Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a
majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC:
SRNEQ, “Sorrento”), an innovative revenue-generating company
focused on acquiring, developing and commercializing non-opioid
pain management products for the treatment of acute and chronic
pain, announced that on September 11, 2023, Scilex, Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP, “Oramed”) and Sorrento executed
non-binding term sheets relating to, among other things, the
Securities Transfer (as defined below) (the “Securities Transfer
Term Sheet”) (which the official committee of unsecured creditors
and the official committee of equity security holders in Sorrento’s
bankruptcy cases have each signed as “Consenting Parties” thereto)
and the Note (as defined below) (the “Note Term Sheet” and together
with the Securities Transfer Term Sheet, the “Scilex Term Sheets”).
After a hearing before the Bankruptcy Court in Sorrento’s
bankruptcy cases on September 12, 2023, such court entered a final
order approving the Scilex Term Sheets. The Scilex Term Sheets are
subject to entry into definitive documentation relating thereto.
The transactions contemplated by the Scilex Term Sheets are
expected to close on or about September 19, 2023.
Pursuant to the Securities Transfer Term Sheet, the parties to
the Securities Transfer Term Sheet agreed that the Company would be
declared the new successful bidder and would acquire all of the
shares of Scilex common stock owned by Sorrento (other than such
shares held in abeyance by Sorrento on behalf of certain warrant
holders of Sorrento), (ii) all of the shares of Scilex preferred
stock owned by Sorrento, and (iii) all of the warrants for the
purchase of shares of Scilex common stock owned by Sorrento (the
“Transfer Warrants”)(collectively, the “Securities Transfer”) for
aggregate consideration consisting of: (i) $110 million (comprised
of cash payments of $10 million and assumption of certain
indebtedness of Sorrento in the amount of $100 million); plus (ii)
the assumption by the Company of certain legal fees and expenses in
the amount of approximately $12.25 million; plus (iii) a credit bid
of all amounts owed to the Company under the junior secured term
loan facility provided by the Company to Sorrento.
The Note Term Sheet provides that, among other things, the
Company will issue a senior secured note to Oramed in an amount
equal to the unpaid principal and accrued and unpaid interest under
Sorrento’s $100 million senior secured debtor in possession term
loan facility with Oramed (as noted above, the original aggregate
principal amount of such facility is $100 million), secured by a
senior lien on substantially all of the Company’s assets, subject
to certain exclusions as set forth in the Note Term Sheet (the
“Note”).
“This transaction is a testament to our significant execution
over the past few years as well as our board’s confidence in our
multi-faceted strategy to continue to build long term value for our
shareholders. Approximately four years ago, we successfully merged
Semnur Pharmaceuticals and Scilex Pharmaceuticals into Scilex
Holding Company. On November 10, 2022, we completed our business
combination to become a public company and began trading on Nasdaq
on November 11, 2022. Our achievements over these past years
demonstrates the ability of our management team to execute on its
goals. This transaction reinforces the confidence we have in
our strategy and our commitment to deliver long-term value to our
shareholders,” said Jaisim Shah, President and Chief Executive
Officer of Scilex.
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 SEMDEXA™, 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 Elyxyb™ 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 Elyxyb™ (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 Elyxyb™ in April 2023, and is
planning to commercialize Gloperba® in the fourth quarter of 2023,
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; 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 2023. For further information regarding
the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161
– Corticosteroid Lumbar Epidural Analgesia for Radiculopathy –
Full Text View – ClinicalTrials.gov.
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 consummation of the
Securities Transfer and the other transactions contemplated by the
Scilex Term Sheets, 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 Company’s ability to execute definitive
documents in respect of and to close the transactions contemplated
by the Scilex Term Sheets, in a timely manner or at all, the
failure to satisfy conditions to completion of the transactions
contemplated by the Scilex Term Sheets, including receipt of
required approvals, or the failure to close such transactions for
any other reason; the occurrence of any event, change or other
circumstances that could give rise to the termination of the
transactions contemplated by the Scilex Term Sheets or the
definitive documentation relating thereto; 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 results of the Phase 2 trial for SP-103 or Phase 1 trials for
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 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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