v3.25.1
Segment Information
 3 Months Ended 12 Months Ended
Mar. 31, 2025
Dec. 31, 2024
Segment Information [Abstract]    
Segment Information

11. Segment Information

 

ASC 280, “Segment Reporting,” establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate discrete financial information is available that is evaluated regularly by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company and the Company’s CODM view the Company’s operations and manage its business on the basis of one reportable segment, which is focused on the prevention and treatment of disease by developing and commercializing therapeutics that modulate the innate immune system.

 

The CODM of the Company is the Chief Executive Officer. The CODM assesses the performance of the Company and decides how to allocate resources based upon consolidated net loss that is also reported within the condensed consolidated statements of operations. The measure of segment assets that is reviewed by the CODM is reported within the condensed consolidated balance sheets as consolidated total assets. The CODM uses consolidated net loss to monitor period-over-period results and decides where to allocate and invest additional resources within the business to continue growth. The following is a summary of the significant expense categories and consolidated net loss details provided to the CODM:

 

   Three Months Ended
March 31,		 
   2025   2024 
Segment operating expenses:        
Research and development:        
GEM-AKI, GEM-CKD and GEM-PSI clinical study expenses  $470,578   $333,225 
Other expenses(1)   23,613    89,015 
Personnel expenses (including stock-based compensation)   364,639    295,342 
General and administrative   1,236,157    1,184,556 
Change in fair value of warrant liability   (1,417)   (68,427)
Other income (expense), net(2)   (42,485)   847,722 
Net loss  $(2,051,085)  $(2,681,433)

 

(1) Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, and other unallocated costs.
(2) Clinical trial related settlement expenses with A-IR Clinical Research Ltd., foreign currency transaction gains and losses and interest income from our cash balances in savings accounts.

12. Segment Information

 

ASC 280, “Segment Reporting,” establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate discrete financial information is available that is evaluated regularly by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company and the Company’s CODM view the Company’s operations and manage its business on the basis of one reportable segment, which is focused on the prevention and treatment of disease by developing and commercializing therapeutics that modulate the innate immune system (see Note 1 for a brief description of the Company’s business).

The CODM of the Company is the Chief Executive Officer. The CODM assesses the performance of the Company and decides how to allocate resources based upon consolidated net loss that is also reported within the Consolidated Statements of Operations. The measure of segment assets that is reviewed by the CODM is reported within the Consolidated Balance Sheets as consolidated Total assets. The CODM uses consolidated net loss to monitor period-over-period results and decides where to allocate and invest additional resources within the business to continue growth. The following is a summary of the significant expense categories and consolidated net loss details provided to the CODM:

 

   Year Ended
December 31,		 
   2024   2023 
Segment operating expenses:        
Research and development:        
Product Candidates clinical study expenses  $1,681,731   $209,702 
Manufacturing expenses   390,022    697,429 
Other program expenses(1)   77,679    2,190,493 
Other expenses(2)   172,369    282,948 
Personnel expenses (including stock-based compensation)   1,227,195    765,330 
General and administrative   4,426,113    4,510,762 
Change in fair value of warrant liability   (81,441)   (8,328,937)
Other (expense) income, net(3)   7,144,868    (207,473)
Net loss  $(15,038,536)  $(120,254)
(1)Other program expenses include pre-clinical costs and clinical preparation costs primarily for our Product Candidates.

 

(2)Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, and other unallocated costs.

 

(3)LifeSci Capital LLC judgment expense, reimbursement of costs, clinical trial related settlement expenses with A-IR Clinical Research Ltd., expense in connection with the deferred underwriting commissions, foreign currency transaction gains and losses and interest income from our cash balances in savings accounts.