Florida
|
0-24696
|
59-3248917
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
PART
I - FINANCIAL INFORMATION
|
||
Item
1:
|
Financial
Statements
|
|
Condensed
Consolidated Balance Sheets as of March 31, 2007
(unaudited)
|
||
and
December 31, 2006
|
3
|
|
Condensed
Consolidated Statements of Operations for the three
|
||
months
ended March 31, 2007 and 2006 (unaudited)
|
4
|
|
Condensed
Consolidated Statement of Changes in Stockholders'
|
||
Equity
for the three months ended March 31, 2007 (unaudited)
|
5
|
|
Condensed
Consolidated Statements of Cash Flows for the three
|
||
months
ended March 31, 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)
|
|||||||
March
31, 2007
|
December
31, 2006
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
|
$
|
6,231
|
$
|
39,505
|
|||
Account
receivable
|
164
|
708
|
|||||
Inventory
|
67,060
|
66,352
|
|||||
Prepaid
expenses
|
25,095
|
19,938
|
|||||
Total
current assets
|
98,550
|
126,503
|
|||||
FURNITURE
AND EQUIPMENT, less
accumulated depreciation
|
|||||||
of
$110,963
at
March 31, 2007 and $105,534 at
|
|||||||
December
31, 2006
|
51,426
|
60,321
|
|||||
OTHER
ASSETS
|
|||||||
Security
deposits
|
8,160
|
58,503
|
|||||
Intangible
assets, less accumulated amortization
|
|||||||
of
$1,388,271at
March 31, 2007 and $1,279,041 at
|
|||||||
December
31, 2006
|
3,854,771
|
3,964,001
|
|||||
Goodwill
|
3,615,393
|
3,615,393
|
|||||
Total
other assets
|
7,478,324
|
7,637,897
|
|||||
TOTAL
ASSETS
|
$
|
7,628,300
|
$
|
7,824,721
|
|||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
647,661
|
$
|
408,665
|
|||
Accrued
compensation
|
339,969
|
87,385
|
|||||
Accrued
expenses
|
509,246
|
436,590
|
|||||
Related
party loans
|
3,310,436
|
5,367,205
|
|||||
Derivative
liability
|
329,500
|
-
|
|||||
Total
current liabilities
|
5,136,812
|
6,299,845
|
|||||
LONG-TERM
LIABILITIES
|
|||||||
Stock
settlement obligation:
|
|||||||
Related
party
|
961,538
|
961,538
|
|||||
Other
|
1,875,000
|
1,875,000
|
|||||
Total
liabilities
|
7,973,350
|
9,136,383
|
|||||
CONTINGENCIES
(Note 6)
|
-
|
-
|
|||||
STOCKHOLDERS'
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,
|
|||||||
2007:
247,473,726 shares issued and outstanding
|
|||||||
2006:
205,473,726 shares issued and outstanding
|
22,720,050
|
17,260,050
|
|||||
Additional
paid-in capital
|
3,174,031
|
3,803,031
|
|||||
Accumulated
deficit
|
(26,210,606
|
)
|
(22,353,888
|
)
|
|||
Accumulated
other comprehensive loss
|
(28,525
|
)
|
(20,855
|
)
|
|||
Total
stockholders' deficit
|
(345,050
|
)
|
(1,311,662
|
)
|
|||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$
|
7,628,300
|
$
|
7,824,721
|
Three
Months
|
|
Three
Months
|
|
||||
|
|
ended
|
|
ended
|
|
||
|
|
March
31, 2007
|
|
March
31, 2006
|
|||
REVENUE
|
$
|
5,012
|
$
|
161,286
|
|||
COST
OF REVENUE
|
4,260
|
45,195
|
|||||
GROSS
PROFIT
|
752
|
116,091
|
|||||
OPERATING
EXPENSES
|
|||||||
Selling,
general and administrative
|
2,062,665
|
425,870
|
|||||
including
$1,560,000 related
|
|||||||
party
stock based compensation
|
|||||||
in
2007
|
|||||||
Research
and development
|
378,975
|
354,322
|
|||||
Impairment
loss on intangible asset
|
-
|
585,000
|
|||||
Depreciation
and amortization
|
116,646
|
188,217
|
|||||
Total
Operating Expenses
|
2,558,286
|
1,553,409
|
|||||
OPERATING
LOSS
|
(2,557,534
|
)
|
(1,437,318
|
)
|
|||
OTHER
INCOME (EXPENSES)
|
|||||||
Interest
expense
|
(46,230
|
)
|
(38,239
|
)
|
|||
Derivative
gain
|
299,500
|
-
|
|||||
Loss
on related party debt extinguishment
|
(1,560,000
|
)
|
-
|
||||
Other,
net
|
7,546
|
(12,130
|
)
|
||||
LOSS
BEFORE INCOME TAXES
|
(3,856,718
|
)
|
(1,487,687
|
)
|
|||
PROVISION
FOR INCOME TAXES
|
-
|
-
|
|||||
NET
LOSS
|
$
|
(3,856,718
|
)
|
$
|
(1,487,687
|
)
|
|
LOSS
PER COMMON SHARE
|
|||||||
Basic
and Diluted
|
$
|
(0.02
|
)
|
$
|
(0.01
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF
|
|||||||
COMMON
SHARES OUTSTANDING
|
|||||||
Basic
and Diluted
|
233,165,733
|
191,232,034
|
Accumulated
|
||||||||||||||||||||||
Additional
|
Other
|
Other
|
||||||||||||||||||||
Common
|
Stock
|
Paid-in
|
Accumulated
|
Comprehensive
|
Comprehensive
|
|||||||||||||||||
Shares
|
Amount
|
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
|
|||||||||||||||
Reclassifaction
of equity to
|
||||||||||||||||||||||
derivative
liability
|
-
|
-
|
(629,000
|
)
|
-
|
-
|
-
|
(629,000
|
)
|
|||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(3,856,718
|
)
|
($3,856,718
|
)
|
-
|
(3,856,718
|
)
|
||||||||||||
Foreign
currency translation
|
||||||||||||||||||||||
adjustment
|
-
|
-
|
-
|
-
|
(7,670
|
)
|
(7,670
|
)
|
(7,670
|
)
|
||||||||||||
Comprehensive
loss
|
($3,864,388
|
)
|
||||||||||||||||||||
Balance,
March 31, 2007
|
247,473,726
|
$
|
22,720,050
|
$
|
3,174,031
|
$
|
(26,210,606
|
)
|
$
|
(28,525
|
)
|
$
|
(345,050
|
)
|
|
|
Three
Months
|
|
Three
Months
|
|
||
|
|
ended
|
|
ended
|
|
||
|
|
March
31, 2007
|
|
March
31, 2006
|
|||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(3,856,718
|
)
|
$
|
(1,487,687
|
)
|
|
Adjustments
to reconcile net loss to cash
|
|||||||
flows from operating activities:
|
|||||||
Depreciation
and amortization
|
116,646
|
188,217
|
|||||
Impairment
loss on intangible asset
|
-
|
585,000
|
|||||
Loss
on disposition of furniture and equipment
|
-
|
18,330
|
|||||
Derivative
gain
|
(299,500
|
)
|
-
|
||||
Charges
for common stock issued for services
|
1,560,000
|
-
|
|||||
Loss
on related party debt extinguishment
|
1,560,000
|
-
|
|||||
Interest
expense accrued for stockholder loan
|
45,442
|
38,023
|
|||||
Net
(increase) decrease in assets:
|
|||||||
Accounts
receivable
|
544
|
(9,714
|
)
|
||||
Inventory
|
(708
|
)
|
8,089
|
||||
Other
assets
|
(5,157
|
)
|
3,171
|
||||
Net
increase (decrease) in liabilities:
|
|||||||
Accounts
payable
|
238,996
|
(41,691
|
)
|
||||
Accrued
compensation
|
252,584
|
50,582
|
|||||
Accrued
expenses
|
72,656
|
110,957
|
|||||
Deferred
revenue
|
-
|
(8,304
|
)
|
||||
Total
adjustments
|
3,541,503
|
942,660
|
|||||
Net
cash flows from operating activities
|
(315,215
|
)
|
(545,027
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Acquisition
of furniture and equipment
|
(1,532
|
)
|
(3,825
|
)
|
|||
Proceeds
from sale of furniture and equipment
|
3,221
|
6,547
|
|||||
Refund
(payment) of security deposits
|
50,400
|
(2,731
|
)
|
||||
Net
cash flows from investing activities
|
52,089
|
(9
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Proceeds
from related party loans
|
237,789
|
1,204,218
|
|||||
Proceeds
from notes payable
|
-
|
2,601
|
|||||
Payment
of notes payable
|
-
|
(39,000
|
)
|
||||
Net
cash flows from financing activities
|
237,789
|
1,167,819
|
|||||
Effect
of exchange rate changes
|
(7,937
|
)
|
(5,753
|
)
|
|||
Net
change in cash
|
(33,274
|
)
|
617,030
|
||||
Cash
balance, beginning of period
|
39,505
|
8,975
|
|||||
Cash
balance, end of period
|
$
|
6,231
|
$
|
626,005
|
|||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
788
|
$
|
216
|
|||
Supplemental
schedule of non-cash investing and financing
activities:
|
|||||||
Common
stock issued in exchange for current liabilities
|
$
|
2,340,000
|
$
|
121,500
|
|||
Reclassifaction
of equity to derivative liability
|
$
|
629,500
|
$
|
-
|
·
|
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 will also 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 will
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 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
|
·
|
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 Enzyme-Linked ImmunoSorbent Assay
(“ELISA”) antibody test uniquely recognizes calcifying nanoparticles known
as nanobacteria, and plan to further validate the functionality of
this
diagnostic test. ELISA is a biochemical technique used mainly as
a
diagnostic tool in medicine.
|
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 March
|
|
|||||||||
|
|
2007
|
|
2006
|
|
%
Change
|
|
|||
Revenue
|
|
$
|
5,012
|
|
$
|
161,286
|
|
|
-97%
|
|
Cost
of revenue
|
|
|
4,260
|
|
|
45,195
|
|
|
-91%
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Profit
|
|
|
752
|
|
|
116,091
|
|
|
-99%
|
|
Gross
Profit percentage
|
|
|
15%
|
|
|
72%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative
|
|
|
2,062,665
|
|
|
425,870
|
|
|
384%
|
|
Research
and development
|
|
|
378,975
|
|
|
354,322
|
|
|
7%
|
|
Impairment
loss on intangible asset
|
|
|
-
|
|
|
585,000
|
|
|
-
|
|
Depreciation
and amortization
|
|
|
116,646
|
|
|
188,217
|
|
|
-38%
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(2,557,534)
|
|
|
(1,437,318)
|
|
|
78%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
-
|
|
Other
income (expense)
|
|
|
(1,299,184)
|
|
|
(50,369)
|
|
|
2,479%
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
($3,856,718)
|
|
|
($1,487,687)
|
|
|
159%
|
|
|
|
Three
months ended March
|
|
||||
|
|
2007
|
|
2006
|
|||
Nanobac
Supplement
|
|
$
|
-
|
|
$
|
120,293
|
|
Observation
Rights
|
|
|
-
|
|
|
6,000
|
|
Diagnostic
Products
|
|
|
5,012
|
|
|
34,993
|
|
|
|
|
|
|
|
|
|
|
|
$
|
5,012
|
|
$
|
161,286
|
|
Three
Months ended Mar 31
|
|
||||||
|
|
2007
|
|
2006
|
|||
U.S.
Payroll and medical directors
|
51%
|
|
52%
|
|
|||
Finland
payroll and laboratory
|
25%
|
|
31%
|
|
|||
Research
studies
|
23%
|
|
10%
|
|
|||
Other
|
1%
|
|
7%
|
|
|||
100%
|
|
100%
|
|
Three
months ended March
|
|||||||
2007
|
2006
|
||||||
Interest
expense
|
|||||||
Related
party loans
|
($45,442
|
)
|
($38,023
|
)
|
|||
Other
|
($788
|
)
|
(216
|
)
|
|||
Derivative
gain
|
299,500
|
-
|
|||||
Loss
on related party debt extinguishment
|
(1,560,000
|
)
|
-
|
||||
Loss
on disposition of assets
|
-
|
(18,330
|
)
|
||||
Foreign
exchange gain (loss)
|
7,207
|
7,002
|
|||||
Other,
net
|
339
|
(802
|
)
|
||||
Total
|
($1,299,184
|
)
|
($50,369
|
)
|
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
|
|||||||
24,583,334
|
(a) |
The
following exhibits are filed as part of this
report:
|
(b)
|
Reports
on Form 8-K
|
Dated: May 18, 2007 | NANOBAC PHARMACEUTICALS, INCORPORATED |
/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
|
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
|