OTLK Outlook Therapeutics, Inc. - 8-K

EX-99.1
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tm2616461d1_ex99-1.htm
EXHIBIT 99.1

Exhibit 99.1

Outlook Therapeutics Announces Resubmission
of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

ISELIN,
N.J., June 1, 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 the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA™
for the treatment of neovascular age-related macular degeneration (nAMD).

As previously
announced, Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter (CRL) related to the ONS-5010 Biologics
License Application reviewed by the FDA. In their decision, the FDA Office of New Drugs concluded that substantial evidence of effectiveness
has been established for LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), therefore additional
trials are not required.

The FDR
decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics to focus on
reach ing an agreement on final product labeling.
Additionally, as indicated in the formal decision, this will be a Class 1 resubmission with a PDUFA date and decision expected within
60 days of FDA’s receipt of the resubmission.

Dr. Baruch Kuppermann, Steinert Endowed
Professor, Chair, Dept of Ophthalmology and Visual Sciences, Director, Gavin Herbert Eye Institute University of California, Irvine, stated,
“ONS-5010/LYTENAVA™ has the potential to offer clinicians and patients an important additional option for treating
wet AMD. If approved as the first on-label ophthalmic formulation of bevacizumab, ONS-5010 will enable patients to benefit from wider
access and provide an attractive alternative for anti-VEGF treatment of wet AMD.”

“We
are incredibly pleased to reach this important milestone. This resubmission represents the strength of our application and the tremendous
dedication of our entire organization,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Our team worked
through an extensive and rigorous review and appeal process, maintaining close collaboration with the FDA. We are encouraged with the
Class 1 review designation. We remain committed to bringing ONS-5010/LYTENAVA™ to patients who deserve FDA-approved options
for the treatment of nAMD .”

When approved,
ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing,
FDA-approved labeling, and robust pharmacovigilance.

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. When approved, it
will be the first ophthalmic formulation approved by the FDA.

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). 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.

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, 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

[email protected]