Outlook Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet

Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet AMD

N.J., May 31, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop

and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that

the U.S. Food and Drug Administration (FDA) has requested additional information in order to complete the filing of the Company's

Biologics License Application (BLA) for ONS-5010/ LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration

(wet AMD). Outlook Therapeutics has voluntarily withdrawn its BLA for ONS-5010 and is actively working to respond to the FDA's request.

The Company plans to re-submit a revised BLA by September 2022.

Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, "We remain confident in ONS-5010 and its potential

to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment

of bevacizumab that was never approved for any ophthalmic indications. We are continuing to have productive discussions with the FDA and

are committed to providing the additional information necessary to support the application. We look forward to a successful resubmission

and ultimately the potential approval of ONS-5010 for the treatment of wet AMD. We also look forward to a future where virtually all retina

patients treated with bevacizumab are receiving an FDA-approved ophthalmic therapy."

a compilation of the data from its previously completed clinical trials - NORSE ONE, NORSE TWO and NORSE THREE - Outlook Therapeutics

submitted the BLA to the FDA in March 2022. NORSE ONE, a proof-of-concept and clinical experience trial, helped validate the protocols

and approach for NORSE TWO, the pivotal safety and efficacy trial. The NORSE TWO data were statistically significant and clinically relevant

for the primary and all secondary endpoints. NORSE THREE was an open-label supplementary safety trial conducted to ensure that a sufficient

number of patients had been dosed with ONS-5010 ophthalmic bevacizumab to support the regulatory submission.

About ONS-5010 / LYTENAVA (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection

for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are

available, clinicians wishing to treat retinal patients with bevacizumab must use unapproved repackaged IV bevacizumab provided by compounding

pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace

the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.

Bevacizumab-vikg 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-vikg 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. VEGF is a protein that promotes the growth of abnormal

new blood vessels and promotes leakage from these vessels, leading to retinal edema and hemorrhage. With wet AMD, abnormally high levels

of VEGF are secreted in the eye and lead to loss of vision. Since the advent of anti-VEGF therapy, it has become the standard-of-care

treatment option within the retina community globally.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a pre-commercial biopharmaceutical

company working to develop and launch ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of

bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook

Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating

retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. For more information, please visit www.outlooktherapeutics.com.

Forward-Looking Statements

This press release contains 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," "estimate," "expect," "intend," "may,"

"might," "plan," "potential," "predict," "project,"

"should," "will," the negative of terms like these or other comparable terminology, and other words or terms

of similar meaning. These include, among others, statements about ONS-5010's potential as the first FDA-approved ophthalmic

formulation of bevacizumab-vikg, our ongoing discussions with the FDA, our ability to provide adequate information to the FDA to

support a successful resubmission of the BLA, the timing of a resubmission of the BLA and commercial launch of ONS-5010 and plans

for regulatory approvals in other markets. 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

pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, as

well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission, including the

Annual Report on Form 10-K for the fiscal year ended September 30, 2021 and subsequent Quarterly Reports on Form 10-Q, which include

the uncertainty of future impacts related to the ongoing COVID-19 pandemic. 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.

LaVoie Health Science

Chief Executive Officer