Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2022 and Provides Corporate Update ONS-5010 / LYTENAVA (bevacizumab-vikg) Biologics License Application (BLA) submitted to U.S. Food and Drug

Outlook Therapeutics

Reports Financial Results for Second Quarter Fiscal Year 2022 and Provides Corporate Update

N.J., May 13, 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 recent

corporate highlights and financial results for its fiscal second quarter ended March 31, 2022.

quarter was marked by the achievement of the most important milestone to date for Outlook Therapeutics - the submission of our

BLA for ONS-5010. In anticipation of potentially providing an on-label, FDA-approved alternative for wet AMD patients in the United States,

we are ramping up our pre-commercial launch activities. To support these efforts, we have continued to add to the expertise of our commercial

team to build momentum among partners, payors and the retina community. We are focused on positioning ourselves to unlock the full potential

of ONS-5010," commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics.

(bevacizumab-vikg) Development Updates

Therapeutics' wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and

NORSE THREE. With the successful completion of these clinical trials, Outlook Therapeutics submitted its BLA under the Public Health

Service Act (PHSA) 351(a) regulatory pathway in March 2022. If the BLA is approved, it is expected to result in 12 years of

marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet

announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for approval to

provide the product in a pre-filled, silicone oil-liquid free syringe that meets the FDA's strict specifications for ophthalmic

use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial to compare

the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with visual

impairment due to retinal disorders. Patients will be treated for three months and the enrollment of patients in the arm of the study

receiving ONS-5010 in vials has already been completed.

Pre-Launch Commercial Planning Underway

National Eye Institute (NEI), use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for at

least 50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion

market for anti-VEGF drugs to treat retina diseases.

of potential FDA marketing approval in early 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class

partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for

finished drug product. The Company also is actively building out its distribution and commercial team structures.

to market in a way that benefits all stakeholders - patients, clinicians and payors - Outlook Therapeutics has been in collaborative

discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents on a parallel path for

approvals in Europe and expects to submit them in the fourth quarter of calendar 2022. Outlook Therapeutics continues to explore potential

strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. Outlook Therapeutics expects

ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians, and payors worldwide for retinal indications.

the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three

Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration

clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials

evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.

Upcoming Anticipated

Financial Highlights

for the Fiscal Second Quarter Ended March 31, 2022

second quarter ended March 31, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $19.7 million, or

$0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and

diluted share, for the same period last year.

Outlook Therapeutics had cash and cash equivalents of $58.4 million, compared to $70.2 million at December 31, 2021. Outlook Therapeutics'

cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.

"We believe Outlook Therapeutics is in a strong financial position," stated Lawrence A. Kenyon, Chief Financial Officer of

Outlook Therapeutics. "We have successfully accessed capital via our ATM program and plan to continue using this financing option,

subject to market conditions. Also, we have initiated discussions with the holders of our unsecured notes to extend the maturity of these

notes until 2024 after we begin generating revenue from LYTENAVA, if approved. With these steps, we believe we have charted a path that

would allow Outlook Therapeutics to launch LYTENAVA without the need to raise significant additional capital."

/ LYTENAVA (bevacizumab-vikg)

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 have had to 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.

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.

About Outlook Therapeutics, Inc.

Outlook Therapeutics

is a pre-commercial biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA (bevacizumab-vikg), an investigational

therapy, as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO.

Outlook Therapeutics has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010

to treat wet AMD. The submission is supported by Outlook Therapeutics' wet AMD registration clinical program, which consists of

three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. 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.

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," "believe," "continue," "could,"

"estimate," "expect," "may," "might," "intend," "potential,"

"predict," should," or "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, including benefits therefrom to patients, payors and physicians, including

expectations of market exclusivity, potential approval and commercial launch of ONS-5010 and the timing thereof, including the

expectation of timing for a PDUFA date, expectations about the sufficiency of our capital to fund our operations through commercial

launch, our ability to extend the maturity date of our unsecured notes, potential financing sources, plans for and the timing of

potential future clinical trials, including the expected completion of NORSE SEVEN and the expected commencement of NORSE FOUR,

NORSE FIVE and NORSE SIX, potential strategic partners, plans for regulatory approvals and commercialization of ONS-5010 in other

markets 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

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 (the

"SEC"), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2021 filed with the SEC, as

supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 and future quarterly reports we file with the

SEC, 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