UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF
1934
Date of Report (Date of earliest event reported): June 29, 2020
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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000-54014
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20-5093315
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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343 Allerton Ave.
South San Francisco, California 94090
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(Address of principal executive offices)
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(650) 577-3600
(Registrant’s telephone number, including area
code)
Not Applicable
(Former name or former address, if changed since last
report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
☐ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a
-12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d -2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e -4(c))
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Common
Stock, par value $0.001 per share
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VTGN
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Nasdaq
Capital Market
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17
CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR 240.12b-2)
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act ☐
Item 2.02 Results of Operations and
Financial Condition.
On June 29, 2020, VistaGen Therapeutics, Inc. (the
“Company”) issued a press release to announce the
Company’s financial results for its fiscal year ended March
31, 2020 and to provide an update on the Company’s central
nervous system (“CNS”) product pipeline. A copy of the press
release is attached to this Current Report on Form 8-K as Exhibit
99.1.
The information in this Current Report
on Form 8-K, including the information set forth in
Exhibit 99.1, is being furnished and shall not be deemed
“filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the
“Exchange
Act”), nor shall Exhibit
99.1 filed herewith be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Index
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Exhibit No.
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Description
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Press
Release issued by VistaGen Therapeutics, Inc., dated June 29,
2020
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Signatures
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
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VistaGen
Therapeutics, Inc.
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Date:
June 30, 2020
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By:
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/s/ Shawn K. Singh
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Shawn
K. Singh
Chief
Executive Officer
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Exhibit 99.1
VistaGen Therapeutics Reports Fiscal Year 2020 Results and Provides
CNS Pipeline Update
VistaGen
Eligible to Receive up to $177 Million, Including Upfront and
Potential Milestone Payments, in Addition to Royalties, under PH94B
License in Key Asian Markets Announced Subsequent to Fiscal 2020
Year End
SOUTH SAN FRANCISCO, Calif., June 29, 2020 – VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS) diseases
and disorders with high unmet need, today reported financial
results for its fiscal year ended March 31,
2020.
“As
these unprecedented times persist, with the chaotic implementation
of public safety measures and the civil unrest in the fight for
social justice, we continue to live in a world filled with
heightened uncertainty and unfamiliarity. The spike in the number
of individuals experiencing anxiety and depression is unparalleled
and it appears the upward trajectory will continue. While
innovative means of providing mental health support have been
initiated, many needs are still not being met,” stated
Shawn
Singh, Chief Executive Officer of VistaGen.
Singh continued, “VistaGen is uniquely positioned to develop
a robust investigational pipeline of novel treatments for millions
of people globally today and for generations to come who are
unfortunately suffering due to this heightened mental health
pandemic. We have
continued to make progress across our CNS pipeline, notably, with
PH94B, our first-in-class, rapid-onset neuroactive nasal
spray for social anxiety disorder, having recently announced
a strategic collaboration with EverInsight for up to $177 million
in upfront and potential milestone payments to develop and
commercialize PH94B in key Asian markets. This partnership further
highlights the value of this asset, which has global market
potential as a rapid-onset and safe, acute anxiety therapy, and
provides our company with additional working capital to continue
the significant progress we have made in preparation for our Phase
3 program in parallel with emphasis on additional strategic
collaborations for development and commercialization of our
pipeline in key regional markets outside the
U.S.”
VistaGen’s CNS Pipeline:
VistaGen is developing three differentiated, patent-protected, CNS
product candidates for large global markets where current
treatments are inadequate to address rising mental health
challenges worldwide, as well as need for non-additive,
non-sedating relief from pain, unwanted movement disorders and
other neurological conditions besetting increasing numbers of
individuals worldwide. VistaGen’s CNS product candidates in
development are as follows:
PH94B Neuroactive Nasal Spray
PH94B
is a first-in-class neuroactive nasal spray with therapeutic
potential in a wide range of indications involving anxiety or
phobia. Self-administered in microgram doses, PH94B does not
require systemic uptake and distribution to produce its rapid-onset
anti-anxiety effects and, therefore, has an excellent safety
profile.
Strategic Partnership with EverInsight Therapeutics for up to $177
Million in Upfront and Potential Milestone Payments, in Addition to
Royalties
●
VistaGen and
EverInsight Therapeutics, a company currently funded by the CBC
Group (formerly C-Bridge Capital), one of the largest and most
active healthcare-dedicated investment firms in Asia, entered into
a strategic partnership for Phase 3 clinical development and
commercialization of PH94B, initially for acute treatment of SAD,
in multiple key anxiety markets in Asia.
o
VistaGen is eligible to receive up to $177M, including a $5 million
upfront payment and up to $172 million in potential milestone
payments, if Phase 3 development efforts are successful, in
addition to royalties.
Social Anxiety Disorder (SAD)
●
FDA granted
VistaGen Fast Track designation for development of PH94B for
on-demand treatment of SAD, the first such designation granted by
the FDA for development of a drug candidate for SAD. The Company is
currently in final-stage discussions with the FDA regarding key
details of its plan for Phase 3 clinical development of PH94B for
SAD in the U.S., with the initial objective of developing PH94B as
the first FDA-approved on-demand, rapid-onset acute treatment of
SAD.
o
Michael Liebowitz,
M.D., Professor of Clinical Psychiatry at Columbia University,
director of the Medical Research Network in New York City, and
creator of the Liebowitz Social Anxiety Scale (LSAS), will serve as
Principal Investigator of the Company’s Phase 3 clinical
studies.
Adjustment Disorder with Anxiety related to the COVID-19
Pandemic
●
Through the FDA's
new Coronavirus Treatment Acceleration Program (CTAP), VistaGen submitted a protocol
and development plan for an exploratory open-label Phase 2A study
of PH94B for treatment of adjustment disorder with anxiety (AjDA)
related to the COVID-19 pandemic.
o
Phase 2A study in
AjDA to be conducted in New York City, with Dr. Michael Liebowitz,
M.D., serving as Principal Investigator.
Based on its rapid-onset pharmacology, microgram-level dosing, lack
of systemic exposure, excellent safety profile and the rapidly
rising incidence of anxiety disorders, the Company is also
assessing potential exploratory Phase 2A studies of PH94B for
treatment of postpartum anxiety, post-traumatic stress disorder
(PTSD), preoperative anxiety, and panic disorder.
PH10 Neuroactive Nasal Spray
Major Depressive Disorder (MDD)
PH10 is an odorless, fast-acting synthetic neurosteroid delivered
intranasally that has therapeutic potential in a wide range of
neuropsychiatric indications involving depression.
Self-administered in microgram doses, PH10 does not require
systemic uptake and distribution to produce its antidepressant
effects. The Company is initially developing PH10 as a potential
fast-acting, non-sedating, non-addictive stand-alone treatment of
MDD.
●
Positive results of
exploratory double-blind, randomized, placebo-controlled Phase 2A
clinical study of PH10 for treatment of MDD were newly published in
peer-reviewed British
Journal of Pharmaceutical and Medical Research.
●
Following successfully completed Phase 2A development for MDD, the
Company is preparing for planned Phase 2B clinical development of
PH10 in the U.S. for MDD.
o
Maurizio Fava, M.D., Director of the Clinical Research Program and
Executive Vice Chair of the Department of Psychiatry at
Massachusetts General Hospital, and Slater Family Professor of
Psychiatry at Harvard Medical School, will be the Principal
Investigator of the planned Phase 2B study.
●
U.S. Patent and Trademark Office (USPTO)
granted U.S. Patent No.
10,322,138 related to
methods of treating MDD with PH10. Newly
granted patent will not expire until at least 2034. Counterpart
foreign patents have already been issued in China, Europe, Japan
and several other countries.
Considering its rapid-onset pharmacology, microgram-level dosing,
lack of systemic exposure, excellent safety profile and the rapidly
rising incidence of depression-related disorders, the Company is
also assessing potential exploratory Phase 2A studies of PH10 for
treatment of postpartum depression, treatment-resistant depression
and suicidal ideation.
AV-101
AV-101
is a novel, oral prodrug that targets the NMDAR
(N-methyl-D-aspartate receptor). Abnormal NMDAR function is
associated with numerous CNS diseases and disorders. AV-101’s
active metabolite, 7-chloro-kynurenic acid (7-Cl-KYNA), is a potent
and selective full antagonist of the glycine coagonist site of the
NMDAR. Unlike ketamine and other NMDAR antagonists, 7-Cl-KYNA is
not an ion channel blocker. VistaGen is currently assessing
AV-101’s potential in combination with probenecid, a safe and
well-known oral drug used to treat gout and to increase the
therapeutic benefit of numerous antibacterial, anticancer and
antiviral drugs, to treat MDD, neuropathic pain, dyskinesia
associated with levodopa therapy for Parkinson’s disease,
epilepsy and suicidal ideation.
●
VistaGen reported
new positive preclinical data of AV-101 administered with
probenecid, demonstrating substantially increased brain
concentration effects of AV-101 (7-fold) and its active metabolite,
7-Cl-KYNA (35-fold).
●
AV-101 with
probenecid could result in far more profound therapeutic benefits
for patients with MDD than in prior clinical studies that did not
involve probenecid.
●
VistaGen and Nuformix entered strategic agreement to develop novel
crystalline forms of AV-101 that may have superior delivery, an
enhanced therapeutic profile and additional intellectual property
protection.
●
The Company reported positive results of preclinical study of
AV-101 in widely-used MPTP non-human primate model for reproducing
unwanted movement complications of Parkinson's disease (PD).
Antidyskinetic activity of AV-101 measured compared favorably with
observations with amantadine in parkinsonian monkeys. Better than
amantadine, with its known side effects (in humans with PD and in
parkinsonian monkeys), no adverse effects with AV-101 were
observed. This study supports AV-101's potential to treat
dyskinesia associated with levodopa therapy for PD, while
maintaining the antiparkinsonian benefits of levodopa therapy and
without causing hallucinations or other serious side effects that
may be associated with amantadine therapy.
●
USPTO issued Notice
of Allowance for U.S. Patent Application 16/003,816 related to
therapeutic use of AV-101 for treatment of dyskinesia induced by
the administration of levodopa. Patent, once issued, will be in
effect until at least 2034.
●
FDA authorized
Investigational New Drug (IND) application for AV-101 as a
potential new treatment of dyskinesia in individuals with PD
receiving levodopa therapy.
●
The Company announced positive results of preclinical study
examining AV-101's analgesic and behavioral profile compared to
pregabalin in accepted “gold standard” preclinical
model for chronic neuropathic pain caused by nerve damage. AV-101,
which does not bind to opioid receptors, demonstrated robust
analgesic effects, similar to pregabalin, but with fewer side
effects as measured in the rotarod assay, providing complementary
support to an earlier preclinical study involving gabapentin, of
AV-101's potential to treat debilitating neuropathic pain, without
causing the burdensome side effects and safety concerns associated
with the medications currently used by millions to treat
neuropathic pain, such as risk of abuse, drowsiness, dizziness and
sedation.
●
Successful results
from AV-101 first-step, Phase 1B clinical study with healthy
U.S. military Veterans conducted by Baylor University measured
NMDAR target engagement of AV-101, supporting potential, with
probenecid, for next step AV-101 exploratory Phase 2A study for
treatment of suicidal ideation in Veterans.
●
Successful Baylor
Study and the recent preclinical studies involving AV-101 and
adjunctive probenecid suggest AV-101’s potential in
NMDAR-focused CNS indications for which Company has positive AV-101
preclinical data without probenecid (depression, epilepsy,
levodopa-induced dyskinesia and neuropathic pain). Company
conducing additional preclinical studies of AV-101 with probenecid
to determine most appropriate next-steps to support exploratory
Phase 2A clinical studies.
Financial Results for the Fiscal Year Ended March 31,
2020:
Research and development (R&D) expense: R&D expense
decreased to $13.4 million for fiscal 2020, compared with $17.1
million in fiscal 2019. In fiscal 2019, our acquisition of the
PH94B and PH10 licenses through the issuance of our common stock,
resulted in an aggregate of $4.25 million of noncash expense and
primarily accounts for the decrease. Other noncash expenses
included in research and development expense (excluding the PH94B
and PH10 license acquisitions in fiscal 2019), primarily stock
compensation and lab equipment depreciation, accounted for
approximately $1.4 million in both fiscal 2020 and fiscal
2019.
General and administrative (G&A) expense: G&A
expense totaled $7.4 million in fiscal 2020 compared to $7.5
million in fiscal 2019. Increased noncash stock compensation and
warrant modification expenses were generally offset by decreases in
cash-based salaries and benefits and investor and public relations
expenses. Noncash general and administrative expense accounted for
approximately $3,543,000 and $2,622,000 in fiscal 2020 and fiscal
2019, respectively.
Net loss: Net loss attributable to common stockholders for
the fiscal year ended March 31, 2020 decreased to approximately
$22.0 million compared to $25.7 million for the fiscal year ended
March 31, 2019, the decrease resulting primarily from the $4.25
million noncash expense associated with the stock-based acquisition
of the licenses to develop and commercialize PH94B and PH10 in
fiscal 2019.
Cash: At March 31, 2020, VistaGen had cash and cash
equivalents of $1.4 million. Subsequent to March 31, 2020, the
Company received proceeds of approximately $3.0 million, including
proceeds of approximately $2.8 million from equity sales and
approximately $200,000 from a potentially forgivable loan under the
Paycheck Protection Act. In addition, in June 2020, the Company
entered into a strategic licensing and collaboration agreement with
EverInsight for the development and commercialization of PH94B for
anxiety disorders in multiple key Asian markets. Under the
agreement, VistaGen is eligible to receive up to $177 million in
upfront and potential milestone payments, in addition to royalties,
including a $5 million upfront payment.
Shares outstanding: As of June 29, 2020, there were
55,773,682 shares of the Company’s common stock
outstanding.
About VistaGen
VistaGen
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for anxiety, depression and
certain CNS diseases and disorders where current treatments are
inadequate, resulting in high unmet need.
VistaGen's pipeline is
focused on three clinical-stage CNS drug candidates, PH94B, PH10
and AV-101, each with a differentiated mechanism of action, an
exceptional safety profile, and therapeutic potential in multiple
large and growing CNS markets. For more information, please
visit www.vistagen.com
and connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development and commercialization of our
three drug candidates for various therapeutic purposes, including
(i) PH94B for social anxiety disorder and multiple other
anxiety-related disorders; (ii) PH10 for MDD and multiple
additional depression-related disorders and suicidal ideation, and
(iii) AV-101 for dyskinesia in patients with Parkinson's disease
receiving levodopa therapy, epilepsy, major depressive disorder,
neuropathic pain and suicidal ideation. In addition, statements
concerning the Company's future expectations may include statements
regarding intellectual property and commercial protection of each
of our drug candidates. Each of these statements constitute
forward-looking statements for the purposes of the safe harbor
provisions under the Private Securities Litigation Reform Act of
1995. These forward-looking statements are neither promises nor
guarantees of future performance and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
may cause actual results to differ materially from those
contemplated in these forward-looking statements. Those risks
include the following: (i) we may encounter unexpected adverse
events in patients during our clinical development of any product
candidate that cause us to discontinue further development; (ii) we
may not be able to successfully demonstrate the safety and efficacy
of our product candidates at each stage of clinical development;
(iii) success in preclinical studies or in early-stage clinical
studies may not be repeated or observed future studies, and ongoing
or future preclinical and clinical results may not support further
development of, or be sufficient to gain regulatory approval to
market any of our product candidates; (iv) decisions or actions of
regulatory agencies may negatively affect the progress of, and our
ability to proceed with, further clinical studies or to obtain
marketing approval for our drug candidates; (v) we may not be able
to obtain or maintain adequate intellectual property protection and
other forms of marketing and data exclusivity for our product
candidates; (vi) we may not have access to or be able to secure
substantial additional capital to support our operations, including
our ongoing nonclinical and clinical development activities; and
(vii) we may encounter technical and other unexpected hurdles in
the manufacturing and development of any of our product candidates.
Certain other risks are more fully discussed in the section
entitled "Risk Factors" in our most recent annual report on Form
10-K, as well as discussions of potential risks, uncertainties, and
other important factors in our other filings with the Securities
and Exchange Commission (SEC). Our SEC filings are available on the
SEC's website at www.sec.gov. In
addition, any forward-looking statements represent our views only
as of the issuance of this 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.
VistaGen Company Contact
Mark A.
McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email: IR@vistagen.com
VistaGen Investor Contact
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com
VistaGen Media Contact
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
Phone:
+1 (212) 896-1241/+1 (508) 843-6428
Email: VistaGen@KCSA.com
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March
31,
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March 31,
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2020
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2019
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ASSETS
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Current
assets:
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Cash and cash
equivalents
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$1,355,100
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$13,100,300
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Receivable
from supplier
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-
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300,000
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Prepaid
expenses and other current assets
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225,100
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228,600
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Total current
assets
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1,580,200
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13,628,900
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Property and
equipment, net
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209,600
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312,700
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Right of use
asset - operating lease
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3,579,600
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-
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Deferred
offering costs
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355,100
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22,300
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Security
deposits and other assets
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47,800
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47,800
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Total
assets
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$5,772,300
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$14,011,700
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LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
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Current
liabilities:
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Accounts
payable
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$1,836,600
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$1,055,000
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Accrued
expenses
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561,500
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1,685,600
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Current note
payable
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56,500
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57,300
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Operating
lease obligation - current portion
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313,400
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-
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Financing
lease obligation - current portion
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3,300
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3,000
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Total current
liabilities
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2,771,300
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2,800,900
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Non-current
liabilities:
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Accrued
dividends on Series B Preferred Stock
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5,011,800
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3,748,200
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Deferred rent
liability
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-
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381,100
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Operating
lease obligation - non-current portion
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3,715,600
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Financing
lease obligation - non-current portion
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3,000
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6,300
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Total
non-current liabilities
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8,730,400
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4,135,600
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Total
liabilities
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11,501,700
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6,936,500
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Commitments
and contingencies (Note 15)
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Stockholders’
equity (deficit):
|
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at March 31,
2020 and 2019:
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|
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Series
A Preferred, 500,000 shares authorized, issued and outstanding at
March 31, 2020 and 2019
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500
|
500
|
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Series
B Preferred; 4,000,000 shares authorized at March 31, 2020 and
2019; 1,160,240 shares
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|
|
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issued
and outstanding at March 31, 2020 and 2019
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1,200
|
1,200
|
|
Series
C Preferred; 3,000,000 shares authorized at March 31, 2020 and
2019; 2,318,012 shares
|
|
|
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issued
and outstanding at March 31, 2020 and 2019
|
2,300
|
2,300
|
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Common stock,
$0.001 par value; 175,000,000 and 100,000,000 shares authorized at
March 31, 2020
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and
2019, respectively; 49,348,707 and 42,758,630 shares issued and
outstanding at March 31, 2020
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and
2019, respectively
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49,300
|
42,800
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Additional
paid-in capital
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200,092,800
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192,129,900
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Treasury
stock, at cost, 135,665 shares of common stock held at March 31,
2020 and 2019
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(3,968,100)
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(3,968,100)
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Accumulated
deficit
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(201,907,400)
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(181,133,400)
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Total
stockholders’ equity (deficit)
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(5,729,400)
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7,075,200
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Total
liabilities and stockholders’ equity (deficit)
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$5,772,300
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$14,011,700
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VISTAGEN THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Amounts in dollars, except share amounts)
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Fiscal
Years Ended March 31,
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2020
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2019
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|
Operating
expenses:
|
|
|
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Research and
development
|
$13,374,200
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$17,098,500
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General and
administrative
|
7,427,300
|
7,457,800
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|
Total
operating expenses
|
20,801,500
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24,556,300
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Loss from
operations
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(20,801,500)
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(24,556,300)
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Other income
(expenses), net:
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|
|
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Interest
income (expense), net
|
30,100
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(8,000)
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Loss on
extinguishment of debt
|
-
|
(22,700)
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Loss before income
taxes
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(20,771,400)
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(24,587,000)
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Income
taxes
|
(2,600)
|
(2,600)
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Net loss and
comprehensive loss
|
$(20,774,000)
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$(24,589,600)
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|
|
|
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Accrued
dividend on Series B Preferred stock
|
(1,263,600)
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(1,139,900)
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|
|
|
|
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Net loss
attributable to common stockholders
|
$(22,037,600)
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$(25,729,500)
|
|
|
|
|
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Basic and diluted
net loss attributable to common
|
|
|
|
stockholders
per common share
|
$(0.50)
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$(0.90)
|
|
|
|
|
|
Weighted average
shares used in computing
|
|
|
|
basic and
diluted net loss attributable to common
|
|
|
|
stockholders
per common share
|
43,869,523
|
28,562,490
|