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, retains Warshaw
Burstein, LLP and Christian Attar Law to investigate potential
naked short selling activities, short positions, lending program
activities and constitute market manipulation of its restricted
shares of common stock that were part of the previously announced
dividend of Scilex common stock (the “Restricted Dividend Shares”)
then-held by Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”)
that breach the restrictions on transfer which are currently in
place through March 31, 2024 on these Restricted Dividend
Shares.
As previously announced on October 3, 2023 and October 4, 2023,
Scilex currently maintains two programs in place for short sellers
and lenders having short positions of the Restricted Dividend
Shares. Those two programs allow short sellers (the “Short Seller
Proposal”) and lenders (the “Lender Proposal”) of short positions
to opt into settlements of their short positions and related relief
by purchasing shares in the open market in order to close or cover
the short positions and close out the short lending programs. On
October 3, 2023, Scilex notified all record holders of the Short
Seller Proposal via email and express mail. This Short Seller
Proposal was commenced on October 5, 2023 and continues until
October 27, 2023. On October 4, 2023, Scilex notified all lenders
of short positions via email and express mail. The Lender should
notify the short sellers to follow the same procedures outlined in
the Short Seller Proposal. This Lender Proposal shall commence on
October 9, 2023 and continue until October 31, 2023.
Scilex believes it has been targeted by stock manipulators to
drive the market price of its securities downward. Scilex has
decided to investigate any potential wrongdoing and is reserving
all the rights to seek any damages from short sellers and lenders
of short positions who have engaged in market manipulation schemes
and have not fully participated in the two programs for voluntary
settlements. Warshaw Burstein, LLP and Christian Attar Law have
decades of experience investigating and successfully prosecuting
claims of market manipulation against short sellers and lenders of
short positions. Recently, on September 29, 2023, Warshaw Burstein
and Christian Attar Law prevailed against formidable opposition
from major banks and brokerage houses in a decision in the U.S.
district court for the southern district of New York holding that
broker-dealers could be held primarily liable for failing to
fulfill their “Gatekeeping Responsibilities” of monitoring their
clients’ trading activities. For further details see
https://www.wbny.com/Warshaw-Burstein-Prevails-Against-Major-Banks-and-Brokerage-Houses-Opposition
About Warshaw Burstein, LLP
Warshaw Burstein, LLP is a full-service law firm
in New York City, that since its formation 97 years ago, has
distinguished itself through superior and cost-effective legal
service and personalized client care and attention. For more
information, please visit www.wbny.com or visit LinkedIn, Facebook
and Twitter: @warshawburstein.
About Christian Attar Law
Christian Attar engages in all types of civil
litigation, including shareholder and partnership disputes, and
stock fraud. The Group operates domestically and internationally,
with its corporate headquarters based in Houston, Texas.
To learn more about the company, visit
ChristianAttarLaw.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 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 is pending official minutes in writing
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 acute low back 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 neck pain which also has showed promising top-line
efficacy and safety results. Scilex is planning to initiate Phase
2/3 trial in 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 Scilex retaining Warshaw
Burstein, LLP and Christian Attar Law to investigate activities
that constitute market manipulation of its stock price, the
anticipated timing for completion of the Short Seller Proposal and
Lender Proposal and procedures for participating in the Short
Seller Proposal and Lender Proposal and executing a release
agreement, Scilex’s beliefs of the scale of short selling, lending
program activities and market manipulation of its stock price,
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-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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