Outlook Therapeutics, Inc.

8-K · tm2616461d1_8k.htm iXBRL

0001649989

 2026-06-01
 2026-06-01

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 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 File Number)
 (IRS Employer Identification No.)

  

 111
 S. Wood Avenue, Unit
 #100

 Iselin , New Jersey

 08830

 (Address of principal executive offices)
 (Zip Code)

  

 Registrant's telephone number, including area code:
 ( 609 ) 619-3990

  

  

 Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

  

 ¨
 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

  
  

 ¨
 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

  
  

 ¨
 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

  
  

 ¨
 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

  

 Securities pursuant to Section 12(b) of the Act:

  

 Title of Each Class
  
 Trading Symbol(s)
  
 Name of Each Exchange

on Which
Registered

 Common Stock
  
 OTLK
  
 The Nasdaq Stock Market LLC

  

 Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).

  

 Emerging growth company ¨

  

 If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨

  

  

  

  

  

 Item 8.01
 Other Events.

  

 On June 1, 2026, Outlook Therapeutics, Inc (the
“Company”) issued a press release announcing that it has resubmitted the Biologics License
Application for ONS-5010 to the U.S. Food and Drug Administration.

  

 The press release is attached as Exhibit 99.1
to this Current Report on Form 8-K and incorporated into this item 8.01 by reference.

  

 Item 9.01.
 Financial Statements and Exhibits.

  

 (d) Exhibits

  

 Exhibit No.
  
 Description

  
  
  

 99.1
  
 Press Release, dated June 1, 2026

  
  
  

 104
  
 Cover Page Interactive Data File (embedded within the Inline XBRL document).

  

  

  

  

 SIGNATURES

  

 Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  

  
 Outlook Therapeutics, Inc.

  
  

 Date: June 1, 2026
 By:
 /s/ Lawrence A. Kenyon

  
  
 Lawrence A. Kenyon

  
  
 Chief Financial Officer