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Segment Reporting
12 Months Ended
Dec. 31, 2024
Segment Reporting [Abstract]  
Segment Reporting

14. SEGMENT REPORTING

The Company has one reportable segment: Therapeutics. This segment is dedicated to developing and commercializing transformative treatments for patients with serious immunological diseases. The Company’s lead product candidate, atacicept, a fully humanized TACI-Fc fusion protein that binds both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) and is self-administered subcutaneously, is currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN). The Company also holds worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections for which the Company completed a Phase 2 clinical trial in 2022.

Since inception, the Company has devoted substantially all its resources to research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. The Company does not have any product candidates approved for commercial sale and has not generated any revenue from product sales.

The accounting policies used in the segment reporting are the same as those described in the summary of significant accounting policies (Note 2). The Company’s Chief Operating Decision Maker (CODM) is the Chief Executive Officer. The CODM assesses performance for the single reportable segment and decides how to allocate resources based on net loss and total operating expenses. As the Company has not generated any revenue, total operating expenses is equivalent to loss from operations on the statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total assets.

The CODM uses net loss as the reportable segment’s primary measure of profit or loss to evaluate the segment’s financial position and to determine the need for additional financing or equity offerings. The CODM also uses total operating expenses as a measure to evaluate controllable spend from total current assets, in deciding how to allocate resources within the Therapeutics segment.

The Company's reportable segment total operating expenses, including significant segment expenses, and net loss for the years ended December 31, 2024 and 2023, consisted of the following (in thousands):

 

 

Therapeutics

 

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Payroll and related

 

$

48,843

 

 

$

28,878

 

Direct research and development - clinical trials

 

 

32,279

 

 

 

19,611

 

Direct research and development - contract manufacturing

 

 

50,753

 

 

 

35,049

 

Depreciation and amortization

 

 

105

 

 

 

22

 

Other segment items*

 

 

35,190

 

 

 

18,452

 

Total operating expenses

 

 

167,170

 

 

 

102,012

 

Loss from operations

 

 

(167,170

)

 

 

(102,012

)

Other income (expense):

 

 

 

 

 

 

Interest income

 

 

20,714

 

 

 

7,979

 

Interest expense

 

 

(7,626

)

 

 

(3,786

)

Other segment items**

 

 

1,935

 

 

 

1,830

 

Loss before provision for income taxes

 

 

(152,147

)

 

 

(95,989

)

Provision for income taxes

 

 

(1

)

 

 

(1

)

Segment and consolidated net loss

 

$

(152,148

)

 

$

(95,990

)

 

 

 

 

 

 

 

Other Significant Items:

 

 

 

 

 

 

Expenditures for additions to long-lived assets

 

$

(972

)

 

$

(63

)

*Other segment items included in total operating expenses primarily consist of consulting and contractors, professional services, equipment and software, travel and entertainment, facilities, medical affairs, commercial planning, and corporate communications.

**Other segment items included in loss before provision for income taxes consist of currency exchange gains and losses and other income/expense.

The Company's reportable segment assets consisted of the following (in thousands):

 

 

Therapeutics

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Total segment assets

 

$

655,681

 

 

$

175,546

 

Total consolidated assets

 

$

655,681

 

 

$

175,546