Quarterly report [Sections 13 or 15(d)]

SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES (Details)

v3.25.2
SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2025
Jun. 30, 2024
Jun. 30, 2025
Jun. 30, 2024
License and other revenues $ 400 $ 400
Research and development costs        
Non-cash stock-based compensation     5,531 2,869
Total research and development costs 5,943 9,218 15,884 16,425
Selling, general and administrative costs        
Total selling, general and administrative costs 17,149 8,646 26,935 15,769
Other segment items () [1] (131,525) (25,270) (139,223) (8,022)
Net income (loss) 108,833 7,406 96,804 (24,172)
Research and Development Expense [Member]        
Research and development costs        
Salaries & related costs 2,235 4,441 6,916 7,996
Non-cash stock-based compensation 232 224 902 570
Other selling, general and administrative costs () [2] 3,476 4,553 8,066 7,859
Selling, General and Administrative Expenses [Member]        
Research and development costs        
Salaries & related costs 4,670 3,434 8,323 5,696
Non-cash stock-based compensation 2,598 1,099 4,629 2,299
Other selling, general and administrative costs () [3] 2,736 2,653 5,631 4,963
Selling, general and administrative costs        
Pre-commercial preparation costs 2,290 1,460 3,497 2,811
Regulatory and production costs $ 4,855 $ 4,855
[1] Other segment items includes 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 expense.
[2] Other research and development expenses 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 general and administrative expenses primarily consist of office facility costs, public reporting company related costs, professional fees (e.g., legal expenses) and other general operating expenses not otherwise included in research and development expenses.