Full Press Release Details
Outlook Therapeutics Provides COVID-19
Impact Update on Ongoing Clinical
Trials NORSE 1 and NORSE 2
CRANBURY, N.J., April
14, 2020 (GLOBE NEWSWIRE) - Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the "Company"), a late clinical-stage biopharmaceutical
company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications,
today provided a clinical update on the impact of the COVID-19 pandemic on the status of NORSE 1 and NORSE 2, its ongoing registration
clinical trials for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab.
All clinical and chemistry,
manufacturing and control (CMC) activities are currently active for both NORSE 1 and NORSE 2, registration clinical trials evaluating
ONS-5010 for treatment of wet age-related macular degeneration (wet AMD). The Company has confirmed with the Ophthalmic Division
of the U.S. Food and Drug Administration (FDA) that it considers both approved and investigational treatments for sight-threatening
conditions such as wet AMD not to be elective, and that as such they should continue during the COVID-19 restrictions.
NORSE 1 completed enrollment
in August 2019 and is on pace to meet its schedule as expected. The Company anticipates reporting data during the third calendar
quarter of 2020. At this time, COVID-19 is not expected to affect the completion of NORSE 1 and anticipated data readout date.
NORSE 2, which commenced
enrollment in July 2019 and is being conducted in the United States, continues to screen, enroll and treat patients, subject to
additional COVID-19 safety protocols for both patients and staff at trial sites. Due to these additional safety protocols, some
sites have temporarily shut down and patient enrollment has slowed. Outlook estimates that final enrollment could be delayed by
one to three months, depending on local conditions, which have varying degrees of "shelter-in-place" and other type
of executive orders mandating various restrictions.
"In these unprecedented
times across the globe, the safety of the patients and medical staff engaged in our NORSE 1 and NORSE 2 clinical trials is our
top priority. We are fortunate enough not to expect any delay in our NORSE 1 clinical trial and anticipate reporting data from
the study in August of this year, as planned. We want to share our deepest appreciation to all medical staff and patients for their
ongoing participation in this important clinical work," said Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics.
"While the full impact of COVID-19 remains uncertain, we are confident that the statistical analysis plans we have built
into the NORSE 2 clinical trial will mitigate potential missed visits and the slower pace of enrollment we are currently experiencing.
Our team remains dedicated to advancing the program efficiently while minimizing delays as much as possible."
About ONS-5010 / LYTENAVA
ONS-5010 / LYTENAVA (bevacizumab-vikg) 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. ONS-5010 is currently being evaluated in two registration clinical trials for wet AMD (NORSE
1 and NORSE 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication. If approved,
ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat approved retinal diseases. The
Company currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial
Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet
AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels.
Anti-VEGF injection therapy blocks this growth. 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 late clinical-stage biopharmaceutical
company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including
wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). If ONS-5010
/ LYTENAVA (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab, is approved, Outlook Therapeutics
expects to commercialize it as the first and only approved ophthalmic formulation of bevacizumab for use in treating approved retinal
diseases in the United States, 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 "may,"
"might," "will," "should," "expect," "plan," "anticipate,"
"project," "believe," "estimate," "predict," "potential," "intend"
or "continue," the negative of terms like these or other comparable terminology, and other words or terms of similar
meaning. These include statements about its plans for filing a BLA for ONS-5010 / LYTENAVA (bevacizumab-vikg), its commercialization
plans for ONS-5010, expected data read-out dates for NORSE 1, and the impact of the COVID-19 pandemic on its ongoing ONS-5010 clinical
trials. Although the Company believes that it has a reasonable basis for forward-looking statements contained herein, they are
based on current expectations about future events affecting the Company 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, the uncertainty regarding the COVID-19 pandemic and its duration, as well
as those risks detailed in the Company's filings with the Securities and Exchange Commission. 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. The Company
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.
For additional details on the Company's financial performance
during the quarter, please see the Company's filings with the Securities and Exchange Commission.
Outlook Therapeutics:
Media Relations Specialist
LaVoie Health Science
Chief Executive Officer