Attached files
Exhibit 99.3
VistaGen
Therapeutics Announces Receipt of $5 Million Non-Dilutive Upfront
License Payment from EverInsight
Therapeutics for PH94B Strategic Collaboration
Collaboration intended to support Phase 3 development and
commercialization of PH94B for anxiety-related disorders in key
Asian markets
SOUTH SAN FRANCISCO, Calif. and Shanghai, China, August 4,
2020 –
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.
VistaGen Contacts:
Company
Mark A.
McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email: IR@vistagen.com