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

Note 17 - Segments

v3.25.3
Note 17 - Segments
12 Months Ended
Sep. 30, 2025
Notes to Financial Statements  
Segment Reporting Disclosure [Text Block]

Note 17 - Segments

 

Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the CODM, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s CODM is Mitchell S. Steiner, M.D., our Chairman, President and Chief Executive Officer, who views the Company’s operations as one operating segment, which is focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. The Company does not have revenue, incurs expenses primarily in the U.S., and manages the business activities on a consolidated basis. 

 

The accounting policies of the drug development segment are the same as those described in the summary of significant accounting policies.

 

The CODM assesses performance for the drug development segment and decides how to allocate resources based on net loss that is also reported on the income statement as consolidated net loss. The measure of segment assets is reported on the balance sheet as cash, cash equivalents, and restricted cash. 

 

The Company has not generated any product revenue from continuing operations in the current period and expects to continue to incur significant expenses and operating losses for the foreseeable future as the Company advances its product candidates through all stages of development and clinical trials. As such, the CODM uses cash forecast models in deciding how to invest into the drug development segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results, net cash used in operating activities for the period and cash on hand are used in assessing performance of the segment.

 

The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended  September 30, 2025 and 2024:

 

   

2025

   

2024

 

Operating expenses:

               

Research and development

  $ 15,588,185     $ 12,782,167  

General and administrative

    19,942,747       24,609,801  

Total operating expenses

    35,530,932       37,391,968  
                 

Other segment items:

               

Gain on sale of ENTADFI® assets

    10,780,290       1,222,908  

Gain on extinguishment of debt

    8,624,778        

Change in fair value of equity securities

    (323,773 )     (176,077 )

Other income, net

    768,380       1,085,199  

Net loss from discontinued operations, net of taxes

    (7,045,022 )     (2,541,488 )
                 

Net loss

  $ (22,726,279 )   $ (37,801,426 )

 

The Company is a single operating segment and therefore the measure of segment net loss is the same as consolidated net loss and does not require reconciliation.

 

For the years ended  September 30, 2025 and 2024, net cash used in operating activities was $30.0 million and $21.7 million, respectively. The table below summarizes the significant asset categories regularly reviewed by the CODM for the years ended  September 30, 2025 and 2024:

 

   

2025

   

2024

 
                 

Cash, cash equivalents and restricted cash

  $ 15,794,562     $ 24,916,285