|
Delaware
|
51-0402415
|
|
(State
of jurisdiction of
|
(IRS
Employer
|
|
incorporation
or organization)
|
Identification
No.)
|
|
ITEM
|
PAGE | ||||
|
PART
I.
|
|||||
|
1.
|
|
Financial Statements | |||
|
a.
|
Balance
Sheets - September 30, 2006 (unaudited) and December 31,
2005
|
1
|
|||
|
b.
|
Statements
of Operations -- Three months ended September 30, 2006 (unaudited),
September 30, 2005 (unaudited); Nine months ended September 30, 2006
(unaudited), September 30, 2006 (unaudited); and from Inception through
September 30, 2006 (unaudited)
|
2
|
|||
|
c.
|
Statement
of Cash Flows -Nine months ended September 30, 2006 (unaudited),
September 30, 2005 (unaudited) and from Inception through September
30,
2006 (unaudited)
|
3
|
|||
|
|
d.
|
Notes
to Financial Statements
|
4
|
||
|
2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
12
|
|||
|
3.
|
Controls and Procedures |
14
|
|||
|
PART
II.
|
|||||
|
2.
|
Changes in Securities |
15
|
|||
|
6.
|
Exhibits and Reports on Form 8-K |
15
|
|||
|
|
|
September
30, 2006 |
|
December
31,
2005 |
|||
| ASSETS | |||||||
|
CURRENT
ASSETS
|
|||||||
|
Cash
|
$
|
828,433
|
$
|
22,068
|
|||
|
Deposits
and prepaid expenses
|
-
|
-
|
|||||
|
Total
Current Assets
|
828,433
|
22,068
|
|||||
|
PROPERTY,
PLANT AND EQUIPMENT, net
|
279,961
|
294,428
|
|||||
|
OTHER
ASSETS
|
|||||||
|
Notes
receivable - related party
|
46,619
|
46,619
|
|||||
|
Interest
receivable - related party
|
20,363
|
18,090
|
|||||
|
Deferred
loan origination fees, net of accumulated amortization
|
-
|
7,283
|
|||||
|
Patents
and patents pending, net of accumulated amortization
|
799,203
|
883,002
|
|||||
|
Total
Other Assets
|
866,185
|
954,994
|
|||||
|
TOTAL
ASSETS
|
$
|
1,974,579
|
$
|
1,271,490
|
|||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
|
CURRENT
LIABILITIES
|
|||||||
|
Accounts
payable
|
$
|
77,703
|
$
|
246,776
|
|||
|
Accounts
payable - related party
|
-
|
182,200
|
|||||
|
Loan
payable - related party
|
1,414,500
|
||||||
|
Accrued
interest on convertible debt
|
177,932
|
-
|
|||||
|
Current
portion of convertible notes payable
|
4,608,253
|
4,490,485
|
|||||
|
Total
Current Liabilities
|
6,278,388
|
4,919,461
|
|||||
|
LONG-TERM
DEBT
|
|||||||
|
Convertible
notes payable, net of current portion
|
1,362,359
|
1,286,134
|
|||||
|
Note
payable to related parties
|
-
|
127,631
|
|||||
|
Total
Long-Term Debt
|
1,362,359
|
1,413,765
|
|||||
|
Total
Liabilities
|
7,640,747
|
6,333,226
|
|||||
|
COMMITMENTS
AND CONTINGENCIES
|
-
|
-
|
|||||
|
STOCKHOLDERS'
EQUITY (DEFICIT)
|
|||||||
|
Preferred
stock, par value $0.001; 20,000,000 shares authorized,
|
|||||||
|
no
shares issued and outstanding
|
-
|
-
|
|||||
|
Common
stock, par value $0.001; 200,000,000 shares authorized,
|
|||||||
|
89,667,405
and 57,563,400 shares issued and outstanding, respectively
|
89,666
|
54,347
|
|||||
|
Additional
paid-in capital
|
7,456,573
|
6,948,814
|
|||||
|
Stock
options and warrants
|
1,492,251
|
1,235,551
|
|||||
|
Deficit
accumulated during development stage
|
(14,704,658
|
)
|
(13,300,448
|
)
|
|||
|
Total
Stockholders' Equity (Deficit)
|
(5,666,168
|
)
|
(5,061,736
|
)
|
|||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
$
|
1,974,579
|
$
|
1,271,490
|
|||
|
From
Inception
|
||||||||||||||||
|
(December
2, 1985)
|
||||||||||||||||
|
Three
Months Ended September 30,
|
Nine
Months Ended September 30,
|
through
September 30, |
||||||||||||||
|
2006
|
2005
|
2006
|
2005
|
2006
|
||||||||||||
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||||
|
REVENUES
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
89,947
|
||||||
|
OPERATING
EXPENSES
|
||||||||||||||||
|
Research
and development
|
-
|
72,389
|
4,901
|
238,820
|
3,920,435
|
|||||||||||
|
Promotional
fees
|
-
|
-
|
-
|
212
|
62,570
|
|||||||||||
|
Professional
fees
|
152,272
|
48,382
|
254,263
|
157,838
|
3,215,337
|
|||||||||||
|
Vesting
of stock options and warrants
|
-
|
-
|
151,700
|
590,200
|
233,200
|
|||||||||||
|
Scientific
advisory board - warrants
|
-
|
-
|
-
|
1,900
|
1,231,609
|
|||||||||||
|
Business
development
|
-
|
76,000
|
39,500
|
76,000
|
41,400
|
|||||||||||
|
Directors'
fees
|
144,200
|
-
|
144,200
|
-
|
443,253
|
|||||||||||
|
Depreciation
and amortization
|
21,977
|
25,920
|
72,150
|
75,981
|
952,556
|
|||||||||||
|
Administrative
salaries and benefits
|
-
|
60,846
|
99,194
|
197,890
|
1,477,192
|
|||||||||||
|
Insurance
|
-
|
18,257
|
-
|
54,770
|
324,452
|
|||||||||||
|
Shareholder
relations and transfer fees
|
-
|
3,022
|
6,660
|
14,712
|
318,058
|
|||||||||||
|
Rent
|
-
|
5,100
|
10,200
|
15,300
|
361,578
|
|||||||||||
|
Travel
and entertainment
|
-
|
4,192
|
1,302
|
23,073
|
332,101
|
|||||||||||
|
Telephone
and communications
|
-
|
1,329
|
2,291
|
4,277
|
64,708
|
|||||||||||
|
Office
|
-
|
1,042
|
-
|
4,224
|
81,868
|
|||||||||||
|
General
and administrative
|
2,906
|
4,103
|
20,910
|
22,520
|
772,666
|
|||||||||||
|
Total
Operating Expenses
|
321,355
|
320,582
|
807,271
|
1,477,717
|
13,832,983
|
|||||||||||
|
LOSS
FROM OPERATIONS
|
(321,355
|
)
|
(320,582
|
)
|
(807,271
|
)
|
(1,477,717
|
)
|
(13,743,036
|
)
|
||||||
|
OTHER
INCOME (EXPENSES)
|
||||||||||||||||
|
Miscellaneous
income
|
-
|
-
|
-
|
2,682
|
27,682
|
|||||||||||
|
Interest
and dividend income
|
4,042
|
982
|
5,896
|
4,069
|
177,335
|
|||||||||||
|
Internal
gain on sale of securities
|
-
|
-
|
-
|
-
|
157,520
|
|||||||||||
|
Forgiveness
of debt
|
-
|
-
|
-
|
-
|
2,192,837
|
|||||||||||
|
Forgiveness
of payables
|
-
|
-
|
-
|
-
|
45,396
|
|||||||||||
|
Loss
on disposal of office equipment
|
-
|
-
|
-
|
-
|
(2,224
|
)
|
||||||||||
|
Loss
on abandonment of patents
|
-
|
-
|
(92,500
|
)
|
-
|
(136,175
|
)
|
|||||||||
|
Interest
expense
|
(172,693
|
)
|
(156,591
|
)
|
(510,335
|
)
|
(439,253
|
)
|
(3,423,993
|
)
|
||||||
|
Total
Other Income (Expenses)
|
(168,651
|
)
|
(155,609
|
)
|
(596,939
|
)
|
(432,502
|
)
|
(961,622
|
)
|
||||||
|
LOSS
BEFORE INCOME TAXES
|
(490,006
|
)
|
(476,191
|
)
|
(1,404,210
|
)
|
(1,910,219
|
)
|
(14,704,658
|
)
|
||||||
|
INCOME
TAXES
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
|
NET
LOSS
|
$
|
(490,006
|
)
|
$
|
(476,191
|
)
|
(1,404,210
|
)
|
$
|
(1,910,219
|
)
|
$
|
(14,704,658
|
)
|
||
|
BASIC
AND DILUTED NET LOSS
|
||||||||||||||||
|
PER
COMMON SHARE
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
(0.02
|
)
|
$
|
(0.04
|
)
|
|||||
|
WEIGHTED
AVERAGE NUMBER OF
|
||||||||||||||||
|
BASIC
AND DILUTED COMMON STOCK
|
||||||||||||||||
|
SHARES
OUTSTANDING
|
77,894,385
|
54,137,820
|
62,197,026
|
54,067,645
|
||||||||||||
|
From
Inception
|
||||||||||
|
(December
2, 1985)
|
||||||||||
|
Nine
Months Ended September 30,
|
through
September 30, |
|||||||||
|
2006
|
2005
|
2006
|
||||||||
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
|
Net
(loss)
|
$
|
(1,404,210
|
)
|
$
|
(1,910,219
|
)
|
$
|
(14,704,658
|
)
|
|
|
Adjustments
to reconcile net loss to cash
|
||||||||||
|
used
in operating activities:
|
||||||||||
|
Depreciation
and amortization
|
72,150
|
75,981
|
894,668
|
|||||||
|
Loss
on disposal of equipment
|
-
|
-
|
2,224
|
|||||||
|
Loss
on impairment of patents
|
92,500
|
-
|
136,175
|
|||||||
|
Investment
income
|
-
|
-
|
(157,520
|
)
|
||||||
|
Expenses
paid through issuance of common stock
|
60,000
|
291,339
|
||||||||
|
Expenses
paid through issuance
|
||||||||||
|
of
common stock, warrants and options
|
295,900
|
672,600
|
1,695,362
|
|||||||
|
Accrued
interest paid by convertible debt
|
326,471
|
280,325
|
2,850,020
|
|||||||
|
Expenses
paid through contribution
|
||||||||||
|
of
additional paid-in capital
|
3,332
|
3,332
|
68,078
|
|||||||
|
Organization
costs
|
-
|
(9,220
|
)
|
|||||||
|
Decrease
(increase) in assets:
|
||||||||||
|
Marketable
securities
|
-
|
-
|
-
|
|||||||
|
Deposits
and prepaid expenses
|
-
|
31,785
|
-
|
|||||||
|
Interest
receivable
|
(2,273
|
)
|
(2,273
|
)
|
(60,931
|
)
|
||||
|
Deferred
loan origination cost
|
7,283
|
-
|
(150,012
|
)
|
||||||
|
Increase
(decrease) in liabilities:
|
||||||||||
|
Accounts
payable and accrued expenses
|
(228,755
|
)
|
144,703
|
95,562
|
||||||
|
Accounts
and notes payable, related parties
|
37,637
|
78,618
|
278,805
|
|||||||
|
Payroll
and payroll taxes payable
|
-
|
-
|
-
|
|||||||
|
Accrued
interest
|
177,932
|
155,596
|
177,932
|
|||||||
|
Net
cash provided by (used) in operating activities
|
(622,033
|
)
|
(409,552
|
)
|
(8,592,176
|
)
|
||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||
|
Purchase
of fixed assets
|
-
|
(858
|
)
|
(385,339
|
)
|
|||||
|
Acquisition
of patents
|
(59,102
|
)
|
(105,213
|
)
|
(1,263,707
|
)
|
||||
|
Net
cash used in investing activities
|
(59,102
|
)
|
(106,071
|
)
|
(1,649,046
|
)
|
||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
|
Proceeds
from issuance of common stock
|
-
|
-
|
2,457,254
|
|||||||
|
Internal
gain on sale of securities
|
-
|
-
|
157,520
|
|||||||
|
Proceeds
from convertible notes
|
-
|
190,000
|
6,754,000
|
|||||||
|
Proceeds
from notes payable
|
1,487,500
|
-
|
1,876,008
|
|||||||
|
Payments
on notes payable
|
-
|
-
|
(175,127
|
)
|
||||||
|
Net
cash provided by (used) in financing activities
|
1,487,500
|
190,000
|
11,069,655
|
|||||||
|
Net
increase in cash
|
806,365
|
(325,623
|
)
|
828,433
|
||||||
|
Cash,
beginning
|
22,068
|
367,337
|
-
|
|||||||
|
Cash,
ending
|
$
|
828,433
|
$
|
41,714
|
$
|
828,433
|
||||
|
SUPPLEMENTAL
CASH FLOW DISCLOSURES:
|
||||||||||
|
Interest
expense paid
|
$
|
-
|
$
|
-
|
$
|
341,166
|
||||
|
Income
taxes paid
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
|
NON-CASH
FINANCING AND INVESTING ACTIVITIES:
|
||||||||||
|
Common
stock issued for a loan payable
|
$
|
73,000
|
$
|
-
|
$
|
286,381
|
||||
|
Common
stock issued for notes receivable
|
$
|
-
|
$
|
-
|
$
|
246,619
|
||||
|
Common
stock returned in payment of
|
||||||||||
|
notes
and interest receivable
|
$
|
-
|
$
|
-
|
$
|
240,568
|
||||
|
Warrants
and options issued for services and accrued expenses
|
$
|
112,500
|
$
|
672,600
|
$
|
1,511,962
|
||||
|
Common
stock issued on cashless exercise of warrants
|
$
|
-
|
$
|
-
|
$
|
15,011
|
||||
|
Common
stock issued for convertible debt
|
$
|
397,432
|
$
|
-
|
$
|
1,104,588
|
||||
|
September
30,
2006
|
December
31, 2005
|
||||||
|
Cost
|
Cost
|
||||||
|
Lab
equipment
|
$
|
31,891
|
$
|
31,891
|
|||
|
Office
equipment
|
13,777
|
13,777
|
|||||
|
Furniture
and fixtures
|
22,539
|
22,539
|
|||||
|
Clean
room
|
271,786
|
271,786
|
|||||
|
Total
assets
|
339,993
|
339,993
|
|||||
|
Less
accumulated depreciation
|
(60,032
|
)
|
(45,565
|
)
|
|||
|
Net
fixed assets
|
$
|
279,961
|
$
|
294,428
|
|||
|
Plan
|
Number
of securities to be issued upon exercise of outstanding
options
|
Weighted-average
exercise price of outstanding options
|
Number
of securities remaining available for future issuance under equity
compensation plans
|
|
Equity
compensation plan approved by security holders (1)
|
4,990,000
|
$0.18
|
260,000
|
| (0) |
Omnibus
Equity Incentive Plan
|
|
Number
of Shares
|
Weighted
Average Exercise Price
|
||||||
|
Outstanding
at January 1, 2005
|
6,357,953
|
$
|
0.17
|
||||
|
Granted
|
5,178,453
|
0.15
|
|||||
|
Exercised
|
-
|
-
|
|||||
|
Forfeited
|
(2,637,953
|
)
|
(0.14
|
)
|
|||
|
Options
outstanding at December 31, 2005
|
8,898,453
|
0.16
|
|||||
|
Granted
|
7,210,000
|
0.06
|
|||||
|
Exercised
|
-
|
-
|
|||||
|
Forfeited/Expired
|
-
|
||||||
|
Options
outstanding and exercisable at June 30, 2006
|
16,108,453
|
$
|
0.11
|
||||
|
Weighted
average fair value of options granted in 2006
|
$
|
0.02
|
|||||
|
Outstanding
and Exercisable Options
|
||||||
|
Exercise
Price Range
|
Number
of Shares
|
Weighted
Average Remaining Life
|
Weighted
Average Exercise Price
|
|||
|
$0.03-
$0.42
|
16,108,453
|
7.88
|
$
0.11
|
|||
|
Number
of warrants
|
Weighted
Average Remaining Life
|
Average
exercise price
|
|||
|
Outstanding
|
5,504,227
|
3.86
|
$0.16
|
||
|
Exercisable
|
5,384,227
|
3.95
|
$0.16
|
|
Regular
Checking
|
$
|
1,478
|
||
|
Money
Market
|
172,848
|
|||
|
Certificate
of Deposit
|
652,843
|
|||
|
Total
|
$
|
827,169
|
| 1. |
Evaluation
of possible acquisition candidates;
|
| 2. |
Licensing
agreements with selected pharmaceutical companies seeking opportunities
related to our patented scientific
approaches;
|
| 3. |
Continuation
of our FDA approved Phase I clinical trial at Georgetown University
Medical Center.
|
| (a) |
Exhibit
Number
|
Description
|
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Rule 13a-14(a).
|
|
|
31.2
|
Certification
of Chief Financial Officer Pursuant to Rule 13a-14(a).
|
|
|
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
|
32.2
|
Certification
of Chief Financial Officer Pursuant to 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
|
|
Exhibit
Number
|
Description
|
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Rule 13a-14(a).
|
|
31.2
|
Certification
of Chief Financial Officer Pursuant to Rule 13a-14(a).
|
|
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
32.2
|
Certification
of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|