NUTRA PHARMA CORP - Quarter Report: 2008 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
|
For
the
quarterly period ended March 31, 2008
o |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
For
the
transition period from _________ to ________
Commission
file numbers 000-32141
NUTRA
PHARMA CORP.
(Name
of
registrant as specified in its charter)
California
|
91-2021600
|
(State
or Other Jurisdiction of Organization)
|
(IRS
Employer Identification Number)
|
791
Park of Commerce Blvd, Suite 300, Boca Raton, FL 33487
(Address
of principal executive offices)
(954)
509-0911
(Issuer's
telephone number)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past
90 days. Yes x No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes o No x
The
number of shares outstanding of the registrant’s common stock, par value $0.001
per share, at May 12, 2008 was 186,135,682.
TABLE
OF
CONTENTS
PART
I. FINANCIAL INFORMATION
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|
Item
1. Financial Statements
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||
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|
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Consolidated
Balance Sheets as of March 31, 2008 (Unaudited) and December 31,
2007
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3
|
|
|
|
|
Consolidated
Statements of Operations for the three months ended March 31, 2008
and
2007 (Unaudited)
|
4
|
|
|
|
|
Consolidated
Statements of Cash Flows for the three months ended March 31, 2008
and
2007 (Unaudited)
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5
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|
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|
Notes
to Unaudited Consolidated Financial Statements
|
6
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|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
10
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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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|
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Item
1. Legal Proceedings
|
16
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|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
17
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|
|
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Item
5. Other Information
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17
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|
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Item
6. Exhibits
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17
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SIGNATURES
|
17
|
2
Part
I. Financial
Information
Item
1. Financial
Statements
NUTRA
PHARMA CORP.
|
(A
Development Stage Company)
|
Consolidated
Balance Sheets
|
March
31,
|
December
31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
|
$
|
114,982
|
$
|
122,810
|
|||
Inventory
|
11,425
|
11,425
|
|||||
Total
current assets
|
126,407
|
134,235
|
|||||
Receivable
from Receptopharm
|
250,000
|
-
|
|||||
Other
assets
|
9,950
|
9,950
|
|||||
TOTAL
ASSETS
|
$
|
386,357
|
$
|
144,185
|
|||
LIABILITIES
AND STOCKHOLDERS' (DEFICIT)
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
23,806
|
$
|
22,496
|
|||
Accrued
expenses
|
22,000
|
30,000
|
|||||
Due
to officers
|
812,749
|
1,944,414
|
|||||
Other
loans payable
|
100,000
|
100,000
|
|||||
Total
current liabilities
|
958,555
|
2,096,910
|
|||||
Stockholders'
(deficit):
|
|||||||
Common
stock, $0.001 par value, 2.0 billion shares authorized
|
|||||||
166,635,682
and 81,895,682 shares issued and outstanding, respectively
|
166,636
|
81,896
|
|||||
Additional
paid-in capital
|
19,988,233
|
18,074,473
|
|||||
(Deficit)
accumulated during the development stage
|
(20,727,067
|
)
|
(20,109,094
|
)
|
|||
Total
stockholders' (deficit)
|
(572,198
|
)
|
(1,952,725
|
)
|
|||
TOTAL
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
|
$
|
386,357
|
$
|
144,185
|
See
the
accompanying notes to the financial statements.
3
NUTRA
PHARMA CORP.
|
(A
Development Stage Company)
|
Consolidated
Statements of Operations
|
(Unaudited)
|
For
the
|
||||||||||
Period
From
|
||||||||||
February
1,
|
|
|||||||||
|
|
|
|
|
|
2000
|
|
|||
|
|
|
|
|
|
(Inception)
|
|
|||
|
|
Three
Months Ended March 31,
|
|
Through
|
|
|||||
|
|
|
|
|
|
March
31,
|
|
|||
|
|
2007
|
|
2008
|
|
2008
|
||||
|
|
|
||||||||
Sales
|
$
|
-
|
$
|
-
|
$
|
20,200
|
||||
Cost
of sales
|
-
|
-
|
3,472
|
|||||||
|
||||||||||
Gross
profit
|
-
|
-
|
16,728
|
|||||||
|
||||||||||
Costs
and expenses:
|
||||||||||
General
and administrative
|
312,970
|
177,284
|
7,120,677
|
|||||||
Research
and development
|
47,179
|
-
|
1,740,237
|
|||||||
General
and administrative - stock based compensation
|
-
|
425,000
|
7,354,657
|
|||||||
Write-off
of advances to potential acquiree
|
-
|
-
|
629,000
|
|||||||
Finance
costs
|
-
|
-
|
786,000
|
|||||||
Interest
expense
|
16,012
|
15,689
|
411,748
|
|||||||
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
|
)
|
||||||
Total
costs and expenses
|
376,161
|
617,973
|
20,743,795
|
|||||||
Net
loss
|
$
|
(376,161
|
)
|
$
|
(617,973
|
)
|
$
|
(20,727,067
|
)
|
|
Per
share information - basic and diluted:
|
||||||||||
Loss
per common share
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
||||
Weighted
average common shares outstanding
|
73,280,262
|
87,318,319
|
See
the
accompanying notes to the financial statements.
4
NUTRA
PHARMA CORP.
|
(A
Development Stage Company)
|
Consolidated
Statements of Cash Flows
|
(Unaudited)
|
|
For
the
|
|
||||||||
|
|
|
|
|
|
Period
From
|
|
|||
|
|
|
|
|
|
February
1,
|
|
|||
|
|
|
|
|
|
2000
|
|
|||
|
|
|
|
|
|
(Inception)
|
|
|||
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|
|
|
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|
Years
Ended
|
|
|||
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|
Three
Months Ended March 31,
|
|
Through
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|
|||||
|
|
|
|
|
|
March
31,
|
|
|||
|
|
2007
|
|
2008
|
|
2008
|
||||
|
|
|||||||||
Cash
flows from operating activities:
|
||||||||||
|
|
|
||||||||
Net
cash (used in) operating activities
|
$
|
(359,359
|
)
|
$
|
(186,328
|
)
|
$
|
(5,874,440
|
)
|
|
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
|
|||||||
Acquisition
of property and equipment
|
-
|
-
|
(96,029
|
)
|
||||||
Loan
to Receptopharm
|
-
|
(250,000
|
)
|
(485,000
|
)
|
|||||
Net
cash (used in) investing activities
|
-
|
(250,000
|
)
|
(582,776
|
)
|
|||||
Cash
flows from financing activities:
|
||||||||||
Common
stock issued for cash
|
-
|
373,500
|
3,173,000
|
|||||||
Proceeds
from convertible loans
|
-
|
-
|
304,750
|
|||||||
Proceeds
from notes payable
|
-
|
-
|
100,000
|
|||||||
Loans
from stockholders, net of repayments
|
351,914
|
55,000
|
2,994,448
|
|||||||
Net
cash provided by financing activities
|
351,914
|
428,500
|
6,572,198
|
|||||||
Net
increase (decrease) in cash
|
(7,445
|
)
|
(7,828
|
)
|
114,982
|
|||||
Cash
- beginning of period
|
18,892
|
122,810
|
-
|
|||||||
Cash
- end of period
|
$
|
11,447
|
$
|
114,982
|
$
|
114,982
|
||||
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
|
$
|
-
|
$
|
1,200,000
|
$
|
2,062,012
|
||||
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
|
See
the
accompanying notes to the financial statements.
5
Notes
to
Consolidated Unaudited Financial Statements
March
31,
2008
1.
BASIS
OF PRESENTATION
The
accompanying unaudited financial statements have been prepared in accordance
with generally accepted accounting principles (GAAP) for interim financial
information and Rule 8.03 of Regulation SX. They do not include all of the
information and footnotes required by GAAP for complete financial statements.
In
the opinion of management, all adjustments (consisting only of normal recurring
adjustments) considered necessary for a fair presentation have been included.
The results of operations for the periods presented are not necessarily
indicative of the results to be expected for the full year. For further
information, refer to the financial statements of the Company as of
December 31, 2007, and for the two years then ended, including notes
thereto included in the Company’s Form 10-KSB.
The
accompanying financial statements are prepared in accordance with accounting
principles generally accepted in the United States of America, which require
management to make estimates and assumptions. These estimates and assumptions
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements
and
the reported amounts of revenue and expense. Actual results may differ from
these estimates.
Principles
of Consolidation
The
consolidated financial statements presented herein include the accounts of
Nutra
Pharma and its subsidiary, Designer Diagnostics Inc. (collectively, the
“Company”).
Income
(Loss) per Share
The
Company calculates net income (loss) per share as required by Statement of
Financial Accounting Standards (SFAS) 128, “Earnings per Share.” Basic
earnings (loss) per share, is calculated by dividing net income
(loss) by the weighted average number of common shares outstanding for the
period. Diluted earnings (loss) per share, is calculated by dividing net
income
(loss) by the weighted average number of common shares and dilutive common
stock equivalents outstanding. During periods in which the Company incurs
losses, common stock equivalents, if any, are not considered, as their effect
would be anti dilutive.
2.
BASIS
OF REPORTING
The
Company’s financial statements are presented on a going concern basis, which
contemplates the realization of assets and satisfaction of liabilities in
the
normal course of business. At March 31, 2008, the Company had negative working
capital of $832,148, a stockholders’ deficit of $572,198 and an accumulated
deficit of $20,727,067. In addition, the Company has no revenue generating
operations.
The
Company’s ability to continue as a going concern is contingent upon its ability
to secure additional financing, increase ownership equity, and attain profitable
operations. In addition, the Company’s ability to continue as a going concern
must be considered in light of the problems, expenses and complications
frequently encountered in established markets and the competitive environment
in
which the Company operates.
The
Company is pursuing financing for its operations and seeking additional
investments. In addition, the Company is seeking to establish a revenue base.
Failure to secure such financing or to raise additional equity capital and
to
establish a revenue base may result in the Company depleting its available
funds
and not being able to pay its obligations.
6
The
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the
amounts
and classification of liabilities that may result from the possible inability
of
the Company to continue as a going concern.
3.
ACQUISITION OF RECEPTOPHARM, INC.
On
December 12, 2003, the Company entered into an acquisition agreement (the
“Agreement”), whereby it agreed to acquire up to a 49.5% interest in
ReceptoPharm, Inc. (“ReceptoPharm”), a privately held biopharmaceutical company
based in Ft. Lauderdale, Florida. ReceptoPharm is a development stage company
engaged in the research and development of proprietary therapeutic proteins
for
the treatment of several chronic viral, autoimmune and neuro-degenerative
diseases.
Pursuant
to the Agreement, the Company acquired its interest in ReceptoPharm’s common
equity for $2,000,000 in cash, which equates to a purchase price of $.45
per
share. ReceptoPharm intended to use such funds to further research and
development, which could significantly impact future results of
operations.
At
December 31, 2005, the Company had funded a total of $1,860,000 to ReceptoPharm
under the Agreement, which equated to a 37% ownership interest in ReceptoPharm.
In February 2006, the Company funded an additional $140,000 to ReceptoPharm,
thereby completing the $2,000,000 investment. As of December 31, 2006, the
Company owned 4,444,445 shares or 38% of the issued and outstanding common
equity of ReceptoPharm. In addition to its ownership interest, as of December
31, 2006, the Company had loaned ReceptoPharm $825,000 for working capital
purposes.
For
accounting purposes, the Company through March 31, 2007, had been treating
its
capital investment in ReceptoPharm as a vehicle for research and development.
Because the Company is solely providing financial support to further the
research and development of ReceptoPharm, such amounts are being charged
to
expense as incurred by ReceptoPharm. ReceptoPharm presently has no ability
to
fund these activities and is dependent on the Company to fund its operations.
In
these circumstances, ReceptoPharm is considered a variable interest entity
and
has been consolidated. The creditors of ReceptoPharm do not have recourse
to the
general credit of the Company.
Effective
in April 2007 the Company ceased advancing funds to Receptopharm and had
no
further commitment to fund them. As such, the Company deconsolidated
Receptopharm from its financial statements at June 30, 2007. This
deconsolidation resulted in a gain of $1,081,095. This gain resulted from
the
Company reversing the net losses of Receptopharm included in its consolidated
financial statements and including the net losses as if the equity method
had
been applied. In addition, the Company wrote off the balance of its investment
in ($2,000,000) and advances to ($975,000) Receptopharm as discussed above
as
they were deemed to be impaired at June 30, 2007.
The
gain
was computed as follows:
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
|
During
the three months ended March 31, 2008, the Company loaned Receptopharm $250,000
for working capital purposes (see Note 9).
7
4.
DUE TO
OFFICERS
During
the three months ended March 31, 2008, the Company borrowed an additional
$55,000 from its President, Rik Deitsch, increasing the total amount owed
under
to Mr. Deitsch to $2,012,749. This demand loan is unsecured and bears interest
at a rate of 4.0%. Included in the amount owed to Mr. Deitsch is $118,374
of
accrued interest.
On
March
14, 2008, the Company’s Board of Directors approved an offer made by Mr.
Deitsch, to discharge $1,200,000 of Mr. Deitsch’s outstanding loan to the
Company in exchange for 48,000,000 shares of restricted common stock. The
price
per share in this loan conversion was the fair market value of the common
shares
of $0.025. After this conversion, the remaining balance of Mr. Deitsch’s loan to
the Company was $812,749 as of March 31, 2008.
5.
STOCKHOLDERS’ DEFICIT
In
December 2007, the Company sold an aggregate of 4,800,000 shares of restricted
common stock at $0.025 per share and received gross proceeds of $120,000.
These
shares were not issued to the purchasers until March 13, 2008.
From
January 1 through March 19, 2008, the Company completed private placements
of
restricted shares of its common stock, whereby it sold an aggregate of
14,940,000 shares at a price per share of $0.025. The Company received proceeds
of $373,500 in connection with the sale of these shares.
In
total,
the Company sold 19,740,000 shares at a price per share of $0.025 and received
proceeds of $493,500. In addition, the Company granted one (1) warrant for
each
share sold which gives each investor the right to purchase one additional
share
until December 31, 2012 at an exercise price of $0.10 per share.
6.
STOCK
BASED COMPENSATION
On
March
13, 2008, the Company’s Board of Directors authorized the issuance of an
aggregate of 17,000,000 shares of its restricted common stock in exchange
for
services rendered, as follows:
1,000,000
shares to each of four (4) consultants
2,000,000
shares to one (1) consultant
1,000,000
shares to an employee of the Company
5,000,000
shares to the Company’s Chairman and Chief Executive Officer
2,500,000
shares to a Director of the Company
2,500,000
shares to a Director of the Company
The
shares described above were valued at $0.025 per share which was the fair
market
value of the Company’s common stock on the date of grant. The Company recorded
stock based compensation of $425,000 in connection with the issuance of these
shares.
7.
STOCK
OPTIONS
A
summary
of stock options is as follows:
|
Number
of
shares
|
Weighted
average
exercise
price
|
Weighted
average
fair
value
|
|||||||
|
|
|
|
|||||||
Balance
December 31, 2007
|
3,000,000
|
$
|
0.25
|
$
|
0.16
|
|||||
Exercised
|
-
|
-
|
-
|
|||||||
Issued
|
-
|
-
|
-
|
|||||||
Forfeited
|
-
|
-
|
-
|
|||||||
|
||||||||||
Balance
March 31, 2008
|
3,000,000
|
$
|
0.25
|
$
|
0.16
|
The
following table summarizes information about fixed-price stock
options:
Exercise
Prices
|
Weighted
Average
Number
Outstanding
|
Weighted
Average
Contractual
Life
|
Weighted
Average
Exercise
Price
|
|||||||
|
|
|
|
|||||||
$.20
|
1,000,000
|
2.8
years
|
$
|
.20
|
||||||
$.27
|
2,000,000
|
3.0
years
|
$
|
.27
|
||||||
|
3,000,000
|
All
options are vested and exercisable.
8
8.
CONTINGENCIES
On
April 4, 2005, a Motion to Enforce Settlement Agreement was filed against
the Company in the Circuit Court of Broward County Florida by Bio Therapeutics,
Inc. f/k/a Phylomed Corp. in Nutra
Pharma Corp. v. Bio Therapeutics, Inc. (17th
Judicial Circuit, Case No. 03-008928 (03). This proceeding results from the
Company’s alleged breach of a settlement agreement that was entered into between
Bio Therapeutics and the Company in resolution of a previous lawsuit between
the
Company and Bio Therapeutics that was resolved by entering into a Settlement
Agreement. In conjunction with the settlement agreement, the Company also
entered into a related License Agreement and Amendment to the License Agreement
(“License Agreement”) with Bio Therapeutics regarding certain pieces of
intellectual property owned by Bio Therapeutics. In the April 4, 2005
motion, Bio Therapeutics alleges that the Company breached certain provisions
of
the License Agreement and requested that the Court grant its motion to enforce
the Settlement Agreement by declaring the License Agreement terminated,
enjoining the Company from further use of license products that was granted
to
it by the License Agreement, and awarding attorneys’ fees and costs to Bio
Therapeutics.
During
the last quarter of 2007, the Company moved for summary judgment regarding
Bio
Therapeutics’ Motion to Enforce Settlement Agreement and the Court and on April
28, 2008, the Court (i) granted the Company’s Cross Motion for Summary Judgment;
(ii) declared Bio Therapeutics Amended Motion for Summary Judgment moot;
and
(iii) denied Bio Therapeutics Motion to Enforce Settlement Agreement.
9.
SUBSEQUENT EVENTS
On
April
10, 2008, the Company completed a transaction pursuant to which it acquired
the
remaining sixty-two percent (62%) of Receptopharm’s issued and outstanding
common shares in exchange for a maximum of 30,000,000 shares of the Company’s
common stock. Prior to April 10, 2008, the Company owned 4,444,444 shares
or approximately 38% of Receptopharm’s common stock (See Note 4.) As a
result of this transaction, the Company now owns 100% of the issued and
outstanding common stock of Receptopharm. As of May 12, 2008, the Company
had issued 19,000,000 shares of its common stock in connection with this
transaction. In addition, during April 2008, the Company loaned
Receptopharm an additional $100,000 for working capital purposes.
On
April
29, 2008, the Company’s president advanced an additional $100,000 to the Company
for working capital purposes, increasing the balance owed to $912,749.
During
April 2008, the Company sold 500,000 shares of
its restricted common stock to two (2) accredited investors at a price of
$0.025
per share and received proceeds of $12,500.
9
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations
PLAN
OF OPERATIONS
Pending
adequate financing, we plan on spending total estimated expenses of $500,000
for
the next 12 months, which will include: (a) $380,000 pertaining directly to
our
operations; and (b) $120,000 pertaining the operations of our subsidiary,
Designer Diagnostics. Our Plan of Operations does not involve: (a) any expected
purchase or sale of a plant or significant equipment; and/or (b) any expected
significant changes in the number of our employees.
EXPENSES
PERTAINING TO OUR OPERATIONS
Type
of 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
|
*
Salaries include the following: (a) Chief Executive Officer - $130,000; and
(b)
Administrative Assistant - $45,000
FUNDING
OF DESIGNER DIAGNOSTICS, INC.
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
|
OUR
PLAN
OF OPERATIONS TO DATE:
To
date,
we have accomplished the following in our Plan of Operations:
In
approximately October 2005, we completed pre-clinical studies with various
companies that ReceptoPharm has agreements with pertaining to ReceptoPharm’s
Multiple Scherosis (MS) and HIV drugs, which consist of (a) and (b)
below:
(a)
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
10
(b)
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.
ཉ
|
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.
|
ཉ
|
In
February 2006, we completed the initial funding of ReceptoPharm in
the
amount of $2,000,000.
|
ཉ
|
In
January 2006, we established Designer Diagnostics to sell NonTuberculois
Mycobacterium test kits.
|
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
From
March and April of 2006, ReceptoPharm published two clinical trials
on the
use of their technology for the treatment of
pain.
|
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
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.
|
11
ཉ
|
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.
|
ཉ
|
In
January of 2007, ReceptoPharm began its Phase IIb human clinical
trial for
the treatment of AMN.
|
ཉ
|
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.
|
ཉ
|
In
March of 2007, Designer Diagnostics engaged the U.S. Commercial Service
to
help build international sales of its diagnostic test
kits.
|
ཉ
|
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.
|
ཉ
|
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).
|
ཉ
|
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.
|
ཉ
|
On
April 11, 2007, ReceptoPharm filed a patent for method of treating
autoimmune diseases, including MS and Rheumatoid
Arthritis.
|
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
During
July 2007, ReceptoPharm successfully completed enrollment in its
phase llb
human clinical trial for the treatment of AMN.
|
12
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
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.
|
ཉ
|
In
December 2007, ReceptoPharm successfully completed its six-month
patient
crossover in the Phase IIb/IIIa clinical trial for the treatment
of
Adrenomyeloneuropathy (AMN).
|
ཉ
|
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).
|
|
ཉ
|
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.
|
OUR
TWELVE-MONTH PLAN OF OPERATIONS PENDING ADEQUATE FINANCING
We
intend
to accomplish the following regarding our Plan of Operations over the next
twelve months.
Designer
Diagnostics, Inc.
Designer
Diagnostics’ NTM Test Kits are now being marketed and will continue to be
marketed to a global audience, including:
ཉ
|
Hospitals;
|
ཉ
|
Pharmaceutical
companies;
|
ཉ
|
Biotechnology
companies;
|
ཉ
|
Medical
device distributors;
|
ཉ
|
Governmental
organizations;
|
ཉ
|
Environmental
testing facilities; and
|
ཉ
|
Government
water and soil testing facilities at the local, state and federal
levels.
|
Over
the
next twelve months, Designer Diagnostics will attempt to distribute the test
kits to the above companies and organizations. Our first sales occurred during
our second quarter of 2006. When and if sales of the test kits exceed our
operating budget, we will use the test kit proceeds to fund drug research and
clinical studies in the area of MS and HIV.
Third-party
researchers are currently validating Designer Diagnostics’ TB Test Kit and we
anticipate research completion some time in 2008. Additionally, the test kits
are now utilized for environmental analysis for the presence of NTM in the
water
and/or soil. This allows investigators to easily find the source of
contamination and may greatly reduce NTM infections and outbreaks.
13
Designer
Diagnostics’ President will attempt to develop a distribution network and
actively market the test kits to supply administrators of companies and/or
governmental organizations in the following markets: hospitals; pharmaceutical;
biotechnology; medical device distributors. Designer Diagnostics will also
attempt to acquire other medical diagnostic products to develop that same
distribution market. Designer Diagnostic’s President will also seek license
agreements to develop revenue streams consisting of drug discovery, drug
development, and new medical device technologies.
ReceptoPharm
Clinical
Studies
In
January of 2007, ReceptoPharm began their clinical study in AMN.
AMN
is a
genetic disorder that affects the central nervous system. The disease causes
neurological disability that is slowly progressive over several decades.
Throughout our twelve month Plan of Operations and for 3 months thereafter,
ReceptoPharm plans to conduct clinical studies of its AMN drug. The study is
underway and completed its patient recruitment process and is being conducted
by
the Charles Dent Metabolic Unit located in London, England to conduct a clinical
study that provides for:
ཉ
|
Recruitment
of 20 patients with AMN;
|
ཉ
|
Administering
ReceptoPharm’s AMN drug under development;
and
|
ཉ
|
Monitoring
patients throughout a 15-month
protocol.
|
The
clinical study is classified as a Phase IIb/IIIa study and is the final step
required for regulatory approval of the drug.
In
the
areas of HIV and MS, ReceptoPharm plans to complete preclinical studies of
its
MS drug under development over the next 12 months. These include toxicology
studies as well as pharmacokinetic studies required for regulatory approval.
ReceptoPharm also plans to conduct clinical studies of its HIV and MS drugs
under development. These "Phase II" studies will either prove or disprove the
preliminary efficacy of ReceptoPharm's' HIV/MS drugs under development.
ReceptoPharm is in the process of attempting to secure agreements with third
parties to conduct such clinical studies.
Liquidity
and Capital Resources
Our
independent registered public accounting firm issued a going concern opinion
on
our audited financial statements for the fiscal year ended December 31, 2007.
We
have experienced recurring net losses and at March 31, 2008, we had an
accumulated deficit of $20,727,067, a working capital deficit of $832,148 and
a
stockholders’ deficit of $572,918. Our operations have been largely reliant upon
receiving loans from our Chief Executive Officer. At March 31, 2008, we were
indebted to our Chief Executive Officer in the amount of $812,749. Our ability
to continue as a going concern is contingent upon our ability to secure
additional financing, increase ownership equity, and attain profitable
operations. In addition, our ability to continue as a going concern must be
considered in light of the problems, expenses and complications frequently
encountered in established markets and the competitive environment in which
we
operate.
We
have
estimated expenses of $500,000 pertaining to our twelve month Plan of Operations
or $41,666 of monthly expenditures. Based on our current cash position, we
only
have enough funds to accomplish our operational plan for a period of three
months. Our ability to meet these expenses is dependent upon our ability to
raise additional capital or our management loaning us sufficient funds to meet
our expenses.
We
will
attempt to satisfy our estimated cash requirements for our twelve month Plan
of
Operations through the sale of Designer Diagnostics’ test kits; however, if
sales do not achieve adequate levels to provide for our operations, we will
be
have to raise additional capital through divestiture of assets, a private
placement of our equity securities or, if necessary, possibly through
shareholder loans or traditional bank financing or a debt offering; however,
because we are a development stage company with a limited operating history
and
a poor financial condition, we may be unsuccessful in obtaining shareholder
loans, conducting a private placement of equity or debt securities, or in
obtaining bank financing. In addition, if we only have nominal funds by which
to
conduct our operations, we may have to curtail our research and development
activities, which will negatively impact development of our possible
products.
14
We
have
no alternative Plan of Operations. In the event that we do not obtain adequate
financing to complete our Plan of Operations or if we do not adequately
implement an alternative plan of operations that enables us to conduct
operations without having received adequate financing, we may have to liquidate
our business and undertake any or all of the following actions:
ཉ
|
Sell
or dispose of our assets, if any;
|
ཉ
|
Pay
our liabilities in order of priority, if we have available cash to
pay
such liabilities;
|
ཉ
|
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;
|
ཉ
|
File
a Certificate of Dissolution with the State of California to dissolve
our
corporation and close our business;
|
ཉ
|
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
|
ཉ
|
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.
|
Based
upon our current assets, however, we will not have the ability to distribute
any
cash to our shareholders. If we have any liabilities that we are unable to
satisfy and we qualify for protection under the U.S. Bankruptcy Code, we may
voluntarily file for reorganization under Chapter 11 or liquidation under
Chapter 7. Our creditors may also file a Chapter 7 or Chapter 11 bankruptcy
action against us. If our creditors or we file for Chapter 7 or Chapter 11
bankruptcy, our creditors will take priority over our shareholders. If we fail
to file for bankruptcy under Chapter 7 or Chapter 11 and we have creditors,
such
creditors may institute proceedings against us seeking forfeiture of our assets,
if any.
We
do not
know and cannot determine which, if any, of these actions we will be forced
to
take. If any of these foregoing events occur, you could lose your entire
investment in our shares.
Results
of Operations
We
did
not recognize any revenues in the quarters ended March 31, 2008 and
2007.
15
General
and administrative expenses decreased by 43.4% or $135,686 from $312,970 for
the
quarter ended March 31, 2007, to $177,284 for the quarter ended March 31, 2008.
This decrease is due primarily to the fact that in 2007, we consolidated the
results of operations of Receptopharm. We did not consolidate the results of
operations of Receptopharm in the quarter ended March 31, 2008.
We
incurred a net loss of $617,973 during the quarter ending March 31, 2008
compared to a net loss of $376,161 for the comparable period in 2007. Of the
total loss in 2008, $425,000 was attributable to non-cash stock based
compensation related to the issuance of 17,000,000 shares of our common stock
to
employees and consultants in exchange for services rendered.
Off-Balance
Sheet Arrangements
We
have
not entered into any transaction, agreement or other contractual arrangement
with an entity unconsolidated with us under whom we have:
ཉ
|
an
obligation under a guarantee contract;
|
|
|
ཉ
|
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;
|
|
|
ཉ
|
any
obligation, including a contingent obligation, under a contract that
would
be accounted for as a derivative instrument, or;
|
|
|
ཉ
|
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.”
|
We
do not
have any off-balance sheet arrangements or commitments that have a current
or
future effect on its financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures,
or
capital resources that is material, other than those which may be disclosed
in
this Management’s Discussion and Analysis of Financial Condition and the audited
Consolidated Financial Statements and related notes.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Not
applicable
Item
4T. Controls and Procedures
As
required by Rule 13a-15 under the Securities Exchange Act of 1934, as amended
(“Exchange Act) we carried out an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures. This evaluation was
carried out under the supervision of our Chief Executive Officer who is also
our
Principal Financial and Accounting Officer. Following this inspection, this
officer concluded that our disclosure controls and procedures were effective
as
of March 31, 2008, the end of the period covered by this report. There have
been
no changes in our internal controls or in other factors, which have materially
affected, or are reasonably likely to materially affect, internal controls
subsequent to the date of the evaluation.
Disclosure
controls and procedures are controls and other procedures that are designed
to
ensure that information required to be disclosed in our reports filed or
submitted under the Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the Securities and Exchange
Commission’s rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information
required to be disclosed in our reports filed under the Exchange Act is
accumulated and communicated to management, including our Chief Executive
Officer, who also acted as our Principal Financial Officer as appropriate,
to
allow timely decisions regarding required disclosure.
PART
II. OTHER
INFORMATION
Item
1. Legal
Proceedings
On
April 4, 2005, a Motion to Enforce Settlement Agreement was filed against
us in the Circuit Court of Broward County Florida by Bio Therapeutics, Inc.
f/k/a Phylomed Corp. in Nutra
Pharma Corp. v. Bio Therapeutics, Inc. (17th
Judicial Circuit, Case No. 03-008928 (03). This proceeding results from our
alleged breach of a settlement agreement that was entered into between Bio
Therapeutics and us in resolution of a previous lawsuit between us and Bio
Therapeutics that was resolved by entering into a Settlement Agreement. In
conjunction with the settlement agreement, we also entered into a related
License Agreement and Amendment to the License Agreement (“License Agreement”)
with Bio Therapeutics regarding certain pieces of intellectual property
owned by Bio Therapeutics. In the April 4, 2005 motion, Bio Therapeutics
alleges that the Company breached certain provisions of the License Agreement
and requested that the Court grant its motion to enforce the Settlement
Agreement by declaring the License Agreement terminated, enjoining us from
further use of license products that was granted to it by the License Agreement,
and awarding attorneys’ fees and costs to Bio Therapeutics. During the last
quarter of 2007, we moved for summary judgment regarding Bio Therapeutics’
Motion to Enforce Settlement Agreement and the Court and on April 28, 2008,
the
Court (i) granted us a Cross Motion for Summary Judgment; (ii) declared Bio
Therapeutics Amended Motion for Summary Judgment moot; and (iii) denied Bio
Therapeutics Motion to Enforce a Settlement Agreement.
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Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
We
previously filed Forms 8-K filed on the following dates that detail our various
securities sales and issuances during the quarter ending March 31, 2008 and
thereafter on April 8, 2008 and April 14, 2008.
Item
5. Other
Information
We
previously filed a Form 8-K on April 14, 2008, which reported that as of March
14, 2008 there was a change in our control whereby our Chief Executive Officer,
Rik J. Deitsch obtained control of us as a result of the issuance of an
aggregate of fifty-three million (53,000,000) shares of our common stock to
Rik
J. Deitsch, five million (5,000,000) of which were issued for services and
forty-eight million (48,000,000) shares for discharge of debt we owed to him.
As
of March 31, 2008, Rik J. Deitsch owned 32.7% of our outstanding shares of
common stock.
Item
6. Exhibits
Exhibit
No.
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Title
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31.1
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Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
302 of the Sarbanes-Oxley Act of 2002.
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32.1
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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.
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SIGNATURES
In
accordance with the requirements of the Securities Exchange Act of 1934, the
registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Dated:
May 20, 2008
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NUTRA
PHARMA CORP.
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Registrant
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/s/ Rik
J. Deitsch
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Rik
J. Deitsch
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Chief
Executive Officer/Principal Financial Officer
Chief
Financial Officer/Principal Financial Officer
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