Positive top-line results from Phase 3
PALISADE-2 trial of rapid-onset fasedienol (PH94B) nasal spray in
social anxiety disorder (SAD)
Itruvone (PH10) nasal spray now staged for
Phase 2B clinical development as a stand-alone, non-systemic
treatment for major depressive disorder (MDD)
Positive exploratory Phase 2A trial of PH80
nasal spray provides new optimism for the acute treatment of
moderate to severe vasomotor symptoms (hot flashes) in women due to
menopause
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 2024 first quarter ended June
30, 2023.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230810272661/en/
"The positive outcome of our PALISADE-2 study demonstrated that
fasedienol significantly reduced the mean Subjective Units of
Distress Scale score, reducing anxiety during a stressful public
speaking challenge. The study outcome is a pivotal achievement for
fasedienol and our diverse pherine platform. These results mark the
first positive U.S. Phase 3 study of an investigational therapy for
social anxiety disorder in over 15 years,” said Shawn Singh, Chief
Executive Officer of Vistagen. “We believe these results reinforce
the promise of our pherine pipeline to address growing unmet
treatment needs. We now move forward confidently advancing the
Phase 3 program for fasedienol in SAD with planning for initiation
of additional Phase 3 studies in 2024.”
"Our strong understanding of each pherine product candidate's
scientific and therapeutic potential gives us confidence in our
ability to continue to innovate for patients and deliver long-term
value for shareholders. With a collective body of positive safety
and efficacy studies supporting our clinical-stage pipeline, we
believe there are many strategic paths to accelerate our progress
in achieving key clinical and regulatory milestones for each
program over the next 12 months," said Mr. Singh.
Corporate Update
Positive Phase 3 PALISADE-2 study of fasedienol yields
statistically significant top-line results for the acute treatment
of anxiety in adults with SAD.
The Company’s Phase 3 PALISADE-2 trial (n=141) met its primary
efficacy endpoint, the difference in mean Subjective Units of
Distress Scale (SUDS) score during the public speaking challenge at
baseline (Visit 2) and treatment (Visit 3) for patients who
received fasedienol (n=70) versus placebo (n=71) at Visit 3.
Fasedienol-treated patients demonstrated a statistically
significant greater change in mean SUDS score (least-squares (LS)
mean = -13.8) compared to placebo (LS mean = -8.0), for a
difference between groups of -5.8 (p=0.015).
The trial also met its secondary endpoint, demonstrating a
statistically significant difference in the proportion of
clinician-assessed responders between fasedienol and placebo as
measured by the Clinical Global Impressions Improvement (CGI-I)
scale. Responders were identified as those who were rated ‘very
much less anxious’ or ‘much less anxious’ with 37.7% (n=70) of
fasedienol-treated patients rated as responders, as compared to
21.4% (n=71) of those treated with placebo (p=0.033).
Additionally, the trial met the important exploratory endpoint
of the difference in the proportion of patient-assessed responders
between fasedienol and placebo as measured by the Patient’s Global
Impression of Change (PGI-C) scale. Responders were identified as
those who self-rated ‘very much less anxious’ or ‘much less
anxious’ with 40.6% (n=70) of fasedienol-treated patients rated as
responders, as compared to 18.6% (n=71) of those treated with
placebo (p=0.003).
Finally, the trial also met the exploratory endpoint of the
difference in the proportion of patients in each treatment group
with a 20-point improvement in patient-assessed SUDS score from
baseline (Visit 2) to treatment (Visit 3). Of the
fasedienol-treated patients, 35.7% (n=70) demonstrated this
statistically significant and clinically meaningful improvement in
SUDS score, as compared to 18.6% (n=71) in the placebo-treated
group (p=0.020).
Fasedienol was observed to be well-tolerated with no severe or
serious adverse events (AEs) reported. All treatment-emergent AEs
reported for the overall study were mild or moderate. There were no
AEs reported in the fasedienol treatment arm above 2%
occurrence.
Fasedienol is a rapid-onset investigational neuroactive nasal
spray with a proposed rapid-onset, non-systemic mechanism of action
that sets it apart from all currently approved anti-anxiety
medications.
Phase 3 PALISADE-3 study of fasedienol for the acute
treatment of anxiety in adults with SAD.
Based on the positive top-line results of the Phase 3 PALISADE-2
study, we are currently preparing for our Phase 3 PALISADE-3 trial,
with potential to initiate the trial during the first half of
calendar 2024. Like PALISADE-2, PALISADE-3 will be designed as a
U.S. multi-center, randomized, double-blind, placebo-controlled,
Phase 3 clinical study to evaluate the efficacy, safety, and
tolerability of the acute administration of fasedienol to relieve
anxiety symptoms in adult patients with SAD during a simulated
anxiety-provoking public speaking challenge, as measured using the
patient-reported SUDS as the primary efficacy endpoint.
Preparations for Phase 3 FEARLESS Program in SAD underway
after positive U.S. Food and Drug Administration (FDA) feedback on
use of Liebowitz Social Anxiety Scale (LSAS) as a primary efficacy
endpoint in a Phase 3 real-world study.
To complement our PALISADE Phase 3 Program for fasedienol in
SAD, the Company is currently preparing for its Phase 3 FEARLESS
trial, with potential to initiate the trial in the second half of
calendar 2024 with a study design similar to the registration
trials for the three drugs currently approved for the treatment of
SAD using the LSAS as the primary efficacy endpoint. Accordingly,
FEARLESS will be designed as a randomized, double-blind,
placebo-controlled Phase 3 trial of fasedienol in adults with SAD
to evaluate the efficacy, safety and tolerability of multiple
administrations of fasedienol, on a patient-tailored as-needed
basis, up to six times per day in their daily lives, in a
real-world setting over a multiple week period. To complement the
positive results of PALISADE-2, we believe the Phase 3 FEARLESS
study design also will align with the way SAD patients will use
fasedienol in their daily lives, should it be approved, because our
planned fasedienol treatment model includes both repeated
experiences of acute reduction of anxiety during performance and
social events, evidenced by decreased SUDS scores as in PALISADE-2,
as well as longer-term overall reduction in severity of SAD
evidenced by reductions in LSAS scores, as will be assessed in
FEARLESS.
The Company believes that each of PALISADE-3 and FEARLESS has
the potential to complement PALISADE-2 as a potential New Drug
Application (NDA)-enabling adequate and well-controlled Phase 3
clinical trial of fasedienol for treatment of SAD.
Successful U.S. Phase 1 study of itruvone stages Phase 2B
development in MDD.
Results from the successful U.S. Phase 1 trial of itruvone nasal
spray build on successful Phase 1 studies and a positive
randomized, double-blind, placebo-controlled Phase 2A study of
itruvone in MDD previously conducted in Mexico and enable Phase 2B
development of itruvone in the U.S. as an innovative stand-alone
rapid-onset pherine product candidate for treatment of MDD. The
U.S. Phase 1 trial was a randomized, double-blind,
placebo-controlled clinical study investigating the safety and
tolerability of a single dose and of multiple doses of itruvone
nasal spray in healthy adult subjects. There were no reported
serious AEs or discontinuations due to AEs in the study. Overall,
itruvone nasal spray was well-tolerated and demonstrated a
favorable safety profile, consistent with all prior clinical
studies of itruvone.
Newly reported preclinical data for itruvone nasal spray
support potential antidepressant activity via peripheral nasal
neurons without entry into the brain.
Recently reported preclinical data of radiolabeled intranasal
itruvone in laboratory rats further validate its potential to treat
MDD without systemic absorption. These new data additionally
support the proposed mechanism of action of itruvone nasal spray as
binding to receptors of peripheral chemosensory neurons in the
nasal cavity but not to neuronal receptors in the brain, thereby
limiting the transport of molecules to the circulatory system and
minimizing potential systemic exposure. The preclinical data
further the substantial body of evidence supporting itruvone’s
favorable safety profile.
Positive exploratory Phase 2A trial of PH80 nasal spray
provides new optimism for the acute treatment of moderate to severe
vasomotor symptoms (hot flashes) in women due to menopause.
In a previously unreported randomized, double-blind,
placebo-controlled exploratory Phase 2A clinical study of PH80
designed to explore the efficacy, safety, and tolerability of PH80
for the acute management of menopausal hot flashes in women, PH80
induced significant reduction in the daily number of hot flashes
compared to placebo at the end of the first week of treatment, and
the improvement was maintained through each treatment week until
the end of the treatment period. At baseline, subjects reported a
mean daily number of hot flashes of 7.7 (PH80, n=18) and 8.0
(placebo, n=18). After one week of treatment, the number of hot
flashes dropped to 2.8 (PH80) and 6.4 (placebo) (p<.001), and
after four weeks of treatment, the number of hot flashes dropped to
1.5 (PH80) and 5.1 (placebo) (p<.001). 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 AEs,
and the AE profiles were comparable between PH80 and placebo. All
36 subjects completed four weeks of treatment and no subject
discontinued participation in the study as a result of AEs.
Fiscal Year 2024 First Quarter
Financial Results
Research and development (R&D) expense: Research and
development expense decreased by approximately $11.1 million, from
$15.3 million to $4.2 million for the quarter ended June 30, 2022
and 2023, respectively. The decrease in R&D expense is
primarily due to completing our initial Phase 3 PALISADE Program
studies in SAD and the exploratory Phase 2A study in adjustment
disorder, as well as reduced nonclinical development and outsourced
manufacturing and regulatory activities for fasedienol and
itruvone.
General and administrative (G&A) expense: General and
administrative expense decreased by approximately $1.8 million from
$4.8 million for the quarter ended June 20, 2022, to $3.0 million
for the quarter ended June 30, 2023, primarily due to the
termination of pre-commercialization activities in August 2022.
Net loss: Net loss attributable to common stockholders
for the first quarter ended June 30, 2023, was approximately $6.9
million compared to a Net Loss of $19.8 million for June 30,
2022.
Cash position: At June 30, 2023, the Company had cash and
cash equivalents of approximately $9.6 million. Since June 30, 2023
and through August 10, 2023, the Company sold and settled an
aggregate of 1,487,293 shares of common stock under its Sales
Agreement with Jefferies and received gross cash proceeds of
$16,893,700. Additional sales of 1,965,940 shares under the Sales
Agreement are expected to settle on or before August 14, 2023,
subject to customary settlement procedures, for expected gross cash
proceeds of $15,172,023.
As of August 10, 2023, the Company had 9,362,444 shares of
common stock outstanding.
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.
U.S. Dial-in (Toll-Free): 1-800-954-1051 International Dial-in
Number (Toll): 1-212-231-2924 Conference ID: 22027732 Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1627439&tp_key=9f0f4cb009
A live audio conference call webcast will also be available via
the above link. 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, August 10, 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 access ID number: 22027732.
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 the 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 prodrug antagonist of
the N-methyl-D-aspartate receptor (NMDAR). Pherines are neuroactive
nasal sprays designed with an innovative proposed mechanism of
action that activates chemosensory neurons in the nasal cavity and
can beneficially impact key neural circuits in the brain without
systemic absorption or direct activity on 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 most recent Annual
Report on Form 10-K for the fiscal year ended March 31, 2023, and
in the Company’s Quarterly Report on Form 10-Q for the period ended
June 30, 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)
June 30,
March 31,
2023
2023
(Unaudited) ASSETS Current assets: Cash and
cash equivalents
$
9,622,300
$
16,637,600
Prepaid expenses and other current assets
1,889,400
802,700
Deferred contract acquisition costs - current portion
67,100
67,100
Total current assets
11,578,800
17,507,400
Property and equipment, net
475,800
507,300
Right-of-use asset - operating lease
2,153,800
2,260,300
Deferred offering costs
522,100
495,700
Deferred contract acquisition costs - non-current portion
200,900
217,600
Security deposits
100,900
100,900
Total assets
$
15,032,300
$
21,089,200
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
1,623,200
$
2,473,100
Accrued expenses
424,700
787,400
Note payable
784,200
105,300
Deferred revenue - current portion
714,300
714,300
Operating lease obligation - current portion
501,100
485,600
Financing lease obligation - current portion
1,700
1,700
Total current liabilities
4,049,200
4,567,400
Non-current liabilities: Deferred revenue - non-current
portion
2,137,000
2,314,600
Operating lease obligation - non-current portion
1,990,100
2,119,800
Financing lease obligation - non-current portion
7,000
7,400
Total non-current liabilities
4,134,100
4,441,800
Total liabilities
8,183,300
9,009,200
Commitments and contingencies Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
June 30, 2023 and March 31, 2023: no shares outstanding at June 30,
2023 and March 31, 2023
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
June 30, 2023 and March 31, 2023; 7,879,673 and 7,315,583 shares
issued at June 30, 2023 and March 31, 2023, respectively
7,900
7,300
Additional paid-in capital
344,564,000
342,892,500
Treasury stock, at cost, 4,522 shares of common stock held at June
30, 2023 and March 31, 2023
(3,968,100
)
(3,968,100
)
Accumulated deficit
(333,754,800
)
(326,851,700
)
Total stockholders’ equity
6,849,000
12,080,000
Total liabilities and stockholders’ equity
$
15,032,300
$
21,089,200
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 (Unaudited) (Amounts in Dollars, except
share amounts) Three Months Ended June 30,
2023
2022
Revenues: Sublicense revenue
$
177,600
$
310,100
Total revenues
177,600
310,100
Operating expenses: Research and development
4,197,200
15,291,400
General and administrative
2,978,200
4,791,800
Total operating expenses
7,175,400
20,083,200
Loss from operations
(6,997,800
)
(19,773,100
)
Other income, net: Interest income, net
97,200
2,300
Loss before income taxes
(6,900,600
)
(19,770,800
)
Income taxes
(2,500
)
(5,500
)
Net loss and comprehensive loss
$
(6,903,100
)
$
(19,776,300
)
Basic and diluted net loss
$
(0.94
)
$
(2.87
)
Weighted average shares used in computing basic and diluted
net loss
7,377,005
6,886,736
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/20230810272661/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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