OTLK News & Events

Outlook Therapeutics announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 16.129M shares of its common stock at an offering price of 31c per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the company will issue unregistered warrants to purchase up to an aggregate of 16.129M shares of common stock at an exercise price of 31c per share. The unregistered warrants will become exercisable on the later of the date of stockholder approval of the issuance of the shares underlying the warrants and the effective date of an amendment to the company's certificate of incorporation to increase the authorized shares of the company and will expire five years following the later of the date the unregistered warrants are first exercisable and the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about April 23, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Outlook Therapeutics announced that it has completed its Federal Dispute Resolution meeting with the Office of New Drugs at the U.S. Food and Drug Administration. The meeting was conducted as part of the Company's ongoing efforts to seek alignment with the FDA regarding the regulatory pathway for ONS-5010 / LYTENAVA and as a follow-up to its recent Type A meeting with the Division of Ophthalmology and Office of Specialty Medicine regarding the December 30, 2025 Complete Response Letter, CRL, for the Biologics License Application, BLA, for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration. "We appreciate the opportunity to engage in constructive dialogue with the FDA through the FDR process," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "We believe this meeting represents an important step in advancing our regulatory strategy, and we look forward to receiving formal feedback from the Agency in May 2026. Outlook Therapeutics remains committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval."

Outlook Therapeutics announced that it submitted a formal dispute resolution request to the FDA as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter for the Biologics License Application for ONS-5010, or Lytenava. The FDA has accepted the request and granted a meeting with the deciding official to be conducted in April. The company stated its submission includes a comprehensive presentation of clinical data that it believes supports the efficacy and safety of ONS-5010 for the treatment of neovascular age-related macular degeneration. "We look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for LYTENAVA demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval and bring a much-needed FDA approved option for patients," said Bob Jahr, CEO of Outlook Therapeutics.

Outlook Therapeutics announced that it has commenced a best-efforts public offering of its common stock and accompanying warrants exercisable for shares of its common stock. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.