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)
|
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
PART
I. FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1. Financial Statements
|
3
|
|
|
|
|
|
Consolidated
Balance Sheets as of June 30, 2008 (Unaudited) and December 31,
2007
|
3
|
|
|
|
|
Consolidated
Statements of Operations for the three months ended June 30, 2008
and 2007
(Unaudited)
|
4
|
|
|
|
|
Consolidated
Statements of Cash Flows for the three months ended June 30, 2008
and 2007
(Unaudited)
|
5
|
|
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6
|
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
10
|
|
|
|
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
17
|
|
|
|
|
Item
4T. Controls and Procedures
|
17
|
|
|
||
PART
II. OTHER INFORMATION
|
||
|
|
|
Item
1. Legal Proceedings
|
18
|
|
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
18
|
|
|
|
|
Item
5. Other Information
|
18
|
|
|
|
|
Item
6. Exhibits
|
20
|
|
|
|
|
SIGNATURES
|
20
|
June
30,
2008
|
December
31,
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
|
$
|
43,411
|
$
|
122,810
|
|||
Inventory
|
11,425
|
11,425
|
|||||
Prepaid
expenses
|
25,514
|
-
|
|||||
Total
current assets
|
80,350
|
134,235
|
|||||
Property
and equipment, net
|
14,455
|
-
|
|||||
Goodwill
|
2,397,749
|
-
|
|||||
Other
assets
|
8,133
|
9,950
|
|||||
TOTAL
ASSETS
|
$
|
2,500,687
|
$
|
144,185
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
130,053
|
$
|
22,496
|
|||
Accrued
expenses
|
737,289
|
30,000
|
|||||
Due
to officers
|
1,324,279
|
1,944,414
|
|||||
Other
loans payable
|
100,300
|
100,000
|
|||||
Total
current liabilities
|
2,291,921
|
2,096,910
|
|||||
Stockholders'
equity (deficit):
|
|||||||
Common
stock, $0.001 par value, 2.0 billion shares authorized 186,135,682
and
81,895,682 shares issued and outstanding, respectively
|
186,136
|
81,896
|
|||||
Additional
paid-in capital
|
21,106,232
|
18,074,473
|
|||||
(Deficit)
accumulated during the development stage
|
(21,083,602
|
)
|
(20,109,094
|
)
|
|||
Total
stockholders' equity (deficit)
|
208,766
|
(1,952,725
|
)
|
||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
$
|
2,500,687
|
$
|
144,185
|
For
the
|
||||||||||||||||
Period
From
|
||||||||||||||||
February
1,
|
||||||||||||||||
2000
|
||||||||||||||||
(Inception)
|
||||||||||||||||
Three Months Ended June 30,
|
Six Months Ended June 30,
|
Through
June
30,
|
||||||||||||||
2007
|
2008
|
2007
|
2008
|
2008
|
||||||||||||
Sales
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
20,200
|
||||||
Cost
of sales
|
-
|
-
|
-
|
-
|
3,472
|
|||||||||||
Gross
profit
|
-
|
-
|
-
|
-
|
16,728
|
|||||||||||
Costs
and expenses:
|
||||||||||||||||
General
and administrative
|
2,161
|
342,233
|
315,131
|
519,517
|
7,462,910
|
|||||||||||
Research
and development
|
(47,179
|
)
|
-
|
-
|
-
|
1,740,237
|
||||||||||
General
and administrative - stock based compensation
|
-
|
-
|
-
|
425,000
|
7,354,657
|
|||||||||||
Write-off
of advances to potential acquiree
|
-
|
-
|
-
|
-
|
629,000
|
|||||||||||
Finance
costs
|
-
|
-
|
-
|
-
|
786,000
|
|||||||||||
Interest
expense
|
18,123
|
14,302
|
34,135
|
29,991
|
426,050
|
|||||||||||
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
|
(1,107,990
|
)
|
356,535
|
(731,829
|
)
|
974,508
|
21,100,330
|
|||||||||
Net
income (loss)
|
$
|
1,107,990
|
$
|
(356,535
|
)
|
$
|
731,829
|
$
|
(974,508
|
)
|
$
|
(21,083,602
|
)
|
|||
Net
income (loss) per common share - basic
|
$
|
0.02
|
$
|
(0.00
|
)
|
$
|
0.01
|
$
|
(0.01
|
)
|
||||||
Net
income (loss) per common share - diluted
|
$
|
0.02
|
$
|
(0.00
|
)
|
$
|
0.01
|
$
|
(0.01
|
)
|
||||||
Weighted
average common shares outstanding - basic
|
73,500,462
|
184,221,396
|
73,391,179
|
135,769,858
|
||||||||||||
Weighted
average common shares outstanding - diluted
|
73,500,462
|
184,221,396
|
73,391,179
|
135,769,858
|
For
the
|
||||||||||
Period
From
|
||||||||||
February
1,
|
||||||||||
2000
|
||||||||||
(Inception)
|
||||||||||
Years
Ended
|
||||||||||
Six
Months Ended June 30,
|
Through
June
30,
|
|||||||||
2007
|
2008
|
2008
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
cash (used in) operating activities
|
$
|
(479,650
|
)
|
$
|
(490,843
|
)
|
$
|
(6,178,955
|
)
|
|
Cash
flows from investing activities:
|
||||||||||
Cash
reduction due to deconsolidation of Infectech
|
-
|
-
|
(2,997
|
)
|
||||||
Cash
reduction due to deconsolidation of Receptopharm
|
-
|
-
|
(1,754
|
)
|
||||||
Cash
acquired in acquisition of Infectech
|
-
|
-
|
3,004
|
|||||||
Cash
acquired in acquisition of Receptopharm
|
40,444
|
40,444
|
||||||||
Acquisition
of property and equipment
|
-
|
-
|
(96,029
|
)
|
||||||
Loan
to Receptopharm
|
-
|
(300,000
|
)
|
(300,000
|
)
|
|||||
Investments
carried at cost
|
-
|
-
|
(235,000
|
)
|
||||||
Net
cash (used in) investing activities
|
-
|
(259,556
|
)
|
(592,332
|
)
|
|||||
Cash
flows from financing activities:
|
||||||||||
Common
stock issued for cash
|
-
|
461,000
|
3,260,500
|
|||||||
Proceeds
from convertible loans
|
-
|
-
|
304,750
|
|||||||
Proceeds
from notes payable
|
-
|
-
|
100,000
|
|||||||
Loans
from stockholders, net of repayments
|
468,203
|
210,000
|
3,149,448
|
|||||||
Net
cash provided by financing activities
|
468,203
|
671,000
|
6,814,698
|
|||||||
Net
increase (decrease) in cash
|
(11,447
|
)
|
(79,399
|
)
|
43,411
|
|||||
Cash
- beginning of period
|
11,447
|
122,810
|
-
|
|||||||
Cash
- end of period
|
$
|
-
|
$
|
43,411
|
$
|
43,411
|
Total
number of Nutra Pharma shares issued
|
30,000,000
|
|||
Market
price of Nutra Pharma common stock on April 10, 2008
|
$
|
0.035
|
||
Value
of shares issued
|
$
|
1,050,000
|
||
Loan
to Receptopharm forgiven at closing
|
300,000
|
|||
Liabilities
of Receptopharm assumed at closing
|
1,119,413
|
|||
Total
purchase cost to be allocated
|
$
|
2,469,413
|
||
Allocation
of purchase cost:
|
||||
Fair
value of Receptopharm assets at closing
|
$
|
71,664
|
||
Purchase
cost in excess of fair value of assets acquired
|
2,397,749
|
|||
Total
purchase cost
|
$
|
2,469,413
|
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, 2007
|
3,000,000
|
$
|
0.25
|
$
|
0.16
|
|||||
Exercised
|
-
|
-
|
-
|
|||||||
Issued
|
-
|
-
|
-
|
|||||||
Forfeited
|
-
|
-
|
-
|
|||||||
|
||||||||||
Balance
June 30, 2008
|
3,000,000
|
$
|
0.25
|
$
|
0.16
|
Exercise
Price
|
Weighted
Average
Number
Outstanding
|
Weighted
Average
Contractual
Life
|
Weighted
Average
Exercise
Price
|
|||||||
|
|
|
|
|||||||
$.20
|
1,000,000
|
2.8
years
|
$
|
.20
|
||||||
$.27
|
2,000,000
|
3.0
years
|
$
|
.27
|
||||||
|
3,000,000
|
·
|
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.
|
·
|
an
obligation under a guarantee contract;
|
|
|
·
|
a
retained or contingent interest in assets transferred to the
unconsolidated entity or similar arrangement that serves as credit,
liquidity or market risk support to such entity for such
assets;
|
|
|
·
|
any
obligation, including a contingent obligation, under a contract that
would
be accounted for as a derivative instrument,
or;
|
·
|
any
obligation, including a contingent obligation, arising out of a variable
interest in an unconsolidated entity that is held by us and material
to us
where such entity provides financing, liquidity, market risk or credit
risk support to, or engages in leasing, hedging or research and
development services with us.”
|
Type
of Expenditure
|
Total
Expenditure
|
Monthly
Expenditure
|
|||||
|
|
|
|||||
Salaries*
|
$
|
175,000
|
$
|
14,583
|
|||
|
|||||||
Travel
related expenses for our Chief Executive Officer pertaining
to research and due diligence
|
40,000
|
3,333
|
|||||
|
|||||||
Professional
Fees -Legal and Accounting
|
165,000
|
13,750
|
|||||
|
|||||||
Total
|
$
|
380,000
|
$
|
31,666
|
Type
of Expenditure
|
Total
Expenditure
|
Monthly
Expenditure
|
|||||
|
|
|
|||||
Salaries
|
$
|
350,000
|
$
|
29,167
|
|||
|
|||||||
Clinical
Trial expenses
|
1,045,000
|
87,083
|
|||||
R
& D Expenses
|
394,000
|
32,833
|
|||||
Cost
of raw materials and production
|
236,000
|
19,667
|
|||||
|
|||||||
Operating
Expenses (Rent, Supplies, Utilities, etc..)
|
50,000
|
4,167
|
|||||
|
|||||||
Total
|
$
|
2,075,000
|
$
|
172,917
|
Type
of 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 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 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 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 Nan gene 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 is to validate the efficacy
of the test kits for use with Tuberculosis and Non-Tubernulosis
Mycobacterium patients as well as for 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. The
studies are ongoing with plans to complete testing throughout 2008.
|
|
·
|
During
May 2007, Designer Diagnostics completed the 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.
|
|
·
|
In
August of 2007, ReceptoPharm successful results on the use of their
technology for the treatment of pain. The latest data demonstrated
that
RPI-78 was as effective as morphine at blocking pain signals in that
part
of the brain that signals the presence of pain. It was also confirmed
that
the drug did not use an opioid mechanism. Moreover, the duration
of
RPI-78’s effect was superior to
morphine’s.
|
|
·
|
In
November 2007, the Designer Diagnostics test kit technology was showcased
at the 38th Union World Conference on Lung Health in South Africa.
The
test kits were used to isolate NTM from clinical samples of 300 AIDS
patients and for the first time ever on the Indian subcontinent,
M.
Wolinskyi was successfully isolated in clinical samples. In addition,
these test kits were also used for the first time to isolate NTM
from soil
and water samples collected from the environment of patients with
NTM
disease.
|
|
·
|
In
November 2007, Designer Diagnostics was featured in an article published
in the International Journal of TB and Lung Diseases. The article,
which
was authored by leading NonTuberculous Mycobacterium (NTM) research
scientist, Dr. Rahul Narang, covered Designer Diagnostics’ paraffin
culture technology to isolate NTM.
|
|
·
|
In
December 2007, ReceptoPharm successfully completed its six-month
patient
crossover in the Phase IIb/IIIa clinical trial for the treatment
of
Adrenomyeloneuropathy (AMN).
|
|
·
|
On
December 27, 2007 the Company expanded its licensing agreement with
NanoLogix, Inc., to include intellectual property for the use of
testing
the environment for NonTuberculous Mycobacterium
(NTM).
|
|
·
|
In
February 2008, Designer Diagnostics started marketing the first-ever
environmental test kit for the detection of Nontuberculous Mycobacteria
(NTM) in water and soil.
|
·
|
On
April 10, 2008, we completed the acquisition of ReceptoPharm through
our
purchase of their remaining 61.9% interest. ReceptoPharm is now our
wholly
owned subsidiary and will act as our Drug Discovery division.
|
|
·
|
On
May 19, 2008, we announced today that ReceptoPharm, Inc. had received
approval from the Florida Department of Agriculture and Consumer
Services
to conduct trials of its leading antiviral drug candidate, RPI-MN,
as a
treatment for Feline Leukemia Virus (FeLV).
|
|
·
|
On
July 19, 2008, we announced the successful completion of ReceptoPharm’s
Phase IIb/IIIa clinical trial of its leading drug candidate for
neurological and autoimmune disorders, RPI-78M, as a treatment for
Adrenomyeloneuropathy (AMN).
|
|
·
|
On
August 6, 2008, we announced that ReceptoPharm had renewed its
collaborative agreement with the Centers for Disease Control and
Prevention (CDC) to study RPI-78M and RPI-MN as a possible therapy
for
Rabies.
|
|
·
|
On
August 14, 2008, we announced initial positive safety data from
ReceptoPharm’s Phase IIb/IIIa clinical study of RPI-78M for treating
Adrenomyeloneuropathy (AMN).
|
·
|
Hospitals;
|
·
|
Pharmaceutical
companies;
|
·
|
Biotechnology
companies;
|
·
|
Medical
device distributors;
|
·
|
Governmental
organizations;
|
|
|
·
|
Environmental
testing facilities; and
|
|
|
·
|
Government
water and soil testing facilities at the local, state and federal
levels.
|
·
|
Recruitment
of 20 patients with AMN;
|
·
|
Administering
ReceptoPharm’s AMN drug under development;
and
|
·
|
Monitoring
patients throughout a 15-month
protocol.
|
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 19, 2008
|
|
|
|
|
|
|
|
NUTRA
PHARMA CORP.
|
|
|
|
Registrant
|
|
|
|
|
|
|
|
/s/ Rik
J. Deitsch
|
|
|
|
Rik
J. Deitsch
|
|
|
|
Chief
Executive Officer/Principal Financial Officer
Chief
Financial Officer/Principal Financial Officer
|
|
|
|