Full Press Release Details
Oncobiologics announces strategic partnership
GMS Tenshi Holdings Pte. Limited
-Up to $50 million in combination
of equity, warrants and license fees-
Cranbury, NJ - September 8, 2017
- Oncobiologics, Inc. (NASDAQ: ONS) today announced that it entered into a Purchase Agreement on September 7, 2017 with
GMS Tenshi Holdings Pte. Limited ("GMS Tenshi"), providing for the private placement of up to $25.0 million of Oncobiologics'
Series A Convertible Preferred Stock ("Series A"), as well as warrants to acquire up to an additional 16,750,000 shares
of its common stock (the "Warrants") having an aggregate exercise price of approximately $15 million.
In connection with the entry into the Purchase
Agreement, Oncobiologics and GMS Tenshi also entered into a Joint Development and License Agreement (the "License"),
providing for the license to GMS Tenshi of rights to ONS-3010 (HUMIRA biosimilar) and ONS-1045 (AVASTIN biosimilar) in
emerging markets, excluding China, India and Mexico. The License supersedes and replaces a previous strategic license agreement
entered into on July 25, 2017 with GMS Tenshi, which licensed only ONS-1045, and which resulted in payments totaling $2.5 million
in up-front and milestone fees to Oncobiologics. The License includes an aggregate $2.5 million of additional upfront payments
due in part at signing and upon initial closing of the sale of Series A under the Purchase Agreement, as well as potential additional
milestones of up to $5.0 million and a net profit share.
Oncobiologics has also entered into an
agreement with an existing investor and holder of senior secured notes of Oncobiologics to exchange $1.5 million of its senior
secured notes for non-voting Series B Convertible Preferred Stock and forgive the unpaid interest on such exchanged notes.
Oncobiologics Chairman and CEO, Pankaj
Mohan, Ph.D., commented, "This investment by GMS Tenshi represents the culmination of our efforts to align with a strategic
financial partner with a global strategy to accelerate commercialization of our biosimilar candidates and enhance our partnering
and licensing capabilities. The principals of GMS Tenshi are internationally known biopharma entrepreneurs with the know-how to
rapidly deliver critically needed biosimilars to emerging markets around the globe. We believe that we now have a partner with
the necessary financial and global commercial pharmaceutical expertise that, when combined with our unique BioSymphony Platform,
will allow us to realize our vision to bring affordable biologic drugs to patients in need around the world."
Oncobiologics intends to use the net proceeds
from the private placement primarily for the initiation of Phase 3 clinical trials for its lead biosimilar candidate, ONS-3010,
and for working capital and general corporate purposes. ONS-3010 has successfully completed Phase 1 clinical trials and is preparing
to enter Phase 3 in 2018. Oncobiologics is developing ONS-3010 as a differentiated HUMIRA biosimilar with a unique formulation
and an innovative Phase 3 clinical program designed to prove biosimilarity to, and interchangeability with, HUMIRA in a single
GMS Tenshi is a Singapore based joint-venture
between Tenshi Life Sciences Private Limited - the private investment vehicle of Arun Kumar, and GMS Holdings, a private
investment company headquartered in Amman, Jordan owning a portfolio of diversified businesses globally. Arun Kumar is the founder
of the Strides Group of companies, including India-based pharmaceutical company Strides Arcolab Limited (currently Strides Shasun
Limited) and Stelis Biopharma Limited, a company engaged in the development of biotherapeutic drugs (including biosimilars). GMS
Holdings is a founder and major shareholder in MS Pharma, a leading branded generics company in the Middle East and North Africa
region. In the United States, GMS Holdings was a co-founder of and majority shareholder in Alvogen, Inc. a specialty generic pharmaceutical
company, which it sold in 2014. Together with Strides Shasun and Tenshi Life Sciences, GMS Holdings is a strategic investor in
A statement issued by GMS Tenshi noted,
"We believe that bringing affordable biosimilars to emerging markets where they are so desperately needed is of critical
importance to global healthcare. As pharma specialists, we also recognize the technical challenges in developing and manufacturing
complex biologics, and we saw that the Oncobiologics team and its BioSymphony Platform offered the scientific and engineering
capabilities required to accomplish this. GMS Tenshi is excited to invest in Oncobiologics to accelerate the commercialization
of its flagship biosimilar product candidates (namely ONS-3010 and ONS-1045), as well as other pipeline and new product candidates.
Our objective is to help Oncobiologics prepare ONS-3010 so that it can be launched alongside other first-wave HUMIRA biosimilars
with potentially improved tolerability compared to the originator product as reported in the successful Phase 1 trial."
Under the Purchase Agreement, Oncobiologics
will initially sell 32,628 shares of its Series A to GMS Tenshi for approximately $3.3 million of cash upon satisfaction of certain
initial closing conditions, and enter into an Investor Rights Agreement in connection therewith. Under the Investor Rights Agreement,
Oncobiologics will grant GMS Tenshi certain registration rights with respect to the shares of its common stock issuable upon conversion
of the Series A and exercise of the Warrants. Effective upon the closing of the initial sale of Series A to GMS Tenshi, Oncobiologics'
Board also will elect Faisal G. Sukhtian and Joe Thomas, each of whom will be designated by GMS Tenshi under the Investor Rights
Agreement, to its Board of Directors, which individuals will fill vacancies on the Board created by the resignations of Robin Smith
Hoke and Donald J. Griffith, which will also be effective as of the closing of the initial sale of Series A to GMS Tenshi. Oncobiologics
also entered into an Exchange and Purchase Agreement on September 7, 2017 with an existing investor and agreed to exchange $1.5
million aggregate principal amount of the outstanding senior secured notes held by such investor for 1,500,000 of Oncobiologics'
non-voting, Series B Convertible Preferred Stock ("Series B") concurrent with the issuance of the remaining 217,372
shares of Series A. Oncobiologics and the holders of its senior secured notes also agreed to amend the terms of such notes to extend
the maturity date by 12 months, among other items.
The closing of the sale of the additional
217,372 remaining shares of Series A and the Warrants is subject to a number of additional closing conditions, including receipt
of stockholder approval and other customary closing conditions. Under the Investor Rights Agreement, GMS Tenshi will have the right
to designate up to two additional directors in connection with the closing of the sale of such remaining securities. Oncobiologics
will also grant GMS Tenshi certain information rights, a right of first offer over certain future issuances of securities, as well
as a right of participation in certain future securities issuances. In the event that the final closing does not occur, Oncobiologics
has agreed to pay GMS Tenshi, under certain circumstances, $12.5 million in liquidated damages in addition to other expenses, and
GMS Tenshi will have a right to put all of the Series A purchased at the initial closing to Oncobiologics.
Oncobiologics intends to file a proxy statement
with the U.S. Securities and Exchange Commission for its Annual Meeting of Stockholders, pursuant to which it will seek stockholder
approval of the issuance of the Series A and Warrants to GMS Tenshi, change of control of Oncobiologics, along with election of
directors and other items to be set forth therein.
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 Oncobiologics, Inc. and its BioSymphony
Oncobiologics is a clinical-stage biopharmaceutical
company focused on identifying, developing, manufacturing and commercializing complex biosimilar therapeutics. Its current focus
is on technically challenging and commercially attractive monoclonal antibodies (mAbs) in the disease areas of immunology and
oncology. Oncobiologics is advancing its pipeline of biosimilar products, two of which are currently in clinical development.
Led by a team of biopharmaceutical experts, Oncobiologics operates from an in-house state-of-the-art fully integrated research
and development, and manufacturing facility in Cranbury, New Jersey. Oncobiologics employs its BioSymphony Platform to
address the challenges of biosimilar development and commercialization by developing high quality mAb biosimilars in an efficient
and cost-effective manner on an accelerated timeline. For more information, please visit www.oncobiologics.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 whether or not the closing of the sale of the Series A and Warrants to GMS Tenshi will
occur, our ability to receive potential additional upfront and milestone payments under the License Agreement, the effects of partnering
with GMS Tenshi on our ability to continue development of, and potentially commercialize, our biosimilar product candidates, and
the exchange of senior secured notes for Series B, among others. Although we believe that we have a reasonable basis for forward-looking
statements contained herein, we caution you that they are based on current expectations about future events affecting us and are
subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to
predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those