Outlook Therapeutics Inc. 2026年季度报告

Outlook Therapeutics, Inc.Table of Contents Therapeutics,” “Outlook,” “the Company,” “we,” “us,” “our” and similar references refer to OutlookTherapeutics, Inc. and its consolidated subsidiaries. The Outlook logo, LYTENAVA and other trademarksor service marks of Outlook Therapeutics, Inc. appearing in this report are the property of OutlookTherapeutics, Inc. This report also contains registered marks, trademarks and trade names of othercompanies. All other trademarks, registered marks and trade names appearing in this report are the References to ONS-5010 and/or LYTENAVA refer to an ophthalmic formulation of bevacizumab for use inretinal indications which, as the context requires: (i) is currently commercially available in Germany andin the United Kingdom as LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This report contains forward-looking statements about us and our industry that involve substantial risksand uncertainties. All statements other than statements of historical facts contained in this report, includingstatements regarding our future financial condition, business strategy and plans, and objectives ofmanagement for future operations, are forward-looking statements. In some cases, you can identifyforward-lookingstatements by terminology such as“anticipate,”“believe,”“continue,”“could,” We have based these forward-looking statements largely on our current expectations and projections aboutfuture events and financial trends that we believe may affect our financial condition, results of operations,business strategy and financial needs. These forward-looking statements are subject to a number of knownand unknown risks, uncertainties and assumptions, including risks described in the section titled “RiskFactors” contained in our Annual Report on Form 10-K for the year ended September 30, 2025, filed with ●our ability to obtain and maintain regulatory approval for ONS-5010/LYTENAVA in the UnitedStates and other markets;●our ability to successfully commercialize and generate revenues from the sale of LYTENAVA™(bevacizumab gamma) in the United Kingdom and European Union;●the rate and degree of market acceptance of our current and future product candidates, includingour commercialization strategy and manufacturing capabilities for ONS-5010/LYTENAVA;●our ability to fund our working capital requirements, the sufficiency of our current cash resourcesand our need for additional funding;●our expectations regarding the potential market size and the size of the patient populations for ourproduct candidates, if approved, for commercial use;●whether the results of our clinical trials will be sufficient to support domestic or global regulatoryapprovals;●the initiation, timing, progress and results of our clinical trials of our lead product candidate, These risks are not exhaustive. Additional factors could harm our business and financial performance, suchas risks associated with the current macroeconomic environment, including as a result of the impacts offluctuations in inflation, and interest rates, tariffs and trade tensions, current or potential future bankfailures or geopolitical instability and uncertainty. Moreover, we operate in a very competitive and rapidlychanging environment. New risk factors emerge from time to time, and it is not possible for ourmanagement to predict all risk factors, nor can we assess the impact of all factors on our business or theextent to which any factor, or combination of factors, may cause actual results to differ materially fromthose contained in, or implied by, any forward-looking statements. Given these uncertainties, you should Outlook Therapeutics,Inc.Consolidated Statements of Operations Outlook Therapeutics,Inc.Notesto Unaudited Interim Consolidated Financial Statements 1.Organization and Description of Business Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5,2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delawarecorporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. TheCompanyis a biopharmaceutical company focused on developing and commercializing ONS- 5010/LYTENAVATM, an ophthalmic formulation of bevacizumab for use in retinal indications. The In May 2024 the Company received Marketing Authorization from the European Commission forLYTENAVA (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wetage-related macular degeneration (“AMD”) in the European Union (“EU”). Additionally, in July 2024 theCompany also received marketing authorization for LYTENAVA (bevacizumab gamma) in the UnitedKingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”). In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial to support its Biologi