Outlook Therapeutics (NASDAQ:OTLK) posted a net loss attributable to common stockholders of $23.1 million, or $0.38 per basic and diluted share, for the fiscal first quarter ended December 31, 2025.
This compares with net income of $17.4 million, or $0.72 per share, in the year-ago quarter, which benefited from certain non-recurring items.
On an adjusted basis, excluding non-cash changes such as warrant liability adjustments and other items totaling approximately $9.6 million, the net loss improved to $13.5 million, or $0.22 per share, from an adjusted net loss of $21.6 million, or $0.89 per share, in the prior-year period.
The company continues to focus on commercial rollout of LYTENAVA (bevacizumab gamma) in Europe, where it is approved for wet AMD.
Unit sales more than doubled quarter-over-quarter in the period ended December 31, 2025, reflecting growing adoption in initial launch markets of Germany and the United Kingdom, along with increasing numbers of prescribing accounts and clinicians.
The commercial launch in Austria commenced in January 2026, with additional European market expansions planned throughout 2026 to build on early momentum.
On the U.S. regulatory front, Outlook Therapeutics submitted a Type A meeting request to the FDA to address a Complete Response Letter (CRL) received on December 30, 2025, for the Biologics License Application (BLA) of ONS-5010/LYTENAVA (bevacizumab-vikg) in wet AMD.
The CRL cited a single deficiency related to a purported lack of substantial evidence of effectiveness and recommended submission of additional confirmatory evidence, despite prior acknowledgment that the NORSE TWO pivotal trial met its safety and efficacy endpoints.
Prior to the formal request, the company held informal discussions with the FDA.
The timing of the Type A meeting remains subject to agency scheduling, with further updates expected as appropriate.