Price Graph
Price
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These terms and conditions govern your use of the website alphaminr.com and its related services.
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☑
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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Nevada
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20-5093315
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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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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Large accelerated filer
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[ ]
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Accelerated filer
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[ ]
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Non-Accelerated filer
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[ ]
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Smaller reporting company
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[X]
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Emerging growth company
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[ ]
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Page
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1
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2
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3
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4
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5
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19
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30
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31
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31
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69
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69
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69
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|
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|
|
|
70
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|
|
June 30,
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March 31,
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|
|
2020
|
2020
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|
|
(Unaudited)
|
(Note 2)
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ASSETS
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|
|
|
Current
assets:
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|
|
|
Cash
and cash equivalents
|
$
1,545,900
|
$
1,355,100
|
|
Prepaid
expenses and other current assets
|
633,000
|
225,100
|
|
Total
current assets
|
2,178,900
|
1,580,200
|
|
Property
and equipment, net
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184,200
|
209,600
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|
Right
of use asset - operating lease
|
3,492,100
|
3,579,600
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|
Deferred
offering costs
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263,900
|
355,100
|
|
Security
deposits and other assets
|
47,800
|
47,800
|
|
Total
assets
|
$
6,166,900
|
$
5,772,300
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|
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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
|
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
|
|
Financing
lease obligation - current portion
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3,400
|
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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|
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|
Non-current
portion of notes payable
|
124,700
|
-
|
|
Accrued
dividends on Series B Preferred Stock
|
5,347,600
|
5,011,800
|
|
Operating
lease obligation - non-current portion
|
3,631,100
|
3,715,600
|
|
Financing
lease obligation - non-current portion
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2,100
|
3,000
|
|
Total
non-current liabilities
|
9,105,500
|
8,730,400
|
|
Total
liabilities
|
11,778,600
|
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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||
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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
|
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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||
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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, $0.001 par value; 175,000,000 shares authorized at June 30,
2020 and March 31, 2020;
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||
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55,937,472
and 49,348,707 shares issued and outstanding at June 30, 2020 and
March 31, 2020, respectively
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Additional
paid-in capital
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203,330,700
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200,092,800
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Treasury
stock, at cost, 135,665 shares of common stock held at June 30,
2020 and March 31, 2020
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(3,968,100
)
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(3,968,100
)
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Accumulated
deficit
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(205,034,200
)
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(201,907,400
)
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Total
stockholders’ deficit
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(5,611,700
)
|
(5,729,400
)
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Total
liabilities and stockholders’ deficit
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$
6,166,900
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$
5,772,300
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Three Months Ended June 30,
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2020
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2019
|
|
Operating
expenses:
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|
Research
and development
|
$
1,731,200
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$
4,313,900
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General
and administrative
|
1,390,600
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1,910,100
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Total
operating expenses
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3,121,800
|
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
|
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
|
51,321,355
|
42,622,965
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Three Months Ended June 30,
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2020
|
2019
|
|
Cash
flows from operating activities:
|
|
|
|
Net
loss
|
$
(3,126,800
)
|
$
(6,209,900
)
|
|
Adjustments to reconcile net loss to net cash used in
operating activities:
|
|
|
|
Depreciation
and amortization
|
25,400
|
26,200
|
|
Stock-based
compensation
|
674,600
|
1,063,000
|
|
Amortization
of fair value of common stock issued for services
|
-
|
69,100
|
|
Amortization
of fair value of warrants issued for services
|
-
|
10,300
|
|
Changes
in operating assets and liabilities:
|
|
|
|
Receivable
from supplier
|
-
|
300,000
|
|
Prepaid
expenses and other current assets
|
39,200
|
(80,900
)
|
|
Right
of use asset - operating lease
|
87,500
|
81,700
|
|
Operating
lease liability
|
(72,200
)
|
(61,100
)
|
|
Accounts
payable and accrued expenses
|
(434,400
)
|
40,200
|
|
Net
cash used in operating activities
|
(2,806,700
)
|
(4,761,400
)
|
|
|
|
|
|
Cash
flows from property and investing activities:
|
|
|
|
Net
cash used in investing activities
|
-
|
-
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
Net
proceeds from issuance of common stock and warrants, including
Units
|
62,600
|
-
|
|
Expense
related to registration of shares underlying outstanding
warrants
|
(29,400
)
|
-
|
|
Net
proceeds from sale of common stock under equity line
|
2,790,600
|
-
|
|
Proceeds
from issuance of note under Payroll Protection Plan
|
224,400
|
-
|
|
Repayment
of capital lease obligations
|
(800
)
|
(700
)
|
|
Repayment
of notes payable
|
(49,900
)
|
(41,100
)
|
|
Net
cash provided by (used in) financing activities
|
2,997,500
|
(41,800
)
|
|
Net
increase (decrease) in cash and cash equivalents
|
190,800
|
(4,803,200
)
|
|
Cash
and cash equivalents at beginning of fiscal year
|
1,355,100
|
13,100,300
|
|
Cash
and cash equivalents at end of fiscal year
|
$
1,545,900
|
$
8,297,100
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of noncash activities:
|
|
|
|
Insurance
premiums settled by issuing note payable
|
$
322,200
|
$
230,200
|
|
Accrued
dividends on Series B Preferred
|
$
335,800
|
$
320,600
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Total
Stockholders’
|
|
|
Series A Preferred Stock
|
Series B Preferred Stock
|
Series C Preferred Stock
|
Common Stock
|
Paid-in
|
Treasury
|
Accumulated
|
Equity
|
||||
|
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Deficit
|
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at March 31, 2019
|
500,000
|
$
500
|
1,160,240
|
$
1,200
|
2,318,012
|
$
2,300
|
42,758,630
|
$
42,800
|
$
192,129,900
|
$
(3,968,100
)
|
$
(181,133,400
)
|
$
7,075,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued
dividends on Series B Preferred stock
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(302,500
)
|
-
|
-
|
(302,500
)
|
|
Stock-based
compensation expense
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,063,000
|
-
|
-
|
1,063,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the quarter ended June 30, 2019
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(6,209,900
)
|
(6,209,900
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at June 30, 2019
|
500,000
|
$
500
|
1,160,240
|
$
1,200
|
2,318,012
|
$
2,300
|
42,758,630
|
$
42,800
|
$
192,890,400
|
$
(3,968,100
)
|
$
(187,343,300
)
|
$
1,625,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at March 31, 2020
|
500,000
|
$
500
|
1,160,240
|
$
1,200
|
2,318,012
|
$
2,300
|
49,348,707
|
$
49,300
|
$
200,092,800
|
$
(3,968,100
)
|
$
(201,907,400
)
|
$
(5,729,400
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from sale of units of common stock and warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for
cash in private placement
|
-
|
-
|
-
|
-
|
-
|
-
|
125,000
|
200
|
49,800
|
-
|
-
|
50,000
|
|
Net
proceeds from sale of common stock under equity line
|
-
|
-
|
-
|
-
|
-
|
-
|
6,201,995
|
6,200
|
2,741,300
|
-
|
-
|
2,747,500
|
|
Issuance
of common stock at fair value for professional
services
|
-
|
-
|
-
|
-
|
-
|
-
|
233,645
|
200
|
124,800
|
-
|
-
|
125,000
|
|
Sale
of common stock pursuant to 2019 Employee Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
Plan
|
-
|
-
|
-
|
-
|
-
|
-
|
28,125
|
-
|
12,600
|
-
|
-
|
12,600
|
|
Expenses
related to S-3 registration statement for shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
underlying
outstanding warrants
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(29,400
)
|
-
|
-
|
(29,400
)
|
|
Accrued
dividends on Series B Preferred stock
|
|
|
|
|
|
|
-
|
-
|
(335,800
)
|
-
|
-
|
(335,800
)
|
|
Stock-based
compensation expense
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
674,600
|
-
|
-
|
674,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the quarter ended June 30, 2020
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(3,126,800
)
|
(3,126,800
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at June 30, 2020
|
500,000
|
$
500
|
1,160,240
|
$
1,200
|
2,318,012
|
$
2,300
|
55,937,472
|
$
55,900
|
$
203,330,700
|
$
(3,968,100
)
|
$
(205,034,200
)
|
$
(5,611,700
)
|
|
|
Three Months Ended June 30,
|
|
|
|
2020
|
2019
|
|
|
|
|
|
Research
and development expense
|
$
226,600
|
$
390,600
|
|
General
and administrative expense
|
448,000
|
672,400
|
|
Total
stock-based compensation expense
|
$
674,600
|
$
1,063,000
|
|
Assumption:
|
Weighted
Average
|
Range
|
|
Market
price per share at grant date
|
$
0.41
|
$
0.40 to 0.54
|
|
Exercise
price per share
|
$
0.41
|
$
0.40 to 0.55
|
|
Risk-free
interest rate
|
0.39
%
|
0.35%
to 0.44
%
|
|
Expected
term in years
|
5.36
|
5.20 to
5.94
|
|
Volatility
|
84.10
%
|
82.93%
to 85.85
%
|
|
Dividend
rate
|
0.0
%
|
0.0
%
|
|
Shares
|
1,945,000
|
|
|
|
|
|
|
Fair Value per share
|
$
0.28
|
|
|
|
At June 30,
|
At March 31,
|
|
|
2020
|
2020
|
|
|
|
|
|
Series A Preferred stock issued and
outstanding
(1)
|
750,000
|
750,000
|
|
Series B Preferred stock issued and
outstanding
(2)
|
1,160,240
|
1,160,240
|
|
Series C Preferred stock issued and
outstanding
(3)
|
2,318,012
|
2,318,012
|
|
Outstanding
options under the Company's Amended and Restated 2016 (formerly
2008) Stock Incentive Plan and 2019 Omnibus Equity Incentive
Plan
|
11,948,088
|
10,003,088
|
|
Outstanding
warrants to purchase common stock
|
26,589,834
|
26,555,281
|
|
Total
|
42,766,174
|
40,786,621
|
|
____________
|
|
|
|
|
June 30,
|
March 31,
|
|
|
2020
|
2020
|
|
|
|
|
|
Clinical
and nonclinical materials and contract services
|
$
115,200
|
$
115,200
|
|
Fair
value of securities issued for professional services
|
125,000
|
-
|
|
Insurance
|
391,200
|
107,200
|
|
All
other
|
1,600
|
2,700
|
|
|
$
633,000
|
$
225,100
|
|
|
June 30,
|
March 31,
|
|
|
2020
|
2020
|
|
|
|
|
|
Laboratory
equipment
|
$
892,500
|
$
892,500
|
|
Tenant
improvements
|
214,400
|
214,400
|
|
Computers
and network equipment
|
54,600
|
54,600
|
|
Office
furniture and equipment
|
84,600
|
84,600
|
|
|
1,246,100
|
1,246,100
|
|
Accumulated
depreciation and amortization
|
(1,061,900
)
|
(1,036,500
)
|
|
Property
and equipment, net
|
$
184,200
|
$
209,600
|
|
|
June 30,
|
March 31,
|
|
|
2020
|
2020
|
|
|
|
|
|
Office
equipment subject to financing lease
|
$
14,700
|
$
14,700
|
|
Accumulated
depreciation
|
(10,100
)
|
(9,400
)
|
|
Net
book value of ofice equipment subject to
|
|
|
|
financing
lease
|
$
4,600
|
$
5,300
|
|
|
June 30,
|
March 31,
|
|
|
2020
|
2020
|
|
Accrued
expenses for clinical and nonclinical
|
|
|
|
materials,
development and contract services
|
$
397,100
|
$
462,300
|
|
Accrued
professional services
|
194,600
|
76,500
|
|
All
other
|
16,100
|
22,700
|
|
|
$
607,800
|
$
561,500
|
|
|
June 30, 2020
|
March 31, 2020
|
||||
|
|
Principal
|
Accrued
|
|
Principal
|
Accrued
|
|
|
|
Balance
|
Interest
|
Total
|
Balance
|
Interest
|
Total
|
|
|
|
|
|
|
|
|
|
7.30%
and 6.30% Notes payable
|
|
|
|
|
|
|
|
to
insurance premium financing company (current)
|
$
328,800
|
$
-
|
$
328,800
|
$
56,500
|
$
-
|
$
56,500
|
|
|
|
|
|
|
|
|
|
1% Note
payable under Paycheck Protection Program
|
224,400
|
400
|
224,800
|
-
|
-
|
-
|
|
less:
current portion
|
(99,700
)
|
(400
)
|
(100,100
)
|
-
|
-
|
-
|
|
|
|
|
|
|
|
|
|
Non-current
portion
|
$
124,700
|
$
-
|
$
124,700
|
$
-
|
$
-
|
$
-
|
|
|
|
|
|
|
|
|
|
Total
current notes payable
|
$
428,500
|
$
400
|
$
428,900
|
$
56,500
|
$
-
|
$
56,500
|
|
|
|
Warrants
|
Warrants
|
|
Exercise
|
|
Outstanding at
|
Exercisable at
|
|
Price
|
Expiration
|
June 30,
|
June 30,
|
|
per Share
|
Date
|
2020
|
2020
|
|
|
|
|
|
|
$
0.50
|
3/25/2021
to 4/30/2024
|
8,151,312
|
8,026,312
|
|
$
0.73
|
7/25/2025
|
3,870,077
|
-
|
|
$
0.805
|
12/31/2022
|
80,431
|
80,431
|
|
$
1.50
|
12/13/2022
|
9,596,200
|
9,596,200
|
|
$
1.82
|
3/7/2023
|
1,388,931
|
1,388,931
|
|
$
3.51
|
12/31/2021
|
50,000
|
50,000
|
|
$
5.30
|
5/16/2021
|
2,705,883
|
2,705,883
|
|
$
7.00
|
9/2/2020
to 3/3/2023
|
747,000
|
747,000
|
|
|
|
|
|
|
|
26,589,834
|
22,594,757
|
|
|
|
As of June 30, 2020
|
As of March 31, 2020
|
|
Assets
|
|
|
|
Right
of use asset – operating lease
|
$
3,492,100
|
$
3,579,600
|
|
|
|
|
|
Liabilities
|
|
|
|
Current
operating lease obligation
|
$
325,700
|
$
313,400
|
|
Non-current
operating lease obligation
|
3,631,100
|
3,715,600
|
|
Total
operating lease liability
|
$
3,956,800
|
$
4,029,000
|
|
|
For the Three Months Ended
|
For the Three Months Ended
|
|
|
June 30, 2020
|
June 30, 2019
|
|
Operating
lease cost
|
$
212,800
|
$
208,800
|
|
Fiscal Years Ending March 31,
|
|
|
2021
(remaining nine months)
|
$
488,000
|
|
2022
|
668,400
|
|
2023
|
726,000
|
|
2024
|
766,000
|
|
2025
|
789,000
|
|
Thereafter
|
1,931,400
|
|
Total
lease expense
|
5,368,800
|
|
Less
imputed interest
|
(1,412,000
)
|
|
Present
value of operating lease liabilities
|
$
3,956,800
|
|
|
As of June 30, 2020
|
|
Assumed
remaining lease term in years
|
7.08
|
|
Assumed
discount rate
|
8.54
%
|
|
|
For the Three Months Ended
|
For the Three Months Ended
|
|
|
June 30, 2020
|
June 30, 2019
|
|
Cash
paid for amounts included in the measurement of lease
liabilities
|
$
197,500
|
$
188,200
|
|
Item 2.
|
|
M
A
NAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
|
|
Three Months Ended June 30,
|
|
|
|
2020
|
2019
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research
and development
|
$
1,731
|
$
4,314
|
|
General
and administrative
|
1,391
|
1,910
|
|
Total
operating expenses
|
3,122
|
6,224
|
|
|
|
|
|
Loss
from operations
|
(3,122
)
|
(6,224
)
|
|
|
|
|
|
Interest
income (expense), net
|
(3
)
|
16
|
|
Other
income
|
1
|
-
|
|
|
|
|
|
Loss
before income taxes
|
(3,124
)
|
(6,208
)
|
|
Income
taxes
|
(3
)
|
(2
)
|
|
|
|
|
|
Net
loss
|
(3,127
)
|
(6,210
)
|
|
Accrued
dividends on Series B Preferred Stock
|
(336
)
|
(302
)
|
|
Net
loss attributable to common stockholders
|
$
(3,463
)
|
$
(6,512
)
|
|
|
Three Months Ended June 30,
|
|
|
|
2020
|
2019
|
|
|
|
|
|
Salaries
and benefits
|
$
348
|
$
340
|
|
Stock-based
compensation
|
227
|
391
|
|
Consulting
and other professional services
|
93
|
136
|
|
Technology
licenses and royalties
|
108
|
167
|
|
Project-related
research, licenses and supplies:
|
|
|
|
Elevate
study and other AV-101 expenses
|
165
|
2,666
|
|
PH94B
and PH10 project expenses
|
635
|
424
|
|
Stem
cell and all other
|
5
|
42
|
|
|
805
|
3,132
|
|
Rent
|
138
|
136
|
|
Depreciation
|
12
|
12
|
|
|
|
|
|
Total
Research and Development Expense
|
$
1,731
|
$
4,314
|
|
|
Three Months Ended June 30,
|
|
|
|
2020
|
2019
|
|
|
|
|
|
Salaries
and benefits
|
$
348
|
$
344
|
|
Stock-based
compensation
|
448
|
672
|
|
Board
fees
|
46
|
46
|
|
Legal,
accounting and other professional fees
|
195
|
279
|
|
Investor
and public relations
|
112
|
304
|
|
Insurance
|
102
|
82
|
|
Travel
expenses
|
4
|
30
|
|
Rent
and utilities
|
90
|
90
|
|
All
other expenses
|
46
|
63
|
|
|
$
1,391
|
$
1,910
|
|
|
Three Months Ended June 30,
|
|
|
|
2020
|
2019
|
|
|
|
|
|
Interest
income
|
$
-
|
$
19
|
|
Interest
expense on financing lease, insurance premium financing
notes
|
|
|
|
and
Payroll Protection Program loan
|
(3
)
|
(3
)
|
|
Interest
income (expense), net
|
$
(3
)
|
$
16
|
|
|
Three Months Ended June 30,
|
|
|
|
2020
|
2019
|
|
|
|
|
|
Net
cash used in operating activities
|
$
(2,807
)
|
$
(4,761
)
|
|
Net
cash used in investing activities
|
-
|
-
|
|
Net
cash provided by (used in) financing activities
|
2,998
|
(42
)
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents
|
191
|
(4,803
)
|
|
Cash
and cash equivalents at beginning of period
|
1,355
|
13,100
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
$
1,546
|
$
8,297
|
|
Item 4.
|
|
C
O
NTROLS AND PROCEDURES
|
|
|
●
|
Delayed product development:
We have, and may continue
to face delays and other disruptions to our ongoing clinical
development programs for PH94B, PH10 and AV-101 due to the ongoing
COVID-19 pandemic. In addition, regulatory oversight and actions
regarding our products may be disrupted or delayed in regions
impacted by COVID-19, including the U.S. and
elsewhere, which may impact review and approval timelines for our
product candidates in various stages of development. Although
we remain focused on advancing our clinical development programs
for our current product candidates, our research and development
efforts may be impacted if our employees, our contract research
organizations (
CROs
) or our
third-party contract development and manufacturing organizations
(
CDMOs
) have reductions in
force or are advised to continue to work remotely as part of social
distancing measures or other protective measures necessitated by
the COVID-19 pandemic.
|
|
|
●
|
Negative impacts on our suppliers, manufacturers and
employees
: COVID-19 or similar infectious diseases has
impacted and may in the future impact the health of our employees,
contractors, suppliers, CROs or CDMOs, or reduce the availability
of our workforce or the workforce of one or more of the companies
with which we do business, divert our attention toward succession
planning, or create disruptions in our supply or distribution
networks. Since the beginning of the COVID-19 pandemic, we have
experienced delays of the delivery of supplies of active
pharmaceutical ingredient (
API
or
drug substance
) and formulated drug
product required to advance development of PH94B and PH10. Although
our supply of raw materials and API remains sufficiently
operational, we may experience adverse effects of such events in
the future, which may result in a significant, material delay of or
disruption to our clinical development programs, and our
operations. Additionally, having shifted to remote working
arrangements, we also face a heightened risk of cybersecurity
attacks or data security incidents and are more dependent on
internet and telecommunications access and
capabilities.
|
|
●
|
if we submit a NDA and it is reviewed by a FDA advisory committee,
the FDA may have difficulties scheduling an advisory committee
meeting in a timely manner or the advisory committee may recommend
against approval of our application or may recommend that the FDA
require, as a condition of approval, additional nonclinical or
clinical studies, limitations on approved labeling or distribution
and use restrictions;
|
|
●
|
a FDA advisory committee may recommend, or the FDA may require, a
Risk Evaluation and Mitigation Strategies (
REMS
) safety program as a condition of approval or
post-approval;
|
|
●
|
a FDA advisory committee or the FDA or applicable regulatory agency
may determine that there is insufficient evidence of overall
effectiveness or safety in a NDA and require additional clinical
studies;
|
|
●
|
the FDA or the applicable foreign regulatory agency may determine
that the manufacturing processes or facilities of third-party
contract manufacturers with which we contract do not conform to
applicable requirements, including current Good Manufacturing
Practices (
cGMPs
); or
|
|
●
|
the FDA or applicable foreign regulatory agency may change its
approval policies or adopt new regulations.
|
|
●
|
delays due to events resulting from the ongoing COVID-19
pandemic;
|
|
●
|
the regulatory authority may deny permission to proceed with
planned clinical trials or any other clinical trials we may
initiate, or may place a planned or ongoing clinical trial on
hold;
|
|
●
|
delays in filing or receiving approvals from regulatory authorities
of additional INDs that may be required;
|
|
●
|
negative or ambiguous results from nonclinical or clinical
studies;
|
|
●
|
delays in reaching or failing to reach agreement on acceptable
terms with prospective CROs, investigators and clinical trial
sites, the terms of which can be subject to extensive negotiation
and may vary significantly among different CROs, investigators and
clinical trial sites;
|
|
●
|
delays in the manufacturing of, or insufficient supply of product
candidates necessary to conduct nonclinical or clinical trials,
including delays in the manufacturing of sufficient supply of drug
substance or finished drug product;
|
|
●
|
inability to manufacture or obtain clinical supplies of a product
candidate meeting required quality standards;
|
|
●
|
difficulties obtaining Institutional Review Board
(
IRB
) approval to conduct a clinical trial at a
prospective clinical site or sites;
|
|
●
|
challenges in recruiting and enrolling patients to participate in
clinical trials, including the proximity of patients to clinical
trial sites;
|
|
●
|
eligibility criteria for a clinical trial, the nature of a clinical
trial protocol, the availability of approved effective treatments
for the relevant disease and competition from other clinical trial
programs for similar indications;
|
|
●
|
severe or unexpected adverse drug-related side effects experienced
by patients in a clinical trial;
|
|
●
|
delays in validating any endpoints utilized in a clinical
trial;
|
|
●
|
the regulatory authority may disagree with our clinical trial
design and our interpretation of data from prior nonclinical
studies or clinical trials, or may change the requirements for
approval even after it has reviewed and commented on the design for
our clinical trials;
|
|
●
|
reports from nonclinical or clinical testing of other CNS
indications or therapies that raise safety or efficacy concerns;
and
|
|
●
|
difficulties retaining patients who have enrolled in a clinical
trial but may be prone to withdraw due to rigors of the clinical
trial, lack of efficacy, side effects, personal issues or loss of
interest.
|
|
●
|
failure to conduct the clinical trial in accordance with regulatory
requirements or approved clinical protocols;
|
|
●
|
inspection of the clinical trial operations or trial sites by the
regulatory authority that reveals deficiencies or violations that
require us to undertake corrective action, including the imposition
of a clinical hold;
|
|
●
|
unforeseen safety issues, including any that could be identified in
nonclinical carcinogenicity studies, adverse side effects or lack
of effectiveness;
|
|
●
|
changes in government regulations or administrative
actions;
|
|
●
|
problems with clinical supply materials that may lead to regulatory
actions; and
|
|
●
|
lack of adequate funding to continue nonclinical or clinical
studies.
|
|
●
|
experience disruptions to their operations, such as reduced
staffing and supply chain disruptions, as a result of the ongoing
COVID-19 pandemic;
|
|
●
|
have staffing difficulties and/or undertake obligations beyond
their anticipated capabilities and resources;
|
|
●
|
fail to comply with contractual obligations;
|
|
●
|
experience regulatory compliance issues;
|
|
●
|
undergo changes in priorities or become financially distressed;
or
|
|
●
|
form relationships with other entities, some of which may be our
competitors.
|
|
●
|
the efficacy and safety of our product candidates as demonstrated
in clinical trials, and, if required by any applicable regulatory
authority in connection with the approval for the applicable
indications, to provide patients with incremental health benefits,
as compared with other available therapies;
|
|
●
|
limitations or warnings contained in the labeling approved for our
product candidates by the FDA or other applicable regulatory
authorities;
|
|
●
|
the clinical indications for which our product candidates are
approved;
|
|
●
|
availability of alternative treatments already approved or expected
to be commercially launched in the near future;
|
|
●
|
the potential and perceived advantages of our product candidates
over current treatment options or alternative treatments, including
future alternative treatments;
|
|
●
|
the willingness of the target patient population to try new
therapies and of physicians to prescribe these
therapies;
|
|
●
|
the strength of marketing and distribution support and timing of
market introduction of competitive products;
|
|
●
|
publicity concerning our products or competing products and
treatments;
|
|
●
|
pricing and cost effectiveness;
|
|
●
|
the effectiveness of our sales and marketing
strategies;
|
|
●
|
our ability to increase awareness of our product candidates through
marketing efforts;
|
|
●
|
our ability to obtain sufficient third-party coverage or
reimbursement; or
|
|
●
|
the willingness of patients to pay out-of-pocket in the absence of
third-party coverage.
|
|
●
|
regulatory authorities may withdraw or limit their approval of such
product candidates;
|
|
●
|
regulatory authorities may require the addition of labeling
statements, such as a “black box” warning or a
contraindication;
|
|
●
|
we may be required to change the way such product candidates are
distributed or administered, conduct additional clinical trials or
change the labeling of the product candidates;
|
|
●
|
we may be subject to regulatory investigations and government
enforcement actions;
|
|
●
|
we may decide to remove such product candidates from the
marketplace;
|
|
●
|
we could be sued and held liable for injury caused to individuals
exposed to or taking our product candidates; and
|
|
●
|
our reputation may suffer.
|
|
●
|
issue warning letters or untitled letters;
|
|
●
|
seek an injunction or impose civil or criminal penalties or
monetary fines;
|
|
●
|
suspend or withdraw marketing approval;
|
|
●
|
suspend any ongoing clinical trials;
|
|
●
|
refuse to approve pending applications or supplements to
applications submitted by us;
|
|
●
|
suspend or impose restrictions on operations, including costly new
manufacturing requirements; or
|
|
●
|
seize or detain products, refuse to permit the import or export of
products, or require that we initiate a product
recall.
|
|
●
|
The federal anti-kickback statute prohibits, among other things,
persons from knowingly and willfully soliciting, offering,
receiving or providing remuneration, directly or indirectly, in
cash or in kind, to induce or reward either the referral of an
individual for, or the purchase, order or recommendation of, any
good or service, for which payment may be made under federal
healthcare programs such as Medicare and Medicaid.
|
|
●
|
The federal False Claims Act imposes criminal and civil penalties,
including those from civil whistleblower or qui tam actions,
against individuals or entities for knowingly presenting, or
causing to be presented, to the federal government, claims for
payment that are false or fraudulent or making a false statement to
avoid, decrease, or conceal an obligation to pay money to the
federal government.
|
|
●
|
The federal Health Insurance Portability and Accountability Act of
1996, as amended by the Health Information Technology for Economic
and Clinical Health Act, imposes criminal and civil liability for
executing a scheme to defraud any healthcare benefit program and
also imposes obligations, including mandatory contractual terms,
with respect to safeguarding the privacy, security and transmission
of individually identifiable health information.
|
|
●
|
The federal false statements statute prohibits knowingly and
willfully falsifying, concealing or covering up a material fact or
making any materially false statement in connection with the
delivery of or payment for healthcare benefits, items or
services.
|
|
●
|
The federal transparency requirements, sometimes referred to as the
“Sunshine Act,” under the Patient Protection and
Affordable Care Act, require manufacturers of drugs, devices,
biologics and medical supplies that are reimbursable under
Medicare, Medicaid, or the Children’s Health Insurance
Program to report to the Department of Health and Human Services
information related to physician payments and other transfers of
value and physician ownership and investment
interests.
|
|
●
|
Analogous state laws and regulations, such as state anti-kickback
and false claims laws and transparency laws, may apply to sales or
marketing arrangements and claims involving healthcare items or
services reimbursed by non-governmental third-party payors,
including private insurers, and some state laws require
pharmaceutical companies to comply with the pharmaceutical
industry’s voluntary compliance guidelines and the relevant
compliance.
|
|
●
|
Guidance promulgated by the federal government in addition to
requiring drug manufacturers to report information related to
payments to physicians and other healthcare providers or marketing
expenditures and drug pricing.
|
|
●
|
Foreign
Corrupt Practices Act and its application to marketing and selling
practices as well as to clinical trials.
|
|
●
|
our customers’ ability to obtain reimbursement for our
product candidates in foreign markets;
|
|
●
|
our inability to directly control commercial activities because we
are relying on third parties;
|
|
●
|
the burden of complying with complex and changing foreign
regulatory, tax, accounting and legal requirements;
|
|
●
|
different medical practices and customs in foreign countries
affecting acceptance in the marketplace;
|
|
●
|
import or export licensing requirements;
|
|
●
|
longer accounts receivable collection times;
|
|
●
|
longer lead times for shipping;
|
|
●
|
language barriers for technical training;
|
|
●
|
reduced protection of intellectual property rights, different
standards of patentability and different availability of prior art
in some foreign countries as compared with the U.S.;
|
|
●
|
the existence of additional potentially relevant third party
intellectual property rights;
|
|
●
|
foreign currency exchange rate fluctuations; and
|
|
●
|
the interpretation of contractual provisions governed by foreign
laws in the event of a contract dispute.
|
|
●
|
develop and obtain required regulatory approvals for
commercialization of PH94B, PH10, AV-101 and/or other product
candidates;
|
|
●
|
maintain, leverage and expand our intellectual property
portfolio;
|
|
●
|
establish and maintain sales, distribution and marketing
capabilities, and/or enter into strategic partnering arrangements
to access such capabilities;
|
|
●
|
gain market acceptance for our product candidates; and
|
|
●
|
obtain adequate capital resources and manage our spending as costs
and expenses increase due to research, production, development,
regulatory approval and commercialization of product
candidates.
|
|
●
|
our ability to identify potential candidates in the public domain,
obtain sufficient quantities of them, and assess them using our
bioassay systems;
|
|
●
|
if we seek to rescue drug candidates that are not available to us
in the public domain, the extent to which third parties may be
willing to out-license or sell certain candidates to us on
commercially reasonable terms;
|
|
●
|
our medicinal chemistry collaborator’s ability to design and
produce proprietary NCEs based on the novel biology and
structure-function insight we provide
using
CardioSafe
3D;
and
|
|
●
|
financial resources available to us to develop and commercialize
lead NCEs internally, or, if we sell or out-license them to
partners, the resources such partners choose to dedicate to
development and commercialization of any NCEs they acquire or
license from us.
|
|
●
|
initiate and successfully complete nonclinical and clinical trials
that meet their prescribed endpoints;
|
|
●
|
initiate and successfully complete all safety studies required to
obtain U.S. and foreign marketing approval for our product
candidates;
|
|
●
|
timely complete and compose successful regulatory submissions such
as NDAs or comparable documents for both the U.S. and foreign
jurisdictions;
|
|
●
|
commercialize our product candidates, if approved, by developing a
sales force or entering into collaborations with third parties for
sales and marketing capabilities; and
|
|
●
|
achieve market acceptance of our product candidates in the medical
community and with third-party payors.
|
|
●
|
the number and characteristics of the product candidates we
pursue;
|
|
●
|
the scope, progress, results and costs of researching and
developing our product candidates, and conducting preclinical and
clinical studies;
|
|
●
|
the timing of, and the costs involved in, obtaining regulatory
approvals for our product candidates;
|
|
●
|
the cost of commercialization activities if any of our product
candidates are approved for sale, including marketing, sales and
distribution costs;
|
|
●
|
the cost of manufacturing and formulating our product candidates
and any products we successfully commercialize;
|
|
●
|
our ability to establish and maintain strategic partnerships,
licensing or other collaborative arrangements and the financial
terms of such agreements;
|
|
●
|
market acceptance of our product candidates;
|
|
●
|
the effect of competing technological and market
developments;
|
|
●
|
our ability to obtain government funding for our research and
development programs;
|
|
●
|
the costs involved in obtaining, maintaining and enforcing patents
to preserve our intellectual property;
|
|
●
|
the costs involved in defending against such claims that we
infringe third-party patents or violate other intellectual property
rights and the outcome of such litigation;
|
|
●
|
the timing, receipt and amount of potential future licensee fees,
milestone payments, and sales of, or royalties on, our future
products, if any; and
|
|
●
|
the extent to which we may acquire or invest in additional
businesses, product candidates and technologies.
|
|
●
|
decreased demand for product candidates that we may
develop;
|
|
●
|
injury to our reputation;
|
|
●
|
withdrawal of clinical trial participants;
|
|
●
|
costs to defend the related litigation;
|
|
●
|
a diversion of management's time and our resources;
|
|
●
|
substantial monetary awards to trial participants or patients;
or
|
|
●
|
product recalls, withdrawals or labeling, marketing or promotional
restrictions.
|
|
●
|
any issued patents related to PH94B, PH10, AV-101 or any
pending patent applications, if issued and challenged by others,
will include or maintain claims having a scope sufficient to
protect PH94B, PH10, AV-101 or any other products or product
candidates against generic or other competition, particularly
considering that any patent rights to these compounds
per se
have expired;
|
|
●
|
any of our pending patent applications will issue as patents at
all;
|
|
●
|
we will be able to successfully commercialize our product
candidates, if approved, before our relevant patents
expire;
|
|
●
|
we were the first to make the inventions covered by each of our
patents and pending patent applications;
|
|
●
|
we were the first to file patent applications for these
inventions;
|
|
●
|
others will not develop similar or alternative technologies that do
not infringe our patents;
|
|
●
|
others will not use pre-existing technology to effectively compete
against us;
|
|
●
|
any of our patents, if issued, will ultimately be found to be valid
and enforceable, including on the basis of prior art relating to
our patent applications and patents;
|
|
●
|
any patents currently held or issued to us in the future will
provide a basis for an exclusive market for our commercially viable
products, will provide us with any competitive advantages or will
not be challenged by third parties;
|
|
●
|
we will develop additional proprietary technologies or product
candidates that are separately patentable; or
|
|
●
|
our commercial activities or products will not infringe upon the
patents or proprietary rights of others.
|
|
●
|
cease developing, selling or otherwise commercializing our product
candidates;
|
|
●
|
pay substantial damages for past use of the asserted intellectual
property;
|
|
●
|
obtain a license from the holder of the asserted intellectual
property, which license may not be available on reasonable terms,
if at all; and
|
|
●
|
in the case of trademark claims, redesign, or rename, some or all
of our product candidates to avoid infringing the intellectual
property rights of third parties, which may not be possible and,
even if possible, could be costly and time-consuming.
|
|
●
|
the scope of rights granted under the license agreement and other
interpretation-related issues;
|
|
●
|
whether and the extent to which our technology and processes
infringe on intellectual property of the licensor that is not
subject to the licensing agreement;
|
|
●
|
our right to sublicense patent and other rights to third parties
under collaborative development relationships;
|
|
●
|
our diligence obligations with respect to the use of the licensed
technology in relation to our development and commercialization of
our product candidates, and what activities satisfy those diligence
obligations; and
|
|
●
|
the ownership of inventions and know-how resulting from the joint
creation or use of intellectual property by our licensors and us
and our partners.
|
|
●
|
others may be able to develop and/or practice technology that is
similar to our technology or aspects of our technology but that is
not covered by the claims of patents, should such patents issue
from our patent applications;
|
|
●
|
we might not have been the first to make the inventions covered by
a pending patent application that we own;
|
|
●
|
we might not have been the first to file patent applications
covering an invention;
|
|
●
|
others may independently develop similar or alternative
technologies without infringing our intellectual property
rights;
|
|
●
|
pending patent applications that we own or license may not lead to
issued patents;
|
|
●
|
patents, if issued, that we own or license may not provide us with
any competitive advantages, or may be held invalid or unenforceable
or be narrowed, as a result of legal challenges by our
competitors;
|
|
●
|
third parties may compete with us in jurisdictions where we do not
pursue and obtain patent protection;
|
|
●
|
we may not be able to obtain and/or maintain necessary or useful
licenses on reasonable terms or at all; and
|
|
●
|
the patents of others may have an adverse effect on our
business.
|
|
●
|
volatility resulting from uncertainty and general ecomnic
conditions caused by the ongoing COVID-19 pandemic;
|
|
●
|
plans for, progress of or results from nonclinical and clinical
development activities related to our product
candidates;
|
|
●
|
the failure of the FDA or other regulatory authority to approve our
product candidates;
|
|
●
|
announcements of new products, technologies, commercial
relationships, acquisitions or other events by us or our
competitors;
|
|
●
|
the success or failure of other CNS therapies;
|
|
●
|
regulatory or legal developments in the U.S. and other
countries;
|
|
●
|
announcements regarding our intellectual property
portfolio;
|
|
●
|
failure of our product candidates, if approved, to achieve
commercial success;
|
|
●
|
fluctuations in stock market prices and trading volumes of similar
companies;
|
|
●
|
general market conditions and overall fluctuations in U.S. equity
markets;
|
|
●
|
variations in our quarterly operating results;
|
|
●
|
changes in our financial guidance or securities analysts’
estimates of our financial performance;
|
|
●
|
changes in accounting principles;
|
|
●
|
our ability to raise additional capital and the terms on which we
can raise it;
|
|
●
|
sales or purchases of large blocks of our common stock, including
sales or purchases by our executive officers, directors and
significant stockholders;
|
|
●
|
establishment
of short positions by holders or non-holders of our stock or
warrants;
|
|
●
|
additions or departures of key personnel;
|
|
●
|
discussion of us or our stock price by the press and by online
investor communities; and
|
|
●
|
other risks and uncertainties described in these risk
factors.
|
|
Exhibit
|
|
|
|
Number
|
|
Description
|
|
|
|
|
| 1.1 |
|
Underwriting Agreement, dated August 2, 2020, by and between
VistaGen Therapeutics, Inc. and Maxim Group LLC, incorporated by
reference from Exhibit 1.1 to the Company's Current Report on Form
8-K filed on August 6, 2020.
|
|
|
|
|
|
|
Note
Payable Agreement by and between VistaGen Therapeutics, Inc and
Silicon Valley Bank, incorporated by reference from Exhibit 10.1 to
the Company’s Current Report on Form 8-K filed on April 27,
2020.
|
|
|
|
|
|
|
|
L
icense and Collaboration
Agreement, by and between VistaGen Therapeutics, Inc. and
EverInsight Therapeutics Inc., dated June 24, 2020, filed
herewith.
|
|
|
|
|
|
|
|
Certification of the Principal Executive Officer required by
Rule 13a-14(a) under the Securities Exchange Act of 1934, as
amended, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
Certification of the Principal Financial Officer required by
Rule 13a-14(a) under the Securities Exchange Act of 1934, as
amended, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
Certification of the Principal Executive and Financial Officers
required by Rule 13a-14(b) and Section 1350 of
Chapter 63 of Title 18 of the United States Code, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
|
|
|
|
|
|
|
|
VISTAGEN THERAPEUTICS, INC.
/s/
Shawn K. Singh
Shawn K. Singh
Chief Executive Officer (Principal Executive Officer)
|
|
||
|
|
/s/
Jerrold D. Dotson
|
|
||
|
|
Jerrold D. Dotson
|
|
||
|
|
Chief Financial Officer (Principal Financial and Accounting
Officer)
|
|
||
|
|
||||
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|