Outlook Therapeutics Inc SEC Filings

Outlook Therapeutics director Kurt J. Hilzinger increased his personal stake by buying 400,000 shares of Common Stock in an open-market purchase. The shares were acquired at an average price of $0.4413 per share. Following this transaction, he directly owns 423,655 shares of Outlook Therapeutics common stock.

Outlook Therapeutics announced that the U.S. FDA has granted its appeal after a Formal Dispute Resolution process over the December 30, 2025 Complete Response Letter for the Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat neovascular age-related macular degeneration.

The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™ in this indication and directed internal offices to work with the company on final labeling. Outlook Therapeutics expects to resubmit the BLA in June 2026 as a Class 1 resubmission, with a PDUFA decision anticipated within 60 days of FDA receipt.

Outlook Therapeutics, Inc. is soliciting proxies for a Special Meeting of stockholders to be held on July 16, 2026 to vote on three proposals: (1) approval to authorize issuance of shares underlying certain Warrants (Private Placement, Placement Agent and Amended Warrants) issued in April 2026, (2) an amendment to increase authorized common shares from 260,000,000 to 600,000,000, and (3) a Board‑authorized reverse stock split at a ratio between 1‑for‑10 and 1‑for‑50. The record date for voting is May 18, 2026, when 120,863,252 shares were outstanding. The proxy includes detailed terms for the Offering (Private Placement Warrants to purchase up to 16,129,033 shares; Placement Agent Warrants to purchase up to 2,258,064 shares; Amended Warrants to purchase up to 2,142,854 shares), the Nasdaq 20% approval requirement, and potential effects of approval or non‑approval on authorized share availability, exercisability of warrants, gross proceeds estimates, and Nasdaq listing compliance.

Outlook Therapeutics reported a second fiscal quarter 2026 net loss attributable to common stockholders of $4.5 million, or $0.05 per share, a sharp improvement from a $46.4 million loss, or $1.50 per share, a year earlier largely due to non‑cash fair value movements and prior warrant inducement expenses.

On a non‑GAAP basis, adjusted net loss widened to $14.1 million, or $0.16 per share, from $12.4 million, or $0.40 per share. Revenues were modest at $128,000 and were offset by fixed distribution costs, while European LYTENAVA unit sales declined about 10% versus the prior quarter but have begun to trend upward early in the current quarter.

The company continued its European rollout of LYTENAVA, signed a Swiss distribution agreement with Mediconsult AG, and launched a real‑world evidence study in Germany. It expects an FDA dispute‑resolution decision on ONS‑5010/LYTENAVA in May 2026. Cash and cash equivalents were $7.7 million as of March 31, 2026, excluding $4.2 million of net proceeds from an April 2026 offering.

Outlook Therapeutics proposes an at-the-market offering to sell up to $100,000,000 of common stock through H.C. Wainwright under a sales agreement dated May 13, 2026. The company may sell shares from time to time at prevailing market prices; proceeds are intended for working capital and general corporate purposes. The prospectus supplement states 120,863,252 shares outstanding as of May 7, 2026 and illustrates an illustrative pro forma outstanding share count of up to 524,577,422 shares under an assumed full $100.0 million raise. Sales are at Wainwright’s commercially reasonable efforts and Wainwright will receive a 3.0% commission; the offering is an ATM under Rule 415 and may be suspended or terminated under the Sales Agreement.

Outlook Therapeutics, Inc. entered into a new At The Market Offering Agreement with H.C. Wainwright, allowing the company to sell up to $100,000,000 of common stock from time to time under its effective Form S-3 shelf registration. H.C. Wainwright will act as sales agent and/or principal and earn a 3% commission on gross proceeds.

In connection with this new agreement, Outlook Therapeutics terminated its prior $100,000,000 at-the-market program with BTIG and will no longer sell shares under that facility. The company also reported preliminary, unaudited cash and cash equivalents of approximately $7.7 million as of March 31, 2026, excluding $4.5 million of net proceeds from an April 2026 registered direct equity offering.

Outlook Therapeutics, Inc. Schedule 13G discloses that Mitchell P. Kopin, Daniel B. Asher and Intracoastal Capital LLC (the Reporting Persons) are filing jointly to report beneficial ownership tied to a Securities Purchase Agreement dated April 22, 2026. The Reporting Persons may be deemed to beneficially own 5,990,447 shares of Common Stock, representing 4.99% of the class based on 103,067,190 shares outstanding (prior to the SPA). The filing describes additional shares issuable upon exercise of warrants (including 6,451,613 shares under Intracoastal Warrant 1 and warrants totaling 2,000,000 or adjusted figures subject to blocker provisions) and explains blocker provisions that prevent exercises that would push ownership above 4.99%.

Outlook Therapeutics, Inc. entered into a registered direct offering and concurrent private placement, issuing 16,129,033 shares of common stock and matching common warrants at a combined price of $0.31 per share and warrant, for gross proceeds of about $5.0 million before fees.

The warrants carry a $0.31 exercise price, become exercisable after stockholder approval and an increase in authorized shares, and have a five‑year term from the later of that date and the effectiveness of a resale registration statement. The company also issued placement agent warrants and agreed to standard cash fees, and separately amended 2,142,854 existing warrants to reduce their exercise price to $0.31 and extend their life to five years after future stockholder approval. Net proceeds are planned primarily for working capital and general corporate purposes.