Full Press Release Details
Therapeutics Reports Fiscal 2021 First Quarter Financial Results
and Highlights CNS Pipeline and Business
Received Over $17.5 Million Net Proceeds from PH94B Upfront License
Payment and Public Offering of Common Stock Subsequent to
Meeting with the FDA Sets Key Aspects of Pivotal PH94B Phase 3
SOUTH SAN FRANCISCO, Calif., August 13, 2020 -- (BUSINESS
WIRE) VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS)
disorders, today reported financial results for its fiscal 2021
first quarter ended June 30, 2020.
"We accomplished several meaningful milestones thus far this fiscal
year that positively impact our clinical development programs,
including our PH94B Phase 3 program in social anxiety disorder. We
reached consensus with the FDA on the key aspects of the design of
our pivotal Phase 3 clinical studies of PH94B for acute treatment
of anxiety in adults with social anxiety disorder. This design is
similar to the design of the highly statistically significant Phase
2 study of PH94B in social anxiety disorder,
said Shawn Singh, Chief
Executive Officer of VistaGen. Additionally,
we received the $5 million upfront license payment from our
partnering arrangement with EverInsight Therapeutics for Phase 3
development and commercialization of PH94B in key markets in Asia.
We also completed a successful public offering of our common stock,
resulting in gross proceeds to us of $14.29 million. These
accomplishments significantly strengthen our go-forward development
plans. We believe now more than ever; the global society needs new,
safe, fast-acting treatments for anxiety and depression andwe
remain committed to achieving that goal."
Financial Highlights During and Subsequent to the Fiscal 2021 First
$5 million non-dilutive upfront license payment from EverInsight
Therapeutics, the Company's strategic partner for Phase 3
development and commercialization of PH94B for anxiety-related
disorders in multiple key markets in Asia.
an underwritten public offering of common stock resulting in gross
proceeds of $14.29 million to the Company, before underwriting
discounts and commissions and offering expenses.
CNS Pipeline Highlights:
reached consensus with the FDA on key aspects regarding the
Company's initial pivotal Phase 3 study of PH94B for acute
treatment of anxiety in adults with social anxiety disorder (SAD)
that, among other details, may provide significant time- and
cost-efficiencies for its Phase 3 program.
in the highly statistically significant (p=0.002) Phase 2 study of
PH94B in SAD, VistaGen's Phase 3 study will involve a single
laboratory-simulated anxiety-provoking public speaking
Phase 3 study will be a randomized, double-blind,
placebo-controlled, parallel comparison study conducted at
approximately 12 to 15 sites in North America.
Subjective Units of Distress Scale (SUDS) will be used to assess
the primary efficacy endpoint in the study.
Michael Liebowitz, 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 be the Principal Investigator of the study.
enrollment (completed patients) will be approximately 182 adult
the FDA's Coronavirus Treatment Acceleration Program (CTAP),
VistaGen submitted its preliminary protocol and development plan
for an exploratory, open-label Phase 2A study of PH94B for acute
treatment of adjustment disorder with anxiety (AjDA), including,
but not limited to, anxiety-provoking stressors related to the
diverse impact of the COVID-19 pandemic (e.g., fear and anxiety
regarding health and safety, economic loss, unemployment, social
isolation, distance-learning, etc.) and civil unrest.
Company is currently working closely with the FDA on plans for the
Phase 2A study in AjDA, which, when study preparations are
completed, will be conducted in New York City by Dr. Michael
Financial Results for the Fiscal Quarter Ended June 30,
Net loss: Net loss attributable
to common stockholders for the fiscal quarter ended June 30, 2020
decreased to approximately $3.5 million compared to $6.5 million
for the fiscal quarter ended June 30, 2019.
Research and development (R&D) expense: R&D expense decreased to approximately $1.7
million from $4.3 million for the quarters ended June 30, 2020 and
2019, respectively, primarily due to the completion of our Phase 2
study of AV-101 in major depressive disorder in the fourth calendar
quarter of 2019. Expenses related to that study and other AV-101
related nonclinical activities decreased by $2.5 million in the
quarter ended June 30, 2020 compared to expense in the quarter
ended June 30, 2019. Noncash research and development expenses,
primarily stock-based compensation, and depreciation in both
periods, accounted for approximately $249,000 and $416,000 in the
quarters ended June 30, 2020 and 2019,
General and administrative (G&A) expense: G&A expense decreased to approximately $1.4
million from approximately $1.9 million for the quarters ended June
30, 2020 and 2019, respectively. Noncash G&A expense, $466,000
in the quarter ended June 30, 2020, decreased from $772,000 in the
quarter ended June 30, 2019, primarily due to decreases in
stock-based compensation and the noncash components of investor and
public relations expense attributable to the amortization of the
fair value of common stock or warrants granted to service
Cash Position: At June 30,
2020, VistaGen had cash and cash equivalents of $1.5 million,
compared to $1.4 million at March 31, 2020. After June 30,
2020, the Company received net
proceeds totaling approximately $17.5 million from (i) the $5.0
million gross non-dilutive upfront license fee payment from
EverInsight Therapeutics, Inc. pursuant our PH94B strategic
collaboration agreement for development and commercialization of