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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

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

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-Based Compensation (Details)	12 Months Ended
	Dec. 31, 2024
2018 Plan
Share-Based Compensation Awards
Consecutive trading days	30 days
Employee Stock Option \| Minimum \| 2018 Plan
Share-Based Compensation Awards
Vesting period	1 year
Employee Stock Option \| Minimum \| Participants owning more than 10% of voting power
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%
Employee Stock Option \| Maximum
Share-Based Compensation Awards
Term of award	10 years
Employee Stock Option \| Maximum \| 2018 Plan
Share-Based Compensation Awards
Vesting period	4 years
Employee Stock Option \| Maximum \| Employees and nonemployees owning less than 10% of voting power
Share-Based Compensation Awards
Term of award	10 years
Employee Stock Option \| Maximum \| Participants owning more than 10% of voting power
Share-Based Compensation Awards
Term of award	5 years

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Provision for Income Taxes (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cost incurred as a result of GILTI	$ 0

INVENTORIES

12 Months Ended

Dec. 31, 2024

INVENTORIES

INVENTORIES

NOTE 6—INVENTORIES

Inventories consist of the following (in thousands):


	December 31, 2024		December 31, 2023

Raw Material	$	150	$	—
Work In Progress		22,560		14,021
Finished Goods		2,276		2,992
Total Inventories	$	24,986	$	17,013

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


	December 31, 2024		December 31, 2023

CURRENT ASSETS
Inventories	$	7,214	$	5,065
Total recorded in Current Assets		7,214		5,065

NONCURRENT ASSETS
Inventories, long-term		17,772		11,948
Total recorded in Noncurrent Assets		17,772		11,948
Total Inventories	$	24,986	$	17,013

As of December 31, 2024 and 2023, the Company has classified $17,772,000 and $11,948,000, respectively, of raw materials and 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 inventories, long-term.

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 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	44,988,313	43,672,112
Common stock, shares outstanding	44,988,313	43,672,112

ORGANIZATION AND DESCRIPTION OF BUSINESS

12 Months Ended

Dec. 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 radioimmunotherapy, and antibody-based therapeutic products for the treatment of cancer. Y-mAbs is leveraging the Company’s proprietary radioimmunotherapy and the antibody platforms, and the Company’s deep expertise in the field of radioimmunotherapy and antibodies to develop a broad portfolio of innovative medicines largely in the space of pre-targeted radio-isotope labeled therapeutics.

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

ACCRUED LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2024

ACCRUED LIABILITIES

Schedule of accrued liabilities

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


	December 31,		December 31,
	2024		2023

Accrued licensing, milestone and royalty payments	$	5,016	$	3,452
Accrued clinical costs		1,386		597
Accrued compensation and board fees		4,444		3,858
Accrued manufacturing costs		1,528		2,531
Accrued sales reserves		1,759		2,309
Accrued business realignment and restructuring expense		1,447		—
Other		826		419
Total	$	16,406	$	13,166

STOCK-BASED COMPENSATION - PRSUs Assumptions (Details) - Performance-based Restricted Stock Unit (PRSUs) - shares	12 Months Ended
	Dec. 31, 2024	Dec. 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

OTHER BENEFITS

12 Months Ended

Dec. 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 for the years ended December 31, 2024 and 2023, respectively.

The Company has established a retirement program for employees of the 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 years ended December 31, 2024 and 2023, respectively. In addition, health insurance benefits for our Danish employees are fully paid for by such employees. The Company’s Danish subsidiary does not incur any costs for these health insurance benefits.

ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Accrued liabilities
Accrued licensing, milestone and royalty payments	$ 5,016	$ 3,452
Accrued clinical costs	1,386	597
Accrued compensation and board fees	4,444	3,858
Accrued manufacturing costs	1,528	2,531
Accrued sales reserves	1,759	2,309
Accrued business realignment and restructuring expense	1,447
Other	826	419
Total	$ 16,406	$ 13,166

INTANGIBLE ASSETS, NET (Tables)

12 Months Ended

Dec. 31, 2024

INTANGIBLE ASSETS, NET

Schedule of intangible assets, net

The Company’s intangible assets, net as of December 31, 2024 and December 31, 2023 are as follows (in thousands).

December 31, 2024

December 31, 2023

Gross

Net

Gross

Net

Carrying

Accumulated

Carrying

Accumulated

Carrying

Amount

Amortization

Amount

Amortization

Amount

DANYELZA

3,300

1,024

2,276

3,300

669

2,631

INCOME TAXES - Reconciliation of Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
INCOME TAXES
U.S. federal statutory income tax rate (as a percent)	21.00%	21.00%
Difference between income taxes expected at U.S. federal statutory income tax rate and income taxes provided:
Taxes on income at U.S. federal statutory rate	$ (6,258)	$ (4,382)
State and local taxes, net of federal tax effects	(984)	(411)
Effect of rate change	2,396	(2,127)
Foreign tax rate differential	(75)	(110)
Valuation allowance	2,231	6,407
Tax credits	(394)	(135)
Deferred adjustments	(107)	439
Shared based compensation	1,323	1,011
Return to provision	1,809
Other	(87)	(131)
Total income taxes (tax benefits)	$ (146)	$ 561

STOCK-BASED COMPENSATION - Stock option grants (Details) - shares		12 Months Ended
	Jul. 22, 2024	Dec. 31, 2024
Share-Based Compensation Awards
Granted (in shares)		2,302,924
New non-executive director
Share-Based Compensation Awards
Granted (in shares)		27,900
Non-executive directors, excluding new non-executive director
Share-Based Compensation Awards
Granted (in shares)		87,270
Employees excluding non-executive directors
Share-Based Compensation Awards
Granted (in shares)		2,187,754
Non-employee directors \| Lawsuit filed by shareholder in the Court of Chancery of the State of Delaware on February 8, 2023
Share-Based Compensation Awards
Number of shares under options that were cancelled in legal settlement	60,000	60,000
Employee Stock Option \| Maximum
Share-Based Compensation Awards
Term of award		10 years
Employee Stock Option \| New non-executive director
Share-Based Compensation Awards
Vesting period		3 years
Employee Stock Option \| Non-executive directors
Share-Based Compensation Awards
Vesting period		1 year
Employee Stock Option \| Tranche one \| Employees excluding non-executive directors
Share-Based Compensation Awards
Vesting (as a percent)		25.00%
Vesting period		1 year
Employee Stock Option \| Tranche two \| Employees excluding non-executive directors
Share-Based Compensation Awards
Vesting period		36 months

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Other policies (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Foreign currency translation gain (loss)	$ 1,815	$ (882)
Foreign currency transaction gain (loss)	$ (2,041)	$ 524

STOCK-BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Share-Based Compensation Awards
Stock-based compensation expenses	$ 14,559	$ 14,453
Share based compensation acceleration cost	718	1,706
Research and development
Share-Based Compensation Awards
Stock-based compensation expenses	5,459	8,410
Selling, general and administrative
Share-Based Compensation Awards
Stock-based compensation expenses	9,100	6,043
Restricted Stock Units (RSUs), Excluding PRSUs
Share-Based Compensation Awards
Stock-based compensation expenses	2,087	696
Performance-based Restricted Stock Unit (PRSUs)
Share-Based Compensation Awards
Stock-based compensation expenses	350
Employee Stock Option
Share-Based Compensation Awards
Stock-based compensation expenses	$ 12,122	$ 13,757

- 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

LICENSE AGREEMENTS AND COMMITMENTS - Lease agreements (Details) $ in Thousands	1 Months Ended
	Sep. 30, 2024 USD ($) item	Feb. 01, 2026 USD ($)	Feb. 01, 2025 USD ($)	Aug. 31, 2023 USD ($)	Nov. 01, 2021 USD ($)	Dec. 31, 2019 ft²	Feb. 28, 2019 USD ($) ft²	Jan. 31, 2018
Future corporate headquarters, New Jersey
Leases
Lease term	10 years 9 months
Rent free period	9 months
Fixed rent payable per annum in first year after the nine month rent free period commencing upon entity occupying the premises	$ 362
Option to extend	true
Number of options to extend lease \| item	2
Option to extend, period	5 years
Future corporate headquarters, New Jersey \| Minimum
Leases
Lease payable per month	$ 30
Future corporate headquarters, New Jersey \| Maximum
Leases
Fixed rent payable per annum	411
Lease payable per month	$ 34
Laboratory, New Jersey
Leases
Lease term							3 years
Fixed rent payable per annum							$ 177
Lease payable per month							$ 15
Leased area (in square feet) \| ft²							4,548
Additional leased area (in square feet) \| ft²						235
Laboratory, New Jersey \| Forecast
Leases
Fixed rent payable per annum		$ 188	$ 182
Lease payable per month		$ 16
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

INVENTORIES (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Inventories
Raw Material	$ 150
Work In Progress	22,560	$ 14,021
Finished Goods	2,276	2,992
Total Inventories	24,986	17,013
CURRENT ASSETS
Inventories	7,214	5,065
NONCURRENT ASSETS
Inventories, long-term	17,772	11,948
Other long-term assets
NONCURRENT ASSETS
Inventories, long-term	17,772	11,948
Raw materials and work in progress	$ 17,772	$ 11,948

LICENSE AGREEMENTS AND COMMITMENTS - Summary of Significant Agreements and Commitments (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Financial statement information
Accrued liabilities current	$ 16,406	$ 13,166
Accrued liabilities non-current	3,200	5,375
License agreement \| MSK
Milestones
Maximum Clinical Milestones	2,450
Maximum Regulatory Milestones	8,100
Maximum Sales-based Milestones	20,000
Financial statement information
Cash paid	5,264	6,027
Expense	5,653	5,158
Accrued liabilities current	3,291	2,452
Accrued liabilities non-current	1,500	1,950
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	1,000	605
Expense	0	4,125
Accrued liabilities current	1,425	1,000
Accrued liabilities non-current	$ 1,700	$ 3,125

NET PRODUCT REVENUE

12 Months Ended

Dec. 31, 2024

NET PRODUCT REVENUE

NET PRODUCT REVENUE

NOTE 4—NET PRODUCT REVENUE

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


	Year ended December 31,
	2024		2023

Net product revenue by geographical location:
United States	$	65,981	$	67,814
International:
Western Europe		2,091		8,621
Eastern Asia		7,456		5,503
Latin America		4,716		1,481
Western Asia		4,051		—
Other regions		890		900
Total international		19,204		16,505
Total net product revenue	$	85,185	$	84,319

The Company recognized royalty revenue from the distribution partners of $7,018,000 and $4,453,000 in the years ended December 31, 2024 and 2023, respectively.

Product sales to certain distribution partners that accounted for more than 10% of total net product revenue for the years ended December 31, 2024 and 2023 consists of the following:


	Year ended December 31,
	2024		2023

McKesson	41	%	46	%
Cardinal Health	20		13
Cencora	16		22
WEP	2		10

Revenue from product sales is recorded as 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 December 31, 2024, the Company had recorded accounts receivable allowances of approximately $626,000 and accrued liabilities of $1,759,000 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		403		12,791		128		13,322
Payments/credits received in current year		(356)		(12,457)		(97)		(12,910)
Change in estimate related to sales in the prior year		—		(828)		—		(828)
Balance December 31, 2024	$	88	$	2,200	$	97	$	2,385

During the year ended December 31, 2024, the Company recorded a change in estimate related to assessed Medicaid claims data experience and reserves for historical earned periods. The change in estimate resulted in a benefit of $828,000 for the year ended December 31, 2024.

- 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
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

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

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
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-Section 50
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

LICENSE AGREEMENTS AND COMMITMENTS - Lease costs (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Leases
Total operating lease costs	$ 982	$ 1,033
Cash paid for amounts included in the measurement of lease liabilities	989	1,057
Research and development
Leases
Total operating lease costs	620	780
Selling, general and administrative
Leases
Total operating lease costs	$ 362	$ 253

BUSINESS REALIGNMENT AND RESTRUCTURING CHARGE

12 Months Ended

Dec. 31, 2024

RESTRUCTURING CHARGE

RESTRUCTURING CHARGE

NOTE 14 — BUSINESS REALIGNMENT AND RESTRUCTURING CHARGE

On January 9, 2025, following Board approval, the Company announced a business realignment plan designed to optimize the Company’s operations by realigning dedicated internal resources to two business units, with the goal of increasing operational flexibility and speed, and accelerating clinical development programs within the Company’s radiopharmaceutical platform. The Company is expecting to complete the business realignment plan through 2026. In connection with this business realignment, the Company expects a reduction in the current workforce by up to approximately 13%, depending on whether a number of the impacted employees accept newly created positions. Severance benefits were primarily related to written arrangements in place with certain employees. In addition, affected employees will be offered separation benefits in exchange for their execution of a severance agreement and general release. As a result of the reduction in the workforce and realignment plan, the Company incurred restructuring expense of approximately $2,585,000, which related to severance benefits of $2,076,000 and acceleration of stock-based compensation of $509,000. The Company recognized $1,523,000 for the year ended December 31, 2024. For the year ended December 31, 2024, the Company recorded $959,000 and $564,000, respectively, within research and development and selling, general, and administrative, on the Consolidated Statements of Net Loss and Comprehensive Loss. Following this business realignment, the Company has two businesses units– DANYELZA and Radiotherapies - each of which comprises a reportable segment. All historical segment financial information will be recast to conform to this new reporting structure in our financial statements and accompanying notes, beginning with our Quarterly Report Form 10-Q filing for the quarter ending March 31, 2025.

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 year ended December 31, 2023, the Company recognized restructuring expenses of $4,482,000, based on the currency rate for the period. For the year ended December 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, which were paid as of December 31, 2023, and acceleration of stock-based compensation of $1,706,000 which was recognized in the year ended December 31, 2023 as there is no longer a service condition related to such awards.

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (29,666)	$ (21,427)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	535	735
Stock-based compensation	14,559	14,453
Foreign currency and other transactions	1,987	(1,259)
Provision for bad debt	520	0
Changes in assets and liabilities:
Accounts receivable, net	2,246	(9,923)
Inventories	(2,149)	1,637
Other current assets	582	17
Inventories, long-term	(5,824)	(6,667)
Other assets	55	(145)
Accounts payable	(1,385)	(6,856)
Accrued liabilities and other	2,826	2,203
NET CASH USED IN OPERATING ACTIVITIES	(15,714)	(27,232)
CASH FLOWS FROM INVESTING ACTIVITIES
NET CASH PROVIDED BY INVESTING ACTIVITIES
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercised stock options	4,311	100
NET CASH PROVIDED BY FINANCING ACTIVITIES	4,311	100
Effect of exchange rates on cash and cash equivalents		7
NET DECREASE IN CASH AND CASH EQUIVALENTS	(11,403)	(27,125)
Cash and cash equivalents at the beginning of period	78,637	105,762
Cash and cash equivalents at the end of period	67,234	78,637
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid for income taxes	713	367
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES
Right-of-use assets obtained in exchange for lease obligations	$ 320	636
Acquisition of treasury shares upon repayment of secured promissory note		$ 480

INCOME TAXES - Deferred assets (liabilities) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Deferred tax assets/(liabilities):
Acquired intangibles	$ 3,216	$ 3,702
Unrealized foreign exchange loss, tax asset	449
Unrealized foreign exchange loss, tax liability		(87)
Accrued royalty	842	671
Stock based compensation	12,857	11,603
Net operating loss carryforwards	83,233	83,237
Tax credit carryforwards	16,431	16,336
Right of use asset	(437)	(507)
Lease liabilities	455	515
Capitalized research and experimentation	33,613	33,088
Inventory capitalization	231
Other	301	402
Total deferred tax assets/(liabilities)	151,191	148,960
Valuation allowance	(151,191)	(148,960)
Net deferred tax assets/(liabilities)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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, restricted stock units, performance restricted stock units 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 the 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 receivables and has not reversed any allowances during the years ended December 31, 2024 and 2023. The Company recognized a $520,000 allowance for credit loss in the year ended December 31, 2024. There is no allowance for doubtful accounts in the year ended December 31, 2023.

Concentration of Credit Risk

The Company’s product sales are made through arrangements primarily with three national U.S. specialty distributors. As of December 31, 2024, the net accounts receivable balances from such distributors totaled 73% of the Company’s outstanding accounts receivable. See Note 4 – Net Product Revenue, for details of product sales to certain customers that accounted for more than 10% of total net product revenue. The remainder of the Company’s accounts receivable as of December 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 the 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 inventory 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 write-off occurs. Such write-off, should they occur, are recorded within cost of goods sold. The determination of whether inventory costs will be realizable requires estimates by management. The Company had inventory write-offs totaling $578,000 and $831,000 in the years ended December 31, 2024 and 2023, respectively, which were each recorded in cost of goods sold on the Consolidated Statements of Net Loss and Comprehensive Loss.

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 December 31, 2024
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	64,120	$	—	$	64,120
Total	$	—	$	64,120	$	—	$	64,120


	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 years ended December 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. 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 are 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. 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.

Net product revenue

The Company recognizes revenue from sales of DANYELZA at a point in time when 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 December 31, 2024, within accounts receivable on the Consolidated Balance Sheets. The unbilled accounts receivable from WEP was immaterial as of December 31, 2024.

In May 2024, the Company entered into an exclusive named patient program license and distribution agreement with INPHARMUS İLAÇ SANAYİ TİCARET ANONİM ŞİRKETİ, or INPHARMUS, formerly TRPharm for the distribution of DANYELZA in Turkey. There are no regulatory or sales-based milestone payments or royalties under this distribution agreement. In January 2025 the Company entered into an amendment with INPHARMUS to expand the defined territories in the agreement to include certain countries in the Persian Gulf.

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 until the regulatory approval is obtained. 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 it is appropriate to recognize revenue.

In December 2020, the Company entered into a development and commercialization arrangement with SciClone Pharmaceuticals International 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 December 2024, the Company entered into the first amendment to the development and commercialization agreement with SciClone, which provides for a reduced royalty rate for future qualified sale made by SciClone. The amendment did not have material impact on consolidated financial statements as of December 31, 2024.

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, West Bank and 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. In February 2025, the Company entered into an amended agreement with Swixx to remove Russia from its covered territories. 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 in Latin America of DANYELZA. Under the terms of the agreement, the Company may receive regulatory-based milestone payments up to $3,000,000, of which $1,000,000 was received in April 2022 upon the submission of the updated FDA BLA dossier for DANYELZA. In addition, the Company is entitled to royalties based upon DANYELZA net sales generated by Adium in Latin America. The agreement with Adium does not contain a regulatory-based milestone related to the Brazilian Health Regulatory Agency’s approval for marketing authorization, which was granted during the three months ended June 30, 2023. During the year ended December 31, 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. In January 2024, the Company accepted the price approval for the first product in Brazil from the Brazilian Medicines Market Regulation Chamber, or CMED, and received $500,000 regulatory-based payment from Adium. 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.

In October 2024, the Company entered into a license agreement with Nobelpharma Co., Ltd., or Nobelpharma, for DANYELZA within Japan. As part of the agreement, the Company received a non-refundable one-time payment of $2,000,000 upon execution of the agreement in November 2024. The Company considered the license to be distinct from other promises within the arrangement based on the rights and know-how transferred and anticipated lack of significant involvement required from the joint steering committee. Accordingly, the full transaction price of $2,000,000 was recognized upon transferring of the license and know-how to Nobelpharma. Further, the Company is entitled to receive up to $31,000,000 in regulatory-based and sales-based milestone payments in addition to royalty payments on commercial sales of DANYELZA, if successfully approved and commercialized in Japan. The Company expects that the remaining regulatory-based and sales-based milestones will be recognized when each milestone is achieved. The Company also considered that the pricing terms for the cost-plus manufacturing and supply terms, included within the arrangement, did not represent a material right to Nobelpharma at inception as the terms reflected stand-alone selling price for similar goods or services.

Segment Information

As of December 31, 2024, the Company has managed the business as one reportable segment, which is engaged solely in operations related to the discovery, development, distribution and commercialization of novel antibody-based therapeutic products for the treatment of cancer. The majority of the Company’s revenue were generated in the United States, with additional revenue from Western Europe, Latin America and other parts of the world. The Company has multiple customers with more than 10% net product revenue for the years ended December 31, 2024 and 2023, respectively. Refer to Note 4 – Net Product Revenue for details. The Company’s chief operating decision maker is the Chief Executive Officer.

The accounting policies of the segment are the same as those described in Note 3 – Summary of Significant Accounting Policies. The chief operating decision maker assesses performance for the Company based on consolidated net income/(loss). The measure of segment assets is reported on the Consolidated Balance Sheets as total consolidated assets.

In addition to the significant expense categories included within consolidated net income/(loss) presented on the Company’s Consolidated Statements of Net Loss and Comprehensive Loss, see below for disaggregated amounts that comprise research and development expenses:


	December 31,
	2024		2023


Outsourced manufacturing	$	11,142	$	13,731
Clinical trials		10,042		6,934
Outsourced research and supplies		368		949
Milestones and license acquisition costs		(375)		4,125
Personnel costs		15,322		14,043
Professional and consulting fees		1,796		1,685
Stock-based compensation		5,233		6,252
Information technology expenses		2,420		2,442
Other		3,042		4,058
Total research and development	$	48,990	$	54,219

The chief operating decision maker uses consolidated net income/(loss) to evaluate the profitability generated from segment assets in deciding whether to reinvest in DANYELZA or into other parts of the entity, such as other product candidates.

Consolidated net income/(loss) is used to monitor the budget versus actual results. The monitoring of budgeted versus actual results is used in assessing the performance of the segment and in establishing management compensation.

Property and Equipment

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


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

Depreciation expense on property and equipment was $180,000 and $386,000 for the years ended December 31, 2024 and 2023, respectively.

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

Impairment of Long-Lived Assets

The Company reviews the recorded values of long-lived assets for impairment whenever events or changes in business circumstance indicate that the carrying amount of an asset or group of assets may not be fully recoverable. If an indicator of impairment exists, the Company compares the projected undiscounted cash flows generated by the asset to the long-lived assets carrying amount. If the projected undiscounted cash flows of the long-lived assets are less than the carrying amount, the long-lived assets are written down to the fair value of in the period in which the impairment occurs.

The Company did not have impairment of long-lived assets for the years ended December 31, 2024 and 2023, respectively.

Provision for Income Taxes

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

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

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

In accordance with guidance issued by Financial Accounting Standards Board (“FASB”), companies should make and disclose a policy election as to whether they will recognize deferred taxes for basis differences expected to reverse as Global Intangible Low-Taxed Income (“GILTI”) or whether they will account for GILTI as period costs if and when incurred. The Company has elected to recognize the resulting tax with respect to the GILTI provision as a period cost. No costs were incurred by the Company through December 31, 2024 as a result of GILTI.

Research and Development

Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation cost for the Company’s employees and consultants that perform research activities, the fees paid to maintain licenses, the payments to third-party CMOs and CROs for manufacturing and services performed for products in development, and consumables and other materials used in research and development. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of accrued liabilities, we analyze progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Actual results could differ from our estimates.

Additionally, the Company is obligated to make certain royalty and clinical, regulatory and sales-based milestone payments in accordance with the contractual terms of the MSK License, CD33 License, MabVax Sublicense, and SADA License based upon the resolution of certain contingencies. The Company records the clinical and regulatory milestone payments when the achievement of the milestones or payment of the milestones is deemed probable, and the amount of the payment is reasonably estimable. As it relates to clinical and regulatory milestone payments under the licensing arrangements, those may become due and payable with the passage of time whether or not the milestones have actually been met. When evaluating whether milestones should be recognized under the licensing arrangements, the Company relies on the collective clinical experience within the organization to determine the likelihood of achievement, as well as the current stage of the compounds under development, estimates of the progress of the Company’s preclinical studies and clinical trials, completion of milestone events per underlying agreements, the time expected to complete certain development activities, each party’s termination right under the license agreements, invoices received and contracted costs when evaluating whether the clinical milestones should be recognized in each reporting period. The Company reviews estimates each period and determines whether to make revisions to such estimates as necessary.

Selling, General and Administrative

The Company expenses selling, general, and administrative costs as incurred. Selling, general and administrative costs consist primarily of salaries, bonus, benefits, and stock-based compensation expenses for personnel in executive, commercial, finance and administrative functions. Other significant costs include costs of commercialization of DANYELZA, costs of legal matters and insurance. Advertising and promotion costs are included in selling, general, and administrative expenses and were immaterial in the years ended December 31, 2024 and 2023, respectively. Advertising and product promotion costs are expensed as incurred.

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 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, which generally ranges from one to four years, specified in the grant agreements, and generally become immediately exercisable upon the occurrence of a change in control, as defined in the Plan Agreement. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock.

The fair value of 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.

Comprehensive Loss

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

Foreign Currency

The consolidated financial statements of the Company’s international subsidiary with a functional currency other than the U.S. dollar is translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and average exchange rates during the period for operating results. Translation gains and losses are included in Accumulated Other Comprehensive Income/(Loss) in the Consolidated Statement of Net Loss and Comprehensive Loss. The Company recognized foreign currency translation gains of $1,815,000 and foreign currency translation losses of $882,000 for the years ended December 31, 2024 and 2023, respectively. Foreign currency transaction gains and losses are included in interest and other income/(loss), net, in the consolidated statements of net loss and comprehensive loss. The Company recorded a foreign currency transaction loss of $2,041,000 and a foreign currency transaction gain of $524,000 for the years ended December 31, 2024, and 2023, respectively.

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.

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 2023-07, Segment reporting (Topic 280), effective January 1, 2024. ASU 2023-07 addresses improvement of reportable segment disclosure requirements. The adoption of this new standard did not have a material impact on the Company’s consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (Subtopic 220-40). ASU 2024-03 requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement and disclosures about selling expenses. ASU 2024-03 is required to be adopted by the Company for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is evaluating the impact of this update on the Company's future 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 and accounting standard updates 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.

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
Exercise of stock options		100			100
Exercise of stock options (in shares)	50,000
Retirement of treasury shares		(480)			(480)
Retirement of treasury shares (in shares)	(58,763)
Stock-based compensation expense		14,453			14,453
Stock-based compensation expense (in shares)	10,766
Foreign currency translation			(882)		(882)
Net Income (Loss)				(21,427)	(21,427)
Balance at the end of period at Dec. 31, 2023	$ 4	558,002	449	(457,470)	100,985
Balance at the end of period (in shares) at Dec. 31, 2023	43,672,112
Increase (Decrease) in Stockholders' Equity
Exercise of stock options		4,311			$ 4,311
Exercise of stock options (in shares)	1,188,304				1,188,304
Stock-based compensation expense		14,559			$ 14,559
Stock-based compensation expense (in shares)	127,897
Foreign currency translation			1,815		1,815
Net Income (Loss)				(29,666)	(29,666)
Balance at the end of period at Dec. 31, 2024	$ 4	$ 576,872	$ 2,264	$ (487,136)	$ 92,004
Balance at the end of period (in shares) at Dec. 31, 2024	44,988,313

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2024

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

NOTE 10—STOCKHOLDERS’ EQUITY

Authorized Stock

As of December 31, 2024 and 2023, the Company had 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, respectively.

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 44,988,313 shares and 43,672,112 shares of common stock as of December 31, 2024 and 2023, respectively.

Preferred Stock

Preferred stock may be issued from time to time in one or more series with such designations, preferences and relative participating, optional or other special rights and qualifications, limitations or restrictions as approved by the Company’s Board of Directors. No preferred stock has been issued as of December 31, 2024 and 2023, respectively.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

LICENSE AGREEMENTS AND COMMITMENTS - MSK License Agreement (Details) - MSK $ in Thousands		12 Months Ended
	Nov. 08, 2024 USD ($)	Dec. 31, 2024 USD ($) agreement
License agreement
Agreements
Number of license agreements \| agreement		3
Annual minimum royalties payable		$ 80
Percentage of income generated from sale of first PRV MSK is entitled to receive		40.00%
Percentage of income generated from sale of subsequent PRV MSK is entitled to receive		33.00%
Minimum term of license agreement		15 years
License agreement, Amendment
Agreements
Reduction of total potential milestone payments	$ 900
Reversal of accrued milestone payments	$ 375

LICENSE AGREEMENTS AND COMMITMENTS - Lease maturities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Maturities of operating lease liabilities
First fiscal year	$ 670	$ 996
Second fiscal year	187	526
Third fiscal year	16
Total lease payments	873	1,522
Less: Imputed interest	(53)	(103)
Total operating lease liabilities as of period end	$ 820	$ 1,419
Operating Lease, Liability, Statement of Financial Position	Operating lease liabilities, current portion, Operating lease liabilities, long-term portion	Operating lease liabilities, current portion, Operating lease liabilities, long-term portion

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Segment Information (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($) segment	Dec. 31, 2023 USD ($)
Segment Information
Number of reportable segments \| segment	1
Total research and development	$ 48,990	$ 54,219
Single reportable segment
Segment Information
Outsourced manufacturing	11,142	13,731
Clinical trials	10,042	6,934
Outsourced research and supplies	368	949
Milestones and license acquisition costs	(375)	4,125
Personnel costs	15,322	14,043
Professional and consulting fees	1,796	1,685
Stock-based compensation	5,233	6,252
Information technology expenses	2,420	2,442
Other	3,042	4,058
Total research and development	$ 48,990	$ 54,219

LICENSE AGREEMENTS AND COMMITMENTS - Legal matters (Details) $ in Thousands				12 Months Ended
	Jul. 22, 2024 USD ($) shares	Jun. 26, 2024 USD ($)	Aug. 25, 2021 stockholder	Dec. 31, 2024 USD ($) shares
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
Settlement amount		$ 19,650
Insurance proceeds				$ 16,025
Class-action lawsuit filed in the U.S. District Court, Southern District of New York, on January 18, 2023 \| Selling, general and administrative
Legal Matters
Net impact of settlement				3,625
Lawsuit filed by shareholder in the Court of Chancery of the State of Delaware on February 8, 2023
Legal Matters
Amount of litigation expense for plaintiff and their counsel paid by entity	$ 225
Lawsuit filed by shareholder in the Court of Chancery of the State of Delaware on February 8, 2023 \| Selling, general and administrative
Legal Matters
Amount of litigation expense for plaintiff and their counsel paid by entity				$ 225
Lawsuit filed by shareholder in the Court of Chancery of the State of Delaware on February 8, 2023 \| Non-employee directors
Legal Matters
Number of shares under options that were initially granted as compensation to each non-employee director for each of 2020 and 2021 that were cancelled in legal settlement \| shares	5,000
Number of shares under options that were cancelled in legal settlement \| shares	60,000			60,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Property and Equipment
Depreciation expense	$ 180	$ 386
Asset Impairment
Impairment of long-lived assets	$ 0	$ 0
Furniture and fixtures
Property and Equipment
Estimated Useful Life	5 years
Machinery and equipment
Property and Equipment
Estimated Useful Life	5 years
Leasehold improvements \| Maximum
Property and Equipment
Estimated Useful Life	15 years

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2024	Feb. 25, 2025	Jun. 30, 2024
Cover [Abstract]
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2024
Document Transition Report	false
Securities Act 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	202 Carnegie Center
Entity Address, Address Line Two	Suite 301
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	646
Local Phone Number	885-8505
Title of 12(b) Security	Common Stock
Trading Symbol	YMAB
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
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
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction	false
Entity Shell Company	false
Entity Public Float			$ 450
Entity Common Stock, Shares Outstanding		45,218,177
Auditor Firm ID	238
Auditor Name	PricewaterhouseCoopers LLP
Auditor Location	Florham Park, New Jersey
Entity Central Index Key	0001722964
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	FY
Amendment Flag	false

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Inventories (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Inventory write-offs	$ 578	$ 831

LICENSE AGREEMENTS AND COMMITMENTS - SADA License Agreement (Details) - SADA License Agreement - MSK and MIT $ in Thousands	Dec. 31, 2024 USD ($)
Agreements
Annual minimum royalties payable from tenth anniversary	$ 40
Annual minimum royalties payable once patent has been issued	60
Maximum sales based milestone payments due for each construct previously generated	$ 60,000

NET PRODUCT REVENUE - Concentrations (Details) - Customer Concentration Risk - Revenue - Product	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
McKesson
Concentration risk
Concentration risk percentage (as a percent)	41.00%	46.00%
Cardinal Health
Concentration risk
Concentration risk percentage (as a percent)	20.00%	13.00%
Cencora
Concentration risk
Concentration risk percentage (as a percent)	16.00%	22.00%
WEP
Concentration risk
Concentration risk percentage (as a percent)	2.00%	10.00%

INVENTORIES (Tables)

12 Months Ended

Dec. 31, 2024

INVENTORIES

Schedule of inventories

Inventories consist of the following (in thousands):


	December 31, 2024		December 31, 2023

Raw Material	$	150	$	—
Work In Progress		22,560		14,021
Finished Goods		2,276		2,992
Total Inventories	$	24,986	$	17,013

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


	December 31, 2024		December 31, 2023

CURRENT ASSETS
Inventories	$	7,214	$	5,065
Total recorded in Current Assets		7,214		5,065

NONCURRENT ASSETS
Inventories, long-term		17,772		11,948
Total recorded in Noncurrent Assets		17,772		11,948
Total Inventories	$	24,986	$	17,013

BASIS OF PRESENTATION - Accumulated deficit (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
BASIS OF PRESENTATION
Accumulated deficit	$ (487,136)	$ (457,470)

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

BASIS OF PRESENTATION

12 Months Ended

Dec. 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 $487,136,000 as of December 31, 2024 and $457,470,000 as of December 31, 2023. Through December 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 $67,234,000 and $78,637,000 as of December 31, 2024 and 2023, respectively. As of the issuance date of the consolidated financial statements for the year ended December 31, 2024, the Company expects that the cash and cash equivalents at December 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 issuance of such financial statements.

The Company may raise additional capital to fund future operations through the sale of the Company’s 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 includes working with distributors and may include working with a collaborator. 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 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”). All intercompany balances and transactions have been eliminated.

BUSINESS REALIGNMENT AND RESTRUCTURING CHARGE (Details) $ in Thousands		1 Months Ended	12 Months Ended		14 Months Ended
	Jan. 09, 2025 segment item	May 31, 2023	Dec. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)	Mar. 04, 2025 USD ($)
RESTRUCTURING CHARGE
Share based compensation acceleration cost			$ 718	$ 1,706
2025 Business Realignment Plan
RESTRUCTURING CHARGE
Restructuring charges			$ 1,523
Restructuring Charges, Statement of Income or Comprehensive Income			Research and development, Selling, general, and administrative
2025 Business Realignment Plan \| Research and development
RESTRUCTURING CHARGE
Restructuring charges			$ 959
Restructuring Charges, Statement of Income or Comprehensive Income			Research and development
2025 Business Realignment Plan \| Selling, general and administrative
RESTRUCTURING CHARGE
Restructuring charges			$ 564
Restructuring Charges, Statement of Income or Comprehensive Income			Selling, general, and administrative
2023 Strategic Restructuring Plan
RESTRUCTURING CHARGE
Reduction in workforce (as a percent)		35.00%
Restructuring charges				$ 4,482
Restructuring Charges, Statement of Income or Comprehensive Income				Research and development, Selling, general, and administrative
Severance termination benefits				$ 2,776
Share based compensation acceleration cost				1,706
2023 Strategic Restructuring Plan \| Research and development
RESTRUCTURING CHARGE
Restructuring charges				$ 3,346
Restructuring Charges, Statement of Income or Comprehensive Income				Research and development
2023 Strategic Restructuring Plan \| Selling, general and administrative
RESTRUCTURING CHARGE
Restructuring charges				$ 1,136
Restructuring Charges, Statement of Income or Comprehensive Income				Selling, general, and administrative
Subsequent Event
RESTRUCTURING CHARGE
Number of business units \| segment	2
Subsequent Event \| 2025 Business Realignment Plan
RESTRUCTURING CHARGE
Number of business units realigned \| item	2
Restructuring expenses incurred					$ 2,585
Severance termination benefits					2,076
Share based compensation acceleration cost					$ 509
Subsequent Event \| 2025 Business Realignment Plan \| Forecast \| Maximum
RESTRUCTURING CHARGE
Reduction in workforce (as a percent)	13.00%

STOCK-BASED COMPENSATION (Tables)

12 Months Ended

Dec. 31, 2024

Share-Based Compensation Awards

Schedule of stock-based compensation expense

During the years ended December 31, 2024 and 2023, respectively, the Company recognized the following stock-based compensation expense (in thousands):


	Year ended December 31,
	2024		2023
Stock-based compensation by type of award
Restricted stock units (excluding PRSUs)	$	2,087	$	696
PRSUs		350		—
Stock options		12,122		13,757
Total stock-based compensation expense	$	14,559	$	14,453

Stock-based compensation by type of expense
Research and development expenses	$	5,459	$	8,410
Selling, general and administrative expenses		9,100		6,043
Total stock-based compensation expense	$	14,559	$	14,453

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 December 31, 2024, by type of award and the weighted-average period over which the Company expects to recognize the expense (in thousands):


	December 31, 2024
	Unrecognized		Weighted average
	compensation expense		recognition period (years)
Type of award
Restricted stock units (excluding PRSUs)	$	3,645		1.7
PRSUs		307		1.1
Stock options		20,498		2.7
Total unrecognized stock-based compensation expense	$	24,450

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 as of December 31, 2023	9,307,330	$	17.26	$	10,012	6.44
Granted	2,302,924		11.38
Exercised	(1,188,304)		3.63
Forfeited/cancelled	(497,924)		12.73
Outstanding as of December 31, 2024	9,924,026	$	17.75	$	8,086	6.54
Exercisable as of December 31, 2024	6,333,988	$	22.33	$	5,022	5.31

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


	Year ended December 31,
	2024		2023


Risk-free interest rate	4.1	%	3.9	%
Expected term (in years)	6.2		6.2
Expected volatility	84.4	%	82.9	%
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 as of December 31, 2023	351,407	$	5.06	1.99
Granted	471,439		11.17
Vested	(127,897)		5.57
Forfeited	(97,314)		8.54
Outstanding as of December 31, 2024	597,635	$	9.20	1.71

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 as of December 31, 2023	—	$	—	—
Granted	54,000		12.19
Vested	—		—
Forfeited	—		—
Outstanding as of December 31, 2024	54,000	$	12.19	1.12

Schedule of assumptions used to determine fair value of stock awards


	Year ended December 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.

+ References

+ Details

STOCK-BASED COMPENSATION

12 Months Ended

Dec. 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. However, options outstanding under the 2015 Plan continue to be governed by 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 September 2018. 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 and ending in 2028, 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 December 31, 2024, the Company had 2,621,432 shares available for grant under the 2018 Equity Incentive Plan. Options granted under the 2018 Plan vest according to the schedule, which generally ranges from one to four years, specified in the grant agreements, 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 years ended December 31, 2024 and 2023, respectively, the Company recognized the following stock-based compensation expense (in thousands):


	Year ended December 31,
	2024		2023
Stock-based compensation by type of award
Restricted stock units (excluding PRSUs)	$	2,087	$	696
PRSUs		350		—
Stock options		12,122		13,757
Total stock-based compensation expense	$	14,559	$	14,453

Stock-based compensation by type of expense
Research and development expenses	$	5,459	$	8,410
Selling, general and administrative expenses		9,100		6,043
Total stock-based compensation expense	$	14,559	$	14,453

The expense for the year ended December 31, 2024 was inclusive of a modification and acceleration of stock-based compensation of $718,000 related to the resignation of the Company’s former Chief Financial Officer as described in NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS. The expense for the year ended December 31, 2023 was inclusive of an acceleration of stock-based compensation of $1,706,000. Refer to NOTE 14— BUSINESS REALIGNMENT AND RESTRUCTURING CHARGE for further details.

Unrecognized Stock-Based Compensation Expense


	December 31, 2024
	Unrecognized		Weighted average
	compensation expense		recognition period (years)
Type of award
Restricted stock units (excluding PRSUs)	$	3,645		1.7
PRSUs		307		1.1
Stock options		20,498		2.7
Total unrecognized stock-based compensation expense	$	24,450

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 as of December 31, 2023	351,407	$	5.06	1.99
Granted	471,439		11.17
Vested	(127,897)		5.57
Forfeited	(97,314)		8.54
Outstanding as of December 31, 2024	597,635	$	9.20	1.71

During the year ended December 31, 2024, 20,970 shares of RSUs were granted to non-executive directors, which will vest on the earlier of the first anniversary of the date of grant and the date immediately preceding the Company’s annual meeting of stockholders in 2025, provided that in each case the recipient remains as a non-executive director through the vesting date. In addition, 4,660 shares of RSUs were granted to a new non-executive director, which will vest in equal quarterly installments until the third anniversary of the date of grant, provided that the recipient remains as non-executive director through the vesting date. The remaining 445,809 shares of RSUs granted in the year ended December 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. The weighted average fair value of RSUs granted for the year ended December 31, 2024 and 2023 was $11.17 and $4.84, respectively. The total fair value of RSUs vested during the years ended December 31, 2024 and 2023 is $712,000 and $201,000, respectively. All unvested outstanding RSUs are expected to vest as of December 31, 2024, subject to the impact from business realignment announced in January 2025.

Performance-Based Restricted Stock Unit (PRSU) Activity

The following table summarizes PRSUs issued and outstanding:


				Weighted
		Weighted		average
		average		remaining
	Performance	grant		vesting
	Restricted Stock Units	price		life (years)
Outstanding as of December 31, 2023	—	$	—	—
Granted	54,000		12.19
Vested	—		—
Forfeited	—		—
Outstanding as of December 31, 2024	54,000	$	12.19	1.12

The PRSUs for 54,000 shares issued in the year ended December 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 year ended December 31, 2024 using a Monte-Carlo simulation model were as follows:


	Year ended December 31,
	2024

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

The Company did not issue any PRSUs in the year ended December 31, 2023. All unvested outstanding PRSUs are expected to vest as of December 31, 2024.

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 as of December 31, 2023	9,307,330	$	17.26	$	10,012	6.44
Granted	2,302,924		11.38
Exercised	(1,188,304)		3.63
Forfeited/cancelled	(497,924)		12.73
Outstanding as of December 31, 2024	9,924,026	$	17.75	$	8,086	6.54
Exercisable as of December 31, 2024	6,333,988	$	22.33	$	5,022	5.31

Options granted during the years ended December 31, 2024 have a maximum contractual term of ten years. Outstanding options consist of vested and expected to vest options. All unvested outstanding options are expected to vest as of December 31, 2024, subject to the impact of the business realignment announced in January 2025.

During the year ended December 31, 2024, 2,187,754 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, 27,900 options were granted to a new non-executive director, which will vest in equal monthly installments until the third anniversary of the date of grant, provided that the recipient remains as non-executive director through vesting date, and 87,270 options were granted to non-executive directors, which will vest in equal monthly installments until the first anniversary of the date of grant, provided that in each case the recipient remains a non-executive director through vesting date. During the year ended December 31, 2024, the Company cancelled 60,000 options issued to the Company’s non-employee directors in accordance with the terms of the Company’s legal settlement described in NOTE 9—LICENSE AGREEMENTS AND COMMITMENTS. The cancellation of these options did not result in any financial impact as the options were fully vested before the cancellation date and no replacement consideration was issued.

The weighted average fair value of stock options granted for the year ended December 31, 2024 and 2023 was $8.39 and $3.86, respectively. The total intrinsic value of stock options exercised during 2024 and 2023 was $11,366,000 and $215,000, respectively. The assumptions that the Company used to determine the fair value of the stock options granted to employees and directors in the years ended December 31, 2024 and 2023, respectively 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 year ended December 31, 2024.


	Year ended December 31,
	2024		2023


Risk-free interest rate	4.1	%	3.9	%
Expected term (in years)	6.2		6.2
Expected volatility	84.4	%	82.9	%
Expected dividend yield	—	%	—	%

INCOME TAXES

12 Months Ended

Dec. 31, 2024

INCOME TAXES

INCOME TAXES

NOTE 12—INCOME TAXES

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


	For The Year Ended December 31,
	2024		2023
United States	$	(28,030)	$	(17,232)
Foreign		(1,782)		(3,634)
Total	$	(29,812)	$	(20,866)

The Company's current income tax benefit was $146,000 and income tax provision was $561,000 during the year ended December 31, 2024 and 2023, respectively.

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


	For The Year Ended December 31,
	2024		2023
Current income tax
Federal	$	(94)	$	200
State		(52)		361
Foreign		—		—
Total current income taxes (tax benefits)		(146)		561
Deferred income tax
Federal		—		—
State		—		—
Foreign		—		—
Total deferred income taxes (tax benefits)		—		—
Total income taxes (tax benefits)	$	(146)	$	561

The difference between income taxes expected at the U.S. federal statutory income tax rate of 21% for tax years ended December 31, 2024 and 2023, respectively, and income taxes provided are set forth below (in thousands):


	For The Year Ended December 31,
	2024		2023
Taxes on income at U.S. federal statutory rate	$	(6,258)	$	(4,382)
State and local taxes, net of federal tax effects		(984)		(411)
Effect of rate change		2,396		(2,127)
Foreign tax rate differential		(75)		(110)
Valuation allowance		2,231		6,407
Tax credits		(394)		(135)
Deferred adjustments		(107)		439
Shared based compensation		1,323		1,011
Return to provision		1,809		—
Other		(87)		(131)
Total	$	(146)	$	561

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


	December 31, 2024		December 31, 2023
Deferred tax assets/(liabilities):
Acquired intangibles	$	3,216	$	3,702
Unrealized foreign exchange loss		449		(87)
Accrued royalty		842		671
Stock-based compensation		12,857		11,603
Net operating loss carryforwards		83,233		83,237
Tax credit carryforwards		16,431		16,336
Right-of-use asset		(437)		(507)
Lease liabilities		455		515
Capitalized research and experimentation		33,613		33,088
Inventory capitalization		231		—
Other		301		402
Total deferred tax assets/(liabilities)		151,191		148,960
Valuation allowance		(151,191)		(148,960)
Net deferred tax assets/(liabilities)	$	—	$	—

The Company maintains a full valuation allowance on 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 the Company’s evaluation, the Company considered 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 the Company’s U.S. and foreign deferred tax assets will be maintained. The Company will continue to assess the realizability of the Company’s deferred tax assets and will adjust the valuation allowance as needed.

As of December 31, 2024, the Company had U.S. federal and various state net operating loss (“NOL”) carryforwards of approximately $239,939,000 and $194,117,000, respectively. The Company also had U.S. federal tax credit carryforwards of $16,431,000 as of December 31, 2024. The federal NOL of approximately $239,939,000 can be carried forward indefinitely but is limited to offset 80% of taxable income. The state and local jurisdiction NOLs and tax credit carryforwards will begin to expire in 2030. The NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986 (“IRC”). The Company has performed an analysis of the Company’s Section 382 ownership changes through December 31, 2023. Due to the large annual limitation, the Company believes that it is more likely than not that none of the net operating loss carryforwards will expire as a result of the limitation from the ownership change under Section 382. The Company also has Danish NOL carryforwards of $24,444,000 which have an indefinite carryforward period.

The Company recognizes income tax benefits for tax positions determined more likely than not to be sustained upon examination, based on the technical merits of the positions. As of December 31, 2024 and 2023, the Company has determined that there were no uncertain tax positions. The Company’s tax returns for the years 2018 to 2023 are all open for tax examination by U.S. federal and state, and the Danish tax authorities.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
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-Paragraph 12B
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-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 14
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-URI https://asc.fasb.org/1943274/2147482685/740-10-50-14

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

STOCK-BASED COMPENSATION - RSUs (Details) - Restricted Stock Units (RSUs), Excluding PRSUs - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Restricted stock units issued and outstanding
Outstanding as of beginning of period (in shares)	351,407
Granted (in shares)	471,439
Vested (in shares)	(127,897)
Forfeited (in shares)	(97,314)
Outstanding as of end of period (in shares)	597,635	351,407
Weighted average grant price
Weighted average grant price, Outstanding as of beginning of period (in dollars per share)	$ 5.06
Weighted average grant price, Granted (in dollars per share)	11.17	$ 4.84
Weighted average grant price, Vested (in dollars per share)	5.57
Weighted average grant price, Forfeited (in dollars per share)	8.54
Weighted average grant price, Outstanding as of end of period (in dollars per share)	$ 9.2	$ 5.06
Weighted average remaining vesting life	1 year 8 months 15 days	1 year 11 months 26 days
Fair value of RSUs vested	$ 712	$ 201
Non-executive directors
Restricted stock units issued and outstanding
Granted (in shares)	20,970
Non-executive directors \| Maximum
Weighted average grant price
Vesting period	1 year
Employees excluding non-executive directors
Restricted stock units issued and outstanding
Granted (in shares)	445,809
Weighted average grant price
Vesting period	3 years
New non-executive director
Restricted stock units issued and outstanding
Granted (in shares)	4,660

STOCK-BASED COMPENSATION - 2018 Plan (Details) - 2018 Plan - shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2018
Share-Based Compensation Awards
Shares reserved for issuance (in shares)		5,500,000
Shares available for grant (in shares)	2,621,432
Maximum
Share-Based Compensation Awards
Annual increase on share reserve (as a percent)	4.00%
Employee Stock Option \| Minimum
Share-Based Compensation Awards
Vesting period	1 year
Employee Stock Option \| Maximum
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

STOCK-BASED COMPENSATION - Unrecognized compensation expense (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
Unrecognized compensation related to employee stock options
Unrecognized compensation	$ 24,450
Restricted Stock Units (RSUs), Excluding PRSUs
Unrecognized compensation related to employee stock options
Unrecognized compensation	$ 3,645
Weighted average recognition period	1 year 8 months 12 days
Performance-based Restricted Stock Unit (PRSUs)
Unrecognized compensation related to employee stock options
Unrecognized compensation	$ 307
Weighted average recognition period	1 year 1 month 6 days
Employee Stock Option
Unrecognized compensation related to employee stock options
Unrecognized compensation	$ 20,498
Weighted average recognition period	2 years 8 months 12 days

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (29,666)	$ (21,427)

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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+ Details

ACCRUED LIABILITIES

12 Months Ended

Dec. 31, 2024

ACCRUED LIABILITIES

ACCRUED LIABILITIES

NOTE 8—ACCRUED LIABILITIES

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


	December 31,		December 31,
	2024		2023

Accrued licensing, milestone and royalty payments	$	5,016	$	3,452
Accrued clinical costs		1,386		597
Accrued compensation and board fees		4,444		3,858
Accrued manufacturing costs		1,528		2,531
Accrued sales reserves		1,759		2,309
Accrued business realignment and restructuring expense		1,447		—
Other		826		419
Total	$	16,406	$	13,166

INCOME TAXES - Net Operating Loss Carryforwards (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
U.S. federal
Operating Loss Carryforwards
Net operating loss carryforwards	$ 239,939
Tax credit carryforwards	16,431
Operating loss carryforward, indefinite	239,939
State
Operating Loss Carryforwards
Net operating loss carryforwards	194,117
Danish
Operating Loss Carryforwards
Net operating loss carryforwards	$ 24,444

NET PRODUCT REVENUE - Receivables, allowances and accrued liabilities (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
NET PRODUCT REVENUE
Allowance for credit loss	$ 520	$ 0
Accrued liabilities	$ 16,406	$ 13,166

INCOME TAXES - Loss before income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Domestic and foreign loss before income taxes:
United States	$ (28,030)	$ (17,232)
Foreign	(1,782)	(3,634)
LOSS BEFORE INCOME TAXES	$ (29,812)	$ (20,866)

- 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.

+ References

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+ Details

NET LOSS PER SHARE - Anti-dilutive securities (Details) - shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
NET LOSS PER SHARE
Potentially dilutive securities outstanding	10,575,661	9,658,737

INTANGIBLE ASSETS, NET

12 Months Ended

Dec. 31, 2024

INTANGIBLE ASSETS, NET

INTANGIBLE ASSETS, NET

NOTE 7— 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 December 31, 2024 and December 31, 2023 are as follows (in thousands).

December 31, 2024

December 31, 2023

Gross

Net

Gross

Net

Carrying

Accumulated

Carrying

Accumulated

Carrying

Amount

Amortization

Amount

Amortization

Amount

DANYELZA

3,300

1,024

2,276

3,300

669

2,631

In October 2024, following the approval of Patent Term Extension, the patent for DANYELZA was extended to February 2034. Intangible assets are now being amortized on a straight-line based over a remaining useful life of approximately 9.4 years. Amortization expenses were $355,000 for the years ended December 31, 2024 and 2023. Annual amortization expense is expected to be $248,000 each year for the five-year period from 2025 to 2029, and $1,036,000 thereafter.

LICENSE AGREEMENTS AND COMMITMENTS - Lease term and discount rate (Details)	Dec. 31, 2024	Dec. 31, 2023
LICENSE AGREEMENTS AND COMMITMENTS
Weighted average remaining lease term	1 year 4 months 20 days	1 year 7 months 9 days
Weighted average discount rate	8.50%	8.30%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 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 December 31, 2024
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	64,120	$	—	$	64,120
Total	$	—	$	64,120	$	—	$	64,120


	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

Schedule of segment research and development expenses


	December 31,
	2024		2023


Outsourced manufacturing	$	11,142	$	13,731
Clinical trials		10,042		6,934
Outsourced research and supplies		368		949
Milestones and license acquisition costs		(375)		4,125
Personnel costs		15,322		14,043
Professional and consulting fees		1,796		1,685
Stock-based compensation		5,233		6,252
Information technology expenses		2,420		2,442
Other		3,042		4,058
Total research and development	$	48,990	$	54,219

Schedule of property and equipment


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

INCOME TAXES - Current and deferred income taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Current income tax
Federal	$ (94)	$ 200
State	(52)	361
Total current income taxes (tax benefits)	(146)	561
Total income taxes (tax benefits)	$ (146)	$ 561

- Definition

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

+ References

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+ Details

STOCKHOLDERS' EQUITY - Authorized, Common and Preferred Stock (Details) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 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	44,988,313	43,672,112
Preferred stock, shares issued	0	0

NET PRODUCT REVENUE (Tables)

12 Months Ended

Dec. 31, 2024

NET PRODUCT REVENUE

Schedule of product revenue by geographic location

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


	Year ended December 31,
	2024		2023

Net product revenue by geographical location:
United States	$	65,981	$	67,814
International:
Western Europe		2,091		8,621
Eastern Asia		7,456		5,503
Latin America		4,716		1,481
Western Asia		4,051		—
Other regions		890		900
Total international		19,204		16,505
Total net product revenue	$	85,185	$	84,319

Schedule of product sales to certain customers that accounted for more than 10% of total product revenue, net


	Year ended December 31,
	2024		2023

McKesson	41	%	46	%
Cardinal Health	20		13
Cencora	16		22
WEP	2		10

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		403		12,791		128		13,322
Payments/credits received in current year		(356)		(12,457)		(97)		(12,910)
Change in estimate related to sales in the prior year		—		(828)		—		(828)
Balance December 31, 2024	$	88	$	2,200	$	97	$	2,385

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition - License revenue (Details) - USD ($) $ in Thousands	1 Months Ended			12 Months Ended
	Oct. 31, 2024	Jan. 31, 2024	Apr. 30, 2022	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2020	Feb. 28, 2025	Jan. 31, 2025	May 31, 2024	May 31, 2021	Nov. 30, 2020
Agreements
Revenue				$ 87,685	$ 84,819
License and distribution agreement \| INPHARMUS
Agreements
Maximum regulatory-based or sales-based milestone payments or royalty arrangements receivable										$ 0
Distribution agreement, Amendment \| INPHARMUS \| Subsequent Event
Agreements
Maximum regulatory-based or sales-based milestone payments or royalty arrangements receivable									$ 0
Product
Agreements
Revenue				85,185	84,319
Product \| Distribution agreement \| WEP
Agreements
Maximum regulatory-based or sales-based milestone payments or royalty arrangements receivable						$ 0
License
Agreements
Revenue				$ 2,500	500
License \| Development and commercialization agreement \| 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 \| License agreement \| Nobelpharma Co., Ltd.
Agreements
Revenue	$ 2,000
Non-refundable amount received	2,000
Maximum product and commercial milestone payments receivable	$ 31,000
License \| Distribution agreement \| Swixx BioPharma AG \| Subsequent Event
Agreements
Maximum regulatory-based or sales-based milestone payments or royalty arrangements receivable								$ 0
License \| Distribution agreement \| Adium
Agreements
Revenue		$ 500	$ 1,000		$ 500
Maximum regulatory-based milestone payments receivable											$ 3,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Operating Leases (Details) $ in Thousands	Dec. 31, 2024 USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Residual value guarantees	$ 0

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
CURRENT ASSETS
Cash and cash equivalents	$ 67,234	$ 78,637
Accounts receivable, net	19,688	22,454
Inventories	7,214	5,065
Other current assets	4,373	4,955
Total current assets	98,509	111,111
Property and equipment, net	42	224
Operating lease right-of-use assets	817	1,412
Intangible assets, net	2,276	2,631
Other assets	488	543
Inventories, long-term	17,772	11,948
TOTAL ASSETS	119,904	127,869
LIABILITIES
Accounts payable	6,662	6,060
Accrued liabilities	16,406	13,166
Operating lease liabilities, current portion	630	902
Total current liabilities	23,698	20,128
Accrued milestones	3,200	5,375
Operating lease liabilities, long-term portion	190	517
Other liabilities	812	864
TOTAL LIABILITIES	27,900	26,884
Commitments and contingencies (Note 9)
STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value, 5,500,000 shares authorized and none issued at December 31, 2024 and December 31, 2023
Common stock, $0.0001 par value, 100,000,000 shares authorized at December 31, 2024 and December 31, 2023; 44,988,313 and 43,672,112 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively	4	4
Additional paid-in capital	576,872	558,002
Accumulated other comprehensive income	2,264	449
Accumulated deficit	(487,136)	(457,470)
TOTAL STOCKHOLDERS' EQUITY	92,004	100,985
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 119,904	$ 127,869

INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	12 Months Ended
INTANGIBLE ASSETS, NET (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Intangible assets
Net Carrying Amount, Intangible assets	$ 2,276	$ 2,631
Intangible assets remaining useful life	9 years 4 months 24 days
Amortization expense	$ 355	355
Amortization expense
2025	248
2026	248
2027	248
2028	248
2029	248
Thereafter	1,036
Capitalized milestone payments - DANYELZA
Intangible assets
Gross Carrying Amount, Intangible assets	3,300	3,300
Accumulated Amortization	1,024	669
Net Carrying Amount, Intangible assets	$ 2,276	$ 2,631

STOCK-BASED COMPENSATION - PRSUs Activity (Details) - Performance-based Restricted Stock Unit (PRSUs)	12 Months Ended
	Dec. 31, 2024 tranche $ / shares shares	Dec. 31, 2023 shares
Restricted stock units issued and outstanding
Granted (in shares) \| shares	54,000	0
Outstanding as of 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 as of end of period (in dollars per share) \| $ / shares	$ 12.19
Weighted average remaining vesting life	1 year 1 month 13 days
Number of equal tranches over which awards vest \| tranche	3
Vesting period	3 years

NET LOSS PER SHARE (Tables)

12 Months Ended

Dec. 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):


	Year ended December 31,
	2024		2023

Net loss (numerator)	$	(29,666)	$	(21,427)
Weighted-average shares (denominator), basic and diluted		44,329		43,645
Basic and diluted net loss per share	$	(0.67)	$	(0.49)

LICENSE AGREEMENTS AND COMMITMENTS

12 Months Ended

Dec. 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”), the CD33 License Agreement, dated November 13, 2017, between the Company and MSK (the “CD33 License”), and the amendment to the MSK License Agreement, dated November 8, 2024, between the Company and MSK (the “Amendment to MSK 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 milestone and royalty payments are inclusive of obligations under the MSK License Agreement, Amendment to MSK License Agreement and SADA License Agreement, collectively. In connection with restructuring in 2023, activities relating to the GD2-GD3 Vaccine and CD33 antibody constructs were deprioritized. The Company has incurred immaterial expenses and liabilities for the two programs as of and for the years ended December 31, 2024 and 2023.

MSK License

The MSK License 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 even if the related milestone activity is not achieved.

On November 8, 2024, the Company entered into an amendment with MSK where the Company has agreed to return the licensed patent rights related to omburtamab, and related drug substance inventory and regulatory work products to MSK in order to facilitate the continued development of the project under MSK’s control and expense. The Company has decided to stop developing a pharmaceutical product comprising the antibody omburtamab, ¹³¹O-omburtamab and ¹⁷⁷Lu-omburtamab-DTPA. The amendment of the MSK License also resulted in a $900,000 reduction of total potential milestone payments, of which $375,000 were accrued as of December 31, 2023. The accrued liabilities were reversed through research and development expense in the year ended December 31, 2024.

To the extent the Company enters into sublicense arrangements, the Company is required to pay to MSK a percentage of certain payments that the Company receives from sublicensees of the rights licensed to the Company by MSK, which percentage will be based upon the date the Company receives such payments or the achievement of certain clinical milestones. The Company has entered into sublicenses and distribution agreements related to DANYELZA under the MSK License with Takeda Israel, Swixx and SciClone in 2020, with Adium in 2021, WEP in 2022, INPHARMUS and Nobelpharma. in 2024.

The terms of the MSK License provide that MSK is entitled to receive 40% of the income generated from the sale of first PRV, and 33% of any income generated from the sale of any subsequent PRV or the sale of other comparable incentives provided by any non-U.S. jurisdiction. The Company sold the first PRV in connection with DANYELZA, and collected the proceeds in January 2021.

The MSK License will expire, on a country by country basis, and on a licensed product by licensed product or licensed service by licensed service basis, on the later of (i) the expiration of the last to expire of the patents and patent applications covering such licensed product or service in such country, (ii) the expiration of any market exclusivity period granted by a regulatory authority for such licensed product or service in such country, or (iii) 15 years from the first commercial sale of such licensed product or service in such country.

MSK may terminate the MSK License upon prior written notice in the event of our uncured material breach, or upon prior written notice if such breach is of a payment obligation. MSK may also terminate the MSK License upon written notice in the event of our bankruptcy or insolvency or our conviction of a felony relating to the licensed products, or if the Company challenges the validity or enforceability of any licensed patent right. In addition, the Company has the right to terminate the MSK License in its entirety at will upon prior written notice to MSK, but if the Company has commenced the commercialization of licensed products and/or licensed services the Company can only terminate at will if the Company ceases all development and commercialization of such licensed products and/or licensed services.

The Company’s failure to meet certain conditions under the MSK License could cause the related license to such licensed product to be canceled and could result in termination of the MSK License by MSK.

SADA License

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 Self-Assembly DisAssembly Pretargeted RadioImmuno Therapy, or SADA PRIT, technology platform.

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 the Company’s 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.

The Company is also obligated to pay MSK and MIT certain clinical, regulatory and sales-based milestone payments under the SADA License Agreement. Certain clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the SADA License Agreement even if the related milestone activity is not achieved.

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

The Company did not recognize any expenses related to milestones under the SADA License Agreement during the year ended December 31, 2024. The Company made a payment of $1,000,000 in the year ended December 31, 2024 as required under the terms and conditions of the agreement.

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. 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.

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

Summary of Significant License Agreements and Related Commitments

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		$ 8,100		$ 20,000
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 as of and for the years ended December 31, 2024 and 2023, respectively (in thousands):

Cash paid

Expense

Accrued

twelve

liabilities

months

current

non-current

current

non-current

ended

as of

December 31,

Agreements

2024

2023

2024

2023

2024

2023

MSK

5,264

6,027

5,653

5,158

3,291

1,500

2,452

1,950

SADA

1,000

605

—

4,125

1,425

1,700

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, and the SADA License Agreement are excluded from the above table as the Company does not consider such obligations to be probable as of December 31, 2024 and December 31, 2023.

Research and development is inherently uncertain and should such research and development fail, the MSK License Agreement and the SADA License Agreement 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.

Contractual Agreements with Former Chief Financial Officer

On July 16, 2024, the Company entered into a separation agreement with the Company’s former Chief Financial Officer and a consultancy agreement with Investeringsselskabet GH ApS, pursuant to which the Company’s former Chief Financial Officer is providing consulting services to the Company. The terms of the separation agreement resulted in modifications to the vesting and expiration terms of the individual’s outstanding equity awards, which resulted in a non-cash stock-based compensation expense of $718,000 recorded within selling, general, and administrative on the Consolidated Statements of Net Loss and Comprehensive Loss for the year ended December 31, 2024 as there is no longer a service condition related to such awards. Under the terms of the consultancy agreement, which commenced on August 1, 2024, the Company is obligated to pay approximately $520,000 over a one-year period starting from the commencement of the agreement. The Company recognized the expenses related to the consultancy agreement within selling, general, and administrative on the Consolidated Statements of Net Loss and Comprehensive Loss for the year ended December 31, 2024 as the Company does not expect any substantive service to be performed under the consultancy agreement.

Lease Agreements

In September 2024, the Company entered into a lease agreement for office space in Princeton, New Jersey to which the Company plans to transition the Company’s headquarters location in the first half of 2025. The term of the lease is for ten years and nine months from the date the Company begins to occupy the premises, whereby the first nine months are rent free. Fixed rent payable under the lease ranges from approximately $362,000 in the first year after the free rent period concludes to $411,000 in the last year of the lease, with annual escalation. Rent is payable in equal monthly installments ranging from approximately $30,000 to $34,000 for each respective year. Pursuant to the lease agreement, the Company has two options to extend the lease for an additional five-year period per each option. At lease inception, the Company concluded the renewal option was not reasonably certain of being exercised. The Company has the option to terminate the lease before its expiration under limited circumstances. The lease agreement did not result in any financial impact for the year ended December 31, 2024 as the leased space has not been made available for use; therefore, the commencement date had not occurred as of December 31, 2024. As part of the lease agreement, the Company was offered temporary office space for free before the lease commences.

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 and the lease has been amended twice extending the term to February 2027. 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 until February 2025. The fixed rent payable will increase to $182,000 per annum from February 2025 to February 2026, and will further increase to approximately $188,000 per annum payable in equal monthly installments of approximately $16,000 per month, from February 2026 to the end of the lease term.

In January 2018, the Company entered into a lease agreement in connection with the Company’s former 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 modified the lease by reducing the amount of space subject to the lease. The lease modification resulted in an immaterial charge in the year ended December 31, 2023.

Operating lease expenses for the years ended December 31, 2024 and 2023, respectively, were as follows (in thousands):


	Year ended December 31,
	2024		2023
Operating lease expenses by type of expense
Research and development	$	620	$	780
Selling, general and administrative		362		253
Total operating lease expenses	$	982	$	1,033

Cash paid for amounts included in the measurement of lease liabilities was $989,000 and $1,057,000 for the years ended December 31, 2024 and 2023, respectively, and were included in net cash used in operating activities in the Company’s Consolidated Statements of Cash Flows.

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



	December 31, 2024		December 31, 2023
Years ending December 31,
2024		—		996
2025		670		526
2026		187		—
2027		16		—
Total lease payments		873		1,522
Less: Imputed interest		(53)		(103)
Total operating lease liabilities as of period end	$	820	$	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 December 31, 2024, the weighted average remaining lease term is 1.39 years and the weighted average discount rate used to determine the operating lease liability is 8.5%. As of December 31, 2023, the weighted average remaining lease term was 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 was 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 lawsuit asserted claims against Mr. Thomas Gad, the Company’s Chief Business Officer, and Vice Chairman of the Company’s board of directors, and sought 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 based on the record at the time. The parties have since completed documentary discovery and depositions. On February 1, 2024, both the Plaintiff and Mr. Gad filed their respective motions for summary judgment. On August 5, 2024 the Court denied Plaintiff’s motion for summary judgement, granted Mr. Gad’s motion for summary judgement and terminated the case. On August 26, 2024, Plaintiff filed a notice of appeal. The Company shall participate in the remaining appeal as a nominal party only, as it did in the

underlying action and mediation. Plaintiff/Appellant’s appeal brief was filed on December 9, 2024. The named defendants have until March 31, 2025 to file their response.

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). On June 26, 2024, without admitting any liability, the remaining defendants entered into a Stipulation and Agreement of Settlement (“Stipulation”) that would resolve the lawsuit upon Court approval. As part of the Settlement, in exchange for a full release of all claims, the Company agreed to make payment of $19,650,000. The Company recorded settlement amount of $3,625,000, net against the insurance proceeds of $16,025,000, within selling, general and administrative expense on the Consolidated Statements of Net Loss and Comprehensive Loss for the year ended December 31, 2024. On October 28, 2024, the Court approved the settlement and entered a final judgement and order of dismissal with prejudice on October 29, 2024. The Company considered the case to be closed as of December 31, 2024.

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

The Company was 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). Complaint purported 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, and sought, 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. On July 22, 2024, the parties executed a settlement agreement. As part of the resolution, the Company agreed to: (i) cancel 5,000 shares of stock options issued to each of the Company’s non-employee directors as compensation for the years 2020 and 2021, for a total of 60,000 options; (ii) amend the Company’s Compensation Committee Charter to provide that the Compensation Committee shall meet at least quarterly, or more frequently as necessary, to undertake its duties; and (iii) disclose in the annual proxy statements the constituents of the Company’s peer group and relevant financial and business metrics considered in establishing the peer group, including market capitalization, and a reasonably detailed description of the process for determining and approving such peer group. The Company also agreed to pay $225,000 in attorney’s fees and expenses in full satisfaction of any and all claims by the plaintiff and his counsel for fees and expenses in the action, which was paid in August 2024. On September 25, 2024, the defendants filed an affidavit confirming the dismissal of the action. The Company has recorded the fees and expenses paid to the plaintiffs’ counsel of $225,000 within selling, general and administrative expense on the consolidated statements of net loss and comprehensive loss for the year ended December 31, 2024. The Company has considered the case to be closed as of December 31, 2024.

OTHER BENEFITS (Details) - USD ($) $ in Thousands	12 Months Ended
OTHER BENEFITS (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
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

NET LOSS PER SHARE

12 Months Ended

Dec. 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):


	Year ended December 31,
	2024		2023

Net loss (numerator)	$	(29,666)	$	(21,427)
Weighted-average shares (denominator), basic and diluted		44,329		43,645
Basic and diluted net loss per share	$	(0.67)	$	(0.49)

Potentially dilutive securities excluded from the computation of diluted earnings per share relate to stock options and unvested restricted share units outstanding totaled 10,575,661 shares and 9,658,737 shares as of December 31, 2024 and 2023, respectively.

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 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

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2024

INCOME TAXES

Schedule of domestic and foreign loss before income taxes

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


	For The Year Ended December 31,
	2024		2023
United States	$	(28,030)	$	(17,232)
Foreign		(1,782)		(3,634)
Total	$	(29,812)	$	(20,866)

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

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


	For The Year Ended December 31,
	2024		2023
Current income tax
Federal	$	(94)	$	200
State		(52)		361
Foreign		—		—
Total current income taxes (tax benefits)		(146)		561
Deferred income tax
Federal		—		—
State		—		—
Foreign		—		—
Total deferred income taxes (tax benefits)		—		—
Total income taxes (tax benefits)	$	(146)	$	561

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


	For The Year Ended December 31,
	2024		2023
Taxes on income at U.S. federal statutory rate	$	(6,258)	$	(4,382)
State and local taxes, net of federal tax effects		(984)		(411)
Effect of rate change		2,396		(2,127)
Foreign tax rate differential		(75)		(110)
Valuation allowance		2,231		6,407
Tax credits		(394)		(135)
Deferred adjustments		(107)		439
Shared based compensation		1,323		1,011
Return to provision		1,809		—
Other		(87)		(131)
Total	$	(146)	$	561

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

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


	December 31, 2024		December 31, 2023
Deferred tax assets/(liabilities):
Acquired intangibles	$	3,216	$	3,702
Unrealized foreign exchange loss		449		(87)
Accrued royalty		842		671
Stock-based compensation		12,857		11,603
Net operating loss carryforwards		83,233		83,237
Tax credit carryforwards		16,431		16,336
Right-of-use asset		(437)		(507)
Lease liabilities		455		515
Capitalized research and experimentation		33,613		33,088
Inventory capitalization		231		—
Other		301		402
Total deferred tax assets/(liabilities)		151,191		148,960
Valuation allowance		(151,191)		(148,960)
Net deferred tax assets/(liabilities)	$	—	$	—

LICENSE AGREEMENTS AND COMMITMENTS - Contractual Agreement with Former Chief Financial Officer (Details) - USD ($) $ in Thousands		12 Months Ended
	Jul. 16, 2024	Dec. 31, 2024	Dec. 31, 2023	Aug. 01, 2024
Stock-based compensation
Stock-based compensation		$ 14,559	$ 14,453
Bo Kruse, Former Chief Financial Officer
Stock-based compensation
Stock-based compensation	$ 718
Payment amount for consulting services				$ 520

NET PRODUCT REVENUE - Reserves for discounts and allowances (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
Change in reserves for discounts and allowances
Discounts, Balance at beginning of period	$ 41
Discounts, Current provisions relating to sales in current year	403
Discounts, Payments/credits received in current year	(356)
Discounts, Balance at end of period	88
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	12,791
Contractual Allowances and Government Rebates, Payments/credits received in current year	(12,457)
Contractual Allowances and Government Rebates, Change in estimate related to sales in the prior year	(828)
Contractual Allowances and Government Rebates, Balance at end of period	2,200
Returns, Balance at beginning of period	66
Returns, Current provisions relating to sales in current year	128
Returns, Payments/credits received in current year	(97)
Returns, Balance at end of period	97
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	13,322
Reserves for discounts and allowances, Payments/credits received in current year	(12,910)
Reserves for discounts and allowances, Change in estimate related to sales in the prior year	(828)
Reserves for discounts and allowances, Balance at end of period	2,385
Amount of benefit recorded due to change in estimate related to assessed Medicaid claims data experience and reserves for historical earned periods	828
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	626
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	$ 1,759

LICENSE AGREEMENTS AND COMMITMENTS (Tables)

12 Months Ended

Dec. 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


	Maximum		Maximum		Maximum
	Clinical		Regulatory		Sales-based
Agreements	Milestones		Milestones		Milestones
MSK		$ 2,450		$ 8,100		$ 20,000
SADA		4,730		18,125		23,750

Cash paid

Expense

Accrued

twelve

liabilities

months

current

non-current

current

non-current

ended

as of

December 31,

Agreements

2024

2023

2024

2023

2024

2023

MSK

5,264

6,027

5,653

5,158

3,291

1,500

2,452

1,950

SADA

1,000

605

—

4,125

1,425

1,700

1,000

3,125

Schedule of operating lease expenses

Operating lease expenses for the years ended December 31, 2024 and 2023, respectively, were as follows (in thousands):


	Year ended December 31,
	2024		2023
Operating lease expenses by type of expense
Research and development	$	620	$	780
Selling, general and administrative		362		253
Total operating lease expenses	$	982	$	1,033

Maturities of operating lease liabilities

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



	December 31, 2024		December 31, 2023
Years ending December 31,
2024		—		996
2025		670		526
2026		187		—
2027		16		—
Total lease payments		873		1,522
Less: Imputed interest		(53)		(103)
Total operating lease liabilities as of period end	$	820	$	1,419

STOCK-BASED COMPENSATION - Stock option valuation (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Share-Based Compensation Awards
Weighted average grant-date fair value of stock options granted (in dollars per share)	$ 8.39	$ 3.86
Intrinsic value of stock options exercised	$ 11,366	$ 215
Employee Stock Option
Stock Award Valuation
Risk-free interest rate (as a percent)	4.10%	3.90%
Expected term (in years)	6 years 2 months 12 days	6 years 2 months 12 days
Expected volatility (as a percent)	84.40%	82.90%

- 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

12 Months Ended

Dec. 31, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

Cash and Cash Equivalents

Accounts Receivable, Net

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 December 31, 2024
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	—	$	64,120	$	—	$	64,120
Total	$	—	$	64,120	$	—	$	64,120


	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 years ended December 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

Net product revenue

●

Rebates and chargebacks

●

Discounts and distribution-related fees

●

Returns

License revenue

Segment Information


	December 31,
	2024		2023


Outsourced manufacturing	$	11,142	$	13,731
Clinical trials		10,042		6,934
Outsourced research and supplies		368		949
Milestones and license acquisition costs		(375)		4,125
Personnel costs		15,322		14,043
Professional and consulting fees		1,796		1,685
Stock-based compensation		5,233		6,252
Information technology expenses		2,420		2,442
Other		3,042		4,058
Total research and development	$	48,990	$	54,219

Property and Equipment

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


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

Depreciation expense on property and equipment was $180,000 and $386,000 for the years ended December 31, 2024 and 2023, respectively.

Impairment of Long-Lived Assets

The Company did not have impairment of long-lived assets for the years ended December 31, 2024 and 2023, respectively.

Provision for Income Taxes

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

Research and Development

Selling, General and Administrative

Stock-Based Compensation

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

Comprehensive Loss

Foreign Currency

Earnings Per Share

Recently Issued Accounting Pronouncements

Consolidated Statements of Net Loss and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
REVENUES
Total revenues	$ 87,685	$ 84,819
COST OF GOODS SOLD	15,001	11,366
GROSS PROFIT	72,684	73,453
OPERATING COSTS AND EXPENSES
License royalties	250	50
Research and development	48,990	54,219
Selling, general, and administrative	54,645	44,856
Total operating costs and expenses	103,885	99,125
Loss from operations	(31,201)	(25,672)
OTHER INCOME, NET
Interest and other income	1,389	4,806
LOSS BEFORE INCOME TAXES	(29,812)	(20,866)
(Benefits)/provision for income taxes	(146)	561
NET LOSS	(29,666)	(21,427)
Other comprehensive income/(loss)
Foreign currency translation	1,815	(882)
COMPREHENSIVE LOSS	$ (27,851)	$ (22,309)
Net loss per share attributable to common stockholders, basic (in dollars per share)	$ (0.67)	$ (0.49)
Net loss per share attributable to common stockholders, diluted (in dollars per share)	$ (0.67)	$ (0.49)
Weighted average common shares outstanding, basic (in shares)	44,328,962	43,645,388
Weighted average common shares outstanding, diluted (in shares)	44,328,962	43,645,388
Product
REVENUES
Total revenues	$ 85,185	$ 84,319
License
REVENUES
Total revenues	$ 2,500	$ 500

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurements (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	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	64,120	75,501
Recurring \| Money market funds
Fair value measurements
Cash equivalents	64,120	75,501
Recurring \| Level 2
Fair value measurements
Cash equivalents	64,120	75,501
Recurring \| Level 2 \| Money market funds
Fair value measurements
Cash equivalents	$ 64,120	$ 75,501

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Credit Risk (Details) - Credit Concentration Risk - Accounts Receivable - Three Customers	12 Months Ended
	Dec. 31, 2024 customer
Concentration risk
Number of customers	3
Concentration risk percentage (as a percent)	73.00%

NET PRODUCT REVENUE - Disaggregation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Product revenue, net by geographical location:
Revenue	$ 87,685	$ 84,819
Product
Product revenue, net by geographical location:
Revenue	85,185	84,319
Product, Royalty \| Distribution agreement
Product revenue, net by geographical location:
Revenue	7,018	4,453
United States \| Product
Product revenue, net by geographical location:
Revenue	65,981	67,814
International \| Product
Product revenue, net by geographical location:
Revenue	19,204	16,505
Western Europe \| Product
Product revenue, net by geographical location:
Revenue	2,091	8,621
Eastern Asia \| Product
Product revenue, net by geographical location:
Revenue	7,456	5,503
Latin America \| Product
Product revenue, net by geographical location:
Revenue	4,716	1,481
Western Asia \| Product
Product revenue, net by geographical location:
Revenue	4,051
Other regions \| Product
Product revenue, net by geographical location:
Revenue	$ 890	$ 900

BASIS OF PRESENTATION - Cash and cash equivalents (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
BASIS OF PRESENTATION
Cash and cash equivalents	$ 67,234	$ 78,637
Substantial Doubt about Going Concern, within One Year	false

STOCK-BASED COMPENSATION - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Options
Outstanding as of beginning of period (in shares)	9,307,330
Granted (in shares)	2,302,924
Exercised (in shares)	(1,188,304)
Forfeited/cancelled (in shares)	(497,924)
Outstanding as of end of period (in shares)	9,924,026	9,307,330
Exercisable as of end of period (in shares)	6,333,988
Weighted average exercise price
Outstanding as of beginning of period (in dollars per share)	$ 17.26
Granted (in dollars per share)	11.38
Exercised (in dollars per share)	3.63
Forfeited/cancelled (in dollars per share)	12.73
Outstanding as of end of period (in dollars per share)	17.75	$ 17.26
Exercisable as of end of period (in dollars per share)	$ 22.33
Aggregate intrinsic value
Outstanding (in dollars)	$ 8,086	$ 10,012
Exercisable (in dollars)	$ 5,022
Weighted average remaining contractual life (years)
Outstanding (in years)	6 years 6 months 14 days	6 years 5 months 8 days
Exercisable (in years)	5 years 3 months 21 days

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accounts Receivable, Net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Amount of write-offs	$ 0	$ 0
Allowance for credit loss	$ 520	$ 0

NET LOSS PER SHARE - Basic and diluted (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
NET LOSS PER SHARE
Net loss (numerator), Basic (in dollars)	$ (29,666)	$ (21,427)
Net loss (numerator), Diluted (in dollars)	$ (29,666)	$ (21,427)
Weighted-average shares (denominator), basic (in shares)	44,328,962	43,645,388
Weighted-average shares (denominator), diluted (in shares)	44,328,962	43,645,388
Basic net loss per share (in dollars per share)	$ (0.67)	$ (0.49)
Diluted net loss per share (in dollars per share)	$ (0.67)	$ (0.49)

- Definition

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

+ References

+ 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

+ Details

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 60
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476176/805-60-65-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-3

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-11

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (b)
-Publisher FASB
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-4

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
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-Name Accounting Standards Codification
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-Paragraph 5
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482662/260-10-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-10

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 11
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-11

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
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-Name Accounting Standards Codification
-Section 45
-Paragraph 60B
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-60B

+ 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