Form 8-K

8-K — Outlook Therapeutics, Inc.

Accession: 0001104659-26-040387

Filed: 2026-04-07

Period: 2026-04-07

CIK: 0001649989

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): April 7, 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 April 7, 2026, Outlook Therapeutics, Inc. (the

“Company”) issued a press release announcing that it submitted a formal dispute resolution request (FDRR) to the U.S. Food

and Drug Administration (FDA) as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter (CRL)

for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab) for the treatment of neovascular age-related macular

degeneration, and that the FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026.

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 April 7, 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: April 7, 2026

By:

/s/ Lawrence A. Kenyon

Lawrence A. Kenyon

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2611268d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Outlook Therapeutics

Announces Formal Dispute Resolution Request for

ONS-5010/LYTENAVA™

(bevacizumab-vikg) Accepted by FDA

ISELIN,

N.J., April 7, 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 that it submitted a formal dispute resolution request (FDRR) to the U.S. Food and

Drug Administration (FDA) as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter (CRL)

for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related

macular degeneration. The FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026.

Subsequent

to receiving the CRL in December 2025, Outlook Therapeutics has engaged with the FDA on multiple occasions, including a formal Type

A meeting on March 2, 2026, which led to the submission of the FDRR and associated meeting.

“We

look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for LYTENAVA demonstrated

in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval and bring a much-needed FDA approved option for patients,”

said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

The

Company’s submission includes a comprehensive presentation of the existing clinical, functional, and pharmacodynamic data, and

safety findings, which Outlook Therapeutics believes collectively support the efficacy and safety of ONS-5010/LYTENAVA™ for the

treatment of neovascular age-related macular degeneration.

Outlook

Therapeutics will continue to work collaboratively with the FDA throughout the formal dispute resolution process and will provide updates

as appropriate.

ONS-5010/LYTENAVA™

demonstrated clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO randomized, double-masked,

active-controlled Phase 3 trial, which met its primary and key secondary endpoints. Additional evidence from NORSE EIGHT and other data

submitted in the BLA further support the efficacy and safety profile of ONS-5010, consistent with its anti-VEGF mechanism of action.

No safety concerns have been raised by the FDA.

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

FDA-approved labeling, and robust pharmacovigilance.

The

product candidate is supported by a fully domestic, end-to-end U.S. manufacturing supply chain.

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. If approved, it has the potential

to be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA for use in ophthalmology.

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) to enhance the standard of care for bevacizumab for the treatment of retina diseases. 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.

In the United States,

ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be

the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including 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 “anticipate,” “believe,” “continue,” “expect,” “may,” “on track,”

“plan,” “potential,” “target,” “will,” 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 the Annual Report on Form 10-K for the fiscal year ended

September 30, 2025, filed with the SEC on December 19, 2025, as supplemented by the Quarterly Report on Form 10-Q for

the fiscal quarter ended December 31, 2025 and future reports Outlook Therapeutics files with the SEC, which include uncertainty

of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, 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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