Ensysce Biosciences, Inc.
(“Ensysce”) and
Leisure Acquisition
Corp. (“LACQ”) (NASDAQ: LACQ, LACQU,
LACQW), a special purpose acquisition company formed for
the purpose of effecting a merger, acquisition or similar business
combination, announced today that Ensysce has received U.S. Food
and Drug Administration (“FDA”) allowance for an Investigational
New Drug (IND) application for PF614-MPAR™, a two-step
extended-release oxycodone prodrug which is designed to provide
abuse deterrent and overdose protection properties.
PF614-MPAR™ is designed as an extended-release oxycodone prodrug
with both trypsin-activated abuse protection (TAAP) and overdose
protection through multi-pill abuse resistance (MPAR™). TAAP
chemical modification inactivates the active ingredient in PF614
and provides abuse deterrence, and the combination with the trypsin
inhibitor, nafamostat, in MPAR™ is designed to provide the
additional layer of overdose protection. The MPAR™ overdose
protection technology has been demonstrated in animals and the
Phase 1 study with PF614 is being conducted to further validate the
MPAR™ overdose protection technology. Ensysce believes its TAAP
prodrugs and MPAR products are differentiated from current marketed
opioid technologies due to their ability to reduce the potential
for abuse as well as overdose and, therefore, make the products
safer to keep in the medicine cabinet.
The trial, “A Single Dose Study to Evaluate the Pharmacokinetics
of oxycodone and PF614, when PF614 Solution is Co-Administered with
Nafamostat, as an Immediate Release Solution and/or Extended
Release (ER) Capsule Formulations in Healthy Subjects” is being
conducted by Dr. Maricer Escalon MD, MS, MBA at Quotient Sciences -
Miami, Inc.
“Ensysce is pleased to bring PF614-MPAR™ into clinical
development with the financial support of the National Institute on
Drug Abuse,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of
Ensysce Biosciences. “Importantly, our proprietary prodrug approach
is highly differentiated from currently marketed opioid products
and designed to significantly reduce abuse potential and overdose
protection. We remain focused on our commitment to stem the
prescription drug abuse epidemic and look forward to bringing our
unique pipeline of products to the industry, which will ultimately
provide safer options for both prescribers and patients.”
As previously announced, on February 1, 2021, Ensysce entered
into a definitive agreement for a business combination with LACQ,
which would result in Ensysce becoming a publicly listed company.
Upon closing of the transaction, LACQ intends to change its name to
Ensysce Biosciences, Inc. and remain on the Nasdaq Capital Market,
listed under the new ticker symbol “ENSC”.
About Ensysce BiosciencesEnsysce Biosciences,
San Diego, CA is a clinical-stage biotech company using its
proprietary technology platforms to develop safer prescription
drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP™)
and Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is
in the process of developing a new class of powerful, tamper-proof
opioids that prevent both drug abuse and overdoses. Ensysce’s
products are anticipated to provide safer options to treat severe
pain and assist in preventing deaths caused by opioid abuse,
reducing the human and economic cost. The platforms are covered by
an extensive worldwide intellectual property portfolio for a wide
array of prescription drug prodrug compositions. For more
information, please visit www.ensysce.com.
About Leisure Acquisition Corp.LACQ is a blank
check company formed for the purpose of effecting a merger or other
business combination with a target company. LACQ is led
by Lorne Weil and Daniel Silvers and completed
its Initial Public Offering in December 2017. LACQ is listed
on the Nasdaq Capital Market (NASDAQ: LACQ). Additional
information can be found at www.leisureacq.com.
Important Information and Where to Find ItThis
press release relates to a proposed transaction between Ensysce and
LACQ. This press release does not constitute an offer to sell or
exchange, or the solicitation of an offer to buy or exchange, any
securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, sale or exchange would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. In connection with the
transaction described herein, LACQ has filed or intends to file
relevant materials with the SEC, including a registration statement
on Form S-4, which will include a proxy statement/ prospectus.
Promptly after the registration statement is declared effective by
the SEC, LACQ will mail the definitive proxy statement/prospectus
and a proxy card to each stockholder entitled to vote at the
special meeting relating to the transaction. Investors and security
holders of LACQ are urged to read these materials (including any
amendments or supplements thereto) and any other relevant documents
in connection with the transaction that LACQ will file with the SEC
when they become available because they will contain important
information about LACQ, Ensysce and the transaction. The
preliminary proxy statement/prospectus, the definitive proxy
statement/prospectus and other relevant materials in connection
with the transaction (when they become available), and any other
documents filed by LACQ with the SEC, may be obtained free of
charge at the SEC's website (www.sec.gov). The documents filed by
LACQ with the SEC also may be obtained free of charge at LACQ's
website at www.leisureacq.com or upon written request to
LACQ at 250 West 57th Street, Suite 415, New York, New
York 10107, or by calling LACQ at (212) 565-6940.
Participants in the SolicitationLACQ, Ensysce
and their respective directors and executive officers may be deemed
to be participants in the solicitation of proxies from Leisure’s
shareholders in connection with the proposed transaction.
Information about LACQ’s and Ensysce’s directors and executive
officers and their ownership of Leisure’s securities is set forth
in Leisure’s Amendment No. 3 to the Registration Statement on Form
S-4 filed with the SEC on April 21, 2021. Additional information
regarding the interests of those persons and other persons who may
be deemed participants in the proposed transaction may be obtained
by reading the final proxy statement/prospectus regarding the
proposed transaction when it becomes available. You may obtain free
copies of these documents as described in the preceding
paragraph.
Non-SolicitationThis press release is not a
proxy statement or solicitation of a proxy, consent or
authorization with respect to any securities or in respect of the
potential transaction and shall not constitute an offer to sell or
a solicitation of an offer to buy the securities of LACQ, the
combined company or Ensysce, nor shall there be any sale of any
such 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 such state or
jurisdiction. No offer of securities shall be made except by means
of a prospectus meeting the requirements of the Securities Act.
Forward Looking StatementsCertain statements
included in this press release that are not historical facts are
forward-looking statements for purposes of the safe harbor
provisions under the United States Private Securities Litigation
Reform Act of 1995. Forward-looking statements are sometimes
accompanied by words such as "believe," "may," "will," "estimate,"
"continue," "anticipate," "intend," "expect," "should," "would,"
"plan," "predict," "potential," "seem," "seek," "future," "outlook"
and similar expressions that predict or indicate future events or
trends or that are not statements of historical matters. These
forward-looking statements include, but are not limited to,
statements regarding Ensysce's business strategy, prospective
milestones, cash resources and ability to obtain additional
funding, current and prospective drug product candidates, planned
clinical trials and preclinical activities and potential product
approvals, as well as the potential for market acceptance of any
approved products and the related market opportunity. These
statements are based on various assumptions, whether or not
identified in this press release, and on the current expectations
of the respective management teams of Ensysce and LACQ and are not
predictions of actual performance. These forward-looking statements
are provided for illustrative purposes only and are not intended to
serve as and must not be relied on by an investor as, a guarantee,
an assurance, a prediction or a definitive statement of fact or
probability. Actual events and circumstances are difficult or
impossible to predict and will differ from assumptions. Many actual
events and circumstances are beyond the control of Ensysce and
LACQ. These forward-looking statements are subject to a number of
risks and uncertainties, including the risk that the potential
product candidates that Ensysce develops may not progress through
clinical development or receive required regulatory approvals
within expected timelines or at all; the risk that clinical trials
may not confirm any safety, potency or other product
characteristics described or assumed in this press release; the
risk that Ensysce will be unable to successfully market or gain
market acceptance of its product candidates; the risk that
Ensysce's product candidates may not be beneficial to patients or
successfully commercialized; the risk that Ensysce has
overestimated the size of the target market, their willingness to
try new therapies and the willingness of physicians to prescribe
these therapies; the effects of competition on Ensysce's business;
the risk that third parties on which Ensysce depends for
laboratory, clinical development, manufacturing and other critical
services will fail to perform satisfactorily; the risk that
Ensysce's business, operations, clinical development plans and
timelines, and supply chain could be adversely affected by the
effects of health epidemics, including the ongoing COVID-19
pandemic; the risk that Ensysce will be unable to obtain and
maintain sufficient intellectual property protection for its
investigational products or will infringe the intellectual property
protection of others; the potential inability of the parties to
successfully or timely consummate the proposed business
combination, including the risk that any regulatory approvals are
not obtained, are delayed or are subject to unanticipated
conditions that could adversely affect the combined company or the
expected benefits of the proposed business combination or that the
approval of the stockholders of LACQ is not obtained; the risk that
LACQ is unable to maintain the listing of its securities on the
Nasdaq stock market; the risk that proceeds from
Ensysce’s forward equity purchase facility may be less
than anticipated; the risk of failure to realize the anticipated
benefits of the proposed business combination; the amount of
redemption requests made by LACQ's stockholders, and those factors
discussed in LACQ's Form 10-K for the year ended December 31,
2020, under the heading "Risk Factors," and other documents LACQ
has filed, or will file, with the SEC, including a registration
statement on Form S-4 that will include a proxy
statement/prospectus. If any of these risks materialize or LACQ's
and Ensysce's assumptions prove incorrect, actual results could
differ materially from the results implied by these forward-looking
statements. There may be additional risks that neither LACQ nor
Ensysce presently know, or that neither LACQ nor Ensysce currently
believe are material, that could also cause actual results to
differ from those contained in the forward-looking statements. In
addition, forward-looking statements do not reflect LACQ's or
Ensysce's expectations, plans or forecasts of future events and
views as of the date of this press release. Neither LACQ nor
Ensysce anticipate that subsequent events and developments will
cause LACQ's and Ensysce's assessments to change. However, LACQ and
Ensysce specifically disclaim any obligation to update these
forward-looking statements. These forward-looking statements should
not be relied upon as representing LACQ's or Ensysce's assessments
of any date subsequent to the date of this press release.
Accordingly, undue reliance should not be placed upon the
forward-looking statements.
Ensysce Biosciences ContactsLynn Kirkpatrick,
PhD (CEO, Ensysce): +1 858-263-4196
Leisure Acquisition Corp. ContactGeorge
Peng (CFO, LACQ): +1 646 565 6940
SOURCE Leisure Acquisition Corp.; Ensysce Biosciences,
Inc.
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