AV-101, VistaGen’s Oral NMDA Receptor Modulator,
Granted FDA Fast-Track Designation for Major Depressive
Disorder
VistaGen Therapeutics, Inc. (NASDAQ:VTGN), a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (CNS)
diseases and disorders, today reported financial results for its
fiscal year ended March 31, 2018 and provided an overview of
year-to-date highlights.
“VistaGen is committed to developing new generation medicines
for millions of people suffering from life-altering CNS diseases
and disorders without adequate treatment options. AV-101, our lead
CNS product candidate, is an oral, non-opioid, non-sedating NMDA
receptor modulator. Because the NMDA receptor is widely distributed
throughout the brain and is essential for neuronal plasticity,
AV-101 has the potential to impact a wide range of CNS indications,
including transforming the current drug treatment paradigm for
depression,” commented Shawn Singh, Chief Executive Officer of
VistaGen.
Mr. Singh continued, “We are excited about AV-101’s potential to
deliver fast-acting, ketamine-like antidepressant effects without
ketamine’s side effects or safety concerns, first as an adjunctive
treatment with current FDA-approved SSRIs and SNRIs, as we are
evaluating in our ELEVATE, and eventually as both an at-home
complement to ketamine therapy and as a stand-alone, first-line
oral therapy for depression. We believe AV-101 also has the
potential to produce gabapentin- and amantadine-like therapeutic
benefits for neuropathic pain and Parkinson’s disease
levodopa-induced dyskinesia, respectively, in each case without
involving opioid receptors or causing sedation, hallucinations or
other psychological side effects. Overall, during Fiscal 2018, our
focused strategy and execution against our core goals resulted in
achievement of multiple major milestones that have set the stage
for dynamic outcomes in Fiscal 2019 and beyond. The significant
progress we have made presents potentially game-changing treatment
options for patients and opportunities to drive value for our
stockholders.”
Operational Highlights During Fiscal 2018 and
Year-to-Date:
AV-101 Regulatory Milestones
- FDA authorization to initiate ELEVATE, our U.S. multi-center,
Phase 2 study of AV-101 as an adjunctive treatment for Major
Depressive Disorder.
- FDA Fast Track Designation for development of AV-101 as an
adjunctive treatment for Major Depressive Disorder.
AV-101 Global Intellectual Property Milestones
- U.S. Patent and Trademark Office (USPTO) issuance of three key
U.S. patents, fundamentally expanding commercial exclusivity of
AV-101 in the U.S., the world’s largest pharmaceutical market:
- U.S. Patent No. 9,993,453, therapeutic uses of AV-101 to treat
depression. Patent will not expire until at least 2034.
- U.S. Patent No. 9,993,450, AV-101 oral dosage formulations for
neurological indications - not limited to depression. Patent
will not expire until at least 2034.
- U.S. Patent No. 9,834,801, methods of producing AV-101. Patent
will not expire until at least 2034.
- European Patent Office grant of European Patent for AV-101,
treatment of depression, Parkinson's disease levodopa-induced
dyskinesia (PD LID) and use of multiple dosage forms to treat these
CNS disorders. This patent has been validated in Belgium, Denmark,
France, Germany, Ireland, Italy, Portugal, Spain, Switzerland and
the United Kingdom. It will be in effect until January
2034.
- European Patent Office issuance of Notice of Intention to grant
European Patent counterpart to U.S. Patent No. 9,834,801, methods
of producing AV-101.
- Japanese Patent Office issuance of Notice of Allowance for the
Japanese counterpart to U.S. Patent No. 9,834,801, methods of
producing AV-101.
- Chinese Patent Office issuance of Chinese counterpart to U.S.
Patent No. 9,834,801, methods of producing AV-101.
AV-101 Peer-Reviewed Publications
- Journal of Pain, featuring AV-101 on the cover and highlighting
AV-101’s gabapentin-like potential for treating multiple
hyperpathic pain states, without sedation, supporting a future
Phase 2 clinical study of AV-101 as a potential oral, non-opioid,
non-sedating at-home treatment alternative for neuropathic pain.
- Scandinavian Journal of Pain, discussing the two first-in-human
AV-101 Phase 1 safety studies that demonstrated
statistically-significant positive results in four well-established
preclinical models of pain.
Stem Cell Technology Intellectual Property Milestones
- USPTO issuance of:
- U.S. Patent No. 9,834,754 related to proprietary methods for
producing hematopoietic precursor stem cells, which are stem cells
that give rise to all blood cells and most bone marrow cells in the
body, with potential to impact both direct and supportive therapy
for autoimmune disorders and cancer, with CAR-T cell applications,
and foundational technology which may provide approaches for
producing bone marrow stem cells for bone marrow transfusions.
- U.S. Patent Application No. 14/782,070 related to methods of
producing pluripotent stem cell-derived chondrocytes, chondrocyte
lineage cells, cartilage-like tissue and cartilage. The patent
covers claims to the therapeutic administration of these cells and
tissues to treat osteoarthritis, the most common chronic condition
of the joints, and joint injuries affecting cartilage.
- In a manner similar to our sublicense agreement with BlueRock
Therapeutics involving cardiac stem cell technology, the foregoing
patents may enable strategic collaborations involving our
intellectual property relating to blood, cartilage and/or liver
cells for cell-based therapy, cell repair therapy, regenerative
medicine and/or tissue engineering.
- Japanese Patent Office issuance of a Notice of Allowance for
the Japanese counterpart to U.S. Patent No. 9,834,754, methods for
producing blood cells, platelets and bone marrow stem cells.
Anticipated Milestones Over Next 12 Months
- Second Half of 2018:
- NIMH completion of NIMH-sponsored AV-101 Phase 2 MDD
monotherapy study
- FDA authorization to initiate U.S. Phase 2 study of AV-101 for
neuropathic pain
- FDA Fast Track designation of AV-101 for development as a
non-opioid, non-sedating treatment for neuropathic pain
- First Half of 2019:
- Initiate AV-101 Phase 2 study in neuropathic pain
- FDA authorization to initiate U.S. Phase 2 study of AV-101 for
Parkinson’s disease levodopa-induced dyskinesia
- Topline results of ELEVATE, AV-101 Phase 2 study for adjunctive
treatment of Major Depressive Disorder
Financial Results for the Fiscal Year Ended March 31,
2018:
Net loss attributable to common stockholders for the fiscal year
ended March 31, 2018 (“Fiscal Year 2018”) was approximately $14.3
million, compared to $10.3 million for the fiscal year ended March
31, 2017 (“Fiscal Year 2017”).
Research and development expense totaled approximately $7.8
million for Fiscal Year 2018, compared with approximately $5.2
million for Fiscal Year 2017. The increase in research and
development expense in Fiscal Year 2018 reflects expanded
nonclinical and clinical development of AV-101, particularly
preparations for and initiation of our ELEVATE, our AV-101 Phase 2
study in MDD in the fourth quarter of Fiscal Year 2018.
General and administrative expense in Fiscal Year 2018 was
relatively flat at approximately $6.4 million, including
approximately $2.9 million of noncash expense, compared to
approximately $6.3 million, including $3.1 million of noncash
expense, in Fiscal Year 2017.
At March 31, 2018, the Company had cash and cash equivalents of
approximately $10.4 million, compared to approximately $2.9 million
at March 31, 2017.
About ELEVATE
ELEVATE is VistaGen’s U.S. multi-center Phase 2, randomized,
double-blind, placebo-controlled clinical trial designed to examine
the efficacy and safety of oral AV-101 as an adjunctive treatment
for MDD in patients with an inadequate response to standard
antidepressant therapy with either an FDA-approved selective
serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine
reuptake inhibitor (SNRI). Approximately 180 patients will be
randomized to receive either AV-101 or placebo, orally, once daily,
in conjunction with their ongoing antidepressant. The primary
endpoint of the study is the change from baseline as measured by
the Montgomery-Asberg Depression Rating Scale (MADRS). Dr. Maurizio
Fava of Massachusetts General Hospital and Harvard Medical School
is the Principal Investigator of the ELEVATE study. Top-line
results are expected in the first half of 2019.
About Major Depressive Disorder (MDD)
MDD is a serious biologically-based mood disorder, affecting
approximately 16 million adults in the United
States.2 Individuals with MDD exhibit depressive symptoms,
such as a depressed mood or a loss of interest or pleasure in daily
activities, for more than a two-week period, as well as impaired
social, occupational, educational or other important functioning
which has a negative impact on their quality of life. About one in
eight Americans aged 12 and over takes an FDA-approved
antidepressant.3 While current FDA-approved antidepressants
are widely used, about two-thirds of patients with MDD do not
respond to their initial antidepressant treatment.4 Inadequate
response to current antidepressants is among the key reasons MDD is
one of the leading public health concerns in the United States,
creating a significant unmet medical need for new agents with
fundamentally different mechanisms of
action.--------------------------1 Zanos, P., et al. (2015)
"The Prodrug 4-Chlorokynurenine Causes Ketamine-Like Antidepressant
Effects, but Not Side Effects, by NMDA/GlycineB-Site Inhibition." J
Pharmacol Exp Ther 355:76-85
2 Nat. Inst. of Mental Health website, 2017; Available
at https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
3 Pratt LA, Brody DJ, Gu Q. Antidepressant use among
persons aged 12 and over: United States, 2011-2014. NCHS data
brief, no 283
(2017). www.cdc.gov/nchs/products/databriefs/db283.htm
4 Rush AJ, et al. Am J. Psychiatry. 2006, 163(11):
1905-1917 (STAR*D Study)
About AV-101
AV-101 is an oral, non-opioid, non-sedating NMDA receptor
glycine B (NMDAR GlyB) antagonist that offers the potential to be a
new at-home treatment for multiple CNS indications with high unmet
medical need. AV-101 is currently in Phase 2 clinical development
in the United States. ELEVATE is VistaGen’s ongoing Phase
2 clinical trial designed to evaluate the efficacy and safety of
adjunctive use of oral AV-101 for MDD in patients with an
inadequate response to standard antidepressant therapy with either
an FDA-approved selective serotonin reuptake inhibitor (SSRI) or
serotonin norepinephrine reuptake inhibitor (SNRI).
AV-101 belongs to a new generation of investigational medicines
in neuropsychiatry known as glutamate receptor modulators having
the potential to treat MDD faster than current FDA-approved SSRIs
and SNRIs. AV-101’s mechanism of action (MOA) is
fundamentally different from that of all current FDA-approved SSRIs
and SNRIs for depression, most of which, if effective for a given
patient, take many weeks to achieve therapeutic benefits. VistaGen
believes AV-101 has potential as a first line oral monotherapy and
as an adjunctive oral therapy. As an adjunctive therapy, AV-101 may
have potential both to displace atypical antipsychotics such as
aripiprazole in the current MDD drug treatment paradigm for
patients with an inadequate response to current antidepressants
approved by the FDA and to prevent relapse of MDD following
successful treatment with the FDA-approved anesthetic, ketamine
hydrochloride, an ion-channel blocking NDMA receptor antagonist
(ketamine), whether administered by intravenous (IV) injection or
as an intranasal spray formulation. AV-101 may have potential to
deliver ketamine-like antidepressant effects on an at-home basis,
without the requirement for inconvenient administration in a
medical setting, and without causing psychological or other side
effects and safety concerns associated with ketamine therapy.
AV-101 may also have the potential to treat neuropathic pain,
epilepsy, Parkinson's disease levodopa-induced dyskinesia, suicidal
ideation and other CNS diseases and disorders where NMDA receptor
modulation and AMPA pathway activation may achieve therapeutic
benefits. The FDA has granted Fast Track designation to
AV-101 for development as a potential adjunctive treatment of
MDD.
About VistaGen
VistaGen Therapeutics, Inc. is a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other CNS diseases and disorders with high unmet
need.
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 of AV-101, the
potential of AV-101 for the treatment of MDD and various other CNS
diseases and disorders and our intellectual property and commercial
protection of AV-101 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. Among these risks is the
possibility that (i) we may encounter unexpected adverse events in
patients in our ELEVATE study that cause us to discontinue further
development of AV-101, (ii) we may not be able to successfully
demonstrate the safety and efficacy of AV-101 at each stage of
clinical development, (iii) success in preclinical studies or in
early-stage clinical trials may not be repeated or observed in
ongoing or future AV-101 studies, and ongoing or future preclinical
and clinical results may not support further development of AV-101
or be sufficient to gain regulatory approval to market AV-101, (iv)
decisions or actions of regulatory agencies may negatively affect
the progress of the ELEVATE study or the initiation, timing and
progress of future AV-101 clinical trials, and our ability to
proceed with further clinical studies or to obtain marketing
approval, (v) we may not be able to obtain or maintain adequate
intellectual property protection and other forms of marketing and
data exclusivity for AV-101, (vi) we may not have access to or be
able to secure substantial additional capital to support our
operations, including clinical development of AV-101 activities
described above; and (vii) we may encounter technical and
other unexpected hurdles in the manufacturing and development of
AV-101 or other 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, and subsequent quarterly reports
on Form 10-Q, 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.
Company ContactMark A. McPartland VistaGen
Therapeutics Inc. Phone: +1 (650) 577-3600
Email: IR@vistagen.com
Investor ContactValter Pinto / Allison Soss
KCSA Strategic Communications Phone: +1 (212) 896-1254/+1 (212)
896-1267 Email: VistaGen@KCSA.com
Media ContactCaitlin Kasunich / Lisa Lipson
KCSA Strategic Communications Phone: +1 (212) 896-1241/+1 (508)
843-6428 Email: VistaGen@KCSA.com
|
VISTAGEN THERAPEUTICS |
Consolidated Balance Sheets |
(Amounts in dollars, except share amounts) |
|
|
|
|
|
|
|
|
|
March 31, |
|
March 31, |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
ASSETS |
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
10,378,300 |
|
|
$ |
2,921,300 |
|
Prepaid
expenses and other current assets |
|
644,800 |
|
|
|
456,600 |
|
Total
current assets |
|
11,023,100 |
|
|
|
3,377,900 |
|
Property and equipment,
net |
|
207,400 |
|
|
|
286,500 |
|
Security deposits and
other assets |
|
47,800 |
|
|
|
47,800 |
|
Total
assets |
$ |
11,278,300 |
|
|
$ |
3,712,200 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
1,195,700 |
|
|
$ |
867,300 |
|
Accrued
expenses |
|
206,300 |
|
|
|
443,000 |
|
Current
notes payable |
|
53,900 |
|
|
|
54,800 |
|
Capital
lease obligations |
|
2,600 |
|
|
|
2,400 |
|
Total
current liabilities |
|
1,458,500 |
|
|
|
1,367,500 |
|
|
|
|
|
Non-current
liabilities: |
|
|
|
Accrued
dividends on Series B Preferred Stock |
|
2,608,300 |
|
|
|
1,577,800 |
|
Deferred
rent liability |
|
285,600 |
|
|
|
139,200 |
|
Capital
lease obligations |
|
9,300 |
|
|
|
11,900 |
|
Total
non-current liabilities |
|
2,903,200 |
|
|
|
1,728,900 |
|
Total
liabilities |
|
4,361,700 |
|
|
|
3,096,400 |
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
Preferred
stock, $0.001 par value; 10,000,000 shares authorized at March 31,
2018 and 2017: |
|
|
|
Series A
Preferred, 500,000 shares authorized, issued and outstanding at
March 31, 2018 and 2017 |
|
500 |
|
|
|
500 |
|
Series B
Preferred; 4,000,000 shares authorized at March 31, 2018 and 2017;
1,160,240 shares |
|
|
|
issued
and outstanding at March 31, 2018 and 2017 |
|
1,200 |
|
|
|
1,200 |
|
Series C
Preferred; 3,000,000 shares authorized at March 31, 2018 and 2017;
2,318,012 shares |
|
|
|
issued
and outstanding at March 31, 2018 and 2017 |
|
2,300 |
|
|
|
2,300 |
|
Common
stock, $0.001 par value; 100,000,000 and 30,000,000 shares
authorized at March 31, 2018 and |
|
|
|
March 31,
2017, respectively; 23,068,280 and 8,974,386 shares issued and
outstanding at March 31, 2018 |
|
|
|
and March
31, 2017, respectively |
|
23,100 |
|
|
|
9,000 |
|
Additional paid-in capital |
|
167,401,400 |
|
|
|
146,569,600 |
|
Treasury
stock, at cost, 135,665 shares of common stock held at March 31,
2018 and 2017 |
|
(3,968,100 |
) |
|
|
(3,968,100 |
) |
Accumulated deficit |
|
(156,543,800 |
) |
|
|
(141,998,700 |
) |
Total
stockholders’ equity |
|
6,916,600 |
|
|
|
615,800 |
|
Total
liabilities and stockholders’ equity |
$ |
11,278,300 |
|
|
$ |
3,712,200 |
|
|
|
|
|
|
VISTAGEN THERAPEUTICS |
CONSOLIDATED STATEMENT OF OPERATIONS AND
COMPREHENSIVE LOSS |
Amounts in Dollars, except share amounts |
|
|
|
|
|
|
|
|
|
Fiscal Years Ended March
31, |
|
2018 |
|
2017 |
Revenues: |
|
|
|
Sublicense revenue |
$ |
- |
|
|
$ |
1,250,000 |
|
Total
revenues |
|
- |
|
|
|
1,250,000 |
|
Operating
expenses: |
|
|
|
Research
and development |
|
7,762,500 |
|
|
|
5,203,700 |
|
General
and administrative |
|
6,437,100 |
|
|
|
6,294,800 |
|
Total
operating expenses |
|
14,199,600 |
|
|
|
11,498,500 |
|
Loss from
operations |
|
(14,199,600 |
) |
|
|
(10,248,500 |
) |
Other expenses,
net: |
|
|
|
Interest
expense, net |
|
(8,900 |
) |
|
|
(4,600 |
) |
Loss on
extinguishment of accounts payable |
|
(135,000 |
) |
|
|
- |
|
|
|
|
|
Loss before income
taxes |
|
(14,343,500 |
) |
|
|
(10,253,100 |
) |
Income taxes |
|
(2,400 |
) |
|
|
(2,400 |
) |
Net loss and
comprehensive loss |
|
(14,345,900 |
) |
|
|
(10,255,500 |
) |
|
|
|
|
Accrued
dividend on Series B Preferred stock |
|
(1,030,400 |
) |
|
|
(1,257,000 |
) |
Deemed
dividend from trigger of down round |
|
|
|
provision
feature |
|
(199,200 |
) |
|
|
- |
|
Deemed
dividend on Series B Preferred Units |
|
- |
|
|
|
(111,100 |
) |
|
|
|
|
Net loss attributable
to common stockholders |
$ |
(15,575,500 |
) |
|
$ |
(11,623,600 |
) |
|
|
|
|
Basic and diluted net
loss attributable to common |
|
|
|
stockholders per common share |
$ |
(1.12 |
) |
|
$ |
(1.54 |
) |
|
|
|
|
Weighted average shares
used in computing basic |
|
|
|
and
diluted net loss attributable to common |
|
|
|
stockholders per common share |
|
13,890,041 |
|
|
|
7,531,642 |
|
|
|
|
|
|
|
|
|
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