Full Press Release Details
Therapeutics Announces $16.0 Million Private Placement to Advance
the Development of ONS-5010 / LYTENAVA (bevacizumab-vikg)
MONMOUTH JUNCTION, N.J., May 26, 2020 - 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
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
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."
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
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.
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
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
/ 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.
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
About Outlook Therapeutics,
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
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.
details on the Company's financial performance during the quarter, please see the Company's filings with the Securities
and Exchange Commission.
Outlook Therapeutics:
Chief Executive Officer
Media Relations Specialist
LaVoie Health Science