Full Press Release Details
Oncobiologics Advances ONS-5010 into
wet AMD Clinical Trial
Receives commitment for $20 million in proceeds
from equity private placement
Restructures and extends maturity on $13.5
million of outstanding senior secured notes
CRANBURY, N.J., November 6, 2018 (GLOBE NEWSWIRE)
- Oncobiologics, Inc. (NASDAQ:ONS) today announced that it has begun dosing patients in its first clinical trial for ONS-5010,
a proprietary ophthalmic bevacizumab product candidate, in patients with wet age related macular degeneration (wet AMD).
This first clinical study for ONS-5010, the Company's
lead product candidate, is being conducted outside of the United States and is designed to serve as the first of two adequate and
well controlled studies for wet AMD. The U.S. portion of the second study is scheduled to begin in early 2019 upon the submission
of an investigational new drug (IND) application. The Company's wet AMD clinical program was reviewed at a successful end
of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted earlier in 2018. If the program is successful,
it will support the Company's plans to submit for regulatory approval in multiple markets in 2020. The Company is developing
ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.
"The commencement of the ONS-5010 clinical program targeting
ophthalmic indications is a major achievement and I am extremely proud of the team for reaching this key milestone so quickly,"
said Lawrence A. Kenyon, President, CEO and CFO. "We were able to enter the clinic in less than 12 months from the start
of the project. ONS-5010 presents an exciting opportunity to meet the need for affordable critical therapeutic options for patients
and we are planning to build on the progress achieved to date."
Capital Financing and Debt Restructuring
Oncobiologics also announced today that it has received an equity
financing commitment for $20 million and restructured and extended the maturity of its senior secured notes that were previously
scheduled to mature on December 22, 2018. In combination with these improvements to its balance sheet, the Company has committed
to reduce expenses, sell or license the rights to some or all of its clinical stage biosimilar assets and to explore strategic
options for its manufacturing plant.
On November 5, 2018, Oncobiologics entered into a purchase agreement
with BioLexis Pte. Limited (formerly known as "GMS Tenshi Holdings Pte. Limited"), the Company's strategic business
partner and largest investor, providing for the private placement of $20.0 million of shares of its common stock at $0.9327 per
share, the Nasdaq "minimum price" on that date. The closing of the sale of the first tranche of this private placement
for an aggregate of 8,577,248 shares of Oncobiologics' common stock for aggregate cash proceeds of $8.0 million is expected
to occur on or about November 7, 2018, subject to customary closing conditions. The remaining $12.0 will fund in three equal tranches
on each of December 3, 2018, January 3, 2019 and February 1, 2019, as set forth in the purchase agreement. Oncobiologics intends
to use the net proceeds from the private placement primarily for clinical trials for its lead product candidate, ONS-5010, and
for working capital and general corporate purposes, including the agreed repayments on the senior secured notes.
Also on November 5, 2018, Oncobiologics reached an agreement
with the holders of its senior secured notes to extend the maturity of the senior secured notes, which have a face value of $13.5
million, up to 12 months, or until December 22, 2019, in exchange for making several payments of principal and interest through
August 31, 2019, subject to meeting additional capital raising commitments, with an initial payment of $2.2 million payable upon
initial closing of sale of shares to BioLexis. In addition, Oncobiologics agreed to make the senior secured notes convertible
into common stock at a price of 1.11924 per share (120% of the price per share paid by BioLexis under the purchase agreement)
and reduced the strike price of the warrants held by such holders to $1.50 and extended the expiration of these warrants by three
years. Oppenheimer & Co. Inc. acted as financial advisor to Oncobiologics in connection with the restructuring of its senior
Oncobiologics also undertook to take such steps as may be reasonably
necessary to amend the exercise price to $1.50 and further extend the expiration date of its outstanding Series A warrants (NASDAQ:
ONSIW) by three years.
"We appreciate the expanded investment by our partner,
BioLexis, and the continued engagement by our long term senior secured note investors to improve and extend our ability to fund
and advance the ONS-5010 program," continued Mr. Kenyon. "This capital commitment and debt restructuring are important
steps towards our goal to remove all debt from our balance sheet by the end of 2019. We are also exploring all possible opportunities
to monetize past investments to support future growth at Oncobiologics."
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 any 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.
ONS-5010 is a proprietary ophthalmic formulation of bevacizumab
to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases. Bevacizumab is a full length
humanized anti-VEGF (Vascular Endothelial Growth Factor) antibody which inhibits VEGF and associated angiogenic activity. The Company's
proprietary ophthalmic bevacizumab product candidate is an anti-VEGF recombinant humanized monoclonal antibody (or mAb) formulated
as a single use vial for IVT injection. By inhibiting the VEGF receptor from binding, bevacizumab prevents the growth and maintenance
of tumor blood vessels. Previously, this product candidate met the primary and secondary endpoints in a 3-arm single-dose pharmacokinetic
(PK) Phase 1 clinical trial. All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence
interval of 80-125% when compared to both U.S.- and EU-sourced Avastin reference products.
About AMD and wet AMD
Age related macular degeneration, AMD,
is a common eye condition and a leading cause of vision loss among people age 50 and older. Wet AMD is a form of "late stage"
AMD, and is also called neovascular AMD. In wet AMD, abnormal blood vessels grow underneath the retina. These vessels can leak
fluid and blood, which may lead to swelling and damage of the macula causing vision loss. With wet AMD, abnormally high levels
of vascular endothelial growth factor (VEGF) are secreted in the eyes. 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. Wet AMD is a significant disease worldwide, with over 1.8 million
patients diagnosed in the United States, top five European countries and Japan alone in 2016 (GlobalData). Revenue from anti-VEGFs
(Avastin , Lucentis ,Eylea and Macugen ) exceeded $8 billion annually in those ophthalmic markets in 2016
(GlobalData). Although not currently FDA-approved for use in treating wet AMD, it is believed that bevacizumab accounts for approximately
50% of all wet AMD prescriptions in the United States.
About BioLexis Pte. Limited
BioLexis is a Singapore based joint-venture between Tenshi Life
Sciences Private Limited, and GMS Holdings, a private investment company owning a portfolio of diversified businesses globally.
Together with Strides Shasun and Tenshi Life Sciences, GMS Holdings is a strategic investor in Stelis Biopharma.
Oncobiologics, Inc. and its BioSymphony Platform
Oncobiologics is a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing
complex monoclonal antibody (mAb) therapeutics. Oncobiologics has advanced three product candidates into clinical development.
By leveraging its proprietary BioSymphony Platform, Oncobiologics is able to produce high-quality innovative and biosimilar
mAb candidates in an efficient and cost-effective manner. The BioSymphony engine is particularly suitable for developing technically
challenging and commercially attractive mAbs to meet the need for clinically important yet affordable drugs. Led by a team of
biopharmaceutical experts, Oncobiologics operates from a state-of-the-art fully integrated research, development, and manufacturing
facility in Cranbury, New Jersey. 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 the Company's planned clinical trials for ONS-5010, the ability to successfully conduct such clinical trials, and plans
for seeking regulatory approval for ONS-5010, as well as statements about the Company's ability to reduce expenses, monetize
its product candidate portfolio and other assets, achieve the necessary milestones to obtain the committed funding from BioLexis,
raise additional capital, and amend its Series A warrants. Although Oncobiologics 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