OTLK News & Events

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.

Outlook Therapeutics announced an amendment to its existing convertible note with Avondale Capital and the issuance of a new non-convertible, unsecured note with Atlas Sciences,. Under the amendment to the Existing Note, the maturity date of the Existing Note has been extended to December 31, 2026, with no other changes to the terms. The lender has confirmed that the Existing Note is not in default. In addition, Outlook Therapeutics entered into the $18.4 million New Note. The Company expects to receive $17 million in net proceeds, after original issue discount. Proceeds from the New Note will be used to pay down a portion of the Existing Note, reducing the balance and leaving approximately $10.8 million of principal and interest remaining on the Existing Note. The New Note bears interest at a rate equal to the Prime Rate plus 3%, subject to a minimum interest rate of 9.5% per annum, and matures on June 16, 2027.