Podstawowe statystyki
| LEI | 5493007AWUJ6HPMCBH11 |
| CIK | 1649989 |
SEC Filings
SEC Filings (Chronological Order)
| June 1, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| June 1, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 1, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| June 1, 2026 |
Exhibit 99.1 Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg) ISELIN, N.J., June 1, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today an |
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| June 1, 2026 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission O |
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| May 29, 2026 |
8,539,709 Shares of Common Stock As Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 PROSPECTUS SUPPLEMENT (To Prospectus Dated April 5, 2024) 8,539,709 Shares of Common Stock Pursuant to this prospectus supplement and accompanying prospectus, we are offering 8,539,709 shares of our common stock, par value $0.01 per share, to a single accredited institutional investor, or the purchaser. The offering price for each sha |
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| May 29, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 29, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 28, 2026 |
Exhibit 4.1 GMS Ventures & Investments Intertrust Corporate Services(Cayman)Ltd, 190 Elgin Avenue, George Town Grand Cayman, E9, KYI-9007 962 6 582 7999 May 28, 2026 Re: Amendment to Existing Warrants Ladies and Gentlemen: Reference is hereby made to the registered direct offering on or about the date hereof (the “Offering”) by Outlook Therapeutics, Inc. (the “Company”) of shares of the Company’s |
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| May 28, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 28, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 28, 2026 |
Exhibit 10.1 Execution Version SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of May 28 2026, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and the purchaser identified on the signature pages hereto (including its successors and assigns, the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Ag |
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| May 26, 2026 |
Exhibit 99.1 Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Company plans to resubmit BLA to the FDA in June 2026 ISELIN, N.J., May 26, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for t |
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| May 26, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 26, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 22, 2026 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission On |
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| May 18, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 18, 2026 |
Exhibit 99.1 Outlook Therapeutics Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update · Completed Formal Dispute Resolution Meeting with FDA regarding Complete Response Letter (CRL) for ONS-5010; Decision Expected This Month · Continued expansion of LYTENAVA™ (bevacizumab gamma) in Europe with Commercial Distribution Agreement with Mediconsult AG in Switzerland |
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| May 15, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2026 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| May 13, 2026 |
AT THE MARKET OFFERING AGREEMENT Exhibit 10.1 AT THE MARKET OFFERING AGREEMENT May 13, 2026 H.C. Wainwright & Co., LLC 430 Park Avenue New York, New York 10022 Ladies and Gentlemen: Outlook Therapeutics, Inc., a corporation organized under the laws of Delaware (the “Company”), confirms its agreement (this “Agreement”) with H.C. Wainwright & Co., LLC (the “Manager”) as follows: 1. Definitions. The terms that follow, wh |
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| May 13, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 13, 2026 |
Up to $100,000,000 Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 PROSPECTUS SUPPLEMENT (To Prospectus dated April 5, 2024) Up to $100,000,000 Common Stock We have entered into a sales agreement dated May 13, 2026, or the Sales Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, relating to the issuance and sale of shares of our common stock, par value $0.01 per share, offered by this prospectus |
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| April 23, 2026 |
FORM OF PLACEMENT AGENT COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| April 23, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 22, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| April 23, 2026 |
16,129,033 Shares of Common Stock As Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 PROSPECTUS SUPPLEMENT (To Prospectus Dated April 5, 2024) 16,129,033 Shares of Common Stock We are offering to certain investors 16,129,033 shares of our common stock, par value $0.01 per share. The offering price for each share of common stock is $0.31. In a concurrent private placement, we are also offering to the purchasers of shar |
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| April 23, 2026 |
FORM OF COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR |
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| April 23, 2026 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of April 22, 2026, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditi |
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| April 21, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 21, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| April 21, 2026 |
Exhibit 99.1 Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Formal decision expected in May 2026 ISELIN, N.J., April 21, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has c |
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| April 7, 2026 |
Exhibit 99.1 Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA ISELIN, N.J., April 7, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it submitted a formal dispute resolution reque |
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| April 7, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 7, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| March 25, 2026 |
FORM OF PLACEMENT AGENT COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Exhibit 4.2 FORM OF PLACEMENT AGENT COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Warrant Number: Issue Date: March 25, 2026 THIS PLACEMENT AGENT COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [●] or its permitted assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at a |
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| March 25, 2026 |
FORM OF COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Exhibit 4.1 FORM OF COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Warrant Number: Issue Date: March 25, 2026 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [●] or his, her or its permitted assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after |
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| March 25, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 23, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 25, 2026 |
As Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 PROSPECTUS SUPPLEMENT (To Prospectus Dated April 5, 2024) $5,000,000 20,000,000 Shares of Common Stock 20,000,000 Common Warrants to Purchase up to 20,000,000 Shares of Common Stock 20,000,000 Shares of Common Stock Underlying Common Warrants 1,400,000 Placement Agent Warrants to Purchase up to 1,400,000 Shares of Common Stock 1,400,0 |
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| March 25, 2026 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of March 23, 2026, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditi |
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| March 23, 2026 |
Subject to Completion, dated March 23, 2026 As Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 The information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities and are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted. Subject to Complet |
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| March 16, 2026 |
Exhibit 10.2 PROMISSORY NOTE Effective Date: March 16, 2026 U.S. $18,360,000.00 FOR VALUE RECEIVED, Outlook Therapeutics, Inc., a Delaware corporation (“Borrower”), promises to pay to Atlas Sciences, LLC, a Utah limited liability company, or its successors or assigns (“Lender”), $18,360,000.00 and any interest, fees, charges, and late fees accrued hereunder on the date that is fifteen (15) months |
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| March 16, 2026 |
Exhibit 99.1 Supplemental Risk Factors Except as set forth below, as of March 16, 2026, there have been no material changes to the risk factors that were previously disclosed in Item 1A in the Company’s Annual Report on Form 10-K for the year ended September 30, 2025 filed with the Securities and Exchange Commission on December 19, 2025. There is substantial doubt about our ability to continue as |
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| March 16, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 13, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 16, 2026 |
AMENDMENT #2 TO CONVERTIBLE PROMISSORY NOTE Exhibit 10.3 March 13, 2026 AMENDMENT #2 TO CONVERTIBLE PROMISSORY NOTE This Amendment #2 to Convertible Promissory Note (this “Amendment #2”) is entered into as of March 12, 2026, by and between Avondale Capital, LLC, a Utah limited liability company (“Lender”), and Outlook Therapeutics, Inc., a Delaware corporation (“Borrower”). Capitalized terms used but not otherwise defined herein shall have |
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| March 16, 2026 |
Exhibit 10.1 Note Purchase Agreement This Note Purchase Agreement (this “Agreement”), dated as of March 16, 2026 (the “Effective Date”), is entered into by and between Outlook Therapeutics, Inc., a Delaware corporation (“Company”), and Atlas Sciences, LLC, a Utah limited liability company, its successors and/or assigns (“Investor”). A. Company and Investor are executing and delivering t |
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| March 11, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| March 11, 2026 |
Exhibit 99.1 840 Walnut Street Julia A. Haller, MD Suite 1510 Philadelphia, PA 19107 Ophthalmologist-in-Chief and William Tasman, MD, Endowed Chair Professor and Chair of Ophthalmology Sidney Kimmel Medical College at Thomas Jefferson University Jhaller@willseye org T 215-928-3073 March 6, 2026 Mr. Bob Jahr Chief Executive Officer Outlook Therapeutics, Inc. 111S. Wood Ave, Unit #100 Iselin, NJ 0 |
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| March 10, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 10, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 5, 2026 |
Exhibit 99.1 Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA™ (bevacizumab-vikg) ISELIN, N.J., March 5, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today provided an update following its recent Type A meeting with the U |
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| March 5, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 5, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| February 18, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 18, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| February 17, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 17, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| February 17, 2026 |
Exhibit 99.1 Outlook Therapeutics Reports First Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update · Continued expansion of LYTENAVA™ (bevacizumab gamma) in Europe underway, including commercial launch in Austria in January 2026 · Additional European launches expected in 2026 · Type A meeting request submitted to the U.S. Food and Drug Administration for ONS-5010 ISELIN, N.J. |
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| February 17, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| February 11, 2026 |
Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter Exhibit 99.1 Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter ISELIN, N.J., February 11, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has submitted a Type A meeting request to the U.S. Food and Drug Adm |
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| February 11, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 11, 2026 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| January 26, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| January 26, 2026 |
CORPORATE ANNUAL REPORT NASDAQ: OTLK outlooktherapeutics.com 202UNITEDSTATES SECURITIESANDEXCHANGECOMMISSION WASHINGTON,D.C.20549 FORM10-K ☒ ANNUALREPORTPURSUANTTOSECTION13OR15(d)OFTHESECURITIESEXCHANGEACTOF1934 ForthefiscalyearendedSeptember30,2025 OR ☐ TRANSITIONREPORTPURSUANTTOSECTION13OR15(d)OFTHESECURITIESEXCHANGEACTOF1934 Forthetransitionperiodfrom to CommissionFileNumber:001-37759 OUTLOOKT |
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| January 26, 2026 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission O |
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| January 2, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 31, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| January 2, 2026 |
Exhibit 99.1 Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD • FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA ISELIN, N.J., December 31, 2025 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for b |
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| December 19, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37759 OUTLOO |
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| December 19, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 19, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| December 19, 2025 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of the Registrant d Name of Subsidiary State or Other Jurisdiction Outlook Therapeutics Pty Ltd Australia Outlook Therapeutics NL B.V. Netherlands Outlook Therapeutics CH GmbH Switzerland Outlook Therapeutics DE GmbH Germany Outlook Therapeutics Limited (dormant subsidiary) England and Wales Outlook Therapeutics Limited Republic of Ireland This list does not include joint |
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| December 19, 2025 |
Outlook Therapeutics Reports Financial Results for Fiscal Year 2025 Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Fiscal Year 2025 ISELIN, N.J., December 19, 2025 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for fiscal year 2025. Financial Highlights for the Fiscal Year Ended September 30, 2 |
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| December 19, 2025 |
Exhibit 10.12 OUTLOOK THERAPEUTICS, INC. NON-EMPLOYEE DIRECTOR COMPENSATION POLICY AS AMENDED AND RESTATED EFFECTIVE OCTOBER 1, 2024 Each member of the Board of Directors (the “Board”) who is not also serving as an employee of Outlook Therapeutics, Inc. (the “Company”) or any of its subsidiaries (each such member, an “Eligible Director”) will receive the compensation described in this Non-Employee |
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| December 19, 2025 |
Description of Registrant’s securities. Exhibit 4.1 Description of Registrant’s Securities The following is a description of the capital stock of Outlook Therapeutics, Inc. (the “Company,” “we,” “our,” or “us”). The following summary description is based on the provisions of our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), our Amended and Restated Bylaws, (the “Bylaws”), and the app |
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| November 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 13, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| November 3, 2025 |
Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 Exhibit 99.1 Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 ISELIN, N.J., November 3, 2025 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administr |
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| November 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 3, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commis |
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| September 29, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 29, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Comm |
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| September 29, 2025 |
Outlook Therapeutics Provides Update on Type A Meeting with FDA Exhibit 99.1 Outlook Therapeutics Provides Update on Type A Meeting with FDA ISELIN, N.J., September 29, 2025 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the |
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| September 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 5, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| September 2, 2025 |
Exhibit 99.1 Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD · FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA · Outlook Therapeutics plans to work with FDA to address the Agency’s issues · Company to host a conference call and webcast today, August 28th at 8:30 |
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| September 2, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 28, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commiss |
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| August 14, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 14, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commiss |
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| August 14, 2025 |
Exhibit 10.2 Confidential Portions of this Exhibit have been omitted because they are both not material and the type of information that the registrant customarily and actually treats as private or confidential. Information that has been omitted has been marked in this exhibit with, black boxes, in accordance with Regulation S-K, Item 601(b)(10)(iv). MASTER SERVICES AGREEMENT (1)ALLOGA (NEDERLAND) |
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| August 14, 2025 |
Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2025 and Provides Corporate Update · First commercial sales of LYTENAVA™ (bevacizumab gamma) achieved in Europe · ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, N.J., August 14, 2025 — Outlook Therapeutics, Inc. (Nasdaq: |
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| August 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| July 1, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 28, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| July 1, 2025 |
Exhibit 10.1 EXECUTIVE Employment Agreement This Executive Employment Agreement (“Agreement”) is made and entered into as of June 28, 2025, by and between Robert Jahr (“Executive”) and Outlook Therapeutics, Inc. (“Company”). Whereas, the Company desires to employ Executive as its Chief Executive Officer and President and provide Executive with certain compensation and benefits in return for Execut |
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| June 2, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 2, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 23, 2025 |
9,285,714 Shares of Common Stock Warrants to Purchase 18,571,428 Shares of Common Stock As Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 PROSPECTUS SUPPLEMENT (To Prospectus Dated April 5, 2024) 9,285,714 Shares of Common Stock Warrants to Purchase 18,571,428 Shares of Common Stock We are offering (i) 9,285,714 shares of our common stock and (ii) accompanying warrants, or the purchase warrants, to purchase up to an aggregate of 18,571,428 shares of our common stock (an |
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| May 23, 2025 |
Underwriting Agreement, dated May 22, 2025, by and between the Company and BTIG LLC. Exhibit 1.1 OUTLOOK THERAPEUTICS, INC. (a Delaware corporation) 9,285,714 Shares of Common Stock Warrants to Purchase up to 18,571,428 Shares of Common Stock UNDERWRITING AGREEMENT May 22, 2025 BTIG, LLC as Representative of the several Underwriters c/o BTIG, LLC 350 Bush Street, 9th Floor San Francisco, CA 94104 Ladies and Gentlemen: Outlook Therapeutics, Inc., a Delaware corporation (the “Compan |
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| May 23, 2025 |
Exhibit 4.1 FORM OF COMMON STOCK PURCHASE WARRANT OUTLOOK THERAPEUTICS, INC. Warrant Number: 2025A-[●] Issue Date: May [●], 2025 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [●] or its permitted assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the |
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| May 23, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 22, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 22, 2025 |
Subject to Completion, dated May 22, 2025 As Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 The information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities and are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted. Subject to Complet |
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| May 15, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 15, 2025 |
EX-99.1 2 tm2515284d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update · LYTENAVA™ (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingdom (UK) in Q2 CY2025 · Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, |
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| May 15, 2025 |
Table of Contents tttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttttt UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| May 14, 2025 |
7,074,637 Shares of Common Stock Filed Pursuant to Rule 424(b)(3) Registration No. 333-285438 PROSPECTUS SUPPLEMENT NO. 1 (To Prospectus Dated March 7, 2025) 7,074,637 Shares of Common Stock This Prospectus Supplement No. 1, or the Prospectus Supplement, is being filed to update and supplement the information contained in the “Selling Stockholders” section of our prospectus, dated March 7, 2025, which forms a part of our Registra |
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| May 14, 2025 |
21,720,655 shares of Common Stock Filed Pursuant to Rule 424(b)(3) Registration No. 333-285973 PROSPECTUS SUPPLEMENT NO. 1 (To Prospectus Dated March 28, 2025) 21,720,655 shares of Common Stock This Prospectus Supplement No. 1, or the Prospectus Supplement, is being filed to update and supplement the information contained in the “Selling Stockholders” section of our prospectus, dated March 28, 2025, which forms a part of our Regis |
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| April 11, 2025 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 9, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| April 11, 2025 |
Exhibit 10.1 April 10, 2025 Lawrence A. Kenyon VIA EMAIL/DOCUSIGN Dear Mr. Kenyon, In recognition of your contributions to date and our important future objectives, Outlook Therapeutics, Inc. (the “Company”) is offering you the retention bonus opportunity described below. 1.Retention Bonus. Except as otherwise provided in Section 3 below, if you remain continuously employed by the Company in good |
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| April 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 8, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| March 28, 2025 |
21,720,655 shares of Common Stock Filed pursuant to 424(b)(3) Registration No. 333-285973 PROSPECTUS 21,720,655 shares of Common Stock This prospectus covers the offer and resale by the selling stockholders identified in this prospectus of up to an aggregate of 21,720,655 shares of our common stock, which consists of (i) 7,074,637 shares of our common stock issuable upon the exercise of outstanding Tranche B warrants to purchase s |
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| March 26, 2025 |
OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 March 26, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed March 20, 2025 File No. 333-285973 Ladies and Gentlemen: In accordanc |
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| March 26, 2025 |
March 26, 2025 Lawrence Kenyon Chief Financial Officer and Interim Chief Executive Officer Outlook Therapeutics, Inc. |
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| March 20, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Outlook Therapeutics, Inc. |
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| March 20, 2025 |
As filed with the Securities and Exchange Commission on March 20, 2025 As filed with the Securities and Exchange Commission on March 20, 2025 Registration No. |
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| March 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 11, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 14, 2025 |
Exhibit 3.1 CERTIFICATE OF AMENDMENT OF THE RESTATED CERTIFICATE OF INCORPORATION OF OUTLOOK THERAPEUTICS, INC. Outlook Therapeutics, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, hereby certifies that: First: The name of the Company is Outlook Therapeutics, Inc. (the “Company”). Second: The date of filing of the original Ce |
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| March 7, 2025 |
7,074,637 shares of Common Stock Filed pursuant to 424(b)(3) Registration No. 333-285438 PROSPECTUS 7,074,637 shares of Common Stock This prospectus covers the offer and resale by the selling stockholders identified in this prospectus of up to an aggregate of 7,074,637 shares of our common stock issuable upon the exercise of outstanding Tranche A warrants to purchase shares of our common stock, or the Tranche A Warrants, held by |
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| March 5, 2025 |
OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 CORRESP 1 filename1.htm OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 March 5, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed February 28, 2025 File No. 333-285438 Ladies a |
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| March 4, 2025 |
March 4, 2025 Lawrence A. Kenyon Chief Financial Officer and Interim Chief Executive Officer Outlook Therapeutics, Inc. 111 S. Wood Avenue, Unit #100 Iselin, New Jersey 08830 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed February 28, 2025 File No. 333-285438 Dear Lawrence A. Kenyon: This is to advise you that we have not reviewed and will not review your registration stat |
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| February 28, 2025 |
As filed with the Securities and Exchange Commission on February 28, 2025 As filed with the Securities and Exchange Commission on February 28, 2025 Registration No. |
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| February 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 28, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| February 28, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Outlook Therapeutics, Inc. |
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| February 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| February 14, 2025 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2025 and Provides Corporate Update · ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025 · LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in Germany and the United Kingdom (UK) planned for Q2 CY2025 ISELIN, N.J., |
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| February 14, 2025 |
Exhibit 99.1 JOINT FILING AGREEMENT In accordance with Rule 13d-1(k)(1) promulgated under the Securities Exchange Act of 1934, the undersigned agree to the joint filing of a Statement on Schedule 13G (including any and all amendments thereto) with respect to the Common Stock, $0.01 par value per share, of Outlook Therapeutics, Inc. and further agree to the filing of this agreement as an exhibit th |
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| February 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 14, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| February 10, 2025 |
CORPORATE 2024 ANNUAL REPORT NASDAQ: OTLK outlooktherapeutics.comUNITEDSTATES SECURITIESANDEXCHANGECOMMISSION WASHINGTON,D.C.20549 FORM10-K ☒ ANNUALREPORTPURSUANTTOSECTION13OR15(d)OFTHESECURITIESEXCHANGEACTOF1934 ForthefiscalyearendedSeptember30,2024 OR ☐ TRANSITIONREPORTPURSUANTTOSECTION13OR15(d)OFTHESECURITIESEXCHANGEACTOF1934 Forthetransitionperiodfrom to CommissionFileNumber:001-37759 OUTLOOKT |
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| February 10, 2025 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| January 31, 2025 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| January 31, 2025 |
Exhibit 10.1 Securities Purchase Agreement This Securities Purchase Agreement (this “Agreement”), dated as of January 31, 2025 (the “Effective Date”), is entered into by and between Outlook Therapeutics, Inc., a Delaware corporation (“Company”), and Avondale Capital, LLC, a Utah limited liability company, its successors and/or assigns (“Investor”). A. Company and Investor are executing |
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| January 31, 2025 |
Exhibit 10.2 CONVERTIBLE PROMISSORY NOTE January 31, 2025 U.S. $33,100,000.00 FOR VALUE RECEIVED, Outlook Therapeutics, Inc., a Delaware corporation (“Borrower”), promises to pay to Avondale Capital, LLC, a Utah limited liability company, or its successors or assigns (“Lender”), $33,100,000.00 and any interest, fees, charges, and late fees accrued hereunder on July 1, 2026 (the “Maturity Date”) in |
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| January 31, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 30, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commis |
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| January 23, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A (Amendment No. 1) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2024 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER |
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| January 22, 2025 |
Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that this Statement on Schedule 13D, dated January 17, 2025 (the “Schedule 13D”), with respect to the common stock, par value $0. |
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| January 16, 2025 |
Form of Syntone Inducement Letter. Exhibit 10.2 OUTLOOK THERAPEUTICS, inc. January 16, 2025 To: Holder of Warrants to Purchase Common Stock Re: Inducement Offer to Exercise Warrants to Purchase Common Stock Dear Holder: Outlook Therapeutics, Inc. (the “Company”) is pleased to offer to you (“Holder”, “you” or similar terminology) (i) the opportunity to receive new warrants to purchase shares of the Company’s common stock, par value |
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| January 16, 2025 |
Form of Tranche A Inducement Warrant. Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT TO |
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| January 16, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 16, 2025 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commis |
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| January 16, 2025 |
Exhibit 10.1 OUTLOOK THERAPEUTICS, inc. January 16, 2025 To: Holder of Warrants to Purchase Common Stock Re: Inducement Offer to Exercise Warrants to Purchase Common Stock Dear Holder: Outlook Therapeutics, Inc. (the “Company”) is pleased to offer to you (“Holder”, “you” or similar terminology) (i) the opportunity to receive new warrants to purchase shares of the Company’s common stock, par value |
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| January 16, 2025 |
Form of Syntone Tranche B Inducement Warrant. Exhibit 4.4 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT TO |
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| January 16, 2025 |
Form of Tranche B Inducement Warrant. Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT TO |
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| January 16, 2025 |
Form of Syntone Tranche A Inducement Warrant. Exhibit 4.3 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT TO |
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| December 27, 2024 |
Outlook Therapeutics® Reports Financial Results for Fiscal Year 2024 and Provides Corporate Update Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for Fiscal Year 2024 and Provides Corporate Update · LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK); First commercial launch anticipated in H1 CY25 · Received NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatme |
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| December 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 27, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| December 27, 2024 |
Exhibit 4.1 of the 2024 Form 10-K Exhibit 4.1 Description of Registrant’s Securities The following is a description of the capital stock of Outlook Therapeutics, Inc. (the “Company,” “we,” “our,” or “us”). The following summary description is based on the provisions of our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), our Amended and Restated Bylaws, (the “Bylaws”), and the app |
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| December 27, 2024 |
Exhibit 10.11 OUTLOOK THERAPEUTICS, INC. NON-EMPLOYEE DIRECTOR COMPENSATION POLICY AS AMENDED AND RESTATED EFFECTIVE OCTOBER 1, 2024 Each member of the Board of Directors (the “Board”) who is not also serving as an employee of Outlook Therapeutics, Inc. (the “Company”) or any of its subsidiaries (each such member, an “Eligible Director”) will receive the compensation described in this Non-Employee |
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| December 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37759 OUTLOO |
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| December 27, 2024 |
Insider Trading Policy, as amended and restated. Exhibit 19.1 OUTLOOK THERAPEUTICS, INC. AMENDED AND RESTATED INSIDER TRADING POLICY Initially Adopted by the Board - January 28, 2016 As Amended and Restated by the Board – June 21, 2023 As Amended and Restated by the Board – December 10, 2024 I. INTRODUCTION This policy determines acceptable transactions in the securities of Outlook Therapeutics, Inc. (the “Company” or “Outlook”) by our employees |
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| December 27, 2024 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of the Registrant d Name of Subsidiary State or Other Jurisdiction Outlook Therapeutics Pty Ltd Australia Outlook Therapeutics Limited (dormant subsidiary) England and Wales Outlook Therapeutics Limited Republic of Ireland This list does not include joint ventures in which the Company has an ownership interest. |
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| December 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 10, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| December 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 3, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commis |
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| November 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 27, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| November 27, 2024 |
Outlook Therapeutics® Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial Exhibit 99.1 Outlook Therapeutics® Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial · Final efficacy data expected in January 2025 · Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J., November 27, 2024 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this |
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| November 14, 2024 |
OTLK / Outlook Therapeutics, Inc. / GREAT POINT PARTNERS LLC Passive Investment SC 13G/A 1 greatpoint-otlk093024a1.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* Outlook Therapeutics, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 69012T305 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box t |
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| November 7, 2024 |
SC 13G/A 1 sc13ga11292703311072024.htm AMENDMENT NO. 1 TO THE SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 1)1 Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par v |
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| August 14, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Outlook Therapeutics, Inc. |
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| August 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| August 14, 2024 |
EX-99.1 2 tm2421547d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update · Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD · NORSE EIGHT current enrollment pace supports topline readout target of Q4 CY2024 |
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| August 14, 2024 |
Exhibit 10.1 OUTLOOK THERAPEUTICS, INC. 2024 EQUITY INCENTIVE PLAN 1.GENERAL. (a)Eligible Award Recipients. Subject to Section 4, Employees, Directors and Consultants are eligible to receive Awards. (b)Available Awards. The Plan provides for the grant of the following types of Awards: (i) Incentive Stock Options; (ii) Nonstatutory Stock Options; (iii) Stock Appreciation Rights; (iv) Restricted Sto |
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| August 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 14, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commiss |
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| August 14, 2024 |
Form of Stock Option Grant Notice and Stock Option Agreement under the 2024 Equity Incentive Plan. Exhibit 10.2 Outlook Therapeutics, Inc. 2024 Equity Incentive Plan Stock Option Grant Notice Outlook Therapeutics, Inc. (the “Company”), pursuant to its 2024 Equity Incentive Plan (as amended from time to time, the “Plan”), hereby grants to Optionholder an option to purchase the number of shares of the Company’s Common Stock set forth below. This option is subject to all of the terms and condition |
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| August 14, 2024 |
As filed with the Securities and Exchange Commission on August 14, 2024 As filed with the Securities and Exchange Commission on August 14, 2024 Registration No. |
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| July 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 8, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| June 26, 2024 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| June 14, 2024 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| May 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 28, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 15, 2024 |
Exhibit 3.2 CERTIFICATE OF ELIMINATION OF THE SERIES A CONVERTIBLE PREFERRED STOCK, SERIES B CONVERTIBLE PREFERRED STOCK AND SERIES A-1 CONVERTIBLE PREFERRED STOCK OF OUTLOOK THERAPEUTICS, INC. Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), does hereby certify as follows: FIRST: Pursuant to Section 151(g) of the Delaware General Corporation Law (the “DGCL”) and the authority c |
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| May 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| May 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 15, 2024 |
Exhibit 3.1 RESTATED CERTIFICATE OF INCORPORATION OF OUTLOOK THERAPEUTICS, INC. (Originally incorporated on October 22, 2015 under the name Oncobiologics, Inc.) I. The name of this corporation is Outlook Therapeutics, Inc. (the “Company”). II. The address of the registered office of this Company in the State of Delaware is 800 North State Street, Suite 304, City of Dover, County of Kent, 19901, an |
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| May 15, 2024 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update · Positive opinion received from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ONS-5010/LYTENAVA™ (bevacizumab gamma) · United Kingdom (UK) Marketing Authorization Application (MAA) submitted · NORSE EIGHT fully underway i |
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| May 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 13, 2024 |
Exhibit 99.1 Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD · UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) ISEL |
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| May 6, 2024 |
2,776,867 shares of Common Stock Filed pursuant to 424(b)(3) Registration No. 333-278959 PROSPECTUS 2,776,867 shares of Common Stock This prospectus covers the offer and resale by Syntone Ventures LLC, or the selling stockholder, of up to an aggregate of 2,776,867 shares of our common stock, which consists of (i) 800,000 shares of our common stock held by the selling stockholder that were issued by us at the closing of a private |
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| May 2, 2024 |
OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 May 2, 2024 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed April 26, 2024 File No. 333-278959 Ladies and Gentlemen: In accordance w |
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| May 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 1, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 1, 2024 |
United States securities and exchange commission logo May 1, 2024 Lawrence A. Kenyon Chief Financial Officer Outlook Therapeutics, Inc. 485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed April 26, 2024 File No. 333-278959 Dear Lawrence A. Kenyon: This is to advise you that we have not reviewed and will not review |
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| April 26, 2024 |
As filed with the Securities and Exchange Commission on April 26, 2024 As filed with the Securities and Exchange Commission on April 26, 2024 Registration No. |
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| April 26, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Outlook Therapeutics, Inc. |
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| April 17, 2024 |
OTLK / Outlook Therapeutics, Inc. / Syntone Ventures LLC - SC 13D/A Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 2)* Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 69012T 305 (CUSIP Number) Syntone Ventures LLC 1517 Champlain Crest Way Cary, NC 27513 Attn: President Telephone: (781) 308-0823 (Name, Add |
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| April 17, 2024 |
EX-99.1 2 tm2412152d1ex1.htm EXHIBIT 1 Exhibit 1 JOINT FILING AGREEMENT The undersigned hereby agree that this Amendment No. 2 to the Statement on Schedule 13D, dated April 17, 2024 (the “Schedule 13D/A”), with respect to the common stock, par value $0.01 per share, of Outlook Therapeutics, Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) und |
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| April 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 15, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| April 12, 2024 |
Exhibit 10.1 April 12, 2024 Outlook Therapeutics, Inc. 485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830 Attention: Lawrence A. Kenyon, Chief Financial Officer Dear Mr. Kenyon: Reference is made to the At The Market Sales Agreement, dated as of May 16, 2023 (the “Sales Agreement”), between Outlook Therapeutics, Inc. (the “Company”) and BTIG, LLC (“BTIG”). This letter (the “Amendment |
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| April 12, 2024 |
Up to $93,731,868 Common Stock Filed Pursuant to Rule 424(b)(5) Registration No. 333-278340 PROSPECTUS SUPPLEMENT (To Prospectus dated April 12, 2024) Up to $93,731,868 Common Stock We have entered into an at-the-market-sales agreement, or the Sales Agreement, with BTIG, LLC, or BTIG, acting in its capacity as the sales agent, relating to the offer and sale from time to time of up to $100,000,000 of our common stock, par value |
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| April 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 12, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| April 8, 2024 |
OTLK / Outlook Therapeutics, Inc. / GREAT POINT PARTNERS LLC Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| April 3, 2024 |
United States securities and exchange commission logo April 3, 2024 Lawrence Kenyon Chief Financial Officer Outlook Therapeutics, Inc. |
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| April 3, 2024 |
OUTLOOK THERAPEUTICS, INC. 485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830 (609) 619-3990 April 3, 2024 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed March 28, 2024 File No. 333-278340 Ladies and Gentlemen: In |
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| April 2, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 1, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| April 1, 2024 |
21,428,556 shares of Common Stock Filed pursuant to 424(b)(3) Registration No. 333-278209 PROSPECTUS 21,428,556 shares of Common Stock This prospectus covers the offer and resale by the selling stockholders identified in this prospectus of up to an aggregate of 21,428,556 shares of our common stock, which consists of (i) 8,571,423 shares of our common stock held by the selling stockholders and (ii) 12,857,133 shares of our common |
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| March 28, 2024 |
SC 13G 1 sc13g1292703303282024.htm THE SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. )1 Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Ti |
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| March 28, 2024 |
As filed with the Securities and Exchange Commission on March 28, 2024 Registration No. |
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| March 28, 2024 |
Form of Preferred Stock Warrant Agreement and Warrant Certificate. Exhibit 4.5 OUTLOOK THERAPEUTICS, INC. AND , AS WARRANT AGENT FORM OF PREFERRED STOCK WARRANT AGREEMENT DATED AS OF OUTLOOK THERAPEUTICS, INC. FORM OF PREFERRED STOCK WARRANT AGREEMENT THIS PREFERRED STOCK WARRANT AGREEMENT (this “Agreement”), dated as of [●], between OUTLOOK THERAPEUTICS, INC., a Delaware corporation (the “Company”), and [●], a [corporation] [national banking association] organiz |
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| March 28, 2024 |
EX-99.1 2 ex991.htm EXHIBIT 99.1 Exhibit 99.1 JOINT FILING AGREEMENT In accordance with Rule 13d-1(k)(1) promulgated under the Securities Exchange Act of 1934, the undersigned agree to the joint filing of a Statement on Schedule 13G (including any and all amendments thereto) with respect to the Common Stock, $0.01 par value per share, of Outlook Therapeutics, Inc. and further agree to the filing o |
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| March 28, 2024 |
As filed with the Securities and Exchange Commission on March 28, 2024 As filed with the Securities and Exchange Commission on March 28, 2024 Registration No. |
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| March 28, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Outlook Therapeutics, Inc. |
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| March 28, 2024 |
OTLK / Outlook Therapeutics, Inc. / TANG CAPITAL PARTNERS LP Passive Investment Securities and Exchange Commission Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| March 28, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Outlook Therapeutics, Inc. |
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| March 28, 2024 |
Form of Common Stock Warrant Agreement and Warrant Certificate Exhibit 4.4 OUTLOOK THERAPEUTICS, INC. AND , AS WARRANT AGENT FORM OF COMMON STOCK WARRANT AGREEMENT DATED AS OF OUTLOOK THERAPEUTICS, INC. FORM OF COMMON STOCK WARRANT AGREEMENT THIS COMMON STOCK WARRANT AGREEMENT (this “Agreement”), dated as of [●], between OUTLOOK THERAPEUTICS, INC., a Delaware corporation (the “Company”), and [●], a [corporation] [national banking association] organized and ex |
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| March 28, 2024 |
Exhibit 4.2 OUTLOOK THERAPEUTICS, INC., Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [●], 2024 Debt Securities 1 Table of Contents Page Article 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 Article 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 4 Section 2.01 Designation and Terms of Securities 4 Section 2.02 Form of Securities and Trustee’s Certificat |
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| March 28, 2024 |
Exhibit 99.1 Joint Filing Agreement The undersigned hereby agree that the Statement on Schedule 13G dated March 28, 2024 with respect to the Common Stock, par value $0.01 per share, of Outlook Therapeutics, Inc., and any amendments thereto executed by each and any of the undersigned shall be filed on behalf of each of the undersigned pursuant to and in accordance with the provisions of Rule 13d-1( |
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| March 28, 2024 |
United States securities and exchange commission logo March 28, 2024 Lawrence Kenyon Chief Financial Officer Outlook Therapeutics, Inc. |
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| March 28, 2024 |
Form of Debt Securities Warrant Agreement and Warrant Certificate. Exhibit 4.6 OUTLOOK THERAPEUTICS, INC. AND , AS WARRANT AGENT FORM OF DEBT SECURITIES WARRANT AGREEMENT DATED AS OF OUTLOOK THERAPEUTICS, INC. FORM OF DEBT SECURITIES WARRANT AGREEMENT THIS DEBT SECURITIES WARRANT AGREEMENT (this “Agreement”), dated as of [●], between OUTLOOK THERAPEUTICS, INC., a Delaware corporation (the “Company”), and [●], a [corporation] [national banking association] organiz |
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| March 28, 2024 |
OUTLOOK THERAPEUTICS, INC. 485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830 (609) 619-3990 March 28, 2024 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed March 25, 2024 File No. 333-278209 Ladies and Gentlemen: I |
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| March 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 20, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 25, 2024 |
As filed with the Securities and Exchange Commission on March 25, 2024 As filed with the Securities and Exchange Commission on March 25, 2024 Registration No. |
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| March 25, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Outlook Therapeutics, Inc. |
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| March 20, 2024 |
SC 13D/A 1 ss3153634sc13da.htm UNDER THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 69012T 305 (CUSIP Number) GMS Ventures and Investments c/o Inter |
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| March 20, 2024 |
EX-99.1 2 ss3153634ex9901.htm JOINT FILING AGREEMENT EXHIBIT 1 JOINT FILING AGREEMENT The undersigned hereby agree that this Statement on Schedule 13D, dated March 20, 2024 (the “Schedule 13D”), with respect to the common stock, par value $0.01 per share, of Outlook Therapeutics, Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) under the Secu |
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| March 18, 2024 |
Exhibit 3.1 CERTIFICATE OF AMENDMENT OF THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF OUTLOOK THERAPEUTICS, INC. Outlook Therapeutics, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, hereby certifies that: First: The name of the Company is Outlook Therapeutics, Inc. (the “Company”). Second: The date of filing of the |
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| March 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 13, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 7, 2024 |
Exhibit 3.1 CERTIFICATE OF AMENDMENT OF THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF OUTLOOK THERAPEUTICS, INC. Outlook Therapeutics, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, hereby certifies that: First: The name of the Company is Outlook Therapeutics, Inc. (the “Company”). Second: The date of the filing th |
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| March 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 7, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissio |
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| February 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| February 14, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 14, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| February 14, 2024 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update · NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment · Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 · Anticipate review decision from European regulators in the |
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| February 8, 2024 |
CORPORATE 2024 ANNUAL REPORT NASDAQ: OTLK outlooktherapeutics.com Outlook Therapeutics is a biopharmaceutical company working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. Envisioning a Better Tomorrow for Ophthalmic TherapiesFebruary20 |
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| February 8, 2024 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| January 31, 2024 |
EX-99.1 2 tm244744d1ex-1.htm EXHIBIT 1 EXHIBIT 1 JOINT FILING AGREEMENT The undersigned hereby agree that this Statement on Schedule 13D, dated January 31, 2024 (the “Schedule 13D”), with respect to the common stock, par value $0.01 per share, of Outlook Therapeutics, Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) under the Securities and E |
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| January 31, 2024 |
OTLK / Outlook Therapeutics, Inc. / BioLexis Pte Ltd. - SC 13D/A Activist Investment SC 13D/A 1 tm244744d1sc13da.htm SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 19)* Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 69012T 206 (CUSIP Number) Tenshi Healthcare Pte. Ltd. 36 Robinson Road #13-01 City House Singapor |
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| January 29, 2024 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| January 24, 2024 |
Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT TO |
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| January 24, 2024 |
Form of Registration Rights Agreement. Exhibit 10.3 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of January 22, 2024, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and each of the several investors signatory hereto (each, an “Investor” and, collectively, the “Investors”). This Agreement is made pursuant to the Securities Purchase Agre |
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| January 24, 2024 |
Exhibit 99.1 Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010 · Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010 · NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potenti |
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| January 24, 2024 |
Exhibit 10.4 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of January 22, 2024, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and Syntone Ventures, LLC (including its successors and assigns, the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption fro |
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| January 24, 2024 |
Exhibit 10.2 OUTLOOK THERAPEUTICS, INC. SUPPORT AGREEMENT THIS SUPPORT AGREEMENT (this “Agreement”), dated as of January 22, 2024 is made by and among Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and the stockholder identified on the signature page hereto (“Stockholder”), a holder of shares of common stock, $.01 par value (the “Shares”) of the Company. WHEREAS, the C |
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| January 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 22, 2024 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commis |
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| January 24, 2024 |
Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT |
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| January 24, 2024 |
Exhibit 10.6 THIRD AMENDMENT TO CONVERTIBLE PROMISSORY NOTE This Third Amendment to Convertible Promissory Note (this “Amendment”) is entered into as of January 22, 2024, by and between Streeterville Capital, LLC, a Utah limited liability company (“Lender”), and Outlook Therapeutics, Inc., a Delaware corporation (“Borrower”). Capitalized terms used in this Amendment without definition shall ha |
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| January 24, 2024 |
Exhibit 10.5 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of January 22, 2024, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and Syntone Ventures, LLC (the “Investor”). This Agreement is made pursuant to the Securities Purchase Agreement, dated on or about the date hereof, between the Company and |
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| January 24, 2024 |
Form of Securities Purchase Agreement Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of January 22, 2024, between Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), and the several purchasers identified on the signature pages hereto (each, including its respective successors and assigns, a “Purchaser”). WHEREAS, subject to the terms and conditions set |
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| January 24, 2024 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A (Amendment No. 1) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2023 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER |
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| December 22, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 22, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| December 22, 2023 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of the Registrant d Name of Subsidiary State or Other Jurisdiction Outlook Therapeutics Pty Ltd Australia Outlook Therapeutics Limited (dormant subsidiary) England and Wales Outlook Therapeutics Limited Republic of Ireland This list does not include joint ventures in which the Company has an ownership interest. |
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| December 22, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37759 OUTLOO |
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| December 22, 2023 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU · Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024 · Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in |
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| December 22, 2023 |
Exhibit 10.30 AMENDMENT TO CONVERTIBLE PROMISSORY NOTE This Amendment to Convertible Promissory Note (this “Amendment”) is entered into as of December 21, 2023, by and between Streeterville Capital, LLC, a Utah limited liability company (“Lender”), and Outlook Therapeutics, Inc., a Delaware corporation (“Borrower”). Capitalized terms used in this Amendment without definition shall have the meaning |
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| December 22, 2023 |
Exhibit 10.26 OUTLOOK THERAPEUTICS, INC. NON-EMPLOYEE DIRECTOR COMPENSATION POLICY AS AMENDED AND RESTATED EFFECTIVE OCTOBER 1, 2023 Each member of the Board of Directors (the “Board”) who is not also serving as an employee of Outlook Therapeutics, Inc. (the “Company”) or any of its subsidiaries (each such member, an “Eligible Director”) will receive the compensation described in this Non-Employee |
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| December 22, 2023 |
Incentive Compensation Recoupment Policy. Exhibit 97 OUTLOOK THERAPEUTICS, INC. INCENTIVE COMPENSATION RECOUPMENT POLICY 1.INTRODUCTION The Board of Directors (the “Board”) of Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), has determined that it is in the best interests of the Company and its stockholders to adopt this Incentive Compensation Recoupment Policy (this “Policy”) providing for the Company’s recoupment of R |
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| December 22, 2023 |
Exhibit 4.1 of the 2023 Form 10-K Exhibit 4.1 Description of Registrant’s Securities The following is a description of the capital stock of Outlook Therapeutics, Inc. (the “Company,” “we,” “our,” or “us”). The following summary description is based on the provisions of our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), our Amended and Restated Bylaws, (the “Bylaws”), and the app |
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| December 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 30, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| November 29, 2023 |
EX-99.1 2 tm2331705d1ex1.htm EXHIBIT 1 EXHIBIT 1 JOINT FILING AGREEMENT The undersigned hereby agree that this Statement on Schedule 13D, dated November 29, 2023 (the “Schedule 13D”), with respect to the common stock, par value $0.01 per share, of Outlook Therapeutics, Inc. is filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) under the Securities and |
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| November 29, 2023 |
OTLK / Outlook Therapeutics Inc / BioLexis Pte Ltd. - SC 13D/A Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 18)* Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 69012T 206 (CUSIP Number) Tenshi Healthcare Pte. Ltd. 36 Robinson Road #13-01 City House Singapore, 068877 Attn: Executive Director Teleph |
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| November 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 2, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commis |
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| November 2, 2023 |
Outlook Therapeutics® Provides Update on Type A Meetings with FDA Exhibit 99.1 Outlook Therapeutics® Provides Update on Type A Meetings with FDA ISELIN, N.J., November 2, 2023 — (GLOBE NEWSWIRE) Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has completed the requested Type A Meetings with the |
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| October 20, 2023 |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 16, 2023 Outlook Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37759 38-3982704 (State or Other Jurisdiction of Incorporation) (Commis |
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| August 30, 2023 |
Exhibit 99.1 Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence Outlook Therapeutics working with FDA to address the Agency’s issues Company to host conference call and webcast, today, August |
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| August 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 30, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commiss |
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| August 25, 2023 |
515,755 Shares of Common Stock TABLE OF CONTENTS Filed Pursuant to Rule 424(b)(5) Registration No. 333-273979 515,755 Shares of Common Stock This prospectus relates to the offer and resale, from time to time, by the selling stockholder named under the heading “Selling Stockholder” in this prospectus, or its assigns (the “Selling Stockholder”) of up to 515,755 shares (the “Shares”) of our common stock, par value $0.01 per shar |
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| August 23, 2023 |
CORRESP 1 filename1.htm OUTLOOK THERAPEUTICS, INC. 485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830 (609) 619-3990 August 23, 2023 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed August 14, 2023 File No. 333-2739 |
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| August 22, 2023 |
United States securities and exchange commission logo August 22, 2023 Lawrence Kenyon Chief Financial Officer Outlook Therapeutics, Inc. |
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| August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| August 14, 2023 |
Exhibit 107 Calculation of Filing Fee Tables S-3 (Form Type) Outlook Therapeutics, Inc. |
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| August 14, 2023 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones · Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ISELIN, N.J., August 14, 2023 — Outlook The |
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| August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 14, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commiss |
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| August 14, 2023 |
As filed with the Securities and Exchange Commission on August 14, 2023 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on August 14, 2023 Registration No. |
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| May 16, 2023 |
Exhibit 10.1 EXECUTION VERSION Outlook Therapeutics, inc. UP TO $100,000,000 OF COMMON STOCK (par value $0.01 per share) At-the-market SALES AGREEMENT May 16, 2023 BTIG, LLC 600 Montgomery Street, 6th Floor San Francisco, CA 94111 Ladies and Gentlemen: Outlook Therapeutics, Inc., a Delaware corporation (the “Company”), confirms its agreement (this “Agreement”) with BTIG, LLC (“BTIG” and, together |
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| May 16, 2023 |
Up to $100,000,000 Common Stock TABLE OF CONTENTS Filed Pursuant to Rule 424(b)(5) Registration No. 333-254778 PROSPECTUS SUPPLEMENT (To Prospectus dated April 1, 2021) Up to $100,000,000 Common Stock We have entered into an at-the-market-sales agreement, or the Sales Agreement, with BTIG, LLC, or BTIG, acting in its capacity as the sales agent, relating to the offer and sale from time to time of up to $100,000,000 of our comm |
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| May 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 15, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. |
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| May 15, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commission |
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| May 15, 2023 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update ● Upcoming Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ● Pre-launch commercial activities continue in preparat |
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| April 3, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 30, 2023 (April 3, 2023) Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorp |
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| March 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 29, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commissi |
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| March 30, 2023 |
Exhibit 3.1 Delaware The First State Page 1 5857184 8100 Authentication: 203031597 SR# 20231200775 Date: 03-29-23 You may verify this certificate online at corp.delaware.gov/authver.shtml I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF AMENDMENT OF “OUTLOOK THERAPEUTICS, INC.”, FILED IN THIS OFFICE |
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| February 21, 2023 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1) Outlook Therapeutics, Inc. (Name of Issuer) Common Stock, par value $0.01 per share (Title of Class of Securities) 69012T 206 (C |
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| February 15, 2023 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only ( |
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| February 15, 2023 |
January2023 Toourvalued shareholders, I am pleased to be writing you after a noteworthy 2022 that we believe was foundational for a transformative 2023 for Outlook Therapeutics. |
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| February 14, 2023 |
Exhibit 99.1 Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2023 and Provides Corporate Update · Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation for the |
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| February 14, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Outlook Therapeutics, Inc. |
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| February 14, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 14, 2023 Outlook Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37759 38-3982704 (State or other jurisdiction of incorporation) (Commi |
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| February 14, 2023 |
As filed with the Securities and Exchange Commission on February 14, 2023 As filed with the Securities and Exchange Commission on February 14, 2023 Registration No. |