form10.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 March 31, 2008
Commission
File Number: 0001379006
NANOVIRICIDES,
INC.
(Exact
name of registrant as specified in its charter)
NEVADA
|
76-0674577
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(State
or other jurisdiction)
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(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 x
No o
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 £
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Non-accelerated
filer £
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Smaller
reporting company T
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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 May 18, 2008
was 119,240,835 shares.
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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March 31,
2008
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June 30,
2007
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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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$ |
1,210,836 |
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$ |
967,797 |
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Prepaid
expenses
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338,572 |
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251,722 |
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Other
current assets
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179,050 |
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5,000 |
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Total
current assets
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1,728,458 |
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1,224,519 |
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Property
and equipment, net
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65,803 |
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18,487 |
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OTHER
ASSETS
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Security
deposit
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88,333 |
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100,000 |
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Trademarks,
net
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6,962 |
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7,215 |
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Total
Other Assets
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95,295 |
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107,215 |
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TOTAL
ASSETS
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$ |
1,889,556 |
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$ |
1,350,221 |
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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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$ |
119,602 |
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$ |
72,845 |
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Accounts
payable – related parties
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114,773 |
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262,038 |
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Accrued
expenses
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41,237 |
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65,000 |
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Accrued
payroll to officers and related payroll tax
expense
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237,605 |
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450,000 |
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TOTAL
CURRENT LIABILITIES
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513,217 |
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849,883 |
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COMMITMENTS
AND CONTINGENCIES
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SHAREHOLDERS’
EQUITY
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Common
stock, $0.001 par value; 300,000,000 shares authorized, issued and
outstanding: 119,240,981 and 114,069,144 at March 31, 2008 and June 30,
2007 respectively
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119,241 |
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114,069 |
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Additional
paid-in capital
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9,472,103 |
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6,855,689 |
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Stock
subscription receivable
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(20 |
) |
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(20 |
) |
Deficit
accumulated during the development stage
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(8,214,985 |
) |
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(6,469,400 |
) |
TOTAL
SHAREHOLDERS’ EQUITY
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1,376,339 |
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500,338 |
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TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY
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$ |
1,889,556 |
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$ |
1,350,221 |
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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 March 31,
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Nine
Months Ended March 31,
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For
the Cumulative Period From May 12, 2005 (Inception)
through
March 31, 2008
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2008
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2007
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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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$ |
- |
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$ |
- |
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Operating
expenses:
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Research
and development
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232,784 |
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244,761 |
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550,273 |
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575,715 |
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2,212,743 |
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Refund
credit research and development costs
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- |
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- |
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(166,050 |
) |
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- |
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(166,050 |
) |
General
and administrative (of this amount $47,222, $200,985, $121,566, $279,822
and $1,002,470 was for stock and option based compensation to consultants
and officers for each period presented)
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572,534 |
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683,605 |
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1,408,932 |
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1,732,285 |
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5,491,227 |
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Total
operating expenses
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805,318 |
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928,366 |
) |
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1,793,155 |
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2,308,000 |
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7,537,920 |
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Loss
from operations
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(805,318 |
) |
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(928,366 |
) |
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(1,793,155 |
) |
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(2,308,000 |
) |
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(7,537,920 |
) |
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Other
income (expense):
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Interest
income
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14,431 |
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10,247 |
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47,570 |
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50,937 |
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109,944 |
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Non
cash interest on convertible debentures
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- |
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- |
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- |
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(
7,644 |
) |
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(73,930 |
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Non
cash interest expense on beneficial conversion feature
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of
convertible debentures
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- |
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- |
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- |
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(82,918 |
) |
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(713,079 |
) |
Total other income
(expense)
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14,431 |
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10,247 |
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47,570 |
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(39,625 |
) |
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(677,065 |
) |
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Net
loss
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$ |
(790,887 |
) |
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$ |
(918,119 |
) |
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$ |
(1,745,585 |
) |
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$ |
(2,347,625 |
) |
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$ |
(8,214,985 |
) |
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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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$ |
(.02 |
) |
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$ |
(.02 |
) |
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Weighted
average shares outstanding: basic and diluted
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119,196,586 |
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112,626,302 |
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117,489,413 |
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112,085,679 |
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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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Nine Months Ended
March 31,
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For
the Cumulative Period From May 12, 2005 (Inception) through
March 31, 2008
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2008
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2007
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OPERATING
ACTIVITIES:
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Net
loss
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$ |
(1,745,585
|
) |
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(2,347,625 |
) |
|
$ |
(8,214,985 |
) |
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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|
84,022 |
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|
164,160 |
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|
606,058 |
|
Warrants
granted to scientific advisory board
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|
30,500 |
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|
88,740 |
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|
274,988 |
|
Options
issued to officers as compensation
|
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|
7,044 |
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|
26,922 |
|
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|
121,424 |
|
Depreciation
and amortization
|
|
|
4,783 |
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|
1,615 |
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|
|
7,402 |
|
Amortization
of deferred financing expenses
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|
- |
|
|
|
6,714 |
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|
|
51,175 |
|
Non
cash interest on convertible debentures
|
|
|
- |
|
|
|
7,644 |
|
|
|
73,930 |
|
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
|
|
- |
|
|
|
82,918 |
|
|
|
713,079 |
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
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|
Prepaid
expenses
|
|
|
(86,850 |
) |
|
|
(150,957 |
) |
|
|
(323,572 |
) |
Deferred
expenses
|
|
|
- |
|
|
|
- |
|
|
|
(2,175 |
) |
Other current
assets
|
|
|
(174,050 |
) |
|
|
(100,000 |
) |
|
|
(194,050 |
) |
Accounts
payable- trade
|
|
|
46,757 |
|
|
|
12,624 |
|
|
|
119,602 |
|
Accounts
payable –related parties
|
|
|
(147,265
|
) |
|
|
81,682 |
|
|
|
114,773 |
|
Accrued
expenses
|
|
|
(23,763
|
) |
|
|
(62,431 |
) |
|
|
41,237 |
|
Accrued
payroll to officers and related payroll tax expense
|
|
|
(212,395
|
) |
|
|
163,718 |
|
|
|
237,605 |
|
Other
payroll taxes payable
|
|
|
- |
|
|
|
3,711 |
|
|
|
- |
|
Net
cash used in operating activities
|
|
|
(2,216,802
|
) |
|
|
(2,020,565 |
) |
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|
(6,373,509 |
) |
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INVESTING
ACTIVITIES:
|
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Security
deposit
|
|
|
11,667 |
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|
- |
|
|
|
(88,333 |
) |
Purchases
of property and equipment
|
|
|
(51,846
|
) |
|
|
(18,586 |
) |
|
|
(72,580 |
) |
Purchase
of trademarks
|
|
|
- |
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|
|
(5,630 |
) |
|
|
(7,587 |
) |
Net
cash used in investing activities
|
|
|
(40,179 |
) |
|
|
(24,216 |
) |
|
|
(168,500 |
) |
|
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FINANCING
ACTIVITIES:
|
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Proceeds
from issuance of convertible debentures
|
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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
|
|
|
2,500,020 |
|
|
|
- |
|
|
|
5,742,845 |
|
Proceeds
from exercise of stock warrants attached to convertible
debentures
|
|
|
- |
|
|
|
50,000 |
|
|
|
920,000 |
|
Proceeds
from exercise of stock options
|
|
|
- |
|
|
|
- |
|
|
|
90,000 |
|
Net
cash provided by financing activities
|
|
|
2,500,020 |
|
|
|
50,000 |
|
|
|
7,752,845 |
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
243,039 |
|
|
|
(1,994,781 |
) |
|
|
1,210,836 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
967,797 |
|
|
|
2,507,102 |
|
|
|
- |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD
|
|
$ |
1,210,836 |
|
|
$ |
512,321 |
|
|
$ |
1,210,836 |
|
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:
|
|
Nine Months Ended
March 31,
|
|
|
For the Cumulative Period From May 12, 2005
(Inception) through
March 31, 2008
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services rendered
|
|
$ |
84,022 |
|
|
$ |
164,160 |
|
|
$ |
606,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
options issued to the officers as compensation
|
|
|
7,044 |
|
|
|
26,922 |
|
|
|
121,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
warrants granted to scientific advisory board
|
|
|
30,500 |
|
|
|
88,740 |
|
|
|
274,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for interest on debentures
|
|
|
- |
|
|
|
7,644 |
|
|
|
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 |
|
|
|
1,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt
discount related to beneficial conversion feature of convertible
debt
|
|
|
- |
|
|
|
- |
|
|
|
713,079 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
issued in connection with private placement
|
|
|
- |
|
|
|
- |
|
|
|
1,262,632 |
|
The accompanying notes are an
integral part of these financial statements.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
MARCH
31, 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 and nine month period ended March 31,
2008, are not necessarily indicative of the results that may be expected for the
year ending June 30, 2008. 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-KSB for
the year ended June 30, 2007.
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 solutions. 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 $8,214,985 at March 31,
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
2007 and a cash balance of $1,210,836 at March 31, 2008, substantial additional
financing will be required in future periods, as the Company believes it will
require in excess of $5,000,000 to fund its operations, 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, the Company’s October 4, 2007 Cooperative Research and
Development Agreement for Material Transfer (CRADAMT) with the United States
Army Medical Research Institute of Infectious Diseases, the Company’s
CRADA with the Armed Forces Institute of Pathology and other
agreements ( see “management’s Plan of Operation”) we have 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. During the fourth calendar quarter of 2007, the Company
had received fully paid subscriptions in the aggregate amount of $2,500,000
through the offering of shares of the Company's common stock. It is anticipated
that these funds should enable the Company to support operations through the end
of August, 2008.
Note
4. Summary of Significant Accounting Policies
Accounting Basis - The Company
has not earned any revenue from limited principal operations. Accordingly, the
Company's activities have been accounted for as those of a "Development Stage
Company" as set forth in Financial Accounting Standards Board Statement No. 7
(“SFAS 7"). Among the disclosures required by SFAS 7 are that the Company's
financial statements be identified as those of a development stage company, and
that the statements of earnings, and stockholders' equity and cash flows
disclose activity since the date of the Company's inception.
Cash and Cash Equivalents -
The Company considers highly liquid instruments with original maturities of
three months or less to be cash equivalents.
Property and Equipment -
Equipment is stated at cost and depreciated over the estimated useful lives of
the assets (generally five years) using the straight-line method.
Use of Estimates - The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those
estimates.
Reclassification – Certain
reclassifications have been made in prior year’s financial statements to conform
to classification used in the current year. Such reclassification of prepaid
expenses and other current assets has no effect on the balance of any one total
account.
Research and Development -
Research and development expenses consist primarily of costs associated with the
preclinical and or clinical trials of drug candidates, compensation and other
expenses for research and development, personnel, supplies and development
materials, costs for consultants and related contract research and facility
costs. Expenditures relating to research and development are expensed as
incurred.
Accounting for Stock Based
Compensation – The Company adopted the fair value recognition provisions
of “FASB Statement No. 123(R) Share-Based Payment”, since inception, which
requires compensation cost recognized includes compensation cost for all
share-based payment granted based on the grant-date fair value .
Option-based
officer’s compensation expense for the nine months ended March 31, 2008 and 2007
were $7,044 and $26,922. The fair value of the Company’s option-based awards
granted to executive officers on September 23, 2005, were estimated using the
Black-Scholes option-pricing model with following assumption:
Expected
life in years
|
5
years
|
Risk
free interest rate
|
3.88
to 4.10%
|
Expected
volatility
|
108.00
to 109.00%
|
Dividend
yield
|
0%
|
Computation
of expected volatility is based on the equity volatilities of four comparable
companies. The computation of expected life is as stated in employment
contracts. The risk free interest rates used in the valuations of the fair value
are based on risk free bond rates of similar time periods as the expected life
of the stock options. Because the Company has no historical forfeiture rates,
the stock option expense is not adjusted by an estimate for forfeiture as
required under FASB 123(R).
Accounting for Non-Employee Stock
Based Compensation – The Company accounts for shares and options issued
for non-employees in accordance with the provision of Emerging Issue Task Force
Issue No. 96-18, “Accounting for Equity Instruments that are issued to other
than Employees for Acquiring, or in Conjunction with selling Goods or Services”.
According to the provisions of ETIF 96-18, the Company determines the fair value
of stock and options granted to non-employees on the measurement date which is
either the date of a commitment for performance has been reached or when
performance has been completed, depending upon the facts and circumstances. The
fair value of the shares and options valued at commitment date is expensed
immediately for past services or expensed over the service period for future
services.
Income Taxes - The Company
utilizes Statement of Financial Accounting Standards No. 109, “Accounting for
Income Taxes,” which requires an asset and liability approach to financial
accounting and reporting for income taxes. The difference between the financial
statement and tax basis of assets and liabilities is determined annually.
Deferred income tax assets and liabilities are computed for those temporary
differences that have future tax consequences using the current enacted tax laws
and rates that apply to the periods in which they are expected to affect taxable
income. Valuation allowances are established, if necessary, to reduce the
deferred tax asset to the amount that will, more likely than not, be realized.
Income tax expense is the current tax payable or refundable for the year plus or
minus the net change in the deferred tax assets and liabilities.
Basis Earnings (Loss) per
Share – Basic Earnings (Loss) per Share is calculated in accordance with
SFAS No. 128, "Earnings per Share," by dividing income or loss attributable to
common stockholders by the weighted average common stock outstanding. Diluted
EPS is calculated in accordance with SFAS No. 128 by adjusting weighted average
common shares outstanding by assuming conversion of all potentially dilutive
shares. In periods where a net loss is recorded, no effect is given to
potentially dilutive securities, since the effect would be
antidilutive.
Concentrations of Risk -
Financial instruments that potentially subject us to a significant concentration
of credit risk consist primarily of cash and cash equivalents. The Company
maintains deposits in federally insured institutions in excess of federally
insured limits. The Company does not believe it is exposed to significant credit
risk due to the financial position of the depository institutions in which those
deposits are held.
Segment Reporting - As of
March 31, 2008 the Company has determined that it operates in only one segment.
Accordingly, no segment disclosures have been included in the notes to the
consolidated financial statements.
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 an exclusive license in perpetuity for
technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian
(bird) flu, Influenza and rabies. 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) we will 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, and (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.
TheraCour
has granted us the right to include Dengue Hemorrhagic Fever (DHF) Viruses, and
the Dengue Fever Viruses, Ebola/Marburg Viruses, and certain other hemorrhagic
viruses, as well as Epidemic Keratoconjuntivitis Causing Adenoviruses (EKC),
among the viruses that NanoViricides will be developing drugs to treat. The
Company and TheraCour are negotiating an amendment to the existing Licensing
Agreement to include these additional virus types among the the virus types the
Company is permitted to manufacture, use, and offer for sale. While the Company
is currently negotiating such an amendment with TheraCour, there can be no
assurance that an agreement will be reached, 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).
TheraCour
may terminate the license it has granted to the Company 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 March 31,
2008 and 2007 were $232,784 and $129,959 and for the nine months ended March 31,
2008 and 2007 were $550,273 and $460,914 respectively, and $1,890,943 since
inception. As of March 31, 2008, pursuant to its license agreement
the company has paid a security advance of $182,941 to and held by TheraCour
Pharma, Inc. which is reflected in Prepaid Expenses. The development costs are
to be partially offset by a refundable Connecticut Research and Development tax
credit of $166,050.
No
royalties are due TheraCour from the Company’s inception through March 31,
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 65% 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 March 31, 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 from Good Laboratory Practices (CGLP) style studies. 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 and nine months ended March 31, 2008 and 2007 were $ 0 in
all respective periods and $321,220 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:
|
|
March 31, 2008
|
|
|
June 30, 2007
|
|
|
|
|
|
|
|
|
TheraCour
Pharma, Inc. *
|
|
$ |
182,941 |
|
|
$ |
186,722 |
|
Kard
Scientific, Inc. *
|
|
|
50,000 |
|
|
|
50,000 |
|
Prepaid
other
|
|
|
105,631 |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
338,572 |
|
|
$ |
251,722 |
|
(*
See Note 5. Significant Alliances and Related Parties)
Note
7. Equity Transactions
In
August, 2007, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock at $.80 per share. These warrants, if not
exercised, will expire in August, 2011. The fair value of these
warrants in the amount of $14,8000 was recorded as a consulting
expense.
In
November, 2007 the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock at $.54 per share. These warrants, if not
exercised, will expire in November, 2011. The fair value of these warrants in
the amount of $7,200 was recorded as a consulting expense
In
February, 2008 the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $.52 per share. These warrants, if not
exercised, will expire in February 2012. The fair value of these warrants in the
amount of $8,500 was recorded as a consulting expense.
The
option assumptions used to calculate these values are as follows:
|
|
For
the Three Months
Ended March 31, 2008
|
|
|
For
the Nine Months
Ended March 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
2.46 |
% |
|
|
2.46%-4.31 |
% |
|
|
|
104 |
% |
|
|
74%-104 |
% |
|
|
|
0 |
% |
|
|
0 |
% |
For the
nine months ended March 31, 2008, the Company's Board of Directors authorized
the issuance of 171,691 shares of its common stock with a restrictive legend,
for services. The Company recorded an expense of $84,022.
In
September, 2007, the Company had received fully paid subscriptions in the
aggregate amount of $2,375,000 through the offering of shares of the Company’s
common stock (the “Offering”). The subscriptions are for shares of common stock
at a purchase price of $.50 per share and warrants to purchase 0.30 shares of
common stock at an exercise price of $1.00 per share; which warrants may be
exercised at any time and expire in three years. In accordance with the
Offering, on October 16, 2007, the Company issued 4,750,000 shares of common
stock and warrants to purchase 1,425,000 shares of common stock at an exercise
price of $1.00 per share. These warrants, if not exercised, will expire in
fiscal year ending in 2011. The Company allocated a relative fair value of
$435,000 to these warrants, by using the Black-Scholes option pricing
model. The Company had agreed to use its best efforts to file a
Registration Statement with the Securities and Exchange Commission covering the
resale of the Registrable Securities issued or issuable pursuant to
the Securities Purchase Agreement, and to use its best efforts to obtain
effectiveness of the Registration Statement on or prior to one
hundred and eighty days from the date of closing, and to keep such registration
statement continuously in effect. The company may be required to issue
additional warrants to purchase the company’s common stock if the
Registration Statement is not declared effective by the expiration of the
Effectiveness Period. On January 3, 2008 the Company filed a Form SB-2 with the
Securities and Exchange Commission. This filing became effective as of April 11,
2008
Note
8. Stock Options And Warrants
Stock
Options
The
following table presents the combined activity of stock options issued for the
nine months ended March 31, 2008 as follows:
Stock
Options
|
|
Number of Shares
|
|
|
Weighted Average Exercise Price per share
($)
|
|
|
Weighted Average Remaining Contractual Term
(years)
|
|
|
Aggregate Intrinsic Value
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30,2007
|
|
|
1,875,000 |
|
|
$ |
0.10 |
|
|
|
8.25 |
|
|
$ |
1,537,500 |
|
Granted
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Expired
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Canceled
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at March 31, 2008
|
|
|
1,875,000 |
|
|
$ |
0.10 |
|
|
|
7.48 |
|
|
$ |
825,000 |
|
Exercisable
at March 31, 2008
|
|
|
1,875,000 |
|
|
$ |
0.10 |
|
|
|
7.48 |
|
|
$ |
825,000 |
|
Stock
Warrants
The
following table presents the combined activity of stock warrants issued for the
nine months ended March 31, 2008 as follows:
Stock
Warrants
|
|
Number of Shares
|
|
|
Weighted Average Exercise Price per share
($)
|
|
|
Weighted Average Remaining Contractual Term
(years)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2007
|
|
|
2,695,000 |
|
|
$ |
1.95 |
|
|
|
1.94 |
|
Granted
|
|
|
1,630,000 |
|
|
|
2.59 |
|
|
|
.97 |
|
Exercised
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Expired
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Canceled
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at March 31, 2008
|
|
|
4,325,000 |
|
|
$ |
1.58 |
|
|
|
1.71 |
|
Exercisable
at March 31, 2008
|
|
|
4,325,000 |
|
|
$ |
1.58 |
|
|
|
1.71 |
|
Of the
above warrants, 2,375,000 expire in fiscal year ending June 30, 2009; 160,000
expire in fiscal year ending June 30, 2010; 1,660,000 expire in fiscal year
ending June 30, 2011; and 130,000 expire in fiscal year ended June 30,
2012.
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 carry
forwards will begin to expire in the year 2017 if not utilized. Utilization of
the Company’s net operating loss carry forwards are limited based on changes in
ownership as defined in Internal Revenue Code Section 382. As of March 31, 2008
the Company accumulated a tax loss of $6,398,414 resulting in a deferred tax
benefit of approximately $3,506,600 which has been offset by a 100% valuation
allowance.
During
the nine months ended March 31, 2008, the valuation allowance increased by $977,200 over the June 30,
2007 balance.
The
Company's deferred tax assets are summarized as follows:
|
|
March 31, 2008
|
|
|
June 30, 2007
|
|
Net
operating loss carryforwards
|
|
$ |
2,537,200 |
|
|
|
1,611,400 |
|
Research
and development credit
|
|
|
462,300 |
|
|
|
391,700 |
|
Other
|
|
|
507,100 |
|
|
|
526,300 |
|
Gross
deferred tax assets
|
|
|
3,506,600 |
|
|
|
2,529,400 |
|
Valuation
allowances
|
|
|
(3,506,600 |
) |
|
|
(2,529,400 |
) |
Deferred
tax assets
|
|
$ |
- |
|
|
$ |
- |
|
During
the three months ended on March 31, 2008, the Company recognized a refundable
Research and Development tax credit of $166,050. This credit is included under
“Other Current Assets” on the Company’s Balance Sheet.
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 state the ultimate liability, if any, in these matters. In
management’s opinion, the ultimate resolution of such claims will not have a
material adverse effect on the financial position of the
Company.
On April
4, 2007, the Company signed a Cooperative Research and Development Agreement
(CRADA) with the Walter Reed Army Institute of Research (WRAIR) to create new
treatments for Dengue Fever using the Company’s nanomedicine technology. The
Company is currently negotiating a modification to this agreement as requested
by WRAIR.
On
October 4, 2007, the Company signed a Cooperative Research and Development
Agreement for Material Transfer (CRADAMT) with the U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID) to create new treatments for
Filovirus using the Company’s nanomedicine technology. Each party is
individually responsible for funding its own respective researchers throughout
this agreement, including laboratory facilities, salaries, overhead and indirect
costs, etc.
On
February 4, 2008, the Company signed a Cooperative Research Agreement with the
United Stated Army Institute of Pathology (USAFIP) to test the efficacy of the
Company’s nanomedicine technology in preliminary animal studies against H5N1 and
HIV viruses. The company will fund such studies in the amount of
$122,844.
On
February 4, 2008, the Company signed a Technical Testing Agreement with a major
medical research institute. The agreement provides for certain animal studies to
test the efficacy of the Company’s nanomedicine technology against
Epidemic-Kerato Conjunctivitis (“EKC”) and other viral diseases of the cornea
and conjunctiva. The Company will fund the costs of these studies. These studies
commenced in May, 2008.
While the
licensing agreement between the Company and TheraCour does not provide for the
use of the nanomaterials we license from TheraCour for the treatment of the
Filovirus, TheraCour has permitted the Company to use the nanomaterials to
develop a treatment for Filovirus until such time as the Company and TheraCour
can negotiate an amendment to the Licensing Agreement to include the Filovirus
among the virus types we are permitted to manufacture, use and offer for
sale. While the Company is currently negotiating such an amendment
with TheraCour, there can be no assurance that an agreement will be reached, in
which case TheraCour may revoke our permissive use of its materials for
Filovirus and the EKC virus, which may adversely impact our operations and cause
the termination of our CRADA with the USAMRIID, WRAIR, USAFIP and the Technical
Testing Agreement with the Medical Research Institute.
Note
11. Subsequent Events
On March
27, 2008, the Company announced that it will begin its very first animal studies
against HIV in a mouse model. On April 7, 2008, the Company reported that these
studies have started. The company has budgeted $250,000 for these studies. On
May 5, 2008, the Company reported that its nanoviricide drug candidates against
HIV were found to have significant therapeutic efficacy in animal studies using
a mouse model
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS 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, the Company and Edot-com.com (Nevada) were merged and Edot-com.com, Inc.,
a Nevada corporation, became the surviving entity.
On June
1, 2005, the Company 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. (an approximately 31% shareholder of the
Company) for rights to develop and commercialize novel and specifically targeted
drugs based on TheraCour's targeting technologies, against a number of human
viral diseases. Upon consummation of the Exchange, the Company
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.
For
financial accounting purposes, this acquisition was a reverse acquisition of the
Company by NanoViricides (NVI), under the purchase method of accounting, and was
treated as a recapitalization with NanoViricides as the
acquirer. Accordingly, our historical 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
NanoViricides. With the acquisition of NanoViricides, we no longer
remained an inactive entity and entered the pharmaceuticals
business.
The
Company is considered a development stage company at this time.
Management’s
Plan of Operation
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 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), Human Influenza,
Avian Influenza (Asian Bird Flu Virus including H5N1).
TheraCour
has granted us the right to include Dengue Hemorrhagic Fever (DHF) Viruses, and
the Dengue Fever Viruses, Ebola/Marburg Viruses, and certain other hemorrhagic
viruses, as well as Epidemic Keratoconjuntivitis causing Adenoviruses (EKC),
among the viruses that NanoViricides will be developing drugs to treat. The
Company and TheraCour are negotiating an amendment to the existing Licensing
Agreement to include these additional virus types among the virus types the
Company is permitted to manufacture, use, and offer for sale. 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.
To date,
we have engaged in organizational activities; sourcing compounds and materials;
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 or commence selling our products when planned, nor are we certain that we
will become profitable in the future. We have incurred net losses in each fiscal
period since inception of our operations.
In
December, 2005, the Company signed a Memorandum of Understanding with the
National Institute of Hygiene and Epidemiology in Hanoi (NIHE), a unit of the
Vietnamese Government’s Ministry of Health. This Memorandum of Understanding
calls for cooperation in the development and testing of certain NanoViricides.
The parties agreed that the initial target would be the development of drugs
against H5N1 (avian influenza). NIHE thereafter requested that we
develop a drug for rabies, a request to which we agreed. The initial
phase of this agreement called first for laboratory testing, followed by animal
testing of several drug candidates developed by the Company. Preliminary
laboratory testing of FluCide™-I, AviFluCide-I™ and AviFluCide-HP™ were
successfully performed at the laboratories of the National Institute of Hygiene
and Epidemiology in Hanoi (NIHE). The second phase of the project,
animal and/or additional cell culture testing of the Influenza H1N1
and H5N1 candidates, as well as that of RabiCide-I™, the company’s rabies drug,
were completed during the first calendar quarter of 2007. Whereas the rabies and
H1N1 experimental data have not been completely analyzed.
Results
of the in vitro H5N1 work in Vietnam were reported in a press release on May 7,
2007. The information was as follows: The BSL3 studies against Clade 2 H5N1, a
Dec. 2006 isolate in Vietnam, showed that the nanoviricide developed against
Highly Pathogenic Influenzas, FluCide-HP ™, was highly effective in suppressing
cytopathic effects (CPE), whereas the broad-spectrum nanoviricide against all
influenzas, FluCide™, was slightly less effective than AviFluCide-HP. Both of
these candidates were significantly more effective than oseltamivir (Tamiflu®)
in this blind study performed by the National Institute of Hygiene and
Epidemiology (NIHE) scientists in Vietnam. In addition, the
antibody-fragment-based H5N1 specific (Clade 1, Vietnam, 2004-2005 strains)
AviFluCide™ drug candidate was demonstrated conclusively by Vietnam scientists
to significantly suppress CPE against the rgH5N1 strain (Clade 1), confirming
previous results. The Highly Pathogenic H5N1 subtype of influenza continues to
rapidly evolve and is now found in two distinct subgroups, Clade 1 and Clade 2.
According to CDC scientists, the Vietnam 2004/2005 strains belong to Clade 1,
whereas the Indonesia 2006 (2007), Egypt 2006, and Vietnam 2006 (2007) strains
are different and form the Clade 2 subgroup. The various Clade 2 strains are
antigenically distinct from each other, but closer to each other than to Clade 1
strains. Highly Pathogenic Influenza strains of all clades possess the polybasic
cleavage site. Thus FluCide-HP, designed against this site, is expected to be
effective against all Highly Pathogenic influenza strains. It is felt that it
makes no difference to which type, subtype, or clade, they belong.
Results
of the Rabies animal studies in Vietnam have also been reported in press
releases and in scientific conferences. We have found 20% to 30% survival of
lethally infected mice upon treatment with three different nanoviricides. In
contrast, the standard of care, anti-rabies antibodies, produced 0% (zero)
survival rates. Repeated studies confirmed the results. Currently there is no
treatment for Rabies after infection takes hold.
We have
conducted animal studies for the efficacy of certain nanoviricides against
common influenza and reported the results at scientific conferences and also in
press releases. In these studies, we used Oseltamivir as the positive control.
We found the nanoviricides to be as much as eight to ten times more effective
than Oseltamivir in a super-lethally infected mice model with extension of the
life of the animal as the end point. In contrast, we have demonstrated that the
nanoviricide remained effective against an Oseltamavir resistant strain of the
H5N1 bird flu virus.
On April
9, 2007, the Company signed a Cooperative Research and Development Agreement
with the Walter Reed Army Institute of Research (WRAIR). The joint R&D
effort will focus on creating new treatments for dengue fever using
NanoViricides' virus-killing nanomedicine technology. The company is currently
developing the necessary protocols of study in cooperation with the WRAIR
scientists. We expect to begin the laboratory studies as soon as the
prerequisites are completed. The Company included this project in the following
section in “Requirement for Additional Capital”.
On
October 4, 2007 the Corporation signed a Cooperative Research and Development
Agreement with the United States Army Medical Research Institute of Infectious
Disease (USAMRIID). The joint R&D effort will focus on testing the
Nanoviricides virus killing nanomedicine against the Filoviruses (Ebola and
Marburg viruses). On October 15, 2007, the Company signed a Cooperative Research
and Development Agreement (CRADA) with the U.S. Army Medical Research Institute
of Infectious Diseases (USAMRIID) to create new treatments for Filovirus using
the Company’s nanomedicine technology. Each party is individually responsible
for funding its own respective researchers throughout this agreement, including
laboratory facilities, salaries, overhead and indirect costs, etc.
On
February 19, 2008, the Company issued a press release regarding the results of
the cell culture studies against Ebola Virus conducted by the USAMRIID
scientists. The nanoviricides tested showed very high efficacy as measured by
significant reduction in production of virus in the Ebola infected cells.
Following upon this success, USAMRIID scientist have undertaken preliminary
animal studies.
The
Company said that the same nanoviricide that was highly effective against highly
pathogenic Avian Influenza (HPAI, H5N1, Bird Flu), and Rabies was also highly
effective against Ebola Virus in cell culture studies. The Company believes that
it has developed a broad-spectrum nanoviricide that may have efficacy against a
broad range of distinctly different viruses. To date, the Company is not aware
of any other effective, non-toxic, broad-spectrum anti-viral
agents.
The Ebola
virus produces significant quantities of a decoy called soluble glycoprotein in
infected animals. The Company anticipates that significant optimization efforts
may be needed to overcome these technical challenges in animal
studies.
The
Company intends to pursue such defense and biosecurity related projects to the
extent that government funding becomes available to the Company.
On March
27, 2008, the Company announced that it will begin its very first animal studies
against HIV in a mouse model. On April 7, 2008, the Company reported that these
studies have started.
Management
believes that it has achieved significant milestones in the development of
several antiviral nanoviricide drug candidates within a very short timeframe. We
now have effective drug candidates validated in animal studies against Human
Influenza, Rabies, and HIV (post dated event). In addition we have effective
drug candidates validated in cell culture studies against Avian Flu (H5N1) and
Ebola. Further, we have additional contracts with several renowned agencies to
test our drug candidates against additional disease targets including Dengue
Virus, H5N1 (Avian Flu), and EKC.
Management
believes that it now has validated at least two broad-spectrum antiviral drug
conditions in several disease models. Management believe that in addition to
developing broad-spectrum antivirals, the Company has also established and
validated its platform technologies for development of highly effective,
specific, antiviral agents against particular viral diseases.
Liquidity
and Capital Resources
Requirement
for Additional Capital
Based on
our current operating expenses, we currently have sufficient cash reserves to
meet all of our anticipated obligations through August 31, 2008. As of March 31,
2008 we have a cash balance of $1,210,836, which can support operations through
August 31, 2008. However, we expect we will require in excess of $5,000,000 to
execute the first part of our business plan which covers twelve months of
operations. Assuming that we are successful in raising additional financing, we
anticipate that we will incur the following expenses over the next twelve
months:
1
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Research
and Development costs of $1,500,000: Includes planned costs of
$1,200,000 for multiple drug variations and in-vivo and in-vitro studies
for FluCide™, AviFluCide™, FluCide HP™, and Rabies planned for year ended
June 30, 2008. The Company has allocated the planned costs
of $1,200,000 approximately as follows: FluCide™ $400,000,
AviFluCide™ $300,000, FluCide HP™ $400,000 , and Rabies
$100,000. Depending on the results of these clinical trials, we expect to
commence with early stage development of a drug for HIV for
which we have budgeted $300,000.
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2
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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.
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3
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Capital
costs of $1,250,000: This is the estimated cost for equipment
and laboratory improvements. The Company plans to incur
these costs after completion of certain animal studies, some of which
commenced in the third calendar quarter of
2007.
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4
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Staffing
costs of $1,500,000: This is the estimated cost of hiring
additional scientific staff and consulting firms to assist with, material
characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology
studies, as required for development of necessary data for a future filing
of an Investigational New Drug Application (IND) with the United States
Food and Drug Administration.
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The
Company will be unable to proceed with its planned drug development, meet its
administrative expense requirements, capital costs, or staffing costs without
obtaining additional financing of approximately $2,500,000 to meet its budget.
The Company does not have any arrangements at this time for equity or other
financings. 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.
On
February 27, 2007 the Company leased an R&D facility to occupy 5,000 square
feet of space in Woodbridge, Connecticut, originally built for the Bayer
Pharmaceutical Corporation. 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. The Company believes that an adjacent space may become available
and would be suitable for small scale manufacturing. The facility
will need to be certified by the FDA in order for the Company to produce
experimental materials that can be sent to outside scientists for
pharmaco-kinetic, pharmaco-dynamic and toxicology studies. These three sets of
studies must be completed prior to the Company filing an Investigational New
Drug (IND) Application with the FDA to begin the human safety and efficacy
trials (Phase I , II and III).
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.
Subsequent
Events
On May 5,
2008, the Company reported that its nanoviricide drug candidates against HIV
were found to have significant therapeutic efficacy in animal studies using a
mouse model. The Company believes that it now has validated drug candidates
against HIV. The Company is not aware of any other anti-HIV efforts in which the
very first screening studies led to successful drug candidates.
ITEM 3. Quantitative and Qualitative Disclosures About
Market Risk
The
Company is not exposed to market risk related to interest rates or foreign
currencies.
EVALUATION
OF DISCLOSURE CONTROLS AND PROCEDURES
NNVC
maintains disclosure controls and procedures that are designed to ensure that
information required to be disclosed in reports filed by NNVC under the
Securities Exchange Act of 1934, as amended, is recorded, processed, summarized
and reported within the time periods specified in the Securities and Exchange
Commission's rules and regulations and that such information is accumulated and
communicated to NNVC’s management, including its Chief Executive Officer and
Interim Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure. Our Chief Executive Officer and Interim Chief
Financial Officer evaluated, with the participation of other members of
management, the effectiveness of NNVC’s disclosure controls and procedures (as
defined in Exchange Act Rule 15d-15(e)), as of the end of the period covered by
this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief
Executive Officer and Interim Chief Financial Officer concluded that the
Company's controls were not effective as of March 31, 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. The Company continues
to take steps toward remediation of these weaknesses. The Company intends to
remediate this weakness by its active search for a permanent Chief Financial
Officer and the institution of additional internal reporting provisions and
controls.
Although
the management of our Company, including the Chief Executive Officer and the
Chief Financial Officer, believes that our disclosure controls and internal
controls currently provide reasonable assurance that our desired control
objectives have been met, management does not expect that our disclosure
controls or internal controls will prevent all error and all fraud. A control
system, no matter how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system are met.
Further, the design of a control system must reflect the fact that there are
resource constraints, and the benefits of controls must be considered relative
to their costs. Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all control issues
and instances of fraud, if any, within our Company have been detected. These
inherent limitations include the realities that judgments in decision-making can
be faulty, and that breakdowns can occur because of simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the
controls. The design of any system of controls is also based in part upon
certain assumptions about the likelihood of future events, and there can be no
assurance that any design will succeed in achieving its stated goals under all
potential future conditions.
CHANGE
IN INTERNAL CONTROLS
There
have been no changes in internal controls over financial reporting that occurred
during the most recent fiscal quarter that have materially affected, or are
reasonably likely to materially affect, our internal controls over financial
reporting.
PART
II. OTHER INFORMATION
None.
In
February, 2008, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $.52 per share. These warrants, if not
exercised, will expire in February, 2012.
None.
None.
None
(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.
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:
May 19, 2008
NANOVIRICIDES,
INC.
/s/ Eugene Seymour,
MD
Eugene
Seymour, M.D.
Chief
Executive Officer and
Interim
Chief Financial Officer and Director
/s/ Anil
Diwan
Anil
Diwan
President
and Chairman of the Board of Directors