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, today announced that
the U.S. Patent and Trademark Office has allowed numerous claims
from U.S. patent application no. 17/562,229 and will issue a new
patent containing those claims related to the treatment of acute
pain (the “Patent”), to Scilex in late 2024, further strengthening
the Company’s intellectual property position and coverage for its
acute migraine treatment drug product, ELYXYB®, a liquid,
micro-encapsulation formulation of celecoxib. The Patent, titled
“Methods of Treating Pain,” covers methods of treating acute pain.
Clinicians in a recent market research study expressed their
desire for fast and safe alternatives for two large pools of acute
migraine patients – those who have an insufficient response to
triptan therapy and those who have contraindications to triptan
use. ELYXYB®’s product profile mapped with a high degree of
certainty to these stated unmet needs. In clinical studies,
patients treated with ELYXYB® demonstrated pain relief in as little
as 15 minutes, and significant pain relief compared to placebo
within 45 minutes in approximately 50% of patients.6,7
“We are very excited about the potential of ELYXYB® since
launching the product in the U.S. in April 2023. This is a highly
complementary commercial asset that allows us to provide physicians
with another tool in their pain management armamentarium to treat
migraines earlier in the patient’s journey. These new patents will
provide the ability to file application in the future for acute
pain,” said Jaisim Shah, Chief Executive Officer and President of
Scilex.
For more information on Scilex Holding Company, refer to
www.scilexholding.com
For more information on Semnur Pharmaceuticals, Inc., 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.
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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) (“SEMDEXATM” 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 chronic neck pain and for which Scilex has recently
completed a Phase 2 trial in 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.
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.
About Denali Capital Acquisition Corp.
Denali Capital Acquisition Corp. (“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 will file relevant materials
with the SEC, including a registration statement on Form S-4, which
will include 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 and its directors and executive officers may be deemed
participants in the solicitation of proxies from the SPAC’s
shareholders with respect to the proposed business combination.
Information about the SPAC’s directors and executive officers and a
description of their interests in the SPAC will be included in the
proxy statement/prospectus for the proposed transaction and will be
available at the SEC’s website (www.sec.gov). Additional
information regarding the interests of such participants will be
contained in the proxy statement/prospectus for the proposed
transaction when available.
Semnur and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
shareholders of the SPAC in connection with the proposed business
combination. Information about Semnur’s directors and executive
officers and information regarding their interests in the proposed
transaction will be included in the proxy statement/prospectus for
the proposed transaction.
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 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 SPAC will file a registration statement on
Form S-4 with the SEC, which would include a proxy
statement/prospectus, 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, there will
be risks and uncertainties described in the proxy
statement/prospectus included in the registration statement on Form
S-4 relating to the proposed transaction, which is expected to be
filed by the SPAC with the SEC, 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 meet applicable 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 list its securities
on Nasdaq after 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 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
Reference
1) Source: Celecoxib Oral Solution Approved for
Acute Migraine March
2020. https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migraine2) Source:
Evaluate Pharma data February 16,
20233) Bunchorntavakul C, Reddy K. Acetaminophen
(APAP or N-Acetyl-p-Aminophenol) and Acute Liver Failure. Clin
Liver Dis. 2018 May;22(2):325-346. PMID:
296050694) DelveInsight Acute Pain - Market
Insight, Epidemiology And Market Forecast – 2032; Dec 2022;
https://www.delveinsight.com/report-store/acute-pain-market#:~:text=The%20DelveInsight's%20acute%20pain%20market,be%20either%20acute%20or%20chronic 5) Source:
Acute Migraine Headache: Treatment Strategies.
https://www.aafp.org/pubs/afp/issues/2018/0215/p243.html6) Data
on file. Scilex Holding Company7) Lipton RB, et
al. J Pain Res 2021; 14:549-560.
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.
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