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SEGMENT INFORMATION
 9 Months Ended
Sep. 30, 2025
Segment Reporting [Abstract]  
SEGMENT INFORMATION

NOTE 12 – SEGMENT INFORMATION

 

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the Chief Operating Decision Maker (“CODM”), or decision making group, in deciding how to allocate resources in assessing performance. The Company is a commercial-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases and has one reportable segment. The Company’s CODM is the chief executive officer.

 

The accounting policies of the clinical-stage biopharmaceutical segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the commercial-stage biopharmaceutical segment based on net income (loss), which is reported on the consolidated statements of operations and comprehensive income (loss) as consolidated net income (loss). The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. Expenditures for additions to long-lived assets, which include purchases of property and equipment, are included in total consolidated assets reviewed by the chief operating decision maker and are reported on the consolidated statements of cash flows.

 

To date, the Company has not generated any product revenue. The Company will continue to incur significant expenses and operating losses until ZEVASKYN® can provide sufficient revenue for the Company to be profitable. As such, the CODM uses cash forecast models in deciding how to invest into the commercial-stage biopharmaceutical segment. Such cash forecast models are reviewed to make decisions about allocating resources and assessing the entity-wide operating results and performance. Net income (loss) is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used to make decisions about allocating resources, assessing the performance of the segment and in establishing management’s compensation, along with cash forecast models.

 

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

 

                 
  

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.