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SEGMENT INFORMATION (Tables)

9 Months Ended

Sep. 30, 2025

Segment Reporting [Abstract]

SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES

The table below summarizes the significant expense categories regularly reviewed by the CODM (in thousands):

 SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES

		For the three months ended September 30,								For the nine months ended September 30,
		2025				2024				2025				2024
License and other revenues		$	—			$	—			$	400			$	—
Research and development costs
Salaries & related costs		$	1,689			$	3,492			$	8,605			$	11,488
Non-cash stock-based compensation			223				485				1,125				1,055
Other research and development costs (a)			2,304				4,964				10,370				12,823
Total research and development costs		$	4,216			$	8,941			$	20,100			$	25,366
Selling, general and administrative costs
Salaries & related costs		$	6,975			$	2,235			$	18,084			$	7,931
Non-cash stock-based compensation			2,466				1,320				7,095				3,619
Pre-commercial preparation costs			2,138				814				5,635				3,625
Other selling, general and administrative costs (b)			7,735				2,035				15,435				6,998
Total selling, general and administrative costs		$	19,314			$	6,404			$	46,249			$	22,173
Other segment items (c)			(18,369	)			14,924				(157,592	)			6,902
Net income (loss)		$	(5,161	)		$	(30,269	)		$	91,643			$	(54,441	)

(a)	Other research and development costs include, but are not limited to preclinical lab supplies, preclinical and development costs, clinical trial costs, preclinical manufacturing and manufacturing facility costs, costs associated with preclinical regulatory approvals, preclinical depreciation on lab supplies and manufacturing facilities, and preclinical consultant-related expenses.
(b)	Other selling, general and administrative costs primarily consist of office facility costs, public reporting company related costs, professional fees (e.g., legal expenses), regulatory costs, production costs not attributable to cost of sales and other general operating expenses not otherwise included in research and development expenses.
(c)	Other segment items includes cost of sales, royalties, interest income, interest expense, change in fair value of warrant and derivative liabilities, gain on sale of priority review voucher, other income and income tax (benefit) expense.

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- Definition

Tabular disclosure of the profit or loss and total assets for each reportable segment. An entity discloses certain information on each reportable segment if the amounts (a) are included in the measure of segment profit or loss reviewed by the chief operating decision maker or (b) are otherwise regularly provided to the chief operating decision maker, even if not included in that measure of segment profit or loss.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 25
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-25

Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-30

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- References

No definition available.

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