Business
Outlook Therapeutics Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Corporate Update
Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021Recently reported topline data from the NORSE
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021Recently reported topline data from the NORSE THREE open-label safety study reinforce positive safety profile of ONS-5010 seen in the earlier clinical experience trial (NORSE ONE) ISELIN, N.J., May 14, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2021.Outlook Therapeutics also provided a clinical development and pre-commercialization update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications.“Outlook Therapeutics continues to advance ONS-5010 towards a BLA filing for wet AMD. Having reported promising results from two of the three clinical trials for our planned BLA, we are now in the home stretch and focused on the topline data readout next quarter from NORSE TWO, our pivotal Phase 3 study,” commented Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “Additionally, with the funds raised in February, we are well positioned to complete NORSE TWO and prepare the BLA. We are excited about the upcoming clinical milestones and look forward to providing future updates as we continue to advance ONS-5010.” Recent Corporate Highlights Reported positive topline results from the open-label safety study (NORSE THREE), which demonstrated that ONS-5010 showed no unexpected safety trends and had a safety profile consistent with that of prior published data on the use of bevacizumab for ophthalmic conditions, such as the 2011 CATT study undertaken by the National Eye Institute; andReceived aggregate gross proceeds of $46.2 million from public offerings and private placements of common stock plus warrant exercises in February 2021. Financial Highlights for the Fiscal Second Quarter Ended March 31, 2021For the fiscal second quarter ended March 31, 2021, Outlook Therapeutics reported a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, com...