(19) Segment Reporting

Operating segments are defined as components of the entity for which separate financial information is made available and that is regularly evaluated by the chief operating decision maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company's CODM is its chief executive officer and the Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is focused on the development of a human anti-thymocyte globulin focused on preventing or delaying the progression of T1D.

The CODM assesses the Company's performance by reviewing GAAP operating expense and significant expenses by function along with the annual budget. The chief operating decision maker considers budget-to-actual variances on a quarterly basis when making decisions about the allocation of operating and capital resources.

The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company's single reporting segment. A reconciliation to consolidated operating expenses as our single segment operating loss for the years ended December 31, 2025 and 2024 is included in the table below:

 

 

Year Ended December 31,

 

 

2025

 

 

2024

 

Direct research and development expenses

 

 

 

 

 

 

Research and development salaries and benefits

 

$

11,099,651

 

 

$

8,048,062

 

Clinical trial expense

 

 

10,153,742

 

 

 

4,169,487

 

Lab supplies and animal care

 

 

3,042,325

 

 

 

2,737,075

 

Lab services, consulting, and other direct research costs

 

 

2,111,013

 

 

 

7,295,739

 

Total direct research and development expenses

 

 

26,406,731

 

 

 

22,250,363

 

Indirect research and development expenses

 

 

5,069,381

 

 

 

6,694,046

 

Share based compensation (research and development)

 

 

2,876,220

 

 

 

1,307,258

 

Total research and development expense

 

 

34,352,332

 

 

 

30,251,667

 

General and administrative expense

 

 

 

 

 

 

Administrative payroll

 

 

5,318,225

 

 

 

6,563,608

 

Professional fees and travel

 

 

2,644,934

 

 

 

1,515,131

 

Insurance, office expense, and other administrative expenses

 

 

4,303,443

 

 

 

4,267,987

 

Share based compensation (general and administrative)

 

 

2,334,429

 

 

 

1,634,537

 

Total general and administrative expenses

 

 

14,601,031

 

 

 

13,981,263

 

Total operating expense

 

$

48,953,363

 

 

$

44,232,930

 

The measure of segment assets is reported on the Consolidated Balance Sheets as Cash and cash equivalents and Short-term and Long-term investments.

Long-lived assets are reported on the Consolidated Balance Sheets as Property, plant and equipment, net of accumulated depreciation and these assets are held in the U.S.

Historical Timeline

Fiscal YearFiled
2025Mar 9, 2026Showing above
2024Mar 31, 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.