As of March 31, 2024, the weighted average remaining lease term was 1.37 years and the weighted average discount rate used to determine the operating lease liability was 8.3%. As of December 31, 2023, the weighted average remaining lease term is 1.61 years and the weighted average discount rate used to determine the operating lease liability was 8.3%.

Legal Matters

Donoghue vs. Y-mAbs Therapeutics, Inc., and Gad

The Company has been named a nominal defendant in a lawsuit filed in the U.S. District Court, Southern District of New York, on August 25, 2021, by one of the Company’s stockholders, Deborah Donoghue (Case No. 1:21-cv-07182). The suit names the Company’s Chief Business Officer, and Vice Chairman of the Company’s board of directors, Mr. Thomas Gad as an additional defendant, and it seeks 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 together with appropriate interest and costs of the lawsuit. On December 17, 2021, Mr. Gad filed a Motion to Dismiss the lawsuit. On August 8, 2022, the Court denied Mr. Gad’s Motion to Dismiss the lawsuit. The parties have completed documentary discovery and depositions. On February 1, 2024, both the Plaintiff and Mr. Gad filed their respective motions for summary judgment. 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 has 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.

In re Y-mAbs Therapeutics, Inc. Securities Litigation

On January 18, 2023, a putative class-action lawsuit was filed against the Company and certain of the Company’s current and former officers for alleged violations of the U.S. federal securities laws in the United States District Court, Southern District of New York (Case No.: 1:23-cv-00431). The amended complaint filed on May 23, 2023, asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, on behalf of a proposed class consisting of those who acquired the Company’s common stock between October 6, 2020 and October 28, 2022. The amended complaint alleges that there were material misrepresentations and/or omissions regarding the FDA’s consideration of the Company’s BLA for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma firstly submitted in 2020 and resubmitted in 2022. The amended complaint seeks unspecified damages, and costs and expenses, including attorneys’ fees. On September 29, 2023, the defendants’ motion to dismiss the amended complaint was fully briefed. On February 5, 2024, the Court granted in part and denied in part the defendants’ motion to dismiss. The Court dismissed the plaintiff’s claims relating to three of four categories of challenged statements and dismissed in part plaintiff’s claims relating to the fourth category of challenged statements. The Court also dismissed one of the individual defendants from the case. The Company believes that the remaining claims are without merit and intends to vigorously defend against these claims. The Company has not established a liability for this claim as of March 31, 2024 as the Company does not consider a loss on the claim to be probable.

Hazelton vs. Y-mAbs Therapeutics Inc., and Gad, et al.

The Company has been named a nominal defendant in a lawsuit filed in the Court of Chancery of the State of Delaware, on February 8, 2023, by a purported stockholder, Jeffrey Hazelton (Case No. 2023-0147-LWW). The amended complaint filed on May 12, 2023, purports to bring claims on behalf of the Company against current and former members of the Company’s board of directors for allegedly awarding themselves excessive compensation for fiscal years 2020 and 2021. The amended complaint seeks, among other things, recovery of alleged excessive compensation, an order directing the Company to undertake certain corporate governance reforms, and an award of costs and expenses, including attorneys’ fees. Defendants’ motion to dismiss the amended complaint was fully briefed as of September 8, 2023. On April 3, 2024, the parties informed the Court that they had agreed to resolve the matter on mootness grounds and hoped to reach agreement on formal documentation. The Company has not established a liability for this claim as of March 31, 2024 as the Company does not consider a loss on the claim to be estimable.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition - License revenue (Details) - USD ($) $ in Thousands	1 Months Ended			3 Months Ended			24 Months Ended
	Dec. 31, 2022	Apr. 30, 2022	Nov. 30, 2020	Mar. 31, 2024	Sep. 30, 2023	Mar. 31, 2023	Mar. 31, 2024	May 31, 2021	Dec. 31, 2020
Agreements
Revenue				$ 19,931		$ 20,251
License
Agreements
Revenue				500
License \| Development and commercialization arrangement \| SciClone
Agreements
Revenue	$ 15,000
Maximum regulatory-based milestone payments receivable									$ 40,000
Maximum sales-based milestone payments receivable									60,000
License \| License and distribution agreement \| Takeda Israel
Agreements
Revenue			$ 250
Maximum regulatory-based milestone payments receivable			750
Maximum sales-based milestone payments receivable			$ 500
License \| Distribution agreement \| Swixx BioPharma AG
Agreements
Maximum regulatory-based milestone payments receivable									0
Maximum sales-based milestone payments receivable									$ 0
License \| Distribution agreement \| Adium
Agreements
Revenue		$ 1,000		$ 500	$ 500		$ 2,000
Maximum regulatory-based milestone payments receivable								$ 3,000
License \| Distribution agreement \| WEP
Agreements
Maximum regulatory-based milestone payments receivable	0
Maximum sales-based milestone payments receivable	$ 0

STOCK-BASED COMPENSATION - RSUs (Details) - Restricted Stock Units (RSUs), Excluding PRSUs - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Restricted stock units issued and outstanding
Outstanding and expected to vest at beginning of period (in shares)	351,407
Granted (in shares)	400,277
Vested (in shares)	(108,976)
Forfeited (in shares)	(39,934)
Outstanding and expected to vest at end of period (in shares)	602,774	351,407
Weighted average grant price
Weighted average grant price, Outstanding and expected to vest, Beginning of period (in dollars per share)	$ 5.06
Weighted average grant price, Granted (in dollars per share)	10.96
Weighted average grant price, Vested (in dollars per share)	4.82
Weighted average grant price, Forfeited (in dollars per share)	7.35
Weighted average grant price, Outstanding and expected to vest, End of period (in dollars per share)	$ 8.87	$ 5.06
Weighted average remaining vesting life	2 years 4 months 28 days	1 year 11 months 26 days
New non-executive director
Restricted stock units issued and outstanding
Granted (in shares)	4,660
Employees excluding new non-executive director
Restricted stock units issued and outstanding
Granted (in shares)	395,617
Weighted average grant price
Vesting period	3 years

PRODUCT REVENUE, NET (Tables)

3 Months Ended

Mar. 31, 2024

PRODUCT REVENUE, NET

Schedule of product revenue by geographic location

The Company’s product revenue, net was generated from sales of DANYELZA and consists of the following (in thousands):


	Three months ended March 31,
	2024		2023

United States	$	18,610	$	16,833
Other countries		821		3,418
Total product revenue, net	$	19,431	$	20,251

Schedule of change in reserves for discounts and allowances

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


			Contractual
			Allowances and
	Discounts		Government Rebates		Returns		Total


Balance December 31, 2023	$	41	$	2,694	$	66	$	2,801
Current provisions relating to sales in current year		94		2,667		3		2,764
Payments/credits relating to sales in current year		(54)		(2,690)		—		(2,744)
Change in estimate related to sales in the prior year		—		(294)		—		(294)
Balance March 31, 2024	$	81	$	2,377	$	69	$	2,527

NET LOSS PER SHARE - Anti-dilutive securities (Details) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
NET LOSS PER SHARE
Potentially dilutive securities outstanding	11,226,739	8,894,258

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

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Segment Information (Details)	3 Months Ended
	Mar. 31, 2024 segment
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Number of Operating Segments	1

BASIS OF PRESENTATION

3 Months Ended

Mar. 31, 2024

BASIS OF PRESENTATION

BASIS OF PRESENTATION

NOTE 2—BASIS OF PRESENTATION

The Company has incurred losses in every year 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 the FDA approval in the United States and regulatory approval in other jurisdictions; marketing or sales capability or experience; uncertainty in getting adequate payor 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 received accelerated approval by the FDA in November 2020, but there can be no assurance that the Company’s other research and development efforts 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 and commercialization efforts are successful, it is uncertain when, if ever, the Company will become profitable. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies.

The Company’s consolidated 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 $464,099,000 as of March 31, 2024 and $457,470,000 as of December 31, 2023. Through March 31, 2024, the Company has funded the operations primarily through proceeds from sales of shares of the Company’s common stock, including the initial public offering in September 2018 and the Company’s subsequent public offerings in November 2019 and February 2021, as well as additional funding from the sales of DANYELZA and from the sale of the Company’s Priority Review Voucher (“PRV”) obtained upon FDA approval of DANYELZA.

The Company had cash and cash equivalents of $75,749,000 and $78,637,000 as of March 31, 2024 and December 31, 2023, respectively. As of the issuance date of the consolidated financial statements for the quarter ended March 31, 2024, the Company expects that the cash and cash equivalents as of March 31, 2024 will be sufficient to fund the Company’s operating expenses and capital expenditure requirements as currently planned through at least the next 12 months from the date of the financial statements are issued.

The Company may raise additional capital to fund future operations through the sale of the Company’s equity securities, incurring debt, entering into licensing or collaboration agreements with partners, grants or other sources of financing. These potential financing sources are in addition to the successful commercialization of DANYELZA and our product candidates, for which the Company may obtain regulatory approval and marketing authorization. The Company’s commercialization strategy may include working with a collaborator or distributor. Sufficient funds may not

be available to the Company on attractive terms or at all when needed from equity, debt or other financing. If 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 the Company’s liquidity position which may include significantly reducing the rate of spending through delaying or scaling back operations, or suspending certain research and development programs and other operational programs in addition to other measures.

The accompanying unaudited consolidated financial statements reflect the accounts of the Company and the Company’s wholly-owned subsidiary and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information, Accounting Standards Codification (“ASC”) Topic 270-10 and the instructions to Form 10-Q. Accordingly, these consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim consolidated financial statements include all adjustments (consisting only of normal recurring nature) necessary in the judgment of management for a fair statement of the results for the periods presented. All intercompany balances and transactions have been eliminated. The Company has evaluated subsequent events through the date of this filing. Operating results for the three-month period ended March 31, 2024, are not necessarily indicative of the results that may be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. The consolidated balance sheet data as of December 31, 2023 was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim consolidated financial statements in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

STOCK-BASED COMPENSATION - Stock option grants (Details) - $ / shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Share-Based Compensation Awards
Weighted average grant-date fair value of stock options granted (in dollars per share)	$ 8.24	$ 3.40
Granted (in shares)	1,450,790
New non-executive director
Share-Based Compensation Awards
Granted (in shares)	27,900
Employees excluding new non-executive director
Share-Based Compensation Awards
Granted (in shares)	1,422,890
Employee Stock Option
Share-Based Compensation Awards
Expected term (in years)	6 years 3 months 18 days	6 years 3 months 18 days
Risk-free interest rate (as a percent)	4.10%	3.60%
Employee Stock Option \| Maximum
Share-Based Compensation Awards
Term of award	10 years
Employee Stock Option \| Tranche one \| Employees excluding new non-executive director
Share-Based Compensation Awards
Vesting period	1 year
Vesting (as a percent)	25.00%
Employee Stock Option \| Tranche two \| Employees excluding new non-executive director
Share-Based Compensation Awards
Vesting period	36 months

INCOME TAXES - Summary (Details) - USD ($) $ in Thousands	3 Months Ended
INCOME TAXES - Summary (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023
Domestic and foreign loss before income taxes:
LOSS BEFORE INCOME TAXES	$ (6,469)	$ (6,390)
Income tax expense
Current income tax provision	$ 160

- 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

LICENSE AGREEMENTS AND COMMITMENTS - Lease costs (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Leases
Total operating lease costs	$ 246	$ 340
Cash paid for amounts included in the measurement of lease liabilities	251	259
Research and development expense
Leases
Total operating lease costs	168	283
Selling, general, and administrative
Leases
Total operating lease costs	$ 78	$ 57

STOCK-BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Share-Based Compensation Awards
Stock-based compensation expenses	$ 3,846	$ 5,304
Share based compensation acceleration cost		1,706
Research and development expense
Share-Based Compensation Awards
Stock-based compensation expenses	1,872	2,306
Selling, general, and administrative
Share-Based Compensation Awards
Stock-based compensation expenses	1,974	2,998
Restricted Stock Units (RSUs), Excluding PRSUs
Share-Based Compensation Awards
Stock-based compensation expenses	421	187
Performance-based Restricted Stock Unit (PRSUs)
Share-Based Compensation Awards
Stock-based compensation expenses	53
Employee Stock Option
Share-Based Compensation Awards
Stock-based compensation expenses	$ 3,372	$ 5,117

- Definition

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

+ References

+ Details

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (6,629)	$ (6,390)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	159	182
Stock-based compensation	3,846	5,304
Foreign currency and other transactions	492	(456)
Changes in assets and liabilities:
Accounts receivable, net	1,866	(6,171)
Inventories	(3,383)	(2,243)
Other current assets	1,473	1,722
Other assets	1,318	(2,983)
Accounts payable	176	(4,771)
Accrued liabilities and other	(2,795)	2,682
NET CASH USED IN OPERATING ACTIVITIES	(3,477)	(13,124)
CASH FLOWS FROM INVESTING ACTIVITIES
NET CASH PROVIDED BY INVESTING ACTIVITIES
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercised stock options	588
NET CASH PROVIDED BY FINANCING ACTIVITIES	588
Effect of exchange rates on cash and cash equivalents	1	(9)
NET DECREASE IN CASH AND CASH EQUIVALENTS	(2,888)	(13,133)
Cash and cash equivalents at the beginning of period	78,637	105,762
Cash and cash equivalents at the end of period	$ 75,749	$ 92,629

LICENSE AGREEMENTS AND COMMITMENTS - Lease agreements (Details) $ in Thousands	1 Months Ended
	Feb. 28, 2019 USD ($) ft²	Aug. 31, 2023 USD ($)	Nov. 01, 2021 USD ($)	Dec. 31, 2019 ft²	Jan. 31, 2018
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	$ 177
Lease payable per month	$ 15
Corporate headquarters, New York
Leases
Lease term					6 years
Fixed rent payable per annum		$ 408
Lease payable per month		$ 34
Office space, Denmark
Leases
Lease term			4 years
Lease payable per month			$ 41

NET LOSS PER SHARE (Tables)

3 Months Ended

Mar. 31, 2024

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):


	Three months ended March 31,
	2024		2023

Net loss (numerator)	$	(6,629)	$	(6,390)
Weighted-average shares (denominator), basic and diluted		43,779		43,672
Basic and diluted net loss per share	$	(0.15)	$	(0.15)

STOCK-BASED COMPENSATION - Unrecognized expense (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2024 USD ($)
Unrecognized compensation related to employee stock options
Unrecognized stock-based compensation expense	$ 29,468
Restricted Stock Units (RSUs), Excluding PRSUs
Unrecognized compensation related to employee stock options
Unrecognized stock-based compensation expense	$ 4,872
Weighted average recognition period	2 years 4 months 24 days
Performance-based Restricted Stock Unit (PRSUs)
Unrecognized compensation related to employee stock options
Unrecognized stock-based compensation expense	$ 605
Weighted average recognition period	1 year 10 months 24 days
Employee Stock Option
Unrecognized compensation related to employee stock options
Unrecognized stock-based compensation expense	$ 23,991
Weighted average recognition period	3 years

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, 2022	$ 4	$ 543,929	$ 1,331	$ (436,043)	$ 109,221
Balance at the beginning of period (in shares) at Dec. 31, 2022	43,670,109
Increase (Decrease) in Stockholders' Equity
Stock-based compensation expense		5,304			5,304
Stock-based compensation expense (in shares)	7,658
Foreign currency translation			(306)		(306)
Net Income (Loss)				(6,390)	(6,390)
Balance at the end of period at Mar. 31, 2023	$ 4	549,233	1,025	(442,433)	107,829
Balance at the end of period (in shares) at Mar. 31, 2023	43,677,767
Balance at the beginning of period at Dec. 31, 2023	$ 4	558,002	449	(457,470)	$ 100,985
Balance at the beginning of period (in shares) at Dec. 31, 2023	43,672,112				43,672,112
Increase (Decrease) in Stockholders' Equity
Exercise of stock options		588			$ 588
Exercise of stock options (in shares)	71,550				71,550
Stock-based compensation expense		3,846			$ 3,846
Stock-based compensation expense (in shares)	108,976
Foreign currency translation			399		399
Net Income (Loss)				(6,629)	(6,629)
Balance at the end of period at Mar. 31, 2024	$ 4	$ 562,436	$ 848	$ (464,099)	$ 99,189
Balance at the end of period (in shares) at Mar. 31, 2024	43,852,638				43,852,638

- Definition

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

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-URI https://asc.fasb.org//1943274/2147480167/946-830-55-12

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
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-Section S99
-Paragraph 1
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Reference 9: http://www.xbrl.org/2009/role/commonPracticeRef
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-URI https://asc.fasb.org//1943274/2147480418/310-10-S99-2

+ Details

INVENTORIES (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Inventories
Raw Material	$ 261
Work In Progress	16,550	$ 14,021
Finished Goods	2,378	2,992
Total Inventories	19,189	17,013
CURRENT ASSETS
Inventories	8,448	5,065
NONCURRENT ASSETS
Inventories, Noncurrent	10,741	11,948
Other long-term assets
Inventories
Work In Progress	10,741	11,948
NONCURRENT ASSETS
Inventories, Noncurrent	$ 10,741	$ 11,948

NET LOSS PER SHARE

3 Months Ended

Mar. 31, 2024

NET LOSS PER SHARE

NET LOSS PER SHARE

NOTE 5—NET LOSS PER SHARE

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


	Three months ended March 31,
	2024		2023

Net loss (numerator)	$	(6,629)	$	(6,390)
Weighted-average shares (denominator), basic and diluted		43,779		43,672
Basic and diluted net loss per share	$	(0.15)	$	(0.15)

Potentially dilutive securities excluded from the computation of diluted earnings per share relate to stock options and unvested restricted share units outstanding totaled 11,226,739 shares and 8,894,258 shares as of March 31, 2024 and 2023, respectively.

STOCKHOLDERS' EQUITY

3 Months Ended

Mar. 31, 2024

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

NOTE 10—STOCKHOLDERS’ EQUITY

Authorized Stock

As of March 31, 2024 and December 31, 2023, the Company has authorized a total of 105,500,000 shares, 100,000,000 of which are common stock, par value $0.0001 per share, and 5,500,000 of which are 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 had issued 43,852,638 shares and 43,672,112 shares of common stock as of March 31, 2024 and December 31, 2023.

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 March 31, 2024 or December 31, 2023.

- Definition

The entire disclosure for equity.

+ References

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

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 13
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

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

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Name Accounting Standards Codification
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-Paragraph 6
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-URI https://asc.fasb.org//1943274/2147481004/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
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-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org//505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

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

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
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-Paragraph 14
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-16

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Subparagraph (a)
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Accrued liabilities
Accrued licensing milestone and royalty payments	$ 2,459	$ 3,452
Accrued clinical costs	794	597
Accrued compensation and board fees	2,165	3,858
Accrued manufacturing costs	1,948	2,531
Accrued sales reserves	1,910	2,309
Other	713	419
Total	$ 9,989	$ 13,166

LICENSE AGREEMENTS AND COMMITMENTS - MSK License Agreement (Details) - MSK $ in Thousands	Mar. 31, 2024 USD ($) agreement
Agreements
Number of license agreements \| agreement	3
License Agreement
Agreements
Annual minimum royalties payable \| $	$ 80

STOCK-BASED COMPENSATION - 2015 Plan (Details) - 2015 Plan	12 Months Ended
	Dec. 31, 2015 shares
Share-Based Compensation Awards
Shares reserved for issuance (in shares)	4,500,000
Employee Stock Option
Share-Based Compensation Awards
Vesting period	4 years

- Definition

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

+ References

+ Details

ACCRUED LIABILITIES (Tables)

3 Months Ended

Mar. 31, 2024

ACCRUED LIABILITIES

Schedule of accrued liabilities

Accrued liabilities as of March 31, 2024 and December 31, 2023 are as follows (in thousands):


	March 31,		December 31,
	2024		2023

Accrued licensing, milestone and royalty payments	$	2,459	$	3,452
Accrued clinical costs		794		597
Accrued compensation and board fees		2,165		3,858
Accrued manufacturing costs		1,948		2,531
Accrued sales reserves		1,910		2,309
Other		713		419
Total	$	9,989	$	13,166

LICENSE AGREEMENTS AND COMMITMENTS - Lease maturities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Maturities of operating lease liabilities
Remainder of fiscal year	$ 730
First fiscal year	525	$ 996
Second fiscal year		526
Total lease payments	1,255	1,522
Less: Imputed interest	(74)	(103)
Total operating lease liabilities as of end of period	$ 1,181	$ 1,419
Operating Lease, Liability, Statement of Financial Position	Operating lease liabilities, current portion, Operating lease liabilities, long-term portion

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

Cash and Cash Equivalents

Accounts Receivable, Net

expected future write-offs. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed, and no losses are currently expected.

Concentration of Credit Risk

Inventories

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 cash equivalents, which are measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements as of March 31, 2024
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	71,466	$	—	$	71,466
Total	$	—	$	71,466	$	—	$	71,466


	Fair Value Measurements as of December 31, 2023
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	75,501	$	—	$	75,501
Total	$	—	$	75,501	$	—	$	75,501

During the quarter ended March 31, 2024 and 2023, there were no transfers between Level 1, Level 2, and Level 3.

Operating Lease Right-of-Use Assets and Operating Lease Liabilities

Revenue Recognition

Product revenue, net

●

Rebates and chargebacks

●

Discounts and distribution-related fees

●

Returns

License revenue

Stock-Based Compensation

The fair value of restricted stock units is determined at the grant-date price of the Company’s common stock.

Earnings Per Share

Segment Information

Recently Issued Accounting Pronouncements

INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Intangible assets
Net Carrying Amount, Intangible assets	$ 2,543	$ 2,631
Amortization period	10 years
Amortization expense
2024	$ 355
2025	355
2026	355
2027	355
2028	355
Thereafter	768
Capitalized milestone payments - DANYELZA
Intangible assets
Gross Carrying Amount, Intangible assets	3,300	3,300
Accumulated Amortization	757	669
Net Carrying Amount, Intangible assets	$ 2,543	$ 2,631

STOCK-BASED COMPENSATION

3 Months Ended

Mar. 31, 2024

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

NOTE 11—STOCK-BASED COMPENSATION

2015 Equity Incentive Plan

The Company’s board of directors and stockholders approved and adopted the Amended and Restated 2015 Equity Incentive Plan (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 the Company’s 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 the Company’s employees, directors and consultants and the Company’s subsidiary corporations’ employees and consultants. A total of 4,500,000 shares of the Company’s 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 are allowed under the 2015 Plan.

2018 Equity Incentive Plan

The Company’s board of directors and stockholders approved and adopted the 2018 Equity Incentive Plan (the “2018 Plan”) in connection with the Company’s initial public offering in September 2018. However, options outstanding under the 2015 Plan continue to be governed by the 2015 Plan. The 2018 Plan provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to the Company’s 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, including performance-based restricted stock units (“PRSUs”), to the Company’s employees, directors and consultants and the Company’s parent and subsidiary corporations’ employees and consultants. A total of 5,500,000 shares of the Company’s common stock, inclusive of the awards previously granted under the 2015 Equity Incentive Plan were initially 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 through 2029, equal to 4% of the outstanding shares of common stock as of the last day of the Company’s immediately preceding fiscal year or by a lesser amount determined by the board of

directors. As of March 31, 2024, the Company had 3,106,029 shares available for grant under the 2018 Equity Incentive Plan.

The exercise price of options granted under the plans must at least be equal to the fair market value of the Company’s 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 the Company’s 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 between one and four years and generally become immediately exercisable upon the occurrence of a change in control, as defined in the Plan Agreement.

Stock-Based Compensation Expense

During the three months ended March 31, 2024 and 2023, the Company recognized the following stock-based compensation expense (in thousands):


	Three months ended March 31,
	2024		2023
Stock-based compensation by type of award
Restricted stock units (excluding PRSUs)	$	421	$	187
PRSUs		53		—
Stock options		3,372		5,117
Total stock-based compensation expense	$	3,846	$	5,304

Stock-based compensation by type of expense
Research and development expenses	$	1,872	$	2,306
Selling, general and administrative expenses		1,974		2,998
Total stock-based compensation expense	$	3,846	$	5,304

The expense for the three months ended March 31, 2023 was inclusive of an acceleration of stock-based compensation of $1,706,000, as described further in NOTE 14— RESTRUCTURING CHARGE. There is no financial impact from the restructuring in the three months ended March 31, 2024.

Unrecognized Stock-Based Compensation Expense


	March 31, 2024
	Unrecognized		Weighted average
	compensation expense		recognition period (years)
Type of award
Restricted stock units (excluding PRSUs)	$	4,872		2.4
PRSUs		605		1.9
Stock options		23,991		3.0
Total unrecognized stock-based compensation expense	$	29,468

Restricted Stock Unit (Excluding PRSU) 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 as of December 31, 2023	351,407	$	5.06	1.99
Granted	400,277		10.96
Vested	(108,976)		4.82
Forfeited	(39,934)		7.35
Outstanding and expected to vest as of March 31, 2024	602,774	$	8.87	2.41

During the three months ended March 31, 2024, 4,660 shares of RSUs were granted to a new non-executive director, which will vest equal quarterly installments until the third anniversary of the date of grant, provided that the recipient remains as non-executive director through vesting date. The remaining 395,617 shares of RSUs granted in the three months ended March 31, 2024 will vest annually over the next 3 years, provided in each case that the recipient remains an employee of the Company through each vesting date.

Performance-based Restricted Stock Unit (PRSUs) Activity

The following table summarizes restricted stock units issued and outstanding:


				Weighted
		Weighted		average
		average		remaining
	Performance	grant		vesting
	Restricted Stock Units	price		life (years)
Outstanding and expected to vest as of December 31, 2023	—	$	—	—
Granted	54,000		12.19
Vested	—		—
Forfeited	—		—
Outstanding and expected to vest as of March 31, 2024	54,000	$	12.19	1.87

The PRSUs of 54,000 shares issued in the three months ended March 31, 2024 vest in three equal tranches over a three-year period. The assumptions that the Company used to determine the fair value of the PRSUs granted in the three months ended March 31, 2024 using a Monte-Carlo simulation model were as follows:


	Three months ended March 31,
	2024

Risk-free interest rate	4.2	%
Expected volatility	101.0	%
Expected dividend yield	—	%

The Company did not issue any PRSUs in the three months ended March 31, 2023.

Stock Options

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 as of December 31, 2023	9,307,330	$	17.26	$	10,012	6.44
Granted	1,450,790		11.23
Exercised	(71,550)		8.22
Forfeited	(116,605)		6.34
Outstanding and expected to vest as of March 31, 2024	10,569,965	$	16.61	$	60,339	6.63
Exercisable as of March 31, 2024	6,453,371	$	20.29	$	31,312	5.06

All of the options granted in the three months ended March 31, 2024, have a maximum contractual term of ten years. During the three months ended March 31, 2024, 1,422,890 options were granted and have a vesting schedule in which 25% vest on the first anniversary of the grant date and the remainder vest ratably on a monthly basis over the next 36 months, provided in each case that the recipient remains an employee of the Company through each vesting date. The remaining 27,900 options were granted to a new non-executive director, which will vest equal monthly installments until the third anniversary of the date of grant, provided that the recipient remains as non-executive director through vesting date.

The weighted average fair value of stock options granted for the three months ended March 31, 2024 and 2023 was $8.24 and $3.40, respectively. The assumptions that the Company used to determine the fair value of the stock options granted to employees and directors in the three months ended March 31, 2024 and 2023 are set forth in the table below and presented on a weighted average basis. There were no significant changes to the inputs included in the Black-Scholes option pricing model during the three months ended March 31, 2024:


	Three months ended March 31,
	2024		2023


Risk-free interest rate	4.1	%	3.60	%
Expected term (in years)	6.3		6.3
Expected volatility	84.0	%	82.6	%
Expected dividend yield	—	%	—	%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition - Product revenue, net (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Dec. 31, 2022
Agreements
Discount for prompt payment (as a percent)	2.00%
Distribution agreement \| WEP \| Product
Agreements
Maximum regulatory-based milestone payments receivable		$ 0
Maximum sales-based milestone payments receivable		$ 0

INTANGIBLE ASSETS, NET

3 Months Ended

Mar. 31, 2024

INTANGIBLE ASSETS, NET

INTANGIBLE ASSETS, NET

NOTE 7—INTANGIBLE ASSETS, NET

March 31, 2024

December 31, 2023

Gross

Net

Gross

Net

Carrying

Accumulated

Carrying

Accumulated

Carrying

Amount

Amortization

Amount

Amortization

Amount

DANYELZA

3,300

757

2,543

3,300

669

2,631

Intangible assets are amortized on a straight-line basis based on a 10-year useful life of the assets. Annual amortization expense is expected to be $355,000 each year for the five-year period from 2024 to 2028, and $768,000 thereafter.

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2024	Apr. 30, 2024
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
Document Transition Report	false
Entity File Number	001-38650
Entity Registrant Name	Y-mAbs Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-4619612
Entity Address, Address Line One	230 Park Avenue
Entity Address, Address Line Two	Suite 3350
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10169
City Area Code	646
Local Phone Number	885-8505
Title of 12(b) Security	Common Stock
Trading Symbol	YMAB
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		43,882,638
Entity Central Index Key	0001722964
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Amendment Flag	false

STOCKHOLDERS' EQUITY - Authorized, Common and Preferred Stock (Details) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2024 USD ($) Vote $ / shares shares	Dec. 31, 2023 USD ($) Vote $ / shares shares
STOCKHOLDERS' EQUITY
Total shares authorized	105,500,000	105,500,000
Common stock, authorized shares	100,000,000	100,000,000
Common stock, par value (in dollars per share) \| $ / shares	$ 0.0001	$ 0.0001
Preferred stock, authorized shares	5,500,000	5,500,000
Preferred stock, par value (in dollars per share) \| $ / shares	$ 0.0001	$ 0.0001
Number of votes per common share \| Vote	1	1
Common stock dividends issued \| $	$ 0	$ 0
Common stock, shares issued	43,852,638	43,672,112
Preferred stock, shares issued	0	0

STOCK-BASED COMPENSATION - PRSUs Assumptions (Details) - Performance-based Restricted Stock Unit (PRSUs) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Stock Award Valuation
Risk-free interest rate (as a percent)	4.20%
Expected volatility (as a percent)	101.00%
Granted (in shares)	54,000	0

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Mar. 31, 2024	Mar. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (6,629)	$ (6,390)

- Definition

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

+ References

+ Details