Scilex Holding Company’s Wholly Owned Subsidiary, Scilex Pharmaceuticals Inc., Enters into a Term Sheet with Virpax Pharmaceuticals, Inc. Regarding a Mutual Release and Settlement Agreement
February 26 2024 - 4:53PM
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
its wholly owned subsidiary, Scilex Pharmaceuticals Inc. (“Scilex
Pharma”), and Sorrento Therapeutics, Inc. (“Sorrento”) entered into
a term sheet with Virpax Pharmaceuticals, Inc. (“Virpax”) regarding
a mutual release and settlement agreement (the “Settlement Term
Sheet”) relating to an 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 Settlement Term Sheet, the
parties have agreed to enter a definitive settlement agreement by
or before March 1, 2024 to resolve the ongoing disputes and provide
for, among other things, that Virpax will be obligated to make the
following payments to the Company to settle the Action: (i) $3.5
million by March 1, 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 Settlement Term
Sheet) 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 (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.
Each of the Plaintiffs and Virpax provides mutual
releases of all claims that exist as of the date of the execution
of the Settlement Term Sheet, 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.
The Plaintiffs and Virpax are required to make best efforts to
enter into a definitive agreement with respect to the terms set
forth in the Settlement Term Sheet, but if they fail to do so by or
before March 1, 2024, such term sheet will be binding and
enforceable with respect to all the terms set forth therein.
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.
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 2024.
In addition, Scilex has three product candidates:
(i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel)
(“SEMDEXA™” 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; (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; 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 Second Payment, timing of entering into a definitive
settlement agreement, the settlement of the Action, each parties’
mutual releases of all claims arising from the Action, and the
extent to which any of the noted drug candidates are ever sold and
any related royalty payments in respect thereof.
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, 2022 and subsequent Quarterly
Reports on Form 10-Q filed with the Securities and Exchange
Commission, 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 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.
© 2024 Scilex Holding Company All Rights
Reserved.
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