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SEGMENT INFORMATION (Tables) | 9 Months Ended
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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 + Details
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