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 announced it has entered into a Stock
Purchase Agreement with Syntone Ventures LLC for a private
placement of $16.0 million of common stock at a price of $1.00 per
share. In addition, Outlook Therapeutics entered into a joint
venture agreement with Syntone Technologies Group Co. Ltd.
(“Syntone”) to form a PRC joint venture to develop and
commercialize ONS-5010 / LYTENAVA™ (bevacizumab-vikg) in China
pursuant to a license agreement to be entered into between Outlook
Therapeutics and the joint venture. Outlook Therapeutics will use
$0.9 million of the private placement proceeds to fund its initial
capital contribution to the PRC joint venture.
“We are pleased to enter into this strategic
opportunity to further advance the development of ONS-5010. This
partnership provides many advantages, including the ability to
leverage Syntone’s presence in, and knowledge of, the Chinese
market,” commented Lawrence A. Kenyon, President, CEO and CFO of
the Company. “While our primary focus for the development and
commercialization of ONS-5010 remains on the seven major global
markets, we saw this as an opportunity to bring capital into the
Company at a premium with a motivated strategic investor, and to
enhance the potential commercialization of ONS-5010 in an
additional market with unique characteristics.”
“Syntone’s businesses to date have focused on
creating energy production and critical living materials for
society,” added Syntone’s Chairman Zheng Zongmei. “Because
health problems are also a common issue for humanity, Syntone has
been looking for opportunities to put our ideals into action in
healthcare and we believe Outlook Therapeutics is the ideal
partner. We want to help Outlook Therapeutics bring LYTENAVA™
to those in need, not only in previously targeted markets, but also
in China.”
The closing of the sale of the shares is
expected to occur on or about June 1, 2020, subject to the
satisfaction of customary closing conditions. Outlook Therapeutics
intends to use the net proceeds from the financing for working
capital and general corporate purposes, including in support of its
ONS-5010 development program, with approximately $0.9 million of
the proceeds being used to fund its initial capital contribution to
the planned PRC joint venture. An additional capital
contribution from Outlook Therapeutics of approximately $2.1
million will be required within the next 4 years. The planned
PRC joint venture will be 80% owned by Syntone and 20% owned by
Outlook Therapeutics and is intended to focus on the development
and commercialization of ONS-5010 in the greater China market,
which includes Hong Kong, Taiwan and Macau. Outlook Therapeutics
has agreed to enter into a license agreement providing for the
license to the PRC joint venture of rights to ONS-5010 in greater
China.
The securities in the private placement are
being offered in a private placement under Section 4(a)(2) of the
Securities Act of 1933, as amended (the “Act”) and/or Regulation D
promulgated thereunder, and such securities have not been
registered under the Act or applicable state securities laws.
Accordingly, such securities may not be offered or sold in the
United States except pursuant to an effective registration
statement or an applicable exemption from the registration
requirements of the Act and such applicable state securities
laws.
This news release shall not constitute an offer
to sell or a solicitation of an offer to buy, nor shall there be
any sale of these securities in any state or jurisdiction in which
such offer, solicitation or sale would be unlawful, prior to
registration or qualification under the securities laws of any such
state or jurisdiction.
About Syntone Technologies Group Co. Ltd.
Syntone Technologies Group Co. Ltd., based in Hebei, China, is
part of a larger group of enterprises which have significant
operations in China concentrated in oil and gas but also including
real estate and emerging technology. These enterprises have
experience investing outside of China, including in the United
States. Syntone has identified biotechnology as an area of
interest for investment to provide an opportunity for Chinese
patients to experience the benefits provided by these
therapies. Syntone Ventures LLC is a wholly-owned U.S.-based
subsidiary of Syntone Technologies Group Co. Ltd.
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. ONS-5010 is
currently being evaluated in two adequate and well-controlled
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 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 (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 AMD, DME and 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. Outlook Therapeutics expects to file ONS-5010 with the
U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway. 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 the
closing of the private placement, the expected benefits of the
Syntone relationship and PRC joint venture, as well as the effects
of such relationship on the planned commercialization of ONS-5010.
Although the Company believes that it has a reasonable basis for
the 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, as
well as those risks detailed in the Company’s 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. 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.
CONTACTS: Outlook
Therapeutics:
Lawrence A. Kenyon LawrenceKenyon@outlooktherapeutics.com
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T:
833.475.8247 OTLK@jtcir.com
Media Inquiries:Emmie TwomblyMedia Relations
SpecialistLaVoie Health ScienceM:
857.389.6042etwombly@lavoiehealthscience.com
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