OTLK News & Events

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.

Outlook Therapeutics provided an update following its recent Type A meeting with the FDA to discuss the December 30, 2025 complete response letter for the biologics license application, or BLA, for ONS-5010/Lytenava. The Type A meeting was conducted to clarify the outstanding issue identified in the CRL regarding substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval. The company expects to continue engaging in discussions with the FDA to further clarify the Agency's views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010 toward potential U.S. approval. "We appreciate the FDA's engagement during the Type A meeting and remain committed to working constructively with the Agency," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "Our goal is to reach alignment on the confirmatory evidence supporting our application and to identify the most efficient pathway toward potential approval."