Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly owned subsidiary
of Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an
innovative revenue-generating company focused on acquiring,
developing and commercializing non-opioid pain management products
for the treatment of acute and chronic pain, and Denali Capital
Acquisition Corp., a Cayman Islands exempted company and special
purpose acquisition company (Nasdaq: DECA, the “SPAC”), today
announced the filing of a Registration Statement on Form S-4 (the
“Registration Statement”) by Denali with the Securities and
Exchange Commission (the "SEC") relating to the previously
announced proposed Business Combination.
The Registration Statement contains a preliminary proxy
statement/prospectus in connection with the Business Combination.
While the Registration Statement has not yet become effective and
the information contained therein is subject to change, it provides
important information about Scilex and Denali, as well as the
proposed Business Combination.
For more information on Scilex Holding Company, refer to
www.scilexholding.com
For more information on Semnur Pharmaceuticals, refer to
www.semnurpharma.com
For more information on Scilex Holding Company Sustainability
Report, refer to www.scilexholding.com/investors/sustainability
For more information on ZTlido® including Full Prescribing
Information, refer to www.ztlido.com.
For more information on ELYXYB®, including Full Prescribing
Information, refer to www.elyxyb.com.
For more information on Gloperba®, including Full Prescribing
Information, refer to www.gloperba.com.
https://www.facebook.com/scilex.pharm
https://www.linkedin.com/company/scilex-holding-company/
info@scilexholding.com
About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating
company focused on acquiring, developing and commercializing
non-opioid pain management products for the treatment of acute and
chronic pain. Scilex targets indications with high unmet needs and
large market opportunities with non-opioid therapies for the
treatment of patients with acute and chronic pain and are dedicated
to advancing and improving patient outcomes. Scilex’s commercial
products include: (i) ZTlido® (lidocaine topical system) 1.8%, a
prescription lidocaine topical product approved by the U.S. Food
and Drug Administration (the “FDA”) for the relief of neuropathic
pain associated with postherpetic neuralgia, which is a form of
post-shingles nerve pain; (ii) ELYXYB®, a potential first-line
treatment and the only FDA-approved, ready-to-use oral solution for
the acute treatment of migraine, with or without aura, in adults;
and (iii) Gloperba®, the first and only liquid oral version of the
anti-gout medicine colchicine indicated for the prophylaxis of
painful gout flares in adults.
In addition, Scilex has three product candidates: (i) SP-102 (10
mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or
“SP-102”), a novel, viscous gel formulation of a widely used
corticosteroid for epidural injections to treat lumbosacral
radicular pain, or sciatica, for which Scilex has completed a Phase
3 study and was granted Fast Track status from the FDA in 2017;
(ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a
next-generation, triple-strength formulation of ZTlido, for the
treatment of acute pain and for which Scilex has recently completed
a Phase 2 trial in acute low back pain. SP-103 has been granted
Fast Track status from the FDA in low back pain; and (iii) SP-104
(4.5 mg, low-dose naltrexone hydrochloride delayed-release
capsules) (“SP-104”), a novel low-dose delayed-release naltrexone
hydrochloride being developed for the treatment of fibromyalgia,
for which Phase 1 trials were completed in the second quarter of
2022.
Scilex Holding Company is headquartered in Palo Alto,
California.
For more information on Scilex Holding Company, refer to
www.scilexholding.com
About Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical-late stage
specialty pharmaceutical company focused on the development and
commercialization of novel non-opioid pain therapies. Semnur’s lead
program, SP-102 (SEMDEXA™), is the first non-opioid novel gel
formulation administered epidurally in development for patients
with moderate to severe chronic radicular pain/sciatica.
Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto,
California.
For more information on Semnur Pharmaceuticals, refer to
www.semnurpharma.com
About Denali Capital Acquisition Corp.
Denali Capital Acquisition Corp. (Nasdaq: DECA, the “SPAC”) is a
blank check company formed for the purpose of effecting a merger,
share exchange, asset acquisition, share purchase, reorganization
or similar business combination with one or more businesses or
entities.
Important Information and Where to Find It
This press release relates to a proposed transaction between
Semnur and the SPAC and does not contain all the information that
should be considered concerning the potential business combination
and is not intended to form the basis of any investment decision or
any other decision in respect of the potential business
combination. 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, the SPAC filed relevant materials
with the SEC, including the Registration Statement, which includes
a proxy statement/prospectus. Investors and security
holders of the SPAC are urged to read these materials (including
any amendments or supplements thereto) and any other relevant
documents in connection with the transaction that the SPAC files
with the SEC when, and if, they become available because they will
contain important information about the SPAC, Semnur and the
proposed transaction. The preliminary proxy
statement/prospectus, the definitive proxy statement/prospectus and
other relevant materials in connection with the transaction (when
and if they become available), and any other documents filed by the
SPAC with the SEC, may be obtained free of charge at the SEC’s
website (www.sec.gov). The documents filed by the SPAC with the SEC
also may be obtained free of charge upon written request to:
Denali Capital Acquisition Corp.437 Madison Avenue, 27th
FloorNew York, NY 10022
Participants in the Solicitation
The SPAC, Semnur and their respective directors, executive
officers, other members of management and employees, under SEC
rules, may be deemed to be participants in the solicitation of
proxies of SPAC’s shareholders in connection with the Business
Combination. Investors and security holders may obtain more
detailed information regarding the names and interests in the
Business Combination of SPAC’s directors and officers in SPAC’s
filings with the SEC including the Registration Statement, which
includes the proxy statement of SPAC for the Business Combination,
and such information and names of Semnur’s directors and executive
officers are also in the Registration Statement, which includes the
proxy statement of SPAC for the Business Combination.
Non-Solicitation
This 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 the SPAC, the combined company or Semnur, 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 of 1933, as amended.
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting concerning the matters discussed in this
press release contain forward-looking statements related to Scilex
and its subsidiaries and the SPAC and are subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding the SPAC, Scilex and its subsidiaries, including but not
limited to Semnur, statements relating to Scilex’s declaration and
payment of the Dividend and timing thereof (including that the
Board may change the Record Date and, as a result, the payment date
of the Dividend), the expectation that the Semnur common stock to
be exchanged will be freely tradable upon such exchange, statements
regarding the proposed business combination between Semnur and the
SPAC, including the potential listing of the combined company’s
common stock and warrants on Nasdaq, obtaining the approval from
the SPAC’s shareholders, the expectation that the Registration
Statement will be declared effective by the SEC, the estimated or
anticipated future results and benefits of the combined company
following the proposed business combination, including the ability
of the parties to successfully consummate the proposed business
combination, the timing of the closing of the proposed business
combination, future opportunities for the combined company, Semnur
and the combined company’s proposed business strategies, the
estimated pre-transaction equity valuation of Semnur, the estimated
sales for SP-102, the Company’s outlook, goals and expectations for
2024, and the Company’s development and commercialization plans.
Although each of the SPAC and Scilex and its subsidiaries believes
that it has a reasonable basis for each forward-looking statement
contained in this press release, each of the SPAC and Scilex and
its subsidiaries caution you that these statements are based on a
combination of facts and factors currently known and projections of
the future, which are inherently uncertain. In addition, the risks
and uncertainties described in the proxy statement/prospectus
included in the Registration Statement relating to the proposed
transaction, and described in other documents filed by the SPAC or
Scilex from time to time with the SEC. These filings may identify
and address other important risks and uncertainties that could
cause actual events and results to differ materially from those
contained in the forward-looking statements. Neither the SPAC nor
Scilex and its subsidiaries can assure you that the forward-looking
statements in this communication will prove to be accurate.
Risks and uncertainties that could cause actual results of
Scilex and the SPAC to differ materially and adversely from those
expressed in our forward-looking statements, include, but are not
limited to: the inability of the parties to consummate any proposed
business combination transaction for any reason, including any
failure to satisfy or waive any closing conditions; changes in the
structure, timing and completion of the proposed transaction
between the SPAC and Semnur; the SPAC’s ability to continue its
listing on the Nasdaq Capital Market until closing of the proposed
transaction; the combined company’s ability to gain approval to
list its securities on Nasdaq upon closing of the proposed
transaction; the ability of the parties to achieve the benefits of
the proposed transaction, including future financial and operating
results of the combined company; the ability of the parties to
realize the expected synergies from the proposed transaction; risks
related to the outcome of any legal proceedings that may be
instituted against the parties following the announcement of the
proposed business combination; risks associated with the
unpredictability of trading markets; general economic, political
and business conditions; the risk that the potential product
candidates that Scilex develops may not progress through clinical
development or receive required regulatory approvals within
expected timelines or at all; risks relating to uncertainty
regarding the regulatory pathway for Scilex’s product candidates;
the risk that Scilex will be unable to successfully market or gain
market acceptance of its product candidates; the risk that Scilex’s
product candidates may not be beneficial to patients or
successfully commercialized; the risk that Scilex has overestimated
the size of the target patient population, their willingness to try
new therapies and the willingness of physicians to prescribe these
therapies; risks that the outcome of the trials and studies for
SP-102, SP-103 or SP-104 may not be successful or reflect positive
outcomes; risks that the prior results of the clinical and
investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or
SP-104 may not be replicated; regulatory and intellectual property
risks; and other risks and uncertainties indicated from time to
time and other risks described in Scilex’s and the SPAC’s most
recent periodic reports filed with the SEC, including the
Registration Statement and their Annual Reports on Form 10-K for
the year ended December 31, 2023 and subsequent Quarterly Reports
on Form 10-Q that the Company and the SPAC have respectively filed
or may file, including the risk factors set forth in those filings.
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release, and Scilex and the SPAC undertakes no obligation to update
any forward-looking statement in this press release except as may
be required by law.
Contacts:
Investors and MediaScilex Holding Company 960 San Antonio
RoadPalo Alto, CA 94303Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
Investors and MediaDenali Capital Acquisition Corp. 437 Madison
Avenue, 27th FloorNew York, NY 10022
SEMDEXA™ (SP-102) is a trademark owned by Semnur
Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding
Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex
Holding Company.
Gloperba® is the subject of an exclusive,
transferable license to Scilex Holding Company to use the
registered trademark.
ELYXYB® is a registered trademark owned by
Scilex Holding Company.
All other trademarks are the property of their
respective owners.
© 2024 Scilex Holding Company All Rights
Reserved.
Denali Capital Acquisition (NASDAQ:DECA)
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Denali Capital Acquisition (NASDAQ:DECA)
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から 11 2023 まで 11 2024