v3.26.1
Segment Reporting
 3 Months Ended
Mar. 31, 2026
Segment Reporting [Abstract]  
Segment Reporting

(16) 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 condensed consolidated operating expenses as our single segment operating loss for the three months ended March 31, 2026 and 2025, is included in the table below:

 

 

Three Months Ended March 31,

 

 

2026

 

 

2025

 

Direct research and development expenses

 

 

 

 

 

 

Research and development salaries and benefits

 

$

3,769,049

 

 

$

2,651,894

 

Clinical trial expense

 

 

3,196,835

 

 

 

1,927,208

 

Lab supplies and animal care

 

 

1,094,645

 

 

 

556,421

 

Lab services, consulting, and other direct research costs

 

 

1,002,618

 

 

 

942,704

 

Total direct research and development expenses

 

 

9,063,147

 

 

 

6,078,227

 

Indirect research and development expenses

 

 

1,472,920

 

 

 

1,246,805

 

Share based compensation (research and development)

 

 

2,861,910

 

 

 

332,289

 

Total research and development expense

 

 

13,397,977

 

 

 

7,657,321

 

General and administrative expense

 

 

 

 

 

 

Administrative payroll

 

 

1,818,302

 

 

 

1,352,628

 

Professional fees and travel

 

 

717,451

 

 

 

425,638

 

Insurance, office expense, and other administrative expenses

 

 

1,466,004

 

 

 

1,055,853

 

Share based compensation (general and administrative)

 

 

2,598,002

 

 

 

280,662

 

Total general and administrative expenses

 

 

6,599,759

 

 

 

3,114,781

 

Total operating expense

 

$

19,997,736

 

 

$

10,772,102

 

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

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