JERUSALEM, March 15, 2021 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") announced today that it
has entered into a definitive agreement for a business combination
with Decoy Biosystems, Inc., a privately-held, preclinical-stage
biotechnology company developing novel, multi-targeted products
that safely prime both innate and adaptive anti-tumor and
anti-viral immune responses.
The combined company will advance its immunotherapy platform to
battle a variety of tumor types and chronic viral infections. Decoy
previously held a pre-IND meeting with the FDA, currently plans to
file an IND in the second half of 2021 and to initiate a Phase I
clinical trial in 2022 targeting solid tumors and lymphomas.
"Decoy's bacteria-based platform is a novel modality which has
the potential to dramatically change how we treat cancer and
chronic viral diseases," said Dr. Roger
Pomerantz, who is expected to become the Chairman of the
Board of Directors of the combined company.
"This transformative transaction provides Intec with a robust
clinical pipeline based on a novel immunotherapy platform and gives
Intec entrée into the exciting area of immuno-oncology," said
Jeffrey A. Meckler, Vice Chairman
and Chief Executive Officer of Intec Pharma. "Our transition into
immune-oncology leverages Intec's senior level expertise and offers
an exciting, potential value-creating opportunity for our
shareholders."
"Decoy's killed and non-pathogenic, bacteria-based
immunotherapies are designed to work as a single agent as well as
synergize with existing therapies to prime and activate both the
innate and adaptive immune systems, inducing efficient immune
responses with a wide safety margin. This novel approach has
generated compelling results in standard pre-clinical tumor and
chronic viral infection models, suggesting that the Decoy platform
may overcome many of the the key challenges of previous
immunotherapies," said Michael J.
Newman, Ph.D., Founder and Chief Executive Officer of Decoy
Biosystems. "We believe the planned merger with Intec Pharma is the
right next step to facilitate the advancement of our first clinical
candidate into human trials and accelerate the development of our
unique immunotherapy platform to create best-in-class anti-tumor
and anti-viral therapies for high unmet need
indications."
Transaction Terms
Under the exchange ratio formula in the merger agreement,
without taking into consideration the effect of the respective
levels of cash and liabilities of each of Intec Pharma and Decoy,
upon completion of the merger, the former Decoy stockholders are
expected to own approximately 75% of the combined company, and the
Intec shareholders are expected to own approximately 25% of the
combined company, calculated on a fully diluted basis. The actual
allocation will be subject to adjustment based on, among other
things, Decoy's and Intec Pharma's net cash balance (including, in
the case of Intec Pharma, any proceeds from any disposition of the
Accordion Pill business) at the time of closing and the amount of
closing financing raised, which will dilute securityholders of
Decoy and Intec Pharma on a pro-forma basis.
The combined company is expected to be led by Jeffrey Meckler as Chief Executive Officer and
Michael Newman as Chief Scientific
Officer with Dr. Roger Pomerantz
serving as Chairman. At closing, the combined company's board of
directors is anticipated to consist of eight members, including
five members of Intec Pharma's current board and three members of
Decoy's current board.
The Board of Directors of both companies have approved the
transaction. The merger is expected to close in the third quarter
of 2021, subject to the approval of the shareholders of each
company, the domestication of Intec Pharma to Delaware, the disposition of Intec's Accordion
Pill business, the raising of closing financing, the continued
listing of the combined company on Nasdaq, as well as customary
closing conditions.
A more complete description of the terms and conditions of the
transaction can be found in Intec Pharma's Form 8-K to be filed on
March 15, 2021 with the SEC and in
the merger agreement, which is filed as an exhibit to that Form
8-K.
About Decoy Biosystem
Decoy Biosystems has evolved from over a century of
immunotherapy advances. It is a thoroughly modern, science-driven,
re-invention of Coley's Toxins, the world's first
immunotherapy.
Decoy's approach is based on the hypothesis that efficient
activation of both innate and adaptive immune cells and
associated anti-tumor and anti-viral immune responses will require
a multi-targeted package of immune system danger signals or
pathogen-associated molecular patterns (PAMPs) that can be
administered safely intravenously. Decoy's patented technology
is composed of single strains of attenuated and killed,
non-pathogenic, Gram-negative bacteria, with reduced i.v. toxicity,
but largely uncompromised ability to prime or activate many of the
cellular components of innate and adaptive immunity. This leads to
broad anti-tumor and anti-viral activity, including safe
durable response synergy with five different classes of
existing anti-tumor agents, including checkpoint therapy, targeted
antibody therapy and low-dose chemotherapy in pre-clinical models.
Tumor eradication by Decoy technology produces both innate and
adaptive immunological memory and, importantly, does not
require provision of an exogenous tumor antigen.
Decoy has carried out successful GMP manufacturing of its lead
clinical candidate, Decoy20, and is currently completing
IND-enabling toxicology studies.
Decoy Biosystems operations are located at Johnson & Johnson
Innovation, JLABS at San Diego
(JLABS @ San Diego). JLABS is a
30,000 square-foot life science innovation center, located in
San Diego. The labs provide a
flexible environment for start-up companies pursuing new
technologies and research platforms to advance medical care.
Through a "no strings attached" model, Johnson & Johnson
Innovation does not take an equity stake in the companies occupying
JLABS and the companies are free to develop products - either on
their own, or by initiating a separate external partnership with
Johnson & Johnson Innovation or any other company.
About Intec Pharma Ltd.
Intec Pharma is a clinical-stage biopharmaceutical company
focused on developing drugs based on its proprietary Accordion Pill
platform technology. The Company's Accordion Pill is an oral drug
delivery system that is designed to improve the efficacy and safety
of existing drugs and drugs in development by utilizing an
efficient gastric retention and specific release mechanism. For
more information, visit www.intecpharma.com. Intec
Pharma routinely posts information that may be important to
investors in the Investor Relations section of its website.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act.
Additional Information about the Proposed Merger and Where to
Find It
In connection with the proposed merger between Intec Pharma and
Decoy Biosystems, Intec Pharma will file a Registration Statement
on Form S-4, which will include a document that serves as a proxy
statement and prospectus of Intec Pharma and Intec Pharma plans to
file other documents regarding the proposed merger with the SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY
STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE
SEC CAREFULLY AND IN THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE,
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT SHAREHOLDERS
SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING THE PROPOSED
MERGER. A definitive proxy statement/prospectus will be sent to
Intec Pharma's and Decoy Biosystems' shareholders. Investors and
security holders will be able to obtain these documents (when
available) free of charge from the SEC's website at www.sec.gov.
The documents filed by Intec with the SEC may also be obtained free
of charge from the Company by requesting them by mail at Intec
Pharma Ltd., 12 Hartom Street, Har Hotzvim, Jerusalem 9777512, Israel.
Participants in the Solicitation
Intec Pharma and its respective directors and executive officers
and other members of management and employees and certain of their
respective significant shareholders may be deemed to be
participants in the solicitation of proxies from Intec shareholders
in respect of the proposed merger. Information about the Intec
Pharma's directors and executive officers is available in Intec's
proxy statement, filed June 8, 2020
for the 2020 Annual Meeting of Shareholders, Intec Pharma's Annual
Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC
on March 13, 2020 and the Company's
Current Report on Form 8-K filed on July 17,
2020. Information regarding the persons who may, under the
rules of the SEC, be deemed participants in the proxy solicitation
and a description of their direct and indirect interests, by
security holding or otherwise, will be contained in the proxy
statement/prospectus and other relevant materials to be filed with
the SEC regarding the proposed merger when they become available.
Investors should read the proxy statement/prospectus carefully when
it becomes available before making any voting or investment
decisions. You may obtain free copies of these documents from the
SEC and Intec Pharma as indicated above.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements with the
meaning of the Private Securities Litigation Reform Act. These
include statements regarding management's expectations, beliefs and
intentions regarding, among other things, our product development
efforts, business, financial condition, results of operations,
strategies, plans and prospects. Forward-looking statements can be
identified by the use of forward-looking words such as "believe",
"expect", "intend", "plan", "may", "should", "could", "might",
"seek", "target", "will", "project", "forecast", "continue" or
"anticipate" or their negatives or variations of these words or
other comparable words or by the fact that these statements do not
relate strictly to historical matters. For example, forward-looking
statements are used in this press release when we discuss Decoy's
future plans and expected timeline of its development pipeline and
our expected timing of completion of the merger. Forward-looking
statements relate to anticipated or expected events, activities,
trends or results as of the date they are made. Because
forward-looking statements relate to matters that have not yet
occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the
forward-looking statements. Many factors could cause actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, the following: risks associated with Intec Pharma's
and Decoy's ability to obtain the shareholder approval required to
consummate the proposed merger and the timing of the closing of the
proposed merger, including the risks that a condition to closing
would not be satisfied within the expected timeframe or at all or
that the closing of the proposed merger will not occur; risks
related to the ability to consummate certain closing conditions
including the pre-closing financing and the disposition of the
Accordion Pill business, the occurrence of any event, change, or
other circumstances that could give rise to the termination of the
merger agreement; the outcome of any legal proceedings that may be
instituted against Intec Pharma or Decoy following the announcement
of the merger agreement and the transactions contemplated therein;
unanticipated difficulties or expenditures relating to the proposed
merger, the response of business partners and competitors to the
announcement of the proposed merger, and/or potential difficulties
in employee retention as a result of the announcement and pendency
of the proposed merger; the occurrence of any event, change, or
other circumstance that could give rise to the termination of the
merger agreement or could otherwise cause the transaction to fail
to close; the inability to list the merger shares on Nasdaq or
maintain the listing of the combined company's shares of common
stock on Nasdaq following the proposed merger; the ability to
recognize the anticipated benefits of the proposed merger. Risks
and uncertainties relating to Decoy that may cause actual results
to differ materially from those expressed or implied in any
forward-looking statement include, but not limited to: Decoy's
plans to develop and potentially commercialize its technology, the
timing and cost of Decoy's planned investigational new drug
application and any clinical trials, the completion and receiving
favorable results in any clinical trials, Decoy's ability to obtain
and maintain regulatory approval of any product candidate, Decoy's
ability to protect and maintain its intellectual property and
licensing arrangements, Decoy's ability to develop, manufacture and
commercialize its product candidates, the risk of product liability
claims, the availability of reimbursement, the influence of
extensive and costly government regulation, and Decoy's estimates
regarding future revenue, expenses capital requirements and the
need for additional financing following the merger. These risks, as
well as other risks and uncertainties associated with the merger,
will be discussed in the proxy statement/prospectus that will be
included in the registration statement on Form S-4 to be filed with
the SEC in connection with the merger. Additional risks and
uncertainties are identified and discussed under the heading "Risk
Factors" in Intec's Annual Report and other period filings with the
SEC. All forward-looking statements speak only as of the date of
this presentation and are expressly qualified in their entirety by
the cautionary statements included in this presentation. Neither
Intec nor Decoy undertake any obligation to update or revise
forward-looking statements to reflect events or circumstances that
arise after the date made or to reflect the occurrence of
unanticipated events, except as required by applicable law.
Intec Pharma Investor Contact:
Will O'Connor
Stern IR
+1 212-362-1200
will@sternir.com
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SOURCE Intec Pharma Ltd.