California
|
91-2021600
|
(State
or Other Jurisdiction of
Organization)
|
(IRS
Employer Identification Number)
|
Part
I
|
|
|
Item
1.
|
Description
of Business
|
1
|
Item
2.
|
Description
of Property
|
18
|
Item
3.
|
Legal
Proceedings
|
19
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
19
|
|
|
|
Part
II
|
|
|
Item
5.
|
Market
for Common Equity and Related Stockholder Matters
|
19
|
Item
6.
|
Management's
Discussion and Analysis or Plan of Operation
|
22
|
Item
7.
|
Financial
Statements
|
31
|
Item
8.
|
Changes
in and Disagreements with Accountants and Financial Disclosure
|
31
|
Item
8A.
|
Controls
and Procedures
|
31
|
Item
8B.
|
Other
Information
|
31
|
|
|
|
Part
III
|
|
|
Item
9.
|
Directors,
Executive Officers, Promoters and Control Persons; Compliance with
Section
16(a) of the Exchange Act
|
31
|
Item
10.
|
Executive
Compensation
|
35
|
Item
11.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
36
|
Item
12.
|
Certain
Relationships and Related Transactions
|
36
|
Item
13.
|
Exhibits
|
37
|
Item
14.
|
Principal
Accountant Fees and Services
|
38
|
Signatures
|
38
|
·
|
Multiple
Sclerosis (MS);
|
·
|
HIV/AIDS;
|
·
|
Chronic
pain;
|
·
|
Myasthenia
Gravis (Autoimmune Disease); and
|
·
|
Adrenomyeloneuropathy
(AMN).
|
|
·
|
License
revenues developed through licensing agreements;
|
|
|
|
|
·
|
Joint
venture revenues developed through joint venture in foreign countries
that
will permit local clinical trials and regulatory approval outside
the
United States;
|
|
|
|
|
·
|
Drug
sales should we be successful in obtaining FDA approval; and
|
|
|
|
|
·
|
Test
kit sales sold through our wholly owned subsidiary, Designer Diagnostics,
Inc.
|
Drug
|
|
Potential
Applications
|
RPI-78M
|
|
Multiple
sclerosis (MS), Adrenomyeloneuropathy (AMN), Myasthenia gravis (MG)
and
Amyotrophic lateral sclerosis (ALS).
|
RPI-MN
|
|
HIV,
Rabies, general anti-viral product
|
RPI-78
|
|
Pain
|
RPI-70
|
|
Pain
|
·
|
Alteration
of Proteins and Peptides - These include patented methods for altering
the
3-Dimensional structure of certain proteins and peptides. The natural
peptides bind to receptors in the body with toxic effects. This technology
allows us to alter the structure of these peptides, preserving their
receptor-binding characteristics, while making them non-toxic and
therapeutic. Different receptors have various functions in many disease
states. By the peptides binding to these receptors in a controlled
fashion
certain symptoms of diseases may be treated. In connection with MS,
binding to the acetylcholine receptor on the nerves allows for more
efficient nerve conduction. With HIV, binding to chemokine receptors
may
prevent the virus from entering and infecting new
cells;
|
·
|
Innovative
aerosolized drug delivery system - Many therapeutic agents cannot
be
effectively delivered by aerosol formulation due to their large size
and/or irregular shapes. Since these therapeutic agents cannot be
ingested
orally without being degraded by the digestive system, patients have
no
alternative but to inject these drugs directly. We have a non-exclusive
license to a proprietary aerosol formulation, for which a patent
is now
pending, which greatly enhances the permeability of the mucous membranes
found on the roof of the mouth and the back of the throat. This allows
for
the easy and efficient systemic delivery into the bloodstream of
a much
wider variety of proteins and peptides. This non-exclusive license
for
"Buccal Delivery System" (patent-pending) includes claims that identify
the active mucosal enhancer, its combination with therapeutic agents
and
the mode of delivery through aerosol. This may allow for the effective
and
pain-free delivery of peptide and protein therapeutics for the treatment
of HIV and MS.
|
·
|
Para-Tuberculosis
|
|
|
·
|
Nocardia
|
·
|
Pseudomonas
|
|
|
·
|
MAC
(M.avium Complex)
|
·
|
U.S.
Patent No. 5,989,857, which was granted in November 1999 with 10
claims.
|
·
|
U.S.
Patent No. 6,670,148, which was granted in December 2003, with 9
claims.
The patent further describes the method for preparing a bioactive
peptide
(protein) found in cobra venom, in a stable, inactivated form, by
treating
the peptide with ozone.
|
·
|
Buccal
Delivery System, on which a patent is pending. This application describes
a throat spray that permits efficient delivery of the modified peptide
drugs to the body through oral
mucosa.
|
·
|
Technology
contained in one pending U.S. patent application for the further
development of bioactive peptides in cobra venom for use in the treatment
of HIV and MS.
|
·
|
Technology
contained in two pending U.S. patent applications for Immunokine
Composition and Method, which describes a method for developing modified
peptides from alpha-cobratoxin.
|
·
|
Technology
contained in two patents pending for the topical delivery of our
proprietary wound healing treatment, which was developed in conjunction
with Bio Therapeutics. One of these products is in the form of an
ointment style skin protectant and the other a foaming
aerosol.
|
·
|
Modified
venom and venom components as anti-retroviral agents. The present
invention relates to a class of proteins, and a method for treatment
of
neurological and viral diseases in humans and
animals.
|
·
|
Modified
anticholinergic neurotoxins as modulators of the autoimmune reaction.
The
invention has application to the treatment of certain human autoimmune
diseases, including especially multiple sclerosis, myasthenia gravis,
and
rheumatoid arthritis.
|
·
|
Method
of use of crotoxin as an anti-retroviral agent. Provides a composition
of
matter and a method of using the composition for treating and preventing
of retroviral infections of mammalian
cells.
|
·
|
Method
of production and use of crotoxin as an analgesic. A pharmaceutical
composition including one of crotoxin, mojavetoxin or a related toxin
and
a carrier for use in the treatment of chronic
pain,
|
·
|
Modified
alpha-neurotoxins as painkillers. A composition of matter, a process
of
production thereof, and a method for the treatment of chronic
pain.
|
·
|
Modified
neurotoxins as therapeutic agents for the treatment of diseases and
methods of making. a method for treatment of neurological and viral
diseases and especially to the treatment of heretofore intractable
diseases.
|
U.S. Patent Nos.
|
|
Description
|
|
|
|
#5,989,902
|
|
Method
for determining the antimicrobial agent sensitivity of a
nonparaffinophilic hydrophobic microorganism and an associated apparatus
|
|
|
|
#5,981,210
|
|
Method
for determining a presence or absence of a nonparaffinophilic hydrophobic
microorganism in a body specimen by using a DNA extraction procedure
and a
novel DNA extraction procedure
|
|
|
|
#5,935,806
|
|
Method
and apparatus for speciating and identifying MAI (Mycobacterium Avium
Intracellulare) and testing the same for antibiotic sensitivity
|
|
|
|
#5,882,920
|
|
Apparatus
for determining the presence or absence of a paraffinophilic microorganism
|
|
|
|
#5,854,014
|
|
Apparatus
for testing paraffinophilic microorganisms for antimicrobial sensitivity
|
|
|
|
#5,846,760
|
|
Method
for determining a presence or absence of a nonparaffinophilic hydrophobic
microorganism in a body specimen and an associated kit
|
#5,776,722
|
|
Method
of testing a body specimen taken from a patient for the presence
or
absence of a microorganism a further associated method and associated
apparatus
|
|
|
|
#5,569,592
|
|
Apparatus
for testing MAI (Mycobacterium Avium Intracellulare) for antimicrobial
agent sensitivity
|
#5,472,877
|
|
Apparatus
for determining the presence or absence of MAI (Mycobacterium Avium
Intracellulare)
|
|
|
|
#5,316,918
|
|
Method
and apparatus for testing MAI (Mycobacterium Avium Intracellulare)
for
antimicrobial agent sensitivity
|
|
|
|
#5,153,119
|
|
Method
for speciating and identifying MAI (Mycobacterium Avium
Intracellulare)
|
U.S. Patent Nos.
|
|
Description
|
|
|
|
#5,962,306
|
|
Method
of determining the presence or absence of a nonparaffinophilic
microorganism in a specimen and an associated apparatus
|
|
|
|
#5,891,662
|
|
Method
for determining the antimicrobial agent sensitivity of a
nonparaffinophilic hydrophobic microorganism
|
|
|
|
#5,882,919
|
|
Apparatus
for determining the presence or absence of a nonparaffinophilic
microorganism in a specimen
|
|
|
|
#5,854,013
|
|
Method
of determining presence or absence of a nonparaffinophilic microorganism
in a specimen
|
|
|
|
#5,804,406
|
|
Determining
sensitivity of paraffinophilic microorganisms to
antimicrobials
|
|
|
|
#5,801,009
|
|
Method
for determining the antimicrobial sensitivity of a paraffinophilic
microorganism using various milieus and an associated
apparatus
|
|
|
|
#5,750,363
|
|
Method
for determining the antibiotic agent sensitivity of a nonparaffinophilic
microorganism and an associated apparatus
|
|
|
|
#5,726,030
|
|
Method
for automatically testing the antibiotic sensitivity of a
nonparaffinophilic microorganism
|
|
|
|
#5,721,112
|
|
Method
of determining the presence or absence of a nonparaffinophilic
microorganism in a specimen and an associated apparatus
|
|
|
|
#5,707,824
|
|
Method
of determining the presence or absence of a paraffinophilic
microorganism
|
|
|
|
#5,698,414
|
|
Method
and apparatus for testing paraffinophilic microorganisms for antimicrobial
agent sensitivity
|
|
|
|
#5,677,169
|
|
Method
for determining the antimicrobial agent sensitivity of a
nonparaffinophilic microorganism and an associated
apparatus
|
|
|
|
#5,668,010
|
|
Method
for determining the antimicrobial agent sensitivity of a
nonparaffinophilic microorganism using various milieus and an associated
apparatus
|
#5,663,056
|
|
Method
for determining the antimicrobial agent sensitivity of a
nonparaffinophilic microorganism and an associated
apparatus
|
#5,654,194
|
|
Method
of identifying a nonparaffinophilic microrganism using various milieus
and
an associated apparatus
|
|
|
|
#5,641,645
|
|
Method
for determining the antimicrobial agent sensitivity of a
nonparaffinophilic microrganism using various milieus and an associated
apparatus
|
|
|
|
#5,639,675
|
|
Method
of identifying a nonparaffinophilic microorganism using various mileus
and
an associated apparatus
|
|
|
|
#5,637,501
|
|
Apparatus
for automatically testing the antibiotic sensitivity of a paraffinophilic
microorganism
|
1)
|
They
lack measurable toxicity but are still capable of attaching to and
affecting the target site on the nerve cells. This means that patients
cannot overdose.
|
2)
|
They
display no adverse side effects following years of investigations
in
humans and animals.
|
3)
|
The
products are stable and resistant to heat, which gives the drug a
long
shelf life. The drugs’ stability has been determined to be over 4 years at
room temperature.
|
4)
|
RPI-78M
can be administered orally. It has been routinely delivered by injection
in a manner similar to insulin, but recent research and development
has
given rise to administration by mouth. Oral delivery presents patients
with additional “quality of life” benefits by eliminating or decreasing
the requirement for routine
injections.
|
|
2006
|
2007
|
|||||||||||
|
High
Bid
|
Low
Bid
|
High
Bid
|
Low
Bid
|
|||||||||
First
Quarter
|
.33
|
.17
|
$
|
.13
|
$
|
.09
|
|||||||
Second
Quarter
|
.26
|
.14
|
$
|
.10
|
$
|
.07
|
|||||||
Third
Quarter
|
.16
|
.08
|
$
|
.07
|
$
|
.05
|
|||||||
Fourth
Quarter
|
.14
|
.08
|
$
|
.05
|
$
|
.03
|
|
·
|
Deliver,
prior to any transaction involving a penny stock, a disclosure schedule
prepared by the Securities and Exchange Commission relating to the
penny
stock market, unless the broker-dealer or the transaction is otherwise
exempt;
|
|
·
|
Disclose
commission payable to the broker-dealer and its registered representatives
and current bid and offer quotations for the
securities;
|
|
·
|
Send
monthly statements disclosing recent price information pertaining
to the
penny stock held in a customer's account, the account's value and
information regarding the limited market in penny stocks;
and
|
|
·
|
Make
a special written determination that the penny stock is a suitable
investment for the purchaser and receive the purchaser's written
agreement
to the transaction, prior to conducting any penny stock transaction
in the
customer's account.
|
Equity
Compensation Plan Information
|
||||||||||
Plan
category
|
Number
of securities
to
be issued upon
exercise
of outstanding
options,
warrants and
rights
(a)
|
Weighted-average
exercise
price of
outstanding
options,
warrants
and rights
(b)
|
Number
of securities
remaining
available
for
future issuance
under
equity
compensation
plans
(excluding
securities
reflected
in column (a))
(c)
|
|||||||
Equity
compensation plans approved by security holders
|
0
|
N/A
|
N/A
|
|||||||
Equity
compensation plans not approved by security holders
|
13,000,000
|
$
|
0.59
|
17,005,000
|
||||||
Total
|
13,000,000
|
$
|
0.59
|
17,005,000
|
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 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.
|
·
|
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.
|
·
|
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.
|
Name
|
|
Age
|
|
Position
with the
Company
|
|
Director
Since
|
|
|
|
|
|
|
|
Rik
J. Deitsch
|
|
40
|
|
Chairman,
President, Chief
Executive Officer, and
Chief Financial Officer
|
|
2002
|
Stanley
J Cherelstein
|
|
49
|
|
Director
(1)
|
|
2004
|
|
|
|
|
|
|
|
Stewart
Lonky, M.D.
|
|
61
|
|
Director
(2)
|
|
2004
|
(1) |
Stanley
Cherelstein is the Chairman of our Audit Committee and Compensation
Committee. Additionally, he is our Audit Committee Financial
Expert.
|
(2) |
Dr.
Lonky is a member of our Audit Committee and Compensation
Committee.
|
(3) |
On
May 8, 2007, Dr. Tanvir Khandaker resigned as our Director. He resigned
from his position as our Director to devote his time to other business
interests and his resignation was not due to any disagreement with
our
operations, policies or procedures.
.
|
Name
and principal position
|
Year
|
|
Salary
($)
|
|
Bonus
($)
|
|
Stock
Awards ($)
|
|
Option
Awards ($)
|
|
Non- Equity
Incentive
Plan
Compen- sation ($)
|
|
Nonqualified
Deferred
Compen- sation
Earnings ($)
|
|
All
Other
Compen- sation
($)
|
|
Total
($)
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Rik Deitsch
Chief
Executive Officer,
Chief
Financial Officer,
President
and Chairman of the Board
|
2007
2006
|
130,000
130,000
|
—
—
|
—
—
|
—
—
|
—
—
|
—
—
|
—
—
|
130,000
130,000
|
Name
and Address of Beneficial Owner
|
Shares
of Common
Stock
Beneficially
Owned
|
|
Percent
of
Common
Stock
Outstanding
|
||||
|
|
|
|||||
Opus
International*
19
Hillsyde Court
Cockeysville,
Maryland 21030
|
11,692,556
|
7.0
|
%
|
||||
|
|||||||
Total
|
11,692,556
|
7.0
|
%
|
Name
and Address of
Director
or Executive Officer
|
Shares
of
Common
Stock
Beneficially
Owned
|
Percent
of
Common
Stock
Outstanding
|
|||||
|
|
|
|||||
Rik
J. Deitsch
|
|
|
|
||||
Chief
Executive Officer/President
|
|||||||
791
Park of Commerce Blvd Suite 300
|
|||||||
Boca
Raton, Florida 33487
|
54,500,000
|
32.7
|
%
|
||||
|
|||||||
Stanley
J Cherelstein
|
|
|
|
||||
Director
|
|||||||
791
Park of Commerce Blvd. Suite 300
|
|||||||
Boca
Raton, Florida 33487
|
3,000,000
|
1.8
|
%
|
||||
|
|||||||
Dr.
Stewart Lonky
|
|
|
|
||||
Director
|
|||||||
1158
Chautaqua Boulevard
|
|||||||
Pacific
Palisades, California 90272
|
3,000,000
|
1.8
|
%
|
||||
|
|||||||
All
executive officers and directors as a group (3) persons
|
60,500,000
|
36.3
|
%
|
Report
of Independent Registered Public Accounting Firm
|
F-1
|
Consolidated
Balance Sheet
|
F-2
|
Consolidated
Statements of Operations
|
F-3
|
Consolidated
Statement of Changes in Stockholders' Equity (Capital
Deficit)
|
F-4
|
Consolidated
Statements of Cash Flows
|
F-5
|
Notes
to Consolidated Financial Statements
|
F-6
|
|
Certificate
of Incorporation dated February 1, 2000 (incorporated by reference
to the
Company’s Registration Statement on Form SB-2/A, Registration No.
33-44398, filed on April 6, 2001)
|
|
|
|
|
3.2
|
|
Certificate
of Amendment to Articles of Incorporation dated July 5, 2000 (incorporated
by reference to the Company’s Registration Statement on Form SB-2/A,
Registration No. 33-44398, filed on April 6, 2001)
|
|
|
|
3.3
|
|
Certificate
of Amendment to Articles of Incorporation dated October 31, 2001
(incorporated by reference to the Company’s Registration Statement on Form
SB-2/A, Registration No. 33-44398, filed on April 6,
2001)
|
|
|
|
10.18
|
Patent
Assignment Agreement dated January 24, 2006 between Nanologix, Inc.
and
Nutra Pharma Corp. (incorporated by reference to Form 10-KSB for
period
ending December 31, 2006)
|
|
10.19
|
International
License Agreement between NanoLogix, Inc. and Nutra Pharma Corp.
(incorporated by reference to Form 10-KSB for period ending December
31,
2006)
|
|
14.1
|
Code
of Ethics (incorporated by reference to Report on Form 10-KSB/A filed
on
May 7, 2004).
|
|
21.1
|
Subsidiaries
of Nutra Pharma Corp.
|
|
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.
|
2006
|
2007
|
||||
|
|
||||
$ |
35,300
|
$
|
37,900
|
NUTRA
PHARMA CORP.
|
|
/s/ Rik
J. Deitsch
|
Rik
J. Deitsch, Chairman, President, Chief
Executive
Officer and Chief Financial Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Rik
J. Deitsch
|
|
Chairman
of the Board, President,
Chief
Executive Officer and
|
|
April
15, 2008
|
Rik
J. Deitsch
|
|
Chief
Financial Officer
|
|
|
|
|
|
|
|
/s/
Stanley Cherelstein
|
|
Director
|
|
April
15, 2008
|
Stanley
Cherelstein
|
|
|
|
|
|
|
|
|
|
/s/
Stewart Lonky
|
|
Director
|
|
April
15, 2008
|
Stewart
Lonky
|
ASSETS
|
||||
Current
assets:
|
||||
Cash
|
$
|
122,810
|
||
Inventory
|
11,425
|
|||
Total
current assets
|
134,235
|
|||
Other
assets
|
9,950
|
|||
TOTAL
ASSETS
|
$
|
144,185
|
||
LIABILITIES
AND STOCKHOLDERS' (DEFICIT)
|
||||
Current
liabilities:
|
||||
Accounts
payable
|
$
|
22,496
|
||
Accrued
expenses
|
30,000
|
|||
Due
to officers
|
1,944,414
|
|||
Other
loans payable
|
100,000
|
|||
Total
current liabilities
|
2,096,910
|
|||
Stockholders'
(deficit):
|
||||
Common
stock, $0.001 par value, 2.0 billion shares authorized; 81,895,682
shares
issued and outstanding
|
81,896
|
|||
Additional
paid-in capital
|
18,074,473
|
|||
(Deficit)
accumulated during the development stage
|
(20,109,094
|
)
|
||
Total
stockholders' (deficit)
|
(1,952,725
|
)
|
||
TOTAL
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
|
$
|
144,185
|
For
the
|
||||||||||
Period
From
|
||||||||||
February
1,
|
||||||||||
2000
|
||||||||||
(Inception)
|
||||||||||
Through
|
||||||||||
Years
Ended December 31,
|
December
31,
|
|||||||||
2006
|
2007
|
2007
|
||||||||
Sales
|
$
|
20,200
|
$
|
-
|
$
|
20,200
|
||||
Cost
of sales
|
3,472
|
-
|
3,472
|
|||||||
Gross
profit
|
16,728
|
-
|
16,728
|
|||||||
Costs
and expenses:
|
||||||||||
General
and administrative
|
1,385,971
|
566,921
|
6,943,393
|
|||||||
Research
and development
|
410,920
|
-
|
1,740,237
|
|||||||
General
and administrative - stock based compensation
|
605,421
|
603,050
|
6,929,657
|
|||||||
Write-off
of advances to potential acquiree
|
-
|
-
|
629,000
|
|||||||
Finance
costs
|
-
|
-
|
786,000
|
|||||||
Interest
expense
|
45,594
|
76,075
|
396,059
|
|||||||
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
|
)
|
|||||
Total
costs and expenses
|
2,447,906
|
164,951
|
20,125,822
|
|||||||
Net
loss
|
$
|
(2,431,178
|
)
|
$
|
(164,951
|
)
|
$
|
(20,109,094
|
)
|
|
Per
share information - basic and diluted:
|
||||||||||
Loss
per common share
|
$
|
(0.03
|
)
|
$
|
(0.00
|
)
|
||||
Weighted
average common shares outstanding
|
71,607,011
|
77,113,846
|
Deficit
|
||||||||||||||||
Accumulated
|
||||||||||||||||
Additional
|
During
the
|
|||||||||||||||
Common
|
Stock
|
Paid-in
|
Development
|
|||||||||||||
Shares
|
Par
Value
|
Capital
|
Stage
|
Total
|
||||||||||||
Common
stock issued to founders
|
39,000,000
|
$
|
39,000
|
$
|
(37,050
|
)
|
$
|
-
|
$
|
1,950
|
||||||
Net
loss
|
-
|
-
|
-
|
(1,950
|
)
|
(1,950
|
)
|
|||||||||
Balance
- December 31, 2000
|
39,000,000
|
39,000
|
(37,050
|
)
|
(1,950
|
)
|
-
|
|||||||||
Proceeds
from sale of common stock - $.025 per share
|
1,000,000
|
1,000
|
24,000
|
-
|
25,000
|
|||||||||||
Common
stock issued in connection with acquisition - $.025 per
share
|
4,500,000
|
4,500
|
108,000
|
-
|
112,500
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(67,504
|
)
|
(67,504
|
)
|
|||||||||
Balance
- December 31, 2001
|
44,500,000
|
44,500
|
94,950
|
(69,454
|
)
|
69,996
|
||||||||||
Issuance
of common stock in exchange for services - $.30 to $1.50 per
share
|
656,000
|
656
|
670,874
|
-
|
671,530
|
|||||||||||
Return
of common stock by principal stockholder
|
(10,394,000
|
)
|
(10,394
|
)
|
10,394
|
-
|
||||||||||
Rescission
of common stock issued in acquisition - $.025 per share
|
-
|
-
|
(112,500
|
)
|
-
|
(112,500
|
)
|
|||||||||
Cancellation
of common stock issued in connection with rescission of
acquisition
|
(2,037,500
|
)
|
(2,038
|
)
|
2,038
|
-
|
-
|
|||||||||
Net
loss
|
-
|
-
|
-
|
(1,491,038
|
)
|
(1,491,038
|
)
|
|||||||||
Balance
- December 31, 2002
|
32,724,500
|
32,724
|
665,756
|
(1,560,492
|
)
|
(862,012
|
)
|
|||||||||
Issuance
of common stock in exchange for services - $.38 to $.76 per
share
|
2,196,828
|
2,197
|
1,358,070
|
-
|
1,360,267
|
|||||||||||
Cancellation
of common stock issued in connection with rescission of
acquisition
|
(2,055,000
|
)
|
(2,055
|
)
|
2,055
|
-
|
-
|
|||||||||
Value
of common stock issued by stockholder to third party
|
||||||||||||||||
in
connection with settlement - $.51 per share
|
-
|
-
|
229,500
|
-
|
229,500
|
|||||||||||
Conversion
of stockholder loan into common stock - $.08 per share
|
10,300,000
|
10,300
|
1,637,712
|
-
|
1,648,012
|
|||||||||||
Value
of common stock issued by stockholder to employee
|
||||||||||||||||
for
services rendered - $.15 per share
|
-
|
-
|
75,000
|
-
|
75,000
|
|||||||||||
Issuance
of common stock in connection with acquisition - $.85 per
share
|
4,502,549
|
4,503
|
3,822,664
|
3,827,167
|
||||||||||||
Common
stock deemed irretrievable in connection with rescission of acquisition
-
$.11 per share
|
-
|
-
|
23,375
|
-
|
23,375
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(2,813,456
|
)
|
(2,813,456
|
)
|
|||||||||
Balance
- December 31, 2003
|
47,668,877
|
47,669
|
7,814,132
|
(4,373,948
|
)
|
3,487,853
|
||||||||||
Cancellation
of common stock issued in connection with rescission of
acquisition
|
(199,000
|
)
|
(199
|
)
|
199
|
-
|
-
|
|||||||||
Cancellation
of common stock issued in connection with settlement with third
parties
|
(120,000
|
)
|
(120
|
)
|
120
|
-
|
-
|
|||||||||
Issuance
of common stock in connection with acquisition - $.85 per
share
|
775,538
|
776
|
658,431
|
-
|
659,207
|
|||||||||||
Issuance
of common stock in exchange for services - $.24 to $.66 per
share
|
4,054,200
|
4,054
|
2,061,942
|
-
|
2,065,996
|
|||||||||||
Issuance
of common stock for cash - $.17 to $.25 per share
|
1,285,000
|
1,285
|
223,565
|
-
|
224,850
|
|||||||||||
Conversion
of convertible loans into common stock - $.16 per share
|
595,067
|
595
|
97,405
|
-
|
98,000
|
|||||||||||
Common
shares subscribed for services - 2,000,000 shares at $.40
|
-
|
-
|
800,000
|
-
|
800,000
|
|||||||||||
Common
shares subscribed for cash - 4,105,000 shares at $.17
|
-
|
-
|
697,850
|
-
|
697,850
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(7,986,853
|
)
|
(7,986,853
|
)
|
|||||||||
Balance
- December 31, 2004
|
54,059,682
|
54,060
|
12,353,644
|
(12,360,801
|
)
|
46,903
|
||||||||||
Issuance
of shares subscribed for at December 31, 2004
|
6,105,000
|
6,105
|
(6,105
|
)
|
-
|
-
|
||||||||||
Issuance
of common stock for cash - $.17 to $.20 per share
|
5,667,500
|
5,668
|
1,104,132
|
-
|
1,109,800
|
|||||||||||
Issuance
of common stock in exchange for services - $.26 to $.37 per
share
|
2,007,000
|
2,006
|
716,499
|
-
|
718,505
|
|||||||||||
Issuance
of common stock for loan repayment and interest - $.33 per
share
|
1,458,000
|
1,458
|
479,682
|
-
|
481,140
|
|||||||||||
Issuance
of common stock by Receptopharm in exchange for services
|
-
|
-
|
636,685
|
-
|
636,685
|
|||||||||||
Value
of stock warrants issued to a consultant
|
-
|
-
|
1,500,000
|
-
|
1,500,000
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(5,152,164
|
)
|
(5,152,164
|
)
|
|||||||||
Balance
- December 31, 2005
|
69,297,182
|
69,297
|
16,784,537
|
(17,512,965
|
)
|
(659,131
|
)
|
|||||||||
Issuance
of common stock for cash - $.20 per share
|
3,110,000
|
3,110
|
618,890
|
-
|
622,000
|
|||||||||||
Issuance
of common stock in exchange for services - $.11 to $.21 per
share
|
873,500
|
873
|
123,298
|
-
|
124,171
|
|||||||||||
Issuance
of common stock by Receptopharm in exchange for services
|
-
|
-
|
11,250
|
-
|
11,250
|
|||||||||||
Value
of stock options issued to an officer
|
-
|
-
|
260,000
|
-
|
260,000
|
|||||||||||
Value
of stock warrants issued to a former subsidiary
|
-
|
-
|
210,000
|
-
|
210,000
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(2,431,178
|
)
|
(2,431,178
|
)
|
|||||||||
Balance
- December 31, 2006
|
73,280,682
|
$
|
73,281
|
$
|
18,007,976
|
$
|
(19,944,143
|
)
|
$
|
(1,862,886
|
)
|
|||||
Effect
of deconsolidation of Receptopharm
|
-
|
-
|
(647,938
|
)
|
-
|
(647,938
|
)
|
|||||||||
Issuance
of common stock in exchange for services - $0.07 per share
|
8,615,000
|
8,615
|
594,435
|
-
|
603,050
|
|||||||||||
Common
shares subscribed for cash -$0.025 per share
|
-
|
-
|
120,000
|
-
|
120,000
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(164,951
|
)
|
(164,951
|
)
|
|||||||||
Balance
- December 31, 2007
|
81,895,682
|
$
|
81,896
|
$
|
18,074,473
|
$
|
(20,109,094
|
)
|
$
|
(1,952,725
|
)
|
For the
|
||||||||||
Period From
|
||||||||||
February 1,
|
||||||||||
2000
|
||||||||||
(Inception)
|
||||||||||
Years Ended
|
||||||||||
Through
|
||||||||||
Years Ended December 31,
|
December 31,
|
|||||||||
2006
|
2007
|
2007
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(2,431,178
|
)
|
$
|
(164,951
|
)
|
$
|
(20,109,094
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Amortization
of intangibles
|
-
|
-
|
656,732
|
|||||||
Amortization
of license agreement
|
-
|
-
|
155,210
|
|||||||
Depreciation
|
22,649
|
-
|
64,700
|
|||||||
Write-off
of advances to potential acquiree
|
-
|
-
|
629,000
|
|||||||
Deconsolidation
of Receptopharm
|
-
|
(1,252,244
|
)
|
(1,252,244
|
)
|
|||||
Stock-based
compensation
|
605,420
|
603,050
|
9,038,403
|
|||||||
Finance
costs in connection with conversion of
|
||||||||||
stockholder
loan into common stock
|
-
|
-
|
786,000
|
|||||||
Expenses
paid by stockholder
|
-
|
-
|
474,140
|
|||||||
Losses
on settlements
|
-
|
-
|
1,261,284
|
|||||||
Write-down
of investment in Infectech, Inc.
|
-
|
-
|
620,805
|
|||||||
Equity
in loss of unconsolidated subsidiary
|
-
|
-
|
853,540
|
|||||||
Write-down
of investment in Portage BioMed
|
-
|
-
|
60,000
|
|||||||
Write-down
of investment in Xenacare
|
-
|
-
|
175,000
|
|||||||
Non-cash
interest expense
|
45,594
|
-
|
315,278
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Increase
in inventory
|
(11,425
|
)
|
-
|
(11,425
|
)
|
|||||
Decrease
(increase) in other assets
|
(22,286
|
)
|
30,644
|
(6,316
|
)
|
|||||
Increase
(decrease) in accounts payable
|
(5,037
|
)
|
(21,866
|
)
|
140,706
|
|||||
Increase
(decrease) in accrued expenses
|
59,182
|
-
|
460,169
|
|||||||
Net
cash (used in) operating activities
|
(1,737,081
|
)
|
(805,367
|
)
|
(5,688,112
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Cash
reduction due to deconsolidation of Infectech
|
-
|
-
|
(2,997
|
)
|
||||||
Cash
reduction due to deconsolidation of Receptopharm
|
-
|
(1,754
|
)
|
(1,754
|
)
|
|||||
Cash
acquired in acquisition of Infectech
|
-
|
-
|
3,004
|
|||||||
Acquisition
of property and equipment
|
(9,889
|
)
|
-
|
(96,029
|
)
|
|||||
Investments
carried at cost
|
-
|
-
|
(235,000
|
)
|
||||||
Net
cash (used in) investing activities
|
(9,889
|
)
|
(1,754
|
)
|
(332,776
|
)
|
||||
Cash
flows from financing activities:
|
||||||||||
Common
stock issued for cash
|
622,000
|
120,000
|
2,799,500
|
|||||||
Proceeds
from convertible loans
|
-
|
-
|
304,750
|
|||||||
Proceeds
from notes payable
|
100,000
|
-
|
100,000
|
|||||||
Loans
from stockholders, net of repayments
|
974,835
|
791,039
|
2,939,448
|
|||||||
Net
cash provided by financing activities
|
1,696,835
|
911,039
|
6,143,698
|
|||||||
Net
increase (decrease) in cash
|
(50,135
|
)
|
103,918
|
122,810
|
||||||
Cash
- beginning of period
|
69,027
|
18,892
|
-
|
|||||||
Cash
- end of period
|
$
|
18,892
|
$
|
122,810
|
$
|
122,810
|
||||
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
|
$
|
-
|
$
|
-
|
$
|
206,750
|
||||
Expenses
paid by stockhoder
|
$
|
-
|
$
|
-
|
$
|
119,140
|
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
|
|
Weighted
|
Weighted
|
|||||||||
Number
|
average
|
average
|
||||||||
of
|
exercise
|
fair
|
||||||||
shares
|
price
|
value
|
||||||||
Balance
at December 31, 2005
|
-
|
|||||||||
Issued
|
3,000,000
|
$
|
.25
|
$
|
.16
|
|||||
Balance
at December 31, 2006 And 2007
|
3,000,000
|
$
|
.25
|
$
|
.16
|
Weighted
|
Weighted
|
Weighted-
|
||||||||
Average
|
Average
|
Average
|
||||||||
Exercise
|
Number
|
Contractual
|
Exercise
|
|||||||
Prices
|
Outstanding
|
Life
|
Price
|
|||||||
$.20
|
1,000,000
|
3.05
years
|
$
|
.20
|
||||||
$.27
|
2,000,000
|
.25
years
|
$
|
.27
|
||||||
3,000,000
|
Income
tax provision at the federal statutory rate
|
34
|
%
|
||
Effect
of operating losses
|
(34
|
)%
|
||
0
|
%
|