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8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k.htm |
Exhibit 99.1
2020 Virtual
Annual Meeting of Stockholders
Closing Remarks from Shawn K. Singh, JD, Chief Executive Officer
and Director
Thank
you to the stockholders who participated in this, our first,
virtual annual meeting, as well as those who submitted their
proxies prior to the meeting but were unable to
participate.
I would
like to bring attention to some alarming trends we see involving
America’s state of mind – trends relating to mental
illness in America and medications in the current standard of care
that we believe fall far short of a skyrocketing need.
Even
before the onset of the COVID-19 pandemic and recent civil unrest,
mental illness, especially anxiety and depression, had a vice-like
grip on millions of Americas. Our mental health crisis was already
taking a toll on families, employers and mental health
professionals across the country. Pre-pandemic prevalence data on
the mental illnesses on which our product candidates are focused
– anxiety and depression - reveal alarming numbers: 40
million American adults suffering with anxiety, and over 17 million
battling depression – before the pandemic.
While
these historical numbers are alarming, the coronavirus pandemic and
its diverse and far-reaching consequences involving many aspects of
our lives – education of our children, employment, economic
loss, health, safety, and social relationships - has greatly
amplified the pre-pandemic trends.
And
even as things have started to open up and important progress is
being made with potential vaccines and antiviral drug solutions by
our colleagues in the biotechnology and pharmaceutical industries,
the lingering psychological impacts of the pandemic are starting to
take shape in ways that suggest to us that we are in for a
long-term mental health crisis well beyond the scope revealed by
pre-pandemic data.
As has
always been the case, psychotherapy will be critically important in
the years ahead. Also, medications to complement effective
psychotherapy will be critically important. Unfortunately, after
now many decades of use by millions of patients and tens of
millions of prescriptions by mental health professionals, we
believe it is clear that the anti-anxiety and antidepressant
medications that are part of the current standard of care for
anxiety and depression disorders fall short of the needs of
patients and caregivers.
For
example, benzodiazepines, or benzos, widely-used for anxiety
disorders are associated with significant side effects, such as
sedation and cognitive and memory impairment, as well as serious
risks of misuse, addiction and, especially when combined with
opioids, death. Antidepressants, often prescribed for both anxiety
and depression take a long time (weeks to months) to deliver
therapeutic benefits, if they deliver any benefit at all, and they
are also associated with considerable side effects and safety
concerns.
So now
more than ever, fundamentally different medications for anxiety and
depression are needed, and such medications will be needed for many
years to come in the aftermath of the COVID-19
pandemic.
Now
more than ever, the new generation anti-anxiety and antidepressant
medications we are developing at VistaGen - PH94B, PH10 and AV-101
- are relevant, necessary and demand the highly-focused and
passionate efforts of our team and partners, with the support of
our stockholders, to advance them to patients whose lives are
disrupted by anxiety and depression disorders.
With
the FDA’s recent approval enabling us to replicate the design
of the highly statistically significant (p=0.002) Phase 2 study of
PH94B in Social Anxiety Disorder for our pivotal Phase 3 study of
PH94B for the acute treatment of anxiety in adults with SAD,
together with our new partnership for development and
commercialization of PH94B for anxiety disorders in key markets in
Asia, our receipt of a $5M non-dilutive upfront payment from that
partnering agreement, and our receipt of net proceeds of $12.9
million from our public offering of common stock last month, we are
more excited than ever about your company’s future and our
multiple opportunities to develop and commercialize innovative
medications for anxiety and depression – medications we
believe have the potential to go beyond the current standard of
care and change lives.
Should
you or anyone you know be in need of information about finding help
for treatment of mental illness, please note that we have provided
important contact information on the Finding Help page of our
website at https://www.vistagen.com/finding-help.
On
behalf of our entire team at VistaGen, thank you for your support;
we wish you safety and good health.
Forward-Looking Statements
Various
statements in this message are "forward-looking statements"
concerning VistaGen's future expectations, plans and prospects,
including the potential for successful Phase 3 development of PH94B
for acute treatment of anxiety in adults with social anxiety
disorder, as well as development of PH10 and AV-101 as potential
treatments in multiple CNS indications. These forward-looking
statements are neither promises nor guarantees of future
performance, and are subject to a variety of risks and
uncertainties which could cause actual results to differ materially
from those contemplated in these forward-looking statements,
including the risks that are discussed in the section entitled
"Risk Factors" in our most recent Annual Report on Form 10-K for
the fiscal year ended March 31, 2020, and our subsequent quarterly
report on Form 10-Q, as well as discussions of potential risks,
uncertainties, and other important factors in the company's other
filings with the Securities and Exchange Commission. In addition,
any forward-looking statements represent the Company's views only
as of today and should not be relied upon as representing its views
as of any subsequent date. The Company explicitly disclaims any
obligation to update any forward-looking statements.
VistaGen
Therapeutics, Inc. / www.VistaGen.com
/ IR@VistaGen.com