PALISADE-2 Phase 3 trial with PH94B in social
anxiety disorder restart preparations underway after independent
interim analysis recommends study continue as planned
Preliminary analysis of nearly 400 subjects in
the final data set for the PALISADE Open Label Study demonstrates
robust functional improvement in anxiety-provoking social and
performance situations in daily life, as measured by the Liebowitz
Social Anxiety Scale
Company planning to meet with the U.S. Food and
Drug Administration regarding next step in Phase 3 development of
PH94B in social anxiety disorder
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression and other central nervous system
(CNS) disorders, today reported financial results for its fiscal
year 2023 second quarter ended September 30, 2022 and provided a
corporate update.
“During the past quarter, Vistagen achieved several important
milestones to advance our CNS pipeline. Recent independent data
analysis supports our work to restart our PALISADE-2 Phase 3 study
of PH94B in social anxiety disorder, and preliminary data from
nearly 400 subjects in our PALISADE Open Label Study demonstrate
that PH94B has potential to help millions of individuals suffering
from social anxiety disorder, without the side effects and safety
concerns often associated with prior FDA approvals in SAD and other
off-label treatment options,” said Shawn Singh, Chief Executive
Officer of Vistagen. “We are focused on optimizing clinical studies
for PH94B and we will soon meet with the FDA to pursue a consensus
path forward in our Phase 3 program in social anxiety disorder. We
are also advancing our second pherine asset, PH10. We recently
submitted our U.S. Investigational New Drug application for a small
Phase 1 study to facilitate entering Phase 2B development of PH10
in major depressive disorder. Both therapies have the potential to
offer novel, fast-acting treatment for millions of patients
confronting the effects of debilitating mental health
challenges.”
Second Quarter Fiscal Year 2023 &
Recent Business Highlights
Below is an update on recent development involving the Company’s
pipeline of CNS product candidates — the pherine-based platform
consisting of PH94B and PH10 nasal sprays for anxiety and
depression disorders, respectively, and orally available AV-101 for
CNS indications involving the NMDA (N-methyl-D-aspartate)
receptor.
Independent interim analysis of the Company’s PALISADE-2
Phase 3 Study in social anxiety disorder (SAD) recommends
continuing the study as planned
In September 2022, based on their review of unblinded data from
the 140 subjects who had completed our PALISADE-2 Phase 3 clinical
study of PH94B for the acute treatment of anxiety in adults with
SAD, independent third-party biostatisticians recommended that the
Company continue PALISADE-2 as planned. Although Vistagen did not,
and does not, have access to any unblinded data from PALISADE-2,
based on the outcome of the interim analysis and the recommendation
from the independent biostatisticians, the Company is preparing to
restart PALISADE-2 as soon as practicable and then continue the
study to the full targeted enrollment of 208 subjects, as
originally planned. In parallel with preparing to restart
PALISADE-2, the Company is planning to meet with the U.S. Food and
Drug Administration (FDA) during the first quarter of calendar 2023
to discuss and reach consensus with the FDA on the next step in the
Company’s Phase 3 development program for PH94B as a potential
treatment for adults with SAD.
Preliminary data from PALISADE Open Label Study
The Company initiated the PALISADE Open Label Study (PALISADE
OLS) in October 2021 to evaluate the safety and tolerability of
PH94B in adult subjects with SAD taken as needed prior to acute
anxiety-provoking social and performance situations in daily life,
up to four times per day, over a period of up to 12 months. In
addition to assessing safety and tolerability, the Company included
several exploratory objectives, including assessment of PH94B’s
potential to achieve overall symptom reduction and improvement in
severity of SAD, as measured by the Liebowitz Social Anxiety Scale
(LSAS), the efficacy endpoint required by the FDA for prior SAD
approvals. In August 2022, the Company closed recruitment and
enrollment in the PALISADE OLS. Preliminary analysis of nearly 400
subjects in the final data set for the PALISADE OLS demonstrates
robust functional improvement in anxiety-provoking social and
performance situations in daily life, as measured by the LSAS. The
Company now has two data sets supporting PH94B’s ability to improve
LSAS scores – the PALISADE OLS over a period of one month and
beyond and a published double-blind, placebo-controlled Phase 2
cross-over study after two weeks of use. These two studies combined
demonstrate the potential for PH94B to achieve robust overall
reduction in symptoms of SAD and improvement in severity over time
as measured by the LSAS. The Company believes LSAS measurements
over time may be well-suited for a Phase 3 trial to demonstrate
efficacy and the true impact of PH94B on patients’ lives given that
it measures overall improvement in disease severity by capturing
the reduction in fear and anxiety, as well as the avoidance of
social and performance situations. These studies reinforce the
Company’s confidence in the potential of PH94B, used acutely
as-needed in daily life, to provide rapid-onset, clinically
meaningful, and sustained response with a favorable safety and
tolerability profile. A full assessment of the PALISADE OLS is
expected during the first quarter of calendar 2023.
Enrollment completed in exploratory Phase 2A trial of PH94B
in adjustment disorder with anxiety
The Company has completed enrollment in its ongoing exploratory
double-blind, placebo-controlled Phase 2A clinical trial of PH94B
to evaluate the efficacy, safety and tolerability of PH94B as a
potential treatment of adults with adjustment disorder with anxiety
(AjDA). The study protocol involves multiple administration
assessments of PH94B, which is administered four times per day for
28 days. Vistagen anticipates topline results from this exploratory
Phase 2A AjDA trial during the first quarter of calendar 2023.
Investigational New Drug (IND) application submitted to the
FDA to facilitate U.S. Phase 2B clinical development of PH10 for
major depressive disorder
In a small (n=30) published exploratory randomized,
double-blind, placebo-controlled parallel design Phase 2A study of
PH10 in major depressive disorder (MDD) conducted in Mexico, at a
6.4 microgram dose administered intranasally twice daily for 8
weeks, PH10 significantly reduced depressive symptoms as early as
one week based on the 17-item Hamilton Depression Scale (HAM-D-17)
scores compared to placebo (p = 0.022). PH10 was well-tolerated and
did not cause psychological side effects (such as dissociation and
hallucinations) or other safety concerns that may be associated
with rapid-onset ketamine-based therapies. The Company recently
submitted its U.S. IND application to enable initiation of a small
Phase 1 clinical study of PH10 in the U.S. in healthy volunteers.
Should the FDA permit the Company to proceed, the Company plans to
initiate the study before the end of calendar 2022. This small and
brief Phase 1 study is intended to facilitate Phase 2B development
of PH10 in the U.S. as an innovative potential fast-acting
stand-alone treatment of MDD. Vistagen may also have potential
opportunities to develop PH10 for several other depression-related
disorders.
AV-101 + Probenecid Phase 1B trial progressing
Based on observations and findings from preclinical studies,
Vistagen believes that AV-101, in combination with FDA-approved
oral probenecid, has the potential to become a new oral treatment
alternative for certain CNS indications involving the NMDA
receptor. The Company is currently conducting an exploratory Phase
1B drug-drug interaction clinical study of AV-101 in combination
with probenecid. Upon completion of the study, anticipated during
the second quarter of calendar 2023, the Company plans to consider
exploratory Phase 2A development of AV-101 in combination with
probenecid, on its own or with a collaborator, as a potential oral
treatment for CNS disorders involving the NMDA receptor.
Fiscal Year 2023 Second Quarter Financial Results
Research and development (R&D) expense: Research and
development expense increased by $2.9 million, from $10.0 million
to $12.9 million for the quarters ended September 30, 2021 and
2022, respectively. The increase in R&D expense is primarily
due to expenses related to conducting the PALISADE Phase 3 Program
for PH94B in SAD, including PALISADE-1, PALISADE-2 and the PALISADE
OLS, and the exploratory Phase 2A study of PH94B in AjDA, as well
as nonclinical development, regulatory and outsourced manufacturing
activities for both PH94B and PH10.
General and administrative (G&A) expense: General and
administrative expense increased to approximately $3.7 million for
the quarter ended September 30, 2022 compared to approximately $3.2
million for the quarter ended September 30, 2021. The increase in
G&A expense was primarily due to costs associated with external
legal, accounting and other professional services relating to
corporate finance matters as well as expanded corporate initiatives
surrounding corporate awareness and investor relations.
Net loss: Net loss attributable to common stockholders
for the fiscal quarters ended September 30, 2022 and 2021 was
approximately $17.5 million and $13.2 million, respectively.
Cash position: At September 30, 2022, the Company had
cash and cash equivalents of approximately $35.3 million. As a
result of the conclusion of certain clinical trial activity and
deferral of several research and development and
pre-commercialization activities, the Company anticipates a
decrease in spending over the next few quarters which the Company
expects will extend its cash runway through a series of potential
key milestones and data readouts in 2023.
As of November 9, 2022, the Company had 206,836,345 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 discuss its financial
results for its second quarter fiscal year 2023 ended September 30,
2022 and provide a corporate update.
U.S. Dial-in (Toll-Free): 1-888-599-8686 International Dial-in
Number (Toll): 1-929-477-0402 Conference ID: 5975082 Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1579342&tp_key=aa33644740
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 p.m. Eastern Time on Thursday, November 10,
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 5975082.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage CNS-focused
biopharmaceutical company aiming 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. Candidates include PH94B and PH10, which
belong to a new class of drugs known as pherines, which are
investigational neuroactive steroids designed with a novel
rapid-onset mechanism of action that activates chemosensory neurons
in the nasal passages and can impact the olfactory-amygdala neural
circuits without systemic uptake or direct activity on CNS neurons
in the brain. Vistagen is passionate about transforming mental
health care and redefining what is possible in the treatment of
anxiety and depression – one mind at a time. 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. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Among other things, there can
be no guarantee that any of the Company’s drug candidates will
successfully complete ongoing or future clinical trials, receive
regulatory approval or be commercially successful. Other factors
that may cause such a difference include, without limitation, risks
and uncertainties relating to the results of the Company’s interim
analysis of data currently available from the PALISADE-2 Phase 3
clinical trial and preliminary data from the PALISADE OLS; resuming
enrollment in PALISADE-2; the completion and results of PALISADE-2,
as well as the Company’s ongoing clinical studies of PH94B,
including the Company’s Phase 2A clinical trial of PH94B in adults
experiencing adjustment disorder with anxiety, and ongoing studies
of the Company’s other product candidates, PH10 and AV-101; delays
in launching, conducting and/or completing other ongoing and
planned clinical trials, including delays or other adverse effects
due to the 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; and other technical and
unexpected hurdles in the development, manufacture and
commercialization of the Company’s CNS drug candidates. These risks
are 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, 2022 and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended September 30,
2022, 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)
September 30, March 31,
2022
2022
(unaudited) ASSETS Current assets: Cash and
cash equivalents
$
35,287,200
$
68,135,300
Prepaid expenses and other current assets
1,559,600
2,745,800
Deferred contract acquisition costs - current portion
67,000
116,900
Total current assets
36,913,800
70,998,000
Property and equipment, net
558,800
414,300
Right-of-use asset - operating lease
2,465,700
2,662,000
Deferred offering costs
411,400
321,800
Deferred contract acquisition costs - non-current portion
251,100
146,400
Security deposits
100,900
100,900
Total assets
$
40,701,700
$
74,643,400
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
2,957,800
$
2,758,600
Accrued expenses
1,188,300
1,329,200
Notes payable
730,000
-
Deferred revenue - current portion
712,300
1,244,000
Operating lease obligation - current portion
455,500
433,300
Financing lease obligation - current portion
1,500
-
Total current liabilities
6,045,400
5,765,100
Non-current liabilities: Deferred revenue - non-current
portion
2,671,800
1,557,600
Operating lease obligation - non-current portion
2,371,200
2,605,400
Financing lease obligation - non-current portion
8,300
-
Total non-current liabilities
5,051,300
4,163,000
Total liabilities
11,096,700
9,928,100
Commitments and contingencies Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
September 30, 2022 and March 31, 2022: no shares outstanding at
September 30, 2022 and March 31, 2022
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
September 30, 2022 and March 31, 2022; 206,972,010 and 206,676,620
shares issued at September 30, 2022 and March 31, 2022,
respectively
207,000
206,700
Additional paid-in capital
338,229,600
336,080,700
Treasury stock, at cost, 135,665 shares of common stock held at
September 30, 2022 and March 31, 2022
(3,968,100
)
(3,968,100
)
Accumulated deficit
(304,863,500
)
(267,604,000
)
Total stockholders’ equity
29,605,000
64,715,300
Total liabilities and stockholders’ equity
$
40,701,700
$
74,643,400
VISTAGEN THERAPEUTICS, INC. CONDENSED CONSOLIDATED
STATEMENT OF OPERATIONS (Unaudited) (Amounts in
Dollars, except share amounts) Three Months
Ended Six Months Ended September 30, September
30,
2022
2021
2022
2021
Revenues: Sublicense revenue
$
(892,500
)
$
358,000
$
(582,500
)
$
712,100
Total revenues
(892,500
)
358,000
(582,500
)
712,100
Operating expenses: Research and development
12,894,500
9,936,300
28,185,800
15,393,500
General and administrative
3,702,300
3,221,200
8,494,100
5,864,300
Total operating expenses
16,596,800
13,157,500
36,679,900
21,257,800
Loss from operations
(17,489,300
)
(12,799,500
)
(37,262,400
)
(20,545,700
)
Other income, net: Interest income, net
6,100
5,100
8,400
10,200
Loss before income taxes
(17,483,200
)
(12,794,400
)
(37,254,000
)
(20,535,500
)
Income taxes
-
-
(5,500
)
(3,400
)
Net loss and comprehensive loss
$
(17,483,200
)
$
(12,794,400
)
(37,259,500
)
(20,538,900
)
Accrued dividend on Series B Preferred stock
-
(375,200
)
-
(737,000
)
Net loss attributable to common stockholders
$
(17,483,200
)
$
(13,169,600
)
$
(37,259,500
)
$
(21,275,900
)
Basic and diluted net loss attributable to common
stockholders per common share
$
(0.08
)
$
(0.07
)
$
(0.18
)
$
(0.11
)
Weighted average shares used in computing basic and diluted net
loss attributable to common stockholders per common share
206,811,249
193,227,841
206,704,573
191,585,026
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110006040/en/
Investors: Mark Flather Vice President, Investor Relations (650)
577-3617 mflather@vistagen.com Media: Nate Hitchings SKDK
nhitchings@skdknick.com
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