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Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
Other Events. Exhibits are filed herewith in connection with the registered direct offering (the “Registered Direct Offering”) by Outlook Therapeutics, Inc. (the “Company”) of 8,539,709 shares of the Company’s common stock, $0.01 par value per share, to GMS Ventures and Investments (the “Purchaser”) pursuant to that certain securities purchase agreement entered into on May 28, 2026, by and between the Company and the Purchaser. The Registered Direct Offering was made pursuant to the Company’s…
Other Events. Registered Direct Offering On May 28, 2026, Outlook Therapeutics, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with GMS Ventures and Investments (the “Purchaser”), pursuant to which the Company agreed to issue and sell to the Purchaser, in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market (the “Registered Direct Offering”), 8,539,709 shares (the “Shares”) of the Company’s common stock, $0.…
Other Events. On May 26, 2026, Outlook Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted the Company's appeal following completion of the Formal Dispute Resolution (FDR) process with the Office of New Drugs (OND) regarding the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular de…
and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Entry into a Material Definitive Agreement. On May 13, 2026, Outlook Therapeutics, Inc. (the “Company”) entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright”), pursuant to which the Company may issue and sell shares of its common stock, $0.01 par value per share (“Common Stock”), from time to time through H.C. Wainwright as sales agent and/or principal having an aggregate offering price of up to $100,000,000 (the “Shares”).…
Termination of a Material Definitive Agreement. In connection with entering into the Sales Agreement, the Company terminated, effective May 12, 2026, its at-the-market sales agreement, dated as of May 16, 2023 (as amended, the “Prior Sales Agreement”) with BTIG, LLC with respect to an at-the-market offering program under which the Company could offer and sell, from time to time at its sole discretion, shares of its Common Stock having an aggregate offering price of up to $100,000,000 (the “Pr…
shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by speci…
by reference. The Common Warrants (as defined below), the shares of Common Stock (as defined below) issuable upon exercise of the Common Warrants (the “Common Warrant Shares”), and the Placement Agent Warrants (as defined below) and shares of Common Stock issuable upon exercise thereof have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of any state, and are being offered and sold in reliance on the exemption from registration u…
Other Events. Registered Direct Offering and Concurrent Private Placement On April 22, 2026, Outlook Therapeutics, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to which the Company agreed to issue and sell (i) in a registered direct offering priced at-the-market under the rules of The Nasdaq Stock Market (the “Registered Direct Offering”) an aggregate of 16,129,033 shares (the “Shares”) of the Compa…
Other Events. On April 21, 2026, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has conducted the requested Federal Dispute Resolution meeting with the Office of New Drugs at the U.S. Food and Drug Administration (FDA) to appeal the complete response letter (CRL) dated December 30, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Th…
Other Events. On April 7, 2026, Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing that it submitted a formal dispute resolution request (FDRR) to the U.S. Food and Drug Administration (FDA) as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab) for the treatment of neovascular age-related macular degeneration, and that the FDA has acce…
Other Events. On March 23, 2026, Outlook Therapeutics, Inc. (the “Company”) commenced a best-efforts public offering (the “Offering”) of its common stock and accompanying warrants to purchase shares of common stock. H.C. Wainwright & Co., LLC acted as exclusive placement agent (the “Placement Agent”) in connection with the Offering. In the Offering, the Company agreed to issue and sell (i) 20,000,000 shares of the Company's common stock, par value $0.01 per share (the “Common Stock”), and (ii…
Entry into a Material Definitive Agreement. On March 16, 2026, Outlook Therapeutics, Inc. (the “Company”) entered into a Note Purchase Agreement (the “NPA”) with Atlas Sciences, LLC, a Utah limited liability company (the “Investor”), pursuant to which the Company agreed to issue to the Investor an unsecured promissory note with an original principal balance of $18,360,000 (the “Note”). The Note was issued with an original issue discount of $1,360,000, resulting in a purchase price of $17,000,…
Other Events. In connection with entry into the Note, the Company is providing supplemental risk factors, which are filed herewith as Exhibit 99.1 and are incorporated by reference herein. Forward-Looking Statements This Current Report on Form 8-K, including Exhibit 99.1, which has been filed herewith and incorporated by reference herein, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “expect,” “inten…
Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. The disclosure under
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On March 6, 2026, the Board of Directors (the “Board”) of Outlook Therapeutics, Inc. (the “Company”) accepted the resignation of Dr. Julia Haller from the Board, effective March 11, 2026. The Board has resolved to reduce its size to nine directors immediately upon Dr. Haller’s resignation. Dr. Haller was a Class II director of the Board and served…
Other Events. On March 5, 2026, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has conducted the requested Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated December 30, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. The press release is attached as Exhibit 99.1 to…
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing . On February 18, 2026, Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), received a letter from the Listing Qualifications Staff (the “Nasdaq Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the last 30 consecutive business days, the bid price of the Company’s common stock had closed below $1.00 per share, the minimum closing bid price required…
and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Other Events. On February 11, 2026, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has requested a Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated December 31, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. The press release is attached as Exhibit 99.1 to this Cur…
Other Events. On December 31, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter to the Company’s biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this
Results of Operations and Financial Condition On December 19, 2025, Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its fourth fiscal quarter and year ended September 30,2025 . A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in this
Other Events. On September 29, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has completed the requested Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook…
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Departure of Chief Commercial Officer On September 5, 2025, Mr. Jeff Evanson stepped down as the Chief Commercial Officer of Outlook Therapeutics, Inc. (the “Company”), effective immediately (the “Effective Date”). Mr. Evanson’s departure constitutes a termination of employment without “cause” for purposes of any employment, equity compensation or…
Other Events. On August 28, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter to the Company’s biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this
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