Form 8-K

8-K — Outlook Therapeutics, Inc.

Accession: 0001104659-26-086685

Filed: 2026-07-24

Period: 2026-07-24

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): July

24, 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 July 24, 2026, Outlook Therapeutics, Inc. (the

“Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) approved the Company’s

biologics license application for ONS-5010/LYTENAVA™ (bevacizumab-vikg), an ophthalmic formulation of bevacizumab, for the treatment

of neovascular (wet) age-related macular degeneration (wet AMD). LYTENAVA™ is the first and only FDA-approved ophthalmic formulation

of bevacizumab for the treatment of wet AMD in the United States.

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 July 24, 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: July 24, 2026

By:

/s/ Lawrence A. Kenyon

Lawrence A. Kenyon

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2621316d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Outlook Therapeutics

Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD

Landmark FDA

Approval Is an Important Milestone in Retina Care, Bringing Patients and Physicians an Ophthalmic Bevacizumab Developed Specifically

for the Eye Following Years of Rigorous Clinical and Regulatory Evaluation

Company Launches

Commercial Franchise Positioned to Establish a New Standard as an FDA-Approved Bevacizumab Therapy Across the Approximately $8.5 Billion

U.S. Retina Market

Anticipated 12

Years of Market Exclusivity Under the Biologics Price Competition and Innovation Act (BPCIA)

ISELIN,

N.J., July 24, 2026 —

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on

the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal

diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment

of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.

The approval

establishes LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the

United States. For the first time, retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically

for the eye and supported by rigorous clinical evidence, validated manufacturing, approved labeling, comprehensive quality systems, and

ongoing FDA regulatory oversight. Additionally, the Company anticipates that the approval will provide LYTENAVATM with

12 years of Reference Product Exclusivity under the BPCIA.

Outlook

Therapeutics believes this FDA approval establishes a new benchmark for ophthalmic bevacizumab and positions LYTENAVA™ to become

the new FDA-approved standard for bevacizumab therapy in patients with wet AMD. Bevacizumab already accounts for the majority of first-line

anti-VEGF treatment in wet AMD, underscoring its important role in retina care.1

“For

more than two decades, bevacizumab has served as one of the most widely utilized anti-VEGF therapies in retina care despite the absence

of an FDA-approved ophthalmic formulation. LYTENAVA™ fundamentally changes that landscape. Rather than relying on repackaged formulations

originally intended for intravenous use, physicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed

specifically for intravitreal administration that delivers the manufacturing consistency, product quality, and regulatory oversight patients

deserve.” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

Mr. Jahr

continued by saying, "Today's approval represents a defining moment for Outlook Therapeutics and, more importantly, for the physicians

and patients we have been working to serve. With the approval of LYTENAVA™, physicians now have access to the first FDA-approved

ophthalmic bevacizumab developed specifically for the eye. We believe this approval has the potential to meaningfully advance patient

care and establish LYTENAVA™ as an important new treatment option for retina specialists and wet AMD patients across the United

States."

“The

retina community has been waiting a long time for access to an FDA-approved, ophthalmic formulation of bevacizumab to treat patients suffering

from wet AMD in the United States,” added Firas M. Rahhal, MD, Chairman of Ophthalmology at Good Samaritan Hospital, Los Angeles,

California. “It is exciting news that LYTENAVA™ will soon be an option for patients suffering from this disease.”

Wet AMD

is a chronic, progressive retinal disease and one of the leading causes of severe vision loss among older adults worldwide.2

Patients often require treatment over many years to preserve vision, making manufacturing consistency, product quality, and long-term

reliability especially important throughout treatment.

LYTENAVA™

enters one of the world's largest ophthalmology markets. The U.S. anti-VEGF retina market is estimated at approximately $8.5 billion

annually, with millions of intravitreal injections administered every year.2

The Company

is now executing the commercial launch of LYTENAVA™, including expanding reimbursement and patient support access, building an industry-leading,

specialized retina commercial organization, supporting physicians nationwide, and establishing LYTENAVA™ as the trusted FDA-approved

ophthalmic bevacizumab across the United States.

"FDA

approval is the outcome we have been waiting for. Immediate commercial execution is our next mission," added Mr. Jahr. "Everything

we do from this point forward is focused on delivering LYTENAVA™ to physicians and patients, expanding access, and building what

we believe can become the leading retina care franchise. We are incredibly excited about the opportunity ahead, not only for Outlook Therapeutics,

but most importantly for the patients whose vision we strive to protect."

Outlook

Therapeutics expects to make LYTENAVA™ available to eligible patients in the United States before year-end. The Company is committed

to providing broad patient access support services through comprehensive reimbursement and patient assistance programs designed to help

physicians integrate LYTENAVA™ into routine clinical practice for wet AMD.

Citeline (2023), Global Data (2023) and Market Scope (2022).

National Eye Institute. Age-Related Macular Degeneration (AMD). National Institutes

of Health.

About

LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)

LYTENAVA™

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

(bevacizumab-vikg) is the first ophthalmic formulation approved by the FDA. LYTENAVA™ (bevacizumab gamma) is also 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, LYTENAVA™

must receive pricing and reimbursement approval before it can be sold.

Bevacizumab-vikg

(bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 monoclonal antibody

specific for human vascular endothelial growth factor (VEGF). Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors

(Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors

VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability.

Inhibition of such activity targets a pathophysiologic process that contributes to vision loss.

Important Safety Information and Indication

LYTENAVA (bevacizumab-vikg)

is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular

degeneration (nAMD).

Contraindications

LYTENAVA is

contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with

a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe

intraocular inflammation.

Warnings and Precautions

Intravitreal

injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when

administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection

occur.

Increases in

intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure

prior to and following intravitreal injection with LYTENAVA and manage appropriately.

Although there

was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following

intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including

deaths of unknown cause).

Adverse Reactions

The most common

adverse reaction (≥1%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters

(2%). These are not all the possible side effects of LYTENAVA.

You are encouraged

to report side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch

or call 1-800-FDA-1088. You may also report side effects to Outlook Therapeutics at 1-833-999-OTLK (6855).

Please

see the full US Prescribing Information for LYTENAVA here.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA™ (bevacizumab-vikg

(U.S.), bevacizumab gamma (E.U.)). LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive U.S. FDA approval

and 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 “anticipate,” “believe,” “can,” “could,” “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, express or implied discussions regarding potential marketing approvals, Outlook Therapeutics plans to launch

ONS-5010/LYTENAVA; expectations regarding the potential impact of LYTENAVA in the retina community, new indications or labeling for LYTENAVA,

Outlook Therapeutics development or future revenue plans for LYTENAVA generally, 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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