x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
|
o
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
California
|
91-2021600
|
(State
or Other Jurisdiction of Organization)
|
(IRS
Employer Identification Number)
|
PART
I. FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1. Financial Statements
|
3
|
|
|
|
|
|
Consolidated
Balance Sheet as of June 30, 2007 (Unaudited)
|
3
|
|
|
|
|
Consolidated
Statements of Operations for the three and six months
ended
|
|
|
June
30, 2007 and 2006 (Unaudited)
|
4
|
|
|
|
|
Consolidated
Statements of Cash Flows for the six months ended
|
|
|
June
30, 2007 and 2006 (Unaudited)
|
5
|
|
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6
|
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition or Plan of
Operations
|
11
|
|
|
|
|
Item
3. Controls and Procedures
|
18
|
|
|
|
|
PART
II. OTHER INFORMATION
|
|
|
|
|
|
Item
1. Legal Proceedings
|
18
|
|
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
18
|
|
|
|
|
Item
3. Defaults Upon Senior Securities
|
18
|
|
|
|
|
Item
4. Submission of Matters to a Vote of Security Holders
|
18
|
|
|
|
|
Item
5. Other Information
|
18
|
|
|
|
|
Item
6. Exhibits
|
19
|
|
|
|
|
SIGNATURES
|
19
|
ASSETS
|
||||
Current
assets:
|
||||
Inventory
|
$
|
11,425
|
||
Total
current assets
|
11,425
|
|||
Other
assets
|
9,950
|
|||
TOTAL
ASSETS
|
$
|
21,375
|
||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
||||
Current
liabilities:
|
||||
Accounts
payable
|
$
|
51,538
|
||
Bank
overdraft
|
8,578
|
|||
Accrued
expenses
|
15,000
|
|||
Due
to officers
|
1,621,579
|
|||
Other
loans payable
|
100,000
|
|||
Total
current liabilities
|
1,796,695
|
|||
Stockholders'
deficit:
|
||||
Common
stock, $0.001 par value, 2.0 billion shares
|
||||
authorized;
78,280,682 shares issued and outstanding
|
78,281
|
|||
Additional
paid-in capital
|
17,705,038
|
|||
Deferred
compensation
|
(346,325
|
)
|
||
Deficit
accumulated during the development stage
|
(19,212,314
|
)
|
||
Total
stockholders' deficit
|
(1,775,320
|
)
|
||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$
|
21,375
|
For
the
|
||||||||||||||||
Period
From
|
||||||||||||||||
February
1,
|
||||||||||||||||
2000
|
||||||||||||||||
(Inception)
|
||||||||||||||||
Through
|
||||||||||||||||
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
June
30,
|
||||||||||||||
2006
|
2007
|
2006
|
2007
|
2007
|
||||||||||||
Sales
|
$
|
19,800
|
$
|
-
|
$
|
19,800
|
$
|
-
|
$
|
20,200
|
||||||
Cost
of sales
|
3,406
|
-
|
3,406
|
-
|
3,472
|
|||||||||||
Gross
profit
|
16,394
|
-
|
16,394
|
-
|
16,728
|
|||||||||||
Costs
and expenses:
|
||||||||||||||||
General
and administrative
|
355,409
|
2,161
|
707,148
|
315,131
|
6,691,603
|
|||||||||||
Research
and development
|
29,702
|
(47,179
|
)
|
150,133
|
-
|
1,740,237
|
||||||||||
General
and administrative - stock based compensation
|
260,000
|
-
|
512,750
|
-
|
6,326,607
|
|||||||||||
Write-off
of advances to potential acquiree
|
-
|
-
|
-
|
-
|
629,000
|
|||||||||||
Finance
costs
|
-
|
-
|
-
|
-
|
786,000
|
|||||||||||
Interest
expense
|
-
|
18,123
|
-
|
34,135
|
354,119
|
|||||||||||
Amortization
of license agreement
|
-
|
-
|
-
|
-
|
155,210
|
|||||||||||
Amortization
of intangibles
|
-
|
-
|
-
|
-
|
656,732
|
|||||||||||
Losses
on settlements
|
-
|
-
|
-
|
-
|
1,261,284
|
|||||||||||
Write-down
of investment in subsidiary
|
-
|
-
|
-
|
-
|
620,805
|
|||||||||||
Equity
in loss of unconsolidated subsidiary
|
-
|
-
|
-
|
-
|
853,540
|
|||||||||||
Write-off
of investment in Portage BioMed
|
-
|
-
|
-
|
-
|
60,000
|
|||||||||||
Write-off
of investment in Xenacare
|
-
|
-
|
-
|
-
|
175,000
|
|||||||||||
Net
gain from deconsolidation of Receptopharm
|
- |
(1,081,095
|
)
|
- |
(1,081,095
|
)
|
(1,081,095
|
)
|
||||||||
Total
costs and expenses
|
645,111
|
(1,107,990
|
)
|
1,370,031
|
(731,829
|
)
|
19,229,042
|
|||||||||
Net
income (loss) before provision (benefit) for income taxes
|
(628,717
|
)
|
1,107,990
|
(1,353,637
|
)
|
731,829
|
(19,212,314
|
)
|
||||||||
Provision
(benefit) for income taxes
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Net
income (loss)
|
$
|
(628,717
|
)
|
$
|
1,107,990
|
$
|
(1,353,637
|
)
|
$
|
731,829
|
$
|
(19,212,314
|
)
|
|||
Per
share information - basic and diluted:
|
||||||||||||||||
(Loss)
per common share
|
$
|
(0.01
|
)
|
$
|
0.02
|
$
|
(0.02
|
)
|
$
|
0.01
|
||||||
Weighted
average common shares outstanding
|
71,327,182
|
73,500,462
|
71,563,571
|
73,391,179
|
For
the
|
||||||||||
Period
From
|
||||||||||
February
1,
|
||||||||||
2000
|
||||||||||
(Inception)
|
||||||||||
|
Through
|
|||||||||
Six
Months Ended June 30,
|
June
30,
|
|||||||||
2006
|
2007
|
2007
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
cash (used in) operating activities
|
$
|
(985,453
|
)
|
$
|
(479,650
|
)
|
$
|
(5,721,754
|
)
|
|
Cash
flows from investing activities:
|
||||||||||
Cash
reduction due to deconsolidation of Infectech
|
-
|
-
|
(2,997
|
)
|
||||||
Cash
acquired in acquisition of Infectech
|
-
|
-
|
3,004
|
|||||||
Acquisition
of property and equipment
|
-
|
-
|
(96,029
|
)
|
||||||
Investments
carried at cost
|
-
|
-
|
(235,000
|
)
|
||||||
Net
cash (used in) investing activities
|
-
|
-
|
(331,022
|
)
|
||||||
Cash
flows from financing activities:
|
||||||||||
Common
stock issued for cash
|
612,000
|
-
|
2,679,500
|
|||||||
Proceeds
from convertible loans
|
-
|
-
|
304,750
|
|||||||
Proceeds
from notes payable
|
-
|
-
|
100,000
|
|||||||
Loans
from stockholders, net of repayments
|
429,879
|
468,203
|
2,968,526
|
|||||||
Net
cash provided by financing activities
|
1,041,879
|
468,203
|
6,052,776
|
|||||||
Net
increase (decrease) in cash
|
56,426
|
(11,447
|
)
|
-
|
||||||
Cash
- beginning of period
|
69,027
|
11,447
|
-
|
|||||||
Cash
- end of period
|
$
|
125,453
|
$
|
-
|
$
|
-
|
Net losses included in the consolidated financial statements | $ |
4,056,095
|
||
Investment advances and equity method losses |
(2,975,000
|
) | ||
Gain on deconsolidation | $ |
1,081,095
|
Number
of shares |
Weighted
average exercise price |
Weighted
average fair value |
||||||||
Balance December 31, 2006 | 3,000,000 | $ | 0.25 | $ | 0.16 | |||||
Exercised | - | - | - | |||||||
Issued | - | - | - | |||||||
Forfeited | - | - | - | |||||||
Balance June 30, 2007 | 3,000,000 | $ | 0.25 | $ | 0.16 |
Exercise
Prices |
Weighted
Average Number Outstanding |
Weighted
Average Contractual Life |
Weighted
Average Exercise Price |
|||||||
$.20
|
1,000,000 | 3.8 years | $ | .20 | ||||||
$.27
|
2,000,000 | 1.0 years | $ | .27 | ||||||
3,000,000 |
Type
Expenditure
|
Total
Expenditure
|
Monthly
Expenditure
|
|||||
|
|
|
|||||
Salaries*
|
$
|
175,000
|
$
|
14,583
|
|||
|
|||||||
Travel
related expenses for our Chief Executive Officer
|
|
40,000
|
|
3,333
|
|||
pertaining
to research and due diligence
|
|||||||
|
|||||||
Professional
Fees -Legal and Accounting
|
|
165,000
|
|
13,750
|
|||
|
|||||||
Total
|
$
|
380,000
|
$
|
31,666
|
Type
Expenditure
|
Total
Expenditure
|
Monthly
Expenditure
|
|||||
|
|
|
|||||
Operating
Expenses
|
|
|
|||||
(Rent,
supplies, utilities)
|
$
|
50,000
|
$
|
4,167
|
|||
Salaries
(President)
|
|
70,000
|
|
5,833
|
|||
Total:
|
$
|
120,000
|
$
|
10,000
|
· |
On
January 24, 2006, we obtained NanoLogix’s intellectual property pertaining
to the manufacture of test kits for the rapid isolation, detection
and
antibiotic sensitivity testing of certain microbacteria, which includes
reassignment to us of 11 key patents protecting the diagnostics test
kit
technology and NanoLogix licensing to us, and the remaining 18 patents
that protect the diagnostics test kit
technology.
|
· |
In
February 2006, we completed the initial funding of ReceptoPharm in
the
amount of $2,000,000.
|
· |
In
January 2006, we established Designer Diagnostics to sell NonTuberculois
Mycobacterium test kits.
|
· |
Designer
Diagnostics held a Continuing Medical Education Seminar at the Mahatma
Gandhi Institute in India on March 24, 2006 during the World Stop
TB Day.
At that meeting, Designer Diagnostics officially began marketing
their
test kits for the rapid isolation, detection and antibiotic-sensitivity
testing of microbacteria. In March 2006, we made our first sales
of
Designer Diagnostics’ test
kits.
|
· |
In
May of 2006, ReceptoPharm received approval from the Medicines Health
and
Regulatory Agency (MHRA) for its application of human clinical trials
for
the treatment of Adrenomyeloneuropathy (AMN). The MHRA is the medical
regulatory agency within the British Department of
Health.
|
· |
From
March and April of 2006, ReceptoPharm published two clinical trials
on the
use of their technology for the treatment of
pain.
|
· |
In
June of 2006, ReceptoPharm published the results of their EAE rat
model
of MS, which showed that their drug, RPI-78M, had promising results
in an accepted animal model of the
disease.
|
· |
In
October of 2006, ReceptoPharm received Ethics Committee approval
in the
United Kingdom to begin its Phase IIb human clinical trial for the
treatment of AMN. This approval allows for the late Phase II/early
Phase
III (Iib/IIIa) trial to
begin.
|
· |
From
November 29, 2006 to December 2, 2006, ReceptoPharm presented their
analgesic research on RPI-78M at the International Conference on
Neurotoxins (ICoN) in Hollywood, Florida.
|
· |
In
January of 2007, we completed a series of microarray studies with
various
companies that ReceptoPharm has agreements with pertaining to
ReceptoPharm’s anti-viral drug. The microarray studies indicated that the
exposure of healthy immune T-cells to our antiviral drugs activates
the
primary immune mechanisms. The expression of one such immune trigger,
interferon gamma, is increased by as much as 20 times, acting as
an
effective antiviral agent, but without the significant negative clinical
side effects of other interferon-based therapies. This may explain
the
broad antiviral activity observed with these types of agents. Based
upon
this data, these products could conceivably be used to substitute
for the
flu shot in winter or protect against other contagious viral diseases
when
vaccines are not readily
available.
|
· |
In
January of 2007, Designer Diagnostics received positive results from
its
in-vitro analysis of its Tuberculosis (TB) test kit. Normal culturing
methods can take as long as 10 weeks to produce results, where Designer
Diagnostics test kits have shown similar results within 10
days.
|
· |
In
January of 2007, ReceptoPharm began its Phase IIb human clinical
trial for
the treatment of AMN.
|
· |
In
February of 2007, ReceptoPharm expanded their antiviral clinical
research
into Mexico and Peru where RPI-MN was used in early clinical studies.
ReceptoPharm seeks to conduct two Phase II antiviral trials during
the 2nd
and 3rd quarters of 2007, each with a primary duration of 3-4
months.
|
· |
In
March of 2007, Designer Diagnostics engaged the U.S. Commercial Service
to
help build international sales of its diagnostic test
kits.
|
· |
On
March 7, 2007, ReceptoPharm’s signed a letter of intent to create a Joint
Venture with Nanogene Biotechnology, a Chinese biotech company. The
proposed joint venture will develop the antiviral drug, RPI-MN, for
the Chinese market.
|
· |
In
March of 2007, ReceptoPharm published an article in the Critical
Reviews
in Immunology special conference issue. The article, entitled
“Alpha-Cobratoxin”, discussed Alpha-Cobratoxin as a possible therapy for
Multiple Sclerosis, reviews the literature leading to the development
for
this application, and discusses the background and reasoning behind
ReceptoPharm’s research on its treatment for Multiple Sclerosis
(MS).
|
· |
On
March 27, 2007, we completed our first licensing payment on behalf
of
Designer Diagnostics to NanoLogix for the patents protecting Designer
Diagnostics’ test kits.
|
· |
On
April 11, 2007, ReceptoPharm filed a patent for method of treating
autoimmune diseases, including MS and Rheumatoid
Arthritis.
|
· |
During
April 2007, ReceptoPharm completed its initial discussions with Zhong
Xin
Dong Tai Co., Ltd (“Nanogene Biotechnology”) to develop RPI-MN for the
China market. RPI-MN is ReceptoPharm’s drug candidate being researched for
the treatment of HIV/AIDS and other viral disorders. According to
a signed
Memorandum of Understand between ReceptoPharm and Nanogene Biotechnology.
ReceptoPharm will need to confirm safety and efficacy of RPI_MN by
completing pre-clinical studies at Soochow University located in
China.
Nanogene Biotechnology will provide the drug raw material and ReceptoPharm
will modify the products and provide the proper study protocols.
Upon
successful completion of the pre-clinical studies, ReceptoPharm and
Nanogene Biotechnology will proceed with clinical trials aimed at
gaining
full regulatory approval in China.
|
· |
On
May 2, 2007, Designer Diagnostics announced that it would conduct
clinical
trials for their Tuberculosis and NonTuberculois Mycobacterium diagnostic
test kits at the National Jewish Medical and Research Center in Denver,
Colorado. The purpose of the clinical trials are to validate the
efficacy
of the test kits for use with Tuberculosis and Non-Tubernulosis
Mycobacterium patients as well as for the with environmental testing.
The
clinical trials for Designer Diagnostics are the final step required
by
the FDA prior to applying for FDA regulatory approval of the test
kits.
|
· |
During
May 2007, Designer Diagnostics completed the an upgrade of its
Tuberculosis diagnostic test kits enabling such the test kits to
show more
rapid and reliable results.
|
· |
During
July 2007, ReceptoPharm successfully completed enrollment in its
phase llb
human clinical trial for the treatment of AMN.
|
· |
Hospitals;
|
· |
Pharmaceutical
companies;
|
· |
Biotechnology
companies;
|
· |
Medical
device distributors; and
|
· |
Governmental
organizations.
|
· |
Recruitment
of 20 patients with AMN;
|
· |
Administering
ReceptoPharm's AMN drug under development;
and
|
· |
Monitoring
patients throughout a 15-month
protocol.
|
· |
Sell
or dispose of our assets, if
any;
|
· |
Pay
our liabilities in order of priority, if we have available cash to
pay
such liabilities;
|
· |
If
any cash remains after we satisfy amounts due to our creditors, distribute
any remaining cash to our shareholders in an amount equal to the
net
market value of our net
assets;
|
· |
File
a Certificate of Dissolution with the State of California to dissolve
our
corporation and close our
business;
|
· |
Make
the appropriate filings with the Securities and Exchange Commission
so
that we will no longer be required to file periodic and other required
reports with the Securities and Exchange Commission, if, in fact,
we are a
reporting company at that time;
and
|
· |
Make
the appropriate filings with the National Association of Security
Dealers
to effect a delisting of our common stock, if, in fact, our common
stock
is trading on the Over-the-Counter Bulletin Board at that
time.
|
Exhibit
No.
|
|
Title
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
Dated:
August 17, 2007
|
|||
NUTRA
PHARMA CORP.
Registrant
|
|||
/s/ Rik J. Deitsch | |||
Rik J. Deitsch |
|||
Chief
Executive Officer and Chief Financial Officer
|