Nevada
|
90-0031917
|
|||
(State
or other jurisdiction of incorporation or
organization)
|
(I.R.S.
Employer Identification Number)
|
|||
7327
Oak Ridge Highway, Suite A, Knoxville,
Tennessee
|
37931
|
|||
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
|||
Page
|
|
Part
I
|
|
Item
1A.
Risk
Factors
|
3
|
Item
1B.
Unresolved
Staff Comments
|
8
|
Item
1. Description of Business
|
8
|
History
|
8
|
Description
Of Business
|
9
|
Intellectual
Property
|
15
|
Competition
|
16
|
Federal
Regulation of Therapeutic Products
|
16
|
Personnel
|
18
|
Available
Information
|
19
|
Item
2. Description of Property
|
19
|
Item
3. Legal Proceedings
|
20
|
Item
4. Submission of Matters to a Vote of Security
Holders
|
20
|
Part
II
|
|
Item
5. Market for Common Equity and Related Stockholder
Matters
|
21
|
Item
6. Management's Discussion and Analysis or Plan of
Operation
|
22
|
Plan
of Operation
|
23
|
Item
7. Financial Statements
|
26
|
Forward-Looking
Statements
|
26
|
Item
8. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
|
26
|
Item
8A. Controls and Procedures
|
26
|
Item
8B. Other Information
|
26
|
Part
III
|
|
Item
9. Directors, Executive Officers, Promoters and Control
Persons; Compliance with Section 16(a) of the Exchange Act
|
26
|
Item
10. Executive Compensation
|
27
|
Item
11. Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters
|
27
|
Item
12. Certain Relationships and Related
Transactions
|
27
|
Item
13. Exhibits
|
27
|
Item
14. Principal Accountant Fees and Services
|
27
|
Signatures
|
28
|
Financial Statements |
F-1
|
Exhibit Index |
X-1
|
· |
a
product may be found to be ineffective or have harmful
side effects during subsequent pre-clinical testing or clinical
trials;
|
· |
a
product may fail to receive necessary regulatory
clearance;
|
· |
a
product may be too difficult to manufacture on a large
scale;
|
· |
a
product may be too expensive to manufacture or market;
|
· |
a
product may not achieve broad market acceptance;
|
· |
others
may hold proprietary rights that will prevent a
product from being marketed; or
|
· |
others
may market equivalent or superior products.
|
· |
research
and development;
|
· |
manufacturing;
|
· |
preclinical
and clinical testing;
|
· |
obtaining
regulatory approvals;
and
|
· |
marketing.
|
· |
product
efficacy and safety;
|
· |
the
timing and scope of regulatory
consents;
|
· |
availability
of resources;
|
· |
reimbursement
coverage;
|
· |
price;
and
|
· |
patent
position, including potentially dominant patent
positions of others.
|
· |
Purell
(owned by Johnson &
Johnson),
|
· |
Avagard D (manufactured by 3M) and
|
· | a large number of generic and private-label equivalents to these market leaders. |
· |
H.
Craig Dees, Ph.D., our Chief Executive Officer;
|
· |
Timothy
C. Scott, Ph.D., our
President;
|
· |
Eric
A. Wachter, Ph.D. our Vice President - Pharmaceuticals;
and
|
· |
Peter
R. Culpepper, CPA, our Chief Financial Officer.
|
· |
Researching
diseases and possible therapies in the areas of
dermatology and skin care, oncology, and biotechnology;
|
· |
Developing
prescription drug, medical device and OTC
products based on our research;
|
· |
Marketing
and selling developed
products;
|
· |
Obtaining
additional capital to finance research,
development, production and marketing of our products; and
|
· |
Managing
our business as it grows.
|
· |
absence
of meaningful earnings and ongoing need for external
financing,
|
· |
a
relatively thin trading market for our common stock, which
causes trades of small blocks of stock to have a significant impact
on our
stock price,
|
· |
general
volatilitiy of the stock markers and the market
prices of other publicly traded companies, and
|
· |
investor
sentiment regarding equity markets generally,
including public perception of corporate ethics and governance and
the
accuracy and transparency of financial reporting.
|
· |
broker-dealers
must deliver, prior to the transaction a
disclosure schedule prepared by the SEC relating to the penny stock
market;
|
· |
broker-dealers
must disclose the commissions payable to the
broker-dealer and its registered representative;
|
· |
broker-dealers
must disclose current quotations for the
securities;
|
· |
if
a broker-dealer is the sole market-maker, the
broker-dealer must disclose this fact and the broker-dealers presumed
control over the market; and
|
· |
a
broker-dealer must furnish its customers with monthly
statements disclosing recent price information for all pennies stocks
held
in the customer’s account and information on the limited market in penny
stocks.
|
· |
prescription
drugs, medical and other devices (including
laser devices) and over-the-counter pharmaceutical products in the
fields
of dermatology and oncology; and
|
· |
technologies
for the preparation of human and animal
vaccines, diagnosis of infectious diseases and enhanced production
of
genetically engineered drugs.
|
· |
Xantech
Pharmaceuticals, Inc.
|
· |
Pure-ific
Corporation
|
· |
Provectus
Biotech, Inc.
|
· |
Provectus
Devicetech, Inc.
|
· |
Provectus
Pharmatech, Inc.
|
· |
Over-the-counter
products, which we refer to in this report
as "OTC products;"
|
· |
Prescription
drugs; and
|
· |
Medical
device systems
|
· |
hand
irritation associated with use of disposable gloves
|
· |
eczema
|
· |
mild
to moderate acne
|
· |
Airport
security personnel;
|
· |
Food
handling and preparation
personnel;
|
· |
Sanitation
workers;
|
· |
Postal
and package delivery handlers and
sorters;
|
· |
Laboratory
researchers;
|
· |
Health
care workers such as hospital and blood bank
personnel; and
|
· |
Police,
fire and emergency response
personnel.
|
· |
cosmetic
treatments, such as reduction of wrinkles and
elimination of spider veins and other cosmetic blemishes;
and
|
· |
therapeutic
uses, including photoactivation of Xantryl other
prescription drugs and non-surgical destruction of certain skin
cancers.
|
U.S.
Patent No
|
Title
|
Issue
Date
|
Expiration
Date
|
5,829,448
|
Method
for improved selectivity in -activation of molecular
agents
|
November
3, 1998
|
October
30, 2016
|
5,832,931
|
Method
for improved selectivity in photo-activation and
detection of diagnostic agents
|
November
10, 1998
|
October
30, 2016
|
5,998,597
|
Method
for improved selectivity in -activation of molecular
agents
|
December
7, 1999
|
October
30, 2016
|
6,042,603
|
Method
for improved selectivity in photo-activation of
molecular agents
|
March
28, 2000
|
October
30, 2016
|
6,331,286
|
Methods
for high energy phototherapeutics
|
December
18, 2001
|
December
21, 2018
|
6,451,597
|
Method
for enhanced protein stabilization and for production of
cell lines useful production of such stabilized proteins
|
September
17, 2002
|
April
6, 2020
|
6,468,777
|
Method
for enhanced protein stabilization and for production of
cell lines useful production of such stabilized proteins
|
October
22, 2002
|
April
6, 2020
|
6,493,570
|
Method
for improved imaging and photodynamic therapy
|
December
10, 2002
|
December
10, 2019
|
6,495,360
|
Method
for enhanced protein stabilization for production of
cell lines useful production of such stabilized proteins
|
December
17, 2002
|
April
6, 2020
|
6,519,076
|
Methods
and apparatus for optical imaging
|
February
11, 2003
|
October
30, 2016
|
6,525,862
|
Methods
and apparatus for optical imaging
|
February
25, 2003
|
October
30, 2016
|
6,541,223
|
Method
for enhanced protein stabilization and for production of
cell lines useful production of such stabilized proteins
|
April
1, 2003
|
April
6, 2020
|
6,986,740
|
Ultrasound
contrast using halogenated xanthenes
|
January
17, 2006
|
September
9, 2023
|
6,991,776
|
Improved
intracorporeal medicaments for high energy
phototherapeutic treatment of disease
|
January
31, 2006
|
May
5, 2023
|
7,036,516
|
Treatment
of pigmented tissues using optical energy
|
May
2, 2006
|
January
28, 2020
|
· |
Using
chemicals and combinations already allowed by the FDA;
|
· |
Carefully
making product performance claims to avoid the
need for regulatory approval;
|
· |
Using
drugs that have been previously approved by the FDA
and that have a long history of safe use;
|
· |
Using
chemical compounds with known safety profiles; and
|
· |
In
many cases, developing OTC products which face less
regulation than prescription pharmaceutical
products.
|
· |
Preclinical
laboratory and animal
testing;
|
· |
Submission
of an application that must become effective
before clinical trials may begin;
|
· |
Adequate
and well-controlled human clinical trials to
establish the safety and efficacy of the product for its intended
indication; and
|
· |
FDA
approval of the application to market a given product
for a given indication.
|
High
|
Low
|
|
2005
|
||
First
Quarter (January 1 to March 31)
|
$1.25
|
0.64
|
Second
Quarter (April 1 to June 30)
|
0.85
|
0.52
|
Third
Quarter (July 1 to September 30)
|
0.99
|
0.60
|
Fourth
Quarter (October 1 to December 31)
|
1.14
|
0.77
|
2006
|
||
First
Quarter (January 1 to March 31)
|
1.20
|
0.83
|
Second
Quarter (April 1 to June 30)
|
1.97
|
1.01
|
Third
Quarter (July 1 to September 30)
|
1.47
|
0.94
|
Fourth
Quarter (October 1 to December 31)
|
1.34
|
1.11
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
F-1
|
Consolidated
Balance Sheets as of December 31, 2006 and 2005
|
F-2
|
Consolidated
Statements of Operations for the years December 31, 2006 and 2005
|
F-3
|
Consolidated
Statements of Shareholders' Equity for years ended December 31,
2006 and
2005
|
F-4
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2006
and 2005
|
F-5
|
Notes
to Consolidated Financial Statements
|
F-7
|
Signature
|
Title
|
Date
|
/s/
H. Craig Dees
H.
Craig Dees, Ph.D.
|
Chief
Executive Officer (principal executive officer) and Chairman of
the Board
|
March
22, 2007
|
/s/
Peter R. Culpepper
Peter
R. Culpepper, CPA
|
Chief
Financial Officer (principal financial officer and principal accounting
officer)
|
March
22, 2007
|
/s/
Timothy C. Scott
Timothy
C. Scott, Ph.D.
|
President
and Director
|
March
22, 2007
|
/s/
Eric A. Wachter , Ph.D
Eric
A. Wachter, Ph.D.
|
Vice
President - Pharmaceuticals and Director
|
March
22, 2007
|
/s/
Stuart Fuchs
Stuart
Fuchs
|
Director
|
March
22, 2007
|
December
31,
2006
|
December
31,
2005
|
|||||
Assets
|
||||||
Current
Assets
|
||||||
Cash
and cash
equivalents
|
$
|
638,334
|
$
|
6,878,990
|
||
United
States
Treasury Notes, total face value $6,507,019
|
6,499,034
|
--
|
||||
Prepaid
expenses
and other current assets
|
173,693
|
67,962
|
||||
Total
Current Assets
|
7,311,061
|
6,946,952
|
||||
Equipment
and Furnishings, less accumulated depreciation of
$372,721 and $368,279
|
30,075
|
12,287
|
||||
Patents,
net of amortization of $2,762,777 and $2,091,657
|
8,952,668
|
9,623,788
|
||||
Deferred
loan costs, net of amortization of $103,018 and
$161,004
|
3,713
|
709,092
|
||||
Other
assets
|
27,000
|
27,000
|
||||
$
|
16,324,517
|
$
|
17,319,119
|
|||
Liabilities
and Stockholders’ Equity
|
||||||
Current
Liabilities
|
||||||
Accounts
payable
- trade
|
$
|
64,935
|
$
|
90,124
|
||
Accrued
compensation
|
265,929
|
179,170
|
||||
Accrued
common
stock costs
|
17,550
|
964,676
|
||||
Accrued
consulting expense
|
42,500
|
692,512
|
||||
Other
accrued
expenses
|
46,500
|
61,500
|
||||
Accrued
interest
|
--
|
65,055
|
||||
March
2005
convertible debt, net of debt discount of $2,797 and $884,848
|
364,703
|
221,401
|
||||
November
2005
convertible debt, net of debt discount of $134,008 in 2005
|
--
|
334,828
|
||||
Total
Current Liabilities
|
802,117
|
2,609,266
|
||||
March
2005 convertible debt, net of debt discount of
$46,039 in 2005
|
--
|
322,712
|
||||
Stockholders’
Equity
|
||||||
Common
stock; par value $.001 per share; 100,000,000 shares authorized;
42,452,366 and 27,822,977 shares issued and outstanding,
respectively
|
42,452
|
27,823
|
||||
Paid-in
capital
|
50,680,353
|
40,689,144
|
||||
Deficit
accumulated during the development stage
|
(35,200,405)
|
(26,329,826)
|
|
|||
Total
Stockholders’ Equity
|
15,522,400
|
14,387,141
|
||||
$
|
16,324,517
|
$
|
17,319,119
|
Year
Ended
December
31, 2006
|
Year
Ended
December
31, 2005
|
Cumulative
Amounts from January 17, 2002 (Inception)
Through
December
31, 2006
|
||||
Revenues
|
||||||
OTC
product revenue
|
$
|
1,368
|
$
|
5,552
|
$
|
25,648
|
Medical
device revenue
|
--
|
984
|
14,109
|
|||
Total
revenues
|
1,368
|
6,536
|
39,757
|
|||
Cost
of sales
|
875
|
3,560
|
15,216
|
|||
Gross
profit
|
493
|
2,976
|
24,541
|
|||
Operating
expenses
|
||||||
Research
and development
|
$
|
3,016,361
|
$
|
2,044,391
|
$
|
7,128,207
|
General
and administrative
|
3,534,597
|
2,999,334
|
16,729,968
|
|||
Amortization
|
671,120
|
671,120
|
2,762,777
|
|||
Total
operating loss
|
(7,221,585)
|
(5,711,869)
|
(26,596,411)
|
|||
Gain
on sale of fixed assets
|
75
|
--
|
55,075
|
|||
Loss
on extinguishment of debt
|
--
|
(724,455)
|
(825,867)
|
|||
Investment
income
|
253,393
|
--
|
253,393
|
|||
Net
interest expense
|
(1,902,462)
|
(5,327,529)
|
(8,086,595)
|
|||
Net
loss
|
$
|
(8,870,579)
|
$
|
(11,763,853)
|
$
|
(35,200,405)
|
Basic
and diluted loss per common share
|
$
|
(0.23)
|
$
|
(0.62)
|
||
Weighted
average number of common
shares
outstanding - basic and diluted
|
37,973,403
|
18,825,670
|
Common
Stock
|
|||||||||||||
Number
of Shares
|
Par
Value
|
Paid
in capital
|
Accumulated
Deficit
|
Total
|
|||||||||
Balance,
at January 17 2002
|
$ |
--
|
$
|
--
|
$
|
--
|
$
|
--
|
$
|
--
|
|||
Issuance
to founding shareholders
|
6,000,000
|
6,000
|
(6,000)
|
--
|
--
|
||||||||
Sale
of stock
|
50,000
|
50
|
24,950
|
--
|
25,000
|
||||||||
Issuance
of stock to employees
|
510,000
|
510
|
931,490
|
--
|
932,000
|
||||||||
Issuance
of stock for services
|
120,000
|
120
|
359,880
|
--
|
360,000
|
||||||||
Net
loss for the period from January 17, 2002 (inception) to
April 23, 2002 (date of reverse merger)
|
--
|
--
|
--
|
(1,316,198)
|
(1,316,198)
|
||||||||
Balance,
at April 23, 2002
|
$ |
6,680,000
|
$
|
6,680
|
$
|
1,310,320
|
$
|
1,316,198)
|
$
|
802
|
|||
Shares
issued in reverse merger
|
265,763
|
266
|
(3,911)
|
--
|
(3,645)
|
||||||||
Issuance
of stock for services
|
1,900,000
|
1,900
|
5,142,100
|
--
|
5,144,000
|
||||||||
Purchase
and retirement of stock
|
(400,000)
|
(400)
|
(47,600)
|
--
|
(48,000)
|
||||||||
Stock
issued for acquisition of Valley Pharmaceuticals
|
500,007
|
500
|
12,225,820
|
--
|
12,226,320
|
||||||||
Exercise
of warrants
|
452,919
|
453
|
--
|
--
|
453
|
||||||||
Warrants
issued in connection with convertible debt
|
--
|
--
|
126,587
|
--
|
126,587
|
||||||||
Stock
and warrants issued for acquisition of Pure-ific
|
25,000
|
25
|
26,975
|
--
|
27,000
|
||||||||
Net loss for the period from April 23, 2002
(date of reverse
merger) to December 31, 2002
|
--
|
--
|
--
|
(5,749,937)
|
(5,749,937)
|
||||||||
Balance,
at December 31, 2002
|
$ |
9,423,689
|
$
|
9,424
|
$
|
18,780,291
|
$
|
(7,066,135)
|
$
|
11,723,580
|
|||
Issuance
of stock for services
|
764,000
|
764
|
239,036
|
--
|
239,800
|
||||||||
Issuance
of warrants for services
|
--
|
--
|
145,479
|
--
|
145,479
|
||||||||
Stock
to be issued for services
|
--
|
--
|
281,500
|
--
|
281,500
|
||||||||
Employee
compensation from stock options
|
--
|
--
|
34,659
|
--
|
34,659
|
||||||||
Issuance
of stock pursuant to Regulation S
|
679,820
|
680
|
379,667
|
--
|
380,347
|
||||||||
Beneficial
conversion related to convertible debt
|
--
|
--
|
601,000
|
--
|
601,000
|
||||||||
Net
loss for the year ended December 31, 2003
|
--
|
--
|
--
|
(3,155,313)
|
(3,155,313)
|
||||||||
Balance,
at December 31, 2003
|
$ |
10,867,509
|
$
|
10,868
|
$
|
20,461,632
|
$
|
(10,221,448)
|
$
|
(10,251,052)
|
|||
Issuance
of stock for services
|
733,872
|
734
|
449,190
|
--
|
449,923
|
||||||||
Issuance
of warrants for services
|
--
|
--
|
495,480
|
--
|
495,480
|
||||||||
Exercise
of warrants
|
132,608
|
133
|
4,867
|
--
|
5,000
|
||||||||
Employee
compensation from stock options
|
--
|
--
|
15,612
|
--
|
15,612
|
||||||||
Issuance
of stock pursuant to Regulation S
|
2,469,723
|
2,469
|
790,668
|
--
|
793,137
|
||||||||
Issuance
of stock pursuant to Regulation D
|
1,930,164
|
1,930
|
1,286,930
|
--
|
1,288,861
|
||||||||
Beneficial
conversion related to convertible debt
|
--
|
--
|
360,256
|
--
|
360,256
|
||||||||
Issuance
of convertible debt with warrants
|
--
|
--
|
105,250
|
--
|
105,250
|
||||||||
Repurchase
of beneficial conversion feature
|
--
|
--
|
(258,345)
|
--
|
(258,345)
|
||||||||
Net
loss for the year ended December 31, 2004
|
--
|
--
|
--
|
(4,344,525)
|
(4,344,525)
|
||||||||
Balance,
at December 31, 2004
|
$ |
16,133,876
|
$
|
16,134
|
$
|
23,711,540
|
$
|
(14,565,973)
|
$
|
9,161,701
|
|||
Issuance
of stock for services
|
226,733
|
227
|
152,058
|
--
|
152,285
|
|
|||||||
Issuance
of stock for interest payable
|
|
263,721
|
|
264
|
|
195,767
|
|
--
|
|
196,031
|
|||
Issuance
of warrants for services
|
--
|
--
|
1,534,405
|
--
|
1,534,405
|
||||||||
Issuance
of warrants for contractual
obligations
|
--
|
--
|
985,010
|
--
|
985,010
|
||||||||
Exercise
of warrants and stock options
|
1,571,849
|
1,572
|
1,438,223
|
--
|
1,439,795
|
||||||||
Employee
compensation from stock options
|
--
|
--
|
15,752
|
--
|
15,752
|
||||||||
Issuance
of stock pursuant to Regulation D
|
6,221,257
|
6,221
|
6,506,955
|
--
|
6,513,176
|
||||||||
Debt
conversion to common stock
|
3,405,541
|
3,405
|
3,045,957
|
--
|
3,049,362
|
||||||||
Issuance
of warrants with convertible debt
|
--
|
--
|
1,574,900
|
--
|
1,574,900
|
||||||||
Beneficial
conversion related to convertible debt
|
--
|
--
|
1,633,176
|
--
|
1,633,176
|
||||||||
Beneficial
conversion related to interest expense
|
--
|
--
|
39,529
|
--
|
39,529
|
||||||||
Repurchase
of beneficial conversion feature
|
--
|
--
|
(144,128)
|
--
|
(144,128)
|
|
|||||||
Net
loss for the year ended 2005
|
--
|
--
|
--
|
(11,763,853)
|
|
(11,763,853)
|
|
||||||
Balance,
at December 31, 2005
|
$ |
27,822,977
|
$
|
27,823
|
$
|
40,689,144
|
$
|
(26,329,826)
|
$
|
14,387,141
|
|||
Issuance
of stock for services
|
719,246
|
719
|
676,024
|
--
|
676,743
|
||||||||
Issuance
of stock for interest payable
|
194,327
|
195
|
183,401
|
--
|
183,596
|
||||||||
Issuance
of warrants for services
|
--
|
--
|
370,023
|
--
|
370,023
|
||||||||
Exercise
of warrants and stock options
|
1,245,809
|
1,246
|
1,188,570
|
--
|
1,189,816
|
||||||||
Employee
compensation from stock options
|
--
|
--
|
1,862,456
|
--
|
1,862,456
|
||||||||
Issuance
of stock pursuant to Regulation D
|
10,092,495
|
10,092
|
4,120,329
|
--
|
4,130,421
|
||||||||
Debt
conversion to common stock
|
2,377,512
|
2,377
|
1,573,959
|
--
|
1,576,336
|
||||||||
Beneficial
conversion related to interest expense
|
--
|
--
|
16,447
|
--
|
16,447
|
||||||||
Net
loss for the year ended 2006
|
--
|
--
|
--
|
(8,870,579)
|
(8,870,579)
|
|
|||||||
Balance,
at December 31, 2006
|
$
|
42,452,366
|
$
|
42,452
|
$
|
50,680,353
|
$
|
(35,200,405)
|
$
|
15,522,400
|
Year
Ended
December
31, 2006
|
Year
Ended
December
31, 2005
|
Cumulative
Amounts
from
January
17, 2002
(Inception)
through
December
31, 2006
|
||||||
Cash
Flows From Operating Activities
|
||||||||
Net
loss
|
$
|
(8,870,579)
|
$
|
(11,763,853)
|
|
$
|
(35,200,405)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
||||||||
Depreciation
|
4,442
|
1,708
|
395,722
|
|||||
Amortization
of patents
|
671,120
|
671,120
|
2,762,777
|
|||||
Amortization
of original issue
discount
|
1,062,098
|
2,293,251
|
3,842,924
|
|||||
Amortization
of commitment fee
|
--
|
272,540
|
310,866
|
|||||
Amortization
of prepaid consultant
expense
|
84,020
|
274,337
|
1,211,207
|
|||||
Amortization
of deferred loan costs
|
705,379
|
1,411,970
|
2,257,871
|
|||||
Accretion
of United States Treasury
Bills
|
(182,198)
|
--
|
(182,198)
|
|
||||
Loss
on extinguishment of debt
|
--
|
724,455
|
825,867
|
|||||
Loss
on exercise of warrants
|
--
|
236,146
|
236,146
|
|||||
Beneficial
conversion of convertible
interest
|
16,447
|
39,529
|
55,976
|
|||||
Convertible
interest
|
122,188
|
266,504
|
388,692
|
|||||
Compensation
through issuance of stock
options
|
1,862,456
|
15,752
|
1,928,479
|
|||||
Compensation
through issuance of
stock
|
--
|
--
|
932,000
|
|||||
Issuance
of stock for services
|
26,100
|
388,373
|
5,995,031
|
|||||
Issuance
of warrants for services
|
201,984
|
318,704
|
543,169
|
|||||
Issuance
of warrants for contractual
obligations
|
--
|
985,010
|
985,010
|
|||||
Gain
on sale of equipment
|
(75)
|
--
|
(55,075)
|
|
||||
(Increase)
decrease in assets
|
||||||||
Prepaid
expenses and other current
assets
|
(21,712)
|
46,762
|
(89,674)
|
|
||||
Increase
(decrease) in liabilities
|
||||||||
Accounts
payable
|
(25,189)
|
(64,090)
|
|
61,290
|
||||
Accrued
expenses
|
68,743
|
98,196
|
533,226
|
|||||
Net
cash used in operating activities
|
(4,274,776)
|
(3,783,586)
|
|
(12,261,099)
|
|
|||
Cash
Flows From Investing Activities
|
||||||||
Proceeds
from sale of fixed asset
|
75
|
--
|
180,075
|
|||||
Capital
expenditures
|
(22,230)
|
(13,995)
|
|
(39,922)
|
|
|||
Proceeds
from investments
|
11,000,000
|
--
|
11,000,000
|
|||||
Purchase
of investments
|
(17,316,836)
|
--
|
(17,316,836)
|
|
||||
Net
cash used in investing activities
|
(6,338,991)
|
(13,995)
|
|
(6,176,683)
|
|
|||
Cash
Flows From Financing Activities
|
||||||||
Net
proceeds from loans from
stockholder
|
--
|
25,000
|
174,000
|
|||||
Proceeds
from convertible debt
|
--
|
4,430,836
|
6,706,795
|
|||||
Net
proceeds from sale of common
stock
|
3,183,295
|
7,477,853
|
13,148,493
|
|||||
Proceeds
from exercise of warrants and stock
options
|
1,189,816
|
1,203,649
|
2,398,918
|
|||||
Cash
paid to retire convertible
debt
|
--
|
(1,885,959)
|
|
(2,385,959)
|
|
|||
Cash
paid for deferred loan costs
|
--
|
(515,582)
|
|
(747,612)
|
|
|||
Premium
paid on extinguishments of
debt
|
--
|
(70,000)
|
|
(170,519)
|
|
|||
Purchase
and retirement of common
stock
|
--
|
--
|
(48,000)
|
|
||||
Net
cash provided by financing activities
|
4,373,111
|
10,665,797
|
19,076,116
|
Year
Ended
December
31, 2006
|
Year
Ended
December
31, 2005
|
Cumulative
Amounts
from
January
17, 2002
(Inception)
through December 31, 2006
|
||||||
Net
change in cash and cash equivalents
|
$
|
(6,240,656)
|
$
|
6,868,216
|
$
|
638,334
|
||
Cash
and cash equivalents, at beginning of period
|
$
|
6,878,990
|
$
|
10,774
|
$
|
--
|
||
Cash
and cash equivalents, at end of period
|
$
|
638,334
|
$
|
6,878,990
|
$
|
638,334
|
||
Supplemental
Disclosure of Cash Flow Information
|
||||||||
December
31, 2005
|
||||||||
Interest
paid of $127,444
|
||||||||
Supplemental
Disclosure of Noncash Investing and Financing
Activities
|
Year
ended December 31, 2005
|
||
Net
loss, as reported
|
$(11,763,853)
|
|
Add
stock-based employee compensation expense included in
reported loss
|
15,752
|
|
Less
total stock-based employee compensation expense determined
under the fair
value
based method for all awards
|
(791,111)
|
|
Pro
forma net loss
|
$(12,539,212)
|
|
Basic
and diluted loss per common share, as reported
|
$(0.62)
|
|
Basic
and diluted loss per common share, pro forma
|
$(0.67)
|
2006
|
2005
|
|
Weighted
average fair value per options granted
|
$0.96
|
$0.66
|
Significant
assumptions (weighted average) risk-free interest
rate at grant date
|
4.0%
- 5.0%
|
4.0%
|
Expected
stock price volatility
|
116%
- 130%
|
130%
|
Expected
option life (years)
|
10
|
10
|
Shares
|
Exercise
Price
Per
Share
|
Weighted
Average Exercise Price
|
|
Outstanding
at January 1, 2005
|
1,725,000
|
$0.32
- 1.25
|
$0.97
|
Granted
|
3,275,000
|
$0.64
- 0.94
|
$0.75
|
Exercised
|
(26,516)
|
$
1.10
|
$1.10
|
Forfeited
|
--
|
--
|
--
|
Outstanding
at December 31, 2005
|
4,973,484
|
$0.32
- 1.25
|
$0.83
|
Options
exercisable at December 31, 2005
|
1,017,234
|
$0.32
- 1.25
|
$0.88
|
Outstanding
at January 1, 2006
|
4,973,484
|
$0.32
- 1.25
|
$0.83
|
Granted
|
4,200,000
|
$
1.02
|
$1.02
|
Exercised
|
(158,770)
|
$0.32
- 1.10
|
$1.02
|
Forfeited
|
--
|
--
|
--
|
Outstanding
at December 31, 2006
|
9,014,714
|
$0.32
- 1.25
|
$0.91
|
Options
exercisable at December 31, 2006
|
2,406,378
|
$0.32
- 1.25
|
$0.86
|
Exercise
Price
|
Number
Outstanding at December 31,
2006
|
Weighted
Average Remaining contractual
Life
|
Outstanding
Weighted Average Exercise
price
|
Number
Exercisable at December 31,
2006
|
Exercisable
Weighted Average Exercise
Price
|
$0.32
|
209,375
|
6.58
years
|
$0.32
|
209,375
|
$0.32
|
$0.60
|
100,000
|
6.58
years
|
$0.60
|
100,000
|
$0.60
|
$1.10
|
1,030,339
|
7.17
years
|
$1.10
|
655,339
|
$1.10
|
$0.95
|
100,000
|
7.42
years
|
$0.95
|
100,000
|
$0.95
|
$1.25
|
100,000
|
7.50
years
|
$1.25
|
75,000
|
$1.25
|
$0.64
|
1,200,000
|
8.00
years
|
$0.64
|
300,000
|
$0.64
|
$0.75
|
1,300,000
|
8.42
years
|
$0.75
|
500,000
|
$0.75
|
$0.94
|
775,000
|
8.92
years
|
$0.94
|
266,664
|
$0.94
|
$1.02
|
4,200,000
|
9.50
years
|
$1.02
|
200,000
|
$1.02
|
9,014,714
|
8.68
years
|
$0.91
|
2,406,378
|
$0.86
|
The
following is a summary of nonvested stock option activity
for the year ended December 31, 2006:
|
|||||
Weighted
Average
|
|||||
Number
of Shares
|
Grant-Date
Fair Value
|
||||
Nonvested
at December 31, 2005
|
3,956,250
|
|
$
0.75
|
||
Granted
|
4,200,000
|
|
$
0.96
|
||
Vested
|
(1,547,914)
|
|
$
0.80
|
||
Canceled
|
--
|
|
--
|
||
Nonvested
at December 31, 2006
|
6,608,336
|
|
$
0.87
|
Aggregate
|
|||||
Number
of Shares
|
Intrinsic
Value
|
||||
Outstanding
at December 31, 2006
|
9,014,714
|
|
$
2,491,637
|
||
Exercisable
at December 31, 2006
|
2,406,378
|
|
$
805,303
|
||
Warrants
|
Exercise
Price
Per
Warrant
|
Weighted
Average Exercise Price
|
|
Outstanding
at January 1, 2005
|
4,092,393
|
$0.50
- 1.25
|
$0.99
|
Granted
|
26,179,565
|
$0.50
- 1.25
|
$0.95
|
Exercised
|
(1,545,333)
|
$0.75
- 1.00
|
$0.76
|
Forfeited
|
(1,894,667)
|
$0.90
- 1.00
|
$0.92
|
Outstanding
at December 31, 2005
|
26,831,958
|
$0.50
- 1.25
|
$0.96
|
Warrants
exercisable at December 31, 2005
|
26,831,958
|
$0.50
- 1.25
|
$0.96
|
Outstanding
at January 1, 2006
|
26,831,958
|
$0.50
- 1.25
|
$0.96
|
Granted
|
1,023,657
|
$0.75
- 2.16
|
$0.99
|
Exercised
|
(1,092,534)
|
$0.50
- 1.00
|
$0.94
|
Forfeited
|
(100,000)
|
$1.25
|
$1.25
|
Outstanding
at December 31, 2006
|
26,663,081
|
$0.50
- 2.16
|
$0.96
|
Warrants
exercisable at December 31, 2006
|
26,663,081
|
$0.50
- 2.16
|
$0.96
|
Exercise
Price
|
Number
Outstanding and Exercisable at December 31,
2006
|
Weighted
Average Remaining Contractual
Life
|
Weighted
Average Exercise Price
|
$0.50
|
10,000
|
0.92
|
$0.50
|
$0.75
|
664,275
|
1.25
|
$0.75
|
$0.935
|
17,934,939
|
3.78
|
$0.935
|
$0.94
|
20,000
|
0.25
|
$0.94
|
$0.98
|
525,000
|
3.25
|
$0.98
|
$1.00
|
6,482,043
|
2.37
|
$1.00
|
$1.23
|
275,000
|
3.23
|
$1.23
|
$1.25
|
675,000
|
3.58
|
$1.25
|
$2.125
|
55,147
|
2.38
|
$2.125
|
$2.16
|
21,677
|
2.38
|
$2.16
|
|
26,663,081
|
3.34
|
$0.96
|
Years
Ended December 31,
|
2006
|
2005
|
||||
Amount
|
%
|
Amount
|
%
|
|||
Federal
statutory rate
|
$
(3,016,000)
|
(34.0)
|
$
(3,894,000)
|
(34.0)
|
||
Adjustment
to valuation allowance
|
2,832,000
|
31.9
|
3,412,000
|
29.8
|
||
Non-deductible
financing costs
|
184,000
|
2.1
|
475,000
|
4.1
|
||
|
Other
|
--
|
--
|
7,000
|
0.1
|
|
Actual
tax benefit
|
$ --
|
--
|
|
$
--
|
--
|
December
31,
|
2006
|
2005
|
|
Deferred
tax assets
|
|||
Net
operating loss carryforwards
|
$
5,794,000
|
$
4,126,000
|
|
Stock
compensation
|
633,000
|
--
|
|
|
Warrants
for services
|
1,472,000
|
1,169,000
|
Deferred
tax asset
|
7,899,000
|
5,295,000
|
|
Deferred tax liability - patent amortization | (3,044,000) | (3,272,000) | |
Valuation
allowance
|
(4,855,000)
|
(2,023,000)
|
|
Net
deferred taxes
|
$
--
|
$
--
|