form10q.htm
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
_______________________________
FORM
10 - Q
_______________________________
QUARTERLY REPORT UNDER
SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT
OF 1934.
For
the quarterly period ended September 30, 2009
Commission
File Number: 333-148471
NANOVIRICIDES,
INC.
(Exact
name of registrant as specified in its charter)
NEVADA
|
76-0674577
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(State
or other jurisdiction)
|
(IRS
Employer Identification No.)
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of
incorporation or organization)
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|
135
Wood Street, Suite 205
West
Haven, Connecticut 06516
(Address
of principal executive offices and zip code)
(203)
937-6137
(Registrant’s telephone number,
including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months
(or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days.
Yes Q No
¨
Indicate by check mark whether the registrant has
submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or
for such shorter period that the registrant
was required to submit and post such files).
Yes o No
x (Not required by
smaller reporting companies)
Indicate
by check mark whether the registrant is a larger accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange Act. (Check
one)
Large
accelerated
filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer
¨
|
Smaller
reporting company Q
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes ¨ No
Q
The
number of shares outstanding of the Registrant's Common Stock as of November
20, 2009 was
131,774,554 shares.
(A
Development Stage Company)
FORM
10-Q
INDEX
PART
I FINANCIAL INFORMATION
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Item
1. Financial Statements
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PART
II OTHER INFORMATION
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(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEETS
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September 30,
2009
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(Unaudited)
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June 30,
2009
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ASSETS
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CURRENT
ASSETS:
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Cash
and cash equivalents
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$ |
4,202,675 |
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$ |
1,689,442 |
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Prepaid
expenses
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327,770 |
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321,545 |
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Other
current assets
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109,312 |
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109,312 |
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Total
current assets
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4,639,757 |
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2,120,299 |
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Property
and equipment, net
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707,752 |
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688,618 |
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OTHER
ASSETS:
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Trademark
and patent costs, net
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224,310 |
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192,344 |
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Total
other assets
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224,310 |
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192,344 |
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TOTAL
ASSETS
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$ |
5,571,819 |
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$ |
3,001,261 |
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LIABILITIES
AND STOCKHOLDERS’ EQUITY
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CURRENT
LIABILITIES:
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Accounts
payable
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$ |
131,412 |
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$ |
147,067 |
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Accounts
payable – related parties
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321,312 |
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300,969 |
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Accrued
expenses
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84,258 |
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35,087 |
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Accrued
payroll to officers and related payroll tax
expense
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20,134 |
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32,596 |
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TOTAL
CURRENT LIABILITIES
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557,116 |
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515,719 |
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COMMITMENTS
AND CONTINGENCIES
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STOCKHOLDERS’
EQUITY
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Common
stock, $0.001 par value; 300,000,000 shares authorized; 131,774,554 and
125,299,457 shares issued and outstanding, respectively.
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131,775 |
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125,299 |
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Additional
paid-in capital
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17,734,652 |
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14,455,778 |
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Stock
subscription receivable
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(125,000 |
) |
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(100,000 |
) |
Deficit
accumulated during the development stage
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(12,726,724 |
) |
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(11,995,535 |
) |
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TOTAL
STOCKHOLDERS’ EQUITY
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5,014,703 |
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2,485,542 |
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TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
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$ |
5,571,819 |
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$ |
3,001,261 |
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See
accompanying notes to the financial statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
(Unaudited)
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For
the Three Months Ending
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For
the Period From May 12, 2005 (Inception) Through September 30,
2009 |
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September
30,
2009
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September
30,
2008
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Operating
expenses:
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Research
and development
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$ |
463,922 |
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$ |
454,081 |
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$ |
7,185,885 |
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Refund
Credit for research and development costs
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- |
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(258,318 |
) |
General
and administrative
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268,137 |
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302,753 |
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5,161,024 |
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Total
operating expenses
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732,059 |
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756,834 |
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12,088,591 |
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Loss
from operations
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(732,059 |
) |
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(756,834 |
) |
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(12,088,591 |
) |
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Other
income (expenses)
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Interest
income, net
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870 |
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12,077 |
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148,876 |
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Non
cash interest on convertible debentures
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- |
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(73,930 |
) |
Non
cash interest expense on beneficial conversion feature of convertible
debentures
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- |
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(713,079 |
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Total
other income ( expenses)
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870 |
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12,077 |
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(638,133 |
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Net
loss
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(731,189 |
) |
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(744,757 |
)
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(12,726,724 |
) |
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Net
loss per common share - basic and diluted
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(0.006 |
) |
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(0.006 |
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Weighted
average shares outstanding - basic and diluted
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125,384,198 |
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120,341,445 |
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See
accompanying notes to the financial statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
(Unaudited)
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For
the Three Months Ending
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For the Period From
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September 30,
2009
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September 30,
2008
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May 12,
2005 (Inception)
Through
September 30,
2009
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OPERATING
ACTIVITIES:
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Net
loss
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$ |
(731,189 |
) |
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$ |
(744,757 |
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$ |
(12,726,724 |
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Adjustments
to reconcile net loss to net cash used in operating
activities:
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Shares
issued for services rendered
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31,800 |
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26,200 |
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842,357 |
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Warrants
granted to scientific advisory board
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41,400 |
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47,500 |
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486,241 |
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Amortization
of deferred compensation
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- |
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121,424 |
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Depreciation
and amortization
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3,865 |
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1,628 |
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25,202 |
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Amortization
of deferred financing expenses
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- |
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- |
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51,175 |
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Non
cash interest on convertible debenture
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- |
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- |
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73,930 |
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Non
cash interest expense on beneficial conversion feature of
convertible debentures
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- |
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- |
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713,079 |
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Changes
in assets and liabilities:
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Prepaid
expenses
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(6,225 |
) |
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(98,191 |
) |
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(327,770 |
) |
Other
current assets
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- |
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(109,312 |
) |
Deferred
expenses
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- |
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(2,175 |
) |
Accounts
payable-trade
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(15,655 |
) |
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123,578 |
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418,912 |
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Accounts
payable –related parties
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20,343 |
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172,355 |
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321,312 |
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Accrued
expenses
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49,171 |
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(3,130 |
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84,258 |
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Accrued
payroll to officers and related payroll tax
expense
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(12,462 |
) |
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(165,676 |
) |
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20,134 |
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Net
cash used in operating activities
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(618,952 |
) |
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(640,493 |
) |
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(10,007,957 |
) |
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INVESTING
ACTIVITIES:
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Security
deposit
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|
- |
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12,000 |
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- |
|
Purchases
of property and equipment
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(20,805 |
) |
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(430,200 |
) |
|
|
(723,939 |
) |
Purchase
of Trademark and Patent costs
|
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(34,160 |
) |
|
|
- |
|
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(233,325 |
) |
|
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|
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Net
cash used in investing activities
|
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|
(54,965 |
) |
|
|
(418,200 |
) |
|
|
(957,264 |
) |
FINANCING ACTIVITIES:
|
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Proceeds
from issuance of convertible debentures
|
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|
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|
- |
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|
1,000,000 |
|
Proceeds
from issuance of common stock in connection with the private
placement of common stock, net of fees
|
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|
1,287,250 |
|
|
|
3,227,554 |
|
|
|
11,151,726 |
|
Proceeds
from stock option exercise
|
|
|
|
|
|
|
- |
|
|
|
90,000 |
|
Proceeds
from exercise of warrants
|
|
|
1,899,900 |
|
|
|
- |
|
|
|
2,926,150 |
|
Stock
subscription received
|
|
|
|
|
|
|
- |
|
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|
20 |
|
Net
cash provided by financing activities
|
|
|
3,187,150 |
|
|
|
3,227,554 |
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|
15,167,896 |
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NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
2,513,233 |
|
|
|
2,168,861 |
|
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|
4,202,675 |
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CASH
AND CASH EQUIVALENTS, BEGINNING
|
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|
1,689,442 |
|
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|
816,386 |
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|
- |
|
CASH
AND CASH EQUIVALENT, ENDING
|
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$ |
4,202,675 |
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$ |
2,985,247 |
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$ |
4,202,675 |
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CASH
PAID DURING THE PERIOD FOR:
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INTEREST
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$ |
- |
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$ |
- |
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$ |
- |
|
INCOME
TAXES
|
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$ |
- |
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|
$ |
- |
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$ |
3,037 |
|
See
accompanying notes to the financial statements.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS (CONTINUED)
SUPPLEMENTAL
DISCLOSURE OF NON-CASH ACTIVITY
(Unaudited)
During
the periods indicated below, the Company had the following non-cash
activity:
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Three
Months Ended September 30,
|
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|
For
the Period From May 12, 2005
(Inception)
through
September 30,
2009
|
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|
|
2009
|
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|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services rendered
|
|
$ |
31,800 |
|
|
$ |
26,200 |
|
|
$ |
842,357 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Stock
options issued to the officers as compensation
|
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|
- |
|
|
|
- |
|
|
|
121,424 |
|
|
|
|
|
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|
|
|
|
|
|
|
|
Stock
warrants granted to scientific advisory board
|
|
|
41,400 |
|
|
|
47,500 |
|
|
|
486,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
warrants granted top brokers
|
|
|
- |
|
|
|
9,849 |
|
|
|
9,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for interest on debentures
|
|
|
- |
|
|
|
- |
|
|
|
73,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
of common stock issued in connection with debenture
offering
|
|
|
- |
|
|
|
- |
|
|
|
49,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued upon conversion of convertible debentures
|
|
|
- |
|
|
|
- |
|
|
|
1,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt
discount related to beneficial conversion feature of convertible
debt
|
|
|
- |
|
|
|
- |
|
|
|
713,079 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
Warrants Issued in connection with Private Placement
|
|
|
5,097,300 |
|
|
|
827,485 |
|
|
|
7,681,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for accounts payable
|
|
|
- |
|
|
|
150,000 |
|
|
|
150,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for equipment
|
|
|
- |
|
|
|
|
|
|
|
137,500 |
|
See
accompanying notes to the financial statements.
(A
DEVELOPMENT STAGE COMPANY)
FOR
THE PERIOD FROM MAY 12, 2005 (INCEPTION) TO SEPTEMBER 30, 2009
NOTES
TO FINANCIAL STATEMENTS
(Unaudited)
Note
1. Organization and Nature of Business
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25, 2000
as Edot-com.com, Inc., and was organized for the purpose of conducting internet
retail sales. On April 1, 2005, Edot-com.com, Inc. was incorporated under the
laws of the State of Nevada for the purpose of re-domiciling the Company as a
Nevada corporation. On May 12, 2005, the Corporations were merged and
Edot-com.com, Inc., a Nevada corporation, (the “Company”), became the surviving
entity.
On June
1, 2005, Edot-com.com, Inc. (“ECMM”) acquired NanoViricide, Inc., a privately
owned Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share
Exchange (the “Exchange”). NanoViricides, Inc. was incorporated under
the laws of the State of Florida on May 12, 2005.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate of
80,000,000 newly issued shares of ECMM common stock resulting in an aggregate of
100,000,000 shares of ECMM common stock issued and outstanding representing 80%
of the voting capital stock of ECMM immediately after the Exchange
transaction. NVI then became a wholly-owned subsidiary of ECMM. The
ECMM shares were issued to the NVI Shareholders on a pro rata basis, on the
basis of 4,000 shares of ECMM’s Common Stock for each share of NVI common stock
held by such NVI Shareholder at the time of the Exchange.
As a
result of the ownership interests of the former shareholders of NVI for
financial accounting purposes, the merger between ECMM and NVI has been treated
as a reverse acquisition with NVI deemed the accounting acquirer and ECMM deemed
the accounting acquiree under the purchase method of accounting in accordance
with paragraph 805-40-05-2 of the FASB Accounting Standards
Codification. The reverse merger is deemed a capital transaction and
the net assets of NVI (the accounting acquirer) are carried forward to ECMM (the
legal acquirer and the reporting entity) at their carrying value before the
combination. The acquisition process utilizes the capital structure
of ECMM and the assets and liabilities of NVI which are recorded at historical
cost. The equity of ECMM is the historical equity of NVI retroactively restated
to reflect the number of shares issued by ECMM in the transaction. Accordingly,
the financial statements have been prepared to give retroactive effect to May
12, 2005 (date of inception), of the reverse acquisition completed on June 1,
2005, and represent the operations of NVI.
On June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, ECMM changed its
name to NanoViricides, Inc. and its stock symbol to “NNVC”,
respectively. The Company is considered a development stage company
at this time.
NanoViricides,
Inc. (the “Company”), is a nano-biopharmaceutical company whose business goals
are to discover, develop and commercialize therapeutics to advance the care of
patients suffering from life-threatening viral infections. We are a development
stage company with several drugs in various stages of early development. The
Company’s drugs are based on several patents, patent applications, provisional
patent applications, and other proprietary intellectual property held by
TheraCour Pharma, Inc. (“TheraCour®”), to which the Company has licenses in
perpetuity for the treatment of the following human viral diseases: Human
Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus
(HCV), Herpes Simplex Virus (HSV), Influenza, Rabies, and Asian Bird Flu Virus.
TheraCour has granted the Company the right to include Dengue viruses,
Ebola/Marburg viruses, and viruses causing viral Conjunctivitis (a disease of
the eye) among the viruses the Company is able to treat. However, no
written agreement has been entered into with TheraCour and no assurance can be
given that a written amendment to the licensing agreement with TheraCour will
ever be reached or that, if reached, will be on terms favorable to the
Company.
The
Company focuses its research and clinical programs on specific anti-viral
therapeutics and is seeking to add to its existing portfolio of products through
its internal discovery and clinical development programs and through an
in-licensing strategy. To date, the Company has not developed any commercial
products.
Note
2. Basis of Presentation
The
accompanying unaudited interim financial statements of the Company have been
prepared in accordance with accounting principles generally accepted in the
United States for interim financial information and with the instructions to
Form 10-Q and Rule 10-01 of Regulation S-X of the Securities and Exchange
Commission for Interim Reporting. Accordingly, they do not include all of the
information and footnotes required by accounting principles generally accepted
in the United States of America for complete financial
statements.
In the
opinion of Management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation for the interim periods have been
included. Operating results for the three month period ended September 30, 2009,
are not necessarily indicative of the results that may be expected for the year
ending June 30, 2010. The accompanying financial statements and the information
included under the heading “Management’s Discussion and Analysis or Plan of
Operation” should be read in conjunction with our company’s audited financial
statements and related notes included in our company’s form 10-K for the year
ended June 30, 2009.
Note
3. Summary of Significant Accounting Policies
For a
summary of significant accounting policies (which have not changed from June 30,
2009), see the Company’s Annual Report on Form 10-K for the year ended June 30,
2009.
Recently Issued Accounting
Pronouncements
On June
5, 2003, the United States Securities and Exchange Commission (“SEC”) adopted
final rules under Section 404 of the Sarbanes-Oxley Act of 2002 (“Section 404”),
as amended by SEC Release No. 33-9072 on October 13, 2009. Under the
provisions of Section 404 of the Sarbanes-Oxley Act, public companies and their
independent auditors are each required to report to the public on the
effectiveness of a company’s internal controls. The smallest public
companies with a public float below $75 million have been given extra time to
design, implement and document these internal controls before their auditors are
required to attest to the effectiveness of these controls. This
extension of time will expire beginning with the annual reports of companies
with fiscal years ending on or after June 15, 2010. Commencing with
its annual report for the fiscal year ending June 30, 2010, the Company will be
required to include a report of management on its internal control over
financial reporting. The internal control report must include a
statement
·
|
Of
management’s responsibility for establishing and maintaining adequate
internal control over its financial
reporting;
|
·
|
Of
management’s assessment of the effectiveness of its internal control over
financial reporting as of year end;
and
|
·
|
Of
the framework used by management to evaluate the effectiveness of the
Company’s internal control over financial
reporting.
|
Furthermore,
it is required to file the auditor’s attestation report separately on the
Company’s internal control over financial reporting on whether it believes that
the Company has maintained, in all material respects, effective internal control
over financial reporting.
In June
2009, the FASB issued new accounting guidance related to accounting standards
codification and the hierarchy of GAAP the “FASB Accounting Standards
Codification” (“Codification”), to become the single official source of
authoritative U.S. generally accepted accounting principles (“GAAP”) to be
applied by nongovernmental entities, superseding existing FASB, American
Institute of Certified Public Accountants (“AICPA”), Emerging Issues Task Force
(“EITF”), and related accounting literature. Rules and interpretive releases of
the Securities and Exchange Commission (“SEC”) under authority of federal
securities laws are also sources of authoritative U.S. GAAP for SEC registrants.
This guidance reorganizes the previously issued GAAP pronouncements into
accounting topics and displays them using a consistent structure. The subsequent
issuances of new standards will be in the form of Accounting Standards Updates
that will be included in the Codification. The guidance is effective for the
Company as of the interim period ended September 30, 2009. As the Codification
was not intended to change or alter existing GAAP, it did not have an impact on
the Company’s consolidated financial statements. The only impact will be that
references to authoritative accounting literature will be in accordance with the
new numbering system prescribed by the Codification.
In August
2009, the FASB issued the FASB Accounting Standards Update No. 2009-04 “Accounting for Redeemable Equity
Instruments - Amendment to Section 480-10-S99” which represents an update
to section 480-10-S99, distinguishing liabilities from equity, per EITF Topic
D-98, Classification and
Measurement of Redeemable Securities. The Company does not
expect the adoption of this update to have a material impact on its consolidated
financial position, results of operations or cash flows.
In August
2009, the FASB issued the FASB Accounting Standards Update No. 2009-05 “Fair Value Measurement and
Disclosures Topic 820 – Measuring Liabilities at Fair Value”, which
provides amendments to subtopic 820-10, Fair Value Measurements and Disclosures
– Overall, for the fair value measurement of liabilities. This update
provides clarification that in circumstances in which a quoted price in an
active market for the identical liability is not available, a reporting entity
is required to measure fair value using one or more of the following techniques:
1. A valuation technique that uses: a. The quoted price of the identical
liability when traded as an asset b. Quoted prices for similar liabilities or
similar liabilities when traded as assets. 2. Another valuation technique that
is consistent with the principles of topic 820; two examples would be an income
approach, such as a present value technique, or a market approach, such as a
technique that is based on the amount at the measurement date that the reporting
entity would pay to transfer the identical liability or would receive to enter
into the identical liability. The amendments in this update also clarify that
when estimating the fair value of a liability, a reporting entity is not
required to include a separate input or adjustment to other inputs relating to
the existence of a restriction that prevents the transfer of the liability. The
amendments in this update also clarify that both a quoted price in an active
market for the identical liability when traded as an asset in an active market
when no adjustments to the quoted price of the asset are required are Level 1
fair value measurements. The Company does not expect the adoption of
this update to have a material impact on its consolidated financial position,
results of operations or cash flows.
In
September 2009, the FASB issued the FASB Accounting Standards Update No. 2009-08
“Earnings Per Share –
Amendments to Section 260-10-S99”,which represents technical corrections
to topic 260-10-S99, Earnings per share, based on EITF Topic D-53, Computation of Earnings Per Share
for a Period that includes a Redemption or an Induced Conversion of a Portion of
a Class of Preferred Stock and EITF Topic D-42, The Effect of the Calculation of
Earnings per Share for the Redemption or Induced Conversion of Preferred
Stock. The Company does not expect the adoption of this update to have a
material impact on its consolidated financial position, results of operations or
cash flows.
In
September 2009, the FASB issued the FASB Accounting Standards Update No. 2009-09
“Accounting for
Investments-Equity Method and Joint Ventures and Accounting for Equity-Based
Payments to Non-Employees”. This update represents a
correction to Section 323-10-S99-4, Accounting by an Investor for
Stock-Based Compensation Granted to Employees of an Equity Method
Investee. Additionally, it adds observer comment Accounting Recognition for Certain
Transactions Involving Equity Instruments Granted to Other Than Employees
to the Codification. The Company does not expect the adoption to have a material
impact on its consolidated financial position, results of operations or cash
flows.
In
September 2009, the FASB issued the FASB Accounting Standards Update No. 2009-12
“Fair Value Measurements and
Disclosures Topic 820 – Investment in Certain Entities That Calculate Net Assets
Value Per Share (or Its Equivalent)”, which provides amendments to
Subtopic 820-10, Fair Value Measurements and Disclosures-Overall, for the fair
value measurement of investments in certain entities that calculate net asset
value per share (or its equivalent). The amendments in this update permit, as a
practical expedient, a reporting entity to measure the fair value of an
investment that is within the scope of the amendments in this update on the
basis of the net asset value per share of the investment (or its equivalent) if
the net asset value of the investment (or its equivalent) is calculated in a
manner consistent with the measurement principles of Topic 946 as of the
reporting entity’s measurement date, including measurement of all or
substantially all of the underlying investments of the investee in accordance
with Topic 820. The amendments in this update also require disclosures by major
category of investment about the attributes of investments within the scope of
the amendments in this update, such as the nature of any restrictions on the
investor’s ability to redeem its investments a the measurement date, any
unfunded commitments (for example, a contractual commitment by the investor to
invest a specified amount of additional capital at a future date to fund
investments that will be make by the investee), and the investment strategies of
the investees. The major category of investment is required to be determined on
the basis of the nature and risks of the investment in a manner consistent with
the guidance for major security types in U.S. GAAP on investments in debt and
equity securities in paragraph 320-10-50-1B. The disclosures are required for
all investments within the scope of the amendments in this update regardless of
whether the fair value of the investment is measured using the practical
expedient. The Company does not expect the adoption to have a material impact on
its consolidated financial position, results of operations or cash
flows.
Management
does not believe that any other recently issued, but not yet effective
accounting pronouncements, if adopted, would have a material effect on the
accompanying financial statements.
Reclassification
Certain
reclassifications have been made in prior year’s financial statements to conform
to classification used in the current year. The reclassifications
from general and administrative expenses to research and development expenses
does not change total operating expenses, operating loss or net loss for any
period presented.
Note
4. Substantial Doubt Regarding Ability to Continue as a Going
Concern
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of business.
Accordingly, they do not include any adjustments relating to the realization of
the carrying value of assets or the amounts and classification of liabilities
that might be necessary should the Company be unable to continue as a going
concern. The Company’s significant operating losses and significant
capital requirements, however, raise substantial doubt about the Company’s
ability to continue as a going concern. The Company believes that it has
sufficient cash reserves to achieve all of our budgeted plans through December
31, 2010 .
Since May
2005, the Company has been engaged exclusively in research and development
activities focused on developing targeted nano viral drugs. The
Company has not yet commenced any product commercialization. The Company has
incurred significant operating losses since its inception, resulting in a
deficit accumulated during the development stage of $12,726,724 at September 30,
2009. Such losses are expected to continue for the foreseeable future and until
such time, if ever, as the Company is able to attain sales levels sufficient to
support its operations. There can be no assurance that the Company will achieve
or maintain profitability in the future. Despite the Company’s financings in
2009 and 2008 and a cash and cash equivalent balance of $4,202,675 at September
30, 2009, substantial additional financing will be required in future periods.
The Company believes it will require an additional $3,000,000 during the next
twenty four months, and will also require up to an additional $2,000,000 to
finance planned capital costs, and additional staffing requirements during the
next twenty four months. The Company believes it can adjust its priorities of
drug development, and its Plan of Operations as necessary if it is unable to
raise such funds.
The
Company continues to successfully raise additional capital, On September 30,
2009, the Company accepted subscriptions from certain investors in the aggregate
amount of $3,217,400 from the offerings of shares of the Company ’s common stock
and warrants to purchase common stock and the exercise by the Company’s warrant
holders of their outstanding warrants. The offerings were commenced
in June 2009, when the Company’s stock price levels were approximately
$0.57. The offerings were closed to investors on August 30, 2009,
after an extension by the Company’s Board of Directors from the original
termination date of August 14, 2009. In the Registrant’s offering of
Units comprised of shares of common stock and warrants to purchase common stock,
the Company accepted subscriptions for $1,337,500 for Units consisting of
2,675,000 shares and Warrants to purchase an additional 1,337,500
shares. In the offering to its warrant holders, the Company raised an
aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase 3,759,800
shares. All of the warrants sold in the offerings are exercisable at
the price of $1.00 per share and expire in three years.
The
Company is in discussions with certain potential investors to provide the
additional capital set forth above. Additionally, a grant application for
developing a broad-spectrum nanoviricide against hemorrhagic fever viruses such
as Ebola/Marburg and Dengue is currently pending with the Department of Defense.
No assurances can be given that financing will be available or be sufficient to
meet our capital needs. If we are unable to obtain financing to meet
our working capital requirements, then we may be required to modify our
operations, including curtailing our business significantly or ceasing
operations altogether.
Note
5. Significant Alliances and Related Parties
TheraCour
Pharma, Inc.
Pursuant
to an Exclusive License Agreement we entered into with TheraCour Pharma, Inc.,
(TheraCour), the Company was granted exclusive licenses in perpetuity for
technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian
(bird) flu, Influenza and rabies. The Company and TheraCour have agreed, in
principle, to a Licensing Agreement to include additional virus types among the
virus types the Company is permitted to manufacture, use, and offer for sale,
and for payment of a license fee to TheraCour. TheraCour has permitted the
Company to use its nanomaterials to develop treatments for Dengue viruses,
Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral
Conjunctivitis (a disease of the eye) and Ocular Herpes. Until such time as the
Company and TheraCour can complete an additional Licensing Agreement to include
these additional virus types we are permitted to manufacture, use, and offer for
sale these nanomaterials.. In consideration for obtaining these exclusive
licenses, we agreed: (1) that TheraCour can charge its costs (direct and
indirect) plus no more than 30% of direct costs as a Development Fee and such
development fees shall be due and payable in periodic installments as
billed. (2) to pay $25,000 per month for usage of lab supplies and
chemicals from existing stock held by TheraCour (3) we will pay $2,000 or actual
costs, whichever is higher, for other general and administrative expenses
incurred by TheraCour on our behalf (4) make royalty payments (calculated as a
percentage of net sales of the licensed drugs) of 15% to TheraCour Pharma, Inc.
(5) agreed that TheraCour Pharma, Inc. retains the exclusive right to develop
and manufacture the licensed drugs. TheraCour Pharma, Inc. agreed that it will
manufacture the licensed drugs exclusively for NanoViricides, and unless such
license is terminated, will not manufacture such product for its own sake or for
others, (6) TheraCour may request and NanoViricides, Inc. will pay an advance
payment (refundable) equal to twice the amount of the previous months invoice to
be applied as a prepayment towards expenses.
There can
be no assurance that the license fee will be paid or that the amendment will
become effective, in which case TheraCour may revoke our permissive use of its
materials, which may adversely impact our operations and cause the termination
of our Cooperative Research and Development Agreement (CRADA) with the United
States Army Medical Research Institute of Infectious Diseases
(USAMRIID), and the United States Armed Forces Institute of Pathology
(USAFIP).
TheraCour
may terminate the license upon a material breach by us as specified in the
agreement. However, we may avoid such termination if within 90 days of receipt
of such termination notice we cure the breach.
Development
costs charged by TheraCour Pharma, Inc. for the three months ended September 30,
2009 and 2008, were $257,320 and $220,749 respectively, and $2,565,048 since
inception. As of September 30, 2009, pursuant to its license
agreement the Company has paid a security advance of $263, 656 to and held by
TheraCour Pharma, Inc. which is reflected in prepaid expenses
No
royalties are due TheraCour from the Company’s inception through September 30,
2009.
On
February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000
square feet of space in Woodbridge, Connecticut. Performance of the Company’s
obligations was guaranteed by TheraCour Pharma, Inc., a principal shareholder of
the Company and provider of the materials the Registrant uses in its operations.
This lease expired on January 30, 2009, and we have relocated our operations to
an expanded facility at 135 Wood Street, West Haven, CT.
TheraCour
Pharma, Inc., is affiliated with the Company through the common control of it
and our Company by Anil Diwan, President, who is a director of each
corporation, and owns approximately 70% of the capital stock of TheraCour
Pharma, Inc., which itself owns approximately 30% of the capital stock of the
Company.
TheraCour
Pharma, Inc. owns 31,460,000 shares of the Company’s outstanding common stock as
of September 30, 2009. The Company anticipates the need to procure large
quantities of the nanoviricides drug candidates for the upcoming studies. In
order to support this production scale, TheraCour Pharma, Inc., the Company’s
largest shareholder and licensor of the technology that the Company uses in its
anti-viral drug development, has initiated a program to expand its laboratory
facilities. TheraCour has entered into a Rule 10b5-1 trading plan to sell, over
a one year period, up to 1.8 million shares of the Company’s common stock that
it owns, that will go into effect Feb 17, 2009. The proceeds are expected to be
used to pay for the necessary improvements in laboratory facilities, the
purchase of analytical equipment, and the costs of intellectual property
(patent) protection.
The FASB
has issued guidance related Consolidation of Variable Interest Entities. The
guidance clarifies the application to certain entities in which equity investors
do not have the characteristics of a controlling financial interest or do not
have sufficient equity at risk for the entity to finance its activities without
additional subordinated financial support from other parties. It separates
entities into two groups: (1) those for which voting interests are used to
determine consolidation and (2) those for which variable interests are used to
determine consolidation The guidance clarifies how to identify a variable
interest entity and how to determine when a business enterprise should include
the assets, liabilities, non-controlling interests, and results of activities of
a variable interest entity in its consolidated financial
statements.
The
guidance further requires that a variable interest entity to be consolidated by
its “Primary Beneficiary.” The Primary Beneficiary is the entity, if any, that
stands to absorb a majority of the variable interest entity’s expected losses,
or in the event that no entity stands to absorb a majority of the expected
losses, then the entity that stands to receive a majority of the variable
interest entity’s expected residual returns. If it is reasonably possible that
an enterprise will consolidate or disclose information about a variable interest
entity when the FASB guidance became effective, the enterprise is required to
disclose in all financial statements initially issued after December 31, 2003,
the nature, purpose, size, and activities of the variable interest entity and
the enterprise’s maximum exposure to loss as a result of its involvement with
the variable interest entity. For all periods presented in the financial
statements, the Company evaluated its relationship with TheraCour Pharma, Inc.,
and concluded that it is not a variable interest entity that is subject to
consolidation in the Company’s financial statements.
KARD
Scientific, Inc.
In June
2005, the Company engaged KARD Scientific to conduct pre clinical animal studies
and provide the Company with a full history of the study and final report with
the data collected. Dr. Krishna Menon, the Company’s Chief Regulatory Officer,
is also an officer and principal owner of KARD Scientific. Since inception, lab
fees charged by KARD Scientific for services to the Company total $554,235. The
Company has paid KARD a $50,000 advance payment (refundable) towards future
fees.
Note
6. Prepaid Expenses
Prepaid
expenses are summarized as follows:
|
|
September 30,
2009
|
|
|
June 30,
2009
|
|
|
|
|
|
|
|
|
TheraCour
Pharma, Inc. *
|
|
$ |
263,656 |
|
|
$ |
243,313 |
|
Kard
Scientific, Inc. *
|
|
|
50,000 |
|
|
|
50,000 |
|
Prepaid
other
|
|
|
14,114 |
|
|
|
28,232 |
|
|
|
$ |
327,770 |
|
|
$ |
321,545 |
|
(* See
Note 5. Significant Alliances and Related Parties)
Note
7. Equity Transactions
In August
2009, members of the Scientific Advisory Board were granted warrants to purchase
50,000 shares of common stock at $1.10 per share. These warrants, if not
exercised, will expire in August 2013. The fair value of these warrants in the
amount of $41,400 was recorded as consulting expense.
The fair
value of the Company’s option-based awards granted were estimated using the
Black-Scholes option pricing model and the following assumptions.
On
September 30, 2009, the Registrant accepted subscriptions from certain investors
in the aggregate amount of $3,217,400 from the offerings of shares of the
Registrant’s common stock and warrants to purchase common stock and the exercise
by the Registrant’s warrantholders of their outstanding warrants. The
offerings commenced in June 2009, when the Registrant’s stock price levels were
approximately $0.57. The offerings were closed to investors on August
30, 2009, after an extension by the Registrant’s Board of Directors from the
original termination date of August 14, 2009. The Registrant’s
offering of Units comprised of shares of common stock and warrants to purchase
common stock, the Registrant accepted subscriptions for $1,337,500 for Units
consisting of 2,675,000 shares and Warrants to purchase an additional 1,337,500
shares. In the offering to its warrant holders, the Registrant raised
an aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase
3,759,800 shares. All of the warrants sold in the offerings are
exercisable at the price of $1.00 per share and expire in three
years.
For the
three months ended September 30, 2009, the Company's Board of Directors
authorized the issuance of 40,297 shares of its common stock with a restrictive
legend, for consulting services. The Company recorded an expense of
$31,800.
Note
8. Commitments and Contingencies
The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 7,000 square feet of office and
laboratory space at a base monthly rent of $7,311. Commencing September 1, 2008
the Company rented additional storage space and the base monthly rent increased
to $7,311. The term of lease expires in February 28, 2011, and may be extended,
at the option of the Company, for an additional two years. The lease can be
cancelled by the Company upon providing six months written notice.
On
February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000
square feet of space at 4 Research Drive, in Woodbridge, Connecticut.
The term of the occupancy expired January 30, 2009 at a monthly rent of $11,667,
plus an additional $500 per month for utilities.
At
September 30, 2009, future minimum rental payments due under these operating
leases are as follows:
Total
rent expense amounts to $14,623 and $51,577 for the three months ended September
30, 2009 and 2008 respectively, and $311,377 for the period from
inception.
Note
9. Subsequent Events
The
Company has evaluated all events that occurred after the balance sheet date of
September 30, 2009 through November 22, 2009, the date when the financial
statements were issued. The Management of the Company determined that
there were no reportable events that occurred during that subsequent period to
be disclosed or recorded.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF
OPERATION
The
following discussion and analysis should be read in conjunction with our
unaudited financial statements and related notes included in this report. This
report contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. The statements contained in this
report that are not historic in nature, particularly those that utilize
terminology such as "may," "will," "should," "expects," "anticipates,"
"estimates," "believes," or "plans" or comparable terminology are
forward-looking statements based on current expectations and
assumptions.
Various
risks and uncertainties could cause actual results to differ materially from
those expressed in forward-looking statements. All forward-looking statements in
this document are based on information currently available to us as of the date
of this report, and we assume no obligation to update any forward-looking
statements. Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the actual results to differ
materially from any future results, performance or achievements expressed or
implied by such forward-looking statements.
OUR
CORPORATE HISTORY
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25, 2000
as Edot-com.com, Inc.
and was organized for the purpose of conducting internet retail sales. On
April 1, 2005, Edot-com.com, Inc. was incorporated under
the laws of the State of Nevada for the purpose of re-domiciling the Company as
a Nevada corporation, Edot-com.com (Nevada). On April 15, 2005, Edot-com.com
(Colorado) and Edot-com.com (Nevada) were merged and Edot-com.com, Inc.,
(ECMM) a Nevada
corporation (the “Company”), became the surviving entity. On April 15, 2005, the
authorized shares of common stock was increased to 300,000,000 shares at $.001
par value and the Company effected a 3.2 - 1 forward stock split effective May
12, 2005.
On June
1, 2005, Edot-com.com, Inc. acquired NanoViricides, Inc., a privately owned
Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share Exchange
(the “Exchange”). NVI was incorporated under the laws of the State of Florida on
May 12, 2005 and its sole asset was comprised of a licensing agreement with
TheraCour Pharma, Inc. (“TheraCour,” an approximately 30% shareholder of NVI)
for rights to develop and commercialize novel and specifically targeted drugs
based on TheraCour's targeting technologies, against a number of human viral
diseases. (For financial accounting purposes, the acquisition was a reverse
acquisition of the Company by NVI, under the purchase method of accounting, and
was treated as a recapitalization with NVI as the acquirer). Upon consummation
of the Exchange, ECMM adopted the business plan of NVI.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate of
80,000,000 newly issued shares of ECMM common stock, resulting in an aggregate
of 100,000,000 shares of ECMM common stock issued and outstanding. As a result
of the Exchange, NVI became a wholly-owned subsidiary of ECMM. The ECMM shares
were issued to the NVI Shareholders on a pro rata basis, on the basis of 4,000
shares of the Company’s Common Stock for each share of NVI common stock held by
such NVI Shareholder at the time of the Exchange.
On June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, Edot-com.com, Inc., changed
its name to NanoViricides, Inc. and its stock symbol on the Pink Sheets to
“NNVC”, respectively. The Company submitted a Form-10SB to the SEC to
become a reporting company on November 14, 2006. The Company’s filing status
became effective in March, 2007. On June 28, 2007, the company became
quotable on The OTC Bulletin Board under the symbol NNVC.OB.
The
Company is considered a development stage company at this time.
Management’s
Plan of Operation
NanoViricides,
Inc. (the “Company”), is an early developmental stage nano-biopharmaceutical
company engaged in the discovery, development and commercialization of
anti-viral therapeutics. The Company has no customers, products or revenues to
date, and may never achieve revenues or profitable operations. Our drugs are
based on several patents, patent applications, provisional patent applications,
and other proprietary intellectual property held by TheraCour Pharma, Inc., one
of the Company’s principal shareholders, from which we have licensed, in
perpetuity, the right to develop drug candidates for the treatment of
the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS),
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV),
Rabies, Influenza and Asian Bird Flu Virus. Additionally, TheraCour has
permitted the Company to use its nanomaterials to develop a treatment against
Dengue Fever viruses, Ebola/Marburg viruses, and viruses causing certain eye
diseases. The Company anticipates negotiating with TheraCour an amendment to the
Licensing Agreement to include additional viruses. We are seeking to add to our
existing portfolio of products through our internal discovery pre-clinical
development programs and through an in-licensing strategy. We focus our
laboratory research and pre-clinical programs on specific anti-viral
solutions.
The
Company has incurred significant operating losses since its inception resulting
in a deficit accumulated during the development stage of $12,726,724 at
September 30, 2009. For the three months ended September 30, 2009 the Company
had a net loss of $731,189. Such losses are expected to continue for the
foreseeable future and until such time, if ever, as the Company is able to
attain sales levels sufficient to support its operations.
To date,
we have engaged in organizational activities; sourcing compounds and materials;
developing novel compounds and nanomaterials, and experimentation with studies
on cell cultures and animals. We have generated funding through the issuances of
debt and private placement of common stock. We have not generated any
revenues and we do not expect to generate revenues in the near future. We may
not be successful in developing our drugs and start selling our products when
planned, or that we will become profitable in the future. We have incurred net
losses in each fiscal period since inception of our operations. The Company
currently has no long term debt.
NanoViricides
Technologies, Products in Development, and Collaborations
Pharmaceutical
drug development is an expensive and long duration proposition. Management’s
plan is to develop each of our nanoviricides to the necessary stage(s) and then
engage into co-development relationships with other pharmaceutical companies.
Such co-development relationships usually may entail upfront payments,
milestones payments, cost-sharing, and eventual revenue-sharing, including
royalty on sales. There is no guarantee that we will be able to negotiate
agreements that are financially beneficial to the Company at the present stage.
Management plans to continue to raise additional funds as needed for our
continuing drug development efforts on public markets.
The
Company currently has several drug development programs. Our drug development
programs with large commercial interest include (1) Influenzas, (2) HIV, (3)
topical eye drops for viral diseases of the external eye, and (4) Herpes “cold
sores” and genital Herpes. In addition, the Company believes that, as the holder
of potentially paradigm-shifting antiviral drug development technologies, it has
a social responsibility to develop drugs against diseases affecting large
segments of worldwide populations. In our Social Responsibility programs, we are
developing drugs against Neglected Tropical Diseases (NTDs) caused by viruses
such as Dengue viruses and Rabies. The Company also has BioSecurity programs
that include drug development against hemorrhagic fever viruses such as
Ebola/Marburg, and a unique technology that we call “ADIF™” to combat natural or
bioterrorism attacks by novel viruses as happened with SARS and may happen with
engineered viruses. The Company plans to perform its NTD and BioSecurity R&D
and drug development in collaboration with institutes of renown and with public
funding, in order to minimize the strain on our resources. The Company believes
that this work provides direct benefits to our commercially important programs.
A grant application for developing a broad-spectrum nanoviricide against
hemorrhagic fever viruses such as Ebola/Marburg and Dengue is currently pending
with the Department of Defense.
Our
development model is to employ collaborations with academic labs, government
labs, as well as external service providers in order to minimize our capital
requirements. We currently have collaborations with the Center for Disease
Control and Prevention (CDC) and the National (Central) Institute of Hygiene and
Epidemiology (NIHE) (Vietnam) for Rabies, with NIHE for H5N1 Avian Flu, the
Walter Reed Army Institute of Research (WRAIR) for Dengue family viruses, United
States Army Medical Institute of Infectious Diseases (USAMRIID) for
Ebola/Marburg family of hemorrhagic viruses, and the Long Island Jewish Medical
System, Feinstein Institute of Medical Research (LIJMS) for viral eye diseases
such as epidemic kerato-conjunctivitis (EKC) and herpes keratitis. In
addition, our HIV and common influenza studies were subcontracted to KARD
Scientific, Inc., USA. Some of the biological testing work for Herpes Virus
infection of the eye was subcontracted to TheVac, LLC, laboratories
at the Louisiana Emerging Technology Center located within the
Louisiana State University (LSU) campus in collaboration with the LSU School of
Veterinary Medicine. We have recently signed a Master Service Agreement to
subcontract evaluation of nanoviricide drug candidates against various diseases
including Influenzas and HIV with the Southern Research Institute, Infectious
Diseases Division, Frederick, MD (SRI-F), a well known contract research
organization that performs preclinical testing. Initially, we plan to
perform additional testing of influenza dug candidates including High-Path or
Highly Pathogenic Avian Influenzas (i.e. HPAI) at SRI-F. In addition to H5N1,
several H9N and H7N influenza virus subtypes are highly pathogenic and have
caused or have the potential to cause severe influenza epidemics. We
also plan to perform additional testing of our HIV drug candidates at
SRI-F.
We have
additional collaborations in the process of formalization for work on Dengue
viruses, HIV, Viral Conjunctivitis, HSV “cold sores” and genital herpes, and
other viruses. We typically employ more than one external laboratory to perform
testing for a particular disease agent in order to limit possible laboratory
level bias.
We have
developed lead drug candidates against a number of viral diseases.
Proof-of-principle efficacy studies in animals have been conducted successfully
in many of these.
Nanoviricides
are designed to work by binding to and eliminating virus particles from the
blood-stream, just as antibodies do, only potentially much better. This is
expected to result in reduction in viremia. A nanoviricide is constructed by
chemically attaching a ligand designed to bind to virus particle, to a polymeric
material that forms a flexible nanomicelle by self-assembly. If antibodies are
known to affect a viral disease, it is possible to construct a nanoviricide
against it, and there can be a general expectation of some success, depending
upon the ligand chosen. We can choose a ligand from any of a number of chemical
classes, including small chemicals, peptides, or antibody fragments or even
whole antibodies.
The
NanoViricides’ Concept and Antiviral Strategy
The
Company owns an exclusive worldwide license in perpetuity to technology that
enables the creation of nanoviricides™. A “nanoviricide” is a flexible
nano-scale material approximately a few billionths of a meter in size,
comparable to the size of a virus particle, which is chemically programmed by a
“ligand” to specifically target and attack a particular type of virus. A
nanoviricide also is capable of simultaneously delivering a devastating payload
of active pharmaceutical ingredients (API) into the virus particle, to destroy
its genome (RNA/DNA).
A
nanoviricide is designed to “look like” the portion of a cell membrane to which
a virus particle binds, in a sense. This biomimetic approach is expected to fool
the virus into binding to the nanoviricide, and in an attempt to “enter” it, it
is thought that the virus particle may get destroyed. This is because viruses
have developed ways of uncoating themselves once they enter a cell, in order to
expose the viral genomic material so that it can hijack the cellular machinery
to make its own copies. We call this the “passive view” of how a nanoviricide
may work.
A
nanoviricide is designed as a flexible material, that self-assembles, at about
the same size scale as a typical virus particle. The flexible material we use is
one type of a special polymeric material called TheraCour®, invented by the
Company’s founders. It assembles in solution into a flexible ball, somewhat like
a ball of hair. We call this a nanoviricide micelle, or “nanomicelle” for short.
On first contact with a virus particle, a nanoviricide micelle may bind to a
virus particle because of specific interaction between a ligand attached to the
nanoviricide and the glycoproteins on the virus surface. This may cause the
flexible nanoviricide to reach very close to the virus surface, leading to
additional ligands binding to additional viral coat proteins, in a mode called
“cooperative binding”. Cooperative binding is a well known natural
process that forms the basis of biological recognition such as antibody-antigen
binding, DNA hybridization, and protein assembly, among others. Eventually it is
thought that the interior of the nanomicelle, which is lipidic (oil-like) in
nature, would fuse with the exterior lipidic coat of the virus particle. This
lipidic fusion is also a well known natural process. Such fusion may lead to the
flexible nanomicelle spreading onto the virus surface much like an oil-slick
covering a golf ball. In the process, the coat proteins that the virus uses for
binding to cells may be expected to become unavailable, and are also likely to
even get stripped off completely. The virus particle would then be rendered
incapable of binding to a cell, and thus no longer infectious or capable of
causing disease or of making copies of itself. We call this the “active view” of
how a nanoviricide may work.
Nanoviricides
thus are designed to employ the “Bind-Encapsulate-Destroy” strategy, which is
akin to the “Find-Encircle-Destroy” war strategy that has been successfully
employed historically in many wars.
Antibodies
are a major defense of humans and animals against viruses. After a person is
infected by one particular virus, he/she develops antibodies against the virus.
The infection is fully controlled after a strong antibody response develops.
Subsequent exposure to the same virus does not cause disease. However,
antibodies by themselves do not destroy a virus particle. After a few antibodies
bind to a virus particle, several processes must take place that eventually lead
to destruction of the virus particle. Many viruses have developed ways of
dysregulating this complex immune response cascade.
Nanoviricides,
on the other hand, are designed as “programmed nanomachines” capable of
executing the entire strategy of “Bind-Encapsulate-Destroy” without any
dependence on or assistance from the human immune system.
Antibodies
also may be too specific to a particular virus strain, and thus viruses evade
antibodies by changing their external surface. Vaccines create antibodies in the
recipient, in order to protect the person. Vaccines are thus limited by the
nature of antibodies, and tend to be very specific to particular strains or
groups of strains of a virus. This is why a new seasonal vaccine must be
formulated for influenza every year. This is also why a novel influenza strain
such as bird flu (H5N1) or the 2009/”Swine flu” virus cannot be defended against
by existing vaccines.
Despite
all evolutionary/spontaneous changes such as mutations, re-assortments,
recombinations, etc., a particular virus retains its ability to bind to the same
features on the cell surface at the same sites. In designing a nanoviricide, we
pay particular attention to the design and selection of a ligand. We generally
choose a ligand that mimics the cell surface features to which all virus strains
of a particular virus are known to bind. We therefore believe that a resistant
viral strain against a nanoviricide would be far less likely to occur than
resistance development against any other antiviral agent strategy. If, however,
such resistance does occur, a new nanoviricide can be developed by changing the
ligand appropriately.
We
designed the nanoviricides to act by a novel set of multiple, concerted, mechanisms. However, being
so novel, our drugs are not directly comparable to existing anti-viral
therapies. Thus, the safety and efficacy of the nanoviricides needs to be
established by experimentation, and cannot be anticipated on the basis of any
similar information regarding existing drugs. It is
important to realize that the flexible nanoviricides nanomedicines show
substantial advantages over hard sphere nanoparticles in this antiviral drug
application. Hard sphere nanomaterials such as dendritic materials (dendrimers),
nanogold shells, silica, gold or titanium nanospheres, polymeric particles,
etc., were never designed to be capable of completely enveloping and
neutralizing the virus particle.
The
Company does not claim to be creating a cure for viral diseases. The Company's
objectives are to create the best possible anti-viral nanoviricides and then
subject these compounds to rigorous laboratory and animal testing towards US FDA
and international regulatory approvals. Our long-term research efforts are aimed
at augmenting the nanoviricides that we currently have in development with
additional therapeutic agents to produce further improved anti-viral agents in
the future.
The
Company plans to develop several drugs through the preclinical studies and
clinical trial phases with the goal of eventually obtaining approval from the
United States Food and Drug Administration (“FDA”) and International regulatory
agencies for these drugs. The Company plans, when appropriate, to seek
regulatory approvals in several international markets, including developed
markets such as Europe, Japan, Canada, Australia, and Emerging Regions such as
Southeast Asia, India, China, Central and South America, as well as the African
subcontinent. The seeking of these regulatory approvals would only come when and
if one or more of our drugs, now in early stage of pre-clinical development, has
significantly advanced through the US FDA regulatory process. If and as these
advances occur, the Company may attempt to partner with more established
pharmaceutical companies to advance the various drugs through the approval
process.
There can
be no assurance that the Company will be able to develop effective
nanoviricides, or if developed, that we will have sufficient resources to be
able to successfully manufacture and market these products to commence
revenue-generating operations.
There can
be no assurance that other developments in the field would not impact our
business plan adversely. For example, successful creation and availability of an
effective vaccine may reduce the potential market size for a particular viral
disease.
The
Company's headquarters are currently in West Haven, Connecticut.
We plan
on undertaking the development of drugs against other viruses when adequate
financing becomes available. The Company's ability to achieve progress in the
drugs in development is dependent upon available financing and upon the
Company's ability to raise capital. The Company will negotiate with
TheraCour to obtain licenses for additional viral diseases as necessary.
However, there can be no assurance that TheraCour will agree to license these
materials to the Company, or to do so on terms that are favorable to the
Company.
The total
market size of drugs for the programs in which we already have lead drug
candidates are estimated to be over $40B in 2013.
“H1N1
Swine Flu”, Common Influenzas, High Path Avian Influenzas, Bird Flu, Epidemic
and Pandemic Influenzas
Our
FluCide™ program lead drug candidate has shown efficacies animals that far
exceed that of known drugs such as oseltamivir (Tamiflu®, Roche) against common
influenza in an animal model. Until last year, we had three different drug
development programs for influenzas: FluCide for common influenzas, FluCide-HP™
for highly pathogenic influenzas, and AviFluCide™ specific to H5N1 bird flu. We
have consolidated all three of our influenza drug programs into a single,
broadly active, yet highly effective, pan-influenza FluCide program. The new
FluCide is expected to be highly active against all influenzas, including highly
pathogenic strains such as H5N1, the novel H1N1/2009 Mexico/California “Swine
Flu” epidemic strain, H3N2, H7N, and H9N among others. We are currently
developing a single drug for all influenzas, whether pandemic, epidemic,
seasonal, novel, emerging, human, swine, or avian. We anticipate significant
cost savings as well as simplification in regulatory and eventual marketing
efforts by consolidating these drug programs.
Recently,
with additional SAR (structure-activity-relationship) studies, we have been able
to develop influenza virus binding ligands that are expected to be superior to
the previously used ligands in FluCide-HP. The new ligands are designed to be
closer mimics of the sialic acid receptors (than the previously employed ones),
yet capable of binding to influenza virus hemagglutinin proteins that use either
the “avian” or the “human” types of sialic acid receptors. Pigs are known to be
a “mixing vessel” species, exhibiting both avian and human types of sialic acid
receptors, and thereby re-assortment (mixing) of genetic material from influenza
strains, subtypes, or types, with different host specificities can occur readily
in pigs. We are actively seeking partnerships, collaborations and government
funding for our anti-influenza drug program.
Viral
Diseases of the Eye: Viral Conjunctivitis, Viral Keratitis – Eye
Drops
We are
developing a nanoviricide against adenoviral Epidemic Kerato-Conjunctivits
(EKC). EKC is a severe disease of the eye which in some people causes long term
or permanent blurred vision. In an animal study, our EKCCide™ lead candidate was
shown to rapidly resolve the clinical signs of the disease, when treatment was
started after infection had set in. The clinical success included demonstration
that no SEI’s (immunoprecipitates) were formed in treated animals, as opposed to
control group. SEI’s are known to be the cause of blurred vision. There are
currently no approved drugs available against EKC, and it is an active field of
drug development research. There are about 2.5 million cases of EKC annually in
the USA alone.
The
Company is not aware of any animal studies of anti-EKC drug candidates that have
demonstrated resolution of clinical disease. Based on these successful results,
we expanded our program to develop a single broad-spectrum nanoviricide
treatment effective against most of the viruses causing external eye diseases,
including viral conjunctivitis and viral keratitis. A large majority of external
eye viral infections are caused by adenoviruses or herpes simplex viruses
(mainly HSV-1).
We have
now successfully developed drug candidates that are effective against both
adenoviruses and against HSV-1, viruses that cause most of the viral diseases of
the external eye. Additional animal testing against HSV-1 infection of the eye
is being commissioned at two independent external research centers.
HSV and
some adenoviruses cause most of the cases of keratitis, a serious infection of
the cornea (approximately 250,000 US cases/year). Importantly, HSV infection can
lead to corneal scarring that may necessitate corneal
transplantation. In addition, some adenoviruses cause a majority of
conjunctivitis cases (“Pink eye”). The remaining cases of
conjunctivitis are caused by bacteria and are treatable with topical
antibiotics. Currently there are no effective treatments for viral
diseases of the exterior portion of the eye.
The
nanoviricide eye drug candidate is formulated as simple eye drops.
The total
market for viral conjunctivitis and keratitis is estimated to be in the billions
of dollars. The incidence of severe herpes keratitis is estimated to
be 250,000 cases per year in the USA. In Japan, where EKC is a
reportable disease, it is estimated that there are at least one million cases
per year. The number of cases of non-specific conjunctivitis (pink
eye) is considered to be far greater, possibly into the tens of millions in the
US and hundreds of millions worldwide.
On May 6,
2009, the Company entered into a Clinical Study Agreement with TheVac, LLC, a
company affiliated with the Emerging Technology Center of the Louisiana State
University. At present, TheVac is performing biological testing of anti-herpes
nanoviricides. TheVac is conducting studies on the effect of anti-herpes
nanoviricide drug candidates developed for use against herpes cold sores and
genital herpes in cell culture models. In addition, TheVac is also conducting
studies on the effect of anti-herpes nanoviricides drug candidates in a mouse
model of herpes keratitis. Professor Gus Kousoulas and his team at Louisiana
State University have validated and published on this animal model extensively
in peer-reviewed scientific journals.
HIV
Our very
first animal studies in the standard SCID-hu mice against HIV-I have
demonstrated that our primary nanoviricide drug candidate, HIVCide, as well as
several other nanoviricide drug candidates were found to be superior
to the three-drug oral cocktail (HAART) that is the current standard of
care.
We
designed the anti-HIV nanoviricides using rational drug design principles. The
ligands we have designed in the case of HIV-1 are thought to be broadly
neutralizing. In-silico modeling indicates that our ligands dock to the
conserved CD4 binding site of gp120 of HIV-1. We have even observed successful
docking of some of our ligands with gp120 of the HIV-1 JRFL strain which is
thought to be resistant to HAART.
Resistance
to HAART eventually leads to AIDS. It is possible that HIVCide can be used in
addition to HAART to obtain even stronger beneficial effects, resulting in a
“functional cure” of HIV. We believe that the term “Functional Cure”
of HIV may be defined as: The HIV genome integrates into certain human cells
that go into hiding or dormancy for several years. While dormant, the HIV genome
does not produce HIV virus particles or HIV proteins to any significant extent
and are thought to remain unaffected by current anti-HIV drugs. The current
standard treatment results in very low levels of HIV viremia, but the immune
cells (CD4+ T cells and CD8+T cells) count eventually begins decreasing at a
slow rate. The HAART therapy must be continued for the life of the
patient. A more effective therapy could result in complete loss of
HIV from the blood stream. This may eliminate the slow loss of
healthy immune cell populations, and allow immune system function to return to
normal. Patients may then enjoy a normal life without further daily
treatment, until an episode occurs which mobilizes the “sleeping” cells
containing the HIV genome. Such a therapy would be called a “functional cure”
against HIV. A total cure of HIV would require elimination of the dormant cell
pool containing the HIV genome. Research in the field of reactivating the
dormant pool of HIV infected cells is encouraging. If these cells can be
reactivated, and simultaneously the HIV viremia controlled, researchers have
proposed that this could lead to reduction in the dormant infected cell pool. If
their hypotheses are correct, HIVCide could lead to an eventual cure, possibly
in combination with other drugs.
Nanoviricides
act by a different mechanism than standard anti-HIV therapy. The Company
believes, therefore, that by combining a nanoviricide with current therapy, a
functional cure of HIV may be already achievable. However, there is no way to
predict whether such a treatment would be successful at providing a functional
cure of HIV at present.
Additional
studies in cell cultures are planned to be conducted in the next six months. We
have executed a Master Service Agreement (MSA) with Southern Research Institute,
Infectious Diseases Division, Frederick, MD (SRI-F) to conduct these studies.
SRI-F is a well established Contract Research Organization (CRO) that has
developed, conducted, and published in scientific journals on standardized study
protocols for various mechanisms of anti-HIV action, including microbicides,
antibodies, and small chemical therapeutics. We are also planning additional
animal studies of these drug candidates. We are also planning
additional animal model studies of the HIVCide™ lead drug
candidate.
HIVCide
is expected to be a significant anti-HIV candidate, acting by a novel mechanism
of action and a first-in-class therapeutic, based on current preliminary
data. We intend to develop it further.
Herpes
“Cold Sores” and Genital Herpes
We have
developed nanoviricide drug candidates that are capable of attacking the herpes
virus that causes cold sores and genital herpes. These drug candidates are
designed so that they can be easily formulated as a skin cream or gel
formulation in order to be able to apply readily to cold sores or genital
lesions caused by herpes.
We have
successfully tested these drug candidates in a cell culture model for
effectiveness against Herpes Simplex Virus (HSV-1) infection. This
testing was conducted by TheVac, LLC laboratories at the Louisiana Emerging
Technology Center located within the Louisiana State University (LSU) campus in
collaboration with the LSU School of Veterinary Medicine.
Four
different nanoviricides showed greater than 10,000-fold (>99.99% or 4-logs)
reduction in virus quantity compared to untreated controls in a cell culture
assay employing the LSU proprietary green-fluorescent-protein-tagged (GFP)
modified HSV-1 McKrae strain.
These
nanoviricide drug candidates are designed to act against all herpes simplex
virus strains, including HSV-1 and HSV-2. The Company has commissioned
additional in vitro studies to confirm the results. Animal studies have also
been scheduled.
Herpes
simplex virus (HSV) causes “cold sores” or “fever blisters”, the incidence of
which is second only to the common cold (100 million recurrences annually in the
US alone). In addition, genital herpes prevalence is 67 million infected
individuals in the US alone. This represents 20% of the US population infected
with symptomatic, recurrent disease. It is also believed that a large fraction
of infected individuals remain asymptomatic. Seroprevalence (people with
antibodies) in general French population is about 67% for HSV-1 and 17% for
HSV-2. It is estimated that worldwide incidence and infection rates are very
similar to these high proportions of infection prevalence.
Existing
therapies for herpes virus infections include acyclovir and drugs chemically
related to it (e.g. gancyclovir, valcyclovir, others). These drugs, nucleoside
analogs, act by inhibiting viral DNA synthesis. However, there is known drug
toxicity due to interference with human metabolism. Currently, there is no cure
for herpes infection.
Nanoviricides
are designed to act by a novel and distinctly different mechanism compared to
existing drugs. Nanoviricides are designed to mimic the human cell surface to
which the virus binds. Our results suggest that a nanoviricide could become a
highly sought after drug against HSV.
Neglected
Tropical Diseases and Biosecurity/Biodefense Programs
Ebola,
Marburg, Dengue
We have
obtained significant positive results against Ebola, although the Ebola virus
produces a soluble glycoprotein decoy that may be capable of avoiding certain of
our virus-binding ligands.
We are
currently working on developing anti-Dengue therapeutics. Dengue is an important
NTD. According to the Centers for Disease Control and Prevention in
Atlanta (CDC), dengue fever risk is about 1 illness per 1,000 US travelers, and
it is the most common cause of fever in returned travelers from the Caribbean,
Central America, and South Central Asia. The CDC has also noted "dengue is the
most important mosquito-borne viral disease affecting humans... Each year, tens
of millions of cases of DF occur and, depending on the year, up to hundreds of
thousands of cases of Dengue hemorrhagic fever (DHF)." Dengue fever is also
called “break-bone fever”. The first or primary dengue infection has very low
fatality rates associated with it. However, when a person is infected with a
different type of dengue virus afterwards, the person is at risk of developing
Dengue Hemorrhagic Fever (DHF), or Severe Dengue fever. The fatality rate
associated with DHF/Severe Dengue may be as high as 10%. There is currently no
vaccine or cure for dengue, which causes high fever, muscular pain, headaches,
vomiting, and in some cases skin rash. WHO estimates that 2.5 billion people are
at risk of dengue fever or of DHF out of a total world population of 6.6
billion. Dengue viruses are carried by Aedes aegypti mosquito, which
is gaining ground northwards as the global climate warms up. There have been
several cases of Dengue in the southern regions of the USA.
We have
recently submitted a grant application to the Department of Defense for the
development of broad-spectrum nanoviricides that may be useful in treating
Ebola, Marburg, and Dengue viruses. This application received excellent reviews
and we were notified that it is now in the “reserve list” status, as of June,
2009. A reserve list status indicates that should the agency receive sufficient
funding in the government budgeting process, it is likely to consider the
application for funding. There is no guarantee that this grant application will
be funded. In the absence of public funding, the Company’s ability to develop
these drugs is very limited.
Rabies
Our
RabiCide™ program has resulted in candidates that have enabled survival of 20%
to 30% of infected animals after disease has set in, using a particular animal
model. Further testing is in progress in a different experimental model. We
believe that if this testing succeeds, it may be the first ever therapeutic
against rabies. Currently, rabies is a uniformly lethal disease with only
prophylactic medications available, which are comprised of human antibodies,
monoclonal antibody mixtures, and rabies vaccine virus strains. The potential
market size for a rabies drug worldwide has been estimated at $300M to $500M. In
absence of public funding, the Company’s ability to develop these drugs is very
limited.
Advanced
Technologies : ADIF™ Technologies
We
believe that our technologies and capabilities at attacking different viruses
are fairly well demonstrated. In addition, we have developed
“Accurate-Drug-In-Field™” or ADIF™ technologies that may show efficacy in
treating epidemics like H5N1, SARS or Ebola by developing a targeted therapeutic
in the field to prevent the spread of the disease.
ADIF
technology does not require any knowledge of the molecular biology of the virus,
or even its specific identification. An accurate drug, specifically targeted at
the virus, can be developed in the field, from nanomicelles stockpiled
beforehand. This enables a rapid response timeframe of as short as 3 weeks for
initial drug doses, and potentially less than 3 months for sufficient doses to
curb the spread of the virus outside the affected area. Thus ADIF technologies
are applicable to novel, or engineered viruses, or emerging infections whether
natural or man-made. This technology may have significant applications in the
Biodefense area. We believe that this is the only technology that can enable
humans to combat novel viruses before they spread disease.
We have
already demonstrated the ADIF technology capabilities successfully.
The
Strength of Our Drug Pipeline
Between
the two ends of the spectrum of specific antivirals developed during peace-time
effort, and the specific antivirals developed as a “war-like” effort (ADIF), we
have also demonstrated the capability of developing broad-spectrum
nanoviricides. Broad-spectrum nanoviricides are based on the validated
scientific fact that a large number of virus families employ the same cell
surface receptor. Our nanoviricides are designed as “cell biomimetics,” meaning
that the nanoviricides “look like” a cell to the virus. The
nanoviricide carries a portion of the broad-spectrum receptor on the nanomicelle
surface that the virus attaches to and is then entrapped or dismantled by the
nanoviricide. Such broad-spectrum nanoviricides could be stockpiled to enable
treatment of many infectious agents with very few drugs, and thus would be
valuable to worldwide disease programs, and Strategic National Stockpiling
efforts.
We
believe that the Company has a strong, wide and deep pipeline of drugs. However,
with relatively meager financial resources, the Company continues to juggle
prioritization of the various programs, and program achievements. We are also
working on bolstering our infrastructure with the objective of enabling us to
file pre-IND applications for some of our drug candidates with the FDA. The
Company has received significant interest from major pharmaceutical companies in
its Viral Eye Diseases drug candidate, and HIVCide and FluCide programs to date,
and we expect interest to increase in other programs as well. There is no
guarantee that this interest would result in any financially lucrative
co-development agreements.
All of
our programs are currently at the pre-clinical stage. We have established
preliminary proof of efficacy in cell culture and animal models, and we have
conducted preliminary safety studies that have indicated that all of our
nanoviricides are safe in the animal models as tested. We continue to
work on further experiments necessary for development of our various drug
candidates as FDA approvable drugs.
Last
year, we added two commercially important drug candidates to our pipeline,
namely HIVCide and EKCCide.
This
year, we have greatly expanded the scope of our eye anti-viral treatment to
develop drug candidate eye drops against potentially all viruses infecting the
exterior portion of the eye. Our EKCCide program has now evolved into the
broad-spectrum eye drops antiviral program, which is expected to lead to a
significant expansion in marketability as well as market size if
successful.
A
nanoviricide against Herpes cold sores and genital herpes is a new addition to
our pipeline of drug candidates this year. The market size for herpes simplex
virus treatments is in excess of $2 billion annually.
In
addition, we simplified our anti-influenza drug programs because of the high
efficacies of our new drug candidates into a single pan-Influenza broadly acting
new FluCide. This single drug is being developed for all influenza indications
including seasonal influenzas, highly pathogenic influenzas, bird flu, and novel
epidemic influenzas such as the current novel H1N1/2009. We believe that this
will reduce development costs significantly. This is also expected to help us
gain expanded market share and easier market acceptance, including stockpiling,
when a drug is approved. Emergency Use Authorization can occur under
circumstances such as the current epidemic under certain conditions after an IND
has been filed, prior to a full FDA approval. We are not at the stage of
submitting the necessary applications to the FDA as yet.
We are
developing nanoviricides for different routes of administration, choosing the
best option based on a viral disease pathology. Thus, we are developing eye drop
formulation for the viral diseases of the external eye. We are developing skin
cream and gel formulations for topical application of nanoviricides against oral
and genital herpes. All other drugs candidates including FluCide and HIVCide are
currently being developed as injectables. We believe that it will be possible in
the future to develop aerosols for influenza and nasal sprays for common colds
and similar diseases. This is possible because nanoviricides have been designed
so that they can be formulated in many different ways.
Liquidity
and Capital Resources
Requirement for Additional
Capital
We
currently have sufficient cash reserves to achieve all of our budgeted plans
through December 31, 2010, and we will need to obtain additional financing to
finance studies necessary for an investigational new drug (“IND”) filing with
the FDA.
As of
September 30, 2009 we had a cash and cash equivalent balance of $4,202,675 which
can support operations through December 31, 2010, at our current projected rate
of spending.
However,
in addition to current funds allocated to capital costs and staffing, and in
accordance with our business plan, we have also budgeted for additional capital
costs and staffing costs of approximately $2 million dollars and an additional
$3 million dollars for additional scientific studies in support of an IND filing
with the FDA, for the upcoming twenty-four months. If we are unable
to obtain this additional financing, our business plan will be
delayed.
We
anticipate that we will incur the following expenses over the next twelve
months:
1 Research
and Development subcontractor costs of $1,500,000: Including planned costs of
$1,200,000 for in-vivo and in-vitro studies for pan-influenza
FluCide, NanoViricide eye drops against EKC and other Ocular viral
deceases, HIVCide, and NanoViricides against genital and ocular Herpes, planned
for the next twelve months ending September 30, 2010. The Company has allocated
the planned costs of $1,200,000 evenly over the four drug
candidates.
2 Corporate
overhead of $750,000: This amount includes budgeted office salaries, legal,
accounting and other costs expected to be incurred by being a public reporting
company.
3 Capital
costs of $250,000: This is the estimated cost for equipment and laboratory
improvements expected during the next twelve months ending September 30,
2010.
4 Staffing
costs of $1,000,000: This is the estimated cost of hiring additional scientific
staff and consulting firms to assist with FDA compliance, material
characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology studies, and
other items related to FDA compliance, as required for development of necessary
data for filing an Investigational New Drug Application (IND) with the United
States Food and Drug Administration.
The
Company will be unable to proceed with its planned drug development progress,
meet its administrative expense requirements, capital costs, and staffing costs
after about December 31, 2010 without obtaining additional financing of
approximately $3,000,000 to $5,000,000. If we are unable to obtain
additional financing, our business plan will be significantly delayed or
curtailed. The Company continues to re-prioritize its objectives and
delay certain drug development programs until we can raise sufficient funding
that enables further development of the drugs with the goal of filing an
Investigational New Drug application (IND) to the FDA.
The
Company does not have any arrangements in place, at this time, for equity or
other financing for these further needs of $3-5 million beyond minimum
operations. However, the Copmany is in discussions with certain
investors who would provide such capital. If we are unable to obtain
additional financing, our business plan will be significantly
delayed.
The
Company has limited experience with pharmaceutical drug development. Thus, our
budget estimates are not based on experience, but rather based on advice given
by our associates and consultants. As such these budget estimates may not be
accurate. In addition, the actual work to be performed is not known at this
time, other than a broad outline, as is normal with any scientific work. As
further work is performed, additional work may become necessary or change in
plans or workload may occur. Such changes may have an adverse impact on our
estimated budget. Such changes may also have an adverse impact on our projected
timeline of drug development.
We
believe that this coming year's work-plan will lead us to obtain certain
information about the safety and efficacy of some of the drugs under development
in animal models. If our studies are not successful, we will have to develop
additional drug candidates and perform further studies. If our studies are
successful, then we expect to be able to undertake further studies in animal
models to obtain necessary data regarding the pharmaco-kinetic and
pharmaco-dynamic profiles of our drug candidates. We believe these data will
then enable us to file an Investigational New Drug (IND) application, towards
the goal of obtaining FDA approval for testing the drugs in human
patients.
Most
pharmaceutical companies expect 4 to 10 years of study to be required before a
drug candidate reaches the IND stage. We believe that because we are working in
the infectious agents area, our studies will have objective response end points,
and will be of relatively short durations. Our business plan is based on these
assumptions. If we find that we have underestimated the time duration of our
studies, or we have to undertake additional studies, due to various reasons
within or outside of our control, this will grossly and adversely impact both
our timelines and our financing requirements.
Management
intends to use capital and debt financing, as required, to fund the Company’s
operations. There can be no assurance that the Company will be able to obtain
the additional capital resources necessary to fund its anticipated obligations
for the next twelve months.
The
Company is considered to be a development stage company and will continue in the
development stage until it generates revenues from the sales of its products or
services.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK.
The
Company is not exposed to market risk related to interest rates or foreign
currencies.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation
of disclosure controls and procedures.
Based
upon an evaluation of the effectiveness of disclosure controls and procedures,
our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO") have
concluded that as of the end of the period covered by this Quarterly Report on
Form 10-Q our disclosure controls and procedures (as defined in Rules 13a-15(e)
or 15d-15(e) under the Exchange Act) were effective to provide reasonable
assurance that information required to be disclosed in our Exchange Act reports
is recorded, processed, summarized and reported within the time periods
specified by the rules and forms of the SEC and is accumulated and communicated
to management, including the CEO and CFO, as appropriate to allow timely
decisions regarding required disclosure.
b) Changes
in internal control over financial reporting.
Other
than as described above, there were no material changes in our internal control
over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act)
that occurred as of September 30, 2009, that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
None.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS.
In August
2009, the Scientific Advisory Board (SAB) was granted warrants to purchase
50,000 shares of common stock at $1.10 per share. These warrants, if not
exercised, will expire in August, 2013.
On
September 30, 2009, the Registrant accepted subscriptions from certain investors
in the aggregate amount of $3,217,400 from the offerings of shares of the
Registrant’s common stock and warrants to purchase common stock and the exercise
by the Registrant’s warrantholders of their outstanding warrants. The
offerings were commenced in June 2009, when the Registrant’s stock price levels
were approximately $0.57. The offerings were closed to investors on
August 30, 2009, after an extension by the Registrant’s Board of Directors from
the original termination date of August 14, 2009. In the Registrant’s
offering of Units comprised of shares of common stock and warrants to purchase
common stock, the Registrant accepted subscriptions for $1,337,500 for Units
consisting of 2,675,000 shares and Warrants to purchase an additional 1,337,500
shares. In the offering to its warrantholders, the Registrant raised
an aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase
3,759,800 shares. All of the warrants sold in the offerings are
exercisable at the price of $1.00 per share and expire in three
years.
For the
three months ended September 30, 2009, the Company's Board of Directors
authorized the issuance of additional 40,297 shares of its common stock with a
restrictive legend, for consulting and legal services. The Company recorded an
expense of $31,800.
All of
the securities set forth above were issued by the Company pursuant to Section
4(2) of the Securities Act of 1933, as amended, or the provisions of Rule 504 of
Regulation D promulgated under the Securities Act. All such shares issued
contained a restrictive legend and the holders confirmed that they were
acquiring the shares for investment and without intent to distribute the shares.
All of the purchasers were friends or business associates of the Company’s
Management and all were experienced in making speculative investments,
understood the risks associated with investments, and could afford a loss of the
entire investment. The Company has never utilized an underwriter for an offering
of its securities.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY
HOLDERS
None.
ITEM 5. OTHER INFORMATION
Subsequent
Events
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibit
index
Exhibit
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Certification
of Chief Executive and Interim Chief Financial Officer required by Rule
13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as
amended.
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Certification
of Chief Executive Officer and Interim Chief Financial
Officer required by Rule 13a-14(b) or Rule 15d-14(b) under the
Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350,
as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
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(b) Reports
on Form 8-K. During the fiscal quarter ended September 30, 2009, the
Company filed the following Current Reports on Form 8-K:
On July
7, 2009, the Company filed a Current Report disclosing that it had entered into
a Material Definitive Agreement with certain investors pursuant to which the
Company sold 2,100,700 shares of its common stock, par value $0.001 per share
(the "Common Stock") and warrants (the "Warrants") to purchase an additional
1,050,350 shares of Common Stock at an exercise price of $1.00 per share for an
aggregate purchase price of $1,050,350.
On August
14, 2009, the Company filed a Current Report disclosing, pursuant to Regulation
FD, that the Company issued a press release announcing that WBRZ News 2, a
television news station located in Baton Rouge, Louisiana, televised a segment
describing that the herpes simplex viral load was reduced by 99.9% in in-vitro
studios by Company drug candidates. The segment went on to describe
the studies’ findings and projected plans of future drug
development.
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Dated:
November 22, 2009
NANOVIRICIDES,
INC.
/s/ Eugene Seymour,
MD
Eugene
Seymour, M.D.
Chief
Executive Officer and Interim Chief Financial Officer and Director
(Principal
Executive and Financial Officer)
/s/ Anil
Diwan
Anil
Diwan,
President
and Chairman of the Board of Directors
24