CAMBRIDGE, Massachusetts and
PETACH TIKVA, Israel, August 29, 2016 /PRNewswire/ --
Leap Therapeutics, Inc., a clinical stage immuno-oncology
company, and Macrocure Ltd. (NASDAQ: MCUR) today announced the
signing of a definitive merger agreement. Under the terms of the
agreement, Macrocure will become a wholly owned subsidiary of Leap,
and Leap will become a public company. In connection with the
transaction, Leap will apply to have the shares of the combined
entity listed for trading on NASDAQ upon completion of the
merger.
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Under the terms of the agreement, Macrocure shareholders will
exchange their Macrocure shares for newly issued shares of Leap
common stock. In addition, existing Leap investors, including
entities affiliated with HealthCare Ventures, have committed to
invest an additional $10 million at
the closing of the transaction. On a pro forma basis, after
giving effect to the merger and the investment, Macrocure equity
holders are expected collectively to own approximately 31.8%, and
Leap equity holders are expected collectively to own approximately
68.2%, of the combined company, subject to certain possible
adjustments based on Macrocure's net cash level at closing.
Existing Leap shareholders will receive the right to a royalty,
under certain circumstances, based on future net sales. The
combined company is expected to have a minimum of $30 million of cash at closing to finance future
operations.
"The combination with Macrocure positions our organization as a
leading immuno-oncology company with sufficient capital to advance
our pipeline of first-in-class monoclonal antibodies through
significant value-creating events," commented Christopher K. Mirabelli, PhD, CEO of Leap.
"Importantly, we anticipate achieving substantial clinical
milestones over the course of 2016 and 2017. We plan to
present data and initiate randomized studies for DKN-01, our lead
development candidate, which has demonstrated clinical activity in
esophageal cancer and cholangiocarcinoma when combined with
chemotherapy; and we expect to report data from a repeat-dose study
of TRX518, a novel GITR agonist monoclonal antibody which is
believed to enhance an immune anti-tumor response."
"After careful review of many alternatives, the executive team
and Board of Directors of Macrocure believe this transaction
provides great potential for our shareholders," said Nissim Mashiach, President and Chief Executive
Officer of Macrocure Ltd. "Leap Therapeutics has a maturing
pipeline of novel drug candidates focused on key immuno-oncology
targets that are designed to provide new and valuable treatment
options for patients suffering from aggressive
cancers. Furthermore, Leap's experienced management team has a
track record relating to public and private companies and drug
development success."
The executive team of Leap Therapeutics will remain in their
positions in the combined entity that will be based out of Leap
Therapeutics' current corporate office in Cambridge, Massachusetts. The combined
entity's leadership team will consist of Christopher K. Mirabelli, PhD, who will serve as
Chief Executive Officer and Chairman of the Board of Directors,
Augustine Lawlor as Chief Operating
Officer, and Douglas E. Onsi as
Chief Financial Officer. At the closing, two Macrocure
designated individuals, including Nissim
Mashiach, will join Leap's Board of Directors.
The Board of Directors of both companies have unanimously
approved the proposed merger. Macrocure's shareholders who
hold approximately 51% of Macrocure's voting shares, have entered
into agreements in support of the proposed transaction. While
these agreements assure the approval of the merger, all Macrocure
shareholders will be asked to vote on the merger at a meeting of
shareholders. Additionally, entities affiliated with
HealthCare Ventures and Eli Lilly, which own all of Leap's
outstanding voting shares, have entered into agreements in support
of the proposed transaction. The transaction is expected to
close near year-end, subject to shareholder approval and other
customary closing conditions which are set forth in the merger
agreement.
Raymond James is serving as
exclusive financial advisor to Macrocure Ltd.
Leap expects to file a registration statement on Form S-4 with
the U.S. Securities and Exchange Commission to register the shares
of common stock to be issued in the merger. The registration
statement will contain more detailed information about the
transaction, as well as information about the respective companies.
In addition, Macrocure expects to file a current report on Form 6-K
shortly regarding the transaction. Macrocure also will be mailing a
proxy statement to its shareholders, which will be filed on a
current report on Form 6-K and attached as an appendix to Leap's
Form S-4 registration statement.
About DKN-01
DKN-01 is a humanized monoclonal IgG4 monoclonal antibody with
neutralizing activity against the Dickkopf-1 protein. DKN-01 is
currently being studied in clinical trials in esophageal cancer and
cholangiocarcinoma. DKN-01 demonstrated clinical activity as a
single agent in patients with non-small cell lung cancer in a Phase
1 dose escalation study that was presented at the American Society
for Clinical Oncology (ASCO) 2014 Annual Meeting and in combination
with paclitaxel in patients with esophageal cancer in a study that
was presented at the European Society for Medical Oncology (ESMO)
World GI Congress in 2016. Additional data from the study of
DKN-01 plus the combination of gemcitabine and cisplatin in
patients with cholangiocarcinoma will be presented at the ESMO
Annual Meeting in October 2016.
About TRX518
TRX518 is a humanized aglycosyl IgG1 monoclonal antibody with
agonist activity targeting GITR. TRX518 has been shown to bind and
activate GITR through bivalent binding to the receptor. TRX518 was
engineered to remove Fc-receptor interactions to prevent
complement-mediated cytolysis and antibody-mediated depletion of
leukocytes expressing GITR. TRX518 surrogate antibodies have been
effective in preclinical animal models, prolonging survival or
enhancing immune responses when combined with chemotherapeutics and
checkpoint inhibitors. Initial clinical data on TRX518 was
presented at the ASCO 2016 Annual Meeting.
About Leap Therapeutics
Leap Therapeutics is an immuno-oncology company with two
clinical stage programs. Leap's most advanced clinical candidate,
DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1
(DKK1) protein. DKN-01 is in clinical
trials in esophageal cancer and cholangiocarcinoma. Leap's second
clinical candidate, TRX518, is a novel, humanized GITR agonist
monoclonal antibody designed to enhance the immune system's
anti-tumor response. TRX518 is in clinical trials in patients with
advanced solid tumors. For more information about Leap
Therapeutics, please visit http://www.leaptx.com .
About Macrocure Ltd.
Macrocure Ltd. is a clinical-stage biotechnology company that
was focused on developing a novel therapeutic platform to address
chronic and hard-to-heal wounds. For more information, please visit
www.macrocure.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes forward-looking statements that are
not historical facts, such as statements regarding assumptions and
results related to financial results, forecasts, clinical trials,
and regulatory authorizations. Words such as "will,"
"expect," "anticipate," "plan," "believe," "design," "may,"
"future," "estimate," "predict," "objective," "goal," or variations
thereof and variations of such words and similar expressions are
intended to identify such forward-looking statements.
Forward-looking statements are based on Macrocure's and/or
Leap's current knowledge and its present beliefs and expectations
regarding possible future events and are subject to risks,
uncertainties, and assumptions. Actual results and the timing of
events could differ materially from those anticipated in these
forward-looking statements as a result of several factors
including, but not limited to, the expected timing and likelihood
of completion of the proposed merger, the occurrence of any event,
change, or other circumstance that could result in the termination
of the merger agreement or the anticipated financing, receipt and
timing of any required governmental or regulatory approvals
relating to the registration and listing of Leap's common stock or
otherwise relating to the merger, the anticipated amount needed to
finance the combined company's future operations, unexpected
results of clinical trials, delays or denial in regulatory approval
process, or additional competition in the market. The
forward-looking statements made herein speak only as of the date of
this release and Macrocure and Leap undertake no obligation to
update publicly such forward-looking statements to reflect
subsequent events or circumstances, except as otherwise required by
law.
Additional Information and Where to Find
It
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval with respect to the proposed Merger or
otherwise. No offering of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended, and otherwise in accordance
with applicable law.
In connection with the proposed merger, Leap intends to file
with the U.S. Securities and Exchange Commission (SEC) a
registration statement on Form S-4 containing a prospectus and
other relevant documents relating to the proposed merger and
combined company. Macrocure intends to file a current report
on Form 6-K containing its proxy statement and other documents
relating to the proposed merger. This communication is not a
substitution for the registration statement, final prospectus,
proxy statement, or any other documents that Leap and Macrocure may
file with the SEC or send to shareholders in connection with the
proposed transaction. INVESTORS AND SECURITY HOLDERS ARE
URGED TO READ THE REGISTRATION STATEMENT, THE PROSPECTUS, THE PROXY
STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED, OR TO BE FILED,
WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT LEAP,
MACROCURE, AND THE PROPOSED MERGER. Investors and security holders
will be able to obtain free copies of the registration statement,
the prospectus, the proxy statement, and any other documents filed
by Leap and Macrocure with the SEC (when available) at the SEC's
website at www.sec.gov. Copies of documents filed by Leap may be
obtained for free by contacting Leap Investor Relations by mail at
Leap Therapeutics, Inc., 47 Thorndike Street, Suite B1-1,
Cambridge, MA 02141, Attention:
Investor Relations or by telephone at (617)-714-0360. Copies
of documents filed by Macrocure may be obtained for free by
contacting Macrocure Investor Relations by mail at Macrocure Ltd.,
25 Hasivim Street, Kiryat Matalon,
Petach Tikva 4959383, Israel,
Attention: Investor Relations, by telephone at +(972)-54-565-6011,
or by going to Macrocure's Investor Relations page at
http://investor.macrocure.com/. The contents of Macrocure's website
are not deemed to be incorporated by reference into the
registration statement, the prospectus, or the proxy statement.
Leap Therapeutics Contact
Douglas E. Onsi, Chief Financial
Officer
donsi@leaptx.com
+1-617-714-0360
Macrocure Ltd. Contact
Shai Lankry, Chief Financial
Officer
Shai@macrocure.com
+972-54-565-6011
SOURCE Macrocure Ltd.
