Full Press Release Details
Therapeutics Reports Fiscal 2021 Third Quarter Financial Results
Provides Update on Expected Clinical Studies in Calendar
Multiple clinical studies anticipated to launch in Calendar 2021,
notably pivotal Phase 3 clinical
studies of PH94B as a potential acute treatment of anxiety in
adults with social anxiety disorder (SAD)
Strengthened Balance Sheet upon
closing of $100 million underwritten public
SOUTH SAN FRANCISCO, Calif., February 11, 2021 VistaGen 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 reported its financial results for
its fiscal 2021 third quarter ended December 31, 2020, and provided
an update on planned clinical advancement of its CNS pipeline
throughout the remainder of this calendar
transformative, highlighted by closing a PH94B partnership, a
positive meeting with the FDA regarding the key aspects of the
study design for our upcoming pivotal Phase 3 studies of our PH94B
nasal spray in social anxiety disorder and, during the most recent
quarter, closing a $100 million financing which involved
significant participation from leading healthcare institutional
investors such as Acuta Capital, New Enterprise Associates, OrbiMed
and Venrock Healthcare Capital Partners, among others. We are
encouraged by these transformative milestones. Together, they have
further advanced our tenacious pursuit to bring life-changing
medications to the millions affected by anxiety, depression and
other mental health challenges worldwide,
Singh, Chief Executive Officer of VistaGen.
Mr. Singh continued, We believe we have sufficient capital
to fund all of our currently planned nonclinical and clinical
studies across our pipeline. As a result, we expect to launch
several clinical studies this calendar year, notably our pivotal
Phase 3 clinical studies of PH94B as a potential acute treatment of
anxiety in adults with social anxiety disorder, as well several
small exploratory PH94B Phase 2 studies in adult patients
experiencing additional anxiety-related disorders. This year, we
will also complete preparations to launch Phase 2B clinical
development of PH10 as a potential rapid-onset stand-alone
treatment for major depressive disorder in early 2022. Finally,
later this year, based on successful preclinical studies involving
AV-101 alone and in combination with probenecid, we will launch
Phase 1B clinical development of the combination to enable
potential exploratory Phase 2 development of in several CNS
Corporate Highlights in Fiscal Q3 2021:
Closed $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
Expanded R&D team with appointment of Louis Monti, M.D.,
Ph.D., a pioneer in the development of neuroactive steroids known
as pherines, including PH94B and PH10, as Vice President,
Translational Medicine.
Appointed Senior Vice President, Head of CMC (Chemistry,
Manufacturing and Controls) with the addition of Mark J. Ginski,
Ph.D., an expert with over 25 years of broad CMC leadership
experience, spanning preclinical and clinical
Announced publication in CNS
proposed mechanism of action of investigational neuroactive nasal
sprays, PH94B and PH10, for anxiety and depression disorders,
The Korea Intellectual Property Office (KIPO) in the Republic of Korea issued a
Decision to Grant Patent Application No. 10-2015-7020176 related to
methods of treating depressive disorder for
Results for the Fiscal Quarter Ended December 31,
loss: Net loss attributable to common stockholders for the
fiscal quarter ended December 31, 2020 decreased to approximately
$5.65 million compared to $6.28 million for the fiscal quarter
ended December 31, 2019. Net loss for the nine months ended
December 31, 2020 and 2019 was approximately $11.7 million and
$17.5 million, respectively.
Revenue: VistaGen recognized $313,600 in sublicense revenue
pursuant to its PH94B development and commercialization agreement
with EverInsight Therapeutics (now AffaMed Therapeutics) for the
quarter ended December 31, 2020 compared to none in the quarter
ended December 31, 2019. On June 24, 2020, VistaGen entered into
the agreement with EverInsight Therapeutics, pursuant to which the
Company received a non-dilutive upfront license fee payment of $5.0
million on August 3, 2020.
Research and development
(R&D) expense: Research and
development expense increased from $3.0 million to $3.5 million for
the quarters ended December 31, 2019 and 2020, respectively. Cash
compensation for the quarter ended December 31, 2020 increased by
approximately $0.3 million and was offset by a similar decrease in
noncash stock-based compensation for the same period compared to
expenses in the quarter ended December 31, 2019. PH94B and PH10
development expenses increased by approximately $1.5 million in the
quarter ended December 31, 2020 compared to expense for the quarter
ended December 31, 2019 as drug substance and drug product
manufacturing preceding clinical trials advanced. AV-101-related
expenses decreased primarily due to the completion of the
Company's multi-center Phase 2 study of AV-101 for the
adjunctive treatment of major depressive disorder in the quarter
ended December 31, 2019.
General and administrative
(G&A) expense: General and
administrative expense decreased to approximately $2.1 million from
approximately $2.9 million for the quarters ended December 31, 2020
and 2019, respectively. Cash compensation for the quarter ended