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Outlook Therapeutics , Inc. Logo Outlook Therapeutics Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Corporate Update May 14 , 2021 • Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021 • Recently 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 ; and • Received 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 , 2021 For 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 , compared to a net loss attributable to common stockholders of $ 17.5 million , or $ 0.36 per basic and diluted share for the same period last year . At March 31 , 2021 , Outlook Therapeutics had cash and cash equivalents of $ 37.2 million , compared to $ 5.6 million at December 31 , 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 November 2021 . ONS - 5010 / LYTENAVA TM ( bevacizumab - vikg ) Development Updates In March 2021 , Outlook Therapeutics announced topline results from its NORSE THREE open - label safety study evaluating ONS - 5010 to treat retinal diseases . Topline results from that study 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 . The safety endpoints for NORSE THREE were the frequency and incidence of treatment - emergent adverse events and an evaluation of changes in safety parameters . In the study , 20 out of 197 patients ( 10 % ) experienced an adverse event in the study eye that were most commonly associated with the injection procedure and not ONS - 5010 . There were no serious adverse events associated with treatment . Notably , there were zero cases of ocular inflammation , a concern that has emerged for some other anti - VEGF ( Vascular Endothelial Growth Factor ) therapies used to treat retinal conditions . Outlook Therapeutics completed patient enrollment for its pivotal Phase 3 clinical trial ( NORSE TWO ) 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 quarter of calendar 2021 . Following the data readout of the pivotal NORSE TWO safety and efficacy study next quarter , Outlook Therapeutics plans to submit a new biologics license application ( BLA ) filing under the PHSA 351 ( a ) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved , it will result in 12 years of marketing exclusivity for ONS - 5010 as the first and only ophthalmic formulation of bevacizumab to treat wet AMD approved by the U.S. Food and Drug Administration ( FDA ) . Commercial launch planning for ONS - 5010 has begun , including manufacturing , distribution , physician and patient outreach , and engagement with key opinion leaders and the payor community . With potential for an enhanced safety and cost - effectiveness profile , ONS - 5010 , if approved , is well positioned to become the first - line drug of choice in the United States for retinal indications and to be widely adopted by payors and clinicians