Virpax Pharmaceuticals Announces the Formation of Novvae™ Pharmaceuticals
18 9월 2023 - 8:58PM
Business Wire
--Novvae to Focus Exclusively on OTC Product
Candidates—
--Clinical Trials for Virpax Rx Pipeline are
Anticipated for 2024--
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 viral barrier
indications, today announced that it has formed a new wholly-owned
subsidiary, Novvae™ Pharmaceuticals, Inc. (Novvae), which has been
established to focus exclusively on advancing Virpax’s OTC
pipeline.
“The formation of Novvae allows Virpax to focus exclusively on
the development of its Rx product pipeline as we advance our lead
product candidate, Probudur™ and prepare to enter Phase 2 human
clinical trials in 2024. We are also looking to advance Envelta™
and expect to enter Phase 1 human clinical trials next year,”
commented Anthony P. Mack, Chairman and CEO of Virpax
Pharmaceuticals.
AnQlar™ will be the first asset added to the Novvae pipeline.
AnQlar is being developed as a prophylactic once-a-day antiviral
nasal spray. AnQlar utilizes a pre-filled intranasal device that is
formulated using a chitosan derivative in a nanoparticle
dispersion. Chitosan is a natural anti-microbial. In several
preclinical studies, AnQlar demonstrated 24-hour anti-viral barrier
activity against both Influenza and Covid. AnQlar has completed
IND-enabling studies and Novvae will assume responsibility for
future development leading to its first in human trials.
Additionally, Virpax is in advanced discussions for global
rights of first refusal on two differentiated non-prescription
assets. Should the Company acquire these product candidates, they
would be added to the Novvae pipeline.
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
two other product candidates. PES200 is a product candidate being
developed to manage post-traumatic stress disorder (PTSD) and
NobrXiol™ is a product candidate being developed for the nasal
delivery of a pharmaceutical-grade cannabidiol (CBD) for the
management of rare pediatric epilepsy. 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
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and Private
Securities Litigation Reform Act, as amended, including those
relating to the Company's planned clinical trials, product
development, clinical and regulatory timelines, market opportunity,
competitive position, possible or assumed future results of
operations, business strategies, potential growth opportunities and
other statements that are predictive in nature. 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 formation of Novvae allowing the Company to focus
exclusively on the development of its Rx product pipeline,
advancing Probudur™ and preparing to enter Phase 2 human clinical
trials in 2024, advancing Envelta™ and entering Phase 1 human
clinical trials next year, future development by Novvae leading to
first in human trials for AnQlar, the Company acquiring the global
rights of first refusal on two differentiated non-prescription
assets and adding the product candidates to the Novvae pipeline.
These statements relate to future events or the Company’s financial
performance and involve known and unknown risks, uncertainties, and
other factors, including the ability to be in Phase 2 human
clinical trials for Probudur™ in 2024; the ability to be in Phase 1
human clinical trials for Envelta™ in 2024; the ability to be in
first in human trials for AnQlar; the ability to acquire the global
rights of first refusal on two differentiated non-prescription
assets as planned; the ability to continue the development of the
Company’s patent portfolio; the ability of the nose to brain
intranasal drug delivery pathway to lessen drug-to drug interaction
and reduce drug dosing; the Company’s ability to successfully
complete research and further development and commercialization of
Company drug candidates in current or future indications; the
uncertainties inherent in clinical testing; 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 loss of any executive officers or key personnel or
consultants; competition; changes in the regulatory landscape or
the imposition of regulations that affect the Company's product
candidates; the Company’s ability to continue 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 for the year ended December 31, 2022, and the
Company’s quarterly reports on Form 10-Q, the Company’s Current
Reports on Form 8-K and subsequent filings 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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Investor Relations
Contact:
Betsy Brod Affinity Growth Advisors
Betsy.brod@affinitygrowth.com (917) 923-8541
Media Contact:
Robert Cavosi RooneyPartners rcavosi@rooneypartners.com (646)
638-9891
Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024