Outlook Therapeutics, Inc.

Outlook Therapeutics, Inc. announced the pricing of an underwritten public offering of 55,555,556 shares of its common stock and accompanying warrants. The combined public offering price is $0.99 per share and warrant, with warrants exercisable at $1.10 per share. The company expects to raise approximately $55.0 million in gross proceeds, which will be used to support the commercial launch of LYTENAVA™ in the United States, as well as for working capital and general corporate purposes. The offering is anticipated to close on August 14, 2026.

Outlook Therapeutics announced that its drug LYTENAVA™ (bevacizumab-vikg) received U.S. FDA approval for neovascular age-related macular degeneration (nAMD) on July 24, 2026. The company reported preliminary cash and cash equivalents of approximately $11.2 million as of June 30, 2026, and terminated its prospectus supplement for an At The Market Offering Agreement. Outlook Therapeutics also disclosed substantial doubt about its ability to continue as a going concern, emphasizing the need for significant additional capital to fund LYTENAVA's commercialization, as current funds are only sufficient into September 2026.

Outlook Therapeutics, Inc. announced the commencement of an underwritten public offering of its common stock and accompanying warrants. The company also intends to grant underwriters a 30-day option to purchase additional shares and/or warrants, up to 15% of the offering. Proceeds from the offering are intended to fund the commercial launch of LYTENAVA™ in the United States, as well as for working capital and general corporate purposes.

Outlook Therapeutics, Inc. announced it will report its financial results for the third quarter fiscal year 2026. The company will host a corporate update conference call and webcast on Friday, August 14, 2026, at 8:30 AM ET. The call will be led by CEO Bob Jahr and CFO Lawrence A. Kenyon, providing an update on the company's performance and commercialization efforts for LYTENAVA™.

Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (wet AMD). This approval establishes LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the United States, providing retina specialists and patients with a purpose-built treatment. The company anticipates 12 years of market exclusivity and has commenced commercial launch activities, aiming to make the product available to U.S. patients before year-end in the approximately $8.5 billion U.S. retina market.

Outlook Therapeutics, Inc. announced that its Compensation Committee approved stock option grants and potential cash bonuses for its Chief Executive Officer, Robert C. Jahr, and Chief Financial Officer, Lawrence A. Kenyon. Mr. Jahr received 100,000 options and Mr. Kenyon received 210,078 options, both with an exercise price of $1.4304 per share, vesting on July 21, 2027. Additionally, Mr. Jahr was awarded a potential cash bonus of $420,000 and Mr. Kenyon $200,000, contingent on FDA approval of ONS-5010 (bevacizumab-vikg) by July 31, 2026. These awards recognize their contributions to advancing the Biologics License Application for ONS-5010.

Outlook Therapeutics, Inc. stockholders approved several key proposals at a special meeting on July 16, 2026. These approvals include an amendment to the company's Restated Certificate of Incorporation to increase the authorized number of common stock shares from 260,000,000 to 600,000,000. Additionally, stockholders approved a reverse stock split of the common stock at a ratio between 1-for-10 and 1-for-50, to be determined by the board of directors. The company also received approval for the potential issuance of shares underlying various warrants related to a recent registered direct offering and concurrent private placement.

Outlook Therapeutics, Inc. announced that it has regained compliance with Nasdaq's minimum bid price requirement. The company had previously received a delisting notice on February 18, 2026, for failing to maintain a $1.00 bid price. On June 26, 2026, Nasdaq confirmed that the company's common stock had traded at or above $1.00 for ten consecutive business days, thereby resolving the compliance issue.

Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD). The resubmission has been designated as a Class 1 review, with a PDUFA target action date of July 29, 2026. If approved, ONS-5010/LYTENAVA™ would be the first and only FDA-approved ophthalmic formulation of bevacizumab, and the company has already initiated pre-launch activities.

Outlook Therapeutics, Inc. has filed a definitive proxy statement (DEF 14A) for a Special Meeting of Stockholders scheduled for July 16, 2026. The meeting will address four key proposals: approval of the potential issuance of shares underlying various warrants issued in connection with a registered direct offering and private placement, an increase in the total number of authorized shares of common stock from 260 million to 600 million, and approval of a reverse stock split. The Board of Directors recommends a vote 'For' all proposals.