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 1526, 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 2 8.~~02     Results of~~01 ~~Operations~~Other ~~and Financial Condition~~Events.

On May 1526, 2026, Outlook Therapeutics, Inc. (the “ "Company”") issued a press release announcing ~~its~~that ~~financial~~the ~~results~~U.S. ~~for~~Food ~~its~~and ~~second~~Drug ~~fiscal~~Administration ~~quarter~~(FDA) has granted the Company's appeal ~~which~~following ~~ended~~completion ~~March~~of ~~31,~~the ~~2026.~~Formal ADispute ~~copy~~Resolution (FDR) process with the Office of New Drugs (OND) regarding the ~~press~~December ~~release~~30, is2025 Complete ~~furnished~~Response asLetter ~~Exhibit~~(CRL) ~~99.1~~for tothe ~~this~~Biologics ~~Current~~License ~~Report~~Application on(BLA) ~~Form~~for 8ONS-K5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD).

The ~~information~~FDA ~~contained~~concluded inthat ~~this Item~~substantial ~~2.02~~evidence ~~and~~of effectiveness inhas ~~the~~been ~~accompanying~~established ~~Exhibit~~for ~~99.1~~LYTENAVA™ ~~shall not be deemed filed~~ for ~~purposes~~the treatment of ~~Section~~nAMD, 18and ofdirected the ~~Securities~~Division ~~Exchange Act~~ of ~~1934,~~ asOphthalmology ~~amended~~and (the ~~“Exchange~~Office of ~~Act”),~~Specialty orMedicine ~~incorporated~~to bywork ~~reference~~with ~~in any filing under~~ the ~~Exchange~~Company ~~Act~~to orreach ~~the~~an ~~Securities Act~~agreement ofon ~~1933,~~final aslabeling. ~~amended,~~The ~~except~~Company asexpects ~~shall~~to beresubmit ~~expressly~~the ~~set~~BLA ~~forth~~in byJune 2026 ~~specific~~as ~~reference~~a inClass ~~such~~1 ~~filing~~resubmission.

~~Item~~The 9press release is attached as Exhibit 99.011 to ~~Financial~~this ~~Statements~~Current Report on Form 8-K and ~~Exhibits~~incorporated into this item 8.01 by reference.

~~(d)~~Item 9.01. Financial Statements and Exhibits.

Exhibit No.		Description
99.1		Press Release dated May 15, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

(d) Exhibits

SIGNATURES

Exhibit No.		Description

99.1		Press Release, dated May 26, 2026

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

~~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.~~SIGNATURES

	Outlook Therapeutics, Inc.
Date: May 15, 2026	By:	/s/ Lawrence A. Kenyon
		Lawrence A. Kenyon
		Chief Financial Officer

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: May 26, 2026	By:	/s/ Lawrence A. Kenyon
		Lawrence A. Kenyon
		Chief Financial Officer

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