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Outlook Therapeutics , Inc. Logo Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2021 and Provides Corporate Update February 16 , 2021 • Topline data from pivotal Phase 3 safety and efficacy study ( NORSE TWO ) on target to report in Q3 2021 • Topline data from the open - label safety study ( NORSE THREE ) on target to report in Q2 2021 • Recent funding significantly enhances financial position , extends cash runway through BLA filing and provides strategic optionality to maximize stockholder value -- MONMOUTH JUNCTION , N.J. , Feb. 16 , 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 - vikg for use in retinal indications , today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31 , 2020 . Outlook Therapeutics also provided a clinical development and pre - commercialization update on ONS - 5010 / LYTENAVA TM ( bevacizumab - vikg ) , its investigational ophthalmic formulation of bevacizumab - vikg for the treatment of wet age - related macular degeneration ( wet AMD ) and other retinal indications . " As we look forward to what we believe will be an exciting year at Outlook Therapeutics , I am proud of our team and the tremendous progress we have made , despite the challenges from the current pandemic . Outlook Therapeutics continues to advance ONS - 5010 on multiple fronts as we work towards a BLA filing for ONS - 5010 for wet AMD . On the clinical side , two of the three clinical trials for our planned BLA for wet AMD are now completed . With the cash proceeds received from our successful recent capital raise , we are now focused on the topline data readouts expected over the next two quarters , and completing the CMC work for the BLA submission , expected in December of this year , " commented Lawrence A. Kenyon , President , CEO and CFO of Outlook Therapeutics . " We believe we now have the necessary resources to support our continued development efforts as we evaluate our options for the best path forward to commercialize ONS - 5010 and provide the greatest value to our stockholders . " Recent Corporate Highlights • Secured aggregate gross proceeds in February 2021 of $ 42.6 million to support ONS - 5010 / LYTENAVA TM providing funding through planned Biologics License Application ( BLA ) submission ; • Reported final visit for last patient in open - label safety study ( NORSE THREE ) of ONS - 5010 / LYTENAVATM ( bevacizumab - vikg ) in February 2021 ; and • Announced the formation of a Global Retina Advisory Council in November 2020 to collaborate on outreach to retinal clinicians to support development and commercialization of ONS - 5010 / LYTENAVA T Financial Highlights for the Fiscal First Quarter Ended December 31 , 2020 For the fiscal first quarter ended December 31 , 2020 , Outlook Therapeutics reported a net loss attributable to common stockholders of $ 14.5 million , or $ 0.12 per basic and diluted share , compared to a net loss attributable to common stockholders of $ 18.5 million , or $ 0.62 per basic and diluted share for the same period last year . For the fiscal first quarter ended December 31 , 2020 , Outlook Therapeutics also reported an adjusted net loss attributable to common stockholders of $ 13.7 million , or $ 0.11 per basic and diluted share , as compared to an adjusted net loss attributable to common stockholders of $ 8.2 million , or $ 0.28 per basic and diluted share for the same period last year . Adjusted net loss attributable to common stockholders in the fiscal first quarter ended December 31 , 2020 excludes $ 1.2 million of stock - based compensation expense , $ 0.1 million of depreciation and amortization , $ 0.1 million of non - cash interest expense , a $ 0.1 million change in the fair value of warrant liability , and $ 0.7 million gain on settlement of lease termination obligation . For the fiscal first quarter ended December 31 , 2019 , adjusted net loss attributable to common stockholders excludes $ 0.4 million of stock - based compensation expense , $ 0.2 million of depreciation and amortization , $ 8.1 million loss on extinguishment of debt , $ 0.2 million change in the fair value of warrant liability , $ 0.2 million of Series A - 1 Convertible Preferred Stock dividends and $ 1.7 million of deemed dividend from modification of warrants . At December 31 , 2020 , Outlook Therapeutics had cash and cash equivalents of $ 5.6 million , compared to $ 12.5 million at September 30 , 2020. With the $ 42.6 million in gross proceeds received from the public offerings and private placements of common stock in February 2021 , plus an additional $ 3.6 million received from warrant exercises also in February 2021 , Outlook Therapeutics cash and cash equivalents on hand are sufficient to fund operations through the planned ONS - 5010 BLA submission for wet AMD in late 2021 . ONS - 5010 / LYTENAVATM ( bevacizumab - vikg ) Development Updates Outlook Therapeutics completed patient enrollment in its pivotal Phase 3 ( NORSE TWO ) clinical trial in July 2020 , enrolling a total of 228 patients at 39 clinical trial sites in the United States . Patients in the trial are being treated for 12 months . The primary endpoint for the study is the difference in proportion of patients who gain at least 15 letters in the best corrected visual acuity ( BCVA ) at 11 months for ONS - 5010 dosed on a monthly basis , compared to LUCENTISⓇ , which is being dosed quarterly per the PIER regimen . Outlook Therapeutics expects to report pivotal safety and efficacy data in the third calendar quarter of 2021 . Outlook Therapeutics recently announced the final visit of the last patient for its open - label safety study ( NORSE THREE ) . The study enrolled a total of 197 subjects with a range of retinal diseases for which an anti - VEGF drug is a therapeutic option , including wet AMD , diabetic macular edema ( DME ) and branch retinal vein occlusion ( BRVO ) . Subjects enrolled in the study received three monthly intravitreal doses of ONS - 5010 / LYTENAVATM . The