Outlook Therapeutics, Inc.

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.

Outlook Therapeutics, Inc. announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration (nAMD). This follows a successful appeal of a December 2026 Complete Response Letter, with the FDA Office of New Drugs concluding that substantial evidence of effectiveness has been established and no additional trials are required. The resubmission is designated as a Class 1 review, with a PDUFA date and decision expected within 60 days of FDA's receipt. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab.

Outlook Therapeutics, Inc. completed a registered direct offering of 8,539,709 shares of its common stock. The shares were sold to GMS Ventures and Investments pursuant to a securities purchase agreement entered into on May 28, 2026. This offering was conducted under the company's effective registration statement on Form S-3.

Outlook Therapeutics, Inc. entered into a securities purchase agreement to sell 8,539,709 shares of common stock at $0.5855 per share in a registered direct offering, expecting gross proceeds of approximately $5.0 million. The company intends to use the net proceeds for working capital and general corporate purposes. Additionally, the company amended existing warrants held by the purchaser, GMS Ventures and Investments (affiliated with company directors), reducing the exercise price for 15,488,570 shares from a weighted average of $1.78 to $0.5855 per share.

Outlook Therapeutics, Inc. announced a definitive agreement for a registered direct offering to its largest stockholder, GMS Ventures and Investments. The company will sell 8,539,709 shares of common stock at $0.5855 per share, expecting to raise $5.0 million in gross proceeds for working capital and general corporate purposes. Additionally, the company will amend outstanding common stock warrants for 15,488,570 shares, reducing their exercise price to $0.5855 per share from a previous weighted average of $1.78.

Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted its appeal following the Formal Dispute Resolution process for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD). The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™. As a result, Outlook Therapeutics expects to resubmit the Biologics License Application (BLA) in June 2026, providing a clear path toward U.S. approval for what would be the first FDA-approved ophthalmic formulation of bevacizumab.

Outlook Therapeutics, Inc. reported a significant reduction in its GAAP net loss for the second fiscal quarter ended March 31, 2026, to $4.5 million, or $0.05 per share, compared to $46.4 million, or $1.50 per share, in the prior year. The company completed its formal dispute resolution meeting with the FDA regarding ONS-5010, with a decision expected in May 2026. Concurrently, Outlook Therapeutics continued its European commercial expansion of LYTENAVA, securing a distribution agreement for Switzerland and planning launches in the Netherlands and Ireland later in 2026, despite a 10% sequential dip in European unit sales. The company also strengthened its financial position through recent public and registered direct offerings, raising a total of $8.2 million in net proceeds.

Outlook Therapeutics reported a net loss of $4.45 million for the three months ended March 31, 2026, and $27.51 million for the six months. The company disclosed a working capital deficit and an accumulated deficit of $633.22 million, leading management to express substantial doubt about its ability to continue as a going concern. Outlook Therapeutics is actively seeking additional financing to fund future operations and commercialization efforts. The company also provided updates on its Biologics License Application for ONS-5010/LYTENAVA, having received a third Complete Response Letter from the FDA, while commercial sales of LYTENAVA commenced in Germany and the UK in June 2025.