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 filed an
emergency motion (the “Motion”) for entry of an order compelling
the production of books and records from certain brokers, dealers,
banks and other nominees pursuant to Rule 2004 of the federal rules
of bankruptcy procedure in the U.S. Bankruptcy Court for the
Southern District of Texas (the “Bankruptcy Court”).
Attached to this press release is the court motion filed by Scilex
on October 27, 2023.
On October 3, 2023, Scilex provided a proposal to parties with
short positions (the “Short Sellers”) in shares of Scilex common
stock that were part of the previously announced dividend
of Scilex common stock (the “Scilex Dividend Stock”)
then-held by Sorrento Therapeutics, Inc. (OTC: SRNEQ,
“Sorrento”) who had not yet closed or covered their respective
short positions in the Scilex Dividend Stock (“Short Seller
Proposal”). As previously noted, Scilex believes that, with no
objections from the participating Short Sellers and with widespread
support and assistance from such Short Sellers’ brokers and/or
agents, there should be no further excuses for continuing to hold
the short positions in Scilex. The Short Seller Proposal provided
those Short Sellers with the opportunity to cover their short
positions and avoid any continuing fees, interest, and other
expenses associated with any short positions, as well as an
opportunity to accept the terms provided in Sorrento’s ongoing
Chapter 11 proceedings in order to obtain a release from Scilex for
any claims and causes of action related to any potential naked
short selling or other similar market manipulative
behavior. The Short Seller Proposal ended on October
27, 2023.
On October 4, 2023, Scilex also provided a similar proposal to
the lenders of the short positions in Scilex Dividend Stock held by
the Short Sellers (“Lender”). Specifically, under this “Lender
Proposal,” (i) any Lender that requires the immediate return of
Scilex Dividend Stock that was loaned to Short Sellers, and (ii)
once the applicable Short Sellers have closed out such short
positions in the Scilex Dividend Stock, Scilex will provide a
release of any claims and causes of action related to naked short
selling or other similar market manipulative behavior. Such release
will be provided after Scilex receives written confirmation of the
above two actions. This Lender Proposal is still in effect and will
end on October 31, 2023.
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 is uncompromising in its focus to become the
global pain management leader committed to social, environmental,
economic, and ethical principles to responsibly develop
pharmaceutical products to maximize quality of life. Results from
the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXATM, its
novel, non-opioid product for the treatment of lumbosacral
radicular pain (sciatica), were announced in March 2022. Scilex
participated in the type C meeting for purposes of pre-NDA
discussion with the FDA and reached agreement path forward to file
an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain
(Sciatica) from the FDA. Scilex targets indications
with high unmet needs and large market opportunities with
non-opioid therapies for the treatment of patients with moderate to
severe pain. Scilex launched its first commercial product
ZTlido® in October 2018, in-licensed a commercial product Gloperba®
in June 2022, and launched its third FDA-approved product ElyxybTM
in April 2023. It is also developing its late-stage pipeline, which
includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase
1 candidate. Its commercial product, ZTlido® (lidocaine
topical system) 1.8%, or ZTlido®, is a prescription lidocaine
topical product approved by the U.S. Food and Drug Administration
for the relief of pain associated with post-herpetic neuralgia,
which is a form of post-shingles nerve pain. Scilex
in-licensed the exclusive right to commercialize Gloperba®
(colchicine USP) oral solution, an FDA-approved prophylactic
treatment for painful gout flares in adults, in the U.S. Scilex
in-licensed the exclusive rights to commercialize ElyxybTM
(celecoxib oral solution) in the U.S. and Canada, the only
FDA-approved ready-to-use oral solution for the acute treatment of
migraine, with or without aura, in adults. Scilex launched ElyxybTM
in April 2023, and is planning to commercialize Gloperba® by 2024,
and is well-positioned to market and distribute those
products. Scilex’s three product candidates are SP-102
(injectable dexamethasone sodium phosphate viscous gel product
containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, with FDA Fast Track status; SP-103 (lidocaine topical
system) 5.4%, a Phase 2 study, triple-strength formulation of
ZTlido®, for the treatment of chronic neck pain, with FDA Fast
Track status. We received our SP-103 Phase 2 top-line results in
August 2023 and the trial achieved its objectives characterizing
safety, tolerability and preliminary efficacy of SP-103 in [acute
low back pain associated with muscle spasms]. SP-103 was safe and
well-tolerated. Increase of lidocaine load in topical system by
three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not
result in signs of systemic toxicity or increased application site
reactions with daily applications over one month treatment. We will
continue to analyze the SP-103 Phase 2 trial data along with a
recently completed investigator study of ZTlido in patients with
chronic neck pain which also has showed promising top-line efficacy
and safety results. Scilex is planning to initiate Phase 2/3 trial
in chronic neck pain in 2024; and SP-104, 4.5 mg Delayed Burst
Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for
the treatment of chronic pain, fibromyalgia that has completed
multiple Phase 1 trial programs and is expected to initiate Phase 2
trials in 2024.
Scilex Holding Company is headquartered in Palo Alto,
California.
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 under the safe harbor provisions of Section
21E of the Private Securities Litigation Reform Act of 1995 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 Motion and the
potential for the Bankruptcy Court to refuse to grant the Motion,
statements regarding the anticipated timing for completion of the
Lender Proposal and procedures for participating in the Lender
Proposal and executing a release agreement, Scilex’s plans to
initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans
to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that
it is well positioned to continue its growth over the next several
years, Scilex’s long-term objectives and commercialization plans,
Scilex’s potential to attract new capital, future opportunities for
Scilex, Scilex’s future business strategies, the expected cash
resources of Scilex and the expected uses thereof; Scilex’s current
and prospective 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; statements regarding ZTlido®,
Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or
SP-104, if approved by the FDA; Scilex’s development and
commercialization plans; and Scilex’s products, technologies and
prospects.
Risks and uncertainties that could cause Scilex’s actual results
to differ materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
associated with the unpredictability of trading markets and whether
a market will be established for Scilex’s common stock; general
economic, political and business conditions; risks related to the
ongoing COVID-19 pandemic; 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 for SP-102, SP-103
or SP-104 may not be successful; risks that the prior results of
the clinical 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 set forth in Scilex’s filings with the Securities and
Exchange Commission. 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 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
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 use the registered trademark by Scilex
Holding Company.
ELYXYB® is the subject of an exclusive,
transferable license to use the registered trademark by Scilex
Holding Company.
All other trademarks are the property of their
respective owners.
© 2023 Scilex Holding Company All Rights
Reserved.
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