- Fasedienol (PH94B) PALISADE Phase 3 Program for acute treatment
of social anxiety disorder (SAD) advancing to build on recent
positive PALISADE-2 Phase 3 results
- Preparations to initiate potential fasedienol NDA-enabling
Phase 3 studies in 2024 underway
- Itruvone (PH10) staged for potential Phase 2B clinical
development 2H 2024
- PH80 positive exploratory Phase 2A trial data reported in two
separate women’s health indications – vasomotor symptoms (hot
flashes) due to menopause and premenstrual dysphoric disorder
(PMDD)
- $137.7 million in gross proceeds secured since the beginning of
fiscal 2024 second quarter, including $100 million from an
underwritten public offering of equity securities led by BVF
Partners LP, with participation from Commodore Capital, Great Point
Partners, Logos Capital, Nantahala Capital, Surveyor Capital (a
Citadel company), TCGX, and additional institutional investors
- Strong financial position provides adequate cash runway to a
potential fasedienol U.S. New Drug Application for acute treatment
of SAD
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 second quarter ended
September 30, 2023.
“Vistagen achieved multiple important milestones in recent
months, significantly advancing our innovative pipeline, including
positive Phase 3 results for fasedienol, our lead pherine nasal
spray drug candidate,” said Shawn Singh, Chief Executive Officer.
“With a fortified balance sheet, a robust pipeline of drug
candidates differentiated from the current standards of care, and a
clear path forward in our potential U.S. New Drug
Application-enabling PALISADE Phase 3 Program for fasedienol in
social anxiety disorder, we are confident in our potential to
improve the lives of millions of individuals affected by SAD and
other large market mental health and CNS disorders.”
Corporate Update and Pipeline Highlights
Fasedienol Nasal Spray – PALISADE Phase
3 Program
Positive results in August 2023 from PALISADE-2 Phase 3 study
of fasedienol for the acute treatment of anxiety in adults with SAD
advances the PALISADE Phase 3 development program and paves the way
to initiate potential U.S. New Drug Application (NDA)-enabling
studies in 2024.
- Primary endpoint met, with fasedienol demonstrating a
statistically significant difference in average patient-reported
Subjective Units of Distress Scale (SUDS) score during a public
speaking challenge compared to placebo (p=0.015).
- Secondary endpoint met, 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
(p=0.033).
- Exploratory endpoint met, demonstrating a statistically
significant difference in the proportion of patient-assessed
responders between fasedienol and placebo as measured by the
Patient Global Impression of Change (PGI-C) scale (p=0.003).
- Fasedienol was observed to be well-tolerated and demonstrated a
favorable safety profile consistent with all prior trials.
- PALISADE Phase 3 Program studies to be initiated in 2024 are
designed to build on the positive results observed from PALISADE-2
and enable a potential submission of a fasedienol U.S. NDA in
SAD.
Preparing to initiate PALISADE-3 and PALISADE-4 Phase 3
studies.
To complement the positive top-line results from PALISADE-2, the
Company is preparing to launch two similar Phase 3 clinical trials
in 2024, PALISADE-3 in the first half of 2024 and PALISADE-4 in the
second half of 2024. Like PALISADE-2, each study will be a
randomized, double-blind, placebo-controlled, Phase 3 clinical
trial designed to evaluate the efficacy, safety, and tolerability
of the acute administration of fasedienol to relieve anxiety
symptoms in adult patients with 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 SUDS as the primary efficacy endpoint.
Should it be successful, the Company believes its PALISADE Phase
3 Program may establish substantial evidence of fasedienol’s
effectiveness, supporting a potential fasedienol NDA submission to
the U.S. Food and Drug Administration (FDA) for the acute treatment
of anxiety in adults with SAD in the first half of 2026.
The Company also plans to initiate a small (n= ca. 60) three-arm
randomized, double-blind, placebo-controlled Phase 2B clinical
trial designed to evaluate the efficacy, safety, and tolerability
of a repeat dose of fasedienol (administered 10 minutes after an
initial dose) to further relieve symptoms of acute anxiety in adult
patients with SAD during a single simulated, anxiety-provoking
public speaking challenge in a clinical setting.
The Company is preparing for the following milestones for
fasedienol in SAD:
- Initiate PALISADE-3 Phase 3 study in the first half of
2024;
- Initiate PALISADE-4 Phase 3 study in the second half of 2024;
and
- Initiate fasedienol Phase 2B repeat dose study in the second
half of 2024.
Itruvone Nasal Spray
Itruvone staged for Phase 2B development as a monotherapy for
major depressive disorder (MDD), by the Company or potentially with
a strategic partner.
In June 2023, the Company completed a successful randomized,
double-blind, placebo-controlled Phase 1 clinical trial to
investigate the safety and tolerability of itruvone in healthy
adult subjects. The trial was designed to confirm the favorable
safety profile of itruvone established in three previous clinical
trials conducted in Mexico, including a positive randomized,
double-blind, placebo-controlled Phase 2A study of itruvone in MDD,
and facilitate potential Phase 2B clinical development of itruvone
in the U.S., either by Vistagen alone or potentially with a
strategic development and commercialization partner, as a
non-systemic monotherapy for MDD differentiated from all
FDA-approved antidepressants.
The Company is preparing for the following milestone for
itruvone in MDD:
- Initiate Phase 2B study in the second half of 2024.
PH80 Nasal Spray
Second positive exploratory Phase 2A trial of hormone-free
PH80 nasal spray provides new optimism for the acute management of
multiple indications in women’s healthcare with high unmet medical
need.
In September 2023, the Company announced previously unreported
data of a randomized, double-blind, placebo-controlled exploratory
Phase 2A clinical study designed to explore the efficacy, safety,
and tolerability of intranasal administration of PH80 for the acute
management of premenstrual dysphoric disorder (PMDD) in subjects
with a regular menstrual cycle and at least a one-year history of
PMDD.
- PH80 demonstrated statistically and clinically significant
improvement versus placebo in symptoms of PMDD using the
subject-rated Penn Daily Symptom Report (DSR) as early as Day 4 and
continuing to Day 6 (p=0.008).
- PH80 demonstrated statistically and clinically significant
improvement versus placebo at Day 6 on the clinician-rated
Premenstrual Tension Scale (PMTS) (p=0.006).
- PH80 was well-tolerated with no serious adverse events.
- Along with the positive results reported during the Company’s
fiscal 2024 first quarter from a randomized, double-blind,
placebo-controlled exploratory Phase 2A clinical study designed to
explore the efficacy, safety, and tolerability of PH80 for the
acute management of vasomotor symptoms (hot flashes) due to
menopause, these PMDD data further support PH80’s potential as a
differentiated, non-systemic, hormone-free treatment option for
multiple indications in women’s healthcare with high unmet medical
need.
The Company expects the following milestone for PH80:
- Finalize U.S. IND-enabling studies in the second half of 2024
to facilitate potential Phase 2B development in the U.S. for the
acute treatment of vasomotor symptoms (hot flashes) due to
menopause in the first half of 2025, potentially with a development
and commercialization partner.
Corporate Update
$1.5 million payment received from Fuji Pharma for an
exclusive negotiation agreement for a potential license to develop
and commercialize hormone-free PH80 for vasomotor symptoms (hot
flashes) due to menopause in Japan and potentially other
indications.
In September 2023, Vistagen and Fuji Pharma entered into a
time-limited (up to approximately eighteen months) agreement to
negotiate exclusively with each other regarding a potential license
to develop and commercialize PH80 in Japan, including for the acute
treatment of moderate to severe vasomotor symptoms (hot flashes)
due to menopause, PMDD, and potentially other indications. As
consideration for this agreement, Fuji Pharma agreed to pay to
Vistagen a cash fee of $1.5 million, which payment was received in
November 2023.
Cindy Anderson appointed as Chief Financial Officer,
succeeding Jerrold Dotson who retired after a distinguished
decade-long career with the Company.
In August 2023, the Company 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 biotechnology sector. She joins Vistagen from Alnylam
Pharmaceuticals where she served as the Chief Accounting Officer,
focused on strategic and financial operations. Vistagen would like
to extend its gratitude to Mr. Dotson for his substantial
contributions during his tenure with the Company.
Fiscal Year 2024 Second Quarter
Financial Results
Research and development (R&D) expense: Research and
development expense decreased by approximately $9.0 million, from
$12.9 million to $3.9 million for the quarter ended September 30,
2022 and 2023, respectively. The decrease in R&D expense is
primarily due to completing the initial studies in the Company’s
PALISADE Phase 3 Program for fasedienol in SAD, as well as reduced
nonclinical development, regulatory and outsourced manufacturing,
and regulatory activities for fasedienol and itruvone.
General and administrative (G&A) expense: General and
administrative expense decreased by approximately $0.5 million from
$3.7 million for the quarter ended September 20, 2022, to $3.2
million for the quarter ended September 30, 2023, primarily due to
decreased compensation, consulting, and professional services.
Net loss: Net loss attributable to common stockholders
for the second quarter ended September 30, 2023 was approximately
$6.6 million compared to a net loss of $17.5 million for September
30, 2022.
Cash position: At September 30, 2023, the Company had
cash and cash equivalents of approximately $37.6 million. In
addition, since September 30, 2023, the Company received
approximately $93.5 million in net proceeds from an underwritten
public offering of its equity securities and $1.5 million from Fuji
Pharma for a time-limited exclusive negotiation agreement regarding
a potential license to develop and commercialize PH80 in Japan.
Should its PALISADE Phase 3 Program be successful, the Company
believes that the current cash position will be sufficient to fund
its operations through its potential submission of a U.S. NDA for
fasedienol for the acute treatment of anxiety in adults with SAD in
the first half of 2026.
As of November 9, 2023, the Company had 27,023,038 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 provide a corporate
update.
U.S. Dial-in (Toll-Free): 1-800-245-3047 International Dial-in
Number (Toll): 1-203-518-9765 Conference ID: VISTAGEN Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1641124&tp_key=2213157260
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, November 9, 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: 11153994.
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 contains 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 and differentiated
proposed mechanism of action (MOA) 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 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; 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 September 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)
September 30,
March 31,
2023
2023
(Unaudited)
ASSETS Current assets: Cash and cash equivalents
$
37,608,400
$
16,637,600
Prepaid expenses and other current assets
1,393,300
802,700
Deferred contract acquisition costs - current portion
74,500
67,100
Total current assets
39,076,200
17,507,400
Property and equipment, net
444,300
507,300
Right-of-use asset - operating lease
2,045,000
2,260,300
Deferred offering costs
362,000
495,700
Deferred contract acquisition costs - non-current portion
167,400
217,600
Security deposits
100,900
100,900
Total assets
$
42,195,800
$
21,089,200
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
1,305,000
$
2,473,100
Accrued expenses
292,600
787,400
Note payable
-
105,300
Deferred revenue - current portion
793,000
714,300
Operating lease obligation - current portion
517,100
485,600
Financing lease obligation - current portion
1,800
1,700
Total current liabilities
2,909,500
4,567,400
Non-current liabilities: Deferred revenue - non-current
portion
1,780,600
2,314,600
Operating lease obligation - non-current portion
1,854,000
2,119,800
Financing lease obligation - non-current portion
6,500
7,400
Total non-current liabilities
3,641,100
4,441,800
Total liabilities
6,550,600
9,009,200
Commitments and contingencies (Note 9) Stockholders’
equity: Preferred stock, $0.001 par value; 10,000,000 shares
authorized at September 30, 2023 and March 31, 2023; no shares
outstanding at September 30, 2023 and March 31, 2023
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
September 30, 2023 and March 31, 2023; 12,016,750 and 7,315,583
shares issued at September 30, 2023 and March 31, 2023,
respectively
12,000
7,300
Additional paid-in capital
379,943,800
342,892,500
Treasury stock, at cost, 4,522 shares of common stock held at
September 30, 2023 and March 31, 2023
(3,968,100
)
(3,968,100
)
Accumulated deficit
(340,342,500
)
(326,851,700
)
Total stockholders’ equity
35,645,200
12,080,000
Total liabilities and stockholders’ equity
$
42,195,800
$
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
Six Months Ended
September 30,
September 30,
2023
2022
2023
2022
Revenues: Sublicense revenue
$
277,700
$
(892,500
)
$
455,300
$
(582,500
)
Total revenues
277,700
(892,500
)
455,300
(582,500
)
Operating expenses: Research and development
3,850,600
12,894,500
8,047,800
28,185,800
General and administrative
3,207,300
3,702,300
6,185,500
8,494,100
Total operating expenses
7,057,900
16,596,800
14,233,300
36,679,900
Loss from operations
(6,780,200
)
(17,489,300
)
(13,778,000
)
(37,262,400
)
Other income, net: Interest income, net
192,500
6,100
289,700
8,400
Loss before income taxes
(6,587,700
)
(17,483,200
)
(13,488,300
)
(37,254,000
)
Income taxes
-
-
(2,500
)
(5,500
)
Net loss and comprehensive loss
$
(6,587,700
)
$
(17,483,200
)
$
(13,490,800
)
$
(37,259,500
)
Basic and diluted net loss per common share
$
(0.66
)
$
(2.54
)
$
(1.55
)
$
(5.41
)
Weighted average common share - basic and diluted
10,042,530
6,893,708
8,717,050
6,890,152
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/20231109410625/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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