VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a 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 financial results for its
fiscal year 2022 first quarter ended June 30, 2021 and provided a
corporate update.
“The strong momentum we generated in fiscal 2021 leading up to
the launch of our PALISADE Phase 3 Program for PH94B as a potential
rapid-onset acute treatment of anxiety in adults with social
anxiety disorder continued throughout the first quarter of fiscal
2022. The initiation of PALISADE-1 was a major milestone in the
program. That study is proceeding as planned, with topline data
anticipated in mid-2022. We remain on track to initiate PALISADE-2,
which will be a counterpart of PALISADE-1, later this year,
together with several other planned clinical studies we believe
will be supportive of a potential U.S. New Drug Application for
PH94B if our PALISADE Phase 3 Program is successful. We have also
made progress in our Phase 2A clinical development program for
PH94B, which is focused on additional anxiety disorders beyond SAD.
We recently received from the U.S. Food and Drug Administration
notice that we may proceed with our proposed exploratory Phase 2A
clinical study of PH94B for treatment of adjustment disorder with
anxiety. We expect to initiate that study in the U.S. before year
end,” said Shawn Singh, Chief Executive Officer of VistaGen.
“Our core mission is to improve mental health and well-being for
individuals around the world. As we continue to advance on that
goal and into the next phases of our corporate development, we have
enhanced diversity and collective expertise on our Board and across
all key internal functions. We are well-positioned to drive our
clinical-stage programs through multiple development and regulatory
milestones, as well as appropriately-timed pre-commercial
activities, and, if our PALISADE Phase 3 Program is successful,
PH94B commercial launch operations in the U.S.,” continued
Singh.
Recent Corporate Highlights
- Initiated PALISADE Phase 3 Program for PH94B with PALISADE-1, 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. Topline results from PALISADE-1 are anticipated in
mid-2022.
- Received notice from the U.S. Food and Drug Administration
(FDA) that we may proceed with our exploratory Phase 2A clinical
study of PH94B in adults experiencing adjustment disorder with
anxiety (AjDA).
- Appointed Mary L. Rotunno, J.D. to our Board of Directors,
adding significant healthcare industry expertise as a leader and
strategist as we advance late-stage development of our CNS product
candidates for anxiety and depression disorders.
- Appointed Maggie FitzPatrick to our Board of Directors,
bringing extensive leadership in healthcare consumer-focused
engagement, marketing and public relations. Ms. FitzPatrick has
driven marketing communications initiatives for some of the world’s
largest and most successful companies, including Johnson &
Johnson and Cigna.
- Included in the Russell 2000® Index, one of the most cited
performance benchmarks for small-cap companies, increasing overall
awareness and exposure for VistaGen within the investment
community.
CNS Pipeline Updates
PH94B Nasal Spray
In May, VistaGen initiated its PALISADE Phase 3 Program with
PALISADE-1, 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 expects to initiate PALISADE-2, a
replicate of PALISADE-1, in the second half of calendar 2021. If
successful, these clinical studies are designed to be among the
studies necessary to support a potential PH94B U.S. New Drug
Application (NDA) to the FDA. PH94B has been granted Fast Track
designation status by the FDA for development as an acute treatment
of anxiety in adults with SAD.
Recently, the Company received a notice from the FDA allowing
commencement of its exploratory Phase 2A clinical study of PH94B in
adults experiencing AjDA. The study is expected to start by the end
of 2021. In addition to studies of PH94B in SAD and AjDA, the
Company is also preparing for exploratory Phase 2A clinical studies
of PH94B in adults experiencing other anxiety disorders, including
postpartum anxiety, post-traumatic stress disorder and
pre-procedural anxiety.
PH10 Nasal Spray
Exploratory Phase 2A clinical development of PH10 as a potential
rapid-onset treatment of major depressive disorder (MDD) has been
completed. VistaGen is preparing 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 treatment for
treatment-resistant depression, postpartum depression and suicidal
ideation.
AV-101
VistaGen is currently preparing to initiate a Phase 1B clinical
study to evaluate AV-101 in combination with probenecid during the
second half of calendar 2021. 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, suicidal ideation, epilepsy and
other neurological disorders involving the NMDA
(N-methyl-D-aspartate) receptor.
Fiscal Year 2022 First Quarter Financial
Results
Revenue: The Company recognized $0.4 million in
sublicense revenue from its $5 million upfront payment pursuant to
its PH94B development and commercialization agreement with
EverInsight Therapeutics (now AffaMed Therapeutics) during the
quarter ended June 30, 2021, compared to none in the quarter ended
June 30, 2020.
Research and development (R&D) expense:
Research and development expense increased by $3.9 million, from
$1.7 million to $5.6 million for the quarters ended June 30, 2020
and 2021, respectively. The increase in R&D expense is
primarily related to the commencement of our PALISADE Phase 3
Program for PH94B in SAD with PALISADE-1, as well as other clinical
and nonclinical developmental and manufacturing activities for both
PH94B and PH10, which accounted for increased expenses of
approximately $2.7 million during the quarter ended June 30, 2021
in comparison to the same quarter in the prior year. Salaries and
benefits expense for the quarter ended June 30, 2021 increased by
approximately $1.0 million versus 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 $2.5
million for the quarter ended June 30, 2021 compared to
approximately $1.4 million for the quarter ended June 30, 2020.
Salaries and benefits expense for the quarter ended June 30, 2021
increased by approximately $0.6 million versus the comparable
prior-year quarter, primarily due to the hiring of additional
senior management and other administrative personnel.
Net loss: Net loss for the quarters ended June
30, 2021 and 2020 was approximately $7.7 million and $3.1 million,
respectively.
Cash Position: At June 30, 2021, the Company
had cash and cash equivalents of approximately $97.8 million.
As of August 11, 2021, the Company had 192,903,896 shares of
common stock outstanding.
Conference Call
VistaGen will host a conference call and live audio webcast this
afternoon at 2:00 p.m. Pacific Time to provide a corporate update
and discuss its financial results for its fiscal year 2022 first
quarter ended June 30, 2021.
U.S. Dial-in (Toll Free): 1-800-935-5014 International Dial-in
Number (Toll): 1-212-231-2920 Conference ID: 21996610 Webcast Link:
http://public.viavid.com/index.php?id=146257
A telephone playback of the conference call will be available
after approximately 5:00 p.m. Pacific Time on August
12, 2020. 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
21996610.
About VistaGenVistaGen Therapeutics is a
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 drug candidates has a
differentiated potential mechanism of action, has been
well-tolerated in all clinical studies to date and 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 us and our management, are
inherently uncertain. Our 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 our 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 our 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 our 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 our CNS drug candidates to meet demand; entry of
competitive products; and other technical and unexpected hurdles in
the development, manufacture and commercialization of our CNS drug
candidates; and the risks more fully discussed in the section
entitled "Risk Factors" in our most recent Annual Report on Form
10-K for the fiscal year ended March 31, 2021 and in our most
recent Quarterly Report on Form 10-Q for the quarter ended June 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). Our 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 our views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements, other than as may be required by law. If we do update
one or more forward-looking statements, no inference should be made
that we will make additional updates with respect to those or other
forward-looking statements.
VistaGen Company ContactsMedia:Mark
McPartlandPhone: (650) 577-3606Email: markmcp@vistagen.com
Investors:Mark FlatherPhone: (650) 577-3617Email:
mflather@vistagen.com
VISTAGEN THERAPEUTICS, INC. |
CONSOLIDATED BALANCE SHEETS |
(unaudited) |
(Amounts in dollars, except share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
March 31, |
|
|
|
|
2021 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
97,776,900 |
|
|
$ |
103,108,300 |
|
Receivable from collaboration partner |
|
|
|
44,000 |
|
|
|
40,600 |
|
Prepaid expenses and other current assets |
|
|
|
1,871,400 |
|
|
|
835,100 |
|
Deferred contract acquisition costs - current portion |
|
|
|
133,500 |
|
|
|
133,500 |
|
Total current assets |
|
|
|
99,825,800 |
|
|
|
104,117,500 |
|
Property and equipment, net |
|
|
|
482,800 |
|
|
|
367,400 |
|
Right of use asset - operating lease |
|
|
|
3,125,300 |
|
|
|
3,219,600 |
|
Deferred offering costs |
|
|
|
224,700 |
|
|
|
294,900 |
|
Deferred contract acquisition costs - non-current portion |
|
|
|
200,800 |
|
|
|
234,100 |
|
Security deposits and other assets |
|
|
|
47,800 |
|
|
|
47,800 |
|
Total assets |
|
|
$ |
103,907,200 |
|
|
$ |
108,281,300 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
|
$ |
2,316,200 |
|
|
$ |
838,300 |
|
Accrued expenses |
|
|
|
2,150,000 |
|
|
|
1,562,700 |
|
Deferred revenue - current portion |
|
|
|
1,420,200 |
|
|
|
1,420,200 |
|
Operating lease obligation - current portion |
|
|
|
378,400 |
|
|
|
364,800 |
|
Financing lease obligation - current portion |
|
|
|
2,200 |
|
|
|
3,000 |
|
Total current liabilities |
|
|
|
6,267,000 |
|
|
|
4,189,000 |
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
Accrued dividends on Series B Preferred Stock |
|
|
|
6,634,500 |
|
|
|
6,272,700 |
|
Deferred revenue - non-current portion |
|
|
|
2,136,200 |
|
|
|
2,490,300 |
|
Operating lease obligation - non-current portion |
|
|
|
3,252,700 |
|
|
|
3,350,800 |
|
Total non-current liabilities |
|
|
|
12,023,400 |
|
|
|
12,113,800 |
|
Total liabilities |
|
|
|
18,290,400 |
|
|
|
16,302,800 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
June 30, 2021 and March 31, 2021: |
|
|
|
|
|
Series A Preferred, 500,000 shares authorized, issued and
outstanding at June 30, 2021 and March 31, 2021 |
|
|
|
500 |
|
|
|
500 |
|
Series B Preferred; 4,000,000 shares authorized at June 30, 2021
and March 31, 2021; 1,131,669 shares |
|
|
|
|
|
issued and outstanding at June 30, 2021 and March 31, 2021 |
|
|
|
1,100 |
|
|
|
1,100 |
|
Series C Preferred; 3,000,000 shares authorized at June 30, 2021
and March 31, 2021; 2,318,012 shares |
|
|
|
|
|
issued and outstanding at June 30, 2021 and March 31, 2021 |
|
|
|
2,300 |
|
|
|
2,300 |
|
Series D Preferred; 2,000,000 shares authorized at June 30, 2021
and March 31, 2021; no shares and 402,149 |
|
|
|
|
|
shares issued and outstanding at June 30, 2021 and March 31, 2021,
respectively |
|
|
|
- |
|
|
|
400 |
|
Common stock, $0.001 par value; 325,000,000 shares authorized at
June 30, 2021 and March 31, 2021; 191,632,008 |
|
|
|
|
|
and 180,751,234 shares issued at June 30, 2021 and March 31, 2021,
respectively |
|
|
|
191,600 |
|
|
|
180,800 |
|
Additional paid-in capital |
|
|
|
316,975,600 |
|
|
|
315,603,100 |
|
Treasury stock, at cost, 135,665 shares of common stock held at
June 30, 2021 and March 31, 2021 |
|
|
|
(3,968,100 |
) |
|
|
(3,968,100 |
) |
Accumulated deficit |
|
|
|
(227,586,200 |
) |
|
|
(219,841,600 |
) |
Total stockholders’ equity |
|
|
|
85,616,800 |
|
|
|
91,978,500 |
|
Total liabilities and stockholders’ equity |
|
|
$ |
103,907,200 |
|
|
$ |
108,281,300 |
|
|
|
|
|
|
|
VISTAGEN THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS |
(Amounts in Dollars, except share amounts) |
(Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
Sublicense revenue |
|
$ |
354,100 |
|
|
$ |
- |
|
Total revenues |
|
|
354,100 |
|
|
|
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
5,603,600 |
|
|
|
1,731,200 |
|
General and administrative |
|
|
2,496,700 |
|
|
|
1,390,600 |
|
Total operating expenses |
|
|
8,100,300 |
|
|
|
3,121,800 |
|
Loss from operations |
|
|
(7,746,200 |
) |
|
|
(3,121,800 |
) |
Other income (expenses), net: |
|
|
|
|
Interest income (expense), net |
|
|
5,100 |
|
|
|
(3,200 |
) |
Other income |
|
|
- |
|
|
|
600 |
|
Loss before income taxes |
|
|
(7,741,100 |
) |
|
|
(3,124,400 |
) |
Income taxes |
|
|
(3,400 |
) |
|
|
(2,400 |
) |
Net loss and comprehensive loss |
|
|
(7,744,500 |
) |
|
|
(3,126,800 |
) |
|
|
|
|
|
Accrued dividends on Series B Preferred stock |
|
|
(361,800 |
) |
|
|
(335,800 |
) |
|
|
|
|
|
Net loss attributable to common stockholders |
|
$ |
(8,106,300 |
) |
|
$ |
(3,462,600 |
) |
|
|
|
|
|
Basic and diluted net loss attributable to common |
|
|
|
|
stockholders per common share |
|
$ |
(0.04 |
) |
|
$ |
(0.07 |
) |
|
|
|
|
|
Weighted average shares used in computing |
|
|
|
|
basic and diluted net loss attributable to common |
|
|
|
|
stockholders per common share |
|
|
189,924,158 |
|
|
|
51,321,355 |
|
|
|
|
|
|
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