Note 17. Segment Reporting

The Company is comprised of a single reportable segment, its Device Segment. This organizational structure aligns with how our Chief Operating Decision Maker (“CODM”), the Chief Executive Officer, manages the Company’s business, including resource allocation and performance assessment. The Company is focused entirely on the development, regulatory approval and commercialization of the Company’s adult and pediatric Selective Cytopheretic Devices (SCDs). The Company had a total of 19 employees at December 31, 2024, and total assets of $4.7 and $3.5 million, as of December 31, 2024 and 2023, respectively.

For segment reporting purposes, the CODM uses operating profit/(loss) to evaluate segment performance and allocate resources. As a Company that only recently began limited commercial sales of QUELIMMUNE, the CODM is primarily focused on evaluating the overall spending for research and development activities needed to fund further development of the SCDs, and general and administrative activities incurred to support the research and development activities of the Company. Accounting policies associated with the Company’s sole segment are the same as those described in Note 1.

All of the Company’s sales are located within the United States. As of the date of this report, the Company has obtained regulatory approval for commercial sales in the U.S. of QUELIMMUNE from the FDA. The Company does not have any inter-entity sales or transfers.

The following table represents the Company’s sole segment’s operating results for the years ended December 31, 2024 and 2023, respectively.

 

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

 

 

 

 

 

 

Net Revenue

 

$

135

 

$

Cost of goods sold

 

 

 

 

Gross profit

 

$

135

 

$

Operating expenses

 

 

 

 

 

 

Research and development

 

 

9,105

 

 

5,973

General and administrative

 

 

8,872

 

 

8,237

Total operating expenses

 

$

17,977

 

$

14,210

Loss from operations

 

$

(17,842)

 

$

(14,210)

Non-operating expenses (*)

 

 

(6,985)

 

 

(12,022)

Net loss before taxes

 

$

(24,827)

 

$

(26,232)

 

(*) - Non-operating expenses consist of interest expense, interest income, and gains and losses from changes in the fair value of liability classified financial instruments such as warrants and convertible debt.

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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.