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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): 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) |
(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. ¨
On September 29, 2025, Outlook Therapeutics,
Inc (the “Company”) issued a press release announcing that it has completed the requested Type A Meeting with the U.S. Food
and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application
(BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
Based on the discussion with the FDA, Outlook
Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting
minutes.
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 September 29, 2025 |
| |
|
| 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: September 29, 2025 |
By: |
/s/
Lawrence A. Kenyon |
| |
|
Lawrence A. Kenyon |
| |
|
Chief Financial Officer |
