Registration-directed fasedienol PALISADE Phase 3 program for
the acute treatment of social anxiety disorder progressing on
track
PALISADE-3 Phase 3 trial recently initiated; PALISADE-4 Phase 3
trial initiation anticipated in 2H 2024
Vistagen (Nasdaq: VTGN), a neuroscience-focused
biopharmaceutical company dedicated to pursuing a pioneering
approach to the development of groundbreaking therapies for
psychiatric and neurological disorders based on nose-to-brain
neurocircuitry, today reported financial results for its fiscal
year ended March 31, 2024, and provided a corporate update.
“Vistagen’s fiscal 2024 proved to be a year full of remarkable
accomplishments. Most notably, with our PALISADE-2 trial of
fasedienol, we became the first company to report positive results
of a Phase 3 trial for the acute treatment of social anxiety
disorder, a mental health disorder affecting the lives of over 30
million adults in the U.S for which there is no FDA-approved acute
treatment option. In addition, we recently initiated our PALISADE-3
Phase 3 trial, which, if successful, has the potential to
complement PALISADE-2 in support of a fasedienol U.S. New Drug
Application submission,” said Shawn Singh, Chief Executive Officer
of Vistagen. “Our primary focus is on the high-quality execution of
our registration-directed PALISADE Phase 3 program for fasedienol
in social anxiety disorder, as well as the further progression of
our non-systemic, neurocircuitry-focused pherine development
programs involving itruvone for major depressive disorder and
hormone-free PH80 for menopausal hot flashes. We are
well-positioned on a path toward achieving multiple potential
value-creating catalysts during the year ahead as we pursue our
mission to develop and commercialize differentiated neuroscience
therapies to improve patients' lives worldwide.”
Fasedienol for the Acute Treatment of
Social Anxiety Disorder (SAD)
- Reported Positive PALISADE-2 Phase 3 Trial Results. In
the second quarter of fiscal 2024, Vistagen announced positive
top-line results from PALISADE-2, a U.S. multi-center, randomized,
double-blind, placebo-controlled Phase 3 trial designed to evaluate
the efficacy, safety, and tolerability of fasedienol for the acute
treatment of SAD after a single dose of fasedienol during a
simulated, anxiety-provoking public speaking challenge in a
clinical setting, as measured using the patient-reported Subjective
Units of Distress Scale (SUDS) as the primary efficacy endpoint.
Fasedienol is Vistagen’s lead investigational neuroactive pherine
formulated as a rapid-onset nasal spray to activate olfactory and
brain neural circuits without requiring systemic uptake or binding
to neurons in the brain. Fasedienol’s proposed MOA is fundamentally
differentiated from the MOA of all currently approved treatments
for anxiety disorders. Currently, there is no FDA-approved drug
therapy for the acute treatment of SAD. With PALISADE-2, Vistagen
became the first company to report a positive Phase 3 trial of a
drug candidate for the acute treatment of SAD.
- Initiated PALISADE-3 Phase 3 Trial; Preparation for
PALISADE-4 Phase 3 Trial Underway. In the fourth quarter of
fiscal 2024, Vistagen launched its PALISADE-3 Phase 3 trial of
fasedienol for the acute treatment of SAD. With PALISADE-3
initiated, the Company is now preparing to launch its PALISADE-4
Phase 3 trial in the second half of calendar 2024. PALISADE-3 and
PALISADE-4 are designed similarly to PALISADE-2, including an
open-label extension for a period of up to 12 months with subjects
able to use fasedienol up to 6 times per day in their everyday
lives prior to anxiety-provoking social and performance
stressors.
Itruvone for Major Depressive Disorder
(MDD)
- Completed Successful U.S. Phase 1 Trial to Enable U.S. Phase
2B Development. In the first quarter of fiscal 2024, Vistagen
announced favorable safety and tolerability data from its U.S.
Phase 1 clinical trial of itruvone to build on successful Phase 1
and Phase 2A clinical studies of itruvone previously conducted
outside the U.S. Leveraging positive results from an exploratory
Phase 2A trial in MDD, preparations and planning are underway for
U.S. Phase 2B development of itruvone as a novel, non-systemic
stand-alone treatment for MDD.
- Reported Key Pherine Mechanism of Action (MOA) Data. In
the second quarter of fiscal 2024, the Company reported preclinical
data demonstrating that a single intranasal administration of
radiolabeled itruvone ([14C]PH10) was essentially undetectable in
the brain and most other tissues, including blood and plasma.
Similar to previously reported preclinical MOA data of fasedienol,
these new preclinical data for itruvone further support its unique
proposed MOA as involving binding to receptors of peripheral
chemosensory neurons in the nasal cavity, but not to neuronal
receptors in the central nervous system, and thereby limiting
transport of molecules to the circulatory system and minimizing
potential systemic exposure. Itruvone’s proposed MOA is
fundamentally differentiated from the MOA of all currently approved
treatments for depression disorders.
PH80 for Women’s Health
Indications
- Announced Positive Exploratory Phase 2A Data Study for the
Treatment of Vasomotor Symptoms (Hot Flashes) due to Menopause.
In the first quarter of fiscal 2024, Vistagen announced positive
data from a previously unreported exploratory Phase 2A clinical
trial conducted outside the U.S. in which PH80, Vistagen’s
rapid-onset, hormone-free neuroactive pherine nasal spray,
demonstrated statistically significant efficacy versus placebo for
the treatment of vasomotor symptoms (hot flashes) due to menopause.
Potential U.S. IND-enabling studies are underway to facilitate
further Phase 2 development of PH80 in the U.S. for the treatment
of menopausal hot flashes. PH80’s proposed MOA is fundamentally
differentiated from the MOA of all currently approved treatments
for menopausal hot flashes.
- Announced Positive Exploratory Phase 2A Data Study for
Treatment of Premenstrual Dysphoric Disorder (PMDD). In the
second quarter of fiscal 2024, the Company announced positive data
from a previously unreported exploratory Phase 2A clinical trial
conducted outside the U.S. in which PH80 demonstrated statistically
significant efficacy versus placebo for the treatment of PMDD.
Corporate Updates
- In the first quarter of fiscal 2024, Vistagen was awarded
Mental Health America’s Platinum Bell Seal for workplace mental
health, an award the Company received again in the first quarter of
fiscal 2025. Receipt of this prestigious award demonstrates
Vistagen’s ongoing commitment to bringing mental health awareness
and action to the forefront of its workplace and corporate
objectives.
- In the second quarter of fiscal 2024, Vistagen announced the
appointment of Cindy Anderson as Chief Financial Officer. Ms.
Anderson brings almost two decades of financial and operating
strength from her experiences in the biopharmaceutical sector.
- In the second quarter of fiscal 2024, Vistagen entered into an
Exclusive Negotiation Agreement with Fuji Pharma Co., Ltd. (Fuji
Pharma), a leading company in Japan focused on women’s health, to
negotiate exclusively with Fuji Pharma for a potential agreement to
develop and commercialize Vistagen’s hormone-free pherine nasal
spray, PH80, in Japan for the treatment of vasomotor symptoms (hot
flashes) due to menopause.
- In the third quarter of fiscal 2024, Vistagen closed an
underwritten public offering, providing the Company with cash
runway to execute critical milestones in its registration-directed
PALISADE Phase 3 program for fasedienol in SAD and across other
programs in its neuroscience pipeline.
Financial Results for Fiscal Year
2024
Research and development (R&D) expenses
- R&D expenses were $20.0 million for the year ended March
31, 2024, as compared to $44.4 million for the year ended March 31,
2023. The decrease in R&D expenses was primarily due to a
decrease in clinical and development expenses related to the timing
of expenses incurred for the Company’s Phase 3 trials of fasedienol
in SAD.
General and administrative (G&A) expenses
- G&A expenses were $14.1 million for the year ended March
31, 2024, as compared to $14.7 million for the year ended March 31,
2023. The decrease in G&A expenses was primarily due to a
decrease in professional fees and stock-based compensation expense,
offset by an increase in compensation and related expenses.
Net loss
- Net loss was $29.4 million for the year ended March 31, 2024,
as compared to $59.2 million for the year ended March 31,
2023.
Other financial highlights
- Cash and cash equivalents were $119.2 million as of March 31,
2024.
- As of June 10, 2024, the Company had 27,029,731 shares of
common stock issued and 3,577,240 pre-funded warrants
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.
U.S. Dial-in (Toll-Free): 1-877-407-9716 International
Dial-in Number (Toll): 1-201-493-6779 Conference ID:
13746589 Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1670447&tp_key=0236806001
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 Tuesday, June 11, 2024. 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 13746589.
About Vistagen
Headquartered in South San Francisco, CA, Vistagen (Nasdaq:
VTGN) is a neuroscience-focused biopharmaceutical company dedicated
to pursuing a pioneering approach to the development and
commercialization of groundbreaking therapies for psychiatric and
neurological disorders based on its deep understanding of
nose-to-brain neurocircuitry. Designed exclusively as nasal sprays,
Vistagen’s diversified pipeline of pherine product candidates
rapidly activate chemosensory neurons in the nasal cavity to impact
fundamental neurocircuitry in the olfactory system and the brain,
with favorable safety profiles observed in all clinical studies
completed to date. Vistagen’s pipeline also includes an oral
prodrug with potential to modulate NMDA receptor activity. At
Vistagen, we are passionate about creating novel and differentiated
treatments that set new standards of care for millions of people
living with anxiety, depression, and other neurological 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, PH80 or its other drug candidates. Other
factors that may cause such a difference include, without
limitation, risks and uncertainties relating to delays in
launching, conducting and/or completing ongoing and planned
nonclinical studies and clinical trials, including PALISADE-3 and
PALISADE-4 or additional Phase 2 clinical trials of itruvone or
PH80; the period over which the Company anticipates its available
financial resources will fund its operating expense; the timing of
completion of preclinical studies and clinical trials and related
preparatory work required to apply for an maintain regulatory
approval for any of our product candidates; 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
nonclinical 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, 2024, 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 (in thousands, except share and par value
amounts) March 31,
2024
2023
ASSETS Current assets: Cash and cash equivalents
$
119,166
$
16,638
Prepaid expenses and other current assets
1,432
802
Deferred contract acquisition costs - current portion
74
67
Total current assets
120,672
17,507
Property and equipment, net
435
507
Right-of-use asset - operating lease
1,820
2,260
Deferred offering costs
495
496
Deferred contract acquisition costs - non-current portion
130
218
Security deposits
101
101
Total assets
$
123,653
$
21,089
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
1,547
$
2,473
Accrued expenses
2,235
796
Note payable
-
105
Deferred revenue - current portion
791
714
Operating lease obligation - current portion
550
486
Total current liabilities
5,123
4,574
Deferred revenue - non-current portion
2,674
2,315
Operating lease obligation - non-current portion
1,570
2,120
Total liabilities
9,367
9,009
Commitments and contingencies Stockholders’ equity: Preferred
stock, $0.001 par value; 10,000,000 shares authorized at March 31,
2024 and March 31, 2023; no shares outstanding at March 31, 2024
and March 31, 2023
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
March 31, 2024 and March 31, 2023; 27,029,731 and 7,315,583 shares
issued at March 31, 2024 and March 31, 2023, respectively
27
7
Additional paid-in capital
474,441
342,893
Treasury stock, at cost, 4,522 shares of common stock held at March
31, 2024 and March 31, 2023
(3,968
)
(3,968
)
Accumulated deficit
(356,214
)
(326,852
)
Total stockholders’ equity
114,286
12,080
Total liabilities and stockholders’ equity
$
123,653
$
21,089
VISTAGEN THERAPEUTICS CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except
share and per share amounts) Year Ended March 31,
2024
2023
Revenues: Sublicense and other revenue
$
1,064
$
(227
)
Total revenues
1,064
(227
)
Operating expenses: Research and development
20,022
44,377
General and administrative
14,063
14,664
Total operating expenses
34,085
59,041
Loss from operations
(33,021
)
(59,268
)
Other income, net: Interest income, net
3,351
26
Other income
312
-
Loss before income taxes
(29,358
)
(59,242
)
Income taxes
(4
)
(6
)
Net loss and comprehensive loss
$
(29,362
)
$
(59,248
)
Basic and diluted net loss per common share
$
(1.52
)
$
(8.51
)
Weighted average common shares outstanding, basic and diluted
19,354,500
6,958,749
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240611760116/en/
Investors: Mark A. McPartland Vistagen Therapeutics
markmcp@vistagen.com
Media: Caren Scannell Vistagen Therapeutics
cscannell@vistagen.com
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