Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update LYTENAVA (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingd

Outlook Therapeutics Reports Financial Results

for Second Quarter Fiscal Year 2025 and Provides Corporate Update

ISELIN, N.J., May 15, 2025 - Outlook Therapeutics, Inc. (Nasdaq:

OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today

reported financial results for the second quarter of fiscal year 2025 and provided a corporate update.

Therapeutics remains on track in 2025 to transform into a commercial-stage company with the planned upcoming commercial launch of LYTENAVA

(bevacizumab gamma) in Germany and the United Kingdom for the treatment of wet AMD. In addition to the commercial progress we are making

in Europe, in the U.S. we are positioned to potentially receive FDA approval later this year for ONS-5010 / LYTENAVA (bevacizumab-vikg)

for the treatment of wet AMD, with a PDUFA decision date scheduled for August 27th. We continue to build momentum and

remain laser focused on our goal of providing patients, physicians and payers with a much needed, approved ophthalmic formulation of bevacizumab,"

commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics.

Anticipated Milestones

LYTENAVA (bevacizumab gamma) European Commercial Update

Outlook Therapeutics continues to advance its plans to launch LYTENAVA (bevacizumab gamma) in Germany and the UK, expected to take

place in the second quarter of calendar year 2025. In May 2024, the European Commission granted Marketing Authorization for LYTENAVA

(bevacizumab gamma) for the treatment of wet AMD in the European Union (EU). Additionally, in July 2024, the UK Medicines and Healthcare

products Regulatory Agency (MHRA) granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for the same indication in the

UK. In December 2024, the National Institute for Health and Care Excellence (NICE) recommended LYTENAVA (bevacizumab gamma)

as an option for the treatment of wet AMD.

LYTENAVA (bevacizumab gamma) is the first

and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK. Currently, off-label

repackaged bevacizumab is one of the most frequently used first-line anti-VEGF treatments in Europe (approximately 2.8 million injections

annually) and the United States (approximately 2.7 million injections annually) for the treatment of retinal diseases1. ONS-5010/LYTENAVA

has the potential to mitigate certain risks associated with the current off-label use of repackaged bevacizumab.

Outlook Therapeutics may also seek authorization

in other European countries, Japan, and elsewhere. As previously announced, Outlook Therapeutics has entered into a strategic collaboration

with Cencora (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA globally following regulatory approvals.

The collaboration and integrated approach are designed to support market access and efficient distribution of LYTENAVA to benefit

all stakeholders, including retina specialists, providers and patients in certain European markets and, if approved, in the United States.

ONS-5010 / LYTENAVA (bevacizumab-vikg)

Clinical and Regulatory Update

In April 2025, Outlook Therapeutics announced

that the FDA acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational

ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA has determined that the BLA is a Class 2 review, which

results in a six-month review period from the date of resubmission. The FDA set a PDUFA goal date of August 27, 2025. ONS-5010, if

approved, will be branded as LYTENAVA (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive

12 years of regulatory exclusivity.

The ONS-5010 BLA resubmission was based on the

efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested

by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter

(CRL), the FDA informed Outlook Therapeutics that, in order to meet the FDA's requirement for a second adequate and well-controlled

clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment

na ve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT). Outlook Therapeutics believes that the complete data set

for NORSE EIGHT and the additional CMC information in the BLA resubmission, combined with the data from the other NORSE clinical trials,

provides the required evidence to support approval of the ONS-5010 BLA in the United States.

1 (Citeline (2023), Global Data (2023) and Market Scope

(2022); ASRS 2024 Membership Survey Presented at ASRS NY 2022; Market Scope 2024 US Retina Quarterly Updates; GlobalData: Age-Related

Macular Degeneration: Global Drug Forecast and Market Analysis to 2028 (April 2020)

Financial Highlights for the Fiscal Second

Quarter Ended March 31, 2025

For the fiscal second quarter ended March 31, 2025, Outlook Therapeutics reported a net loss attributable to common stockholders

of $46.4 million, or $1.50 per basic and diluted share, compared to a net loss attributable to common stockholders of $114.3 million,

or $8.01 per basic and diluted share, for the same period last year. For the fiscal second quarter ended March 31, 2025, Outlook

Therapeutics also reported an adjusted net loss attributable to common stockholders of $12.5 million, or $0.40 per basic and diluted

share, as compared to an adjusted net loss attributable to common stockholders of $22.1 million, or $1.55 per basic and diluted share,

for fiscal second quarter 2024.

Adjusted net loss attributable to common stockholders

for the fiscal second quarter ended March 31, 2025 includes $33.9 million of warrant inducement expenses, $2.1 million of loss from

change in fair value of convertible promissory notes and $2.1 million of gain from change in fair value of warrant liability. Adjusted

net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2024 includes $34.1 million of warrant

related expenses, $49.6 million of loss from change in fair value of warrant liability and $8.5 million of loss from change in fair value

of convertible promissory notes.

As of March 31, 2025, Outlook Therapeutics

had cash and cash equivalents of $7.6 million.

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

is an ophthalmic formulation of bevacizumab 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 MHRA

in the UK for the treatment of wet AMD.

In the United States, ONS-5010 / LYTENAVA (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/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 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 is working

to initiate its commercial launch of LYTENAVA (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in

the second quarter of calendar 2025. In the United States, ONS-5010/LYTENAVA is investigational, and a BLA has been resubmitted

to the FDA. 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.

Non-GAAP Financial Measures

Outlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the

United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission (SEC). In an effort

to provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook

Therapeutics' financial performance, Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the

SEC. In this press release, Outlook Therapeutics uses "adjusted net loss attributable to common stockholders," which is defined

as net loss attributable to common stockholders excluding warrant inducement expenses and changes in fair value of warrants and convertible

promissory notes, as well as "adjusted net loss attributable to common stockholders per share of common stock - basic and

diluted," which is defined as net loss attributable to common stockholders per share of common stock - basic and diluted excluding

warrant inducement expenses and changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because

they adjust for certain non-cash items that impact financial results but not cash flows and that management believes are not related to

its core business. Management uses these NGFMs to evaluate Outlook Therapeutics' financial performance against internal budgets

and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics' core operating results and facilitating