Business
Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2023 and Provides Corporate Update
Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation for the treatment of wet age-related macular degeneration (wet AMD)Cash runway through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023 ISELIN, N.J., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2022. Recent Corporate Highlights Strengthened Medical Affairs and Commercial Expertise with Appointments of Surendra Sharma, MD, Senior Vice President of Medical Affairs, and Glen Olsheim, Executive Director of Commercial Excellence.Closed on approximately $54 million in net proceeds from two financings to support pre-launch commercial activities through anticipated FDA approval of ONS-5010 in third calendar quarter of 2023 and into the fourth calendar quarter of 2023. Approximately $24 million registered direct equity offering priced at-the-market under Nasdaq rules.Approximately $30 million net proceeds from issuance of an unsecured convertible promissory note with an initial conversion price of $2.00 per share. Received validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for ONS-5010/ LYTENAVA™ (bevacizumab-vikg).Announced that the FDA accepted its Biologics License Application (BLA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD and set a PDUFA goal date of August 29, 2023. “Our first fiscal quarter of 2023 continued to demonstrate solid execution toward the potential commercialization of ONS-5010. With the accepted FDA filing of our BLA for ONS-5010 and PDUFA date set for August 29, 2023, and review of our MAA in the EU underway with a decision date expected in early 2024, we are well on our way toward our goal of becoming a commercial-stage company,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. ...