10-K
1
vtgn_10k.htm
ANNUAL REPORT
vtgn_10k
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
For the fiscal year ended: March 31, 2021
or
Commission file number: 001-37761
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
343 Allerton Avenue
South San Francisco, California 94080
(650) 577-3600
(Address, including zip code, and telephone number, including area
code, of registrant’s principal executive
office)
Securities registered pursuant to Section 12(b) of the
Act
Title of each class Name of each exchange on which registered
Common Stock, par value $0.001 per share The Nasdaq Capital Market
Securities registered pursuant to Section 12(g) of the
Act
None
Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities
Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or 15(d) of the
Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to
file such reports), and (2) has been subject to such filing
requirements for the past 90
days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such
files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
or a smaller reporting company. See the definitions of “large
accelerated filer,” “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the
Exchange Act.
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.☐
Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the
effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b))
by the registered public accounting firm that prepared or issued
its audit report. Yes ☐ No ☒
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the
Act). Yes ☐ No ☒
The aggregate market value of the common stock of the registrant
held by non-affiliates of the registrant on September 30, 2020, the
last business day of the registrant’s second fiscal quarter,
was: $51,365,745.
As ofJune 28, 2021,
there were191,382,350sharesof the registrant’s common stock, $0.001 par
value per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Items 10, 11, 12, 13 and 14 of Part III incorporate by
reference certain information from VistaGen Therapeutics,
Inc.’s definitive proxy statement, to be filed with the
Securities and Exchange Commission on or before July 29,
2021.
TABLE OF CONTENTS
Item No. Page No.
PART I
1. Business 1
1A. Risk Factors 31
1B. Unresolved Staff Comments 65
2. Properties 65
3. Legal Proceedings 65
4. Mine Safety Disclosures 65
PART II
6. Selected Financial Data 66
7A. Quantitative and Qualitative Disclosures About Market Risk 80
8. Financial Statements and Supplementary Data 81
9A. Controls and Procedures 121
9B. Other Information 121
PART III
10. Directors, Executive Officers and Corporate Governance 122
11. Executive Compensation 122
14. Principal Accounting Fees and Services 122
PART IV
15. Exhibits and Financial Statement Schedules 123
EXHIBIT INDEX 123
-i-
Forward-Looking Statements
This Annual Report on Form 10-K (Annual Report or
Report) contains
forward-looking statements that involve substantial risks and
uncertainties. All statements contained in this Annual Report other
than statements of historical facts, including statements regarding
our strategy, future operations, future financial position, future
revenue, projected costs, prospects, plans, objectives of
management and expected market growth, are forward-looking
statements. These statements involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements.
The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,”
“may,” “plan,” “predict,”
“project,” “target,”
“potential,” “will,” “would,”
“could,” “should,” “continue,”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include,
among other things, statements about:
●
the continued impact of the coronavirus
(COVID-19) pandemic, efforts to contain the pandemic and
resulting economic downturn on or affecting our operations and
financial condition;
●
the
availability of capital to satisfy our working capital requirements
and development and commercialization objectives;
●
the
accuracy of our estimates regarding expenses, future revenues and
capital requirements;
●
our plans to develop and commercialize our product
candidates, including, among other things, PH94B as a potential
acute treatment of anxiety in adults with social anxiety disorder
(SAD) and other anxiety disorders, PH10 as a potential
treatment for major depressive disorder (MDD) and other depression-related disorders, and
AV-101 as a potential treatment of MDD and depression-related
disorders and neurological diseases and disorders involving the
Central Nervous System (CNS);
●
our ability to initiate and complete necessary preclinical and
clinical studies to advance the development of our product
candidates, including the PALISADE Phase 3 program and other
studies, to successfully complete any such preclinical and clinical
studies, and for those studies to generate positive results;
●
economic,
regulatory and political developments in the U.S. and foreign
countries;
●
the performance of our third-party contract
manufacturer(s) (CMOs), contract research organizations
(CROs) and other third-party preclinical and clinical
drug development collaborators and regulatory service providers on
whose services we rely to support our
operations;
●
our ability to obtain and maintain intellectual
property (IP) protection for our core assets, including our
product candidates;
●
the
size of the potential markets for our product candidates and our
ability to enter and serve those markets;
●
the
rate and degree of market acceptance of our product candidates for
any indication once approved;
●
the
success of competing products and product candidates in development
by others that are or become available for the indications that we
are pursuing in the markets we seek to enter on our own or with
collaborators;
●
the
loss of key scientific, clinical or nonclinical development,
regulatory, and/or management personnel, internally or from one or
more of our third-party collaborators, CMOs, CROs or other service
providers; and
●
other risks and uncertainties, including those
listed under Part I, Item 1A of this Annual Report titled
“Risk
Factors.”
These forward-looking statements are only predictions and we may
not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements, so you should not
place undue reliance on our forward-looking statements. Actual
results or events could differ materially from the plans,
intentions and expectations disclosed in one or more of the
forward-looking statements we make in this Annual Report. We have
based these forward-looking statements largely on our current
expectations and projections about future events and trends that we
believe may affect our business, financial condition and operating
results. We have included important factors in the cautionary
statements included in this Annual Report, particularly in Part I,
Item 1A, titled “Risk
Factors,” that could
cause actual future results or events to differ materially from the
forward-looking statements that we make. Our forward-looking
statements in this Annual Report do not reflect the potential
impact of any future acquisitions, mergers, dispositions, joint
ventures or investments we may make.
You should read this Annual Report and the documents that we have
filed as exhibits to this Annual Report with the understanding that
our actual future results may be materially different from what we
expect. We do not assume any obligation to update any
forward-looking statements in this Annual Report, whether as a
result of new information, future events or otherwise, except as
required by applicable law.
-ii-
PART I
All brand names or trademarks appearing in this Annual Report are
the property of their respective holders. Unless the context
requires otherwise, references in this report to
“VistaGen,” the “Company,”
“we,” “us,” and “our” refer to
VistaGen Therapeutics, Inc., a Nevada corporation. All references
to future quarters and years in this Annual Report refer to
calendar quarters and calendar years, unless reference is made
otherwise.
Item 1. Business
Overview
We are a biopharmaceutical
company committed to developing and commercializing
differentiated new generation medications that go beyond the
current standard of care for widespread anxiety, depression and
other central nervous system (CNS) disorders. Our CNS pipeline includes three CNS
product candidates, PH94B Nasal Spray, PH10 Nasal Spray and AV-101,
each with a differentiated profile, favorable safety results
observed in all clinical studies to date and therapeutic potential
in multiple CNS indications. PH94B Nasal Spray (PH94B) is being developed for multiple anxiety
disorders. We recently initiated our PH94B Phase 3 development
program, which we refer to as the PALISADE program, with
PALISADE-1, a U.S., multi-center, randomized, double-blind,
placebo-controlled Phase 3 clinical study to evaluate the efficacy
and safety of PH94B for the acute treatment of anxiety in adults
with social anxiety disorder (SAD), as well as preparations for the additional
studies required to support our potential U.S. New Drug Application
(NDA) for that indication should the PALISADE Phase 3
program be successful. We are also preparing for exploratory Phase
2A clinical studies of PH94B in adults experiencing several other
anxiety disorders. PH10 Nasal Spray (PH10) is being developed as a stand-alone treatment
for multiple depression disorders. Exploratory Phase 2A clinical
development of PH10 for major depressive disorder
(MDD) has been completed. We are now preparing for
planned Phase 2B clinical development of PH10 for this indication.
We are preparing for a Phase 1B clinical study of AV-101 in
combination with probenecid to assess potential future Phase 2A
clinical development of the combination for MDD or certain
neurological indications. Our goal is to become a biopharmaceutical
company that develops and commercializes innovative CNS therapies
for highly prevalent neuropsychiatry and neurology indications
where current treatments options are inadequate to meet the needs
of millions of patients in markets worldwide.
Our Product Candidates
PH94B
is a synthetic investigational neurosteroid developed from
proprietary compounds called pherines. With its novel mechanism of
action, PH94B is an odorless nasal spray administered at
microgram-level doses to achieve rapid-onset anti-anxiety, or
anxiolytic, effects. The pharmacological activity of PH94B is
fundamentally differentiated from that of all FDA-approved
anti-anxiety drugs, including all antidepressants approved by the
U.S. Food and Drug Administration (FDA) for treatment of SAD, as well as
all benzodiazepines and beta blockers prescribed on an off-label
basis. PH94B engages peripheral chemosensory receptors in nasal
passages that trigger a subset of neurons in the main olfactory
bulbs (OB) at the base of
the brain. The OB neurons then stimulate inhibitory GABAergic
neurons in the limbic amygdala, decreasing the activity of the
sympathetic nervous system, and facilitating fear extinction
activity of the limbic-hypothalamic system, the main fear and
anxiety center in the brain, as well as in other parts of the
brain. Importantly, PH94B does not require systemic uptake and
distribution to produce its rapid-onset anti-anxiety effects.
Our ongoing PALISADE Phase 3 program
for PH94B is designed to further demonstrate its potential as a
fast-acting, non-sedating, non-addictive acute treatment of anxiety
in adults with SAD. We believe PH94B also has potential to be
developed as a novel treatment for adjustment disorder with
anxiety, postpartum anxiety, post-traumatic stress disorder,
procedural anxiety, panic and other anxiety disorders. PH94B has
been granted Fast Track designation status by the FDA for
development for the acute treatment of SAD.
PH10 is
a synthetic investigational neurosteroid, which also was developed
from proprietary compounds called pherines. Its novel, rapid-onset
mechanism of action (MOA)
is fundamentally differentiated from the MOA of all current
treatments for MDD and other depression disorders. PH10 is
self-administered at microgram-level doses as an odorless nasal
spray. PH10 activates nasal chemosensory cells in the nasal
passages, connected to neural circuits in the brain that produce
antidepressant effects. Specifically, PH10 engages peripheral
chemosensory receptors in the nasal passages that trigger a subset
of neurons in the main OB that stimulate neurons in the limbic
amygdala. This is turn increases activity of the
limbic-hypothalamic sympathetic nervous system and increases the
release of catecholamines. Importantly, unlike all currently
approved oral antidepressants (ADs), PH10 does not require systemic
uptake and distribution to produce rapid-onset of antidepressant
effects. In all clinical studies to date, PH10 has not caused
psychological side effects (such as dissociation and
hallucinations) or safety concerns that may be associated with
rapid-onset ketamine-based therapy (KBT), including intravenous ketamine or
intranasal ketamine (esketamine). We
believe PH10 has potential to be a new stand-alone treatment for
MDD and several other depression disorders.
AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate
receptor), an ionotropic glutamate receptor in the brain. Abnormal
NMDAR function is associated with numerous CNS diseases and
disorders. AV-101 is an oral prodrug of 7-chloro-kynurenic acid
(7-Cl-KYNA), which is a potent and selective full antagonist of the
glycine co-agonist site of the NMDAR that inhibits the function of
the NMDAR. However, unlike ketamine and many other NMDAR
antagonists, 7-Cl-KYNA is not an ion channel blocker. At doses
administered in all studies to date, AV-101 has been observed to be
well tolerated and has not exhibited dissociative or hallucinogenic
psychological side effects or safety concerns. In light of these
observations and findings from preclinical studies, we believe that
AV-101, in combination with FDA-approved probenecid, has potential
to become a new oral treatment alternative for certain CNS
indications involving the NMDAR. We are currently preparing to
evaluate AV-101 in combination with probenecid in a Phase 1B
clinical study. The FDA has granted Fast Track designation for
development of AV-101 as a potential adjunctive treatment for MDD
and as a non-opioid treatment for neuropathic pain
(NP).
-1-
Our
Strategy
Our
goal is to be a leading biopharmaceutical company committed to
development and commercialization of novel proprietary CNS
therapies that go beyond the current standard of care for treatment
of anxiety, depression and other CNS diseases and disorders with
high unmet need. Key elements of our strategy to achieve our goal
are as follows:
●
Focus on highly
prevalent anxiety, depression and neurological disorders affecting
both adult and pediatric populations where the current standard of
care is undesirable or inadequate to meet patient
needs.
●
Pursue global
development, on our own in the U.S. and on our own or with
collaborators outside the U.S., of novel proprietary
CNS product candidates which are fundamentally differentiated from
currently approved therapies;
●
Emphasize
development and commercialization of proprietary
CNS product candidates with potential for (i) rapid-onset
therapeutic effects, (ii) exceptional safety and tolerability, and
(iii) significant commercial potential in multiple CNS indications
in global markets with currently limited, undesirable or inadequate
treatment options;
●
Commercialize on
our own, and retain all commercial rights to, our CNS product
candidates in the U.S. and partner with highly-qualified
third-party collaborators to commercialize our CNS product
candidates in selected markets outside the U.S.; and
●
Continue internal
research and development efforts to (i) evaluate the expanded
therapeutic and commercial potential for our existing CNS product
candidates in the treatment of additional CNS indications and (ii)
identify additional proprietary CNS product candidates for our CNS
product pipeline.
Our CNS Product Pipeline
The
following table summarizes the status of our CNS clinical
development programs as of the filing date of this Annual
Report.
PH94B Nasal Spray
Social Anxiety Disorder
Social Anxiety Disorder (SAD) affects over 23 million Americans.
According to the U.S. National Institutes of Health (NIH), SAD is the third most common
psychiatric condition after depression and substance abuse. A
person with SAD feels intense, persistent symptoms of anxiety or
fear in certain social situations, such as meeting new people,
dating, being on a job interview, answering a question in class, or
talking to a cashier in a store. Doing common everyday things in
front of people - such as eating or drinking in front of others or
using a public restroom - causes profound anxiety or fear of being
humiliated, evaluated, judged, or rejected. The fear that people
with SAD have in social situations is so strong that they feel it
is beyond their ability to control. SAD can get in the way of going
to work, attending school, or doing a wide variety of things in
situations that have a potential for interpersonal interaction.
People with SAD may worry about these and other things for weeks
before they happen. Sometimes, they end up staying away from places
or events where they think they might have to do something that
will embarrass them. Some people with SAD do not have anxiety in
social situations, but instead have performance anxiety. They feel
physical symptoms of anxiety in performance situations, such as
giving a lecture, a speech or a presentation at school or work, as
well as playing a sports game, or dancing or playing a musical
instrument on stage. Without treatment, SAD can last for many years
or a lifetime and lead to avoidance and
opportunity costs that can significantly impact a person's
employment, social activities and relationships, and be very
disruptive to overall quality of life.
-2-
Existing treatments for SAD have not been effective acute treatment
options for the large patient population suffering from SAD. Only
three drugs, all chronic oral antidepressant drugs (ADs), are approved by the FDA
specifically for treatment of SAD, and no drug is FDA-approved for
acute, on-demand treatment of anxiety in adults with SAD. These
FDA-approved chronic oral ADs have slow onset of effect (often many
weeks or months) and significant side effects that may make them
inadequate or inappropriate treatment alternatives for many
individuals affected by acute SAD episodes. Benzodiazepines, often
referred to as “benzos,” and beta blockers, both of
which have not been studied systematically in controlled studies
for treatment of SAD. They are not FDA-approved to treat SAD, but
are prescribed on an off-label basis by psychiatrists and other
physicians for the treatment of SAD. Unlike ADs, which can take
several weeks to take full effect, benzodiazepines, which act as
direct positive modulators of GABA-A receptors, have a rapid-onset
effect by potentiating GABA-A and slowing the nervous system to
induce a calming effect that can last up to twelve hours. However,
the safety concerns and side effects of benzodiazepines, many of
which are similar to side effects of alcohol, also can appear
rapidly. Extended use of benzodiazepines may lead to physical
dependence and weaning off. Benzodiazepines can take up to many
months, often resulting in severe withdrawal symptoms, including
muscle pain, sweating, blurred vision, depression, seizures and
delirium tremens similar to those experienced with alcohol
withdrawal. Benzodiazepines users can also build up a tolerance
that requires increasingly larger doses over time. When taken with
opioid drugs, benzodiazepine use may be quite dangerous, so much so
that in September 2020 the FDA issued an update to its 2016 Drug
Safety Communication requiring that benzodiazepines display a
“black box” label on bottles to warn against their
potential for dangerous interactions with opioids, as well as
potential risk of abuse, misuse, overuse and addiction. We believe
PH94B, with its rapid-onset anti-anxiety effects, demonstrated in
Phase 2 development without requiring systemic uptake and
distribution, and its lack of benzodiazepine-like side effects and
safety concerns in all clinical studies to date, has potential to
displace both ADs and benzodiazepines in the current treatment
paradigm for SAD, as well as in many other current anxiety disorder
treatment paradigms.
In a
peer-reviewed, published, randomized, double-blind,
placebo-controlled Phase 2 clinical trial (n=91), with Dr. Michael
Liebowitz, the creator of the Liebowitz Social Anxiety Scale
(LSAS), as principal
investigator, PH94B was significantly more effective than placebo
in reducing both public-speaking (performance) anxiety (p=0.002)
and social interaction anxiety (p=0.009) in laboratory-induced
challenges of individuals with SAD, as assessed using
patient-reported anxiety ratings on the Subjective Units of
Distress Scale (SUDS)
within 15 minutes of self-administration of a non-systemic 1.6
microgram dose of PH94B.
-3-
In all
Phase 1 and Phase 2 studies to date, PH94B’s safety profile
has been exceptional, without indication of abuse potential,
psychological side effects (such as dissociation, euphoria or
hallucinations), sedation or other side effects and safety concerns
that may be associated with ADs approved by the FDA for treatment
of SAD, as well as with benzodiazepines and beta blockers
prescribed off-label.
Based
on its novel mechanism of pharmacological action, rapid-onset of
therapeutic effects and exceptional safety and tolerability profile
in all clinical studies to date, we have initiated our PH94B
PALISADE Phase 3 development program with PALISADE-1, a U.S.,
multi-center, randomized, double-blind, placebo-controlled Phase 3
clinical study to evaluate the efficacy and safety of PH94B for the
acute treatment of anxiety in adults with SAD, as well as
preparations for the additional studies required to support our
potential U.S. New Drug Application (NDA) for that indication should our
PH94B PALISADE Phase 3 development program for SAD be successful.
With respect to SAD, our goal is to develop and commercialize
PH94B, on our own in the U.S. and with collaborators in markets
outside the U.S., as the first FDA-approved, fast-acting,
on-demand, acute treatment of anxiety for adults with SAD. We also
plan to develop and commercialize PH94B in a similar manner for the
acute treatment of anxiety in pediatric patients with
SAD.
Adjustment Disorder with Anxiety
Almost
everyone experiences significant life events, changes, or stressors
and while some individuals adjust to such changes within a few
months, others cannot and may struggle with adjustment
disorder. Adjustment disorder with anxiety (AjDA) is an emotional or behavioral
reaction considered excessive or disproportionate to a sudden
change, stressful event or major life change, such as loss of work,
divorce or health setback, occurring within three months of the
stressor, and/or significantly impairing a person’s social,
occupational and/or other important areas of functioning. The
stress-related disturbance does not represent normal bereavement or
meet the criteria for another mental disorder and is not merely an
exacerbation of a preexisting mental disorder.
The mental health stressors associated with the COVID-19 pandemic
have directly or indirectly affected hundreds of millions of
individuals around the world and have considerably increased the
prevalence of AjDA. We believe the mental health impact of the
COVID-19 pandemic will be long-term and varied across a wide range
of anxiety disorders. PH94B has potential as a novel, treatment of
anxiety for adults with AjDA, including stress and impaired
functioning as a result of recent-onset of stressors brought on by
the health, safety, economic and social circumstances, including,
but not limited to, circumstances related to and consequences of
the COVID-19 pandemic and civil unrest in 2020. With successful
Phase 2 development of PH94B for acute treatment of anxiety in
adults with SAD completed and Phase 3 development for that
indication now underway, we are preparing to initiate exploratory
Phase 2A clinical development of PH94B for treatment of anxiety in
adults with AjDA. Dr. Michael Liebowitz, Professor of Clinical
Psychiatry at Columbia University and director of the Medical
Research Network in New York City, will serve as Principal
Investigator of the exploratory Phase 2A study.
Postpartum Anxiety
Even
before the COVID-19 pandemic, there was compelling research
indicating that about approximately 17% of new mothers battle
anxiety. Recent research reflects that the prevalence of postpartum
anxiety (PPA) among new
mothers increased significantly during the COVID-19 pandemic.
Combined with commonly experienced hormone changes and sleep
deprivation, key additional factors contributing to increasing
mental health challenges among new mothers during the COVID-19
pandemic include job loss, lack of secure housing and access to
healthcare, physical isolation from friends and family, increased
childcare, educational and household duties, and fear and
uncertainty about the state of the world for themselves and their
newborn children.
-4-
With
its potential to produce rapid-onset therapeutic effects at
microgram-level doses, without requiring systemic uptake and
distribution to achieve those therapeutic effects, and without
causing sedation, we believe PH94B may be ideally suited for new
mothers suffering with PPA, especially new mothers who are
interested in breastfeeding and who would prefer a non-systemic,
non-sedating therapeutic alternative to current
therapies.
In
collaboration with clinical investigators at a leading university
medical center in the U.S., we are exploring opportunities to
assess PH94B’s potential as a novel rapid-onset treatment for
PPA in a small exploratory Phase 2A clinical study.
Post-Traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a clinically diagnosed psychiatric disorder
that develops in some people who have experienced or witnessed a
shocking, scary, dangerous or life-threatening event, such as
military combat, natural disasters, terrorist incidents, serious
accidents, or physical or sexual assault in adulthood or
childhood. Symptoms of PTSD include flashbacks, nightmares,
severe anxiety, uncontrollable intrusive thoughts, and emotional
numbing after the event. More than 8 million people in the U.S.
suffer from PTSD. Anyone can develop PTSD at any age. According to
the National Center for PTSD, about seven or eight out of every 100
people will experience PTSD at some point in their lives. The
prevalence of PTSD is even higher in populations at risk for
exposure to trauma, such as military service members and first
responders. PTSD is often accompanied by depression or one or more
of the other anxiety disorders, and PTSD sufferers also have a
higher rate of suicide and often struggle with simultaneous
addiction, leading to an even greater social and economic burden of
the disorder.
It is natural to feel afraid during and after a
traumatic situation. Fear triggers many split-second changes in the
body to help defend against danger or to avoid it. This
“fight-or-flight” response is a typical reaction meant
to protect a person from harm. Because PTSD is associated with a
heightened “fight or flight” response mediated by
increased sympathetic nervous response to conditioned stimuli, an
agent which decreases sympathetic tone may be able to treat some
symptoms of PTSD. In Phase 2 studies, at microgram doses,
PH94B has been shown to have rapid-onset anti-anxiety effects in
patients with both generalized anxiety disorder
(GAD)
and SAD. PH94B may therefore have utility as an as-needed,
rapid-onset treatment of symptoms of PTSD. Available
therapeutic options for PTSD are limited, including only two
FDA-approved antidepressants, which have limited efficacy and
undesirable side effects.
In
collaboration with clinical investigators at leading university
medical centers in the U.S., we are exploring opportunities