v3.26.1
Segment Information
9 Months Ended
Jun. 30, 2026
Segment Information  
Segment Information

11. Segment Information

Operating segments are components of an enterprise for which discrete financial information is available and reviewed by the chief operating decision maker (“CODM”) to allocate resources and assess performance. The Company has one reportable segment, which consists of the development and commercialization of LYTENAVA™, an ophthalmic formulation of bevacizumab for the treatment of wet AMD. The Company’s CODM is its Chief Executive Officer, who evaluates and manages the business on a consolidated basis for purposes of resource allocation and performance assessment.

The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies. To date, the Company has generated insignificant product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated statements of operations. The CODM uses budget versus forecasted expense and cash forecast models in making decisions. Such models are reviewed to assess the entity-wide operating results and performance, including how long cash is expected to be sufficient. The measure of segment assets is reported on the consolidated balance sheet as total assets.

The table below summarizes the significant expense categories regularly reviewed by the CODM for the three and nine months ended June 30, 2026 and 2025:

Three months ended June 30, 

2026

2025

Revenues, net

$

8,700

$

1,505,322

Cost of revenues

16,965

439,815

Gross profit

(8,265)

1,065,507

Operating expenses:

Research and development expenses

ONS-5010/LYTENAVA development

2,187,470

5,847,020

Compensation and related benefits

567,189

906,195

Stock-based compensation

63,266

91,636

Other research and development

433,174

289,855

3,251,099

7,134,706

Selling, general and administrative expenses

Professional fees

1,173,827

1,315,395

Compensation and related benefits

1,520,593

1,943,321

Stock-based compensation

728,405

1,579,176

Europe commercial expenses

3,042,474

3,867,013

Facilities, fees and other related costs

1,085,546

974,576

7,550,845

9,679,481

Segment loss from operations

(10,810,209)

(15,748,680)

Other segment items (i)

(9,509,063)

(4,403,822)

Segment loss before income taxes

$

(20,319,272)

$

(20,152,502)

Nine months ended June 30, 

2026

2025

Revenues, net

$

(1,071,694)

$

1,505,322

Cost of revenues

195,918

439,815

Gross profit

(1,267,612)

1,065,507

Operating expenses:

Research and development expenses

ONS-5010/LYTENAVA development

8,317,752

18,282,667

Compensation and related benefits

1,725,206

1,831,860

Stock-based compensation

254,202

289,889

Other research and development

1,088,811

797,459

11,385,971

21,201,875

Selling, general and administrative expenses

Professional fees

4,667,134

5,120,664

Compensation and related benefits

4,101,809

5,806,232

Stock-based compensation

2,176,102

6,757,008

Europe commercial expenses

11,919,248

9,177,513

Facilities, fees and other related costs

2,803,272

2,749,275

25,667,565

29,610,692

Segment loss from operations

(38,321,148)

(49,747,060)

Other segment items (i)

(9,509,339)

617,766

Segment loss before income taxes

$

(47,830,487)

$

(49,129,294)

Other segment items included in segment loss include loss on equity method investment, interest income, interest expense, loss from change in fair value of promissory notes, warrant related expenses, warrant inducement expenses, and gain from change in fair value of warrant liability.