Annual report [Section 13 and 15(d), not S-K Item 405]

SEGMENT INFORMATION

v3.25.1
SEGMENT INFORMATION
 12 Months Ended
Dec. 31, 2024
Segment Reporting [Abstract]  
SEGMENT INFORMATION

NOTE 16 – 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 clinical-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 clinical-stage biopharmaceutical segment based on net loss, which is reported on the consolidated statements of operations and comprehensive loss as consolidated net 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 expects to continue to incur significant expenses and operating losses while it seeks regulatory approval for pz-cel.

 

As such, the CODM uses cash forecast models in deciding how to invest into the clinical-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 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 for the years ended December 31, 2024, and 2023:

 

 SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES

    2024     2023  
    For the year ended December 31,  
    2024     2023  
             
License and other revenues   $ —     $ 3,500  
                 
Research and development costs                
Salaries & related costs     15,345       11,373  
Non-cash stock-based compensation     1,561       1,086  
Other research and development costs (a)     17,454       18,632  
Total research and development costs     34,360       31,091  
                 
General and administrative costs                
Salaries & related costs   $ 10,729     $ 6,942  
Non-cash stock-based compensation     5,067       3,682  
Pre-commercial preparation costs     4,818       1,224  
Other general and administrative costs (b)     9,237       7,156  
Total general and administrative costs   $ 29,851     $ 19,004  
                 
Other segment items (c)     (477 )     7,593  
Net loss   $ (63,734 )   $ (54,188 )

 

(a) Other research and development expenses include, but are not limited to lab supplies, preclinical and development costs, clinical trial costs, manufacturing and manufacturing facility costs, costs associated with regulatory approvals, depreciation on lab supplies and manufacturing facilities, and consultant-related expenses.
(b) 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.
(c) Other segment items includes royalties, interest income, interest expense, change in fair value of warrant and derivative liabilities and other income.