VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a late-stage
biopharmaceutical company committed to developing and
commercializing a new generation of medicines with the potential to
go beyond the current standard of care for anxiety, depression, and
other central nervous system (CNS) disorders, today reported its
financial results for the fiscal year 2022 second quarter ended
September 30, 2021 and provided a review of the Company’s recent
accomplishments.
“We continued our strong performance throughout the quarter with
notable advances in all programs for our lead product candidate,
PH94B. We advanced our PALISADE Phase 3 Program in social anxiety
disorder with the initiation of a second Phase 3 study, PALISADE-2,
and our PALISADE Long-term Safety Study,” said Shawn Singh, Chief
Executive Officer of VistaGen. “We also launched our exploratory
Phase 2A clinical program for PH94B to begin to assess its
therapeutic potential in anxiety indications beyond SAD. Our Phase
2A study of PH94B in its second potential indication, adjustment
disorder with anxiety, is now underway. Adjustment disorder with
anxiety is among several anxiety disorders which have emerged with
greater prevalence during the COVID pandemic. In addition, we
recently reported data from a PH94B preclinical study that strongly
support its potential mechanism of action, suggesting that, in
sharp contrast to all antidepressants, benzodiazepines and
betablockers used to treat anxiety disorders, PH94B has the
potential to achieve rapid-onset anti-anxiety effects without
requiring systemic uptake or causing benzodiazepine-like side
effects and safety concerns.”
“These milestones are encouraging advances in our focused
efforts to develop and commercialize PH94B, first and foremost for
the acute treatment of anxiety in adults with social anxiety
disorder, if our PALISADE Phase 3 Program is successful, and
ultimately for anxiety indications beyond SAD,” added Mr. Singh.
“As we diligently pursue our goals for our CNS pipeline through
2022 and well beyond, we are well positioned to deliver on our
mission to improve the mental health and daily lives of millions in
the U.S. and around the world who are suffering from the
debilitating effects of anxiety and depression.”
PH94B Clinical Updates
During the quarter, VistaGen initiated PALISADE-2, the second
Phase 3 trial in its PALISADE Phase 3 Program for PH94B in social
anxiety disorder (SAD). PALISADE-2 is a U.S. multi-center,
randomized, double-blind, placebo-controlled Phase 3 clinical study
to evaluate the efficacy, safety, and tolerability of PH94B for the
acute treatment of anxiety in adults with SAD. The Company also
initiated its PALISADE Long-term Safety Study.
The Company expects topline data for PALISADE-1 in mid-2022 and
PALISADE-2 topline data in the second half of 2022. The Company’s
PALISADE Phase 3 Program, if successful, is designed to provide the
data required to support a potential submission of a PH94B U.S. New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) in mid-2023. The FDA has granted PH94B Fast Track designation
status for development in SAD.
VistaGen launched its exploratory Phase 2A clinical program for
PH94B, designed to evaluate its therapeutic potential in several
additional anxiety disorders beyond SAD. The first study in this
program is a Phase 2A clinical trial evaluating PH94B in adults
experiencing adjustment disorder with anxiety (AjDA), with topline
results anticipated in the second half of 2022. The Company intends
to expand the PH94B Phase 2A program in 2022 to include additional
exploratory studies in other anxiety indications. PH94B has
potential as a novel therapeutic for postpartum anxiety,
post-traumatic stress disorder, and procedural anxiety.
New data from a preclinical study of radiolabeled PH94B in
animal models demonstrated that PH94B’s mechanism of action (MOA)
involves binding to peripheral neurons in the nasal passages,
thereby limiting the transport of molecules to the circulatory
system and minimizing potential systemic exposure. These data
support the fundamental differentiation of PH94B’s MOA compared to
that of currently marketed therapies for anxiety disorders,
including antidepressants, benzodiazepines and beta blockers, all
of which require systemic uptake and distribution and are
associated with potential negative side effects and safety
concerns.
Additional Corporate & Pipeline Updates
VistaGen expanded the expertise of its Board of Directors with
the additions of Mary L. Rotunno, J.D. and Maggie Fitzpatrick.
These two appointments bring patient-focused mental health and
healthcare consumer engagement expertise to VistaGen’s
governorship. Ms. Rotunno’s and Ms. Fitzpatrick’s expertise will be
particularly beneficial to the Company as it progresses through
late-stage clinical studies and prepares for potential
commercialization of PH94B. In addition, when combined with the
prior appointments of Ann M. Cunningham, MBA and Joanne Curley
Ph.D., VistaGen’s Board holds a female-led majority, a significant
distinction within the public biopharmaceutical space.
To advance beyond successful exploratory Phase 2A clinical
development of PH10 nasal spray for treatment of major depressive
disorder (MDD), VistaGen is currently preparing regulatory
submissions necessary to initiate a U.S. Phase 2B multi-center,
randomized, double-blind, placebo-controlled study to evaluate the
efficacy, safety, and tolerability of PH10 as a potential
rapid-onset, stand-alone treatment for MDD in mid-2022. PH10 also
has potential as a novel therapeutic for treatment-resistant
depression, postpartum depression, and suicidal ideation.
VistaGen remains on track to initiate a Phase 1B clinical study
to evaluate AV-101 in combination with probenecid during the
current quarter. The FDA has granted Fast Track designation for
development of AV-101 as a potential adjunctive treatment for MDD
and as a non-opioid treatment for neuropathic pain. AV-101 also has
the potential to be developed as a treatment for levodopa-induced
dyskinesia associated with Parkinson’s disease therapy, suicidal
ideation, epilepsy, and other neurological disorders involving the
NMDA (N-methyl-D-aspartate) receptor.
Fiscal Year 2022 Second Quarter Financial
Results
Revenue: During the quarter
ended September 30, 2021, the Company recognized approximately $0.4
million in noncash sublicense revenue from the $5.0 million upfront
payment received in the quarter ended September 30, 2020 related to
its PH94B development and commercialization agreement with AffaMed
Therapeutics, compared to approximately $0.3 million in the quarter
ended September 30, 2020.
Research and development (R&D)
expense: Research and development expense
increased by $7.7 million, from $2.4 million to $10.1 million for
the quarters ended September 30, 2020 and 2021, respectively. The
increase in R&D expense results primarily from the Company’s
PALISADE Phase 3 Program for PH94B in SAD, with the continuation of
PALISADE-1 and the initiation of PALISADE-2 and the PALISADE
Long-term Safety Study, as well as initiation of its Phase 2A study
of PH94B in AjDA, in addition to continuing nonclinical
developmental and outsourced manufacturing activities for both
PH94B and PH10, which accounted for an increase of approximately
$5.9 million during the quarter ended September 30, 2021, compared
to expense in the same quarter in the prior year. Salaries and
benefits expense for the quarter ended September 30, 2021 increased
by approximately $1.6 million versus expense for the comparable
prior-year quarter, primarily due to the hiring of additional
senior management and other personnel focused on clinical
operations, outsourced manufacturing activities, and regulatory
affairs.
General and administrative (G&A)
expense: General and administrative
expense increased to approximately $3.1 million for the quarter
ended September 30, 2021, compared to approximately $1.3 million
for the quarter ended September 30, 2020. Salaries and benefits
expense for the quarter ended September 30, 2021 increased by
approximately $0.9 million versus the comparable prior-year
quarter, primarily due to the hiring of additional senior
management personnel. Additionally, the Company incurred
approximately $0.5 million in customary pre-commercialization
expenses during the quarter ended September 30, 2021.
Net loss: Net loss for the
quarters ended September 30, 2021 and 2020 was approximately $12.8
million and $3.3 million, respectively.
Cash position: At September
30, 2021, the Company had cash and cash equivalents of
approximately $93.6 million.
At November 9, 2021, the Company had 199,702,333 shares of
common stock outstanding.
Conference Call
VistaGen will host a conference call and live audio
webcast this afternoon, Wednesday, November 10, 2021, at 5:00 p.m.
Eastern Time to provide a corporate update and discuss its
financial results for its fiscal year 2022 second quarter ended
September 30, 2021.U.S. Dial-in (Toll-Free):
1-877-407-9716International Dial-in Number (Toll): 1-201-493-6779
Conference ID: 13724394Webcast Link:
https://viavid.webcasts.com/starthere.jsp?ei=1505931&tp_key=4eabb07e30
A telephone playback of the conference call will be available
after approximately 8:00 p.m. Eastern
Time on November 10, 2021. 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 13724394.
About VistaGen
VistaGen Therapeutics is a late-stage biopharmaceutical company
committed to developing and commercializing innovative medicines
with the potential to go beyond the current standard of care for
anxiety, depression and other CNS disorders. Each of VistaGen's
clinical-stage drug candidates has therapeutic potential in
multiple CNS indications. For more information, please visit
www.VistaGen.com and connect with VistaGen on Twitter, LinkedIn,
and Facebook.
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. The Company’s actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to delays in launching and/or conducting planned clinical
trials, including delays due to the impact of the ongoing COVID-19
pandemic; fluctuating costs of materials and other resources
required to conduct the Company’s planned clinical and non-clinical
trials; market conditions; the impact of general economic, industry
or political conditions in the United States or internationally;
adverse healthcare reforms and changes of laws and regulations;
manufacturing and marketing risks, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of the Company’s CNS drug candidates and
difficulty in initiating or conducting clinical trials due to the
ongoing COVID-19 pandemic or otherwise; inadequate and/or untimely
supply of one or more of the Company’s CNS drug candidates to meet
demand; entry of competitive products; and other technical and
unexpected hurdles in the development, manufacture and
commercialization of the Company’s CNS drug candidates; and the
risks 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, 2021 and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended September 30,
2021, 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 Company ContactsMedia:Mark
McPartlandVice President, Corporate DevelopmentPhone: (650)
577-3606Email: markmcp@vistagen.com
Christy CurranSam Brown Inc. Phone: (615) 414-8668Email:
ChristyCurran@sambrown.com
Investors:Mark FlatherVice President, Investor RelationsPhone:
(650) 577-3617Email: mflather@vistagen.com
|
|
VISTAGEN THERAPEUTICS, INC. |
CONSOLIDATED BALANCE SHEETS |
(Amounts in dollars, except share amounts) |
|
|
|
|
|
|
|
|
|
September 30, |
|
March 31, |
|
|
|
|
2021 |
|
|
|
2021 |
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
ASSETS |
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
93,627,100 |
|
|
$ |
103,108,300 |
|
Receivable from collaboration partner |
|
|
|
- |
|
|
|
40,600 |
|
Prepaid expenses and other current assets |
|
|
|
2,676,800 |
|
|
|
835,100 |
|
Deferred contract acquisition costs - current portion |
|
|
|
133,500 |
|
|
|
133,500 |
|
Total current assets |
|
|
|
96,437,400 |
|
|
|
104,117,500 |
|
Property and equipment, net |
|
|
|
496,600 |
|
|
|
367,400 |
|
Right of use asset - operating lease |
|
|
|
3,029,100 |
|
|
|
3,219,600 |
|
Deferred offering costs |
|
|
|
321,600 |
|
|
|
294,900 |
|
Deferred contract acquisition costs - non-current portion |
|
|
|
167,200 |
|
|
|
234,100 |
|
Security deposits |
|
|
|
47,800 |
|
|
|
47,800 |
|
Total assets |
|
|
$ |
100,499,700 |
|
|
$ |
108,281,300 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
|
$ |
2,659,600 |
|
|
$ |
838,300 |
|
Accrued expenses |
|
|
|
3,430,100 |
|
|
|
1,562,700 |
|
Deferred revenue - current portion |
|
|
|
1,420,200 |
|
|
|
1,420,200 |
|
Operating lease obligation - current portion |
|
|
|
401,000 |
|
|
|
364,800 |
|
Financing lease obligation - current portion |
|
|
|
1,300 |
|
|
|
3,000 |
|
Total current liabilities |
|
|
|
7,912,200 |
|
|
|
4,189,000 |
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
Accrued dividends on Series B Preferred Stock |
|
|
|
7,009,700 |
|
|
|
6,272,700 |
|
Deferred revenue - non-current portion |
|
|
|
1,778,200 |
|
|
|
2,490,300 |
|
Operating lease obligation - non-current portion |
|
|
|
3,139,900 |
|
|
|
3,350,800 |
|
Total non-current liabilities |
|
|
|
11,927,800 |
|
|
|
12,113,800 |
|
Total liabilities |
|
|
|
19,840,000 |
|
|
|
16,302,800 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
September 30, 2021 and March 31, 2021: |
|
|
|
|
|
Series A Preferred, 500,000 shares authorized, issued and
outstanding at September 30, 2021 and March 31, 2021 |
|
|
|
500 |
|
|
|
500 |
|
Series B Preferred; 4,000,000 shares authorized at September 30,
2021 and March 31, 2021; 1,131,669 shares |
|
|
|
|
|
issued and outstanding at September 30, 2021 and March 31,
2021 |
|
|
|
1,100 |
|
|
|
1,100 |
|
Series C Preferred; 3,000,000 shares authorized at September 30,
2021 and March 31, 2021; 2,318,012 shares |
|
|
|
|
|
issued and outstanding at September 30, 2021 and March 31,
2021 |
|
|
|
2,300 |
|
|
|
2,300 |
|
Series D Preferred; 2,000,000 shares authorized at September 30,
2021 and March 31, 2021; no shares and 402,149 |
|
|
|
|
|
shares issued and outstanding at September 30, 2021 and March 31,
2021, respectively |
|
|
|
- |
|
|
|
400 |
|
Common stock, $0.001 par value; 325,000,000 shares authorized at
September 30, 2021 and March 31, 2021; 196,558,785 |
|
|
|
|
|
and 180,751,234 shares issued at September 30, 2021 and March 31,
2021, respectively |
|
|
|
196,500 |
|
|
|
180,800 |
|
Additional paid-in capital |
|
|
|
324,808,000 |
|
|
|
315,603,100 |
|
Treasury stock, at cost, 135,665 shares of common stock held at
September 30, 2021 and March 31, 2021 |
|
|
|
(3,968,100 |
) |
|
|
(3,968,100 |
) |
Accumulated deficit |
|
|
|
(240,380,600 |
) |
|
|
(219,841,600 |
) |
Total stockholders’ equity |
|
|
|
80,659,700 |
|
|
|
91,978,500 |
|
Total liabilities and stockholders’ equity |
|
|
$ |
100,499,700 |
|
|
$ |
108,281,300 |
|
|
|
|
|
|
|
VISTAGEN THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS |
(Amounts in Dollars, except share amounts) |
(Unaudited) |
|
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Sublicense revenue |
$ |
358,000 |
|
|
$ |
334,000 |
|
|
$ |
712,100 |
|
|
$ |
334,000 |
|
Total revenues |
|
358,000 |
|
|
|
334,000 |
|
|
|
712,100 |
|
|
|
334,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
10,066,700 |
|
|
|
2,358,200 |
|
|
|
15,670,300 |
|
|
|
4,089,400 |
|
General and administrative |
|
3,090,800 |
|
|
|
1,269,500 |
|
|
|
5,587,500 |
|
|
|
2,660,100 |
|
Total operating expenses |
|
13,157,500 |
|
|
|
3,627,700 |
|
|
|
21,257,800 |
|
|
|
6,749,500 |
|
Loss from operations |
|
(12,799,500 |
) |
|
|
(3,293,700 |
) |
|
|
(20,545,700 |
) |
|
|
(6,415,500 |
) |
Other income (expenses), net: |
|
|
|
|
|
|
|
Interest income (expense), net |
|
5,100 |
|
|
|
(3,900 |
) |
|
|
10,200 |
|
|
|
(7,100 |
) |
Other income |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
600 |
|
Loss before income taxes |
|
(12,794,400 |
) |
|
|
(3,297,600 |
) |
|
|
(20,535,500 |
) |
|
|
(6,422,000 |
) |
Income taxes |
|
- |
|
|
|
(200 |
) |
|
|
(3,400 |
) |
|
|
(2,600 |
) |
Net loss and comprehensive loss |
$ |
(12,794,400 |
) |
|
$ |
(3,297,800 |
) |
|
|
(20,538,900 |
) |
|
|
(6,424,600 |
) |
|
|
|
|
|
|
|
|
Accrued dividends on Series B Preferred stock |
|
(375,200 |
) |
|
|
(347,200 |
) |
|
|
(737,000 |
) |
|
|
(683,000 |
) |
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders |
$ |
(13,169,600 |
) |
|
$ |
(3,645,000 |
) |
|
$ |
(21,275,900 |
) |
|
$ |
(7,107,600 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss attributable to common |
|
|
|
|
|
|
|
stockholders per common share |
$ |
(0.07 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
Weighted average shares used in computing |
|
|
|
|
|
|
|
basic and diluted net loss attributable to common |
|
|
|
|
|
|
|
stockholders per common share |
|
193,227,841 |
|
|
|
67,082,935 |
|
|
|
191,585,026 |
|
|
|
59,245,209 |
|
|
|
|
|
|
|
|
|
Vistagen Therapeutics (NASDAQ:VTGN)
Historical Stock Chart
From Apr 2024 to May 2024
Vistagen Therapeutics (NASDAQ:VTGN)
Historical Stock Chart
From May 2023 to May 2024