Segment Reporting
The Company has one reportable segment relating to research and development of its product. The segment does not currently generate revenues as it is currently conducting clinical trials and has not commercialized.

The Company’s Chief Operating Decision Maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purposes of allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews total expenses and expenses by function and the CODM makes decisions using this information on a global basis. The CODM monitors performance at the consolidated level such that the measure of segment loss is consolidated net loss and the measure of reportable segment assets is reported on the balance sheet as total assets.

The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):

Year Ended December 31,
20252024
Expenses
Clinical operations and development$47,630 $27,146 
Manufacturing and process development48,798 23,411 
Research and development personnel cost and other (including stock-based compensation)25,544 10,330 
Research3,124 2,732 
Total research and development125,096 63,619 
General and administrative personnel costs (including stock-based compensation)20,582 12,545 
Professional fees5,910 3,696 
Facility costs, IT, office expense and other4,016 2,529 
Total general and administrative expenses30,508 18,770 
Total operating expenses155,604 82,389 
Operating loss(155,604)(82,389)
Interest income17,871 14,581 
Total other income, net17,871 14,581 
Net income before losses(137,733)(67,808)
Income tax expense(217)(187)
Segment and consolidated net loss$(137,950)$(67,995)

Included within General and administrative personnel costs are depreciation expense, which is disclosed on the Statement of Cash Flows.

Historical Timeline

Fiscal YearFiled
2025Mar 30, 2026Showing above
2024Mar 27, 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.