Segment Information

3 Months Ended

Dec. 31, 2025

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 ONS-5010/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 months ended December 31, 2025 and 2024:

	Three months ended December 31,
	2025		2024
Revenues, net	$	(1,207,833)	$	—
Cost of revenues		29,626		—
Gross profit		(1,237,459)		—
Operating expenses:
Research and development expenses
ONS-5010/LYTENAVA development		2,594,912		8,725,849
Compensation and related benefits		614,534		569,127
Stock-based compensation		97,818		110,029
Other research and development		327,088		255,145
		3,634,352		9,660,150
Selling, general and administrative expenses
Professional fees		1,247,517		2,321,458
Compensation and related benefits		914,465		2,780,189
Stock-based compensation		783,332		3,562,391
Europe launch expenses		4,800,734		2,466,342
Facilities, fees and other related costs		866,093		816,322
		8,612,141		11,946,702
Segment loss from operations		(13,483,952)		(21,606,852)
Other segment items (i)		(9,574,183)		38,984,466
Segment loss before income taxes	$	(23,058,135)	$	17,377,614

Other segment items included in segment loss includes 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.