x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
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o
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
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California
|
91-2021600
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(State
or Other Jurisdiction of Organization)
|
(IRS
Employer Identification Number)
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Large
accelerated filer o
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller
reporting company x
|
PART
I. FINANCIAL INFORMATION
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4
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||
Item
1. Financial Statements
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4
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|
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||
Consolidated
Balance Sheets as of March 31, 2009 (Unaudited) and December 31,
2008
|
4
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|
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||
Consolidated
Statements of Operations for the three months ended March 31, 2008 and
2009 (Unaudited) and for the period from inception (February 1, 2000) to
March 31, 2009
|
5
|
|
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||
Consolidated
Statements of Cash Flows for the three months ended March 31, 2008 and
2009 (Unaudited) and for the period from inception (February 1, 2000) to
March 31, 2009
|
6
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|
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||
Notes
to Unaudited Consolidated Financial Statements
|
7
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|
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||
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
10
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|
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||
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
20
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||
Item
4T. Controls and Procedures
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20
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PART
II. OTHER INFORMATION
|
20
|
|
|
||
Item
1. Legal Proceedings
|
20
|
|
|
||
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
20
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|
Item
3. Defaults Upon Senior Securities
|
21
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|
Item
4. Submission of Matters to a Vote of Security Holders
|
21
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|
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||
Item
5. Other Information
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21
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|
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||
Item
6. Exhibits
|
21
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SIGNATURES
|
22
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December
31,
|
March 31,
|
|||||||
2008
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 50,910 | $ | 57,551 | ||||
Accounts
receivable
|
- | 13,667 | ||||||
Inventory
|
10,770 | 10,770 | ||||||
Prepaid
expenses
|
27,468 | 11,713 | ||||||
Total current
assets
|
89,148 | 93,701 | ||||||
Property and equipment,
net
|
9,941 | 8,550 | ||||||
Other
assets
|
8,133 | 8,133 | ||||||
TOTAL
ASSETS
|
$ | 107,222 | $ | 110,384 | ||||
LIABILITIES AND STOCKHOLDERS'
DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 156,399 | $ | 182,947 | ||||
Accrued
expenses
|
849,856 | 882,057 | ||||||
Due to
officers
|
1,557,301 | 1,767,327 | ||||||
Other loans
payable
|
100,000 | 100,300 | ||||||
Total current
liabilities
|
2,663,556 | 2,932,631 | ||||||
Stockholders'
deficit:
|
||||||||
Common stock, $0.001 par value,
2,000,000,000 shares authorized;
|
||||||||
211,276,482 shares issued and
outstanding
|
211,277 | 211,277 | ||||||
Additional paid-in
capital
|
21,503,591 | 21,558,591 | ||||||
(Deficit) accumulated during the
development stage
|
(24,271,202 | ) | (24,592,115 | ) | ||||
Total stockholders'
deficit
|
(2,556,334 | ) | (2,822,247 | ) | ||||
TOTAL LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
$ | 107,222 | $ | 110,384 |
Three
Months Ended March 31,
|
For
the
Period From February 1, 2000(Inception) Through |
|||||||||||
2008
|
2009
|
March
31, 2009
|
||||||||||
Sales
|
$ | - | $ | 18,230 | $ | 42,475 | ||||||
Cost of
sales
|
- | 260 | 4,789 | |||||||||
Gross
profit
|
- | 17,970 | 37,686 | |||||||||
Costs and
expenses:
|
||||||||||||
General and
administrative
|
177,284 | 277,342 | 8,430,527 | |||||||||
Research and
development
|
- | 25,220 | 1,765,457 | |||||||||
General and administrative - stock
based compensation
|
425,000 | 20,000 | 7,449,657 | |||||||||
Write-off of advances to potential
acquiree
|
- | - | 629,000 | |||||||||
Finance
costs
|
- | - | 786,000 | |||||||||
Interest
expense
|
15,689 | 16,321 | 469,935 | |||||||||
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
|
617,973 | 338,883 | 24,629,801 | |||||||||
Net loss
|
$ | (617,973 | ) | $ | (320,913 | ) | $ | (24,592,115 | ) | |||
Per share information - basic and
diluted:
|
||||||||||||
Loss per common
share
|
$ | (0.01 | ) | $ | (0.00 | ) | ||||||
Weighted average common shares
outstanding
|
87,318,319 | 211,276,482 |
Three months ended March
31,
|
For the
Period From February 1, 2000(Inception) Years Ended Through |
|||||||||||
2008
|
2009
|
March 31,
2009
|
||||||||||
Net cash (used in) operating
activities
|
$ | (186,328 | ) | $ | (277,359 | ) | $ | (6,941,565 | ) | |||
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 | |||||||||
Acquisition of property and
equipment
|
- | - | (96,029 | ) | ||||||||
Loan to
Receptopharm
|
(250,000 | ) | - | (300,000 | ) | |||||||
Investments carried at
cost
|
- | - | (235,000 | ) | ||||||||
Net cash (used in) investing
activities
|
(250,000 | ) | (592,332 | ) | ||||||||
Cash flows from financing
activities:
|
||||||||||||
Common stock issued for
cash
|
373,500 | 35,000 | 3,643,000 | |||||||||
Proceeds from convertible
loans
|
- | - | 304,750 | |||||||||
Proceeds from notes
payable
|
- | - | 100,000 | |||||||||
Repayment of stockholder
loans
|
- | - | (108,750 | ) | ||||||||
Loans from
stockholders
|
55,000 | 249,000 | 3,652,448 | |||||||||
Net cash provided by financing
activities
|
428,500 | 284,000 | 7,591,448 | |||||||||
Net increase (decrease) in
cash
|
(7,828 | ) | 6,641 | 57,551 | ||||||||
Cash - beginning of
period
|
122,810 | 50,910 | - | |||||||||
Cash - end of
period
|
$ | 114,982 | $ | 57,551 | $ | 57,551 | ||||||
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
stockholder
|
$ | - | $ | - | $ | 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
March 31, 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
|
4.60
years
|
$ |
.10
|
||||||||
$0.20
|
1,000,000
|
1.75
years
|
.20
|
|||||||||
$0.27
|
2,000,000
|
2.00
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 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.
|
|
Whether
we successfully develop and commercialize the 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.
|
•
|
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.
|
•
|
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.
|
•
|
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.
|
•
|
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.
|
|
Hospitals;
|
|
Pharmaceutical
companies;
|
|
Biotechnology
companies;
|
|
|
|
|
|
|
|
|
|
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:
May 20, 2009
|
||||
NUTRA
PHARMA CORP.
|
||||
Registrant
|
||||
/s/
Rik J. Deitsch
|
||||
Rik
J. Deitsch
|
|
|||
Chief
Executive Officer/Principal Financial Officer
|
|