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, announced the
consummation of the previously announced purchase of securities
from Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”).
Pursuant to that certain Stock Purchase Agreement entered into
on September [21], 2023, between Scilex and Sorrento, Scilex,
through its wholly-owned subsidiary, acquired (i) 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 (collectively,
the “Securities Transfer”) for aggregate consideration consisting
of: (i) $110 million (comprised of cash payments of $10 million in
the aggregate and assumption of approximately $100 million in
indebtedness of Sorrento as detailed in the next paragraph); 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 Scilex under the junior secured
debtor-in-possession financing facility provided by Scilex to
Sorrento.
Concurrently and in connection with the consummation of the
Securities Transfer, Scilex assumed approximately $100 million in
indebtedness of Sorrento owed to Oramed Pharmaceuticals Inc.
(Nasdaq: ORMP, “Oramed”) by entering into a Securities Purchase
Agreement with Oramed, pursuant to which, among other things,
Scilex (i) issued to Oramed (A) a senior secured promissory note in
the principal amount of $101,875,000, which is equal to the unpaid
principal and accrued and unpaid interest, fees and expenses under
Sorrento’s $100 million senior secured debtor in possession term
loan facility with Oramed, secured by a senior lien on
substantially all of the Company’s and its subsidiaries’ assets,
subject to certain exclusions (the “Note”), with an interest rate
of SOFR +8.5%, and (B) warrants to purchase up to 13.0 million
shares of Common Stock, subject to the terms and conditions set
forth therein (including vesting restrictions on 8.5 million of
such warrants), each with an exercise price of $0.01 and each with
restrictions on exerciseability, and (ii) caused to be transferred
from its wholly-owned subsidiary to Oramed outstanding warrants
previously held by Sorrento to purchase up to an aggregate of 4.0
million shares of Common Stock.
“This transaction demonstrates our commitment to deliver
long-term value to our shareholders and advance innovative
non-opioid therapies for acute and chronic pain patients. Our
talented team is dedicated in furthering improvements in the care
of patients to enhance quality of life,” said Jaisim Shah,
President and Chief Executive Officer of Scilex Holding
Company.
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® 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 Securities Transfer and
Note transactions, the use of any proceeds from such transactions,
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®, ELYXYBTM,
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
related to any restrictions on the operation of our business and
cash resources as a result of the Securities Transfer, the issuance
of the Note and issuance and transfer of the warrants; 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.
ELYXYBTM 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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