Full Press Release Details
VistaGen Therapeutics Reports Fiscal 2020 First Quarter Financial
SOUTH SAN FRANCISCO, Calif., August 13, 2019 - VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, today announced financial results for its fiscal year 2020
first quarter ended June 30, 2019.
The next few months are potentially transformative for
VistaGen, as we look forward to several clinical and regulatory
milestones before year-end, stated Shawn
Singh, Chief Executive Officer of VistaGen. We have three
differentiated clinical-stage drug candidates, each of which has an
exceptional safety profile in studies to date and significant
therapeutic and commercial potential in multiple large and growing
CNS markets where current treatments are inadequate to meet the
needs of millions of patients. Our team is focused on driving
continued progress across our pipeline, and we are confident in our
efforts to achieve our core goals to deliver both safe and
effective new generation treatments in neuropsychiatry and
neurology for patients and extraordinary value to our loyal
Financial Results for the Fiscal Quarter Ended June 30,
Net loss attributable to common stockholders for the fiscal quarter
ended June 30, 2019 was approximately $6.2 million, including
approximately $1.2 million of noncash charges, compared to $4.2
million for the fiscal quarter ended June 30, 2018, primarily
attributable to increased research and development activities
relating to the Company's CNS drug development
Research and development expense totaled $4.3 million for the
fiscal quarter ended June 30, 2019, compared with $2.7 million for
the fiscal quarter ended June 30, 2018. The increase in research
and development expense is primarily related to the continued
progress of ELEVATE, the Company's Phase 2 clinical study
evaluating efficacy and safety of AV-101, its novel oral NMDA
(N-methyl-D-aspartate) receptor glycine site antagonist, as an
add-on treatment (together with an FDA-approved oral
antidepressant) for adults with major depressive disorder (MDD),
several preclinical studies, including studies supporting
AV-101's potential for treating neuropathic pain (NP) and
levodopa-induced dyskinesia (LID) in patients with
Parkinson's disease, and manufacturing activities involving
AV-101 and the Company's two novel, clinical-stage
neuroactive nasal spray candidates, PH94B for social anxiety
disorder (SAD) and PH10 for MDD.
General and administrative expense was approximately $1.9 million
in the fiscal quarter ended June 30, 2019, compared to
approximately $1.5 million in the fiscal quarter ended June 30,
2018. The increase was primarily attributable to noncash stock
compensation expense.
At June 30, 2019, VistaGen had cash and cash equivalents of $8.3
million, compared to $13.1 million at March 31, 2019.
As of August 13, 2019, there were 42,622,965 shares of common stock
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
where current treatments are inadequate, resulting in high unmet
three differentiated, clinical-stage CNS drug candidates, AV-101,
PH10 and PH94B, each with an exceptional safety profile in all
clinical studies to date and therapeutic potential in multiple
large and growing CNS markets. For more information, please
visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding development and
commercialization of our three drug candidates: (i) AV-101 for MDD,
NP, LID and suicidal ideation; (ii) PH94B for SAD; and (iii) PH10
for MDD. In addition, statements concerning the Company's
future expectations may include statements regarding intellectual
property and commercial protection of our drug candidates. Each of
these statements constitute forward-looking statements for the
purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
neither promises nor guarantees of future performance and are
subject to a variety of risks and uncertainties, many of which are
beyond our control, and may cause actual results to differ
materially from those contemplated in these forward-looking
statements. Those risks include the following: (i) we may encounter
unexpected adverse events in patients during our clinical
development of any product candidate that cause us to discontinue
further development; (ii) we may not be able to successfully
demonstrate the safety and efficacy of our product candidates at
each stage of clinical development; (iii) success in preclinical
studies or in early-stage clinical trials may not be repeated or
observed in ongoing or future studies, and ongoing or future
preclinical and clinical results may not support further
development of, or be sufficient to gain regulatory approval to
market AV-101, PH94B, and/or PH10; (iv) decisions or actions of
regulatory agencies may negatively affect the progress of, and our
ability to proceed with, further clinical studies or to obtain
marketing approval for our drug candidates; (v) we may not be able
to obtain or maintain adequate intellectual property protection and
other forms of marketing and data exclusivity for our product
candidates; (vi) we may not have access to or be able to secure
substantial additional capital to support our operations, including
our ongoing clinical development activities; and (vii) we may
encounter technical and other unexpected hurdles in the
manufacturing and development of any of our product candidates.
Certain other risks are more fully discussed in the section
entitled "Risk Factors" in our most recent annual report on Form
10-K, as well as discussions of potential risks, uncertainties, and