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): August 13, 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 August 13, 2020, VistaGen Therapeutics, Inc.
(the “Company”) issued a press release to announce the
Company’s financial results for its fiscal year 2021 first
quarter ended June 30, 2020. A copy of the press release is
attached to this Current Report on Form 8-K as Exhibit
99.1.
Item 7.01. Regulation FD Disclosure.
On
August 14, 2020, the Company began utilizing a new
corporate presentation. A copy of the updated corporate
presentation is attached to this Current Report on Form 8-K as
Exhibit 99.2.
Disclaimer.
The information in this Current Report
on Form 8-K, including the information set forth in
Exhibits 99.1 and 99.2, are 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 Exhibits
99.1 and 99.2 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 August 13,
2020
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VistaGen
Therapeutics, Inc. Corporate Presentation, dated August
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:
August 14, 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 2021 First Quarter Financial Results
and Highlights CNS Pipeline and Business
Progress
Company
Received Over $17.5 Million Net Proceeds from PH94B Upfront License
Payment and Public Offering of Common Stock Subsequent to
Quarter-end
Positive
Meeting with the FDA Sets Key Aspects of Pivotal PH94B Phase 3
Study
SOUTH SAN FRANCISCO, Calif., August 13, 2020 -- (BUSINESS
WIRE)—VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS)
disorders, today reported financial results for its fiscal 2021
first quarter ended June 30, 2020.
"We accomplished several meaningful milestones thus far this fiscal
year that positively impact our clinical development programs,
including our PH94B Phase 3 program in social anxiety disorder. We
reached consensus with the FDA on the key aspects of the design of
our pivotal Phase 3 clinical studies of PH94B for acute treatment
of anxiety in adults with social anxiety disorder. This design is
similar to the design of the highly statistically significant Phase
2 study of PH94B in social anxiety disorder,”
said Shawn Singh, Chief
Executive Officer of VistaGen. “Additionally,
we received the $5 million upfront license payment from our
partnering arrangement with EverInsight Therapeutics for Phase 3
development and commercialization of PH94B in key markets in Asia.
We also completed a successful public offering of our common stock,
resulting in gross proceeds to us of $14.29 million. These
accomplishments significantly strengthen our go-forward development
plans. We believe now more than ever; the global society needs new,
safe, fast-acting treatments for anxiety and depression andwe
remain committed to achieving that goal."
Financial Highlights During and Subsequent to the Fiscal 2021 First
Quarter:
●
VistaGen received a
$5 million non-dilutive upfront license payment from EverInsight
Therapeutics, the Company’s strategic partner for Phase 3
development and commercialization of PH94B for anxiety-related
disorders in multiple key markets in Asia.
●
VistaGen completed
an underwritten public offering of common stock resulting in gross
proceeds of $14.29 million to the Company, before underwriting
discounts and commissions and offering expenses.
CNS Pipeline Highlights:
●
VistaGen
reached consensus with the FDA on key aspects regarding the
Company’s initial pivotal Phase 3 study of PH94B for acute
treatment of anxiety in adults with social anxiety disorder (SAD)
that, among other details, may provide significant time- and
cost-efficiencies for its Phase 3 program.
o
As
in the highly statistically significant (p=0.002) Phase 2 study of
PH94B in SAD, VistaGen’s Phase 3 study will involve a single
laboratory-simulated anxiety-provoking public speaking
challenge.
o
The
Phase 3 study will be a randomized, double-blind,
placebo-controlled, parallel comparison study conducted at
approximately 12 to 15 sites in North America.
o
The
Subjective Units of Distress Scale (SUDS) will be used to assess
the primary efficacy endpoint in the study.
o
Dr.
Michael Liebowitz, 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 be the Principal Investigator of the study.
o
Target
enrollment (completed patients) will be approximately 182 adult
patients with SAD.
●
Through
the FDA’s Coronavirus Treatment Acceleration Program (CTAP),
VistaGen submitted its preliminary protocol and development plan
for an exploratory, open-label Phase 2A study of PH94B for acute
treatment of adjustment disorder with anxiety (AjDA), including,
but not limited to, anxiety-provoking stressors related to the
diverse impact of the COVID-19 pandemic (e.g., fear and anxiety
regarding health and safety, economic loss, unemployment, social
isolation, distance-learning, etc.) and civil unrest.
o
The
Company is currently working closely with the FDA on plans for the
Phase 2A study in AjDA, which, when study preparations are
completed, will be conducted in New York City by Dr. Michael
Liebowitz.
Financial Results for the Fiscal Quarter Ended June 30,
2020:
Net loss: Net loss attributable
to common stockholders for the fiscal quarter ended June 30, 2020
decreased to approximately $3.5 million compared to $6.5 million
for the fiscal quarter ended June 30, 2019.
Research and development (R&D) expense: R&D expense decreased to approximately $1.7
million from $4.3 million for the quarters ended June 30, 2020 and
2019, respectively, primarily due to the completion of our Phase 2
study of AV-101 in major depressive disorder in the fourth calendar
quarter of 2019. Expenses related to that study and other AV-101
related nonclinical activities decreased by $2.5 million in the
quarter ended June 30, 2020 compared to expense in the quarter
ended June 30, 2019. Noncash research and development expenses,
primarily stock-based compensation, and depreciation in both
periods, accounted for approximately $249,000 and $416,000 in the
quarters ended June 30, 2020 and 2019,
respectively.
General and administrative (G&A) expense: G&A expense decreased to approximately $1.4
million from approximately $1.9 million for the quarters ended June
30, 2020 and 2019, respectively. Noncash G&A expense, $466,000
in the quarter ended June 30, 2020, decreased from $772,000 in the
quarter ended June 30, 2019, primarily due to decreases in
stock-based compensation and the noncash components of investor and
public relations expense attributable to the amortization of the
fair value of common stock or warrants granted to service
providers.
Cash Position: At June 30,
2020, VistaGen had cash and cash equivalents of $1.5 million,
compared to $1.4 million at March 31, 2020. After June 30,
2020, the Company received net
proceeds totaling approximately $17.5 million from (i) the $5.0
million gross non-dilutive upfront license fee payment from
EverInsight Therapeutics, Inc. pursuant our PH94B strategic
collaboration agreement for development and commercialization of
PH94B in key markets in Asia, and (ii) the gross proceeds of
approximately $14.29 million from the sale of shares of common
stock in the underwritten public offering.
As of August 13, 2020, there were 77,998,057 shares of common stock
outstanding.
About PH94B
PH94B
is a rapid-onset (within approximately 15 minutes) synthetic
neurosteroid nasal spray with therapeutic potential across a broad
range of anxiety-related disorders. Easily self-administered in
microgram-level doses, PH94B does not require systemic uptake and
distribution to produce its rapid-onset anti-anxiety
effects.
VistaGen
is preparing for Phase 3 clinical development of PH94B as a
potential new generation fast-acting, non-sedating,
non-addictive acute treatment of anxiety in adults with social
anxiety disorder (SAD). The FDA has granted Fast Track designation
for development of PH94B for this indication, believed to be the
first such designation by the FDA for a drug candidate for
SAD.
With
its rapid-onset pharmacology, lack of systemic exposure and
excellent safety profile in earlier studies, PH94B has potential as
a novel treatment for multiple additional anxiety-related
disorders. VistaGen is also preparing for exploratory Phase 2A
development of PH94B for acute treatment of adjustment
disorder. View more
background information on SAD and a video on PH94B's mechanism of
action.
About PH10
PH10 is an investigational synthetic neurosteroid with therapeutic
potential in a wide range of neuropsychiatric indications involving
depression and suicidal ideation. VistaGen is initially developing
PH10 as a potential fast-acting, non-sedating, non-addictive new
generation stand-alone treatment of major depressive disorder
(MDD). Following successfully completed Phase 2A development for
MDD, VistaGen is now preparing for Phase 2B clinical development of
PH10 for MDD.
About AV-101
AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate
receptor), an ionotropic glutamate receptor in the
brain. Abnormal NMDAR function is associated with numerous CNS
diseases and disorders. AV-101 is an oral prodrug of
7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective
full antagonist of the glycine co-agonist site of the NMDAR that
inhibits the function of the NMDAR. Unlike ketamine and other NMDAR
antagonists, 7-Cl-KYNA is not an ion channel blocker. In all
studies to date, AV-101 has exhibited no dissociative or
hallucinogenic psychological side effects or safety concerns
similar to those that may be caused by amantadine, esketamine and
ketamine. With its exceptionally few side effects and
excellent safety profile, AV-101 has potential to be an oral new
generation treatment for multiple CNS indications. The FDA has
granted Fast Track designation for development of AV-101 as both a
potential adjunctive
treatment for MDD and as
a non-opioid
treatment for neuropathic pain.
About VistaGen Therapeutics, Inc.
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for anxiety, depression and
certain CNS disorders where current treatments are believed by
VistaGen to be inadequate, resulting in high unmet need. Each of
VistaGen's three drug candidates has a differentiated mechanism of
action, an exceptional safety profile, and therapeutic potential in
several large global CNS markets. For more information, please
visit
www.vistagen.com and connect with
VistaGen on Twitter, LinkedIn and Facebook.
Forward Looking Statements
Various statements in this release are "forward-looking statements"
concerning VistaGen's future expectations, plans and prospects,
including the potential for successful Phase 3 development of PH94B
for acute treatment of anxiety in adults with social anxiety
disorder and Phase 2A development for acute treatment of adjustment
disorder, as well as ongoing clinical development of PH10 for the
potential treatment of MDD and AV-101 as a potential treatment in
multiple CNS indications. These forward-looking statements are
neither promises nor guarantees of future performance, and are
subject to a variety of risks and uncertainties which could cause
actual results to differ materially from those contemplated in
these forward-looking statements, including the risks that:
development and approval of PH94B, PH10 or AV-101 may not be
achieved in any market; the FDA may decide that the results of any
of the Company's clinical development programs, including its PH94B
Phase 3 clinical program for acute treatment of anxiety in adult
patients with SAD or any other anxiety-related disorder, are not
sufficient for regulatory approval; development of PH94B, PH10
and/or AV-101 may not be successful in any indication; success in
nonclinical studies or in earlier-stage clinical trials may not be
repeated or observed in future studies which may not support
further development or be sufficient to gain regulatory approval to
market PH94B, PH10 and/or AV-101; adverse events may be encountered
at any stage of development that negatively impact further
development. Other risks and uncertainties include, but are not
limited to, issues related to: adverse healthcare reforms and
changes of laws and regulations; general industry and market
conditions; manufacturing and marketing risks, which may include,
but are not limited to, unavailability of or delays in delivery of
raw materials for manufacture of PH94B, PH10 and/or AV-101;
inadequate and/or untimely supply of PH94B, PH10 and/or AV-101 to
meet demand; entry of competitive products; and other technical and
unexpected hurdles in the development, manufacture and
commercialization of PH94B, PH10 and/or AV-101, as well as those
risks more fully discussed in the section entitled "Risk Factors"
in VistaGen's most recent Annual Report on Form 10-K for the year
ended March 31, 2020, and subsequent quarterly reports on Form
10-Q, as well as discussions of potential risks, uncertainties, and
other important factors in the company's other filings with the
Securities and Exchange Commission. In addition, any
forward-looking statements represent the Company's views only as of
today and should not be relied upon as representing its views as of
any subsequent date. The Company explicitly disclaims 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
Tables
Follow
VISTAGEN THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts
in dollars, except share amounts)
(Unaudited)
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June 30,
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March 31,
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2020
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2020
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ASSETS
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Current
assets:
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Cash
and cash equivalents
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$1,545,900
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$1,355,100
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Prepaid
expenses and other current assets
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633,000
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225,100
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Total
current assets
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2,178,900
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1,580,200
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Property
and equipment, net
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184,200
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209,600
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Right
of use asset - operating lease
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3,492,100
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3,579,600
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Deferred
offering costs
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263,900
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355,100
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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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$6,166,900
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$5,772,300
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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Current
liabilities:
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Accounts
payable
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$1,307,300
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$1,836,600
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Accrued
expenses
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607,800
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561,500
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Current
notes payable, including accrued interest
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428,900
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56,500
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Operating
lease obligation - current portion
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325,700
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313,400
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Financing
lease obligation - current portion
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3,400
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3,300
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Total
current liabilities
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2,673,100
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2,771,300
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Non-current
liabilities:
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Non-current
portion of notes payable
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124,700
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-
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Accrued
dividends on Series B Preferred Stock
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5,347,600
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5,011,800
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Operating
lease obligation - non-current portion
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3,631,100
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3,715,600
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Financing
lease obligation - non-current portion
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2,100
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3,000
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Total
non-current liabilities
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9,105,500
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8,730,400
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Total
liabilities
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11,778,600
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11,501,700
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Commitments
and contingencies (Note 10)
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Stockholders’
equity (deficit):
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized at June 30,
2020 and March 31, 2020:
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Series A
Preferred, 500,000 shares authorized, issued and outstanding at
June 30, 2020 and March 31, 2020
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500
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500
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Series B
Preferred; 4,000,000 shares authorized at June 30, 2020 and March
31, 2020; 1,160,240 shares
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||
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issued and
outstanding at June 30, 2020 and March 31, 2020
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1,200
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1,200
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Series C
Preferred; 3,000,000 shares authorized at June 30, 2020 and March
31, 2020; 2,318,012 shares
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issued and
outstanding at June 30, 2020 and March 31, 2020
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2,300
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2,300
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Common
stock, $0.001 par value; 175,000,000 shares authorized at June 30,
2020 and March 31, 2020;
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||
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55,937,472 and
49,348,707 shares issued and outstanding at June 30, 2020 and March
31, 2020, respectively
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55,900
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49,300
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Additional
paid-in capital
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203,330,700
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200,092,800
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Treasury
stock, at cost, 135,665 shares of common stock held at June 30,
2020 and March 31, 2020
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(3,968,100)
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(3,968,100)
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Accumulated
deficit
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(205,034,200)
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(201,907,400)
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Total
stockholders’ deficit
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(5,611,700)
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(5,729,400)
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Total
liabilities and stockholders’ deficit
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$6,166,900
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$5,772,300
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VISTAGEN THERAPEUTICS
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(Amounts
in Dollars, except share amounts)
(
Unaudited)
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Three Months Ended June 30,
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2020
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2019
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Operating
expenses:
|
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Research and development
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$1,731,200
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$4,313,900
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General
and administrative
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1,390,600
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1,910,100
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Total operating expenses
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3,121,800
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6,224,000
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Loss from
operations
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(3,121,800)
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(6,224,000)
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Other income
(expenses), net:
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Interest income (expense), net
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(3,200)
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16,500
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Other
income
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600
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-
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Loss before
income taxes
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(3,124,400)
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(6,207,500)
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Income
taxes
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(2,400)
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(2,400)
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Net loss and
comprehensive loss
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$(3,126,800)
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$(6,209,900)
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Accrued
dividends on Series B Preferred stock
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(335,800)
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(302,500)
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Net loss
attributable to common stockholders
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$(3,462,600)
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$(6,512,400)
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Basic and
diluted net loss attributable to common
|
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stockholders
per common share
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$(0.07)
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$(0.15)
|
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Weighted
average shares used in computing
|
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basic
and diluted net loss attributable to common
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stockholders
per common share
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51,321,355
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42,622,965
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Exhibit
99.2
