SOUTH SAN FRANCISCO, Calif.,
June 29, 2020 /PRNewswire/
-- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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
THERAPEUTICS, INC.
|
CONSOLIDATED
BALANCE SHEETS
|
(Amounts in dollars,
except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
March 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
1,355,100
|
|
$
13,100,300
|
Receivable from
supplier
|
|
|
-
|
|
300,000
|
Prepaid
expenses and other current assets
|
|
|
225,100
|
|
228,600
|
Total current
assets
|
|
|
1,580,200
|
|
13,628,900
|
Property and
equipment, net
|
|
|
209,600
|
|
312,700
|
Right of use
asset - operating lease
|
|
|
3,579,600
|
|
-
|
Deferred
offering costs
|
|
|
355,100
|
|
22,300
|
Security
deposits and other assets
|
|
|
47,800
|
|
47,800
|
Total
assets
|
|
|
$
5,772,300
|
|
$
14,011,700
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
|
$
1,836,600
|
|
$
1,055,000
|
Accrued
expenses
|
|
|
561,500
|
|
1,685,600
|
Current note
payable
|
|
|
56,500
|
|
57,300
|
Operating lease
obligation - current portion
|
|
|
313,400
|
|
-
|
Financing lease
obligation - current portion
|
|
|
3,300
|
|
3,000
|
Total current
liabilities
|
|
|
2,771,300
|
|
2,800,900
|
|
|
|
|
|
|
Non-current
liabilities:
|
|
|
|
|
|
Accrued
dividends on Series B Preferred Stock
|
|
|
5,011,800
|
|
3,748,200
|
Deferred rent
liability
|
|
|
-
|
|
381,100
|
Operating lease
obligation - non-current portion
|
|
|
3,715,600
|
|
|
Financing lease
obligation - non-current portion
|
|
|
3,000
|
|
6,300
|
Total
non-current liabilities
|
|
|
8,730,400
|
|
4,135,600
|
Total
liabilities
|
|
|
11,501,700
|
|
6,936,500
|
|
|
|
|
|
|
Commitments and
contingencies (Note 15)
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized at March 31, 2020
and 2019:
|
|
|
|
|
|
Series A Preferred, 500,000 shares authorized, issued and
outstanding at March 31, 2020 and 2019
|
|
|
500
|
|
500
|
Series B Preferred; 4,000,000 shares authorized at March 31, 2020
and 2019; 1,160,240 shares issued and outstanding at March 31,
2020 and 2019
|
|
|
1,200
|
|
1,200
|
Series C Preferred; 3,000,000 shares authorized at March 31, 2020
and 2019; 2,318,012 shares issued and outstanding at March 31,
2020 and 2019
|
|
|
2,300
|
|
2,300
|
Common stock,
$0.001 par value; 175,000,000 and 100,000,000 shares authorized at
March 31, 2020 and 2019, respectively; 49,348,707 and
42,758,630 shares issued and outstanding at March 31, 2020 and
2019, respectively
|
|
|
49,300
|
|
42,800
|
Additional
paid-in capital
|
|
|
200,092,800
|
|
192,129,900
|
Treasury stock,
at cost, 135,665 shares of common stock held at March 31, 2020 and
2019
|
|
|
(3,968,100)
|
|
(3,968,100)
|
Accumulated
deficit
|
|
|
(201,907,400)
|
|
(181,133,400)
|
Total
stockholders' equity (deficit)
|
|
|
(5,729,400)
|
|
7,075,200
|
Total
liabilities and stockholders' equity (deficit)
|
|
|
$
5,772,300
|
|
$
14,011,700
|
VISTAGEN
THERAPEUTICS, INC.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(Amounts in Dollars,
except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Years
Ended March 31,
|
|
|
|
2020
|
|
2019
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
|
$
13,374,200
|
|
$
17,098,500
|
|
General and
administrative
|
|
7,427,300
|
|
7,457,800
|
|
Total
operating expenses
|
|
20,801,500
|
|
24,556,300
|
|
Loss from
operations
|
|
(20,801,500)
|
|
(24,556,300)
|
|
Other income
(expenses), net:
|
|
|
|
|
|
Interest income
(expense), net
|
|
30,100
|
|
(8,000)
|
|
Loss on
extinguishment of debt
|
|
-
|
|
(22,700)
|
|
Loss before income
taxes
|
|
(20,771,400)
|
|
(24,587,000)
|
|
Income
taxes
|
|
(2,600)
|
|
(2,600)
|
|
Net loss and
comprehensive loss
|
|
$
(20,774,000)
|
|
$
(24,589,600)
|
|
|
|
|
|
|
|
Accrued
dividend on Series B Preferred stock
|
|
(1,263,600)
|
|
(1,139,900)
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
|
$
(22,037,600)
|
|
$
(25,729,500)
|
|
|
|
|
|
|
|
Basic and diluted net
loss attributable to common stockholders per common
share
|
|
$
(0.50)
|
|
$
(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
|
|
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SOURCE VistaGen Therapeutics