NANOVIRICIDES, INC. - Quarter Report: 2009 March (Form 10-Q)
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, 2009
Commission
File Number: 333-148471
NANOVIRICIDES,
INC.
(Exact
name of registrant as specified in its charter)
NEVADA
|
76-0674577
|
|||
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
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 Yes S No £
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes S No £
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 S
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes £ No
S
The
number of shares outstanding of the Registrant's Common Stock as of May 15, 2009
was 123,023,653 shares.
1
NANOVIRICIDES, INC.
FORM
10-Q
INDEX
PART
I FINANCIAL INFORMATION
|
|
Item
1. Financial Statements
|
|
3
|
|
4
|
|
5
|
|
7
|
|
12
|
|
19
|
|
Item
4. Controls and
Procedures
|
19
|
PART
II OTHER INFORMATION
|
|
Item
1. Legal
Proceedings
|
20
|
20
|
|
Item
3. Defaults Upon Senior
Securities
|
21
|
21
|
|
Item
5. Other
Information
|
21
|
Item
6. Exhibits and Reports
on Form 8-K
|
21
|
22
|
|
Certifications
|
|
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
March
31, 2009
|
||||||||
(Unaudited)
|
June
30, 2008
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 1,228,056 | $ | 816,386 | ||||
Prepaid
expenses
|
413,512 | 328,544 | ||||||
Other
current assets
|
83,183 | 102,873 | ||||||
Total
current assets
|
1,724,751 | 1,247,803 | ||||||
Property
and equipment, net
|
666,479 | 133,738 | ||||||
Other
assets:
|
||||||||
Security
deposit
|
- | 80,000 | ||||||
Trademarks,
net
|
179,536 | 6,709 | ||||||
Total
other assets
|
179,536 | 86,709 | ||||||
Total
assets
|
$ | 2,570,766 | $ | 1,468,250 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable – trade
|
$ | 283,190 | $ | 295,555 | ||||
Accounts
payable – related parties
|
169,975 | 374,394 | ||||||
Accrued
expenses
|
194,759 | 96,130 | ||||||
Payroll tax
payable
|
27,730 | 258,432 | ||||||
Total
current liabilities
|
675,654 | 1,024,511 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
equity:
|
||||||||
Common
stock, $0.001 par value; 300,000,000 shares authorized;122,851,298 and
119,270,677 issued and outstanding
|
$ | 122,851 | $ | 119,271 | ||||
Additional
paid-in capital
|
13,142,976 | 9,532,205 | ||||||
Deficit
accumulated during the development stage
|
(11,370,715 | ) | (9,207,737 | ) | ||||
Total
stockholders’ equity
|
1,895,112 | 443,739 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 2,570,766 | $ | 1,468,250 |
See
accompanying notes to the financial statements.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
(Unaudited)
Three
Months Ended
|
Nine
Months Ended
|
For
the Period From May 12, 2005 (Inception) through March 31,
2009
|
||||||||||||||||||
March
31, 2009
|
March
31, 2008
|
March
31, 2009
|
March
31, 2008
|
|||||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
Research
and development
|
$ | 498,801 | $ | 358,793 | $ | 1,331,661 | $ | 809,140 | $ | 6,114,194 | ||||||||||
Refund
for credit of research and development costs
|
- | - | - | (166,050 | ) | (200,190 | ) | |||||||||||||
General
and administrative
|
293,225 | 446,525 | 861,701 | 1,150,065 | 4,816,164 | |||||||||||||||
Total
operating expenses
|
792,026 | 805,318 | 2,193,362 | 1,793,155 | 10,730,168 | |||||||||||||||
Loss
from operations
|
(792,026 | ) | (805,318 | ) | (2,193,362 | ) | (1,793,155 | ) | (10,730,168 | ) | ||||||||||
Other
income (expense):
|
||||||||||||||||||||
Interest
income
|
4,303 | 14,431 | 30,384 | 47,570 | 146,462 | |||||||||||||||
Non
cash interest on convertible debentures
|
- | - | - | - | (73,930 | ) | ||||||||||||||
Non
cash interest expense on beneficial conversion feature of
convertible debentures
|
- | - | - | - | (713,079 | ) | ||||||||||||||
Total
other income (expense)
|
4,303 | 14,431 | 30,383 | 47,570 | (640,547 | ) | ||||||||||||||
Net
loss
|
$ | (787,723 | ) | $ | (790,887 | ) | $ | (2,162,978 | ) | $ | (1,745,585 | ) | $ | (11,370,715 | ) | |||||
Net
loss per share: basic and diluted
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.02 | ) | ||||||||
Weighted
average shares outstanding: basic and diluted
|
122,793,839 | 119,196,586 | 122,073,961 | 117,489,413 |
See accompanying notes to the financial
statements.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
(UNAUDITED)
Nine
Months Ended
|
For
the Period From May 12, 2005
|
|||||||||||
March
31, 2009
|
March
31, 2008
|
(Inception)
through March 31, 2009
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (2,162,978 | ) | $ | (1,745,585 | ) | $ | (11,370,715 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Shares
issued for services rendered
|
129,800 | 84,022 | 763,757 | |||||||||
Warrants
granted to scientific advisory board
|
107,000 | 30,500 | 414,241 | |||||||||
Options
issued to officers as compensation
|
- | 7,044 | 121,424 | |||||||||
Depreciation
and amortization
|
8,073 | 4,783 | 17,120 | |||||||||
Amortization
of deferred financing expenses
|
- | - | 51,175 | |||||||||
Non
cash interest on convertible debentures
|
- | - | 73,930 | |||||||||
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
- | - | 713,079 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Prepaid
expenses
|
(84,968 | ) | (86,850 | ) | (413,512 | ) | ||||||
Deferred
expenses
|
- | - | (2,175 | ) | ||||||||
Other
assets
|
99,690 | (162,383 | ) | (83,183 | ) | |||||||
Accounts
payable- trade
|
(12,365 | ) | 46,757 | 283,190 | ||||||||
Accounts
payable –related parties
|
(204,419 | ) | (147,265 | ) | 169,975 | |||||||
Accrued
expenses
|
98,629 | (23,763 | ) | 194,759 | ||||||||
Accrued
payroll to officers and related payroll tax expense
|
(230,702 | ) | (212,395 | ) | 27,730 | |||||||
Net
cash used in operating activities
|
(2,252,240 | ) | (2,205,135 | ) | (9,039,205 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchases
of property and equipment
|
(537,417 | ) | (51,846 | ) | (679,324 | ) | ||||||
Purchase
of trademarks
|
(176,226 | ) | - | (183,813 | ) | |||||||
Net
cash used in investing activities
|
(713,643 | ) | (51,846 | ) | (863,137 | ) | ||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from issuance of convertible debentures
|
- | - | 1,000,000 | |||||||||
Proceeds
from issuance of common stock and warrants in connection
with private placements of common stock – net of offering
costs
|
3,377,553 | 2,500,020 | 9,120,398 | |||||||||
Proceeds
from exercise of stock warrants attached to convertible
debentures
|
- | - | 920,000 | |||||||||
Proceeds
from exercise of stock options
|
- | - | 90,000 | |||||||||
Net
cash provided by financing activities
|
3,377,553 | 2,500,020 | 11,130,398 | |||||||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
411,670 | 243,039 | 1,228,056 | |||||||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
816,386 | 967,797 | - | |||||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 1,228,056 | $ | 1,210,836 | $ | 1,228,056 |
See
accompanying notes to the financial statements.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS (CONTINUED)
(UNAUDITED)
Nine
Months Ended
|
For
the Period
|
|||||||||||
March
31,2009
|
March
31,2008
|
From
May 12, 2005 (Inception) through March 31, 2009
|
||||||||||
Supplemental
disclosure of cash flows information:
|
||||||||||||
Interest
paid
|
$ | - | $ | - | $ | - | ||||||
Tax
paid
|
$ | - | $ | - | $ | - | ||||||
Non-cash
investing and financing investing activities:
|
||||||||||||
Common
stock issued for services rendered
|
$ | 129,800 | $ | 84,022 | $ | 763,757 | ||||||
Stock
options issued to the officers as compensation
|
- | 7,044 | 121,424 | |||||||||
Stock
warrants granted to scientific advisory board
|
107,000 | 30,500 | 414,241 | |||||||||
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 | |||||||||
Stock
warrants issued in connection with private placement
|
827,485 | - | 2,090,117 | |||||||||
Common
stock issued upon conversion of accounts
payable
|
150,000 | 150,000 |
See accompanying notes to the financial
statements.
NANOVIRICIDES,
INC
(A
DEVELOPMENT STAGE COMPANY)
FOR
THE PERIOD FROM MAY 12, 2005 (INCEPTION) TO MARCH 31, 2009
NOTES
TO THE FINANCIAL STATEMENTS
(Unaudited)
Note
1. Organization and Nature of Business
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25, 2000
as Edot-com.com, Inc.,
and was organized for the purpose of conducting internet retail
sales. On April 1, 2005, Edot-com.com, Inc. was incorporated under the
laws of the State of Nevada for the purpose of re-domiciling the Company as a
Nevada corporation. On May 12, 2005, the Corporations were merged and
Edot-com.com, Inc., a
Nevada corporation, (the “Company”), became the surviving entity.
On June
1, 2005, Edot-com.com, Inc. (“ECMM”) acquired 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 representing 80%
of the voting capital stock of ECMM immediately after the Exchange
transaction. NVI then became a wholly-owned subsidiary of ECMM. The
ECMM shares were issued to the NVI Shareholders on a pro rata basis, on the
basis of 4,000 shares of ECMM’s Common Stock for each share of NVI common stock
held by such NVI Shareholder at the time of the Exchange.
As a
result of the ownership interests of the former shareholders of NVI for
financial accounting purposes, the merger between ECMM and NVI has been treated
as a reverse acquisition with NVI deemed the accounting acquirer and ECMM deemed
the accounting acquiree under the purchase method of accounting in accordance
with Statement of Financial Accounting Standards No. 141 “Business Combinations” (“SFAS
No. 141”). The reverse merger is deemed a capital transaction and the
net assets of NVI (the accounting acquirer) are carried forward to ECMM (the
legal acquirer and the reporting entity) at their carrying value before the
combination. The acquisition process utilizes the capital structure
of ECMM and the assets and liabilities of NVI which are recorded at historical
cost. The equity of ECMM is the historical equity of NVI retroactively restated
to reflect the number of shares issued by ECMM in the transaction. Accordingly,
the financial statements have been prepared to give retroactive effect to May
12, 2005 (date of inception), of the reverse acquisition completed on June 1,
2005, and represent the operations of NVI.
On June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, ECMM changed its
name to NanoViricides, Inc. and its stock symbol to “NNVC”,
respectively. The Company is considered a development stage company
at this time.
NanoViricides,
Inc. (the “Company”), is a nano-biopharmaceutical company whose business goals
are to discover, develop and commercialize therapeutics to advance the care of
patients suffering from life-threatening viral infections. We are a development
stage company with several drugs in various stages of early development. The
Company’s drugs are based on several patents, patent applications, provisional
patent applications, and other proprietary intellectual property held by
TheraCour Pharma, Inc. (“TheraCour”), to which the Company has licenses in
perpetuity for the treatment of the following human viral diseases: Human
Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus
(HCV), Herpes Simplex Virus (HSV), Influenza, Rabies, and Asian Bird Flu Virus.
TheraCour has granted the Company the right to include Dengue viruses,
Ebola/Marburg viruses, and viruses causing viral Conjunctivitis (a disease of
the eye) among the viruses the Company is able to treat. However, no
written agreement has been entered into with TheraCour and no assurance can be
given that a written amendment to the licensing agreement with TheraCour will
ever be reached or that, if reached, will be on terms favorable to the
Company.
The
Company focuses its research and clinical programs on specific anti-viral
therapeutics and is seeking to add to its existing portfolio of products through
its internal discovery and clinical development programs and through an
in-licensing strategy. To date, the Company has not developed any commercial
products.
Note
2. Basis of Presentation
The
accompanying unaudited interim financial statements of the Company have been
prepared in accordance with accounting principles generally accepted in the
United States for interim financial information and with the instructions to
Form 10-Q and Rule 10-01 of Regulation S-X of the Securities and Exchange
Commission for Interim Reporting. Accordingly, they do not include all of the
information and footnotes required by accounting principles generally accepted
in the United States of America for complete financial statements.
In the
opinion of Management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation for the interim periods have been
included. Operating results for the nine month period ended March 31, 2009, 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
3. 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 10K for the year ended June 30,
2008.
Recently Issued Accounting
Pronouncements
In March
2008, the FASB issued FASB Statement No. 161 Disclosures about Derivative
Instruments and Hedging Activities an amendment of FASB Statement No. 133
(“SFAS No. 161”), which changes the disclosure requirements for derivative
instruments and hedging activities. Pursuant to SFAS No. 161, Entities are
required to provide enhanced disclosures about (a) how and why an entity uses
derivative instruments, (b) how derivative instruments and related hedged items
are accounted for under Statement 133 and its related interpretations, and (c)
how derivative instruments and related hedged items affect an entity’s financial
position, financial performance, and cash flows. SFAS No. 161 is effective
for financial statements issued for fiscal years and interim periods beginning
after November 15, 2008 with early application encouraged. SFAS No. 161
encourages but does not require disclosures for earlier periods presented for
comparative purposes at initial adoption. In years after initial adoption,
this Statement requires comparative disclosures only for periods subsequent to
initial adoption. The Company does not expect the adoption of SFAS No. 161
to have a material impact on the financial results of the Company.
In April
2008, the FASB issued FSP No. 142-3, Determination of the Useful Life of
Intangible Assets. FSP 142-3 amends the factors an entity should consider
in developing renewal or extension assumptions used in determining the useful
life of recognized intangible assets under SFAS 142, Goodwill and Other Intangible
Assets, and adds certain disclosures for an entity’s accounting policy of
the treatment of the costs, period of extension, and total costs
incurred. FSP 143-3 must be applied prospectively to intangible
assets acquired after January 1, 2009. The Company does not expect
the adoption of FSP 142-3 to have a material impact on the financial
results of the Company.
In May
2008, the FASB issued SFAS No. 162, "The Hierarchy of Generally Accepted
Accounting Principles" ("SFAS 162"). SFAS 162 is intended to improve financial
reporting by identifying a consistent framework, or hierarchy, for selecting
accounting principles to be used in preparing financial statements that are
presented in conformity with U.S. GAAP for nongovernmental entities. SFAS 162 is
effective 60 days following the Securities and Exchange Commission's approval of
the Public Company Accounting Oversight Board auditing amendments to AU Section
411, "The Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles." The Company does not expect SFAS 162 to have a material
effect on its financial statements.
Management
does not believe that any other recently issued, but not yet effective
accounting pronouncements, if adopted, would have a material effect on the
accompanying financial statements.
Reclassification
Certain
reclassifications have been made in prior year’s financial statements to conform
to classification used in the current year. The reclassifications
from general and administrative expenses to research and development expenses
does not change total operating expenses, operating loss or net loss for any
period presented.
Note
4. Substantial Doubt Regarding Ability to Continue as a Going
Concern
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of business.
Accordingly, they do not include any adjustments relating to the realization of
the carrying value of assets or the amounts and classification of liabilities
that might be necessary should the Company be unable to continue as a going
concern. The Company’s significant operating losses and significant
capital requirements, however, raise substantial doubt about the Company’s
ability to continue as a going concern.
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 $11,370,715 at March 31,
2009. Such losses are expected to continue for the foreseeable future and until
such time, if ever, as the Company is able to attain sales levels sufficient to
support its operations. There can be no assurance that the Company will achieve
or maintain profitability in the future. Despite the Company’s financings in
2009 and 2008 and a cash and cash equivalent balance of $1,228,056 at March 31,
2009, substantial additional financing will be required in future periods. The
Company believes it will require in excess of $3,000,000 to further advance the
current drug development priorities during the next twelve months, and will also
require up to an additional $2,000,000 to finance planned capital costs, and
additional staffing requirements during the next twelve months. The Company
believes it can adjust its priorities of drug development, and it’s Plan of
Operations as necessary if it is unable to raise such funds. The Company has
taken several steps to conserve resources and reduce expenditures.
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 5.) 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.
Note
5. Significant Alliances and Related Parties
TheraCour
Pharma, Inc.
Pursuant
to an Exclusive License Agreement we entered into with TheraCour Pharma, Inc.,
(TheraCour), the Company was granted exclusive licenses in perpetuity for
technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian
(bird) flu, Influenza and rabies. The Company and TheraCour have agreed, in
principle, to a Licensing Agreement to include additional virus types among the
virus types the Company is permitted to manufacture, use, and offer for sale,
and for payment of a license fee to TheraCour. TheraCour has permitted the
Company to use its nanomaterials to develop treatments for Dengue viruses,
Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral
Conjunctivitis (a disease of the eye) and Ocular Herpes. Until such time as
the Company and TheraCour can complete an additional Licensing Agreement to
include these additional virus types we are permitted to manufacture, use, and
offer for sale these nanomaterials.. In consideration for obtaining these
exclusive licenses, we agreed: (1) that TheraCour can charge its costs (direct
and indirect) plus no more than 30% of direct costs as a Development Fee and
such development fees shall be due and payable in periodic installments as
billed. (2) to pay $25,000 per month for usage of lab supplies and
chemicals from existing stock held by TheraCour (3) we will pay $2,000 or actual
costs, whichever is higher, for other general and administrative expenses
incurred by TheraCour on our behalf (4) make royalty payments (calculated as a
percentage of net sales of the licensed drugs) of 15% to TheraCour Pharma, Inc.
(5) agreed that TheraCour Pharma, Inc. retains the exclusive right to develop
and manufacture the licensed drugs. TheraCour Pharma, Inc. agreed that it will
manufacture the licensed drugs exclusively for NanoViricides, and unless such
license is terminated, will not manufacture such product for its own sake or for
others, (6) TheraCour may request and NanoViricides, Inc. will pay an advance
payment (refundable) equal to twice the amount of the previous months invoice to
be applied as a prepayment towards expenses.
As to the
license fee, there can be no assurance that the license fee will be paid or that
the amendment will become effective, in which case TheraCour may revoke our
permissive use of its materials, which may adversely impact our operations and
cause the termination of our Cooperative Research and Development Agreement
(CRADA) with the United States Army Medical Research Institute of Infectious
Diseases (USAMRIID), 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 nine months ended March 31, 2009
and 2008, were $1,440,649 and $891,791 respectively, and $5,980,336 since
inception. As of March 31, 2009, pursuant to its license agreement
the Company has paid a security advance of $321,164 to and held by TheraCour
Pharma, Inc. which is reflected in prepaid expenses
No
royalties are due TheraCour from the Company’s inception through March 31,
2009.
On
February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000
square feet of space in Woodbridge, Connecticut. Performance of the Company’s
obligations was guaranteed by TheraCour Pharma, Inc., a principal shareholder of
the Company and provider of the materials the Registrant uses in its operations.
This lease expired on January 30, 2009, and we have relocated our operations to
an expanded facility at 135 Wood Street, West Haven, CT.
TheraCour
Pharma, Inc., is affiliated with the Company through the common control of it
and our Company by Anil Diwan, President, who is a director of each
corporation, and owns approximately 70% of the capital stock of TheraCour
Pharma, Inc., which itself owns approximately 30% of the capital stock of the
Company.
TheraCour
Pharma, Inc. owns 35,085,000 shares of the Company’s outstanding common stock as
of March 31, 2009. The Company anticipates the need to procure large quantities
of the nanoviricides drug candidates for the upcoming studies. In order to
support this production scale, TheraCour Pharma, Inc., the Company’s largest
shareholder and licensor of the technology that the Company uses in its
anti-viral drug development, has initiated a program to expand its laboratory
facilities. TheraCour has entered into a Rule 10b5-1 trading plan to sell, over
a one year period, up to 1.8 million shares of the Company’s common stock that
it owns, that will go into effect Feb 17, 2009. The proceeds are expected to be
used to pay for the necessary improvements in laboratory facilities, the
purchase of analytical equipment, and the costs of intellectual property
(patent) protection.
The FASB
has issued 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. Since inception, lab
fees charged by KARD Scientific for services to the Company total $554,235. The
Company has paid KARD a $50,000 advance payment (refundable) towards future
fees.
Note
6. Prepaid Expenses
Prepaid
expenses at March 31, 2009 and June 30, 2008 consisted of the
following:
March
31, 2009
|
June
30, 2008
|
|||||||
TheraCour
Pharma, Inc. *
|
$ | 321,164 | $ | 236,186 | ||||
Kard
Scientific, Inc. *
|
50,000 | 50,000 | ||||||
Prepaid
other **
|
42,348 | 42,358 | ||||||
$ | 413,512 | $ | 328,544 |
(*
See Note 4. Significant Alliances and Related Parties)
(**
See Note 7, 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 and the following assumptions.
For
the three months ended March 31, 2009
|
For
the nine months ended March 31, 2009
|
|
Expected
life in years
|
4
years
|
4
years
|
Risk
free interest rate
|
1.93
|
1.93-2.90
|
Expected
volatility
|
201%
|
104%-201%
|
Dividend
yield
|
0%
|
0%
|
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 $2.50warrants
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.
In
November 2008, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $0.70 per share. These warrants, if
not exercised, will expire in November 2012. The fair value of these warrants in
the amount of $30,500 was recorded as consulting expense.
In
February 2009, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $0.58 per share. These warrants, if
not exercised, will expire in November 2012. The fair value of these warrants in
the amount of $29,000 was recorded as consulting expense.
For the
nine months ended March 31, 2009, the Company issued 169,476 shares of its
common stock in aggregate with a restrictive legend, for consulting services
valued at $129,800, the fair value at the date of issuance.
Note
8. Commitments and Contingencies
Operating
Leases
The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 5,000 square feet of office and
laboratory space at a base monthly rent of $4,692. Commencing September 1, 2008
the Company rented additional space and the base monthly rent increased to
$7,192. The lease expires 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.
Total
rent expense amounts to $148,812 and $149,230 for the nine months ended March
31, 2009 and 2008 respectively, and $393,988 for the period from
inception.
Note
9. Subsequent Events
On April
23, 2009, the Company filed a Definitive Information Statement disclosing that
on March 18, 2009 a majority of the Company’s shareholders consented to an,
amendment of the Company’s Articles of Incorporation to authorize the creation
of a class of 10,000,000 shares of blank check preferred stock (the
“Amendment”). The Amendment became effective on May 13,
2009.
On April 15, 2009, the
Company issued 172,500 shares of its common stock as payment for equipment
purchased.
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF
OPERATION
The
following discussion and analysis should be read in conjunction with our
unaudited financial statements and related notes included in this report. This
report contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. The statements contained in this
report that are not historic in nature, particularly those that utilize
terminology such as "may," "will," "should," "expects," "anticipates,"
"estimates," "believes," or "plans" or comparable terminology are
forward-looking statements based on current expectations and
assumptions.
Various
risks and uncertainties could cause actual results to differ materially from
those expressed in forward-looking statements. All forward-looking statements in
this document are based on information currently available to us as of the date
of this report, and we assume no obligation to update any forward-looking
statements. Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the actual results to differ
materially from any future results, performance or achievements expressed or
implied by such forward-looking statements.
OUR
CORPORATE HISTORY
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25, 2000
as Edot-com.com, Inc.
and was organized for the purpose of conducting internet retail sales. On
April 1, 2005, Edot-com.com, Inc. was incorporated under
the laws of the State of Nevada for the purpose of re-domiciling the Company as
a Nevada corporation, Edot-com.com (Nevada). On April 15, 2005, Edot-com.com
(Colorado) and Edot-com.com (Nevada) were merged and Edot-com.com, Inc.,
(ECMM) a Nevada
corporation (the “Company”), became the surviving entity. On April 15, 2005, the
authorized shares of common stock was increased to 300,000,000 shares at $.001
par value and the Company effected a 3.2 - 1 forward stock split effective May
12, 2005.
On June
1, 2005, Edot-com.com, Inc. acquired NanoViricides, Inc., a privately owned
Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share Exchange
(the “Exchange”). NVI was incorporated under the laws of the State of Florida on
May 12, 2005 and its sole asset was comprised of a licensing agreement with
TheraCour Pharma, Inc. (“TheraCour,” an approximately 30% shareholder of NVI)
for rights to develop and commercialize novel and specifically targeted drugs
based on TheraCour's targeting technologies, against a number of human viral
diseases. (For financial accounting purposes, the acquisition was a reverse
acquisition of the Company by NVI, under the purchase method of accounting, and
was treated as a recapitalization with NVI as the acquirer). Upon consummation
of the Exchange, ECMM adopted the business plan of NVI.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate of
80,000,000 newly issued shares of ECMM common stock, resulting in an aggregate
of 100,000,000 shares of ECMM common stock issued and outstanding. As a result
of the Exchange, NVI became a wholly-owned subsidiary of ECMM. The ECMM shares
were issued to the NVI Shareholders on a pro rata basis, on the basis of 4,000
shares of the Company’s Common Stock for each share of NVI common stock held by
such NVI Shareholder at the time of the Exchange.
On June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, Edot-com.com, Inc., changed
its name to NanoViricides, Inc. and its stock symbol on the Pink Sheets to
“NNVC”, respectively. The Company submitted a Form-10SB to the SEC to
become a reporting company on November 14, 2006. The Company’s filing status
became effective in March, 2007. On June 28, 2007, the company became
quotable on The OTC Bulletin Board under the symbol NNVC.OB.
The
Company is considered a development stage company at this time.
Management’s
Plan of Operation
NanoViricides,
Inc. (the “Company”), is an early developmental stage nano-biopharmaceutical
company engaged in the discovery, development and commercialization of
anti-viral therapeutics. The Company has no customers, products or revenues to
date, and may never achieve revenues or profitable operations. Our drugs are
based on several patents, patent applications, provisional patent applications,
and other proprietary intellectual property held by TheraCour Pharma, Inc., one
of the Company’s principal shareholders, from which we have licensed, in
perpetuity, the right to develop drug candidates for the treatment of
the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS),
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV),
Rabies, Influenza and Asian Bird Flu Virus. Additionally, TheraCour has
permitted the Company to use its nanomaterials to develop a treatment against
Dengue Fever viruses, Ebola/Marburg viruses, and viruses causing certain eye
diseases. The Company anticipates negotiating with TheraCour an amendment to the
Licensing Agreement to include additional viruses. We are seeking to add to our
existing portfolio of products through our internal discovery pre-clinical
development programs and through an in-licensing strategy. We focus our
laboratory research and pre-clinical programs on specific anti-viral
solutions.
The
Company has incurred significant operating losses since its inception resulting
in an accumulated deficit of $11,370,715
at March 31, 2009. For the nine months ended March 31, 2009 the Company had a
net loss of $2,162,978. 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 (in addition to H5N1,
several H9N as well as H7N influenza virus subtypes are highly pathogenic and
have caused 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, Viral Conjunctivitis,
and other viruses.
We have
developed lead drug candidates against a number of viral diseases.
Proof-of-principle efficacy studies in animals have been conducted successfully
in many of these.
Nanoviricides
are designed to work by binding to and eliminating virus particles from the
blood-stream, just as antibodies do, only potentially much better. This 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.
Common
Influenza, High Path Avian Influenzas, Bird Flu, Swine Flu
Our
FluCide™ program has a lead drug candidate that has shown efficacies in animals
that far exceed that of known drugs such as oseltamivir (Tamiflu®, Roche)
against common influenza in an animal model. 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. Recently, with
additional SAR (structure-activity-relationship) studies, we have been able to
develop influenza virus binding ligands that are expected to be superior to the
previously used ligands in FluCide-HP. The new ligands are designed to be
stronger mimics of the sialic acid receptors, capable of binding to influenza
virus hemagglutinin proteins that use either the “avian” or the “human” types of
sialic acid receptors. Pigs are known to be a “mixing vessel” species,
exhibiting both avian and human types of sialic acid receptors, and thereby
re-assortment (mixing) of genetic material from different influenza strains,
subtypes, or types, can occur readily in pigs. The new FluCide is expected to be
highly active against all influenzas, including highly pathogenic strains such
as H5N1, the 2009 H1N1 Mexico epidemic strain, H3N2, H7N, and H9N among others.
We plan on stopping development of FluCide-HP as a separate drug for highly
pathogenic influenzas, thus establishing a single drug for all influenzas,
whether epidemic, or seasonal. We anticipate significant cost savings as well as
simplification in regulatory and eventual marketing efforts by consolidating
these drug programs.
We are
actively seeking partnerships, collaborations and government funding for our
anti-influenza drug program.
Ebola,
Marburg, Dengue
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 have also submitted
a grant application to the New England Regional Center of Excellence
(NERCE) American Recovery and Reinvestment Act Supplement funding
opportunity.
We are
currently working on developing anti-Dengue therapeutics.
We have
recently submitted a grant application to the Department of Defense for the
development of broad-spectrum nanoviricides that may be useful in treating
Ebola, Marburg, and Dengue viruses.
Rabies
Our
RabiCide™ program has resulted in candidates that have enabled survival of 20%
to 30% of infected animals after disease has set in, using a particular animal
model. Further testing is in progress in a different experimental model. We
believe that if this testing succeeds, it may be the first ever therapeutic
against rabies. Currently, rabies is a uniformly lethal disease with only
prophylactic medications available, which 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.
Viral
Diseases of the Eye: Viral Conjunctivitis, Viral Keratitis – Eye
Drops
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.
Based on
these successful results, we have since expanded this program to develop a
single broad-spectrum nanoviricide treatment useful against a majority of
viruses causing external eye diseases such as viral conjunctivitis and viral
keratitis. HSV and some adenoviruses cause most of the cases of
keratitis, a serious infection of the cornea. Importantly, HSV
infection can lead to corneal scarring that may necessitate corneal
transplantation. In addition, some adenoviruses cause a majority of
conjunctivitis cases (“Pink eye”). The remaining cases of
conjunctivitis are caused y bacteria and are treatable with topical
antibiotics. Currently there are no effective treatments for viral
diseases of the exterior portion of the eye.
The eye
drugs are formulated as simple eye drops.
The total
market for viral conjunctivitis and keratitis is estimated to be in the billions
of dollars. The incidence of severe herpes keratitis is estimated to
be 250,000 cases per year in the USA. In Japan, where EKC is a
reportable disease, it is estimated that there are at least one million cases
per year. The number of cases of non-specific conjunctivitis (pink
eye) is considered to be far greater, possibly into the tens of millions in the
US and hundreds of millions worldwide.
The
Company reported on February 27, 2009 that it entered into a Material Transfer
Agreement with a major pharmaceutical company. Pursuant to the terms
of the agreement, the Company is not authorized to disclose the identity or the
terms of the Agreement, except for securities reporting purposes. The
pharmaceutical company will evaluate one of the Company’s compounds as a drug
candidate for certain viral infections of the external eye. The
Agreement also provides that following evaluation, should the pharmaceutical
company so elect, the parties may enter into good faith negotiations for an
exclusive, worldwide license for drug development and commercialization of the
eye drug candidate.
On May 6,
2009, the Company entered into a Clinical Study Agreement with THEVAC, LLC, a
company affiliated with the Emerging Technology Center of the Louisiana State
University. The Company will provide THEVAC with drug compounds that
will be initially tested for their ability to inhibit replication of the HSV-1
virus, utilizing plaque reduction assays and inhibition of cytopathic effects
(CPE)) assays. In addition, the drug compounds will be tested for
their ability to inactivate free virus and inhibit penetration and virus spread
to adjacent cells.
HIV
Our very
first animal studies in SCID-hu mice against HIV-I have resulted in a
demonstration that our primary nanoviricide drug candidate 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 scientists. (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 virus particles or HIV proteins to any significant extent and are
thought to remain unaffected by current anti-HIV drugs. The current standard
treatment results in very low levels of HIV viremia, but the immune cells (CD4+
T cells and CD8+T cells) count eventually begins decreasing at a slow rate. The
HAART therapy must be continued for the life of the patient and the drug mix is
altered as failure occurs. 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, acting by a novel mechanism of
action and a first-in-class therapeutic, based on current preliminary
data. We intend to develop it further.
ADIF™
Technologies
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 Viral Eye Diseases drug
candidate, and HIVCide and FluCide 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 cell culture and animal models, and have
conducted preliminary safety studies that have indicated that all of our
nanoviricides are safe in the animal models as tested. We continue to
work on further experiments necessary for development of our various drug
candidates as FDA approvable drugs.
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
additional viruses. We are seeking to add to our existing portfolio of products
through our internal discovery pre-clinical development programs and through an
in-licensing strategy.
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. The Company may manufacture these drugs itself,
or 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.
The
Company has taken several steps to reduce its operating expenses. We
have not renewed certain consulting contracts, which is expected to result in
annual savings of $150,000 to $300,000. We have not renewed our lease
for laboratory facilities at 4 Research Drive and have constructed and
consolidated our laboratory facilities at 135 Wood Street, West Haven,
Connecticut, for an anticipated annual savings of approximately
$50,000. We have also made several changes which should result in a
reduction in our professional fees of approximately $100,000
annually.
As of
March 31, 2009 we had a cash and cash equivalent balance of $1,228,056 which can
support operations through, approximately, September 30, 2009, at our current
projected rate of spending.
However,
in addition to current funds allocated to capital costs and staffing, and in
accordance with our business plan, we have also budgeted for additional capital
costs and staffing costs of approximately $2 million dollars 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 in-vivo
and in-vitro studies for pan-influenza FluCide, RabiCide, EKCCide, HIVCide, and
Dengue and Ebola/Marburg programs, planned for the next twelve months ending
March 31, 2010. 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 next twelve months ending March 31,
2010.
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, and
other items related to FDA compliance, as required for development of necessary
data for filing an Investigational New Drug Application (IND) with the United
States Food and Drug Administration.
The
Company projects that it will be unable to proceed with its planned drug
development progress, meet its administrative expense requirements, capital
costs, and staffing costs beyond September 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 continues to re-prioritize its objectives
and delay certain drug development programs until we can raise sufficient
funding that enables further development of the drugs with the goal of filing an
Investigational New Drug application (IND) to the FDA.
The
Company does not have any arrangements, at this time, for equity or other
financing for these further needs of $3-5 million 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. As such our
budget estimates may vary significantly from actual expenses incurred. In
addition, the actual work to be performed is not known at this time, other than
a broad outline, as is normal with any scientific work. As further work is
performed, additional work may become necessary or change in plans or workload
may occur. Such changes may have an adverse impact on our estimated budget. Such
changes may also have an adverse impact on our projected timeline of drug
development.
We
believe that this coming year's work-plan will lead us to obtain certain
information about the safety and efficacy of some of the drugs under development
in animal models. If our studies are not successful, we will have to develop
additional drug candidates and perform further studies. If our studies are
successful, then we expect to be able to undertake further studies in animal
models to obtain necessary data regarding the pharmaco-kinetic and
pharmaco-dynamic profiles of our drug candidates. We believe these data will
then enable us to file an Investigational New Drug (IND) application, towards
the goal of obtaining FDA approval for testing the drugs in human
patients.
Most
pharmaceutical companies expect 4 to 10 years of study to be required before a
drug candidate reaches the IND stage. We believe that because we are working in
the infectious agents area, our studies will have objective response end points,
and will be of relatively short durations. Our business plan is based on these
assumptions. If we find that we have underestimated the time duration of our
studies, or we have to undertake additional studies, due to various reasons
within or outside of our control, this will grossly and adversely impact both
our timelines and our financing requirements.
Management
intends to use capital and debt financing, as required, to fund the Company’s
operations. There can be no assurance that the Company will be able to obtain
the additional capital resources necessary to fund its anticipated obligations
for the next twelve months.
The
Company is considered to be a development stage company and will continue in the
development stage until it generates revenues from the sales of its products or
services.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK.
The
Company is not exposed to market risk related to interest rates or foreign
currencies.
ITEM
4. CONTROLS AND PROCEDURES
(a) Evaluation
of disclosure controls and procedures.
Based
upon an evaluation of the effectiveness of disclosure controls and procedures,
our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO") have
concluded that as of the end of the period covered by this Quarterly Report on
Form 10-Q our disclosure controls and procedures (as defined in Rules 13a-15(e)
or 15d-15(e) under the Exchange Act) were effective to provide reasonable
assurance that information required to be disclosed in our Exchange Act reports
is recorded, processed, summarized and reported within the time periods
specified by the rules and forms of the SEC and is accumulated and communicated
to management, including the CEO and CFO, as appropriate to allow timely
decisions regarding required disclosure.
b) Changes
in internal control over financial reporting.
In our
Annual Report on Form 10-K for the year ended June 30, 2008, Management reported
that it was aware that there were the following material weaknesses in our
internal control over financial reporting
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 March 31, 2009 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 believes that it has taken significant steps to remediate these
weaknesses including implementing additional segregation of responsibilities and
authorizations for initiating, authorizing and recording
transactions. In addition, the Company has outsourced certain
financial functions, including reviewing significant transactions and quarterly
financial statements to independent contractors.
Other
than as described above, there were no material changes in our internal control
over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act)
that occurred as of March 31, 2009, that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II. OTHER INFORMATION
Item
1. LEGAL PROCEEDINGS
None.
Item
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS.
In August
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.
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.
In
November 2008, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $0.70 per share. These warrants, if
not exercised, will expire in November 2012. The fair value of these warrants in
the amount of $30,500 was recorded as consulting expense.
In
February 2009, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $0.58 per share. These warrants, if
not exercised, will expire in November 2012. The fair value of these warrants in
the amount of $29,000 was recorded as consulting expense.
For the
nine months ended March 31, 2009, the Company's Board of Directors authorized
the issuance of 106,628 shares of its common stock with a restrictive legend,
for consulting services. The Company recorded an expense of
$79,800.
For the
nine months ended March 31, 2009, the Company's Board of Directors authorized
the issuance of additional 29,248 shares of its common stock with a restrictive
legend, for legal services. The Company recorded an expense of
$50,000.
All of
the securities set forth above were issued by the Company pursuant to Section
4(2) of the Securities Act of 1933, as amended, or the provisions of Rule 504 of
Regulation D promulgated under the Securities Act. All such shares issued
contained a restrictive legend and the holders confirmed that they were
acquiring the shares for investment and without intent to distribute the shares.
All of the purchasers were friends or business associates of the Company’s
Management and all were experienced in making speculative investments,
understood the risks associated with investments, and could afford a loss of the
entire investment. The Company has never utilized an underwriter for an offering
of its securities.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY
HOLDERS
On March
18, 2009 a majority of the Company’s shareholders consented to an, amendment of
the Company’s Articles of Incorporation to authorize the creation of a class of
10,000,000 shares of blank check preferred stock (the
“Amendment”). The Company filed a Definitive Information Statement
with the Securities and Exchange Commission disclosing the action taken by its
shareholders. The Amendment became effective May 13,
2009.
ITEM
5. OTHER INFORMATION
Subsequent
Events
On May 6,
2009, the Company entered into a Clinical Study Agreement with THEVAC, LLC, a
company affiliated with the Emerging Technology Center of the Louisiana State
University. The Company will provide THEVAC with drug compounds that
will be tested for their ability to inhibit replication of the HSV-1 virus,
utilizing plaque reduction assays and inhibition of cytopathic effects (CPE)
assays.
ITEM
6. EXHIBITS AND REPORTS ON FORM 8-K
(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 March 31, 2009, the
Company filed the following Current Reports on Form 8-K:
On
January 13, 2009, the Company filed a Current Report disclosing that it had
dismissed Holtz Rubenstein Reminick LLP as its independent accountant and had
engaged Li & Company, PC as its new independent accountant.
On
February 10, 2009, the Company filed a Current Report disclosing that TheraCour
Pharma, Inc., the largest single shareholder of the Company, had adopted a
written trading plan pursuant to Securities and Exchange Commission Rule 10b5-1,
under which it would sell up to 1,800,000 shares of the Company’s common stock
over a one year period.
On March
2, 2009, the Company filed a Current Report disclosing that on February 25,
2009, it had entered into a Material Transfer Agreement with a pharmaceutical
company to evaluate one of the Company’s compounds as a drug candidate for
certain viral infections of the external eye.
SIGNATURES
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 15, 2009
NANOVIRICIDES,
INC.
/s/ Eugene Seymour, MD
|
|
Eugene
Seymour, M.D.
|
|
Chief
Executive Officer and Interim Chief Financial Officer and
Director
|
|
(Principal
Executive and Financial Officer)
|
|
/s/ Anil Diwan
|
|
Anil
Diwan,
|
|
President
and Chairman of the Board of Directors
|
22