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Outlook Therapeutics Inc. (OTLK-7.17%) has submitted its Annual Report on Form 10-K filing for the fiscal year ended September 30, 2024.
The filing details the company's progress with ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab, which has received marketing authorization in the European Union and the United Kingdom for the treatment of wet age-related macular degeneration (AMD).
The report highlights the company's efforts to obtain regulatory approval for ONS-5010/LYTENAVA in the United States, noting that the FDA requires an additional well-controlled clinical trial due to issues identified in a Complete Response Letter received in August 2023.
Outlook Therapeutics is conducting the NORSE EIGHT trial to address the FDA's requirements. Preliminary data from the trial indicated an improvement in vision and a favorable safety profile, although the trial did not meet the pre-specified non-inferiority endpoint at week 8.
The company plans to resubmit the Biologics License Application (BLA) for ONS-5010/LYTENAVA in the first quarter of 2025, following the collection of additional data expected in January 2025.
The filing also outlines the company's strategy to launch ONS-5010/LYTENAVA in the EU and UK in the first half of 2025 and to seek approval in other markets, including Japan and the United States.
Outlook Therapeutics has entered into a collaboration with Cencora to support the commercial launch of ONS-5010/LYTENAVA in Europe and the United States.
The company acknowledges the risks associated with its business, including its dependence on the success of ONS-5010/LYTENAVA, the need for additional funding, and the potential impact of regulatory changes and competition.
Outlook Therapeutics reported a net loss of $75.4 million for the fiscal year ended September 30, 2024, and emphasizes the need for additional capital to continue its operations and commercialization efforts.
The report also discusses various risks, including litigation related to a securities class action lawsuit and a shareholder derivative action, which could result in substantial damages and affect the company's operations.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Outlook Therapeutics Inc. annual 10-K report dated December 27, 2024. To report an error, please email earnings@qz.com.