Positive results in Phase 3 open label study of
fasedienol (PH94B) in social anxiety disorder (SAD)
Positive U.S. Food and Drug Administration
(FDA) feedback on the use of the Liebowitz Social Anxiety Scale
(LSAS) as the primary efficacy endpoint in future Phase 3 studies
of fasedienol in SAD
Successful itruvone (PH10) U.S. Phase 1 study
supports previous successful Phase 1 studies and a positive Phase
2A study in major depressive disorder (MDD) conducted outside the
U.S. and facilitates next-step U.S. Phase 2B development in MDD
Clinical-stage pipeline expanded to six
differentiated product candidates targeting multiple large CNS
markets
Pursuing multiple global and regional strategic
development and commercialization partnerships to accelerate
clinical and regulatory milestones across the CNS pipeline
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 provided a corporate update and reported
financial results for its fiscal year 2023 ended March 31,
2023.
“We continue to make significant progress across our CNS
pipeline, which now includes six innovative clinical-stage product
candidates, each with a differentiated mechanism of action, a
favorable safety profile and substantial potential to improve
millions of lives affected by anxiety, depression, hot flashes due
to menopause and several other large market CNS disorders without
therapeutic options that adequately satisfy patient needs,” said
Shawn Singh, Chief Executive Officer of Vistagen. “Our deep
understanding of the science and therapeutic potential underlying
each of our product candidates provides a firm foundation for our
confidence in our future. Given the collective body of positive
safety and efficacy studies supporting our clinical-stage pipeline,
now is the opportune time to amplify our efforts with multiple
global and regional strategic development and commercialization
partnerships across our portfolio to accelerate achieving key
clinical and regulatory milestones within each program.”
Corporate Update
Positive results from PALISADE Phase 3 open label study
amplify placebo-controlled Phase 2 studies of fasedienol (PH94B) in
SAD and inform next steps in Phase 3 development to address a large
and growing global unmet need.
Earlier this year, the Company reported that long-term
administration of 3.2 µg of fasedienol, taken as-needed up to four
times per day in a real-world setting, was well-tolerated with no
new safety findings or trends identified, regardless of the number
of doses administered by each subject. Overall, patients
self-administered over 30,000 doses of fasedienol during the study
with a mean duration of 4 months and a maximum study duration of
over 10 months. Additionally, exploratory efficacy results from the
study demonstrated clinically meaningful reductions in fear,
anxiety and avoidance of anxiety-provoking social and performance
situations in daily life, as measured by the Liebowitz Social
Anxiety Scale (LSAS). We believe the continued improvement in LSAS
scores observed in the study indicates the therapeutic potential of
multiple, patient-tailored as-needed administrations of fasedienol
over time to help patients build confidence and resilience,
enabling them to engage in anxiety-provoking social and performance
situations in their daily lives more frequently and with less fear
and anxiety.
Positive FDA feedback on the path forward for development of
fasedienol for SAD – FEARLESS Phase 3 program to center on the
three prior FDA approvals in SAD using the LSAS as the primary
efficacy endpoint.
In the first quarter of calendar 2023, the Company met with the
FDA to discuss the next steps in its FEARLESS Phase 3 development
plan for fasedienol in SAD, including conducting a potential New
Drug Application (NDA)-enabling Phase 3 study of fasedienol in a
real-world setting using the LSAS as the primary efficacy outcome
measure in a manner similar to the registration studies for the
three FDA-approved treatments for SAD. Support for an LSAS-based
study design is demonstrated in the Company’s prior
placebo-controlled Phase 2 study of fasedienol in SAD, in which the
amount of separation between fasedienol and placebo as measured by
the LSAS at the end of the first 2 weeks was comparable to what was
observed after 12 weeks in the registration trials for the
antidepressants currently approved by the FDA for treatment of SAD.
Using the LSAS as the primary efficacy endpoint, all prior
registration studies for these approved medications were
positive.
Positive feedback from the FDA confirmed the acceptable use by
the Company of the LSAS as a primary efficacy endpoint in its Phase
3 study of fasedienol for the treatment of SAD. Previously, the FDA
granted Fast Track designation for the development of fasedienol
for the treatment of SAD. Accordingly, the Company is now
positioned to finalize key components of its NDA-enabling FEARLESS
Phase 3 development program for fasedienol in SAD.
In contrast to the Company’s PALISADE Phase 3 single
administration public speaking challenge studies in SAD conducted
during the acute stage of the COVID-19 pandemic, the Company’s
FEARLESS program in SAD will align with the LSAS-based study design
supporting the precedent-setting NDA-enabling programs for the
three antidepressants currently approved for treatment of SAD. The
Company’s FEARLESS Phase 3 studies will be designed to assess
multiple administrations of fasedienol, on a patient-tailored,
as-needed basis in their daily lives, up to six times per day, in a
real-world outpatient setting over a multiple-week period, with the
clinician-administered LSAS as the primary efficacy endpoint. Dr.
Michael R. Liebowitz, a Columbia University psychiatrist, former
director and founder of the Anxiety Disorders Clinic at the New
York State Psychiatric Institute and current Managing Director of
The Medical Research Network LLC in New York City, is the creator
of the LSAS. Dr. Liebowitz is a renowned authority on SAD and will
serve as the Principal Investigator for the Company’s FEARLESS
Phase 3 program in SAD.
Successful itruvone (PH10) U.S. Phase 1 clinical trial
supports previous successful Phase 1 and Phase 2 studies conducted
outside the U.S. and enables U.S. Phase 2B development in
MDD.
Recently, the Company reported favorable safety and tolerability
data from its U.S. Phase 1 clinical trial of itruvone, its
innovative stand-alone, rapid-onset Phase 2 product candidate for
the treatment of MDD. Itruvone nasal spray was well-tolerated and
consistently continued to demonstrate a favorable safety profile.
Results from this study build on previous successful Phase 1
studies and a positive placebo-controlled Phase 2A study of
itruvone in MDD conducted outside the U.S. The successful U.S.
Phase 1 study is expected to facilitate next step Phase 2B clinical
development of itruvone in the U.S. During the past year, the FDA
granted Fast Track designation for the development of itruvone for
the treatment of MDD.
Positive results reported from Phase 2A study of PH80 in
women diagnosed with vasomotor symptoms (hot flashes) due to
menopause.
The Company recently reported that PH80 nasal spray demonstrated
statistically significant efficacy versus placebo in a previously
unreported exploratory placebo-controlled Phase 2A study for the
acute treatment of vasomotor symptoms (hot flashes) due to
menopause. PH80 induced a statistically significant reduction in
the daily number of menopausal hot flashes compared to placebo at
the end of the first week of treatment (p<.001), and the
improvement was maintained through each treatment week until the
end of the four-week treatment period. PH80 treatment also
significantly reduced the severity, disruption in function and
sweating related to hot flashes during the treatment period as
compared with placebo. PH80 was well-tolerated with no serious
adverse events, and the adverse event profiles were comparable
between PH80 and placebo.
New U.S. and European patents expand PH80 intellectual
property portfolio to include treatment of migraine.
PH80 is designed to initiate neural impulses in the olfactory
bulb transmitted by pathways that rapidly affect the function of
multiple structures in the brain, including the amygdala and
hypothalamus, which have been linked to the pathology of migraine.
Due to its innovative mechanism of action, the Company believes
PH80 also has therapeutic potential to relieve premonitory and aura
symptoms of migraines. Earlier this year, the U.S. Patent and
Trademark Office granted a U.S. patent for PH80 nasal spray for
treatment of migraine and the European Patent Office (EPO) issued
an intention to grant a patent for the treatment of migraine by
intranasal administration of PH80, thereby expanding the
intellectual property portfolio of PH80 as the Company prepares for
potential future development.
AV-101 receives additional European patent bolstering
intellectual property portfolio.
Based on observations and findings from preclinical and clinical
studies, the Company believes that AV-101 has the potential to
become a new oral treatment alternative for multiple CNS
indications involving the NMDAR (N-methyl-D-aspartate receptor).
The Company is currently pursuing partnering and non-dilutive grant
opportunities for Phase 2A clinical development of AV-101 as a
treatment for one or more neurological disorders involving the
NMDAR. Recently, the Company strengthened its AV-101 intellectual
property portfolio after receiving a new patent granted by the EPO
related to the synthesis of AV-101 and certain chemical
intermediaries, which yields AV-101 in commercial quantities and
has the scalability for commercial manufacture. The expanded
intellectual property portfolio significantly enhances the
attractiveness of AV-101 as a valuable asset for potential
strategic development and commercialization partnerships.
The Company is pursuing multiple strategic global and
regional development and commercialization partnerships to
accelerate the achievement of a series of late-stage clinical and
regulatory milestones across its CNS pipeline.
The Company now has six clinical-stage CNS product candidates.
Given the depth of positive clinical studies assessing efficacy and
safety of its CNS pipeline, the Company is pursuing multiple
strategic development and commercialization partnerships, both
global and regional, to efficiently unlock the full value of its
product candidate portfolio. The Company believes global and
regional partnerships designed to amplify its internal activities
can accelerate key development timelines and regulatory milestones
for each of its product candidates, enhancing the Company’s ongoing
efforts to deliver differentiated treatment options with improved
efficacy and favorable safety profiles to millions of individuals
suffering from anxiety, depression and other CNS disorders
worldwide.
Fiscal Year 2023 Financial
Results
Research and development (R&D) expense: Research and
development expense increased by approximately $9.0 million, from
$35.4 million to $44.4 million for the fiscal years ended March 31,
2022 and 2023, respectively. The increase in R&D expense is
primarily due to fasedienol development in SAD and adjustment
disorder with anxiety, as well as nonclinical development and
outsourced manufacturing and regulatory activities for fasedienol
and itruvone.
General and administrative (G&A) expense: General and
administrative expense increased by approximately $1.2 million from
$13.5 million to $14.7 million for the fiscal years ended March 31,
2022 and 2023, respectively.
Net loss: Net loss attributable to common stockholders
for the fiscal years ended March 31, 2022 and 2023 was
approximately $48.7 million and $59.2 million, respectively.
Cash position: At March 31, 2023, the Company had cash
and cash equivalents of approximately $16.6 million.
As of June 27, 2023, the Company had 7,872,479 shares of common
stock outstanding, which reflects the impact of the recent 1-for-30
reverse stock split, which enabled the Company to regain full
compliance with the continued listing standards of the Nasdaq
Capital Market.
Conference Call
Vistagen will host a conference call and live audio webcast this
afternoon at 4:30 p.m. Eastern Time to provide a corporate update
for its fiscal year 2023 ended March 31, 2023.
U.S. Dial-in (Toll-Free): 1-877-407-9716 International Dial-in
Number (Toll): 1-201-493-6779 Conference ID: 13739679 Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1622868&tp_key=e466ec0ec7
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 Wednesday, June 28, 2023.
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 13739679.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. Vistagen is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those currently available for treatment of
anxiety, depression and multiple CNS disorders. Vistagen’s pipeline
includes six clinical-stage product candidates, including
fasedienol (PH94B), itruvone (PH10), PH15, PH80, and PH284, each an
investigational agent belonging to a new class of drugs known as
pherines, as well as AV-101, which is an oral antagonist of the
N-methyl-D-aspartate receptor (NMDAR). Pherines, which are
administered as low-dose nasal sprays, are designed with a novel
rapid-onset mechanism of action that activates chemosensory neurons
in the nasal cavity and can beneficially impact key neural circuits
in the brain 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, depression and several other CNS disorders. 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, if initiated, future clinical
trials, receive regulatory approval or be commercially successful,
or that the Company will be able to successfully replicate the
result of past studies of its product candidates, including
fasedienol, itruvone, AV-101 and/or PH80. Other factors that may
cause such a difference include, without limitation, risks and
uncertainties relating to the Company’s ability to secure adequate
financing for its operations, including financing or collaborative
support for continued clinical development of the Company’s product
candidates; risks and uncertainties related to the Company’s
ability to secure successful strategic global and/or regional
development and commercialization partnerships; other risks and
uncertainties related to delays in launching, conducting and/or
completing ongoing and planned clinical trials; the scope and
enforceability of the Company’s patents, including patents related
to the Company’s pherine drug candidates and AV-101; fluctuating
costs of materials and other resources and services 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
product candidates. These risks are more fully discussed in the
section entitled "Risk Factors" in the Company’s recently filed
Annual Report on Form 10-K for the fiscal year ended March 31,
2023, 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,
2023
2022
ASSETS Current assets:
Cash and cash equivalents
$
16,637,600
$
68,135,300
Prepaid expenses and other
current assets
802,700
2,745,800
Deferred contract acquisition
costs - current portion
67,100
116,900
Total current assets
17,507,400
70,998,000
Property and equipment, net
507,300
414,300
Right-of-use asset - operating
lease
2,260,300
2,662,000
Deferred offering costs
495,700
321,800
Deferred contract acquisition
costs - non-current portion
217,600
146,400
Security deposits
100,900
100,900
Total assets
$
21,089,200
$
74,643,400
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
2,473,100
$
2,758,600
Accrued expenses
787,400
1,329,200
Note payable
105,300
-
Deferred revenue - current portion
714,300
1,244,000
Operating lease obligation - current portion
485,600
433,300
Financing lease obligation - current portion
1,700
-
Total current liabilities
4,567,400
5,765,100
Non-current liabilities: Deferred revenue - non-current
portion
2,314,600
1,557,600
Operating lease obligation - non-current portion
2,119,800
2,605,400
Financing lease obligation - non-current portion
7,400
-
Total non-current liabilities
4,441,800
4,163,000
Total liabilities
9,009,200
9,928,100
Commitments and contingencies Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
March 31, 2023 and March 31, 2022: no shares outstanding at March
31, 2023 and March 31, 2022
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
March 31, 2023 and March 31, 2022; 7,315,404 and 6,889,221 shares
issued at March 31, 2023 and March 31, 2022, respectively
7,300
6,900
Additional paid-in capital
342,892,500
336,280,500
Treasury stock, at cost, 4,522 shares of common stock held at March
31, 2023 and March 31, 2022
(3,968,100
)
(3,968,100
)
Accumulated deficit
(326,851,700
)
(267,604,000
)
Total stockholders’ equity
12,080,000
64,715,300
Total liabilities and stockholders’ equity
$
21,089,200
$
74,643,400
References to common shares and per share amounts have been
retroactively restated to reflect the Company’s 1-for-30 reverse
stock split of its common stock effective on June 6, 2023.
VISTAGEN THERAPEUTICS CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS (Amounts in Dollars, except share amounts)
Fiscal Years Ended
March 31,
2023
2022
Revenues: Sublicense revenue
$
(227,300
)
$
1,108,900
Total revenues
(227,300
)
1,108,900
Operating expenses: Research and development
44,377,100
35,407,800
General and administrative
14,663,600
13,480,000
Total operating expenses
59,040,700
48,887,800
Loss from operations
(59,268,000
)
(47,778,900
)
Other income, net: Interest income, net
26,200
19,900
Loss before income taxes
(59,241,800
)
(47,759,000
)
Income taxes
(5,900
)
(3,400
)
Net loss and comprehensive loss
(59,247,700
)
(47,762,400
)
Accrued dividend on Series B Preferred stock
-
(945,100
)
Net loss attributable to common stockholders
$
(59,247,700
)
$
(48,707,500
)
Basic and diluted net loss attributable to common
stockholders per common share
$
(8.51
)
$
(7.38
)
Weighted average shares used in computing basic and diluted net
loss attributable to common stockholders per common share
6,958,749
6,599,287
References to common shares and per share amounts have been
retroactively restated to reflect the Company’s 1-for-30 reverse
stock split of its common stock effective on June 6, 2023.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230628522486/en/
Investors: Mark McPartland Senior Vice President,
Investor Relations (650) 577-3606 markmcp@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
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