Outlook Therapeutics Closes $55 Million Financing; Extends Cash Runway Through Anticipated FDA Approval of ONS-5010
Outlook Therapeutics announced it closed on approximately $25 million registered direct equity offering, and about $30 million net proceeds from issuance of an unsecured convertible promissory note with an initial conversion price of $2. The $50 million net proceeds from two new financings will support pre-launch activities through anticipated approval of ONS-5010 in third calendar quarter 2023, the company announced during a fiscal year-end update.
The financing comes after Outlook received validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for ONS-5010/ Lytenava (bevacizumab-vikg). The company previously announced that the FDA accepted its Biologics License Application (BLA) for ONS-5010/Lytenava for the treatment of wet AMD and set a PDUFA goal date of August 29, 2023.
Outlook also announed it entered into a strategic commercialization agreement with AmerisourceBergen, which will provide third-party logistics (3PL) services and distribution, as well as medical information and pharmacovigilance services in the United States.
“Our fiscal year 2022 laid a solid foundation for what we believe will be a transformational 2023. We are driving our commercialization planning towards expected launch 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 believe that ONS-5010 has the potential to be a game-changer for patients and physicians in the retina community, and we now have the necessary capital to support these efforts. We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space,” C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics, said in a company news release. “On behalf of the entire team, I would like to thank all stakeholders for their continued support and look forward to what we believe will be an exciting future for Outlook Therapeutics.”