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SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended
--- | --- | ---
Sep. 30, 2025 | Sep. 30, 2024 | Sep. 30, 2025 | Sep. 30, 2024
Segment Reporting Information [Line Items] |  |  |  |  |
License and other revenues |  |  |  | $ 400 |
Research and development costs |  |  |  |  |
Non-cash stock-based compensation |  |  |  | 8,220 | 4,673
Total research and development costs |  | 4,216 | 8,941 | 20,100 | 25,366
Selling, general and administrative costs |  |  |  |  |
Total selling, general and administrative costs |  | 19,314 | 6,404 | 46,249 | 22,173
Other segment items | [1] | (18,369) | 14,924 | (157,592) | 6,902
Net income (loss) |  | (5,161) | (30,269) | 91,643 | (54,441)
Research and Development Expense [Member] |  |  |  |  |
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 selling, general and administrative costs | [2] | 2,304 | 4,964 | 10,370 | 12,823
Selling, General and Administrative Expenses [Member] |  |  |  |  |
Research and development 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
Other selling, general and administrative costs | [3] | 7,735 | 2,035 | 15,435 | 6,998
Selling, general and administrative costs |  |  |  |  |
Pre-commercial preparation costs |  | $ 2,138 | $ 814 | $ 5,635 | $ 3,625
[1] | 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.
[2] | 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.
[3] | 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.

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- Definition The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. + References Reference 1: http://www.xbrl.org/2003/role/exampleRef -Topic 220 -SubTopic 40 -Name Accounting Standards Codification -Section 55 -Paragraph 18 -Publisher FASB -URI https://asc.fasb.org/1943274/2147476153/220-40-55-18 Reference 2: http://www.xbrl.org/2003/role/exampleRef -Topic 220 -SubTopic 40 -Name Accounting Standards Codification -Section 55 -Paragraph 11 -Publisher FASB -URI https://asc.fasb.org/1943274/2147476153/220-40-55-11 Reference 3: http://www.xbrl.org/2003/role/exampleRef -Topic 220 -SubTopic 40 -Name Accounting Standards Codification -Section 55 -Paragraph 4 -Publisher FASB -URI https://asc.fasb.org/1943274/2147476153/220-40-55-4 Reference 4: http://www.xbrl.org/2003/role/exampleRef -Topic 220 -SubTopic 40 -Name Accounting Standards Codification -Section 55 -Paragraph 14 -Publisher FASB -URI https://asc.fasb.org/1943274/2147476153/220-40-55-14 Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef -Topic 220 -SubTopic 10 -Name Accounting Standards Codification -Section S99 -Paragraph 2 -Subparagraph (SX 210.5-03(4)) -Publisher FASB -URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2 Reference 6: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 220 -SubTopic 40 -Name Accounting Standards Codification -Section 50 -Paragraph 6 -Publisher FASB -URI https://asc.fasb.org/1943274/2147476148/220-40-50-6 + Details
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- Definition Amount of noncash expense for share-based payment arrangement. + References Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef -Name Accounting Standards Codification -Section 45 -Paragraph 28 -Subparagraph (a) -SubTopic 10 -Topic 230 -Publisher FASB -URI https://asc.fasb.org/1943274/2147482740/230-10-45-28 + Details
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