Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab-vikg for
use in retinal indications, today provided an update on its
progress towards potential approval and commercialization of
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet
AMD and other retinal diseases.
This week, Outlook Therapeutics completed a
$35.0 million public common stock offering that included
participation by GMS Ventures and Investments, an affiliate of
Outlook Therapeutics’ largest stockholder and strategic partner,
BioLexis Pte. Ltd., as well as partial exercise of the
underwriter’s overallotment option for an additional $3.6 million,
which is expected to close today. Outlook Therapeutics also closed
the previously announced concurrent private placement of common
stock to Syntone Ventures, LLC, its strategic partner in China, for
additional gross proceeds of $3.0 million. The combined net
proceeds from these stock offerings are expected to provide
sufficient capital to fund operations through the expected filing
of the Biologics License Application (BLA) for ONS-5010 for wet
age-related macular degeneration (wet AMD), which is planned for
the end of calendar 2021. This financing also provides Outlook
Therapeutics with optionality as it evaluates the best
commercialization path for ONS-5010.
“This recent financing provides Outlook
Therapeutics with the necessary capital to advance ONS-5010 to BLA
filing for wet AMD and to also continue discussions with potential
partners as we evaluate the best path forward to commercialize
ONS-5010 as LYTENAVA™,” commented Lawrence A. Kenyon, President,
CEO and CFO of Outlook Therapeutics. “Not only have we secured
enough capital to significantly extend our cash runway through
important upcoming milestones in 2021, but we have provided
ourselves with more time to unlock the greatest value and potential
for ONS-5010, the company, and our stockholders. We believe we are
now in an improved position that will allow us to both maximize the
value of this asset and to provide an FDA-approved ophthalmic
formulation of bevacizumab to patients.”
Commercial launch planning has begun, including
distribution, physician and patient outreach, key opinion leader
support and payor community engagement. With an enhanced safety and
cost-effectiveness profile, Outlook Therapeutics expects ONS-5010,
if approved, to be widely adopted by payors and clinicians
worldwide and to become the first-line drug of choice for
payor-mandated “step edit” in the United States for retinal
indications.
Extensive market research indicates that
ONS-5010, if approved, will be a significant therapy in the retinal
anti-VEGF market, currently estimated to be in excess of $13
billion worldwide.
Clinical Progress of ONS-5010 On
Track
All planned clinical trials for ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) for the wet AMD U.S. BLA are now fully
enrolled or completed. Outlook Therapeutics completed patient
enrollment in its pivotal Phase 3 (NORSE TWO) clinical trial in
July 2020, enrolling a total of 227 patients at 39 clinical trial
sites in the United States. Outlook Therapeutics expects to report
pivotal safety and efficacy data in the third calendar quarter of
2021.
Additionally, in November 2020, Outlook
Therapeutics completed enrollment of 195 subjects, ahead of
schedule, with a range of retinal diseases for which an anti-VEGF
drug is a therapeutic option, including wet age-related macular
degeneration (wet AMD), diabetic macular edema (DME) and branch
retinal vein occlusion (BRVO), for its open-label safety study
(NORSE THREE). The study is being conducted to ensure the adequate
number of safety exposures to ONS-5010 are available for the
initial regulatory filings.
Following the data readout from both the
open-label safety study and the pivotal safety and efficacy study,
Outlook Therapeutics plans to submit a new BLA filing to the U.S.
Food and Drug Administration (FDA). If the BLA is approved, it will
result in 12 years of marketing exclusivity.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
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. 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 pharmacists, products that have known risks
of contamination and inconsistent potency and availability. If
approved, ONS-5010 will reduce the need for use of unapproved
repackaged IV bevacizumab from compounding pharmacists for retinal
disease.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (mAb) that inhibits VEGF and associated angiogenic
activity. VEGF is a protein that promotes the growth of new
abnormal blood vessels. With wet AMD, abnormally high levels of
VEGF are secreted in the eye and lead to loss of vision. 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 ONS-5010/LYTENAVA™
(bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab-vikg for use in retinal indications, including wet
AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics
expects to commercialize it as the first and only FDA-approved
ophthalmic formulation of bevacizumab-vikg for use in treating a
range of retinal diseases in the United States, United Kingdom,
Europe, Japan, China and other markets. Outlook Therapeutics
expects to file ONS-5010 with the U.S. FDA as a new BLA under the
PHSA 351(a) regulatory pathway, initially for wet AMD. 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 “potential,” “expect,” “intend,”
“will,” “may,” “might,” “should,” “plan,” “anticipate,” “project,”
“believe,” “estimate,” “predict” or “continue,” the negative of
terms like these or other comparable terminology, and other words
or terms of similar meaning. These include statements about the
sufficiency of the cash runway, the timing of BLA submission, the
expected optionality to evaluate commercialization path, the
ability to maximize the value of ONS-5010, the closing of the
partial exercise of the over-allotment option, ONS-5010’s ability
to meet a clinical and market need, ONS-5010’s potential as the
first FDA-approved ophthalmic formulation of bevacizumab-vikg,
commercialization and pricing of ONS-5010 if approved, clinical
trials in other indications, 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, risks in obtaining necessary
regulatory approvals, and risks of funding such ongoing
development, as well as those risks detailed in Outlook
Therapeutics’ filings with the Securities and Exchange Commission,
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.
CONTACTS:Media
Inquiries:Harriet UllmanAssistant Vice
PresidentLaVoieHealthScienceT:
617-669-3082hullman@lavoiehealthscience.com Investor
Inquiries: Jenene
ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247 OTLK@jtcir.com
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