Scilex Holding Company’s Wholly Owned Subsidiary, Scilex Pharmaceuticals Inc., Entered into a Definitive Mutual Release and Settlement Agreement with Virpax Pharmaceuticals, Inc. Relating to the Previously Announced Term Sheet with Virpax in Respect of S
16 March 2024 - 12:00AM
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. Bankruptcy Court for the Southern District of Texas (the
“Court”), in connection with the bankruptcy proceedings of Sorrento
Therapeutics, Inc. (“Sorrento”), Scilex’s former controlling
stockholder, approved the settlement and mutual release agreement
(the “Definitive Settlement Agreement”) between Scilex’s wholly
owned subsidiary, Scilex Pharmaceuticals Inc. (“Scilex Pharma”),
and Sorrento, on the one hand, and Virpax Pharmaceuticals, Inc.
(“Virpax”), on the other hand. The Definitive Settlement Agreement
relates to the term sheet previously announced by Scilex on
February 26, 2024, regarding a mutual release and settlement
agreement between Scilex Pharma, Sorrento and Virpax in respect of
the action (the “Action”) filed by Scilex Pharma and Sorrento
(together, the “Plaintiffs”) against Anthony Mack, former President
of Scilex Pharma and Virpax, a company founded and then headed by
Mr. Mack. Pursuant to the Definitive Settlement Agreement, Virpax
is obligated to make the following payments to the Company: (i)
$3.5 million by March 18, 2024 (the “Initial Payment”); (ii) $2.5
million by July 1, 2024 (the “Second Payment”); and (iii) to the
extent any of the following drug candidates are ever sold, royalty
payments of (a) 6% of annual Net Sales (as defined in the
Definitive Settlement Agreement) of Epoladerm; (b) 6% of annual Net
Sales of Probudur; and (c) 6% of annual Net Sales of Envelta. Such
royalty payments will end upon the later of (i) expiration of the
last-to-expire valid patent claim of Virpax or its licensor
covering the manufacture, use or sale of such product in such
country; and (ii) expiration of any period of regulatory
exclusivity for such product in such country.
Pursuant to the Definitive Settlement Agreement, each of the
Plaintiffs and Virpax provide mutual releases of all claims that
exist as of March 14, 2024 (the date on which the Definitive
Settlement Agreement was approved by the Court), whether known or
unknown, arising from any allegations set forth in the Action. The
Plaintiffs’ release relates to claims against Virpax only, which
does not affect their claims against Mr. Mack. Plaintiffs have not
released Mr. Mack, and litigation against him remains ongoing.
Plaintiffs’ release as to Virpax is conditioned upon Virpax’s
Initial Payment.
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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Email: 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, expected to launch in the first half of 2024.
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 has 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 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 and a Phase 2 clinical trial is expected to commence 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 timing of the Initial
Payment and the Second Payment, each parties’ mutual releases of
all claims arising from the Action, the extent to which any of the
noted drug candidates are ever sold and any related royalty
payments in respect thereof, Scilex’s expectation to launch
Gloperba® in the first half of 2024 and plans to initiate a Phase 2
clinical trial in 2024 for SP-104.
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
COVID-19 (and other similar disruptions); 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 most recent
periodic reports filed with the Securities and Exchange Commission,
including Scilex’s Annual Report on Form 10-K for the year ended
December 31, 2023, 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 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 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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