Outlook Therapeutics Streamlines Operations, Cuts Workforce By 23% For $1.4M Annual Savings, Aims To Launch LYTENAVA In EU/UK, Prepares BLA Resubmission In Q1 2025 Despite NORSE EIGHT Trial Not Meeting Endpoint; LYTENAVA Receives NICE Recommendation, 10-Year Market Exclusivity

Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that following an internal strategic review, the management team and Board of Directors have implemented initiatives to streamline the organization, reduce operating expenses and preserve capital, with the goal of maximizing its efforts to commercially launch LYTENAVA (bevacizumab gamma) for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK) and supporting the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA to the U.S. Food and Drug Administration (FDA).

Lawrence Kenyon, Interim Chief Executive Officer and Chief Financial Officer commented, "In light of the current financial market conditions and the Company's strategic focus on the commercial launch of LYTENAVA (bevacizumab gamma) in Europe, following 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, we conducted a strategic review with the goal of preserving capital and extending our cash runway as long as possible. As a result of this process, we identified potential efficiencies and are taking immediate cost-saving measures, including a 23% reduction in our workforce representing $1.4 million in annual savings excluding the costs of the reduction in workforce. As we look ahead, we remain steadfast in our belief in the potential of ONS-5010/LYTENAVA to meet the global needs of retina specialists, patients, and payers and are dedicated to advancing our regulatory and commercial efforts."

The Company recently announced that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA (bevacizumab gamma) as an option for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity. Separately, upon receipt of the full efficacy and safety results for the NORSE EIGHT clinical trial in the United States, which are expected in January 2025, Outlook Therapeutics plans to resubmit its BLA application for ONS-5010 in the first quarter of calendar 2025. Previously, the Company announced that ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA in the NORSE EIGHT trial. However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010.