Outlook Therapeutics Announces Closing of $16.0 Million Private Placement
June 03 2020 - 8:05AM
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 the successful closing of its
previously announced private placement of $16.0 million of common
stock at a price of $1.00 per share (representing a 34% premium at
signing) to Syntone Ventures LLC, a U.S.-based affiliate of Syntone
Technologies Group Co. Ltd.
Outlook Therapeutics intends to use the net
proceeds from the financing for working capital and general
corporate purposes, including in support of its development program
for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational
ophthalmic formulation of bevacizumab to treat wet AMD, with
approximately $0.9 million of the proceeds being used to fund its
initial capital contribution to the planned PRC joint venture with
Syntone. An additional capital contribution from Outlook
Therapeutics of approximately $2.1 million will be required within
the next four 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 described above were offered by
Outlook Therapeutics 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 press 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
planned PRC joint venture, and the Company’s additional capital
requirements in connection therewith. 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 and geopolitical environment affecting
Sino-U.S. relations. 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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