Outlook Therapeutics Raises $35M Via Equity To Support ONS-5010 US Application, Shares Spike

by Vandana Singh, Benzinga Editor
February 4, 2021 11:18 AM | 2 min read |
  • Outlook Therapeutics Inc (NASDAQ: OTLK) completed a $35 million public common stock offering that included participation by the Company's largest stockholder and strategic partner, BioLexis, as well as the partial exercise of the underwriter's overallotment option for an additional $3.6 million, which is expected to close today.
  • The Company also closed the previously announced concurrent private placement of common stock to Syntone Ventures, its partner in China, for additional gross proceeds of $3 million.
  • Combined net proceeds will provide sufficient capital to fund operations through the FDA marketing application's expected filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) for wet age-related macular degeneration (wet AMD). Outlook plans to file by the end of 2021.
  • Commercial launch planning has begun, including distribution, physician and patient outreach, key opinion leader support, and payor community engagement. The Company expects ONS-5010, if approved, to be widely adopted by payors and clinicians worldwide. According to market research, ONS-5010, if approved, will be a significant therapy in the retinal anti-VEGF market, currently estimated to be in excess of $13 billion worldwide. If the marketing application is approved, it will result in 12 years of marketing exclusivity.
  • Last year in July, the Company completed patient enrollment in its pivotal ONS-5010 Phase 3 (NORSE TWO) trial, enrolling a total of 227 patients. Pivotal safety and efficacy data is expected in the third calendar quarter of 2021. 
  • Additionally, in November 2020, Outlook completed enrollment of 195 subjects, ahead of schedule, an open-label safety study (NORSE THREE) evaluating ONS-5010/LYTENAVA. Following the data readout from both the open-label safety study and the pivotal safety and efficacy study.
  • ONS-5010 is a full-length, humanized anti-Vascular Endothelial Growth Factor recombinant monoclonal antibody that inhibits VEGF and associated angiogenic activity.
  • Price Action: OTLK share are trading higher by 21.4% at $1.785 on the last check Thursday.
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