CAMBRIDGE, Mass. and
BEIJING, Jan. 3, 2020 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company
developing targeted immuno-oncology therapeutics, and BeiGene, Ltd.
(Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical
company focused on developing and commercializing innovative
molecularly-targeted and immuno-oncology drugs for the treatment of
cancer, today announced an exclusive option and license agreement
for the clinical development and commercialization of DKN-01,
Leap's anti-Dickkopf-1 (DKK1)
antibody, in Asia (excluding
Japan), Australia, and New
Zealand. Leap will retain exclusive rights for the
development, manufacturing, and commercialization of DKN-01 for the
rest of the world. In addition, Leap announced entering into an
agreement for a $27 million equity
financing with BeiGene and two institutional investors.
BeiGene Strategic Collaboration
"We are excited about the potential to combine our anti-PD-1
inhibitor tislelizumab with DKN-01 as there have been promising
signals in a biomarker-defined population of gastric cancer
patients in combination with checkpoint blockade," commented
Yong (Ben) Ben, M.D., Chief Medical
Officer, Immuno-Oncology at BeiGene. "This collaboration with Leap
is another example of our commitment to developing novel treatments
to address unmet medical needs in Asia and around the world."
Under the terms of the agreement, Leap will receive an upfront
cash payment of $3 million from
BeiGene in exchange for granting BeiGene an option to an exclusive
license to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New
Zealand, and will be eligible to receive an additional
payment from BeiGene upon BeiGene's exercise of the option
following initial proof-of-concept studies. Additionally, Leap is
eligible to receive payments from BeiGene based upon the
achievement of certain development, regulatory, and sales
milestones for a total deal value of up to $132 million, together with tiered royalties on
any product sales of DKN-01 in the licensed territory. BeiGene will
also make a $5 million equity
investment in Leap as part of the contemporaneous $27 million equity financing.
"Securing a collaboration to further develop DKN-01 has been our
top strategic priority, and we are excited to begin working with
BeiGene, a global leader in oncology," said Christopher K. Mirabelli, Ph.D., President and
Chief Executive Officer of Leap Therapeutics. "BeiGene is the ideal
partner for Leap given its extensive experience in the development
of oncology drugs throughout Asia
Pacific, where its expertise and product breadth can help us
in our efforts to address serious unmet medical needs in
esophagogastric, gynecologic, and other cancers."
During the option period, Leap has agreed to study the
combination of DKN-01 and tislelizumab. Leap plans to evaluate
DKN-01 with tislelizumab in approximately 40 patients with
second-line gastric cancer (GC) / gastroesophageal junction cancer
(GEJ) whose tumors express high levels of DKK1 to build upon the the positive clinical
experience of DKN-01 in combination with PD-1 inhibitors in these
patients. In addition, Leap plans to evaluate the combination of
DKN-01 with tislelizumab and chemotherapy in approximately 20
patients with first-line GC/GEJ. Leap expects to initiate these
clinical trials in the first half of 2020.
Equity Financing
In connection with the licensing agreement with BeiGene, Leap
has also entered into a securities purchase agreement to issue and
sell in a private placement 1,421,801 shares of newly designated
Series A mandatorily convertible preferred stock to a lead
institutional investor and 1,137,442 shares of newly designated
Series B mandatorily convertible preferred stock to BeiGene and
Perceptive Advisors, each at a price of $10.55 per share, upon the closing of the equity
financing. The preferred stock price reflects a common stock
equivalent price of $1.055, the
closing price for Leap's common stock on the Nasdaq Global Market
on the day of pricing, January 2,
2020. At the closing, the holder of Series A mandatorily
convertible preferred stock will also receive a special voting
preferred share that will entitle it to elect one member of Leap's
Board of Directors. Upon approval by the stockholders of Leap, the
Series A mandatorily convertible preferred stock will be
automatically converted into pre-funded warrants to purchase
14,218,010 shares of common stock and the Series B mandatorily
convertible preferred stock will be automatically converted into
11,374,420 shares of common stock, plus additional shares
representing payment of an 8% per annum accruing dividend. Upon
stockholder approval and conversion of the preferred stock, the
investors will also receive warrants to purchase up to an equal
number of shares of common stock at an exercise price of
$2.11 per share. The aggregate
gross proceeds to Leap from this offering are approximately
$27 million, before deducting
placement agent fees and estimated offering expenses payable by
Leap, and not including proceeds from the exercise of any warrants.
Subject to customary closing conditions, the equity financing is
scheduled to close on or before January 8,
2020.
Leap plans to hold a special meeting of stockholders to approve
an increase in the number of authorized shares of common stock, the conversion of the
convertible preferred stock into shares of common stock, the
issuance of the warrants, and related matters. In connection with
such stockholder meeting, Leap entered into a voting agreement with
entities affiliated with HealthCare Ventures holding an aggregate
of 29.3% of the company's outstanding common stock to vote all of
their beneficially owned shares in favor of the matters to be
proposed at the special meeting of stockholders.
Raymond James & Associates,
Inc. was the placement agent for the equity financing.
The securities being sold in the private placement have not been
registered under the Securities Act of 1933, as amended, or state
securities laws and may not be offered or sold in the United States absent registration with the
Securities and Exchange Commission (SEC) or an applicable exemption
from such registration requirements. Leap has agreed to file a
registration statement with the SEC covering the resale of the
shares of common stock issuable upon conversion of the preferred
stock and exercise of the warrants issued in the private
placement.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be
any sale of the securities in any state in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of such state.
About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and
blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin
signaling, a signaling pathway frequently implicated in
tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell
signaling and in mediating an immuno-suppressive tumor
microenvironment through enhancing the activity of myeloid-derived
suppressor cells and downregulating NK ligands on tumor cells.
About gastroesophageal junction (GEJ) /gastric
adenocarcinoma
The gastroesophageal junction (GEJ) is the area where the
esophagus and stomach join together. Given its anatomic location,
GEJ adenocarcinomas have often been grouped together with either
esophageal or gastric cancers in large. Gastric adenocarcinoma
(gastric cancer) remains one of the most common and deadly cancers
worldwide, especially among older malesi. Based on
GLOBOCAN 2018 data, stomach cancer is the 5th most
common neoplasm and the 3rd most deadly cancer, with an
estimated 783,000 deaths in 2018i. Gastric cancer
incidence and mortality are highly variable by region and highly
dependent on diet and Helicobacter pylori
infectioni.
About Leap Therapeutics
Leap Therapeutics (Nasdaq:LPTX) is focused on developing
targeted and immuno-oncology therapeutics. Leap's most advanced
clinical candidate, DKN-01, is a humanized monoclonal antibody
targeting the Dickkopf-1 (DKK1)
protein, a Wnt pathway modulator. DKN-01 is in clinical trials in
patients with esophagogastric, hepatobiliary, gynecologic, and
prostate cancers. For more information about Leap Therapeutics,
visit http://www.leaptx.com or our public filings with the SEC that
are available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
About BeiGene
BeiGene (Nasdaq:BGNE; HKEX: 06160) is a global, commercial-stage
research-based biotechnology company focused on
molecularly-targeted and immune-oncology cancer therapeutics. With
a team of over 3,300 employees in
the United States, China, Australia, and Europe, BeiGene is advancing a pipeline
consisting of novel oral small molecules and monoclonal antibodies
for cancer. BeiGene is also working to create combination solutions
aimed to have both a meaningful and lasting impact on cancer
patients. In the United States,
BeiGene markets and distributes BRUKINSA™ (zanubrutinib) and in
China, the Company has received
approval to market its anti-PD-1 antibody tislelizumab and markets
ABRAXANE® (nanoparticle albumin-bound paclitaxel), REVLIMID®
(lenalidomide), and VIDAZA® (azacytidine) under a license from
Celegene Corporation Logistics Sarl, a Bristol-Myers Squibb
companyii, and plans to market
XGEVA® (denosumab) under a license from
Amgeniii.
FORWARD-LOOKING STATEMENTS FOR LEAP THERAPEUTICS
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995, which involve risks and
uncertainties. These statements include statements regarding
expectations with respect to the
closing of the equity financing, receiving stockholder approval at
the special meeting of stockholders, development and advancement of
DKN-01, including the initiation, timing and design of future
studies, enrollment in future studies, potential for the receipt of
future option exercise, milestones or royalty payments from
BeiGene, and other future expectations, plans and prospects.
Although Leap believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
forward-looking statements are subject to known and unknown risks,
uncertainties and other factors that could cause actual results to
differ materially from our expectations. Such risks and
uncertainties include, but are not limited to: the accuracy of our
estimates regarding expenses, future revenues, capital requirements
and needs for financing; the outcome, cost, and timing of our
product development activities and clinical trials; the uncertain
clinical development process, including the risk that clinical
trials may not have an effective design or generate positive
results; our ability to obtain and maintain regulatory approval of
our drug product candidates; the size and growth potential of the
markets for our drug product candidates; our ability to continue
obtaining and maintaining intellectual property protection for our
drug product candidates; and other risks. Detailed information
regarding factors that may cause actual results to differ
materially will be included in Leap Therapeutics' periodic filings
with the SEC, including Leap's Annual Report on Form 10-K for the
fiscal year ended December 31, 2018,
as filed with the SEC on April 1,
2019, and Leap's Quarterly Reports on Form 10-Q. Any
forward-looking statements contained in this release speak only as
of its date. We undertake no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
FORWARD-LOOKING STATEMENTS FOR BEIGENE
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
future development and potential commercialization activities of
the specified product candidate under the agreement with Leap,
potential payments payable to Leap, and other information that
is not historical information. Actual results may differ materially
from those indicated in the forward-looking statements as a result
of various important factors, including BeiGene's ability
to demonstrate the efficacy and safety of its drug candidates; the
clinical results for its drug candidates, which may not support
further development or marketing approval; actions of regulatory
agencies, which may affect the initiation, timing and progress of
clinical trials and marketing approval; BeiGene's ability
to achieve commercial success for its marketed products and drug
candidates, if approved; BeiGene's ability to obtain and
maintain protection of intellectual property for its technology and
drugs; BeiGene's reliance on third parties to conduct
drug development, manufacturing and other services; BeiGene's
limited operating history and BeiGene's ability to obtain
additional funding for operations and to complete the development
and commercialization of its drug candidates, as well as those
risks more fully discussed in the section entitled "Risk Factors"
in BeiGene's most recent quarterly report on Form 10-Q, as well as
discussions of potential risks, uncertainties, and other important
factors in BeiGene's subsequent filings with
the U.S. Securities and Exchange Commission. All information
in this press release is as of the date of this press release,
and BeiGene undertakes no duty to update such information
unless required by law.
LEAP THERAPEUTICS CONTACTS:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
BEIGENE MEDIA CONTACT:
Liza Heapes
(857) 302-5663
media@beigene.com
BEIGENE INVESTORS CONTACT:
Craig West
(857) 302-5189
ir@beigene.com
i
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444111/
ii ABRAXANE® is a registered trademark of
Abraxis Bioscience LLC, a Bristol-Myers Squibb company;
REVLIMID® and VIDAZA® are
registered trademarks of Celgene Corporation, a Bristol-Myers
Squibb company
iii XGEVA® is a
registered trademark of Amgen.
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SOURCE Leap Therapeutics, Inc.