- Completed last patient out milestone for PALISADE-1 Phase 3
clinical trial of PH94B in social anxiety disorder (SAD). Topline
results for PALISADE-1 anticipated mid-2022.
- PALISADE-2 on track for topline readout in late 2022.
- Received FDA consensus that data from nonclinical and clinical
studies of PH94B completed to date provide no signal of abuse
potential.
VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a late
clinical-stage, central nervous system (CNS)-focused
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders, today reported its financial results for its fiscal
year ended March 31, 2022 and provided a corporate update.
“Momentum from our accomplishments throughout our fiscal year
2022 have led us to a position of strength as we await topline
results from our PALISADE-1 Phase 3 clinical trial of PH94B in
social anxiety disorder. Our progress, most notably recent drug
development and regulatory milestones, continues to drive our team
forward as we strive to develop much needed innovative medicines
for mental health,” stated Shawn Singh, Chief Executive Officer of
VistaGen.
“We believe individuals should have access to medication that is
not only effective, but also safe and without the potential for
abuse and other harmful side effects. One of the major reasons we
are passionate about developing PH94B is its potential to satisfy
that need for the millions of individuals suffering from social
anxiety disorder. Our recent consensus with the FDA that a Human
Abuse Potential study is not required at this time based on PH94B’s
demonstrated safety in all studies completed to date adds to a
growing body of evidence suggesting that PH94B has potential to
achieve rapid-onset anti-anxiety effects without requiring systemic
uptake or causing benzodiazepine-like side effects and safety
concerns,” said Singh.
“At a time when the current drug treatment paradigm for social
anxiety disorder is falling far short of delivering necessary
relief without worrisome potential consequences, an innovative
treatment alternative is imperative. If successfully developed in
our ongoing PALISADE Phase 3 Program, PH94B has the potential to
fill that void as the first fast-acting, on demand acute treatment
of anxiety for the estimated 25 million Americans who suffer from
social anxiety disorder. We remain steadfast in pursuit of our
mission to improve mental health and well-being for individuals
suffering from anxiety, depression and other CNS related disorders
worldwide – One Mind at a Time," concluded Singh.
Fiscal Year 2022 & Recent Business
Highlights
VistaGen continued consistent progress across its nasal spray,
pherine-based platform and novel oral NMDA (N-methyl-D-aspartate)
receptor programs.
PALISADE Phase 3 Program for PH94B in Social Anxiety Disorder
(SAD) reaches Last Patient Out Milestone in PALISADE-1 –
VistaGen’s PALISADE-1 and PALISADE-2 Phase 3 studies are
randomized, multi-center, double-blind, placebo-controlled clinical
trials in the U.S. designed to evaluate the efficacy, safety and
tolerability of PH94B for the acute treatment of anxiety in adults
with SAD. PH94B is an odorless, tasteless, rapid-onset pherine
nasal spray with a unique potential mechanism of action (MOA) and
no signal of abuse potential in all studies completed to date.
PH94B is designed to work differently than all therapies approved
by the U.S. Food and Drug Administration (FDA) for SAD. Both Phase
3 studies are structured in a manner substantially similar to the
public speaking component of a peer-reviewed Phase 2 study of PH94B
in which researchers observed a statistically significant, rapid
reduction in anxiety in individuals (within 15 minutes) in response
to a public speaking challenge (p=0.002). In June 2022, PALISADE-1
reached the last patient out milestone. Consistent with prior
guidance, the Company anticipates topline data for PALISADE-1 in
mid-2022. PALISADE-2 is progressing, with topline results
anticipated in late 2022. The Company’s PALISADE-1 and PALISADE-2
studies are designed to anchor its potential PH94B U.S. New Drug
Application (NDA) to the FDA should its PALISADE Phase 3 Program be
successful, overall.
Consensus with FDA on abuse potential – No Human Abuse
Potential (HAP) study required at this time – The FDA recently
indicated that it agrees with the Company that data from
nonclinical and clinical studies of PH94B completed to date provide
no signal of abuse potential. The FDA also agreed that additional
nonclinical studies are not necessary to evaluate the abuse
potential of PH94B and, at this time, based on studies completed to
date, a HAP study with PH94B is not required. The Company believes
that this consensus with the FDA regarding abuse liability is very
important as PH94B continues to progress through its Phase 3
development program in SAD.
Nonclinical PH94B data support its differentiated,
non-systemic MOA – The Company recently presented preclinical
data at the Annual Meeting of the Society of Biological Psychiatry
(SOBP), the American Society of Clinical Psychopharmacology (ASCP),
and the Medscape LIVE Psych Update Spring Meeting that support the
MOA of PH94B binding to receptors of peripheral neurons in the
nasal passages, rather than to neuronal receptors in the CNS, and
without measurable systemic exposure. These data suggest that
anxiolytic activity can be achieved without systemic exposure or
transport into the brain, resulting in a lower potential risk for
common side effects. As these preclinical data demonstrate, the
proposed mechanism of action of PH94B is fundamentally unique from
all currently available anti-anxiety therapies.
PALISADE Global Phase 3 Clinical Study in SAD – The
Company and AffaMed Therapeutics completed regulatory preparations
necessary to initiate PALISADE Global in the U.S. and China in the
second half of 2022. Modeled off VistaGen’s PALISADE-1 and
PALISADE-2 Phase 3 clinical studies, PALISADE Global is a replicate
Phase 3 clinical trial designed to evaluate the efficacy, safety,
and tolerability of PH94B for the acute treatment of SAD in adults.
This study is intended to support the registration and
commercialization of PH94B in Greater China and potential other
markets outside of the U.S. should PALISADE Global and the
Company’s PALISADE Phase 3 Program in the U.S. be successful,
overall.
Exploratory clinical evaluation of PH94B expands beyond
SAD – To evaluate PH94B’s potential as a treatment for several
distinct anxiety disorders beyond SAD, the Company is preparing to
launch a series of Phase 2A exploratory clinical trials in addition
to its ongoing Phase 2A clinical trial designed to evaluate the
efficacy, safety and tolerability of PH94B as a potential treatment
of adults with adjustment disorder with anxiety (AjDA). Topline
data from this AjDA trial are anticipated in late 2022. The Phase
2A clinical trials are expected to include exploratory biomarker
studies to assess potential PH94B development opportunities in
post-traumatic stress disorder (PTSD), procedural anxiety and
post-partum anxiety.
PH10 Nasal Spray development continues for multiple
depression disorders – Following positive results from the
exploratory Phase 2A program of PH10 in major depressive disorder
(MDD), the Company is conducting the necessary nonclinical studies
to support the submission of an Investigational New Drug (IND)
application to the FDA for further clinical development of PH10 in
MDD in the U.S. The Company anticipates submission of the PH10 IND
in MDD in 2022, and, if authorized by the FDA, to begin Phase 2B
clinical development of PH10 for MDD as soon as practicable
thereafter. The Company is considering the evaluation of PH10 as a
potential treatment for several distinct depression disorders
beyond MDD.
AV-101 + probenecid Phase 1B trial initiated – Following
positive preclinical data, VistaGen initiated a Phase 1B drug-drug
interaction study of AV-101 in combination with probenecid in late
2021. The Company is considering the evaluation of AV-101 in
combination with probenecid as a potential treatment for several
distinct neurological disorders.
Fiscal Year 2022 Financial Results
Research and development (R&D) expense: Research and
development expense increased by $23.5 million, from $11.9 million
to $35.4 million for the fiscal years ended March 31, 2021 and
2022, respectively. The increase in R&D expense is primarily
due to the preparation, initiation and continuation of the various
clinical trials in the Company’s PALISADE Phase 3 Program for PH94B
in SAD, as well as the addition of senior management and other
personnel across multiple R&D disciplines.
General and administrative (G&A) expense: General and
administrative expense increased to approximately $13.5 million for
the fiscal year ended March 31, 2022 compared to approximately $7.1
million for the fiscal year ended March 31, 2021. The increase in
G&A expense is primarily due to the addition of senior
management and other personnel and phase-appropriate PH94B
pre-launch commercialization activities.
Net loss: Net loss attributable to common stockholders
for the fiscal year ended March 31, 2022 and 2021 was approximately
$48.7 million and $42.3 million, respectively.
Cash position: At March 31, 2022, the Company had cash
and cash equivalents of approximately $68.1 million.
As of June 22, 2022, the Company had 206,640,955 shares of
common stock outstanding.
Conference Call
VistaGen will host a conference call and live audio webcast this
afternoon at 5:00 p.m. Eastern Time to provide a corporate update
and discuss its financial results for its fiscal year 2022 ended
March 31, 2022.
U.S. Dial-in (Toll-Free): 1-877-407-9716 International Dial-in
Number (Toll): 1-201-493-6779 Conference ID: 13729400 Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1544875&tp_key=fd5623fb33
A live audio webcast of the conference call will also be
available via the link provided above. Participants should access
this webcast site 10 minutes before the start of the call. In
addition, a telephone playback of the call will be available after
approximately 8:00 pm Eastern Time on Thursday, June 23, 2022. To
listen to the replay, call toll free 1-844-512-2921 within the
United States or 1-412-317-6671 when calling internationally
(toll). Please use the replay PIN number 13729400.
About VistaGen
VistaGen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused
biopharmaceutical company striving to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available.
VistaGen’s clinical-stage candidates are targeting multiple forms
of anxiety and depression. PH94B and PH10 belong to a new class of
drugs known as pherines, which are odorless, neuroactive steroids
that bind to distinct receptors on chemosensory neurons in the
nasal passages and can impact the limbic amygdala without systemic
uptake or direct activity on CNS neurons in the brain. VistaGen’s
lead candidate, PH94B, is a nasally administered spray currently in
multiple Phase 3 trials in the U.S., with topline results
anticipated in 2022. Should ongoing Phase 3 studies be successful,
PH94B has the potential to be the first FDA-approved, fast-acting,
acute treatment of anxiety for adults with social anxiety disorder.
VistaGen is passionate about transforming mental health care and
redefining what is possible in the treatment of anxiety and
depression. Connect at www.VistaGen.com.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by VistaGen and its management,
are inherently uncertain. The Company’s actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to the completion and results of the Company’s PALISADE-1
and PALISADE-2 Phase 3 clinical trials; the Company’s ability to
submit a NDA to the FDA following the completion of PALISADE-1
and/or PALISADE-2 Phase 3 clinical trials; delays in launching,
conducting and/or completing other ongoing and planned clinical
trials, including delays due to the impact of the ongoing COVID-19
pandemic; fluctuating costs of materials and other resources
required to conduct the Company’s ongoing and/or planned clinical
and non-clinical trials; market conditions; the impact of general
economic, industry or political conditions in the United States or
internationally; adverse healthcare reforms and changes of laws and
regulations; manufacturing and marketing risks, which may include,
but are not limited to, unavailability of or delays in delivery of
raw materials for manufacture of the Company’s CNS drug candidates
due to the ongoing COVID-19 pandemic or otherwise; inadequate
and/or untimely supply of one or more of the Company’s CNS drug
candidates to meet demand; entry of competitive products; and other
technical and unexpected hurdles in the development, manufacture
and commercialization of the Company’s CNS drug candidates; and the
risks more fully discussed in the section entitled "Risk Factors"
in the Company’s most recent Annual Report on Form 10-K for the
fiscal year ended March 31, 2021 and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended December 31,
2021, as well as discussions of potential risks, uncertainties, and
other important factors in our other filings with the U.S.
Securities and Exchange Commission (SEC). The Company’s SEC filings
are available on the SEC’s website at www.sec.gov. You should not
place undue reliance on these forward-looking statements, which
apply only as of the date of this press release and should not be
relied upon as representing the Company’s views as of any
subsequent date. The Company explicitly disclaims any obligation to
update any forward-looking statements, other than as may be
required by law. If the Company does update one or more
forward-looking statements, no inference should be made that the
Company will make additional updates with respect to those or other
forward-looking statements.
VISTAGEN THERAPEUTICS, INC. CONSOLIDATED BALANCE
SHEETS (Amounts in dollars, except share amounts)
March 31,
March 31,
2022
2021
ASSETS Current assets: Cash and cash
equivalents
$
68,135,300
$
103,108,300
Prepaid expenses and other current assets
2,745,800
875,700
Deferred contract acquisition costs - current portion
116,900
133,500
Total current assets
70,998,000
104,117,500
Property and equipment, net
414,300
367,400
Right-of-use asset - operating lease
2,662,000
3,219,600
Deferred offering costs
321,800
294,900
Deferred contract acquisition costs - non-current portion
146,400
234,100
Security deposits
100,900
47,800
Total assets
$
74,643,400
$
108,281,300
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
2,758,600
$
838,300
Accrued expenses
1,329,200
1,562,700
Deferred revenue - current portion
1,244,000
1,420,200
Operating lease obligation - current portion
433,300
364,800
Financing lease obligation - current portion
-
3,000
Total current liabilities
5,765,100
4,189,000
Non-current liabilities: Accrued dividends on Series B
Preferred Stock
-
6,272,700
Deferred revenue - non-current portion
1,557,600
2,490,300
Operating lease obligation - non-current portion
2,605,400
3,350,800
Total non-current liabilities
4,163,000
12,113,800
Total liabilities
9,928,100
16,302,800
Commitments and contingencies Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
March 31, 2022 and 2021: Series A Preferred, 500,000 shares
authorized at March 31, 2022 and 2021; no shares and
-
500
500,000 shares issued and outstanding at March 31, 2022 and March
31, 2021, respectively Series B Preferred; 4,000,000 shares
authorized at March 31, 2022 and 2021; no shares and 1,131,669
shares issued and outstanding at March 31, 2022 and March 31, 2021,
respectively
-
1,100
Series C Preferred; 3,000,000 shares authorized at March 31, 2022
and 2021; no shares and 2,318,012 shares issued and outstanding at
March 31, 2022 and March 31, 2021, respectively
-
2,300
Series D Preferred; 2,000,000 shares authorized at March 31, 2022
and 2021; no shares and 402,149 shares issued and outstanding at
March 31, 2022 and March 31, 2021, respectively
-
400
Common stock, $0.001 par value; 325,000,000 shares authorized at
March 31, 2022 and 2021; 206,676,620 shares and 180,751,234 shares
issued at March 31, 2022 and March 31, 2021, respectively
206,700
180,800
Additional paid-in capital
336,080,700
315,603,100
Treasury stock, at cost, 135,665 shares of common stock held at
March 31, 2022 and 2021
(3,968,100
)
(3,968,100
)
Accumulated deficit
(267,604,000
)
(219,841,600
)
Total stockholders’ equity
64,715,300
91,978,500
Total liabilities and stockholders’ equity
$
74,643,400
$
108,281,300
VISTAGEN THERAPEUTICS, INC. CONDENSED CONSOLIDATED
STATEMENT OF OPERATIONS (Amounts in Dollars, except share
amounts)
Fiscal Years Ended March
31,
2022
2021
Sublicense revenue
$
1,108,900
$
1,089,500
Total revenues
1,108,900
1,089,500
Operating expenses: Research and development
35,407,800
11,925,700
General and administrative
13,480,000
7,097,600
Total operating expenses
48,887,800
19,023,300
Loss from operations
(47,778,900
)
(17,933,800
)
Other income, net: Interest income, net
19,900
1,600
Other income
-
600
Loss before income taxes
(47,759,000
)
(17,931,600
)
Income taxes
(3,400
)
(2,600
)
Net loss and comprehensive loss
$
(47,762,400
)
$
(17,934,200
)
Accrued dividends on Series B Preferred stock
(945,100
)
(1,385,600
)
Beneficial conversion feature on Series D Preferred
-
(23,000,000
)
Net loss attributable to common stockholders
$
(48,707,500
)
$
(42,319,800
)
Basic and diluted net loss attributable to common
stockholders per common share
$
(0.25
)
$
(0.49
)
Weighted average shares used in computing basic and diluted
net loss attributable to common stockholders per common share
197,978,592
86,133,644
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220623005927/en/
VistaGen Therapeutics, Inc. Investors: Mark Flather Vice
President, Investor Relations (650) 577-3617
mflather@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
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