x
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QUARTERLY REPORT UNDER SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
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¨
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TRANSITION REPORT UNDER SECTION
13 OR 15(d) OF THE EXCHANGE
ACT
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California
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91-2021600
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(State
or Other Jurisdiction of Organization)
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(IRS
Employer Identification
Number)
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Large
accelerated filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer ¨
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Smaller
reporting company x
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PART
I. FINANCIAL INFORMATION
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Item
1. Financial Statements
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1
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|
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Consolidated
Balance Sheets as of June 30, 2009 (Unaudited) and December 31,
2008
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1
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|
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Consolidated
Statements of Operations for the three and six months ended June 30, 2008
and 2009 (Unaudited) and for the period from inception (February 1, 2000)
to June 30, 2009
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2
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|
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Consolidated
Statements of Cash Flows for the six months ended June 30, 2008 and 2009
(Unaudited) and for the period from inception (February 1, 2000) to June
30, 2009
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3
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|
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Notes
to Unaudited Consolidated Financial Statements
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4
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|
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Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
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7
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|
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Item
3. Quantitative and Qualitative Disclosures about Market
Risk
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16
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Item
4T. Controls and Procedures
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16
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PART
II. OTHER INFORMATION
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|
|
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Item
1. Legal Proceedings
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16
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|
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Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
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17
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Item
3. Defaults Upon Senior Securities
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17
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Item
4. Submission of Matters to a Vote of Security Holders
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17
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Item
5. Other Information
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17
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Item
6. Exhibits
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18
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SIGNATURES
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18
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December
31,
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June
30,
|
|||||||
2008
|
2009
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|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 50,910 | $ | - | ||||
Inventory
|
10,770 | 10,770 | ||||||
Prepaid
expenses
|
27,468 | 10,149 | ||||||
Total
current assets
|
89,148 | 20,919 | ||||||
Property
and equipment, net
|
9,941 | 9,164 | ||||||
Other
assets
|
8,133 | 8,803 | ||||||
TOTAL
ASSETS
|
$ | 107,222 | $ | 38,886 | ||||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 156,399 | $ | 240,029 | ||||
Accrued
expenses
|
849,856 | 946,857 | ||||||
Due
to officers
|
1,557,301 | 1,851,432 | ||||||
Other
loans payable
|
100,000 | 140,000 | ||||||
Total
current liabilities
|
2,663,556 | 3,178,318 | ||||||
Stockholders'
deficit:
|
||||||||
Common
stock, $0.001 par value, 2,000,000,000 shares authorized;
|
||||||||
211,276,482
and 220,176,482 shares issued and outstanding,
respectively
|
211,277 | 220,177 | ||||||
Additional
paid-in capital
|
21,503,591 | 21,744,691 | ||||||
(Deficit)
accumulated during the development stage
|
(24,271,202 | ) | (25,104,300 | ) | ||||
Total
stockholders' deficit
|
(2,556,334 | ) | (3,139,432 | ) | ||||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$ | 107,222 | $ | 38,886 |
For
the
|
||||||||||||||||||||
Period
From
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||||||||||||||||||||
February
1,
|
||||||||||||||||||||
2000
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||||||||||||||||||||
(Inception)
|
||||||||||||||||||||
Three
Months Ended June 30,
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Six
Months Ended June 30,
|
Through
June
30,
|
||||||||||||||||||
2008
|
2009
|
2008
|
2009
|
2009
|
||||||||||||||||
Sales
|
$ | - | $ | 8,398 | $ | - | $ | 26,628 | $ | 50,873 | ||||||||||
Cost
of sales
|
- | 3,000 | - | 3,260 | 7,789 | |||||||||||||||
Gross
profit
|
- | 5,398 | - | 23,368 | 43,084 | |||||||||||||||
Costs
and expenses:
|
||||||||||||||||||||
General
and administrative
|
342,233 | 294,463 | 519,517 | 571,805 | 8,724,990 | |||||||||||||||
Research
and development
|
- | 10,155 | - | 35,375 | 1,775,612 | |||||||||||||||
General
and administrative - stock based compensation
|
- | 195,000 | 425,000 | 215,000 | 7,644,657 | |||||||||||||||
Write-off
of advances to potential acquiree
|
- | - | - | - | 629,000 | |||||||||||||||
Finance
costs
|
- | - | - | - | 786,000 | |||||||||||||||
Interest
expense
|
14,302 | 17,965 | 29,991 | 34,286 | 487,900 | |||||||||||||||
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 | ) | ||||||||||||||
Write-off
of goodwill
|
- | - | - | - | 2,397,749 | |||||||||||||||
Total
costs and expenses
|
356,535 | 517,583 | 974,508 | 856,466 | 25,147,384 | |||||||||||||||
Net
loss
|
$ | (356,535 | ) | $ | (512,185 | ) | $ | (974,508 | ) | $ | (833,098 | ) | $ | (25,104,300 | ) | |||||
Per
share information - basic and diluted:
|
||||||||||||||||||||
Loss
per common share
|
$ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.00 | ) | ||||||||
Weighted
average common shares outstanding
|
184,221,396 | 215,518,240 | 135,769,858 | 213,409,079 |
For
the
|
||||||||||||
Period
From
|
||||||||||||
February
1,
|
||||||||||||
2000
|
||||||||||||
(Inception)
|
||||||||||||
Six
months ended June 30,
|
Through
June
30,
|
|||||||||||
2008
|
2009
|
2009
|
||||||||||
Net
cash (used in) operating activities
|
$ | (490,843 | ) | $ | (445,440 | ) | $ | (7,109,646 | ) | |||
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
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- | - | 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 | 35,000 | 3,643,000 | |||||||||
Proceeds
from convertible loans
|
- | - | 304,750 | |||||||||
Proceeds
from notes payable
|
- | 40,000 | 140,000 | |||||||||
Repayment
of stockholder loans
|
- | - | (108,750 | ) | ||||||||
Loans
from stockholders
|
210,000 | 319,530 | 3,722,978 | |||||||||
Net
cash provided by financing activities
|
671,000 | 394,530 | 7,701,978 | |||||||||
Net
(decrease) in cash
|
(79,399 | ) | (50,910 | ) | - | |||||||
Cash
- beginning of period
|
122,810 | 50,910 | - | |||||||||
Cash
- end of period
|
$ | 43,411 | $ | - | $ | - | ||||||
Supplemental
Cash Flow Information:
|
||||||||||||
Cash
paid for interest
|
$ | - | $ | - | $ | - | ||||||
Cash
paid for income taxes
|
$ | - | $ | - | $ | - | ||||||
Non-cash
investing and financing activities:
|
||||||||||||
Assumption
of obligation under license agreement
|
$ | - | $ | - | $ | 1,750,000 | ||||||
Value
of shares issued as consideration in acquisition of Nutra Pharma,
Inc.
|
$ | - | $ | - | $ | 112,500 | ||||||
Payments
of license fee obligation by stockholder
|
$ | - | $ | - | $ | 208,550 | ||||||
Conversion
of stockholder loan to common stock
|
$ | - | $ | - | $ | 862,012 | ||||||
Loan
advances to Bio Therapeutics, Inc. by stockholder
|
$ | - | $ | - | $ | 629,000 | ||||||
Value
of common stock issued as consideration in
acquisition of Infectech, Inc.
|
$ | - | $ | - | $ | 4,486,375 | ||||||
Liabilities
assumed in acquisition of Infectech, Inc.
|
$ | 115,586 | ||||||||||
Cancellation
of common stock
|
$ | - | $ | - | $ | 14,806 | ||||||
Value
of common stock issued by stockholder to third party in connection
with settlement
|
$ | - | $ | - | $ | 229,500 | ||||||
Value
of common stock issued by stockholder to employee for services
rendered
|
$ | - | $ | - | $ | 75,000 | ||||||
Net
deferred taxes recorded in connection with
acquisition
|
$ | - | $ | - | $ | 967,586 | ||||||
Notes
payable settled with common stock
|
$ | - | $ | - | $ | 98,000 | ||||||
Settlement
of stockholder loan in exchange for common stock of
subsidiary
|
$ | - | $ | - | $ | 1,384,931 | ||||||
Settment
of debt with common stock
|
$ | 1,200,000 | $ | - | $ | 1,406,750 | ||||||
Expenses
paid by stockhoder
|
$ | - | $ | - | $ | 119,140 | ||||||
Value
of common stock issued for the acquisition of
Receptopharm
|
$ | - | $ | - | $ | 1,050,000 |
|
Number
of
shares
|
Weighted
average
exercise
price
|
Weighted
average
fair
value
|
|||||||||
Balance
December 31, 2008
|
21,440,000
|
$
|
0.12
|
$
|
0.00
|
|||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Issued
|
1,400,000
|
0.10
|
0.00
|
|||||||||
Forfeited
|
-
|
-
|
-
|
|||||||||
Balance
June 30, 2009
|
22,840,000
|
$
|
0.12
|
$
|
0.00
|
Exercise
Price
|
Weighted
Average
Number
Outstanding
|
Weighted
Average
Contractual
Life
|
Weighted
Average
Exercise
Price
|
||||||
$0.10
|
19,840,000
|
4.35
years
|
$
|
.10
|
|||||
$0.20
|
1,000,000
|
1.50
years
|
.20
|
||||||
$0.27
|
2,000,000
|
1.75
years
|
$
|
.27
|
|||||
22,840,000
|
|
·
|
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 Financial Industry Regulatory Authority (FINRA) 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.
|
|
·
|
Whether we successfully develop
and commercialize products from our research and development
activities.
|
|
·
|
If we fail to compete effectively
in the intensely competitive biotechnology area, our operations and market
position will be negatively
impacted.
|
|
·
|
If we fail to successfully
execute our planned partnering and out-licensing of products or
technologies, our future performance will be adversely
affected.
|
|
·
|
The recent economic downturn and
related credit and financial market crisis may adversely affect our
ability to obtain financing, conduct our operations and realize
opportunities to successfully bring our technologies to
market.
|
|
·
|
Biotechnology industry related
litigation is substantial and may continue to rise, leading to
greater costs and possible unpredictable
litigation.
|
|
·
|
If we fail to comply with
extensive legal/regulatory requirements affecting the healthcare industry,
we will face increased costs, and possibly penalties and business
losses.
|
·
|
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
|
•
|
In approximately October 2005, we
completed pre-clinical studies with various companies that ReceptoPharm
has agreements with pertaining to ReceptoPharm’s Multiple Sclerosis (MS)
and HIV drugs, which consist of (a) and (b)
below:
|
•
|
MS Drug under Development
(RPI-78M) - ReceptoPharm conducted microarray and histoculture studies and
related analysis of the cells of Multiple Sclerosis patients to ascertain
how RPI-78M affected the cells of these patients. Microarray analysis is
the study of the gene expression of cells. Histoculture is the study of
the entire cellular environment. We measured the effect of RPI-78M on gene
expression using cDNA microarray technology to identify any potentially
unique changes in gene expression that may be caused by RPI-78M. After
statistical evaluation of the data, the researchers found more than sixty
genes with significant changes in expression as compared to the control.
In analyzing the affected genes, at least thirty of them may have a
specific role in the progression of the disease and symptoms of MS;
and
|
•
|
HIV Drug under Development
(RPI-MN) - Viral isolates are common mutations of HIV. ReceptoPharm,
through an agreement with the University of California, San Diego,
conducted research to study the effect of ReceptoPharm’s drug under
development on different viral isolates to determine the drug’s efficacy
in mutated forms of the HIV virus. The ability of the HIV virus to
establish resistance to therapeutic drugs through genetic mutation is a
major concern in the treatment of HIV/AIDS. HIV does not always make
perfect copies of itself. With billions of viruses being made every day,
lots of small, random differences can occur. The differences are called
mutations and these mutations can prevent drugs from working effectively.
When a drug no longer works against HIV, this is called drug resistance
and the virus with the mutation is considered to be ‘resistant’ to the
drug. With the increasing number of drug-resistant patients, it is of
great importance in the development of new HIV/AIDS therapeutics that they
will be effective against HIV of known resistance characteristics. The
inhibition of multi-resistant HIV-1 strains by RPI-MN preparations was
investigated at the La Jolla Institute of Molecular Medicine. The results
from these trials indicate that the drug is effective against
drug-resistant strains of
HIV.
|
•
|
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 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 are 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.
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•
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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.
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•
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During July 2007, ReceptoPharm
successfully completed enrollment in its phase llb human clinical trial
for the treatment of AMN.
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•
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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.
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•
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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.
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•
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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.
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•
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In December 2007, ReceptoPharm
successfully completed its six-month patient crossover in the Phase
IIb/IIIa clinical trial for the treatment of Adrenomyeloneuropathy
(AMN).
|
•
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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).
|
•
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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.
|
•
|
During July 2008, ReceptoPharm
successfully completed the Phase IIb/IIIIa clinical trial or its drug
candidate for neurological and autoimmune disorders, RPI-78M as a
treatment for AMN.
|
•
|
During August 2008, ReceptoPharm
renewed its collaborative agreement with the Centers for Disease Control
and Prevention to study RPI-78M and RPI-MN for a possible therapy for
Rabies.
|
•
|
During August 2008, ReceptoPharm
reported initial positive safety data from its Phase IIb/IIIIa clinical
study of RPI-78M for treating
AMN.
|
•
|
During November 2008, we
announced that ReceptoPharm will provide RPI-78M under compassionate
release to patients previously enrolled in the Phase IIb/IIIa clinical
study of AMN.
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•
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During December 2008, we
announced that ReceptoPharm has received an agreement from an Ireland
based biotechnology firm, Celtic Biotech, Ltd, to provide GMP certified
drug production of CB-24 for Celtic Biotech’s upcoming European trial for
the treatment of cancer
|
•
|
In February 2009, ReceptoPharm
filed a patent application with the United States Patent and Trademark
Office for the use of RPI-78 as a novel method for treating arthritis in
humans.
|
•
|
In February 2009, ReceptoPharm,
in collaboration with Soochow University in China published positive data
from its recent animal studies on the use of RPI-78 (Cobratoxin) as a
method for treating
arthritis.
|
•
|
In March 2009, ReceptoPharm’s
clean room manufacturing and laboratory facility achieved ISO class 5
certification from Biotec, a UK-based firm specializing in European
clinical drug import and
distribution.
|
•
|
During the quarter ending March
31, 2009, we began generating revenue from ReceptoPharm’s clinical
research services.
|
•
|
A
ReceptoPharm study published in Toxicon, which is the journal of the
International Society of Toxinology, showed that ReceptoPharm’s leading
drug treatment for the treatment of pain, RPI-78, had pain reducing
effects that lasted four times as long as morphine without the negative
side effects associated with opioid-based pain
relievers.
|
•
|
In August 2009, ReceptoPharm
filed a patent application with the United States Patent and Trademark
Office for a new method of oral formulation of cobra venom aimed at
treating pain.
|
·
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Hospitals;
|
·
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Pharmaceutical
companies;
|
·
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Biotechnology
companies;
|
·
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Medical device
distributors;
|
·
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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.
|
|
·
|
We are not and were not a blank
check company at the time of the offer or
sale;
|
|
·
|
The investors had business
experience and were accredited investors as defined by Rule 501 of
Regulation D of the Act;
|
|
·
|
All offers and sales of the
investment were made privately and no party engaged in any general
solicitation or advertising of the proposed
investment;
|
|
·
|
Each investor had a preexisting
social, personal or business relationship with us and members of our
management;
|
|
·
|
The investors were provided with
all information sufficient to allow them to make an informed investment
decision;
|
|
·
|
The investors had the opportunity
to inspect our books and records and to verify statements made to induce
them to invest;
|
|
·
|
The securities representing the
investment were issued with a restrictive legend indicating the securities
represented by the certificate have not been registered;
and
|
|
·
|
No party received any
transaction-based compensation such as commissions in regard to locating
any investor for the venture
|
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, 2009
|
NUTRA
PHARMA CORP.
|
Registrant
|
/s/ Rik J. Deitsch
|
Rik
J. Deitsch
|
Chief
Executive Officer/Principal
Financial
Officer
|