Form 8-K

8-K — Outlook Therapeutics, Inc.

Accession: 0001104659-26-074346

Filed: 2026-06-16

Period: 2026-06-16

CIK: 0001649989

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2618010d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2618010d1_ex99-1.htm)

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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 16, 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 16, 2026, Outlook Therapeutics, Inc. announced

that the U.S. Food and Drug Administration (the “FDA”) had acknowledged receipt of its resubmission of the Biologics License

Application (the “BLA”) for ONS-5010 (bevacizumab-vikg). The FDA determined that the BLA is a Class 1 review, which results

in a 60-day review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release, dated June 16, 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 16, 2026

By:

/s/ Lawrence A. Kenyon

Lawrence A. Kenyon

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2618010d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Outlook Therapeutics

Announces FDA Acceptance of Resubmitted Biologics

License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a

Treatment

for Wet AMD

Prescription

Drug User Fee Act (PDUFA) goal date of July 29, 2026

ISELIN,

N.J., June 16, 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 the U.S. Food

and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™

for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission

is a Class 1 review, with a PDUFA target action date of July 29, 2026.

“We

are very pleased that the FDA has accepted our resubmitted BLA to review the labelling as part of the final step toward potential approval,”

said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “This is great news for Outlook and the LYTENAVA™ team,

patients and the retina community. We look forward to collaborating with the FDA over the coming weeks. We are incredibly grateful to

our teams, partners, and KOLs for their resilience and dedication.”

When approved,

ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing,

FDA-approved labeling, and robust pharmacovigilance. Outlook Therapeutics has initiated pre-launch activities in anticipation of the pending

BLA approval.

About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab

gamma)

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™

(bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing

Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In certain

European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.

In the United

States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. When approved, it will be the first ophthalmic formulation approved

by the FDA.

Bevacizumab-vikg

(bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to

all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking

of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal

injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells,

reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™

(bevacizumab-vikg, bevacizumab gamma). LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European

Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch

of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD.

Forward-Looking Statements

This press release contains statements that may or are considered “forward-looking statements”.

All statements other than statements of historical facts are “forward-looking statements,” including those relating to future

events. In some cases, you can identify forward-looking statements by terminology such as “can,” “potential,”

“target,” when, or “would”, the negative of terms like these or other comparable terminology, and other words

or terms of similar meaning. These include, among others, plans for continued engagement with the FDA and the potential to agree on a

regulatory pathway for ONS-5010, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, the potential for ONS-5010 to receive

approval from the FDA, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable

basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook

Therapeutics and are subject to risks, uncertainties, and factors relating to its operations and business environment, all of which are

difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing

pharmaceutical product candidates, risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory

bodies, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC),

including its Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 19, 2025, as

updated by the Outlook Therapeutics’ subsequent filings,

which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of global

geopolitical conflict, tariffs and trade tensions, fluctuations in interest rates and inflation, and

potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those

expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release

are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these

forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update,

amend, or clarify these forward-looking statements, whether as a result of new information, future events, or otherwise, except as may

be required under applicable securities law.

Investor Inquiries:

Jenene Thomas

Chief Executive Officer

JTC Team, LLC

T: 908.824.0775

OTLK@jtcir.com

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