Florida
|
0-24696
|
59-3248917
|
||
(State
or Other Jurisdiction
|
(Commission
File Number)
|
(I.R.S.
Employer
|
||
of
Incorporation)
|
Identification
Number)
|
Yes x | No o |
Yes o | No x |
Item
1: Financial Statements
|
|||
|
|||
Condensed
Consolidated Balance Sheets as of September 30, 2006 (unaudited)
and December 31, 2005
|
|
3
|
|
Condensed
Consolidated Statements of Operations for the three and nine months
ended September 30, 2006 and 2005 (unaudited)
|
|
4 | |
Condensed
Consolidated Statements of Changes in Stockholders' Equity for the
nine months ended September 30, 2006 (unaudited)
|
|
5 | |
Condensed
Consolidated Statements of Cash Flows for the nine months ended September
30, 2006 and 2005 (unaudited)
|
6
|
||
Notes
to the Condensed Consolidated Financial Statements
|
7
|
||
Item
2:
|
Management’s
Discussion and Analysis of Financial
|
||
Condition
and Results of Operations
|
|
11 | |
Item
3:
|
Controls
and Procedures
|
|
21 |
PART
II - OTHER INFORMATION
|
|||
Item
1:
|
Legal
Proceedings
|
|
22 |
Item
2:
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
23 |
Item
3:
|
Defaults
Upon Senior Securities
|
|
24 |
Item
4:
|
Submission
of Matters to a Vote of Security Holders
|
|
24 |
Item
5:
|
Other
Information
|
|
24 |
Item
6:
|
Exhibits
|
|
24 |
(Unaudited)
|
|||||||
September
30, 2006
|
December
31, 2005
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
|
$
|
110,710
|
$
|
8,975
|
|||
Account
receivable
|
9,052
|
3,283
|
|||||
Inventory
|
112,108
|
117,280
|
|||||
Prepaid
expenses
|
37,555
|
43,725
|
|||||
Total
current assets
|
269,425
|
173,263
|
|||||
FURNITURE
AND EQUIPMENT, less
accumulated depreciation
|
|||||||
of
$96,236
at
September 30, 2006 and $131,163 at December 31,
2005
|
66,322
|
106,952
|
|||||
OTHER
ASSETS
|
|||||||
Security
deposits
|
74,168
|
20,695
|
|||||
Intangible
assets, less accumulated amortization
|
|||||||
of
$1,169,811
at
September 30, 2006 and $1,539,621 at December 31,
2005
|
4,073,231
|
5,053,421
|
|||||
Goodwill
|
3,615,393
|
3,615,393
|
|||||
Total
other assets
|
7,762,792
|
8,689,509
|
|||||
TOTAL
ASSETS
|
$
|
8,098,539
|
$
|
8,969,724
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
326,953
|
$
|
313,932
|
|||
Accrued
compensation
|
211,065
|
462,658
|
|||||
Accrued
expenses
|
368,379
|
376,874
|
|||||
Short-term
notes payable
|
-
|
50,843
|
|||||
Other
liabilities
|
9,068
|
29,425
|
|||||
Related
party loans
|
4,674,493
|
2,434,733
|
|||||
Total
current liabilities
|
5,589,958
|
3,668,465
|
|||||
LONG-TERM
LIABILITIES
|
|||||||
Stock
settlement obligation
|
2,836,538
|
2,836,538
|
|||||
Total
liabilities
|
8,426,496
|
6,505,003
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 6)
|
-
|
-
|
|||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
|||||||
Preferred
stock, no par value, 1,000,000 shares authorized,
|
|||||||
no
shares issued and outstanding
|
-
|
-
|
|||||
Common
stock, no par value, 250,000,000 shares authorized,
|
|||||||
2006:
193,973,426 shares issued and outstanding
|
|||||||
2005:
189,006,760 shares issued and outstanding
|
16,484,550
|
16,307,050
|
|||||
Additional
paid-in capital
|
3,669,231
|
3,503,681
|
|||||
Accumulated
deficit
|
(20,490,865
|
)
|
(17,380,535
|
)
|
|||
Accumulated
other comprehensive income
|
9,127
|
34,525
|
|||||
Total
stockholders' equity (deficit)
|
(327,957
|
)
|
2,464,721
|
||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
$
|
8,098,539
|
$
|
8,969,724
|
Three
Months
|
Three
Months
|
Nine
Months
|
Nine
Months
|
||||||||||
ended
|
ended
|
ended
|
ended
|
||||||||||
September
30, 2006
|
September
30, 2005
|
September
30, 2006
|
September
30, 2005
|
||||||||||
REVENUE
|
$
|
23,894
|
$
|
130,394
|
$
|
222,745
|
$
|
450,247
|
|||||
COST
OF REVENUE
|
11,286
|
47,085
|
79,104
|
149,384
|
|||||||||
GROSS
PROFIT
|
12,608
|
83,309
|
143,641
|
300,863
|
|||||||||
OPERATING
EXPENSES
|
|||||||||||||
Selling,
general and administrative
|
273,813
|
278,199
|
974,972
|
888,716
|
|||||||||
Research
and development
|
357,296
|
264,503
|
1,142,634
|
858,765
|
|||||||||
Impairment
loss on intangible asset
|
-
|
-
|
585,000
|
-
|
|||||||||
Depreciation
and amortization
|
117,860
|
189,462
|
423,888
|
567,188
|
|||||||||
Total
Operating Expenses
|
748,969
|
732,164
|
3,126,494
|
2,314,669
|
|||||||||
OPERATING
LOSS
|
(736,361
|
)
|
(648,855
|
)
|
(2,982,853
|
)
|
(2,013,806
|
)
|
|||||
OTHER
INCOME (EXPENSES)
|
|||||||||||||
Interest
expense
|
(52,847
|
)
|
(20,866
|
)
|
(137,355
|
)
|
(43,380
|
)
|
|||||
Loss
on stock settlement obligation
|
-
|
-
|
-
|
(717,908
|
)
|
||||||||
Other,
net
|
2,025
|
(4,192
|
)
|
9,878
|
(48,509
|
)
|
|||||||
LOSS
BEFORE INCOME TAXES
|
(787,183
|
)
|
(673,913
|
)
|
(3,110,330
|
)
|
(2,823,603
|
)
|
|||||
PROVISION
FOR INCOME TAXES
|
-
|
-
|
-
|
-
|
|||||||||
NET
LOSS
|
$
|
(787,183
|
)
|
$
|
(673,913
|
)
|
$
|
(3,110,330
|
)
|
$
|
(2,823,603
|
)
|
|
LOSS
PER COMMON SHARE
|
|||||||||||||
Basic
and Diluted
|
$
|
0.00
|
$
|
(0.00
|
)
|
$
|
(0.02
|
)
|
$
|
(0.01
|
)
|
||
WEIGHTED
AVERAGE NUMBER OF
|
|||||||||||||
COMMON
SHARES OUTSTANDING
|
|||||||||||||
Basic
and Diluted
|
193,599,067
|
189,006,759
|
192,795,771
|
188,700,715
|
Accumulated
|
|||||||||||||||||||||||||||
Additional
|
Other
|
Other
|
|||||||||||||||||||||||||
Common
|
Stock
|
Paid-in
|
Accumulated
|
Comprehensive
|
Comprehensive
|
||||||||||||||||||||||
Shares
|
Value
|
Capital
|
Deficit
|
Loss
|
Income
|
Total
|
|||||||||||||||||||||
Balance,
December 31, 2005
|
189,006,760
|
$
|
16,307,050
|
$
|
3,503,681
|
($17,380,535
|
)
|
$
|
34,525
|
$
|
2,464,721
|
||||||||||||||||
Stock
issued for services
|
466,666
|
56,000
|
-
|
-
|
-
|
56,000
|
|||||||||||||||||||||
Stock
issued for conversion
|
|||||||||||||||||||||||||||
of
liabilities
|
4,500,000
|
121,500
|
-
|
-
|
-
|
121,500
|
|||||||||||||||||||||
Stock
options issued for services
|
-
|
-
|
165,550
|
-
|
-
|
165,550
|
|||||||||||||||||||||
Comprehensive
loss:
|
|||||||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(3,110,330
|
)
|
($3,110,330
|
)
|
(3,110,330
|
)
|
||||||||||||||||||
Foreign
currency translation
|
|||||||||||||||||||||||||||
adjustment
|
-
|
-
|
-
|
-
|
(25,398
|
)
|
(25,398
|
)
|
(25,398
|
)
|
|||||||||||||||||
Comprehensive
loss
|
($3,135,728
|
)
|
|||||||||||||||||||||||||
Balance,
September 30, 2006
|
193,973,426
|
$
|
16,484,550
|
$
|
3,669,231
|
$
|
(20,490,865
|
)
|
$
|
9,127
|
$
|
(327,957
|
)
|
Nine
Months
|
Nine
Months
|
||||||
ended
|
ended
|
||||||
September
30, 2006
|
September
30, 2005
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(3,110,330
|
)
|
$
|
(2,823,603
|
)
|
|
Adjustments
to reconcile net loss to cash
|
|||||||
flows
from operating activities:
|
|||||||
Depreciation
and amortization
|
423,888
|
567,188
|
|||||
Impairment
loss on intangible asset
|
585,000
|
-
|
|||||
Loss
on disposition of fixed assets
|
18,330
|
-
|
|||||
Loss
on stock settlement liability
|
-
|
717,908
|
|||||
Charges
for common stock issued for services
|
56,000
|
10,500
|
|||||
Interest
expense accrued for stockholder loan
|
137,087
|
41,048
|
|||||
Net
(increase) decrease in assets:
|
|||||||
Accounts
receivable
|
(5,769
|
)
|
(12,814
|
)
|
|||
Inventory
|
5,172
|
2,613
|
|||||
Other
assets
|
6,170
|
21,758
|
|||||
Net
increase (decrease) in liabilities:
|
|||||||
Accounts
payable
|
13,021
|
(155,143
|
)
|
||||
Accrued
compensation
|
(14,943
|
)
|
(35,046
|
)
|
|||
Accrued
expenses
|
(8,495
|
)
|
(111,798
|
)
|
|||
Deferred
revenue
|
(20,357
|
)
|
15,400
|
||||
Total
adjustments
|
1,195,104
|
1,061,614
|
|||||
Net
cash flows from operating activities
|
(1,915,226
|
)
|
(1,761,989
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Acquisition
of furniture and equipment
|
(11,144
|
)
|
(39,425
|
)
|
|||
Proceeds
from sale of furniture and equipment
|
6,547
|
-
|
|||||
Payment
of security deposit
|
(2,731
|
)
|
-
|
||||
Net
cash flows from investing activities
|
(7,328
|
)
|
(39,425
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Proceeds
from issuance of common stock
|
|||||||
pursuant
to subscription agreements
|
-
|
200,000
|
|||||
Stock
issuance costs
|
-
|
(30,373
|
)
|
||||
Proceeds
from stockholder loans
|
2,102,673
|
1,604,551
|
|||||
Proceeds
from notes payable
|
2,601
|
12,581
|
|||||
Payment
of notes payable
|
(53,675
|
)
|
(23,378
|
)
|
|||
Net
cash flows from financing activities
|
2,051,599
|
1,763,381
|
|||||
Effect
of exchange rate changes
|
(27,310
|
)
|
32,297
|
||||
Net
change in cash
|
101,735
|
(5,736
|
)
|
||||
Cash
balance, beginning of year
|
8,975
|
17,908
|
|||||
Cash
balance, end of year
|
$
|
110,710
|
$
|
12,172
|
|||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
268
|
$
|
2,332
|
|||
Supplemental
schedule of non-cash investing and financing
activities:
|
|||||||
Common
stock and options issued in exchange for current
liabilities
|
$
|
287,050
|
$
|
-
|
· |
Therapy
-
We
are entering into agreements to test our proprietary drug combinations
to
treat stone-forming diseases, with a preliminary focus on prostatitis,
which affects millions of men and currently is largely untreatable.
We
will also conduct tests with other stone forming diseases such as
gallstones and kidney stones.
|
· |
Infection
- The
gold standard for proving that something is infectious is Koch's
postulates. We intend to validate earlier findings on Koch's postulates
with calcifying nanoparticles in laboratory animals, including testing
whether the infection can be prevented or treated with a proprietary
drug
combination. In June 2006, a new study published by independent scientists
in a peer reviewed journal demonstrated key elements of Koch’s postulates
by showing that CNPs are implicated in formation of black pigment
gallstones in an animal model. In August 2006, we announced that
we
entered into an agreement to validate this finding with the same
scientists including Dr. LiMin Wang from Shantou University Medical
College, Guangdong, China, who will be the Principle
Investigator
|
· |
Characterization
-
We
have preliminary photographic and biochemical evidence that calcifying
nanoparticles self-replicate in non-precipitating conditions, suggesting
further that they have a self-sustaining mechanism and might be
infectious. In a recent agreement with Fetzer Memorial Trust, we
have
begun experiments at our NASA laboratory in Houston to demonstrate
this
replication via time-lapse photography using award-winning CytoViva
microscope technology capable of breaking through the 200 nanometer
(nm)
barrier for light microscopes. Our Scientific Director at NASA’s Johnson
Space Center has recently taken preliminary photographs of CNPs at
magnifications that we believe had not been previously achieved.
We own
the intellectual property arising from the above experiments.
|
· |
Thrombosis
- Thrombosis
is the cause of death in most hemodialysis patients. We intend to
validate
findings that calcifying nanoparticles discovered in human blood
provoke
thrombosis and might be preventable.
|
· |
Diagnostics
-
We believe that our proprietary Elisa antibody test uniquely recognizes
calcifying nanoparticles known as nanobacteria, and plan to further
validate the functionality of this diagnostic test.
|
Patent
|
General
Subject Matter
|
Expiration
Date
|
||||
US
5,135,851
|
U.S.
|
-Method
for the culture and detection of nanobacteria also known as calcifying
nanoparticles
(issued
in 1992)
|
August
11, 2010
|
|||
US
6,706,290
PCT/EP1999/004555
|
U.S.
& International Application
(PCT)
|
-Methods
for the eradication of Nanobacteria from articles and animals using
various novel combinations of systems, chemicals, compounds, drugs,
prodrugs, supplements, etc.
(issued
in 2004)
|
Jul
6, 2018
|
|||
U.S.
& PCT Applications Filed
|
-Methods
and Compositions (combinations) for treating diseases characterized
by
pathological calcification
(Filed
in 2004)
|
|||||
U.S.
& PCT Applications Filed
|
-Methods
and combinations of compositions including Bisphosphonates, chelators,
and
citrates
(Filed
in 2004)
|
|||||
U.S.
|
-Methods
for the treatment of disease associated with calcification and/or
plaque
formation
(Filed
in 2004)
|
|||||
U.S.
& PCT Application Filed
|
-Detection
of antibodies against compositions of conformationally changed proteins
comprising calcium binding protein hydroxy apatite complexes and
novel in
vitro test methods
(Filed
in 2005)
|
|||||
U.S.
& PCT Applications filed
|
-Methods
and compositions to detect calcifying nanoparticles including the
identification and quantification of proteins thereon and correlation
to
diseases thereof
(Filed
in 2005)
|
Three
months ended September 30,
|
Nine
months ended September 30,
|
|||||||||||||||||||||
2006
|
2005
|
%
Change
|
2006
|
2005
|
%
Change
|
|||||||||||||||||
Revenue
|
$
|
23,894
|
$
|
130,394
|
-82
|
%
|
$
|
222,745
|
$
|
450,247
|
-51
|
%
|
||||||||||
Cost
of revenue
|
11,286
|
47,085
|
-76
|
%
|
79,104
|
149,384
|
-47
|
%
|
||||||||||||||
Gross
Profit
|
12,608
|
83,309
|
-85
|
%
|
143,641
|
300,863
|
-52
|
%
|
||||||||||||||
Gross
Profit percentage
|
53
|
%
|
64
|
%
|
64
|
%
|
67
|
%
|
||||||||||||||
Selling,
general and admin
|
273,813
|
278,199
|
-2
|
%
|
974,972
|
888,716
|
10
|
%
|
||||||||||||||
Research
and development
|
357,296
|
264,503
|
35
|
%
|
1,142,634
|
858,765
|
33
|
%
|
||||||||||||||
Impairment
loss
|
-
|
-
|
585,000
|
-
|
||||||||||||||||||
Depreciation
and amortization
|
117,860
|
189,462
|
-38
|
%
|
423,888
|
567,188
|
-25
|
%
|
||||||||||||||
Operating
loss
|
(736,361
|
)
|
(648,855
|
)
|
13
|
%
|
(2,982,853
|
)
|
(2,013,806
|
)
|
48
|
%
|
||||||||||
Other
income (Expense)
|
(50,822
|
)
|
(25,058
|
)
|
103
|
%
|
(127,477
|
)
|
(809,797
|
)
|
-84
|
%
|
||||||||||
Net
loss
|
($787,183
|
)
|
($673,913
|
)
|
17
|
%
|
($3,110,330
|
)
|
($2,823,603
|
)
|
10
|
%
|
Three
months ended Sep 30,
|
Nine
months ended Sep 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Dietary
Supplements
|
$
|
-
|
$
|
101,338
|
$
|
122,495
|
$
|
363,652
|
|||||
Observation
Rights
|
3,000
|
4,000
|
15,000
|
4,000
|
|||||||||
Diagnostic
Products
|
20,894
|
25,056
|
85,250
|
82,595
|
|||||||||
$
|
23,894
|
$
|
130,394
|
$
|
222,745
|
$
|
450,247
|
Nine
months ended September 30,
|
||||||||
2006
|
2005
|
|||||||
U.S.
Payroll and medical directors
|
52
|
%
|
60
|
%
|
||||
Finland
payroll and laboratory
|
33
|
%
|
31
|
%
|
||||
Research
studies
|
11
|
%
|
6
|
%
|
||||
Other
|
4
|
%
|
3
|
%
|
||||
100
|
%
|
100
|
%
|
Three
months ended Sep 30,
|
Nine
months ended Sep 30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Interest
expense:
|
|||||||||||||
Stockholder
loan
|
($52,807
|
)
|
($20,385
|
)
|
($137,087
|
)
|
($41,048
|
)
|
|||||
Other
|
(40
|
)
|
(481
|
)
|
(268
|
)
|
(2,332
|
)
|
|||||
Loss
on stock settlement obligation
|
-
|
-
|
-
|
(717,908
|
)
|
||||||||
Loss
on disposition of assets
|
-
|
-
|
(18,330
|
)
|
-
|
||||||||
Foreign
exchange gain (loss)
|
1,197
|
(2,107
|
)
|
25,435
|
(38,239
|
)
|
|||||||
Other,
net
|
828
|
(2,085
|
)
|
2,773
|
(10,270
|
)
|
|||||||
Total
|
($50,822
|
)
|
($25,058
|
)
|
($127,477
|
)
|
($809,797
|
)
|
Number
|
||||||||||
of
Shares
|
Per
Share
|
Proceeds
|
||||||||
Common
Stock:
|
||||||||||
Unaffiliated
Investors
|
16,250,000
|
$
|
0.12
|
$
|
1,950,000
|
|||||
Affiliates
|
8,333,333
|
$
|
0.12
|
$
|
1,000,000
|
|||||
24,583,333
|
$
|
2,950,000
|
||||||||
|
Number
|
Exercise
|
||||||||
|
of
Warrants
|
Price
|
||||||||
Warrants:
|
||||||||||
Unaffiliated
Investors
|
8,125,000
|
$
|
0.13
|
|||||||
Unaffiliated
Investors
|
8,125,000
|
$
|
0.18
|
|||||||
Affiliates
|
4,166,667
|
$
|
0.13
|
|||||||
Affiliates
|
4,166,666
|
$
|
0.18
|
|||||||
24,583,333
|
Date: November 6, 2006 | NANOBAC PHARMACEUTICALS, INCORPORATED | |
|
|
|
By: | /s/ John D Stanton | |
John D Stanton |
||
Chief Executive Officer |
EXHIBIT
|
|||
NUMBER
|
DESCRIPTION
|
PAGE
|
|
|
|||
|
|
||
31.1
|
Certification
to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Executive
Officer
|
27
|
|
31.2
|
Certification
to Section 302 of the Sarbanes-Oxley Act of
2002 - Chief Financial Officer
|
28
|
|
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 -
|
||
Chief
Executive Officer
|
29
|
||
32.2
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 -
|
||
Chief
Financial Officer
|
30
|