Full Press Release Details
VistaGen Therapeutics Reports Fiscal Year 2021 Financial Results
and Provides Corporate Update
PALISADE-1 Phase 3 trial underway to evaluate PH94B for rapid-onset
acute treatment of anxiety in adults with social anxiety disorder
Management to host corporate update conference call and audio
webcast today at 2:00 p.m. PT
SOUTH SAN FRANCISCO, Calif., June 29, 2021
Therapeutics, Inc. (NASDAQ:
VTGN), a biopharmaceutical company committed to developing and
commercializing a new generation of medicines with the potential to
go beyond the current standard of care for anxiety, depression and
other central nervous system (CNS) disorders, today provided a
corporate update and reported financial results for its fiscal year
ended March 31, 2021.
Our fiscal year 2021 was transformative, involving several
drug development, financial and regulatory milestones that
fortified the foundation for our very strong start this fiscal
year. Notably, we achieved an important
consensus with the U.S. Food and Drug Administration regarding our
PALISADE Phase 3 program for PH94B in social anxiety
disorder. Building on that positive meeting, we completed a PH94B
collaboration in ex-U.S. markets, strengthened our balance
sheet with substantial investment from numerous long-biased,
healthcare-focused institutional investors, and advanced several
development programs across our CNS pipeline, most notably
preparations for PALISADE-1, our U.S.
multi-center Phase 3 clinical study of PH94B as a potential
rapid-onset, acute treatment of anxiety in adults with social
anxiety disorder. If successful, PALISADE-1 is designed to be among
the studies necessary to support a potential PH94B New Drug
Application to the U.S. Food and Drug Administration in 2023. We
recently initiated PALISADE-1, moving us closer to our goal of
going beyond the current treatment paradigm for social anxiety
disorder, not only displacing antidepressants, benzodiazepines and
beta blockers, but also reaching those in need of support who find
those therapies to be undesirable or inadequate. We anticipate
topline data from PALISADE-1 in mid-2022. Later this year, we
expect to launch PALISADE-2, a second U.S. multi-center Phase 3
clinical study of PH94B designed to be substantially similar to
PALISADE-1 and equally supportive of our U.S. New Drug Application
Singh added, During the current fiscal year, we also expect
to prepare for and initiate several exploratory Phase 2A clinical
trials of PH94B in additional anxiety disorders, advance
preparations necessary to initiate a U.S. multi-center Phase 2B
clinical trial of PH10 as a potential rapid-onset, stand-alone
treatment for major depressive disorder, and initiate a Phase 1B
clinical trial of AV-101 with probenecid, which, if successful, has
the potential to support exploratory Phase 2A development of the
combination in several CNS disorders.
To develop and commercialize game-changing treatments, you
need great people. During the past year, we have strengthened our
team by adding several key personnel with deep CNS drug development
and commercial experience to drive our programs through important
late-stage development milestones and appropriately-timed
pre-commercial and commercial launch operations. We look forward to
initiating several more clinical trials this fiscal year and remain
focused on pursuing our mission to improve mental health and
well-being for individuals in the U.S. and abroad, concluded
Corporate Highlights
and Drug Administration (FDA) on key aspects of the design
of Phase 3 clinical trials of PH94B for acute treatment of anxiety
in adults with SAD after a positive meeting. The Phase 3 clinical
studies of PH94B in the Company's PALISADE Phase 3 program
will substantially mirror the public speaking challenge in the
statistically significant Phase 2 study of PH94B, providing
significant time and cost-efficiency for the program.
strategic licensing and collaboration agreement with EverInsight
Therapeutics, Inc. (now AffaMed Therapeutics, Inc.) for clinical
development and commercialization of PH94B in Greater China, South
Korea and Southeast Asia (Territory), pursuant to which VistaGen
received a non-dilutive upfront payment of $5 million. VistaGen is
eligible to receive additional development and commercial milestone
payments of up to $172 million and tiered royalties on sales of
PH94B in the Territory, if Phase 3 development efforts there are
preclinical data differentiating the mechanism of action (MOA) of
PH94B and PH10 from risk-ridden benzodiazepines, demonstrating that
the MOA of PH94B and PH10 does not involve direct activation of
GABA-A receptors, in distinct contrast to the MOA of
benzodiazepines, which act as direct positive modulators of GABA-A
preclinical data demonstrating the potential of the combination of
AV-101 and probenecid to substantially increase the brain
concentration of AV-101's active metabolite, 7-Cl-KYN, a potent and
selective full antagonist of the NMDA receptor glycine co-agonist
site, thereby reducing, rather than blocking, NMDA receptor
million gross proceeds from partnering and corporate finance
transactions, including a $100 million underwritten public offering
led by Jefferies Group LLC and William Blair & Company
involving significant participation from key healthcare-focused
institutional investors, such as Acuta Capital, New Enterprise
Associates, OrbiMed and Venrock Healthcare Capital
senior leadership to execute corporate initiatives through
CNS Pipeline Updates
is a synthetic investigational neurosteroid developed from
proprietary compounds called pherines. With its novel MOA, PH94B is
an odorless nasal spray administered at microgram-level doses to
achieve rapid-onset anti-anxiety, or anxiolytic, effects. The novel
pharmacological MOA of PH94B is fundamentally differentiated from
that of all FDA-approved anti-anxiety drugs, including all
antidepressants approved by the FDA for treatment of SAD, as well
as all benzodiazepines and beta blockers prescribed on an off-label