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8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k_june242020.htm |
EX-10.1 - MATERIAL CONTRACTS - VistaGen Therapeutics, Inc. | ex10-1.htm |
Exhibit 99.1
VistaGen
Therapeutics and
EverInsight
Therapeutics Enter Strategic Collaboration to Develop and
Commercialize PH94B for Anxiety Disorders in Greater China, South
Korea and Southeast Asia
Collaboration intended to support Phase 3 development and
commercialization of PH94B in key Asian markets
Agreement includes $5 million upfront payment and development and
commercial milestones up to $172 million
SOUTH SAN FRANCISCO, Calif. and Shanghai, China, June 25,
2020 –
VistaGen Therapeutics
(NASDAQ: VTGN), a
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety, depression and other central nervous system
(CNS) diseases and disorders with high unmet need, and EverInsight
Therapeutics Inc., a biopharmaceutical company focused on
developing and commercializing transformative pharmaceutical
products that address critical unmet medical needs for patients in
Greater China and other parts of Asia, today announced they
have entered into a strategic licensing and collaboration agreement
for the clinical development and commercialization of PH94B,
VistaGen’s novel, rapid-onset neurosteroid drug candidate for
multiple anxiety-related disorders, in Greater China, South Korea
and Southeast Asia. In December 2019, VistaGen received Fast Track
designation from the U.S. Food and Drug Administration (FDA) for
development of PH94B for treatment of social anxiety disorder
(SAD), the FDA's first Fast Track designation for a SAD drug
candidate. The goal of the collaboration is to advance and support
Phase 3 development and commercialization of PH94B as a potentially
groundbreaking anti-anxiety medicine for patients in Greater China
and other important Asian markets.
Under the terms of the agreement, EverInsight will be responsible
for clinical development, regulatory submissions and
commercialization of PH94B neuroactive nasal spray for acute
treatment of SAD, and potentially other anxiety-related
indications, in markets in Greater China (Mainland China, Hong
Kong, Macau and Taiwan), South Korea and Southeast Asia (Indonesia,
Malaysia, Philippines, Thailand and Vietnam) (the Territory).
EverInsight will make a non-dilutive upfront payment of $5 million
to VistaGen, and VistaGen is eligible to receive additional
development and commercial milestone payments of up to $172
million. VistaGen will receive tiered royalties on sales of PH94B
in the Territory, if Phase 3 development efforts are successful.
VistaGen retains exclusive rights to develop and commercialize
PH94B in all markets outside the Territory.
"We are pleased to collaborate with EverInsight, a company that
shares our vision and excitement for bringing PH94B, a potentially
transformative treatment for multiple anxiety disorders, to
millions of individuals with unmet needs around the world.
EverInsight is an ideal partner to support Phase 3 clinical
development and commercial launch of PH94B in Greater China and
other Asian markets, as we continue to focus on those activities in
the U.S.,” stated Shawn
Singh, Chief Executive Officer of VistaGen. “Anxiety, including social anxiety
disorder, is a common and potentially debilitating illness that can
have significant emotional, functional and economic effects on
those who suffer, as well as their families, friends and
colleagues. With the recent onset of mental health stressors
associated with the COVID-19 pandemic and social justice unrest,
the rising prevalence of anxiety, depression, and suicide is
alarming. PH94B has a fundamentally different mechanism of action
than all current treatments for social anxiety disorder and
numerous other anxiety disorders, arguably the first new
rapid-onset mechanism of action for treatment of anxiety in several
decades. Our strategic collaboration today with EverInsight
positions PH94B one step closer to becoming a potentially
paradigm-shifting new treatment alternative for individuals
worldwide.”
“We partner with innovative companies that develop novel
medicines with large commercial potential in Greater China and
other Asian markets. PH94B is an extremely valuable asset that the
world desperately needs today to provide potential relief from the
debilitating impact of anxiety on daily life,” said Sean Cao,
Managing Director of CBC Group, which is currently funding
EverInsight. “We are delighted to partner with
VistaGen’s team and are highly confident in our plan to
advance PH94B through the necessary clinical development and
approval process focused on successful commercialization in our
core markets.”
About VistaGen
VistaGen
Therapeutics is a multi-asset, clinical-stage biopharmaceutical
company developing new generation medicines for anxiety, depression
and certain CNS diseases and disorders where current treatments are
inadequate, resulting in high unmet need.
VistaGen's pipeline is focused on
three clinical-stage CNS drug candidates, each with a
differentiated mechanism of action, an exceptional safety profile,
and therapeutic potential in multiple large and growing 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 first-in-class, odorless, 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 doses, PH94B does
not require systemic uptake and distribution to produce its
rapid-onset anti-anxiety effects. VistaGen is initially developing
PH94B as a potential fast-acting, non-sedating, non-addictive new
generation acute treatment of social anxiety disorder (SAD), as
well as for adjustment disorder with anxiety related to the
COVID-19 pandemic. With its rapid-onset pharmacology, lack of
systemic exposure and excellent safety profile, PH94B also has
potential as a novel treatment for postpartum anxiety,
post-traumatic stress disorder, preoperative anxiety, panic
disorder and other anxiety-related disorders. VistaGen is preparing
for Phase 3 clinical development of PH94B for SAD and Phase 2A
development for AjDA associated with the COVID-19 pandemic. The FDA
has granted Fast Track designation for development of PH94B as a
treatment for SAD, the first such designation by the FDA for
SAD. View
more background information on SAD and a video on PH94B's mechanism
of action.
Forward-Looking Statements
Various
statements in this release are “forward-looking
statements” concerning VistaGen's future expectations, plans
and prospects, including: the potential of PH94B to be a paradigm
shift in the treatment of SAD and other anxiety-related disorders;
the potential for successful development and commercialization of
PH94B in the U.S. and the EverInsight markets, including the
Territory; and expectations for future milestones and royalties
under the collaboration described herein. 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 review of PH94B may not
be achieved in any market; regulatory authorities in the U.S. or in
the EverInsight markets, including the Territory, may decide that
the design or results of the PH94B clinical program are not
sufficient for regulatory approval for acute treatment of SAD or
any other indication; 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 ongoing or
future studies which may not support further development or be
sufficient to gain regulatory approval to market the product;
adverse events may be encountered at any stage of development that
negatively impact further development; and even if development
efforts are successful there may be events that limit market
potential or trigger reductions in milestones or royalties under
the collaboration described herein. Other risks and uncertainties
include, but are not limited to, issues related to: adverse
domestic and foreign healthcare reforms and changes of laws and
regulations; general industry and market conditions; changes in
interest rates and currency exchange rates; manufacturing and
marketing risks, which include, but are not limited to, inadequate
capacity to meet demand and unavailability of raw materials; entry
of competitive products; and other technical and other 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 Quarterly
Report on Form 10-Q, 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 companies’ views only as of today, and should not be
relied upon as representing their views as of any subsequent date.
The companies explicitly disclaim any obligation to update any
forward-looking statements.
VistaGen Contacts:
Company
Mark A.
McPartland
VistaGen
Therapeutics Inc.
+1
(650) 577-3600
IR@vistagen.com
Investors
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
+1
(212) 896-1254/+1 (212) 896-1267
VistaGen@KCSA.com
Media
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
+1
(212) 896-1241/+1 (508) 843-6428
VistaGen@KCSA.com
EverInsight and CBC Group Media Contacts:
Hong Kong
Joseph
Lo
Partner
Brunswick
+852
9850 5033
CBCGroup@brunswickgroup.com
Elizabeth
Liang
Director
Brunswick
+852
9015 6858
eliang@brunswickgroup.com
Shanghai
Xiaozhu
Xiao
Associate
Brunswick
+86 138
1739 8201
zxiao@brunswickgroup.com