Quarterly report [Sections 13 or 15(d)]

SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES (Details)

v3.25.3
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.