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Segments
 9 Months Ended
Sep. 30, 2025
Segment Reporting [Abstract]  
Segments
10.
Segments

The Company operates and manages its business as one reportable segment, which is also the Company’s only operating segment. Such segment is the business of developing and commercializing the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with IPF, non-IPF ILD, and RCC. The Company’s chief operating decision maker (“CODM”) is the President and Chief Executive Officer. The CODM assesses performance for the segment and decides how to allocate resources based on consolidated net loss that is also reported on the Company’s consolidated statements of comprehensive loss.

The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.

The CODM uses consolidated net loss to evaluate the Company’s spend and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization.

The accounting policies of the segment are the same as those described in Note 2 of the notes to the Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.

The following table presents reportable segment loss, including significant expense categories, attributable to the Company’s reportable segment for the periods presented:

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Chronic cough in IPF clinical trial expense

 

$

822

 

 

$

4,592

 

 

$

6,743

 

 

$

11,116

 

Refractory chronic cough clinical trial expense

 

 

119

 

 

 

2,035

 

 

 

1,371

 

 

 

4,642

 

Clinical trial material

 

 

4,304

 

 

 

713

 

 

 

5,622

 

 

 

3,875

 

Other clinical trials and studies 1

 

 

780

 

 

 

908

 

 

 

1,344

 

 

 

2,245

 

Other clinical development expenses 2

 

 

1,549

 

 

 

1,217

 

 

 

4,827

 

 

 

2,969

 

Employee compensation (excluding stock compensation expense)

 

 

3,041

 

 

 

2,284

 

 

 

8,816

 

 

 

6,716

 

Stock-based compensation expense

 

 

1,243

 

 

 

822

 

 

 

3,835

 

 

 

2,671

 

Other segment items 3

 

 

2,045

 

 

 

1,497

 

 

 

6,518

 

 

 

5,021

 

Interest income, net

 

 

(2,101

)

 

 

(826

)

 

 

(4,633

)

 

 

(2,759

)

Net loss

 

$

11,802

 

 

$

13,242

 

 

$

34,443

 

 

$

36,496

 

 

(1) Includes expense related to the Company’s drug-drug interaction study, human abuse potential study, Phase 2 CANAL trial of Haduvio for the treatment of chronic cough in patients with IPF, and Phase 2b/3 PRISM trial of Haduvio for the treatment of prurigo nodularis.

(2) Includes expense related to general research and development activities, regulatory, medical affairs, and quality assurance.

(3) Includes general administrative expense, interest expense, net, other (expense) income, net and income tax benefit.