v3.26.1
SEGMENT INFORMATION (Tables)
 6 Months Ended
Jun. 30, 2026
Segment Reporting [Abstract]  
SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES

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

 

   2026   2025   2026   2025 
   For the three months ended June 30,   For the six months ended June 30, 
   2026   2025   2026   2025 
                 
Revenues:                    
Product revenue, net  $11,380   $—   $20,100   $— 
License and other revenues   —    400    —    400 
Total revenues   11,380    400    20,100    400 
                     
Cost of sales   4,177    —    6,873    — 
Royalties   —    100    —    100 
                     
Research and development costs:                    
Salaries & related costs   1,926    2,235    3,659    6,916 
Non-cash stock-based compensation   294    232    517    902 
Other research and development costs (a)   2,801    3,476    10,400    8,066 
Total research and development costs   5,021    5,943    14,576    15,884 
                     
Selling, general and administrative costs:                    
Salaries & related costs   7,254    7,456    15,599    11,109 
Non-cash stock-based compensation   3,075    2,598    5,809    4,629 
Commercial costs   2,015    2,290    3,817    3,497 
Other selling, general and administrative costs (b)   3,491    4,805    10,112    7,700 
Total selling, general and administrative costs   15,835    17,149    35,337    26,935 
                     
Other segment items, net (c)   (6,538)   131,625    (580)   139,323 
Net (loss) income  $(20,191)  $108,833   $(37,266)  $96,804 

 

(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 company reporting 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 include interest income, interest expense, change in fair value of warrant liabilities, gain on sale of priority review voucher, other income and income tax (benefit) expense.