Full Press Release Details
VistaGen Therapeutics Reports Fiscal 2019 Second Quarter Financial
South San Francisco, Calif., October 29, 2018
VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for central nervous
system (CNS) diseases and disorders with high unmet need, today
reported financial results for its fiscal 2019 second quarter ended
the quarter, we continued to focus our resources on AV-101
development, especially advancement of ELEVATE, our Phase 2
adjunctive treatment study for major depressive disorder, and Phase
3-enabling nonclinical and regulatory activities. ELEVATE is well
underway, and we remain confident in our target to deliver topline
results in mid-2019, said Shawn Singh, Chief
Executive Officer of VistaGen.
addition to advancing our core AV-101 development programs, we also
recently enhanced our pipeline with two complementary assets aimed
at the treatment of CNS disorders with high unmet need. We signed
exclusive license agreements to develop and commercialize these
potential first-in-class, intranasally administered, new drug
candidates, PH94B for social anxiety disorder and PH10 for major
depressive disorder. We believe adding these two potential
rapid-onset neuroactive steroid treatments, together with AV-101,
which is focused on achieving rapid-onset antidepressant effects
through NMDA and AMPA receptors, adds significant pipeline strength
and gives us the potential to provide patients with a broad range
of potential new generation solutions to treat depression and other
CNS disorders with serious unmet need, with the goal of eliminating
psychological side effects and safety concerns often associated
with current therapies concluded Mr. Singh.
Operational Highlights:
Continued Advancements in the Clinical Development of
our initial collaboration with the U.S. Department of
Veteran's Affairs (VA) and Baylor University (Baylor), Baylor
commenced a randomized,
double-blind, first-step, cross-over study in healthy
volunteer U.S. Military Veterans to define a dose-response
relationship between AV-101 and relevant biomarkers related to NMDA
function believed to be associated with suicidal ideation. The
results of this initial study could lead to a Phase 2 study
involving AV-101 and U.S. Military Veterans who are battling
suicidal thoughts or behaviors.
Fast Track Designation (FTD) for development of AV-101 as a
non-opioid treatment for neuropathic pain, without sedative or
psychological side effects. Together with our FTD for development
of AV-101 for major depressive disorder (MDD), this is the second
FTD we have received from the FDA for AV-101 since December 2017,
marking another milestone for our regulatory team.
License Agreements to Acquire Two First-in-Class CNS Drug
for exclusive worldwide rights to develop and commercialize PH94B,
a pivotal Phase 3-ready drug candidate with potential to be the
first FDA-approved acute on-demand medication for social anxiety
disorder (SAD), a widespread social phobia which, according to the Anxiety and
Depression Association of America, affects as many as 15 million
for exclusive worldwide rights to develop and commercialize PH10, a
potential first-in-class, intranasally administered neuroactive
steroid with rapid-onset antidepressant effects for MDD as
demonstrated in a Phase 2a study. We believe PH10 is likely to have
rapid-onset antidepressant effects within hours, not days or weeks,
similar to ketamine-based drug candidates, but potentially without
the psychological side effects, safety issues or required in-clinic
Financial Results for the Fiscal Quarter Ended September 30,
loss attributable to common stockholders for the fiscal quarter
ended September 30, 2018 was approximately $7.7 million, compared
to $5.3 million for the fiscal quarter ended September 30, 2017,
primarily attributable to increased research and development
activities relating to the Company's AV-101 programs and
noncash expense of $2.25 million to acquire the exclusive license
to PH94B and exclusive option to license PH10.
and development expense totaled approximately $5.3 million for the
fiscal quarter ended September 30, 2018, compared with
approximately $2.4 million for the fiscal quarter ended September
30, 2017. The increase is primarily attributable to expenses
related to conducting ELEVATE and AV-101 Phase 3-enabling
nonclinical and regulatory activities, including manufacturing
process improvements and production of additional quantities of
AV-101 drug substance, coupled with the acquisition of the
exclusive license to PH94B and the exclusive option to licensePH10
through the issuance of our common stock, which acquisitions
resulted in $2.25 million of noncash expense.
and administrative expense was approximately $2.2 million in the
fiscal quarter ended September 30, 2018, compared to approximately
$2.6 million in the fiscal quarter ended September 30,
September 30, 2018, the Company had cash and cash equivalents of
approximately $7.8 million, compared to approximately $10.4 million
at March 31, 2018. Since September 30, 2018, as a result of
self-placed private placement transactions of unregistered
securities to accredited investors and exercises of outstanding
warrants, the Company has received aggregate cash proceeds of
approximately $2.4 million.
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. 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 drug candidates, including AV-101 for MDD,
neuropathic pain and suicidal ideation, PH94B for SAD, and PH10 for