On February 14, 2024 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported financial results for first quarter fiscal year 2024 and provided a corporate update (Press release, Outlook Therapeutics, FEB 14, 2024, View Source [SID1234640099]).
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"We are proud of the recent progress our team has made. In January 2024, we received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA they approved. We also reached agreement that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the CRL. Importantly, the first subject was enrolled in NORSE EIGHT in January 2024," commented Russell Trenary, President and Chief Executive Officer. "In addition, through a Type A meeting and additional interactions, we have identified the approaches needed to resolve the CMC comments in the CRL. We are working to address the open items and expect to resolve these comments prior to the expected completion of NORSE EIGHT. Finally, we have entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval, to support our regulatory efforts and launch preparations."
Upcoming Anticipated Milestones
Closing of private placement financing in March 2024, subject to receipt of stockholder approval and other closing conditions;
MAA decision date in the EU for ONS-5010 targeted for first half of 2024;
Completion of NORSE EIGHT in the United States anticipated in 2024; and
Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.
ONS-5010 / LYTENAVA (bevacizumab-vikg) Regulatory Update
As previously announced, following a Type A meeting with the FDA in October 2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months (NORSE EIGHT). In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol from the FDA under a SPA for NORSE EIGHT. The SPA confirms that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL. Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
NORSE EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint will be mean change in BCVA from baseline to week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
Additionally, the formal review process of the ONS-5010 MAA by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024. In addition to pursuing potential strategic partnering opportunities in the EU and other regions, Outlook Therapeutics is also exploring potential expanded relationships with Cencora (formerly AmerisourceBergen) to support the launch of ONS-5010 in international markets.
If approved, ONS-5010 / LYTENAVA (bevacizumab-vikg) would be the first approved ophthalmic formulation of bevacizumab in the U.S. or EU.
Financial Highlights for the Fiscal First Quarter Ended December 31, 2023
For the fiscal first quarter ended December 31, 2023, Outlook Therapeutics reported a net loss attributable to common stockholders of $11.2 million, or $0.04 per basic and diluted share, compared to a net loss attributable to common stockholders of $18.7 million, or $0.08 per basic and diluted share, for the same period last year.
In January 2024, the Company announced that it has entered into definitive securities purchase agreements with certain institutional and accredited investors to purchase shares of common stock and accompanying warrants in private placements, the closing of which is conditioned upon stockholder approval of the transactions and certain other corporate actions, expected in the first quarter of 2024. The private placements are expected to provide up to $65 million in gross proceeds at closing, before deducting placement agent fees and offering expenses. In addition, Outlook Therapeutics will have the potential to receive additional gross proceeds of up to $107 million upon the full cash exercise of the warrants being issued in the private placements, before deducting placement agent fees and offering expenses. The warrants include a feature that allows Outlook Therapeutics to require cash exercise if certain stock price and milestone conditions are met.
At December 31, 2023, Outlook Therapeutics had cash and cash equivalents of $10.4 million. Assuming closing of the private placements as planned (subject to closing conditions) and full cash exercise of the related warrants, the proceeds from the private placements are expected to support business operations, complete the execution of NORSE EIGHT, resubmit the ONS-5010 BLA and, if approved, support the commercial launch of ONS-5010.
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no FDA-approved ophthalmic formulations of bevacizumab are available currently, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies—products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 would provide an FDA-approved option for physicians that currently prescribe unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
Bevacizumab-vikg 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-vikg 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.