Florida
|
0-24696
|
59-3248917
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
Item
1:
|
Financial Statements | |
Condensed
Consolidated Balance Sheets as of September 30, 2007
(unaudited)
|
||
and
December 31, 2006
|
3
|
|
Condensed
Consolidated Statements of Operations for the three and
nine
|
||
months
ended September 30, 2007 and 2006 (unaudited)
|
4
|
|
Condensed
Consolidated Statements of Changes in Stockholders'
|
||
Equity
for the nine months ended September 30, 2007 (unaudited)
|
5
|
|
Condensed
Consolidated Statements of Cash Flows for the nine
|
||
months
ended September 30, 2007 and 2006 (unaudited)
|
6
|
|
Notes
to the Condensed Consolidated Financial Statements
|
7
|
|
Item
2:
|
Management’s
Discussion and Analysis of Financial
|
|
Condition
and Results of Operations
|
10
|
|
Item
3:
|
Controls
and Procedures
|
21
|
PART
II - OTHER INFORMATION
|
||
Item
1:
|
Legal
Proceedings
|
23
|
Item
2:
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
24
|
Item
3:
|
Defaults
Upon Senior Securities
|
25
|
Item
4:
|
Submission
of Matters to a Vote of Security Holders
|
25
|
Item
5:
|
Other
Information
|
25
|
Item
6:
|
Exhibits
|
25
|
(Unaudited)
|
|||||||
September
30, 2007
|
December
31, 2006
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
|
$
|
661
|
$
|
39,505
|
|||
Account
receivable
|
1,811
|
708
|
|||||
Inventory
|
9,983
|
66,352
|
|||||
Prepaid
expenses
|
27,588
|
19,938
|
|||||
Total
current assets
|
40,043
|
126,503
|
|||||
FURNITURE
AND EQUIPMENT, less
accumulated depreciation
|
|||||||
of
$124,812 at
September 30, 2007 and $105,534 at
|
|||||||
December
31, 2006
|
41,466
|
60,321
|
|||||
OTHER
ASSETS
|
|||||||
Security
deposits
|
8,838
|
58,503
|
|||||
Intangible
assets, less accumulated amortization
|
|||||||
of
$1,606,731
at
September 30, 2007 and $1,279,041 at
|
|||||||
December
31, 2006
|
3,636,311
|
3,964,001
|
|||||
Goodwill
|
3,615,393
|
3,615,393
|
|||||
Total
other assets
|
7,260,542
|
7,637,897
|
|||||
TOTAL
ASSETS
|
$
|
7,342,051
|
$
|
7,824,721
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
967,976
|
$
|
408,665
|
|||
Accrued
compensation
|
422,869
|
87,385
|
|||||
Accrued
expenses
|
1,357,241
|
436,590
|
|||||
Related
party loans
|
3,915,716
|
5,367,205
|
|||||
Total
current liabilities
|
6,663,802
|
6,299,845
|
|||||
LONG-TERM
LIABILITIES
|
|||||||
Stock
settlement obligation:
|
|||||||
Related
party
|
961,538
|
961,538
|
|||||
Other
|
1,875,000
|
1,875,000
|
|||||
Total
liabilities
|
9,500,340
|
9,136,383
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
-
|
-
|
|||||
STOCKHOLDERS'
EQUITY
|
|||||||
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,
|
|||||||
2007:
247,473,426 shares issued and outstanding
|
|||||||
2006:
205,473,726 shares issued and outstanding
|
22,720,050
|
17,260,050
|
|||||
Additional
paid-in capital
|
2,964,364
|
3,803,031
|
|||||
Accumulated
deficit
|
(27,762,931
|
)
|
(22,353,888
|
)
|
|||
Accumulated
other comprehensive loss
|
(79,772
|
)
|
(20,855
|
)
|
|||
Total
stockholders' equity
|
(2,158,289
|
)
|
(1,311,662
|
)
|
|||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
7,342,051
|
$
|
7,824,721
|
|
|
Three
Months
|
|
Three
Months
|
|
Nine
Months
|
|
Nine
Months
|
|
||||
|
|
ended
|
|
ended
|
|
ended
|
|
ended
|
|
||||
|
|
September
30, 2007
|
|
September
30, 2006
|
|
September
30, 2007
|
|
September
30, 2006
|
|||||
(Restated)
|
|||||||||||||
REVENUE
|
$
|
5,809
|
$
|
23,894
|
$
|
13,253
|
$
|
222,745
|
|||||
COST
OF REVENUE
|
4,667
|
11,286
|
10,829
|
79,104
|
|||||||||
GROSS
PROFIT
|
1,142
|
12,608
|
2,424
|
143,641
|
|||||||||
OPERATING
EXPENSES
|
|||||||||||||
Selling,
general and administrative
|
163,229
|
273,813
|
2,505,393
|
1,534,972
|
|||||||||
Research
and development
|
258,840
|
357,296
|
922,947
|
1,142,634
|
|||||||||
Impairment
loss on intangible asset
|
-
|
585,000
|
|||||||||||
Depreciation
and amortization
|
114,556
|
117,860
|
346,488
|
423,888
|
|||||||||
Total
Operating Expenses
|
536,625
|
748,969
|
3,774,828
|
3,686,494
|
|||||||||
OPERATING
LOSS
|
(535,483
|
)
|
(736,361
|
)
|
(3,772,404
|
)
|
(3,542,853
|
)
|
|||||
OTHER
INCOME (EXPENSES)
|
|||||||||||||
Interest
expense
|
(48,236
|
)
|
(52,847
|
)
|
(138,189
|
)
|
(137,355
|
)
|
|||||
Derivative
gain
|
(296,833
|
)
|
-
|
2,667
|
-
|
||||||||
Loss
on related party debt
|
|||||||||||||
extinguishment
|
-
|
-
|
(1,560,000
|
)
|
-
|
||||||||
Other,
net
|
44,789
|
2,025
|
58,883
|
9,878
|
|||||||||
LOSS
FROM CONTINUING OPERATIONS
|
|||||||||||||
BEFORE
INCOME TAXES
|
(835,763
|
)
|
(787,183
|
)
|
(5,409,043
|
)
|
(3,670,330
|
)
|
|||||
PROVISION
FOR INCOME TAXES
|
-
|
-
|
-
|
-
|
|||||||||
NET
LOSS
|
$
|
(835,763
|
)
|
$
|
(787,183
|
)
|
$
|
(5,409,043
|
)
|
$
|
(3,670,330
|
)
|
|
LOSS
PER COMMON SHARE
|
|||||||||||||
Basic
and Diluted
|
$
|
(0.00
|
)
|
$
|
(0.00
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF
|
|||||||||||||
COMMON
SHARES OUTSTANDING
|
|||||||||||||
Basic
and Diluted
|
247,473,426
|
202,714,452
|
243,469,763
|
197,387,346
|
Accumulated
|
||||||||||||||||||||||
Additional
|
Other
|
Other
|
||||||||||||||||||||
Common
|
Stock
|
Paid-in
|
Accumulated
|
Comprehensive
|
Comprehensive
|
|||||||||||||||||
Shares
|
Value
|
Capital
|
Deficit
|
Loss
|
Loss
|
Total
|
||||||||||||||||
Balance,
December 31, 2006
|
205,473,726
|
$
|
17,260,050
|
$
|
3,803,031
|
($22,353,888
|
)
|
($20,855
|
)
|
($1,311,662
|
)
|
|||||||||||
Stock
issued for services
|
12,000,000
|
1,560,000
|
-
|
-
|
-
|
-
|
1,560,000
|
|||||||||||||||
Stock
issued for extinguishment
|
||||||||||||||||||||||
of
related party loans
|
30,000,000
|
3,900,000
|
-
|
-
|
-
|
-
|
3,900,000
|
|||||||||||||||
Reclassification
of equity
|
||||||||||||||||||||||
to
derivative liability
|
-
|
-
|
(838,667
|
)
|
-
|
-
|
-
|
(838,667
|
)
|
|||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(5,409,043
|
)
|
($5,409,043
|
)
|
(5,409,043
|
)
|
|||||||||||||
Foreign
currency translation
|
||||||||||||||||||||||
adjustment
|
-
|
-
|
-
|
-
|
(58,917
|
)
|
(58,917
|
)
|
(58,917
|
)
|
||||||||||||
Comprehensive
loss
|
($5,467,960
|
)
|
||||||||||||||||||||
Balance,
September 30, 2007
|
247,473,726
|
$
|
22,720,050
|
$
|
2,964,364
|
$
|
(27,762,931
|
)
|
$
|
(79,772
|
)
|
$
|
(2,158,289
|
)
|
|
|
Nine
Months
|
|
Nine
Months
|
|
||
|
|
ended
|
|
ended
|
|
||
|
|
September
30, 2007
|
|
September
30, 2006
|
|||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(5,409,043
|
)
|
$
|
(3,670,330
|
)
|
|
Adjustments
to reconcile net loss to cash
|
|||||||
flows from operating activities:
|
|||||||
Depreciation
and amortization
|
346,488
|
423,888
|
|||||
Impairment
loss on intangible asset
|
-
|
585,000
|
|||||
Loss
on disposition of fixed assets
|
-
|
18,330
|
|||||
Derivative
gain
|
(2,667
|
)
|
-
|
||||
Charges
for common stock issued for services
|
1,560,000
|
616,000
|
|||||
Loss
on related party debt extinguishment
|
1,560,000
|
-
|
|||||
Interest
expense accrued for stockholder loan
|
135,203
|
137,087
|
|||||
Net
(increase) decrease in assets:
|
|||||||
Accounts
receivable
|
(1,103
|
)
|
(5,769
|
)
|
|||
Inventory
|
56,369
|
5,172
|
|||||
Other
assets
|
(7,650
|
)
|
6,170
|
||||
Net
increase (decrease) in liabilities:
|
|||||||
Accounts
payable
|
559,311
|
13,021
|
|||||
Accrued
compensation
|
335,484
|
(14,943
|
)
|
||||
Accrued
expenses
|
67,038
|
(8,495
|
)
|
||||
Deferred
revenue
|
-
|
(20,357
|
)
|
||||
Total
adjustments
|
4,608,473
|
1,755,104
|
|||||
Net
cash flows from operating activities
|
(800,570
|
)
|
(1,915,226
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Acquisition
of furniture and equipment
|
(1,532
|
)
|
(11,144
|
)
|
|||
Proceeds
from sale of furniture and equipment
|
0
|
6,547
|
|||||
Refund
(payment) of security deposits
|
50,400
|
(2,731
|
)
|
||||
Net
cash flows from investing activities
|
48,868
|
(7,328
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Proceeds
from stockholder loans
|
753,308
|
2,102,673
|
|||||
Proceeds
from notes payable
|
-
|
2,601
|
|||||
Payment
of notes payable
|
-
|
(53,675
|
)
|
||||
Net
cash flows from financing activities
|
753,308
|
2,051,599
|
|||||
Effect
of exchange rate changes
|
(40,450
|
)
|
(27,310
|
)
|
|||
Net
change in cash
|
(38,844
|
)
|
101,735
|
||||
Cash
balance, beginning of period
|
39,505
|
8,975
|
|||||
Cash
balance, end of period
|
$
|
661
|
$
|
110,710
|
|||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
2,986
|
$
|
268
|
|||
Supplemental
schedule of non-cash investing and financing
activities:
|
|||||||
Common
stock issued in exchange for current liabilities
|
$
|
2,340,000
|
$
|
287,050
|
|||
Reclassification
of equity to derivative liability
|
$
|
838,667
|
$
|
-
|
·
|
Therapy
-
We
are entering into agreements to support the United States Food and
Drug
Administration pre-Investigational New Drug “(PIND”) 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 also expect to conduct tests
with
other stone forming diseases such as gallstones and kidney
stones.
|
·
|
Pharmaceutical
Drug Development - The
FDA approved Nanobac to move forward with PIND 73,524 for Chronic
Prostatitis/Chronic Pelvic Pain Syndrome (“CP/CPPS”). We are currently
evaluating several contract service providers who have formulation
and
manufacturing capabilities. Once a contract is entered into, we expect
to
begin assembling the supporting documentation for completing the
Investigational New Drug (“IND”) application. We intend to have the IND
submitted by the end of the third quarter, financing permitted. The
submission is part of the process for obtaining FDA approval to begin
clinical studies to determine if Nanobac’s therapy is effective for Type
III Prostatitis patients. Additional clinical and non-clinical studies
will be determined by the outcome of the first
study.
|
·
|
Infection
- The
gold standard for proving that something is infectious and causes
diseases
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 November
1406, 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.
|
·
|
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 Sep 30
|
Nine
months ended Sep 30
|
||||||||||||||||||
2007
|
2006
|
%
Change
|
2007
|
2006
|
%
Change
|
||||||||||||||
Revenue
|
$
|
5,809
|
$
|
23,894
|
-76%
|
|
$
|
13,253
|
$
|
222,745
|
-94%
|
|
|||||||
Cost
of revenue
|
4,667
|
11,286
|
-59%
|
|
10,829
|
79,104
|
-86%
|
|
|||||||||||
Gross
Profit
|
1,142
|
12,608
|
-91%
|
|
2,424
|
143,641
|
-98%
|
|
|||||||||||
Gross
Profit percentage
|
20%
|
|
53%
|
|
18%
|
|
64%
|
|
|||||||||||
Selling,
general and administrative
|
163,229
|
273,813
|
-40%
|
|
2,505,393
|
1,534,972
|
63%
|
|
|||||||||||
Research
and development
|
258,840
|
357,296
|
-28%
|
|
922,947
|
1,142,634
|
-19%
|
|
|||||||||||
Impairment
loss on intangible asset
|
0
|
0
|
0%
|
|
0
|
585,000
|
-100%
|
|
|||||||||||
Depreciation
and amortization
|
114,556
|
117,860
|
-3%
|
|
346,488
|
423,888
|
-18%
|
|
|||||||||||
Operating
loss
|
(535,483
|
)
|
(736,361
|
)
|
-27%
|
|
(3,772,404
|
)
|
(3,542,853
|
)
|
6%
|
|
|||||||
Other
income (Expense)
|
(300,280
|
)
|
(50,822
|
)
|
491%
|
|
(1,636,639
|
)
|
(127,477
|
)
|
1184%
|
|
|||||||
Net
loss
|
($835,763
|
)
|
($787,183
|
)
|
6%
|
|
($5,409,043
|
)
|
($3,670,330
|
)
|
47%
|
|
Three
months ended Sep 30
|
Nine
months ended Sep 30
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Nanobac
Supplement
|
$
|
0
|
$
|
2,202
|
$
|
122,495
|
|||||||
Observation
Rights
|
0
|
6,000
|
12,000
|
||||||||||
Diagnostic
Products
|
5,809
|
15,692
|
13,253
|
88,250
|
|||||||||
$
|
5,809
|
$
|
23,894
|
$
|
13,253
|
$
|
222,745
|
Nine
Months ended Sep 30
|
||
2007
|
2006
|
|
U.S.
Payroll and medical directors
|
56%
|
52%
|
Finland
payroll and laboratory
|
17%
|
33%
|
Research
studies
|
20%
|
11%
|
Other
|
7%
|
4%
|
100%
|
100%
|
Three
months ended Sep 30
|
Nine
months ended Sep 30
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Interest
expense
|
|||||||||||||
Related
party loans
|
($46,319
|
)
|
($52,807
|
)
|
($135,203
|
)
|
($137,087
|
)
|
|||||
Other
|
(1,917
|
)
|
(40
|
)
|
(2,986
|
)
|
(268
|
)
|
|||||
Derivative
gain
|
(296,833
|
)
|
0
|
2,667
|
0
|
||||||||
Loss
on related party debt extinguishment
|
0
|
0
|
(1,560,000
|
)
|
0
|
||||||||
Loss
on disposition of assets
|
0
|
0
|
0
|
(18,330
|
)
|
||||||||
Foreign
exchange gain (loss)
|
44,413
|
1,197
|
58,545
|
25,435
|
|||||||||
Other,
net
|
376
|
828
|
338
|
2,773
|
|||||||||
Total
|
($300,280
|
)
|
($50,822
|
)
|
($1,636,639
|
)
|
($127,477
|
)
|
Number
of Shares
|
Per
Share
|
Proceeds
|
||||||||
Common
Stock, previously issued:
|
||||||||||
Unaffiliated
Investors
|
8,125,000
|
$
|
0.12
|
$
|
975,000
|
|||||
Affiliates
|
4,166,667
|
$
|
0.12
|
500,000
|
||||||
12,291,667
|
$
|
1,475,000
|
||||||||
Common
Stock, future issuances
|
||||||||||
Unaffiliated
Investors
|
5,416,667
|
$
|
0.12
|
$
|
650,000
|
|||||
Affiliates
|
6,875,000
|
$
|
0.12
|
825,000
|
||||||
12,291,667
|
$
|
1,475,000
|
||||||||
Warrants:
|
||||||||||
Unaffiliated
Investors
|
8,125,000
|
$
|
0.13
|
|||||||
Affiliates
|
4,166,667
|
$
|
0.13
|
|||||||
Unaffiliated
Investors
|
5,416,667
|
$
|
0.18
|
|||||||
Affiliates
|
6,875,000
|
$
|
0.18
|
|||||||
24,583,333
|
(a) |
The
following exhibits are filed as part of this
report:
|
(b)
|
Reports
on Form 8-K
|
Dated:
November 14, 2007
|
NANOBAC
PHARMACEUTICALS, INCORPORATED
|
/s/
John D Stanton
|
|
John
D Stanton
|
|
Chief
Executive Officer and
|
|
Chief
Financial Officer
|
EXHIBIT
|
||
NUMBER
|
DESCRIPTION
|
PAGE
|
_________
|
_____________
|
_____
|
|
||
|
|
|
31.1
|
Certification
to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Executive
Officer
|
28
|
|
||
31.2
|
Certification
to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Financial
Officer
|
29
|
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
|
30
|
|
||
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
|
31
|