Full Press Release Details
VistaGen Therapeutics Reports Fiscal Year 2020 Results and Provides
Eligible to Receive up to $177 Million, Including Upfront and
Potential Milestone Payments, in Addition to Royalties, under PH94B
License in Key Asian Markets Announced Subsequent to Fiscal 2020
SOUTH SAN FRANCISCO, Calif., June 29, 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, today reported financial
results for its fiscal year ended March 31,
these unprecedented times persist, with the chaotic implementation
of public safety measures and the civil unrest in the fight for
social justice, we continue to live in a world filled with
heightened uncertainty and unfamiliarity. The spike in the number
of individuals experiencing anxiety and depression is unparalleled
and it appears the upward trajectory will continue. While
innovative means of providing mental health support have been
initiated, many needs are still not being met, stated
Singh, Chief Executive Officer of VistaGen.
Singh continued, VistaGen is uniquely positioned to develop
a robust investigational pipeline of novel treatments for millions
of people globally today and for generations to come who are
unfortunately suffering due to this heightened mental health
continued to make progress across our CNS pipeline, notably, with
PH94B, our first-in-class, rapid-onset neuroactive nasal
spray for social anxiety disorder, having recently announced
a strategic collaboration with EverInsight for up to $177 million
in upfront and potential milestone payments to develop and
commercialize PH94B in key Asian markets. This partnership further
highlights the value of this asset, which has global market
potential as a rapid-onset and safe, acute anxiety therapy, and
provides our company with additional working capital to continue
the significant progress we have made in preparation for our Phase
3 program in parallel with emphasis on additional strategic
collaborations for development and commercialization of our
pipeline in key regional markets outside the
VistaGen's CNS Pipeline:
VistaGen is developing three differentiated, patent-protected, CNS
product candidates for large global markets where current
treatments are inadequate to address rising mental health
challenges worldwide, as well as need for non-additive,
non-sedating relief from pain, unwanted movement disorders and
other neurological conditions besetting increasing numbers of
individuals worldwide. VistaGen's CNS product candidates in
development are as follows:
PH94B Neuroactive Nasal Spray
is a first-in-class neuroactive nasal spray with therapeutic
potential in a wide range of indications involving anxiety or
phobia. Self-administered in microgram doses, PH94B does not
require systemic uptake and distribution to produce its rapid-onset
anti-anxiety effects and, therefore, has an excellent safety
Strategic Partnership with EverInsight Therapeutics for up to $177
Million in Upfront and Potential Milestone Payments, in Addition to
EverInsight Therapeutics, a company currently funded by the CBC
Group (formerly C-Bridge Capital), one of the largest and most
active healthcare-dedicated investment firms in Asia, entered into
a strategic partnership for Phase 3 clinical development and
commercialization of PH94B, initially for acute treatment of SAD,
in multiple key anxiety markets in Asia.
VistaGen is eligible to receive up to $177M, including a $5 million
upfront payment and up to $172 million in potential milestone
payments, if Phase 3 development efforts are successful, in
addition to royalties.
Social Anxiety Disorder (SAD)
VistaGen Fast Track designation for development of PH94B for
on-demand treatment of SAD, the first such designation granted by
the FDA for development of a drug candidate for SAD. The Company is
currently in final-stage discussions with the FDA regarding key
details of its plan for Phase 3 clinical development of PH94B for
SAD in the U.S., with the initial objective of developing PH94B as
the first FDA-approved on-demand, rapid-onset acute treatment of
M.D., Professor of Clinical Psychiatry at Columbia University,
director of the Medical Research Network in New York City, and
creator of the Liebowitz Social Anxiety Scale (LSAS), will serve as
Principal Investigator of the Company's Phase 3 clinical
Adjustment Disorder with Anxiety related to the COVID-19
new Coronavirus Treatment Acceleration Program (CTAP), VistaGen submitted a protocol
and development plan for an exploratory open-label Phase 2A study
of PH94B for treatment of adjustment disorder with anxiety (AjDA)
related to the COVID-19 pandemic.
AjDA to be conducted in New York City, with Dr. Michael Liebowitz,
M.D., serving as Principal Investigator.
Based on its rapid-onset pharmacology, microgram-level dosing, lack
of systemic exposure, excellent safety profile and the rapidly
rising incidence of anxiety disorders, the Company is also
assessing potential exploratory Phase 2A studies of PH94B for
treatment of postpartum anxiety, post-traumatic stress disorder
(PTSD), preoperative anxiety, and panic disorder.
PH10 Neuroactive Nasal Spray
Major Depressive Disorder (MDD)
PH10 is an odorless, fast-acting synthetic neurosteroid delivered
intranasally that has therapeutic potential in a wide range of
neuropsychiatric indications involving depression.
Self-administered in microgram doses, PH10 does not require
systemic uptake and distribution to produce its antidepressant
effects. The Company is initially developing PH10 as a potential
fast-acting, non-sedating, non-addictive stand-alone treatment of
exploratory double-blind, randomized, placebo-controlled Phase 2A
clinical study of PH10 for treatment of MDD were newly published in
peer-reviewed British
Journal of Pharmaceutical and Medical Research.