Full Press Release Details
VistaGen Therapeutics Reports Fiscal
2020 Third Quarter Financial Results and Provides CNS Pipeline
SOUTH SAN FRANCISCO, Calif., February 13, 2020 VistaGen Therapeutics
clinical-stage biopharmaceutical company developing new generation
medicines for central nervous system (CNS) diseases and disorders
with high unmet medical need, today announced financial
results for its fiscal year 2020 third quarter ended December 31,
VistaGen has a multi-asset, clinical-stage CNS pipeline, including
three differentiated drug candidates, two of which, PH94B and PH10,
have positive human clinical data in individuals with social
anxiety disorder (SAD) and major depressive disorder (MDD),
respectively, and one of which, PH94B, is in preparation to advance
into Phase 3 clinical development for the treatment of SAD by the
end of this calendar year. Each of VistaGen's CNS product
candidates has an exceptional safety profile, potential for
rapid-onset therapeutic benefits, and multiple shots on goal in CNS
markets where current treatments are inadequate, resulting
Recent CNS Pipeline Updates:
The U.S. Food and Drug Administration (FDA) has granted Fast Track
designation for development of VistaGen's most advanced drug
candidate, PH94B neuroactive nasal spray for on-demand treatment of
SAD, the first such designation granted by the FDA for development
of a drug candidate for SAD.
VistaGen's Investigational New Drug (IND) application for
AV-101, its oral NMDAR (N-methyl-D-aspartate receptor) antagonist
prodrug, as a potential new treatment of dyskinesia in patients
with Parkinson's disease receiving levodopa therapy, has been
cleared by the FDA, permitting VistaGen to proceed with Phase 2a
clinical development of AV-101 in this indication.
The U.S. Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for U.S. Patent Application 16/003,816 related to
therapeutic use of AV-101 for treatment of dyskinesia induced by
the administration of levodopa. The patent, once issued, will be in
effect until at least 2034.
successful results from an AV-101 first-step, Phase 1b clinical
study with healthy U.S. military Veterans, which study measured
NMDAR target engagement of AV-101 for potential treatment of
suicidal ideation in Veterans. The findings from the study were
presented in a poster, titled "Evoked and Resting
State Gamma Mechanics to Test NMDA Receptor Engagement of
Kynurenine Pathway Modulator AV-101 in Healthy Veterans," at the 2019 Annual Meeting
of the American College of Neuropsychopharmacology (ACNP) on
positive preclinical data of AV-101 administered in combination
with probenecid demonstrating substantially increased brain
concentration effects of AV-101 and its active metabolite,
7-Cl-KYNA. When given together with AV-101, probenecid increased
brain concentrations of AV-101 7-fold and its active metabolite,
7-CI-KYNA, 35-fold. The resulting increased brain levels and
duration of 7-Cl-KYNA suggest the potential impact of AV-101 with
probenecid could result in far more profound therapeutic benefits
for patients with MDD than in prior clinical studies that did not
involve probenecid, as well as in other NMDAR-focused CNS diseases
and disorders. Results on AV-101 transport with adjunctive
probenecid were presented by a collaborator of VistaGen at the
British Pharmacological Society's Pharmacology 2019 annual
conference in Edinburgh, UK, on December 17, 2019.
During the quarter, we made significant progress across our
CNS pipeline, including milestones necessary to advance PH94B, our
first-in-class, rapid-onset neuroactive nasal spray, into Phase 3
clinical development for treatment of social anxiety disorder later
this year, stated Shawn
Singh, Chief Executive Officer of VistaGen.
anxiety disorder, or SAD, affects as many as 20 million American
adults and adolescents and is the third most common mental health
disorder in the U.S. With the alarming prevalence of depression,
anxiety, and suicide, driven increasingly by excessive use of
social media, and staggering increases in dependency, addiction and
even deaths associated with misuse and overuse of benzodiazepines,
the urgency for a differentiated, fast-acting, non-addictive,
non-sedating treatment for SAD and other anxiety-related disorders
is more important now than ever before.
Mr. Singh continued, During the quarter, we were very
pleased that PH94B received the FDA's first ever Fast Track
designation for development of a drug candidate for treatment of
SAD. We look forward to further advancing our ongoing efforts to
meet the needs of millions of individuals with SAD for whom current
treatments fall short, while in parallel advancing development of
our other first-in-class neuroactive nasal spray, PH10, for major
depressive disorder, and our oral prodrug, AV-101, for treatment of
CNS indications involving the NMDA receptor.
Financial Results for the Fiscal Quarter Ended December 31,
loss attributable to common stockholders for the fiscal quarter
ended December 31, 2019 decreased to approximately $6.3 million
compared to $7.5 million for the fiscal quarter ended December 31,
2018, primarily resulting from the $2.0 million noncash expense
associated with the stock-based acquisition of the license to
develop and commercialize PH10 in the 2018 quarter.
and development expense decreased to $3.0 million for the fiscal
quarter ended December 31, 2019, compared with $5.3 million for the
fiscal quarter ended December 31, 2018, primarily due to the 2018
noncash expense associated with the acquisition of the PH10
license. Expenses related to the Elevate study of AV-101 in MDD and
other AV-101 related nonclinical activities decreased in the
quarter ended December 31, 2019 compared to 2018, as the Elevate
study reached its conclusion following final patient dosing in
September 2019. Increased spending for nonclinical activities,
including manufacturing expense for PH94B and PH10, generally
offset the reduction in AV-101 expenses. In addition to the noncash
PH10 license acquisition in the quarter ended December 31, 2018,
other noncash expenses, primarily stock-based compensation and