- Regional license covers China,
Hong Kong, Macau, Singapore, South
Korea and Taiwan
- Oncolytics to receive upfront, licensing fee and milestone
payments to support phase 3 registration study of USD $21.2 million, and eligible to receive up to an
additional USD $65.4 million upon
achievement of clinical, regulatory and commercialization
milestones
- Upon Adlai Nortye's commercialization of REOLYSIN®,
Oncolytics is eligible to receive double digit royalty
payments
- Management to host webcast and conference call tomorrow,
November 17, 2017 at 8:30 am ET for Analysts and Institutional
Investors
CALGARY and SAN DIEGO, CA, Nov. 16,
2017 /PRNewswire/ - Oncolytics Biotech® Inc.
(TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech
company developing REOLYSIN®, an intravenously delivered
immuno-oncolytic virus that activates the innate and adaptive
immune systems to turn 'cold' tumors 'hot', today announced that it
has entered into a Regional Licensing Agreement (The Agreement)
with Adlai Nortye (Adlai), a biopharmaceutical company focused on
discovering and developing important new treatments for cancer and
metabolic diseases. Under the terms of The Agreement, Adlai will
have exclusive development and commercialization rights to REOLYSIN
in China, Hong Kong, Macau, Singapore, South
Korea and Taiwan.
"Adlai Nortye has a top-tier clinical, regulatory and commercial
team with global experience, that will be able to gain significant
regional exposure for REOLYSIN upon potential approval, following
our phase 3 study in HR+/HER2- metastatic breast cancer," said Dr.
Matt Coffey, President and CEO of
Oncolytics Biotech. "China is the
fastest growing pharmaceutical market in the world, and we are
delighted to be able to unlock value for Oncolytics and our
shareholders through this regional partnership. We're very happy
this was able to happen as expediently as it did following our
end-of-phase two meeting with the FDA. On the back of that
meeting we also have escalated our efforts to find a suitable
global or larger regional partner, in regions such as Europe or Japan, and look forward to providing updates
on our progress in the first half of 2018."
"With its impressive clinical data coupled with its unique and
novel mechanism, REOLYSIN will be an instrumental component in
furthering the development of our oncology pipeline," said
Carsten Lu, CEO of Adlai Nortye. "It
immediately makes Adlai Nortye a late stage biotechnology company
and REOLYSIN itself becomes our lead product. Given its potential
in multiple oncological indications and its ability to be used in
combination with multiple chemotherapies and immunotherapies,
REOLYSIN will help to broaden future therapies made available by
Adlai Nortye and advance us towards commercialization."
Terms of The Agreement
Oncolytics will receive an
upfront licensing fee and milestone payments to support the phase 3
registration study in metastatic breast cancer (mBC) of USD
$21.2 million, and is eligible to
receive up to an additional USD $65.4
million upon achievement of clinical, regulatory and
commercialization milestones. Oncolytics is also eligible to
receive double digit royalty payments associated with the
commercialization of REOLYSIN for all indications, subject to
regulatory approval. Included in the USD $21.2 million:
- Upfront payments of USD $5.3
million
- Two milestone payments totalling USD $8
million made up of two common share purchase warrants:
-
- One common share purchase warrant of USD $2 million whereby, upon exercise, Adlai may
purchase Oncolytics' common shares priced at a 120% premium of the
five-day weighted average closing price immediately preceding the
exercise date. Oncolytics has the right to call this warrant when
the first patient is enrolled in the phase 3 mBC study or six
months after execution of The Agreement, whichever is later.
- One common share purchase warrant of USD $6 million whereby, upon exercise, Adlai may
purchase Oncolytics' common shares priced at a 120% premium of the
five-day weighted average closing price immediately preceding the
exercise date. Oncolytics has the right to call this warrant upon
the enrollment of the 50th patient in the phase 3 mBC
study.
- USD $7.9 million based on certain
regulatory advancements.
Oncolytics recently had a favorable End-of-Phase 2 Meeting with
the United States Food and Drug Administration that outlined a
single, 400-patient phase 3 study focused on HR+/HER2-
patients. The Company expects to have formal guidance back
from the European Medicines Agency (EMA) before the end of the year
and to begin enrolling patients in its phase 3 study in
mid-2018.
Adlai Nortye will be responsible for all clinical, regulatory
and commercialization activities in its territories. Oncolytics
maintains exclusive rights outside of these territories and will be
responsible for all development outside of these territories.
Webcast and Conference Call
Oncolytics management will
host a conference call for Analysts and Institutional Investors
regarding this announcement tomorrow, November 17, 2017 at 8:30
am ET. The live call may be accessed by dialing (888)
231-8191 for callers in North America. Overseas callers
should contact investor relations for the toll-free dial
information for their region. A replay of this call will be
available approximately two hours after the call is ended at
855-859-2056 using the replay code 8987978 and will be available
for three months.
A live audio webcast of the call will be accessible on the
Investor Relations page of Oncolytics' website at
www.oncolyticsbiotech.com and will be archived for a full year.
About REOLYSIN
REOLYSIN is a non-pathogenic,
proprietary isolate of the unmodified reovirus: a first-in-class
intravenously delivered immuno-oncolytic virus for the treatment of
solid tumors and hematological malignancies. The compound induces
selective tumor lysis and promotes an inflamed tumor phenotype
through innate and adaptive immune responses to treat a variety of
cancers.
About Oncolytics Biotech Inc.
Oncolytics is a
biotechnology company developing REOLYSIN, an intravenously
delivered immuno-oncolytic virus. The compound induces selective
tumor lysis and promotes an inflamed tumor phenotype – turning
'cold' tumors 'hot' – through innate and adaptive immune responses
to treat a variety of cancers. Oncolytics' clinical development
program emphasizes three pillars: chemotherapy combinations to
trigger selective tumor lysis; immuno-therapy combinations to
produce adaptive immune responses; and immune modulator (IMiD)
combinations to facilitate innate immune responses. Oncolytics
is currently planning its first registration study in metastatic
breast cancer, as well as studies in combination with checkpoint
inhibitors and targeted and IMiD therapies in solid and
hematological malignancies. For further information about
Oncolytics, please visit: www.oncolyticsbiotech.com.
About Adlai Nortye
Adlai Nortye is a science-led
biopharmaceutical company dedicated to discovering, developing and
commercializing new drugs. We focus on discovering and developing
important new treatments for cancer and metabolic diseases. Our
mission is to improve patient lives by identifying and acquiring
differentiated innovative medicines that help people live better,
live longer.
We have 19 patents granted and 7 PCT published. With extensive
experience in peptide and protein drugs, we have expanded our
expertise into small molecules and therapeutic antibodies. Through
close collaborations with global partners, we have successfully
positioned ourselves in the fields of immuno-oncology and metabolic
diseases and have several programs ongoing from early pre-clinical
to phase 3 ready.
This press release contains forward-looking statements,
within the meaning of Section 21E of the Securities Exchange Act of
1934, as amended and forward-looking information under applicable
Canadian securities laws (such forward-looking statements and
forward-looking information are collectively referred to herein as
"forward-looking statements"). Forward-looking statements,
including the Company's belief as to the potential of
REOLYSIN® as a cancer therapeutic; the anticipated
benefits of the regional licensing agreement to the Company; the
amount and use of proceeds to be received by the Company, and the
timing thereof, under the regional licensing agreement and the
exercise of the warrants; the amount of royalties payable to the
Company under the regional licensing agreement; the ability of the
Company to achieve the clinical, regulatory and commercialization
milestones contemplated by the regional licensing agreement and the
warrants; the timing and anticipated results of the Company's
proposed clinical development program; the timing of anticipated
guidance from the EMA; the ability of the Company to achieve its
goals to find additional global partners; the Company's planned
operations; and other statements related to anticipated
developments in the Company's business and technologies involve
known and unknown risks and uncertainties, which could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
research and development projects, the efficacy of REOLYSIN as a
cancer treatment, the success and timely completion of clinical
studies and trials, the Company's ability to successfully
commercialize REOLYSIN, uncertainties related to the research and
development of pharmaceuticals, uncertainties related to the
regulatory process and general changes to the economic environment.
Investors should consult the Company's quarterly and annual filings
with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties relating to the
forward-looking statements. Investors are cautioned against placing
undue reliance on forward-looking statements. The Company does not
undertake to update these forward-looking statements, except as
required by applicable laws.
SOURCE Oncolytics Biotech Inc.