Nevada
|
90-0031917
|
(State
or other jurisdiction of incorporation or
organization)
|
(I.R.S.
Employer Identification
Number)
|
June
30, 2007
|
December
31, 2006
|
|
(Unaudited)
|
(Audited)
|
|
Assets
|
||
Current
Assets
|
||
Cash
and cash
equivalents
|
$ 232,910
|
$ 638,334
|
United States Treasury Notes, total face value $6,571,371 and
$6,507,019
|
6,568,015
|
6,499,034
|
Prepaid
expenses and other
current assets
|
41,804
|
173,693
|
Total
Current Assets
|
6,842,729
|
7,311,061
|
Equipment
and Furnishings, less accumulated depreciation of $377,349 and
$372,721
|
47,574
|
30,075
|
Patents,
net of amortization of $3,098,337 and $2,762,777
|
8,617,108
|
8,952,668
|
Deferred
loan costs, net of amortization of $247,802 in 2006
|
--
|
3,713
|
Other
assets
|
27,000
|
27,000
|
$ 15,534,411
|
$ 16,324,517
|
|
Liabilities
and Stockholders' Equity
|
||
Current
Liabilities
|
||
Accounts
payable –
trade
|
$ 83,396
|
$ 64,935
|
Accrued
compensation
|
291,646
|
265,929
|
Accrued
common stock
costs
|
--
|
17,550
|
Accrued
consulting
expense
|
69,167
|
42,500
|
Other
accrued
expenses
|
29,500
|
46,500
|
March
2005 convertible debt, net
of debt discount of $2,797 in 2006
|
--
|
364,703
|
Total
Current Liabilities
|
473,709
|
802,117
|
Stockholders'
Equity
|
||
Common
stock; par value $.001 per
share; 100,000,000 shares
authorized;
45,760,619 and 42,452,366 shares issued and
outstanding,
respectively
|
45,761
|
42,452
|
Paid
in capital
|
54,911,160
|
50,680,353
|
Deficit
accumulated during the development stage
|
(39,896,219)
|
(35,200,405)
|
Total
Stockholders' Equity
|
15,060,702
|
15,522,400
|
$ 15,534,411
|
$ 16,324,517
|
Three
Months
Ended
June
30, 2007
|
Three
Months
Ended
June
30, 2006
|
Six
Months
Ended
June
30, 2007
|
Six
Months
Ended
June
30, 2006
|
Cumulative
Amounts from January 17, 2002 (Inception) Through
June
30, 2007
|
|||||||||||
Revenues
|
|||||||||||||||
OTC
Product Revenue
|
$
|
--
|
$
|
394
|
$
|
--
|
$
|
1,080
|
$
|
25,648
|
|||||
Medical
Device Revenue
|
--
|
--
|
--
|
--
|
14,109
|
||||||||||
Total
revenues
|
--
|
394
|
--
|
1,080
|
39,757
|
||||||||||
Cost
of Sales
|
--
|
252
|
--
|
691
|
15,216
|
||||||||||
Gross
Profit
|
--
|
142
|
--
|
389
|
24,541
|
||||||||||
Operating
Expenses
|
|||||||||||||||
Research
and
development
|
$
|
1,063,282
|
$
|
814,705
|
$
|
2,152,585
|
$
|
1,265,215
|
$
|
9,280,792
|
|||||
General
and
administrative
|
1,160,777
|
844,600
|
2,366,008
|
1,547,119
|
19,095,976
|
||||||||||
Amortization
|
167,780
|
167,780
|
335,560
|
335,560
|
3,098,337
|
||||||||||
Total
operating loss
|
(2,391,839
|
)
|
(1,826,943
|
)
|
(4,854,153
|
)
|
(3,147,505
|
)
|
(31,450,564
|
)
|
|||||
Gain
on sale of fixed assets
|
--
|
--
|
--
|
--
|
55,075
|
||||||||||
Loss
on extinguishment of debt
|
--
|
--
|
--
|
--
|
(825,867
|
)
|
|||||||||
Investment
income
|
84,159
|
87,771
|
169,748
|
110,268
|
423,141
|
||||||||||
Interest
expense
|
--
|
(590,259
|
)
|
(11,409
|
)
|
(1,592,438
|
)
|
(8,098,004
|
)
|
||||||
Net
loss
|
$
|
(2,307,680
|
)
|
$
|
(2,329,431
|
)
|
$
|
(4,695,814
|
)
|
$
|
(4,629,675
|
)
|
$
|
(39,896,219
|
)
|
Basic
and diluted loss per
common
share
|
$
|
(0.05
|
)
|
$
|
(0.06
|
)
|
$
|
(0.10
|
)
|
$
|
(0.13
|
)
|
|||
Weighted
average number of common shares outstanding – basic and
diluted
|
45,597,872
|
37,364,852
|
44,929,819
|
35,959,198
|
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
|
--
|
3,049,795
|
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
|
--
|
--
|
39,259
|
--
|
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
|
Issuance
of stock for services
|
50,000
|
50
|
83,950
|
--
|
84,000
|
Issuance
of stock for interest payable
|
1,141
|
1
|
1,257
|
--
|
1,258
|
Issuance
of warrants for services
|
--
|
--
|
174,118
|
--
|
174,118
|
Exercise
of warrants and stock options
|
390,295
|
390
|
332,522
|
--
|
332,912
|
Employee
compensation from stock options
|
--
|
--
|
1,426,190
|
--
|
1,426,190
|
Issuance
of stock pursuant to Regulation D
|
2,376,817
|
2,378
|
1,845,760
|
--
|
1,848,138
|
Debt
conversion to common stock
|
490,000
|
490
|
367,010
|
--
|
367,500
|
Net
loss for the six months ended June 30, 2007
|
--
|
--
|
--
|
(4,695,814)
|
(4,695,814)
|
Balance,
at June 30, 2007
|
45,760,619
|
$ 45,761
|
$54,911,160
|
$ (39,896,219)
|
$15,060,702
|
Six
Months Ended
June
30, 2007
|
Six
Months Ended
June
30, 2006
|
Cumulative
Amounts from January 17, 2002 (Inception) through
June
30, 2007
|
|
Cash
Flows From Operating Activities
|
|||
Net
loss
|
$ (4,695,814)
|
$ (4,629,675)
|
$ (39,896,219)
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|||
Depreciation
|
4,628
|
1,944
|
400,350
|
Amortization
of patents
|
335,560
|
335,560
|
3,098,337
|
Amortization
of original issue discount
|
2,797
|
851,365
|
3,845,721
|
Amortization
of commitment fee
|
--
|
--
|
310,866
|
Amortization
of prepaid consultant expense
|
84,019
|
--
|
1,295,226
|
Amortization
of deferred loan costs
|
3,713
|
646,192
|
2,261,584
|
Accretion
of United States Treasury Notes
|
(101,167)
|
(71,281)
|
(283,365)
|
Loss
on extinguishment of debt
|
--
|
--
|
825,867
|
Loss
on exercise of warrants
|
--
|
--
|
236,146
|
Beneficial
conversion of convertible interest
|
--
|
16,447
|
55,976
|
Convertible
interest
|
1,258
|
82,082
|
389,950
|
Compensation
through issuance of stock options
|
1,426,190
|
715,666
|
3,354,669
|
Compensation
through issuance of stock
|
--
|
--
|
932,000
|
Issuance
of stock for services
|
110,667
|
26,100
|
6,105,698
|
Issuance
of warrants for services
|
174,118
|
58,400
|
717,287
|
Issuance
of warrants for contractual obligations
|
--
|
--
|
985,010
|
Gain
on sale of equipment
|
--
|
--
|
(55,075)
|
(Increase)
decrease in assets
|
|||
Officer/Director advance
|
--
|
(273,247)
|
--
|
Prepaid expenses and other current assets
|
47,870
|
23,192
|
(41,804)
|
Increase
(decrease) in liabilities
|
|||
Accounts
payable
|
18,461
|
14,038
|
79,751
|
Accrued expenses
|
8,717
|
(19,253)
|
541,943
|
Net
cash used in Operating Activities
|
(2,578,983)
|
(2,222,470)
|
(14,840,082)
|
Cash
Flows from investing activities
|
|||
Proceeds
from sale of fixed asset
|
--
|
--
|
180,075
|
Capital
expenditures
|
(22,127)
|
(8,601)
|
(62,049)
|
Proceeds
from investments
|
10,005,000
|
2,000,000
|
21,005,000
|
Purchase
of investments
|
(9,972,814)
|
(6,423,379)
|
(27,289,650)
|
Net
cash used in Investing Activities
|
10,059
|
(4,431,980)
|
(6,166,624)
|
Cash
Flows from Financing Activities
|
|||
Net
proceeds from loans from stockholder
|
--
|
--
|
174,000
|
Proceeds
from convertible debt
|
--
|
--
|
6,706,795
|
Net
proceeds from sale of common stock
|
1,830,588
|
525,112
|
14,979,081
|
Proceeds
from exercise of warrants and stock options
|
332,912
|
472,359
|
2,731,830
|
Cash
paid to retire convertible debt
|
--
|
--
|
(2,385,959)
|
Cash
paid for deferred loan costs
|
--
|
--
|
(747,612)
|
Premium
paid on extinguishments of debt
|
--
|
--
|
(170,519)
|
Purchase
and retirement of common stock
|
--
|
--
|
(48,000)
|
Net
cash provided by financing activities
|
2,163,500
|
997,471
|
21,239,616
|
Net
change in cash and cash equivalents
|
$ (405,424)
|
$ (5,656,979)
|
$ 232,910
|
Cash
and cash equivalents, at beginning of period
|
$ 638,334
|
$ 6,878,990
|
$ --
|
Cash
and cash equivalents, at end of period
|
$ 232,910
|
$ 1,222,011
|
$ 232,910
|
Nominee
|
For
|
Withheld
Authority
|
H.
Craig Dees
|
29,767,894
|
55,152
|
Timothy C. Scott
|
29,783,394
|
39,652
|
Eric A. Wachter
|
29,783,994
|
39,052
|
Stuart
Fuchs
|
29,715,294
|
90,552
|