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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): March 31, 2022

 

 

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.)

 

485 Route 1 South

Building F, Suite 320

Iselin, New Jersey

08830
(Address of principal executive offices) (Zip Code)

 

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

 

 

(Former name or former address, if changed since last report)

 

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 March 31, 2022, Outlook Therapeutics, Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab, for the treatment of wet age-related macular degeneration (wet AMD). If approved, ONS-5010 will be branded as LYTENAVA™ (bevacizumab-vikg).

 

 

 

 

  

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: March 31, 2022 By: /s/ C. Russell Trenary III
    C. Russell Trenary III
    President and Chief Executive Officer