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, 2008
Commission
File Number: 0001379006
NANOVIRICIDES,
INC.
(Exact
name of registrant as specified in its charter)
NEVADA
|
76-0674577
|
(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 £ No T
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 T
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes £ No
T
Indicate
by check mark whether the registrant is an accelerated filer (as defined in Rule
12b-2 of the Exchange Act).
Yes £ No T
The
number of shares outstanding of the Registrant's Common Stock as of November 10,
2008 was 122,705,105 shares.
FORM
10-Q
INDEX
PART
I FINANCIAL INFORMATION |
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PART
II OTHER INFORMATION |
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(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEETS
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September 30,
2008
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June 30,
2008
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Unaudited
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ASSETS
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CURRENT
ASSETS:
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Cash
and cash equivalents
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$ |
2,985,247 |
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$ |
816,386 |
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Prepaid
expenses
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426,735 |
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328,544 |
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Other
current assets
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102,873 |
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102,873 |
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Total
current assets
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3,514,855 |
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1,247,803 |
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Property
and equipment, net
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562,436 |
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133,738 |
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OTHER
ASSETS
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Security
deposit
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68,000 |
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80,000 |
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Trademarks,
net
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6,583 |
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6,709 |
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Total
Other Assets
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74,583 |
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86,709 |
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TOTAL
ASSETS
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$ |
4,151,874 |
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$ |
1,468,250 |
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LIABILITIES
AND SHAREHOLDERS’ EQUITY
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CURRENT
LIABILITIES:
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Accounts
payable – trade
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$ |
269,133 |
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$ |
295,555 |
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Accounts
payable – related parties
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546,749 |
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374,394 |
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Accrued
expenses
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93,000 |
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96,130 |
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Accrued
payroll to officers and related payroll tax
expense
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92,756 |
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258,432 |
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TOTAL
CURRENT LIABILITIES
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1,001,638 |
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1,024,511 |
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COMMITMENTS
AND CONTINGENCIES
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SHAREHOLDERS’
EQUITY
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Common
stock, $0.001 par value; 300,000,000 shares authorized at September 30,
2008; issued and outstanding:.122,705,105, and 119,270,677
at September 30, 2008 and June 30, 2008
respectively
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122,705 |
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119,271 |
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Additional
paid-in capital
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12,980,025 |
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9,532,205 |
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Deficit
accumulated during the development stage
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(9,952,494 |
) |
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(9,207,737 |
) |
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TOTAL
SHAREHOLDERS’ EQUITY
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3,150,236 |
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443,739 |
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TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY
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$ |
4,151,874 |
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$ |
1,468,250 |
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The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
(Unaudited)
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Three Months Ended
September 30,
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For
the Cumulative Period From May 12, 2005 (Inception) through
September 30, 2008
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2008
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2007
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Revenues
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$ |
- |
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$ |
- |
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$ |
- |
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Operating
expenses:
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Research
and development
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230,750 |
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158,814 |
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2,932,647 |
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Refund
credit for research and development costs
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- |
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- |
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(200,190 |
) |
General
and administrative (of this amount $73,700, $36,357, and $1,136,322 was
for stock and option based compensation to consultants and officers for
each period presented)
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526,084 |
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423,832 |
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6,561,183 |
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Total
operating expenses
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756,834 |
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582,646 |
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9,293,640 |
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Loss
from operations
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(756,834 |
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(582,646 |
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(9,293,640 |
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Other
income (expense):
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Interest
income
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12,077 |
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7,914 |
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128,155 |
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Non
cash interest on convertible debentures
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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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Total
other income (expense)
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12,077 |
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7,914 |
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(658,854 |
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Net
loss
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$ |
(744,757 |
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$ |
(574,732 |
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$ |
(9,952,494 |
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Net
loss per share: basic and diluted
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$ |
(.01 |
) |
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$ |
(.01 |
) |
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Weighted
average shares outstanding: basic and diluted
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120,341,445 |
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114,222,270 |
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The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
(UNAUDITED)
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Three Months Ended
September 30,
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For the Cumulative Period From May 12, 2005
(Inception) through
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2008
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2007
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September 30,
2008
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OPERATING
ACTIVITIES:
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Net
loss
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$ |
(744,757 |
) |
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$ |
(574,732 |
) |
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$ |
(9,952,494 |
) |
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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26,200 |
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18,400 |
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660,157 |
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Warrants
granted to scientific advisory board
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47,500 |
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14,800 |
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354,741 |
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Options
issued to officers as compensation
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- |
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3,157 |
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121,424 |
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Depreciation
and amortization
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1,628 |
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1,282 |
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10,675 |
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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 debentures
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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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(98,191 |
) |
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21,833 |
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(426,735 |
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Deferred
expenses
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- |
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|
- |
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(2,175 |
) |
Other current
assets
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|
- |
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- |
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(102,873 |
) |
Accounts
payable- trade
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123,578 |
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|
4,972 |
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|
419,133 |
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Accounts
payable –related parties
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172,355 |
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(99,080 |
) |
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|
546,749 |
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Accrued
expenses
|
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|
(3,130 |
) |
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|
(30,247 |
) |
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|
93,000 |
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Accrued
payroll to officers and related payroll tax expense
|
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|
(165,676 |
) |
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|
35,352 |
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|
|
92,756 |
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|
|
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|
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Net
cash used in operating activities
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|
(640,493 |
) |
|
|
(604,263 |
) |
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|
(7,347,458 |
) |
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INVESTING
ACTIVITIES:
|
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Security
deposit
|
|
|
12,000 |
|
|
|
- |
|
|
|
(68,000 |
) |
Purchases
of property and equipment
|
|
|
(430,200 |
) |
|
|
- |
|
|
|
(572,107 |
) |
Purchase
of trademarks
|
|
|
- |
|
|
|
- |
|
|
|
(7,587 |
) |
Net
cash used in investing activities
|
|
|
(418,200 |
) |
|
|
- |
|
|
|
(647,694 |
) |
|
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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 and warrants in connection with
private placements of common stock – net of fees
|
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|
3,227,554 |
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|
2,375,000 |
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|
8,970,379 |
|
Proceeds
from exercise of stock warrants attached to convertible
debentures
|
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|
- |
|
|
|
- |
|
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|
920,000 |
|
Proceeds
from exercise of stock options
|
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|
- |
|
|
|
- |
|
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|
90,000 |
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Stock
subscriptions received
|
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|
- |
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|
- |
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|
20 |
|
Net
cash provided by financing activities
|
|
|
3,227,554 |
|
|
|
2,375,000 |
|
|
|
10,980,399 |
|
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
2,168,861 |
|
|
|
1,770,737 |
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|
2,985,247 |
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CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
816,386 |
|
|
|
967,797 |
|
|
|
- |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD
|
|
$ |
2,985,247 |
|
|
$ |
2,738,534 |
|
|
$ |
2,985,247 |
|
The
accompanying notes are an integral part of these 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:
|
|
Three Months Ended
September 30,
|
|
|
For the Cumulative Period From May 12, 2005
(Inception) through
|
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|
|
2008
|
|
|
2007
|
|
|
September 30,
2008
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services rendered
|
|
$ |
26,200 |
|
|
$ |
18,400 |
|
|
$ |
660,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
options issued to the officers as compensation
|
|
|
- |
|
|
|
3,157 |
|
|
|
121,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
warrants granted to scientific advisory board
|
|
|
47,500 |
|
|
|
14,800 |
|
|
|
354,741 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
Warrants granted to 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
issued in connection with private placement
|
|
|
827,485 |
|
|
|
- |
|
|
|
2,090,117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock issued upon conversion of accounts
payable
|
|
|
150,000 |
|
|
|
- |
|
|
|
150,000 |
|
The accompanying notes are an
integral part of these financial statements.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
SEPTEMBER
30, 2008 AND 2007
(Unaudited)
Note
1. 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, 2008,
are not necessarily indicative of the results that may be expected for the year
ending June 30, 2009. 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, 2008.
Note
2. 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 NanoViricides, 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. 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 the
Company’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 Exchange Transaction the former NVI stockholders held
approximately 80% of the voting capital stock of the Company immediately after
the Exchange Transaction. For financial accounting purposes, this
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. 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, EDOT-COM.COM,
Inc. 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. Our
drugs are based on several patents, patent applications, provisional patent
applications, and other proprietary intellectual property held by TheraCour
Pharma, Inc., to which we have the necessary 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
us the right to include dengue fever among the viruses we are 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.
We focus
our research and clinical programs on specific anti-viral therapeutics. We are
seeking to add to our existing portfolio of products through our internal
discovery and clinical development programs and through an in-licensing
strategy. To date, the Company has not developed any commercial
products.
Note
3. 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.
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 $9,952,494 at September 30,
2008. 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
2008 and 2007 and a cash and cash equivalent balance of $2,985,247 at September
30, 2008, substantial additional financing will be required in future periods,
as the Company believes it will require in excess of $3,000,000 to fund its
operations during the next twelve months, and will also require up to $2,000,000
to finance planned capital costs, and additional staffing requirements during
the next twelve months. Please see “liquidity and Capital
resources”
Based on
the results of in-vivo and in-vitro studies which were completed in the first
calendar quarter of 2007 and the Company’s April 9, 2007 Cooperative Research
and Development Agreement, (CRADA), with the Walter Reed Army Institute of
Research, we commenced a program to seek substantial additional financing, to
meet our planned cash requirements, through private placements of our common
stock and/or incurring debt (See also Note 7). 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. On August 22, 2008, the Company
raised $3,286,000 from the sale of stock and
“Warrants.” This private placement of stock included
150,000 shares of Common Stock and 75,000 Warrants subscribed in consideration
of $150,000 worth of scientific testing performed for the
Company. Also on August 22, 2008, the Company consummated
subscriptions with its Warrants holders, thereby raising an additional
$106,250.
Management’s plan to support
the Company in operation and to maintain its business strategy is to raise funds
through public and private offerings and to rely on officers and directors to
perform essential functions with minimal compensation. If the Company does not
raise all of the money it needs from its public and private offerings, it will
have to find alternative sources, such as a secondary public offering, a private
placement of securities, or loans from its officers, directors, or others. If
the Company requires additional cash and cannot raise it, it will either have to
suspend operations until the cash is raised or cease business
entirely.
The
accompanying financial statements do not include any adjustments related to the
recoverability and classification of assets or the amounts and classifications
of liabilities that might be necessary should the Company be unable to continue
as a going concern.
Note
4. Summary of Significant Accounting Policies
For a
summary of significant accounting policies (which have not changed from
June 30, 2008 ), see the Company’s Annual Report on Form 10-K for the year ended
June 30, 2008.
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 an amendment to the existing Licensing Agreement to include
additional virus types among the virus types the Company is permitted to
manufacture, use, and offer for sale, and for a payment of a license fee to
TheraCour. TheraCour has permitted the Company to use its nanomaterials to
develop a treatment for dengue fever until such time as the Company and
TheraCour can complete an amendment to the Licensing Agreement to include dengue
fever viruses, West Niles Virus, Japanese Encephalitis Virus, and others among
the virus types we are permitted to manufacture, use and offer for sale. In
consideration for obtaining this exclusive license, 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.
As to the
license fee, there can be no assurance that the license fee will be paid or that
the amendment will be 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 Walter Reed Army Institute of Research (WRAIR), 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,
2008 and 2007 were $220,749 and $143,653 respectively, and $2,307,728 since
inception. As of September 30, 2008, pursuant to its license
agreement the company has paid a security advance of $351,878 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,
2008.
On
February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000
square feet of space in Woodbridge, Connecticut. Performance of the Registrant’s
obligations was guaranteed by TheraCour Pharma, Inc., a principal shareholder of
the Registrant and provider of the materials the Registrant uses in its
operations.
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 35,370,000 shares of the Company’s outstanding common stock as
of September 30, 2008
The FASB
has issued Interpretation No. 46 (FIN-46R) (Revised December 2003), Consolidation of Variable Interest
Entities. FIN-46R clarifies the application of Accounting Research
Bulletin No. 51, “Consolidated Financial Statements,” 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 subject of FIN-46R). FIN-46R
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.
FIN-46R
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 FIN-
46R becomes 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. for purposes of FIN-46R,
and concluded that it is not a variable interest entity that is subject to
consolidation in the Company’s financial statements under FIN-46R.
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. Lab fees charged by
KARD Scientific for services for the three months ended September 30, 2008 and
2007 were $ 0 and $ 0, respectively, and $554,235 since inception. 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, 2008
|
|
|
June 30, 2008
|
|
|
|
|
|
|
|
|
TheraCour
Pharma, Inc. *
|
|
$ |
351,878 |
|
|
$ |
236,186 |
|
Kard
Scientific, Inc. *
|
|
|
50,000 |
|
|
|
50,000 |
|
Prepaid
other **
|
|
|
24,857 |
|
|
|
42,358 |
|
|
|
$ |
426,735 |
|
|
$ |
328,544 |
|
|
|
|
|
|
|
|
|
|
(* See
Note 5. Significant Alliances and Related Parties)
(** See
Note 10, Commitments and Contingencies)
Note
7. Equity Transactions
In August
2008, the Scientific Advisory Board (SAB) was granted warrants to purchase
50,000 shares of common stock at $1.56 per share. These warrants, if not
exercised, will expire in August 2012. The fair value of these warrants in the
amount of $47,500 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 with the following assumptions.
For the
three months ended September 30, 2008, the Company's Board of Directors
authorized the issuance of 10,153 shares of its common stock with a restrictive
legend, for consulting services. The Company recorded an expense of
$11,200.
For the
three months ended September 30, 2008, the Company's Board of Directors
authorized the issuance of additional 13,131 shares of its common stock with a
restrictive legend, for legal services. The Company recorded an expense of
$15,000.
On August
22, 2008, the Company consummated subscriptions with certain investors whereby
the Company sold 3,286,000 shares (the “Shares”) of its common stock , par
value$0.001 per share (the “Common Stock”) and (“Warrants”) to purchase
1,643,000 shares of Common Stock at an exercise price of $2.00 per
share for an aggregate purchase price of $3,286,000. The 3,286,000 share private
placement of stock included 150,000 shares of Common Stock and 75,000 warrants
subscribed in consideration of $150,000 of scientific testing and other
laboratory work performed for the Company. The Warrants may be
exercised at any time and expire on September 17, 2011. The Company allocated a
relative fair value of $827,485 to these warrants, by using the Black-Scholes
option pricing model.
Also on
August 22, 2008, the Company consummated subscriptions with certain of its
Warrant holders whereby the Company offered all the holders of its $2.50
Warrants the option of exercising the Warrants at $1.00 per share of Common
Stock, of which warrants to purchase 50,000 shares of Common Stock for an
aggregate price of $50,000 were exercised. Concurrently, the Company consummated
subscriptions with certain other of its Warrant holders whereby the Company
offered all the holders of its $1.00 Warrants the option of exercising the
Warrants at $0.75 per share of Common Stock, of which warrants to purchase
75,000 shares of Common Stock for an aggregate price of $56,250 were
exercised.
Note
8. Stock Options And Warrants
Stock
Options
The
following table presents the combined activity of stock options issued for the
three months ended September 30, 2008 as follows:
Stock
Options
|
|
Number of Shares
|
|
|
Weighted Average Exercise Price per share
($)
|
|
|
Weighted Average Remaining Contractual Term
(years)
|
|
|
Aggregate Intrinsic Value
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2008
|
|
|
1,875,000 |
|
|
$ |
0.10 |
|
|
|
7.25 |
|
|
$ |
2,437,500 |
|
Granted
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Expired
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Canceled
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2008
|
|
|
1,875,000 |
|
|
$ |
0.10 |
|
|
|
6.98 |
|
|
$ |
1,406,250 |
|
Exercisable
at September 30, 2008
|
|
|
1,875,000 |
|
|
$ |
0.10 |
|
|
|
6.98 |
|
|
$ |
1,406,250 |
|
As of
September 30, 2008, there was $ -0- of unrecognized compensation cost, related
to non-vested options granted under employment contracts.
Stock
Warrants
The
following table presents the combined activity of stock warrants issued for the
three months ended September 30, 2007 as follows:
Stock
Warrants
|
|
Number of Shares
|
|
|
Weighted Average Exercise Price per share
($)
|
|
|
Weighted Average Remaining Contractual Term
(years)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2008
|
|
|
4,375,000 |
|
|
$ |
1.58 |
|
|
|
1.46 |
|
Granted
|
|
|
1,707,700 |
|
|
|
1.99 |
|
|
|
2.94 |
|
Exercised
|
|
|
(125,000 |
) |
|
|
0.85 |
|
|
|
- |
|
Expired
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Canceled
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2008
|
|
|
5,957,700 |
|
|
$ |
1.70 |
|
|
|
1.74 |
|
Exercisable
at September 30, 2008
|
|
|
5,957,700 |
|
|
$ |
1.70 |
|
|
|
1.74 |
|
Of the
above warrants, 2,250,000 expire in fiscal year ending June 30, 2009; 160,000
expire in fiscal year ending June 30, 2010; and 1,660,000 expire in fiscal year
ending June 30, 2011 and 1,837,700 expire in fiscal year ended June 30, 2012 and
50,000 expire in fiscal year ended June 30, 2013.
Note
9. Income Taxes
Deferred
taxes arise from the temporary differences between financial statements and
income tax recognition of net operating losses. The net operating loss
carryforwards will begin to expire in the year 2017 if not utilized. Utilization
of the Company’s net operating loss carryforwards are limited based on changes
in ownership as defined in Internal Revenue Code Section 382. As of September
30, 2008 the Company accumulated a tax loss of $9,001,237 resulting in a
deferred tax benefit of approximately $4,510,600 which has been offset by a 100%
valuation allowance.
During
the three months ended September 30, 2008, the valuation allowance increased by
$333,200 over the June 30, 2008 balance.
The
Company's deferred tax assets is summarized as follows:
|
|
September 30, 2008
|
|
|
June 30, 2008
|
|
Net
operating loss carryforwards
|
|
$ |
3,148,900 |
|
|
|
2,901,100 |
|
Research
and development credit
|
|
|
850,100 |
|
|
|
773,100 |
|
Other
|
|
|
511,600 |
|
|
|
503,200 |
|
Gross
deferred tax assets
|
|
|
4,510,600 |
|
|
|
4,177,400 |
|
Valuation
allowances
|
|
|
(4,510,600
|
) |
|
|
(4,177,400 |
) |
Deferred
tax assets
|
|
$ |
- |
|
|
$ |
- |
|
During
the year ended June 30, 2008, the Company recognized a refundable
Research and Development tax credit of $200,190, and has received, to date,
$110,318 of this refundable credit . The remaining credit receivable is included
under “Other Current Assets” on the Company’s Balance Sheet.
The
Company adopted the provisions of Financial Accounting Standards Board (“FASB”)
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes (“FIN 48”),
on July 1, 2007. As required by Interpretation 48, which clarifies SFAS No. 109,
Accounting for Income Taxes, the Company recognizes the financial statement
benefit of a tax
position only after determining that the relevant tax authority would make more
likely than not sustain the position following an audit. For tax positions
meeting this standard, the amount recognized in the financial statements is the
largest benefit that has a greater than 50 percent likelihood of being realized
upon ultimate settlement with the relevant tax authority. At the adoption date,
the Company applied FIN 48 to all tax positions for which the statute of
limitations remained open. The adoption of FIN 48 did not have a material impact
on the financial statements.
Note
10. Commitments and Contingencies
The
Company is dependent upon its license agreement with TheraCour Pharma, Inc. (See
Note 5). If it loses the right to utilize any of the proprietary
information that is the subject of the TheraCour Pharma license agreement
on which it depends, the Company will incur substantial delays and costs in
development of its drug candidates.
While no
legal actions are currently pending, the Company may be party to certain claims
brought against it arising in the ordinary course of business. It is not
possible to estimate the ultimate liability, if any, in these matters. In
Management’s opinion, the ultimate resolution of such claims is not expected to
have a material adverse effect on the financial position of the
Company.
The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 4,100 square feet of office and
laboratory space at a base monthly rent of $4,692 Commencing September 1, 2008
the Company rented additional storage space and the base monthly rent increased
to $7,192. 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 is until January 30, 2009 at a monthly rent of $11,667, plus an
additional $500 per month for utilities.
Total
rent expense amounts to $51,577 and $40,628 for the three months ended September
30, 2008 and 2007 respectively, and $296,754 for the period from
inception.
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, 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 NanoViricide, 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., 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. We focus our laboratory research and
pre-clinical programs on specific anti-viral solutions. 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 those of these additional viruses that the
Company determines it wants to follow for further development. 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.
The
Company has incurred significant operating losses since its inception resulting
in an accumulated deficit of $9,952,494 at September 30, 2008. For the three
months ended September 30, 2008 the Company had a net loss of $744,757. 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. The 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.
The 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 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 the Armed Forces Institute of Pathology (AFIP) and
NIHE for High-Path or Highly Pathogenic Avian Influenzas (which in addtion to
H5N1, several H9N as well as H7N influenza virus subtypes are highly pathogenic
and have cause or have the potential to cause severe influenza epidemics), and
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
EKC. In addition, our HIV and common influenza studies were
subcontracted to KARD Scientific, Inc., USA. We have additional collaborations
in formalization process for work on Dengue viruses, HIV, and other
viruses.
We have
developed lead drug candidates against a number of 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 results
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.
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 comprise 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.
Our
FluCide™ program has a lead drug candidate that has shown efficacies in animals
that far exceed the known drugs such as oseltamivir (Tamiflu®, Roche). Our
FluCide-HP™, has demonstrated efficacies superior to FluCide against both Clade
1 and Clade 2 H5N1 strains, and is expected to be effective against all High
Path influenzas, based on theoretical expectations. With its high efficacies and
spectrum of all potentially epidemic influenza causing viruses, we have been
able to stop the development of H5N1-specific AviFluCide in laboratory
models.
We have
obtained significant positive results against Ebola, although additional
development was expected to be required even as we engaged into this program,
because Ebola virus produces a soluble glycoprotein decoy that may be capable of
fooling certain of our virus-binding ligands.
We are
currently working on developing anti-Dengue therapeutics.
We
recently developed 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. The Company is not aware of
any other animal studies of anti-EKC drug candidates that have demonstrated
resolution of clinical disease. There are about 2.5 million cases of EKC
annually in the USA alone. The EKC market size worldwide is estimated variously
between $300M and $1,000M.
1. Our
very first animal studies in SCID-hu mice against HIV-I have resulted in a
demonstration that our primaryt nanoviricide drug candidate and as
well as several other nanoviricide drug
candidates in the HIVCide™ program were found to be superior to the
three-drug oral cocktail (HAART) given according to standard
protocol. 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, which may result in a “functional cure” of HIV as defined by
Dr. Fauci of NIAID (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 in hiding, they do not produce HIV
to any significant extent and are thought to remain unaffected by current
anti-HIV drugs. The standard treatment results in very low levels of HIV
viremia, but the immune cells (CD4+ T cells) do not increase in count, and may
in fact be decreasing at a slow rate. A more effective therapy could result in
complete loss of HIV from the blood stream, allowing immune system function to
return to normal, and thereby allowing the patient to enjoy normal life without
further daily treatment, until an episode occurs which mobilizes the “sleeping”
cells containing 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. 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 achieved.
However, there is no way to predict whether such a treatment would be successful
at providing a functional cure of HIV at present). Nevertheless, we believe that
HIVCide is a significant anti-HIV candidate, based on current preliminary data,
and we intend to develop it further.
We
believe that our technologies and capabilities at attacking different viruses
are fairly well demonstrated. Our nanoviricides against specific viruses are
discussed earlier. In addition, we have developed “Accurate-Drug-In-Field™” or
ADIF™ technologies that may show efficacy in treating epidemics like H5N1, SARS
or Ebola at source by preventing their spread using a therapeutic developed
directly in the field. ADIF technologies are applicable to novel, or engineered
viruses, or emerging infections whether natural or man-made. This technology may
have significant applications in Biodefense area. Between these two
spectrums of specific antiviral developed during peace-time effort, and specific
antivirals developed as a “war-like” effort (ADIF), we have demonstrated the
capability of developing broad-spectrum nanoviricides. Broad-spectrum
nanoviricides are based on the notion that a large number of virus families
employ the same cell surface receptor. Thus, if we constructed a nanoviricide
that “looks like” a cell to the virus, by carrying the portion of such
broad-spectrum receptor on the nanomicelle surface, the virus would “try to
infect” such a cell biomimetic, and could in the process get entrapped or
dismantled. A nanoviricide is designed as a cell biomimetic, and this has made
our broad-spectrum nanoviricides approach possible. 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 therefore that the Company has a strong, wide and deep pipeline of drugs
several years into the future. 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 or
some of our drug candidates to the FDA. The Company has received significant
interest from major pharmaceutical companies in its EKCCide and HIVCide programs
to date, and we expect interest to pick up 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 conducted preliminary safety studies and have
obtained indications that all of our nanoviricides are safe to the
animal models, and continue to work on further experiments necessary for
development as drugs.
All of
these drugs candidates are being developed as injectables, except EKCCide which
is an ophthalmic formulation or eye drops solution.
Plan
of Operations
The
Company’s drug development business model was formed in May 2005 with a license
to the patents and intellectual property held by TheraCour Pharma, Inc. that
enabled creation of drugs engineered specifically to combat viral diseases in
humans. This exclusive license from TheraCour Pharma Inc. serves as a foundation
for our intellectual property. The Company was granted a worldwide exclusive
perpetual license to this technology for several drugs with specific targeting
mechanisms in perpetuity for the treatment of the following human viral
diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV), 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
those of these additional viruses that the Company determines it wants to follow
for further development. 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.
The
Company intends to perform the regulatory filings and own all the regulatory
licenses for the drugs it is currently developing. The Company will develop
these drugs in part via subcontracts to TheraCour Pharma, Inc., the exclusive
source for these nanomaterials. With sourcing of materials from TheraCour
Pharma, Inc., the Company prefers to manufacture these drugs in our own
facility. However, the Company may manufacture these drugs under subcontract
arrangements with external manufacturers that carry the appropriate regulatory
licenses and have appropriate capabilities. The Company intends to distribute
these drugs via subcontracts with distributor companies or in partnership
arrangements. The Company plans to market these drugs either on its own or in
conjunction with marketing partners. The Company also plans to actively pursue
co-development, as well as other licensing agreements with other Pharmaceutical
companies. Such agreements may entail up-front payments, milestone payments,
royalties, and/or cost sharing, profit sharing and many other instruments that
may bring early revenues to the Company. Such licensing and/or co-development
agreements may shape the manufacturing and development options that the company
may pursue. The Company has received significant interest from certain major
Pharmaceutical companies for potential licensing or co-development of some of
our drug candidates. However, none of these distributor or co-development
agreements is in place at the current time.
To date,
we have engaged in organizational activities; developing and sourcing compounds
and preparing nano-materials; and experimentation involving preclinical studies
using cell cultures and animals. We have generated funding through the issuances
of debt and private placement of common stock (see Item 5 Recent Sales of
Unregistered Securities). 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 we may not
become profitable in the future. We have incurred net losses in each fiscal
period since inception of our operations.
Liquidity
and Capital Resources
Requirement for Additional
Capital
We
currently do not have sufficient cash reserves to achieve all of our budgeted
plans for the next twelve months and we may not be able to obtain the necessary
financing.
As of
September 30, 2008 we had a cash and cash equivalent balance of $2,985,247,
which can support operations through June 30, 2009, at our current 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 for the upcoming
twelve months. If we are unable to obtain this additional financing,
our business plan will be delayed.
Assuming
that we are successful in raising this additional financing, we anticipate that
we will incur the following expenses over the next twelve months:
1 Research
and Development of $1,500,000: Includes planned costs of $1,200,000 for multiple
drug variations and in-vivo and in-vitro studies for
FluCide-1™, FluCide HP™, RabiCide, EKCCide, HIVCide, and Dengue and
Ebola/Marburg programs, planned for the year ending June 30, 2009. The Company
has allocated the planned costs of $1,200,000 evenly over the seven 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 $1,250,000: This is the estimated cost for equipment and laboratory
improvements expected during the year ending June 30, 2009.
4 Staffing
costs of $1,500,000: 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, 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 June 30, 2009 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 will 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, at this time, for equity or other
financing for these further needs of $3-5M beyond minimum
operations. 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.
Going
Concern
The
accompanying financial statements have been prepared assuming the Company will
continue as a going concern. The Company incurred cumulative losses of
$9,952,494 through September 30, 2008. In addition, the Company has not
generated any revenues and no revenues are anticipated and has significant
capital requirements. These conditions raise substantial doubt about the
Company’s ability as a going concern. Management recognizes that in order to
meet the Company’s capital requirements and continue to operate, additional
financing will be necessary.
Management's
plan to support the Company in operation and to maintain its business
strategy is to raise funds through public and private offerings and to rely on
officers and directors to perform
essential functions with minimal compensation. If the Company does not raise all
of the money it needs from its Public and private offerings, it will have to
find alternative sources, such as a secondary public offering a private
placement of securities, or loans from its officers, directors, or others. If
the Company requires additional cash and cannot raise it, it will either have to
suspend operations until the cash is raised or cease business entirely. The
financial statements do not include any adjustment that might result from the
outcome of this uncertainty.
The
accompanying financial statements do not include any adjustments related to
recoverability and classification of assets or the amounts and classifications
of liabilities that might be necessary should the Company be unable to continue
as a going concern.
The
Company is not exposed to market risk related to interest rates or foreign
currencies.
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 not effective as of September 30, 2008
because of the material weaknesses discussed below. Notwithstanding the material
weaknesses discussed below, our Management has concluded that the financial
statements included in this Quarterly Report on Form 10-Q fairly present in all
material respects our financial condition, results of operations and cash flows
for the periods presented in conformity with generally accepted accounting
principles.
1. Timeliness of
Financial Reporting: Our Chief Executive Officer and Interim Chief
Financial Officer concluded that the Company's controls were not effective as of
September 30, 2008 due to inherent weaknesses present in the preparation of
financial statements as a result of the departure of its Chief Financial Officer
on May 16, 2007.
2. Segregation of
Duties: We did not maintain adequate segregation of duties
related to job responsibilities for initiating, authorizing, and recording of
certain transactions. Due to this material weakness, there is a
reasonable possibility that a material misstatement in the financial statements
would not be prevented or detected on a timely basis.
The
Company is taking steps for remediation of these weaknesses including the active
search for a controller and chief financial officer.
Changes
in Internal Control Over Financial Reporting
As
reported herein and in our Annual Report on Form 10-K for the year ended June
30, 2008, Management is aware that there is a significant deficiency in our
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 during the
quarter ended September 30, 2008 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II. OTHER INFORMATION
None.
In
August, 2008, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $1.56 per share. These warrants, if
not exercised, will expire in August, 2012.
For the
three months ended September 30, 2008, the Company's Board of Directors
authorized the issuance of 10,153 shares of its common stock with a restrictive
legend, for consulting services. The Company recorded an expense of
$11,200.
For the
three months ended September 30, 2008, the Company's Board of Directors
authorized the issuance of additional 13,131 shares of its common stock with a
restrictive legend, for legal services. The Company recorded an expense of
$15,000.
On August
22, 2008, the Company consummated subscriptions with certain investors whereby
the Company sold 3,286,000 shares (the “Shares”) of its common stock , par
value$0.001 per share (the “Common Stock”) and (“Warrants”) to purchase
1,643,000 shares of Common Stock at an exercise price of $2.00 per
share for an aggregate purchase price of $3,286,000. The 3,286,000 share private
placement of stock included 150,000 shares of Common Stock and 75,000 warrants
subscribed in consideration of $150,000 of scientific testing and other
laboratory work performed for the Company. The Warrants may be
exercised at any time and expire on September 17, 2011
Also on
August 22, 2008, the Company consummated subscriptions with certain of its
Warrant holders whereby the Company offered all the holders of its $2.50
Warrants the option of exercising the Warrants at $1.00 per share of Common
Stock, of which warrants to purchase 50,000 shares of Common Stock for an
aggregate price of $50,000 were exercised. Concurrently, the Company consummated
subscriptions with certain other of its Warrant holders whereby the Company
offered all the holders of its $1.00 Warrants the option of exercising the
Warrants at $0.75 per share of Common Stock, of which warrants to purchase
75,000 shares of Common Stock for an aggregate price of $56,250 were
exercised.
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.
None.
None.
None
(a) Exhibit
index
Exhibit
|
|
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.
|
|
|
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.
|
(b) Reports
on Form 8-K. During the fiscal quarter ended September 30, 2008, the
Company filed the following Current Reports on Form 8-K:
:
On August
29, 2008 the Company filed a Current Report disclosing the Company’s sale of
3,286,000 shares of common stock and warrants to purchase 1,643,000 shares of
common stock to certain investors. On September 9, 2008 and September 30, 2008,
the Company filed a Current Report disclosing under Regulation FD transcripts of
interviews given by its Chief Financial Officer on September 3, 2008 and
September 26, 2008, respectively
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 18, 2008
NANOVIRICIDES,
INC.
/s/ Eugene Seymour, MD
|
|
Eugene
Seymour, M.D.
|
Chief
Executive Officer and Interim Chief Financial Officer and
Director
|
|
|
|
|
|
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/s/ Anil Diwan
|
|
Anil
Diwan,
|
President
and Chairman of the Board of
Directors
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23