Virpax Pharmaceuticals Announces Proposed Settlement of Litigation with Sorrento Therapeutics, Inc. and Scilex Pharmaceuticals, Inc.
February 27 2024 - 7:30AM
Business Wire
Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”)
(NASDAQ: VRPX), a company specializing in developing
non-addictive products for pain management, post-traumatic stress
disorder, central nervous system (CNS) disorders and anti-viral
barrier indications, today announced that it has entered into a
term sheet to settle the litigation with the Company and Sorrento
Therapeutics, Inc. (Sorrento) and Scilex Pharmaceuticals, Inc.
(Scilex and Sorento, collectively, the “Plaintiffs”). The term
sheet sets forth the principal terms of a mutual release and
settlement agreement to be entered into by the Company and the
Plaintiffs. However, if the parties fail to do so by or before
March 1, 2024, the term sheet will become binding.
As part of the settlement, the parties have agreed to a cash
payment from Virpax to the Plaintiffs of $3.5 million by March 1,
2024, and $2.5 million by July 1, 2024, to settle all claims
against Virpax. Additionally, Virpax will pay the plaintiffs
royalties of 6% of annual net sales of products developed from drug
candidates Epoladerm™, Probudur™ or Envelta™ until the expiration
of the last-to-expire valid patent claim and the expiration of any
period of regulatory exclusivity. Each party releases all claims
against the other party and neither party admits liability for any
claim including those asserted in the lawsuit. Plaintiff’s release
of Virpax is conditioned upon Virpax making its initial
payment.
“I am pleased that we were able to bring this litigation to a
satisfactory conclusion,” stated Gerald Bruce, CEO of Virpax
Pharmaceuticals. “We are now able to fully focus all of our efforts
on the development of our drug product candidates as well as the
Investigational New Drug Applications (IND) for our two lead
programs.”
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
products candidates using its proprietary technologies to optimize
and target drug delivery. Virpax is initially seeking FDA approval
for two prescription drug candidates that employ two different
patented drug delivery platforms. Probudur™ is a single injection
liposomal bupivacaine formulation being developed to manage
post-operative pain and Envelta™ is an intranasal molecular
envelope enkephalin formulation being developed to manage acute and
chronic pain, including pain associated with cancer. Virpax is also
using its intranasal Molecular Envelope Technology (MET) to develop
one other prescription product candidate, NobrXiol™, which is being
developed for the nasal delivery of a pharmaceutical-grade
cannabidiol (CBD) for the management of rare pediatric epilepsy.
Virpax has competitive cooperative research and development
agreements (CRADAs) for two of its prescription drug candidates,
one with the National Institutes of Health (NIH) and one with the
Department of Defense (DOD). Virpax is also seeking approval of two
nonprescription product candidates: AnQlar, which is being
developed to inhibit viral replication caused by influenza or
SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray
film formulation being developed to manage pain associated with
osteoarthritis. For more information, please visit virpaxpharma.com
and follow us on Twitter, LinkedIn and YouTube.
Forward-Looking Statements
This press release contains certain forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995, as amended, including those described below. These
forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets
in which we operate and management's current beliefs and
assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate,"
"intend," "plan," "believe," "estimate," "potential,” "predict,"
"project," "should," "would" and similar expressions and the
negatives of those terms and include statements regarding the entry
into a definitive agreement, the timing of the payments, each
parties releases of claims, and the extent to which any of the
noted drug candidates are ever sold and related royalty payments in
respect thereof. These statements relate to future events and
involve known and unknown risks, uncertainties, and other factors,
including the inability of the Company to satisfy the terms of the
final settlement agreement, including the payment of amounts owed
thereunder the Company’s ability to obtain FDA approval for its
prescription drug candidates and nonprescription drug candidates;
the Company’s ability to maintain competitive cooperative research
and development agreements (CRADAs) for its prescription drug
candidates; the Company’s ability to successfully complete research
and further development and commercialization of Company drug
candidates in current or future indications; the Company’s ability
to obtain additional grants to help fund upcoming clinical trials;
the Company’s ability to move ahead with remaining confirmational
studies for Probudur and Envelta™ as planned; the Company’s ability
to manage and successfully complete clinical trials and the
research and development efforts for multiple product candidates at
varying stages of development; the timing, cost and uncertainty of
obtaining regulatory approvals for the Company’s product
candidates; the Company’s ability to protect its intellectual
property; the Company’s ability to obtain capital to meet its
long-term liquidity needs on acceptable terms, or at all, including
the additional capital which will be necessary to complete clinical
trials that the Company plans to initiate and other factors listed
under "Risk Factors" in the Company’s Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q that the Company has filed with
the U.S. Securities and Exchange Commission. Prospective investors
are cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20240227926537/en/
Investor Relations: Betsy
Brod Affinity Growth Advisors Betsy.brod@affinitygrowth.com (917)
923-8541
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