Fasedienol PALISADE Phase 3 program for the acute treatment of
social anxiety disorder remains on track
PALISADE-3 trial initiation anticipated in 1H 2024; PALISADE-4
trial initiation anticipated in 2H 2024
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company pioneering neuroscience to deliver first-in-class therapies
for psychiatric and neurological disorders, today reported
financial results for its fiscal year 2024 third quarter ended
December 31, 2023 and provided a corporate update.
"Momentum from clinical and corporate milestones achieved
through the end of last quarter have significantly advanced our
efforts to develop and commercialize fasedienol as a potential
first-in-class acute treatment for adults with social anxiety
disorder. Building on the positive results of our PALISADE-2 Phase
3 trial in SAD, we remain on track to initiate our PALISADE-3 Phase
3 trial in SAD during the first half of this year," said Shawn
Singh, Chief Executive Officer of Vistagen. "In parallel, we
continue to make significant progress toward Phase 2B development
of two additional clinical-stage neuroscience assets in our
pipeline, itruvone for major depressive disorder and hormone-free
PH80 for women's health indications, including vasomotor symptoms
(hot flashes) due to menopause."
Fasedienol Nasal Spray for Acute
Treatment of Social Anxiety Disorder (SAD)
To complement Vistagen’s successful PALISADE-2 Phase 3 trial of
fasedienol for the acute treatment of SAD, the Company’s PALISADE-3
trial, anticipated to initiate during the first half of 2024, as
well as its PALISADE-4 trial, which is anticipated to be initiated
in the second half of 2024, will be U.S. multi-center, randomized,
double-blind, placebo-controlled Phase 3 trials designed to
evaluate the efficacy, safety, and tolerability of the acute
administration of fasedienol to relieve anxiety symptoms in adult
patients with SAD, after administration of a single dose of
fasedienol during a public speaking challenge in a clinical
setting, as measured using the patient-reported Subjective Units of
Distress Scale (SUDS) as the primary efficacy endpoint.
Vistagen believes either PALISADE-3 or PALISADE-4, if
successful, together with the positive results from PALISADE-2, may
establish substantial evidence of the effectiveness of fasedienol
in support of a potential fasedienol U.S. New Drug Application
(NDA) submission for the acute treatment of anxiety in adults with
SAD.
Itruvone Nasal Spray for Major
Depressive Disorder (MDD)
Leveraging a successful exploratory Phase 2A trial of itruvone
for the treatment of MDD, preparations and planning are underway
for Phase 2B development.
PH80 Nasal Spray for Vasomotor Symptoms
(Hot Flashes) due to Menopause and other Women’s Health
Indications
Expanding upon successful exploratory Phase 2A trials of PH80 in
two women’s health indications, preparations and planning are
underway for U.S. IND-enabling nonclinical studies to facilitate
U.S. Phase 2B development of hormone-free PH80 for the treatment of
vasomotor symptoms (hot flashes) due to menopause and, potentially,
premenstrual dysphoric disorder (PMDD).
Fiscal Year 2024 Third Quarter
Financial Results
Research and development (R&D) expense: R&D
expense was $4.5 million and $6.9 million for the three months
ended December 31, 2023 and 2022, respectively. The decrease in
R&D expense 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) expense: G&A
expense was $3.8 million and $3.1 million for the three months
ended December 31, 2023 and 2022, respectively. The increase was
primarily due to increases in compensation and related
expenses.
Net loss: Net loss was $6.3 million and $9.8 million for
the three months ended December 31, 2023, and 2022,
respectively.
Cash position: At December 31, 2023, the Company had cash
and cash equivalents of approximately $126.6 million.
As of February 12, 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: 13743176 Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1648110&tp_key=097d964c22
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, February 13, 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: 13743176.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company pioneering neuroscience to deliver
first-in-class therapies for psychiatric and neurological
disorders. Five of Vistagen’s six clinical-stage product candidates
belong to a new class of drugs known as pherines, which have the
potential to rapidly deliver meaningful efficacy with a
differentiated safety profile. Pherines are investigational
neuroactive nasal sprays with innovative proposed mechanisms of
action that activate chemosensory neurons in the nasal passages to
impact fundamental neural circuits in the brain without the need
for systemic absorption or binding to receptors in the brain.
Vistagen’s sixth clinical-stage product candidate, AV-101, is an
investigational oral drug candidate with the potential to inhibit,
but not block, NMDA receptor activity. Vistagen is passionate about
transforming what is possible in the treatment of anxiety,
depression, and other neuroscience 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 the Company’s
submission of an U.S. NDA to the FDA for any product candidate,
including fasedienol; the ability of any clinical trial information
submitted by the Company to the FDA to support an U.S. NDA; other
risks and uncertainties related to delays in launching, conducting
and/or completing ongoing and planned clinical trials, including
PALISADE-3 and PALISADE-4 or additional Phase 2 clinical trials of
itruvone or PH80; 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 December 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. CONDENSED CONSOLIDATED
BALANCE SHEETS
December 31, March 31,
2023
2023
(Unaudited) ASSETS Current assets: Cash and cash
equivalents
$
126,559,200
$
16,637,600
Prepaid expenses and other current assets
1,480,300
802,700
Deferred contract acquisition costs - current portion
74,500
67,100
Total current assets
128,114,000
17,507,400
Property and equipment, net
445,100
507,300
Right-of-use asset - operating lease
1,933,600
2,260,300
Deferred offering costs
325,700
495,700
Deferred contract acquisition costs - non-current portion
148,700
217,600
Security deposits
100,900
100,900
Total assets
$
131,068,000
$
21,089,200
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
1,737,000
$
2,473,100
Accrued expenses
129,300
787,400
Note payable
-
105,300
Deferred revenue - current portion
1,762,800
714,300
Operating lease obligation - current portion
533,500
485,600
Financing lease obligation - current portion
1,900
1,700
Total current liabilities
4,164,500
4,567,400
Deferred revenue - non-current portion
1,899,400
2,314,600
Operating lease obligation - non-current portion
1,713,300
2,119,800
Financing lease obligation - non-current portion
6,000
7,400
Total liabilities
7,783,200
9,009,200
Commitments and contingencies (Note 10) Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
December 31, 2023 and March 31, 2023;no shares outstanding at
December 31, 2023 and March 31, 2023
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
December 31, 2023 and March 31, 2023;27,029,731 and 7,315,583
shares issued at December 31, 2023 and March 31, 2023, respectively
27,000
7,300
Additional paid-in capital
473,918,200
342,892,500
Treasury stock, at cost, 4,522 shares of common stock held at
December 31, 2023 and March 31, 2023
(3,968,100
)
(3,968,100
)
Accumulated deficit
(346,692,300
)
(326,851,700
)
Total stockholders’ equity
123,284,800
12,080,000
Total liabilities and stockholders’ equity
$
131,068,000
$
21,089,200
VISTAGEN THERAPEUTICS CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS (Unaudited)
Three Months Ended Nine Months Ended December
31, December 31,
2023
2022
2023
2022
Revenues: Sublicense and other revenue
$
411,400
$
179,600
$
866,700
$
(402,900
)
Total revenues
411,400
179,600
866,700
(402,900
)
Operating expenses: Research and development
4,537,600
6,854,000
12,585,400
35,039,800
General and administrative
3,757,800
3,092,100
9,943,300
11,586,200
Total operating expenses
8,295,400
9,946,100
22,528,700
46,626,000
Loss from operations
(7,884,000
)
(9,766,500
)
(21,662,000
)
(47,028,900
)
Other income, net: Interest income, net
1,534,200
5,300
1,823,900
13,700
Loss before income taxes
(6,349,800
)
(9,761,200
)
(19,838,100
)
(47,015,200
)
Income taxes
-
-
(2,500
)
(5,500
)
Net loss and comprehensive loss
$
(6,349,800
)
$
(9,761,200
)
$
(19,840,600
)
$
(47,020,700
)
Basic and diluted net loss per common share
$
(0.22
)
$
(1.42
)
$
(1.27
)
$
(6.82
)
Weighted average common shares outstanding,basic and diluted
29,388,085
6,894,603
15,632,451
6,891,641
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240213784404/en/
Investors Inquiries: Mark A. McPartland (650) 577-3606
markmcp@vistagen.com
Media Inquiries: Caren Scannell (650) 577-3601
cscannell@vistagen.com
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