SOUTH SAN FRANCISCO, Calif. and
SHANGHAI, Aug. 4, 2020 /PRNewswire/ -- VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for anxiety, depression
and other central nervous system (CNS) disorders, today announced
receipt of a $5 million non-dilutive
upfront license payment from EverInsight Therapeutics Inc., the
Company's strategic partner focusing on development and
commercialization of PH94B for treatment of anxiety-related
disorders in multiple key markets in Asia.
Previously, VistaGen and EverInsight announced that EverInsight
is responsible for clinical development, regulatory submissions and
commercialization of PH94B, VistaGen's investigational rapid-onset
neuroactive nasal spray, initially for acute treatment of anxiety
in adults with social anxiety disorder, in Greater China (Mainland China, Hong Kong, Macau and Taiwan), South
Korea and Southeast Asia
(Indonesia, Malaysia, Philippines, Thailand and Vietnam). VistaGen is eligible to receive
potential milestone payments, in addition to tiered royalties on
commercial sales, upon achievement of certain development and
commercialization milestones.
About VistaGen
VistaGen Therapeutics is a
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety, depression and certain CNS diseases and
disorders where current treatments are believed by VistaGen to be
inadequate, resulting in high unmet need. Each of VistaGen's three
drug candidates has a differentiated mechanism of action, an
exceptional safety profile, and therapeutic potential in multiple
CNS markets. For more information, please visit www.vistagen.com
and connect with VistaGen on
Twitter, LinkedIn and Facebook.
About EverInsight Therapeutics
EverInsight
Therapeutics Inc. is a biopharmaceutical company focused on
developing and commercializing transformative pharmaceutical
products that address critical unmet medical needs in CNS and
ophthalmology for patients in Greater
China and other Asian markets. The management team of
EverInsight Therapeutics has deep expertise and an extensive track
record of high-quality clinical development, regulatory affairs,
CMC, business development and operations both in China and with leading global pharmaceutical
companies. EverInsight Therapeutics is currently funded by the CBC
Group.
About CBC Group
CBC Group (formerly C-Bridge Capital)
is one of the largest and most active healthcare-dedicated
investment firms in Asia focused
on platform-building and buyout opportunities across three core
areas within the healthcare sector: pharmaceutical & biotech,
medtech and healthcare services. CBC's operationally intensive
approach empowers healthcare sector champions to make
transformative changes to enable sustainable long-term growth,
fulfill unmet medical needs and continuously improve the standard
of living and quality of care in China and the rest of Asia. Founded in 2014, CBC has a strong team
of investment, healthcare and portfolio management professionals
based across Singapore,
Shanghai, Beijing, Hong
Kong and New York.
About PH94B
PH94B is a rapid-onset (within
approximately 15 minutes) synthetic neurosteroid nasal spray with
therapeutic potential across a broad range of anxiety-related
disorders. Easily self-administered in microgram-level doses, PH94B
does not require systemic uptake and distribution to produce its
rapid-onset anti-anxiety effects.
VistaGen is preparing for Phase 3 clinical development of PH94B
as a potential new generation fast-acting, non-sedating,
non-addictive acute treatment of anxiety in adults with social
anxiety disorder (SAD). The FDA has granted Fast Track designation
for development of PH94B for this indication, the first such
designation by the FDA for a drug candidate for SAD.
With its rapid-onset pharmacology, lack of systemic exposure and
excellent safety profile in earlier studies, PH94B has potential as
a novel treatment for multiple anxiety-related disorders.
VistaGen is also preparing for Phase 2A development of PH94B for
adjustment disorder.
Forward-Looking Statements
Various statements in this
release are "forward-looking statements" concerning VistaGen's
future expectations, plans and prospects, including the potential
for successful Phase 3 development and commercialization of PH94B.
These forward-looking statements are neither promises nor
guarantees of future performance, and are subject to a variety of
risks and uncertainties which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: development and approval of
PH94B may not be achieved in any market; the FDA may decide that
the results of the Company's PH94B Phase 3 development program,
including EverInsight's contributions to the Company's Phase 3
development program, are not sufficient for regulatory approval for
acute treatment of anxiety in adult patients with SAD or any other
anxiety-related disorder in any market; development of PH94B may
not be successful in any indication; success in nonclinical studies
or in earlier-stage clinical trials may not be repeated or observed
in future studies which may not support further development or be
sufficient to gain regulatory approval to market PH94B in any
jurisdiction; adverse events may be encountered at any stage of
development that negatively impact further development. Other risks
and uncertainties include, but are not limited to, issues related
to: adverse healthcare reforms and changes of laws and regulations;
general industry and market conditions; manufacturing and marketing
risks, which may include, but are not limited to, unavailability of
or delays in delivery of raw materials for manufacture of PH94B;
inadequate and/or untimely supply of PH94B to meet clinical
development or commercial demand; entry of competitive products;
and other technical and unexpected hurdles in the development,
manufacture and commercialization of PH94B, as well as those risks
more fully discussed in the section entitled "Risk Factors" in
VistaGen's most recent Annual Report on Form 10-K for the year
ended March 31, 2020, as well as
discussions of potential risks, uncertainties, and other important
factors in either company's other filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent the Company's views only as of today and should not be
relied upon as representing its views as of any subsequent date.
The Company explicitly disclaims any obligation to update any
forward-looking statements.
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SOURCE VistaGen Therapeutics