On February 17, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported financial results for the first quarter fiscal year 2026 and provided a corporate update.

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"LYTENAVA (bevacizumab gamma) is demonstrating increasing adoption in Europe following our initial launches, with growing demand and quarter-over-quarter unit sales growth," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "Building on this momentum, we are actively working towards launching into additional EU markets in the near term, following our January launch into Austria, as part of a broader regional expansion strategy."

In addition to the planned launches of LYTENAVA in Ireland and the Netherlands in 2026, followed by France, Italy and Spain in 2027, Outlook Therapeutics also continues with its efforts to potentially partner with established companies in other countries in Europe, Latin America and Asia.

Financial Highlights for the Fiscal First Quarter Ended December 31, 2025

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $23.1 million, or $ 0.38 per basic and diluted share. This compares with net income attributable to common stockholders of $17.4 million, or $0.72 per basic and diluted share for the same period last year.

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $13.5 million, or $0.22 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $21.6 million, or $0.89 per basic and diluted share for the first fiscal quarter of 2025.

Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2025 excludes $6.7 million of loss from change in fair value of promissory notes and $2.8 million of loss from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2024 excludes $40.3 million of gain from change in fair value of warrant liability and $1.3 million of loss from change in fair value of promissory notes.

Revenue in the fiscal quarter ended December 31, 2025 was negatively impacted by an increase in the returns reserve for estimated product returns from the UK distributor resulting from short dated product used for the initial shipments into the distribution channel in June 2025 to support the launch of LYTENAVA in Europe. No further adjustments for these batches are anticipated for the remainder of fiscal year 2026. Overall, unit sales of LYTENAVA in Europe more than doubled in the quarter ended December 31, 2025, as compared to the previous three months.

As of December 31, 2025, Outlook Therapeutics had cash and cash equivalents of $8.7 million, which does not include $2.4 million of net proceeds from sales under its at-the-market offering program after December 31, 2025.

ONS-5010 U.S. Regulatory Update

Outlook Therapeutics has requested a Type A meeting with the U.S. Food and Drug Administration to discuss the Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic bevacizumab formulation for the treatment of wet age-related macular degeneration (wet AMD). The Company submitted the Type A meeting request to work with the FDA on a path forward to resolving the FDA’s request for additional confirmatory evidence. The timing of the Type A meeting is subject to FDA scheduling, and further updates will be provided as appropriate.

"Outlook Therapeutics remains fully committed to advancing ONS-5010 in the United States," Mr. Jahr continued. "Our ongoing discussions with the FDA beginning in September 2025 have confirmed alignment on CMC, safety, and the positive results from NORSE TWO, and we look forward to constructive discussions with the FDA as we seek guidance on confirmatory evidence that will withstand current dynamics."

The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL.

About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA must receive pricing and reimbursement approval before it can be sold.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

(Press release, Outlook Therapeutics, FEB 17, 2026, View Source [SID1234662716])