On December 27, 2024 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), reported financial results for fiscal year 2024 and provided a corporate update (Press release, Outlook Therapeutics, DEC 27, 2024, View Source [SID1234649330]).

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"Over the course of the past year, our team has continued to execute and progress the development of ONS-5010/LYTENAVA in Europe and the United States. Following the receipt of our first positive reimbursement decision worldwide for LYTENAVA from NICE in the United Kingdom, our team continues to make preparations for commercial launch in the UK and Germany, which is expected in the first half of calendar 2025," commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. "We expect to receive the month 3 NORSE EIGHT efficacy data in January 2025 and are continuing preparations for the planned resubmission of our BLA in the first quarter of calendar 2025. We believe that 2025 holds significant opportunity for Outlook Therapeutics and we remain confident in the potential of ONS-5010/LYTENAVA to provide a meaningful impact globally for the treatment of wet AMD."

Upcoming Anticipated Milestones

Final efficacy data from NORSE EIGHT expected in January 2025;
Resubmission of the ONS-5010 BLA targeted for Q1 CY2025;
Initial commercial launches in Europe planned to commence in first half of CY2025; and
Potential for US FDA approval of ONS-5010 in second half of CY2025.
ONS-5010 / LYTENAVA (bevacizumab-vikg) Clinical and Regulatory Update

In May 2024, the European Commission granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for the treatment of wet AMD in the EU. Additionally, in July 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for the same indication in the UK. In December 2024, the National Institute for Health and Care Excellence (NICE) recommended LYTENAVA (bevacizumab gamma) as an option for the treatment of wet AMD. Plans for a potential 2025 launch in the UK and Germany are ongoing. Outlook Therapeutics remains confident that ONS-5010/ LYTENAVA is an important therapy for the treatment of wet AMD in place of off-label repackaged bevacizumab that has not received regulatory approval for use in retina diseases such as wet AMD.

Previously, the Company reported that in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). 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. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.

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. Authorization may also be sought in other European countries, Japan, and elsewhere. As part of a multi-year planning process, Outlook Therapeutics entered into a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA globally following regulatory approvals. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA to benefit all stakeholders, including retina specialists, providers and patients.

In the EU and the UK and other regions outside of the US, Outlook Therapeutics is planning to commercialize LYTENAVA (bevacizumab gamma) directly and is also assessing potential licensing and partnering options. Additionally, if approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA (bevacizumab-vikg) directly in the US.

Financial Highlights for the 2024 Fiscal Year Ended September 30, 2024

For the fiscal year ended September 30, 2024, Outlook Therapeutics reported a net loss of $75.4 million, or $4.06 per basic and diluted share, compared to a net loss of $59.0 million, or $4.72 per basic and diluted share, for the prior fiscal year.

As of September 30, 2024, Outlook Therapeutics had cash and cash equivalents of $14.9 million.

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

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

In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.

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.