Pherin acquisition completed; all future
royalty payment obligations related to PH94B and PH10 eliminated,
three new drug candidates added to Vistagen’s pipeline
PH94B Phase 3 program for social anxiety
disorder advancing towards important next steps
PH10 Phase 1 study initiated to facilitate
plans for Phase 2B development of PH10 for major depressive
disorder; FDA Fast Track designation granted
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 third quarter ended
December 31, 2022.
“Since our last quarterly update, Vistagen has met several
important business objectives,” said Shawn Singh, Chief Executive
Officer of Vistagen. “Our recent acquisition of Pherin
Pharmaceuticals, and now full ownership of PH94B and PH10, puts the
company in a position to significantly enhance the commercial
profile of these two promising pipeline assets. In addition, over
the past two quarters, we advanced core clinical programs in social
anxiety disorder, adjustment disorder and major depressive
disorder. Both PH94B and PH10 have the potential to offer novel,
fast-acting treatment for millions of patients confronting the
effects of debilitating mental health challenges without the side
effects and safety concerns often associated with current
FDA-approved products. We believe Vistagen is now well-positioned
to reach several important milestones during 2023.”
Corporate Update
Company remains confident in PH94B Phase 3 development
program for treatment of social anxiety disorder (SAD).
After further analysis of PALISADE-1, a single administration
Phase 3 public speaking challenge study, the Company has identified
several potential explanations for the unexpected results of the
study, primarily complexities associated with the single-dose
assessment public speaking challenge methodology and conducting the
study during surges in the COVID-19 pandemic. The Company recently
submitted to the U.S. Food and Drug Administration (FDA) proposed
adjustments to the PALISADE-2 study protocol. Should Vistagen
resume PALISADE-2, the proposed amendments are intended to address
various methodological issues believed to have contributed to the
unexpected results of PALISADE-1.
Upon reviewing information and data available this time, the
Company believes it is not yet advisable to make a decision about
resuming PALISADE-2 before discussing its broader Phase 3
development plan for PH94B with the FDA and before further
assessing the potential impact of the proposed adjustments to the
PALISADE-2 protocol in light of two recently completed public
speaking challenge SAD studies conducted by peers, each of which
did not achieve its primary efficacy endpoint. Vistagen is
currently preparing to meet with the FDA to discuss its broader
Phase 3 development plan for PH94B, which plan includes the
possibility of a multiple-administration, randomized, double-blind,
placebo-controlled Phase 3 study of PH94B in adults, using the
Liebowitz Social Anxiety Scale (LSAS) as the primary efficacy
outcome measure to support a potential New Drug Application. The
LSAS was the primary efficacy endpoint in all registration studies
for the three currently FDA-approved treatments for SAD. Given that
LSAS measures overall improvement in disease severity by measuring
the reduction in fear and anxiety over time (rather than from only
a single dose assessment), as well as the avoidance of
anxiety-provoking social and performance situations in a real-world
environment, Vistagen believes the LSAS is appropriate to measure
and reflect the true impact of PH94B on patients’ lives. The
Company expects to announce its plans regarding PALISADE-2
concurrently with other updates to its PH94B Phase 3 development
plan.
Encouraging preliminary data from PALISADE Open Label Study
inform Phase 3 path forward in SAD.
Preliminary analysis of the final data set from nearly 400
subjects observed in the Company’s PALISADE Open Label Study
(PALISADE OLS) provide important additional information about the
safety and tolerability of PH94B in adult subjects with SAD as well
as potential improvement in SAD over time, as measured by the LSAS.
The Company expects to release safety and tolerability results from
the PALISADE OLS, as well as results observed using the LSAS over
time, during the first quarter of calendar 2023.
Exploratory Phase 2A trial of PH94B in adjustment disorder
with anxiety (AjDA) completed.
The Company has completed its exploratory double-blind,
placebo-controlled Phase 2A clinical trial of PH94B to evaluate the
efficacy, safety and tolerability of PH94B as a potential treatment
of adults with AjDA. The study protocol involves multiple
administration assessments of PH94B administered four times per day
for 28 days. Vistagen anticipates reporting topline results from
this exploratory Phase 2A AjDA trial by the end of the first
quarter of calendar 2023.
PH10 receives Fast Track designation in major depressive
disorder (MDD) from FDA; Phase 1 clinical trial underway to
facilitate Phase 2B program.
In December 2022, Vistagen was advised by the FDA that the
Company may proceed with its Phase 1 program following submission
of its U.S. Investigational New Drug (IND) application for clinical
development of PH10 in the U.S. in healthy volunteers. In addition,
the FDA has granted Fast Track designation (FTD) for the
development of PH10 for the treatment of MDD.
The small (n=12) randomized, double-blinded, placebo-controlled
Phase 1 trial is underway and is intended to investigate the safety
and tolerability of PH10 in healthy adult subjects, confirm the
favorable safety profile of PH10 established in three previous
clinical studies conducted in Mexico, including a published Phase
2A study for the treatment of MDD, and facilitate plans for Phase
2B development of PH10 as a stand-alone treatment for MDD. The
Company anticipates completion of the Phase 1 study by the end of
the first quarter of calendar 2023.
AV-101 + Probenecid Phase 1B trial progressing.
Based on observations and findings from preclinical studies,
Vistagen believes that AV-101, alone or in combination with
FDA-approved oral probenecid, has the potential to become a new
oral treatment alternative for certain CNS indications involving
the NMDA receptor. The Company is currently conducting an
exploratory Phase 1B drug-drug interaction clinical study of AV-101
in combination with probenecid and expects to complete the study in
the first half of 2023. Upon completion of the study, the Company
plans to consider exploratory Phase 2A development of AV-101, alone
or in combination with probenecid, on its own or with a
collaborator, as a potential oral treatment for one or more CNS
disorders involving the NMDA receptor.
Acquisition of Pherin Pharmaceuticals, Inc.
completed.
Vistagen recently completed the acquisition of Pherin
Pharmaceuticals, Inc. (Pherin), resulting in Pherin becoming a
wholly-owned subsidiary of the Company. Vistagen secured full
ownership of intellectual property rights to PH94B and PH10 and all
future royalty payment obligations related to those assets have
been eliminated, significantly enhancing the potential commercial
profile of these two late-stage assets. In addition, the Company
now has three new early clinical-stage pherine product candidates:
PH15 for cognition improvement; PH80 for migraine and hot flashes;
and PH284 for appetite-related disorders.
Fiscal Year 2023 Third Quarter
Financial Results
Research and development (R&D) expense: Research and
development expense decreased by $0.9 million, from $7.8 million to
$6.9 million for the quarters ended December 31, 2021 and 2022,
respectively. The decrease in R&D expense is primarily due the
reduction in expenses related to the PALISADE Phase 3 Program for
PH94B in SAD, including PALISADE-1, PALISADE-2 and the PALISADE
OLS, and the exploratory Phase 2A study of PH94B in AjDA, as well
as nonclinical development, regulatory and outsourced manufacturing
activities for both PH94B and PH10.
General and administrative (G&A) expense: General and
administrative expense was flat at approximately $3.1 million for
each of the quarters ended December 31, 2022 and 2021.
Net loss: Net loss attributable to common stockholders
for the fiscal quarters ended December 31, 2022 and 2021 was
approximately $9.8 million and $10.7 million, respectively.
Cash position: At December 31, 2022, the Company had cash
and cash equivalents of approximately $25.0 million.
As of February 7, 2023, the Company had 219,326,526 shares of
common stock outstanding, which reflects the issuance of
approximately 12.4 million unregistered shares of common stock
associated with the Pherin Pharmaceuticals transaction.
Conference Call
Vistagen will host a conference call and live audio webcast this
afternoon at 5:00 p.m. Eastern Time to discuss its financial
results for its third quarter fiscal year 2023 ended December 31,
2022 and 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: 13735532 Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1593644&tp_key=b10e7e1927
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 Tuesday, February 7, 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 13735532.
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. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available for
treatment of anxiety and depression. Vistagen’s product candidates
belong to a new class of drugs known as pherines, which are
designed with a novel rapid-onset mechanism of action that
activates chemosensory neurons in the nasal passages and can impact
key neural circuits 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 and depression. 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 future clinical trials, receive
regulatory approval or be commercially successful. Other factors
that may cause such a difference include, without limitation, risks
and uncertainties relating to the Company’s continued clinical
development program of PH94B in SAD, including the Company’s plan
for continuing PALISADE-2, if at all, and its broader Phase 3
development program; the completion and results the Company’s
ongoing clinical studies of PH94B, including the Company’s Phase 2A
clinical trial of PH94B in adults experiencing adjustment disorder
with anxiety, and ongoing studies of the Company’s other product
candidates, PH10 and AV-101; incorporation of PH50, PH80 and PH284
into the Company’s pre-clinical and clinical development plans and
other risks and uncertainties related to the Company’s recent
acquisition of Pherin Pharmaceuticals, Inc.; delays in launching,
conducting and/or completing other ongoing and planned clinical
trials, including adverse effects resulting from the COVID-19
pandemic; fluctuating costs of materials and other resources
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 CNS
drug 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, 2022 and in
the Company’s most recent Quarterly Report on Form 10-Q for the
quarter ended December 31, 2022, 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)
December 31,
March 31,
2022
2022
(unaudited) ASSETS Current assets: Cash and
cash equivalents
$
25,037,300
$
68,135,300
Prepaid expenses and other current assets
953,200
2,745,800
Deferred contract acquisition costs - current portion
67,000
116,900
Total current assets
26,057,500
70,998,000
Property and equipment, net
540,700
414,300
Right-of-use asset - operating lease
2,364,100
2,662,000
Deferred offering costs
411,400
321,800
Deferred contract acquisition costs - non-current portion
234,200
146,400
Security deposits
100,900
100,900
Total assets
$
29,708,800
$
74,643,400
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable
$
1,598,800
$
2,758,600
Accrued expenses
1,085,200
1,329,200
Note payable
419,100
-
Deferred revenue - current portion
712,300
1,244,000
Operating lease obligation - current portion
470,400
433,300
Financing lease obligation - current portion
1,600
-
Total current liabilities
4,287,400
5,765,100
Non-current liabilities: Non-current portion of notes
payable
-
-
Accrued dividends on Series B Preferred Stock
-
-
Deferred revenue - non-current portion
2,492,200
1,557,600
Operating lease obligation - non-current portion
2,246,800
2,605,400
Financing lease obligation - non-current portion
7,900
-
Total non-current liabilities
4,746,900
4,163,000
Total liabilities
9,034,300
9,928,100
Commitments and contingencies Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
December 31, 2022 and March 31, 2022: no shares outstanding at
December 31, 2022 and March 31, 2022
-
-
Common stock, $0.001 par value; 325,000,000 shares authorized at
December 31, 2022 and March 31, 2022; 207,052,010 and 206,676,620
shares issued at December 31, 2022 and March 31, 2022, respectively
207,100
206,700
Additional paid-in capital
339,060,200
336,080,700
Treasury stock, at cost, 135,665 shares of common stock held at
December 31, 2022 and March 31, 2022
(3,968,100
)
(3,968,100
)
Accumulated deficit
(314,624,700
)
(267,604,000
)
Total stockholders’ equity
20,674,500
64,715,300
Total liabilities and stockholders’ equity
$
29,708,800
$
74,643,400
VISTAGEN THERAPEUTICS CONDENSED CONSOLIDATED
STATEMENT OF OPERATIONS (Unaudited) (Amounts in
Dollars, except share amounts) Three Months
Ended Nine Months Ended December 31, December
31,
2022
2021
2022
2021
Revenues: Sublicense revenue
$
179,600
$
357,900
$
(402,900
)
$
1,070,000
Total revenues
179,600
357,900
(402,900
)
1,070,000
Operating expenses: Research and development
6,854,000
7,780,000
35,039,800
23,173,600
General and administrative
3,092,100
3,118,100
11,586,200
8,982,300
Total operating expenses
9,946,100
10,898,100
46,626,000
32,155,900
Loss from operations
(9,766,500
)
(10,540,200
)
(47,028,900
)
(31,085,900
)
Other income, net: Interest income, net
5,300
5,100
13,700
15,300
Loss before income taxes
(9,761,200
)
(10,535,100
)
(47,015,200
)
(31,070,600
)
Income taxes
-
-
(5,500
)
(3,400
)
Net loss and comprehensive loss
(9,761,200
)
(10,535,100
)
(47,020,700
)
(31,074,000
)
Accrued dividend on Series B Preferred stock
-
(208,100
)
-
(945,100
)
Net loss attributable to common stockholders
$
(9,761,200
)
$
(10,743,200
)
$
(47,020,700
)
$
(32,019,100
)
Basic and diluted net loss attributable to common
stockholders per common share
$
(0.05
)
$
(0.05
)
$
(0.23
)
$
(0.16
)
Weighted average shares used in computing basic and diluted
net loss attributable to common stockholders per common share
206,838,084
202,328,683
206,749,238
195,179,267
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230207005227/en/
Investors: Mark Flather Vice President, Investor Relations (650)
577-3617 mflather@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
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