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 assesses the performance of the Company and decides how to allocate resources on a consolidated basis. The Company’s measure of segment profit or loss is consolidated net loss. 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,

 

 

 

2025

 

 

2024

 

Segment operating expenses:

 

 

 

 

 

 

Research and development:

 

 

 

 

 

 

GEM-AKI and GEM-CKD clinical study expenses

 

$

(2,227,649

)

 

$

(1,681,731

)

Manufacturing expenses

 

 

 

 

 

(390,022

)

Other program expenses(1)

 

 

(74,812

)

 

 

(77,679

)

Other expenses(2)

 

 

(168,536

)

 

 

(172,369

)

Personnel expenses (including stock-based compensation)

 

 

(1,592,860

)

 

 

(1,227,195

)

General and administrative

 

 

(5,006,957

)

 

 

(4,426,113

)

Change in fair value of warrant liability

 

 

2,158

 

 

 

81,441

 

Other income (expense), net(3)

 

 

155,007

 

 

 

(7,144,868

)

Net loss

 

$

(8,913,649

)

 

$

(15,038,536

)

 

(1)
Other program expenses include pre-clinical costs and clinical preparation costs primarily for programs GEM-AKI and GEM-CKD.
(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)
Other income (expense) net includes interest income from our cash balances in savings accounts and foreign currency transaction gains and losses. In 2024 this also included LifeSci judgment expense, reimbursement of costs, clinical trial related settlement expenses with A-IR Clinical Research Ltd., and deferred underwriting commissions.

Historical Timeline

Fiscal YearFiled
2025Feb 26, 2026Showing above
2024Mar 6, 2025

About Segments Disclosures

Segment disclosures break a company into its reportable operating units, revealing revenue, profit, and asset allocation that consolidated financial statements obscure. Under ASC 280, segments must match how the chief operating decision maker views the business, providing a window into internal management structure and resource allocation priorities.

Key signals: compare segment margins to identify which units drive profitability and which destroy value. Watch for changes in the number of reportable segments — segment aggregation or disaggregation often coincides with strategic shifts or attempts to obscure declining performance. Intersegment elimination patterns reveal internal pricing practices. The reconciliation between segment totals and consolidated figures exposes corporate overhead allocation and unallocated items. Geographic revenue concentration highlights regulatory and currency exposure. Compare segment-level capital expenditure against segment revenue to assess where management is investing for future growth versus harvesting existing assets.