NUTRA PHARMA CORP - Quarter Report: 2009 June (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 June 30, 2009
¨
|
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)
|
1537 NW 65th Avenue, Plantation, FL
33313
(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 ¨
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 ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
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 ¨ No x
The
number of shares outstanding of the registrant's common stock, par value $0.001
per share, as of August 14, 2009 was 220,176,482.
TABLE OF
CONTENTS
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial Statements
|
1
|
|
|
Consolidated
Balance Sheets as of June 30, 2009 (Unaudited) and December 31,
2008
|
1
|
|
|
Consolidated
Statements of Operations for the three and six months ended June 30, 2008
and 2009 (Unaudited) and for the period from inception (February 1, 2000)
to June 30, 2009
|
2
|
|
|
Consolidated
Statements of Cash Flows for the six months ended June 30, 2008 and 2009
(Unaudited) and for the period from inception (February 1, 2000) to June
30, 2009
|
3
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
4
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
7
|
|
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
16
|
|
|
Item
4T. Controls and Procedures
|
16
|
PART
II. OTHER INFORMATION
|
|
|
|
Item
1. Legal Proceedings
|
16
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
17
|
Item
3. Defaults Upon Senior Securities
|
17
|
Item
4. Submission of Matters to a Vote of Security Holders
|
17
|
|
|
Item
5. Other Information
|
17
|
|
|
Item
6. Exhibits
|
18
|
|
|
SIGNATURES
|
18
|
Forward
Looking Statements
This
Quarterly Report on Form 10-Q for the period ending June 30, 2009, most
significantly our "Plan of Operations" section, contains forward-looking
statements that involve risks and uncertainties, as well as assumptions that, if
they never materialize or prove incorrect, could cause the results of Nutra
Pharma Corp. (hereafter referred to as "we", "our" or "us") to differ materially
from those expressed or implied by such forward-looking statements. The words or
phrases "would be," "will allow, "intends to," "will likely result," "are
expected to," "will continue," "is anticipated," "estimate," "project," or
similar expressions are intended to identify "forward-looking statements." We
are subject to the following risks in connection with our business: (a) we have
experienced recurring net losses and a working capital deficiency and our
ability to continue as a going concern is dependent upon our ability to secure
additional financing, which raises substantial doubt about our ability to
continue as a going concern; (b) our history of losses makes it difficult to
evaluate our current and future business and our future financial results; (c)
our operational plans are dependent upon obtaining equity or other financing
and/or generating sufficient revenues; (d) we are subject to substantial Federal
Food and Drug Administration ("FDA") and other regulations which may increase
our costs or otherwise adversely affect our operations; (e) a market for our
potential products may never develop; (f) if we fail to adequately protect our
patents, we may be unable to proceed with development of potential drug
products; (g) we are dependent upon patents, licenses and other proprietary
rights from third parties; should we lose such rights our operations will be
negatively affected; (h) to date, we have not generated any significant
revenues; (i) to date, none of our proposed products have received FDA approval;
(j) should we continue to have insufficient funds to conduct our operations,
development of our possible products will be negatively impacted; (k) we may be
unable to compete against our competitors in the medical device and
biopharmaceutical markets since our competitors have superior financial and
technical resources than we do; and (l) we completed our acquisition
of ReceptoPharm as our wholly owned subsidiary in April 2008; our operations and
financial condition will be negatively affected if we fail to efficiently manage
their operations and their expansion plans pending adequate
financing.
All
statements other than statements of historical fact, are statements that could
be deemed forward-looking statements, including: (a) any projections of revenue,
gross margin, expenses, earnings or losses from operations, synergies or other
financial items; (b) any statements of the plans, strategies and objectives of
management for future operations; and (c) any statement concerning developments,
plans, or performance. Unless otherwise required by applicable law, we do not
undertake and we specifically disclaim any obligation to update any
forward-looking statements to reflect occurrences, developments, unanticipated
events or circumstances after the date of such statement.
Part
I. Financial
Information
Item
1. Financial Statements
NUTRA
PHARMA CORP.
(A
Development Stage Company)
Consolidated
Balance Sheets
December
31,
|
June
30,
|
|||||||
2008
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 50,910 | $ | - | ||||
Inventory
|
10,770 | 10,770 | ||||||
Prepaid
expenses
|
27,468 | 10,149 | ||||||
Total
current assets
|
89,148 | 20,919 | ||||||
Property
and equipment, net
|
9,941 | 9,164 | ||||||
Other
assets
|
8,133 | 8,803 | ||||||
TOTAL
ASSETS
|
$ | 107,222 | $ | 38,886 | ||||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 156,399 | $ | 240,029 | ||||
Accrued
expenses
|
849,856 | 946,857 | ||||||
Due
to officers
|
1,557,301 | 1,851,432 | ||||||
Other
loans payable
|
100,000 | 140,000 | ||||||
Total
current liabilities
|
2,663,556 | 3,178,318 | ||||||
Stockholders'
deficit:
|
||||||||
Common
stock, $0.001 par value, 2,000,000,000 shares authorized;
|
||||||||
211,276,482
and 220,176,482 shares issued and outstanding,
respectively
|
211,277 | 220,177 | ||||||
Additional
paid-in capital
|
21,503,591 | 21,744,691 | ||||||
(Deficit)
accumulated during the development stage
|
(24,271,202 | ) | (25,104,300 | ) | ||||
Total
stockholders' deficit
|
(2,556,334 | ) | (3,139,432 | ) | ||||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$ | 107,222 | $ | 38,886 |
See the
accompanying notes to the financial statements.
1
NUTRA
PHARMA CORP.
(A
Development Stage Company)
Consolidated
Statements of Operations
(Unaudited)
For
the
|
||||||||||||||||||||
Period
From
|
||||||||||||||||||||
February
1,
|
||||||||||||||||||||
2000
|
||||||||||||||||||||
(Inception)
|
||||||||||||||||||||
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
Through
June
30,
|
||||||||||||||||||
2008
|
2009
|
2008
|
2009
|
2009
|
||||||||||||||||
Sales
|
$ | - | $ | 8,398 | $ | - | $ | 26,628 | $ | 50,873 | ||||||||||
Cost
of sales
|
- | 3,000 | - | 3,260 | 7,789 | |||||||||||||||
Gross
profit
|
- | 5,398 | - | 23,368 | 43,084 | |||||||||||||||
Costs
and expenses:
|
||||||||||||||||||||
General
and administrative
|
342,233 | 294,463 | 519,517 | 571,805 | 8,724,990 | |||||||||||||||
Research
and development
|
- | 10,155 | - | 35,375 | 1,775,612 | |||||||||||||||
General
and administrative - stock based compensation
|
- | 195,000 | 425,000 | 215,000 | 7,644,657 | |||||||||||||||
Write-off
of advances to potential acquiree
|
- | - | - | - | 629,000 | |||||||||||||||
Finance
costs
|
- | - | - | - | 786,000 | |||||||||||||||
Interest
expense
|
14,302 | 17,965 | 29,991 | 34,286 | 487,900 | |||||||||||||||
Amortization
of license agreement
|
- | - | - | - | 155,210 | |||||||||||||||
Amortization
of intangibles
|
- | - | - | - | 656,732 | |||||||||||||||
Losses
on settlements
|
- | - | - | - | 1,261,284 | |||||||||||||||
Write-down
of investment in subsidiary
|
- | - | - | - | 620,805 | |||||||||||||||
Equity
in loss of unconsolidated subsidiary
|
- | - | - | - | 853,540 | |||||||||||||||
Write-off
of investment in Portage BioMed
|
- | - | - | - | 60,000 | |||||||||||||||
Write-off
of investment in Xenacare
|
- | - | - | - | 175,000 | |||||||||||||||
Net
gain from deconsolidation of Receptopharm
|
- | - | - | - | (1,081,095 | ) | ||||||||||||||
Write-off
of goodwill
|
- | - | - | - | 2,397,749 | |||||||||||||||
Total
costs and expenses
|
356,535 | 517,583 | 974,508 | 856,466 | 25,147,384 | |||||||||||||||
Net
loss
|
$ | (356,535 | ) | $ | (512,185 | ) | $ | (974,508 | ) | $ | (833,098 | ) | $ | (25,104,300 | ) | |||||
Per
share information - basic and diluted:
|
||||||||||||||||||||
Loss
per common share
|
$ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.00 | ) | ||||||||
Weighted
average common shares outstanding
|
184,221,396 | 215,518,240 | 135,769,858 | 213,409,079 |
See the
accompanying notes to the financial statements.
2
NUTRA
PHARMA CORP.
(A
Development Stage Company)
Consolidated
Statements of Cash Flows
(Unaudited)
For
the
|
||||||||||||
Period
From
|
||||||||||||
February
1,
|
||||||||||||
2000
|
||||||||||||
(Inception)
|
||||||||||||
Six
months ended June 30,
|
Through
June
30,
|
|||||||||||
2008
|
2009
|
2009
|
||||||||||
Net
cash (used in) operating activities
|
$ | (490,843 | ) | $ | (445,440 | ) | $ | (7,109,646 | ) | |||
Cash
flows from investing activities:
|
||||||||||||
Cash
reduction due to deconsolidation of Infectech
|
- | - | (2,997 | ) | ||||||||
Cash
reduction due to deconsolidation of Receptopharm
|
- | - | (1,754 | ) | ||||||||
Cash
acquired in acquisition of Infectech
|
- | - | 3,004 | |||||||||
Cash
acquired in acquisition of Receptopharm
|
40,444 | - | 40,444 | |||||||||
Acquisition
of property and equipment
|
- | - | (96,029 | ) | ||||||||
Loan
to Receptopharm
|
(300,000 | ) | - | (300,000 | ) | |||||||
Investments
carried at cost
|
- | - | (235,000 | ) | ||||||||
Net
cash (used in) investing activities
|
(259,556 | ) | - | (592,332 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Common
stock issued for cash
|
461,000 | 35,000 | 3,643,000 | |||||||||
Proceeds
from convertible loans
|
- | - | 304,750 | |||||||||
Proceeds
from notes payable
|
- | 40,000 | 140,000 | |||||||||
Repayment
of stockholder loans
|
- | - | (108,750 | ) | ||||||||
Loans
from stockholders
|
210,000 | 319,530 | 3,722,978 | |||||||||
Net
cash provided by financing activities
|
671,000 | 394,530 | 7,701,978 | |||||||||
Net
(decrease) in cash
|
(79,399 | ) | (50,910 | ) | - | |||||||
Cash
- beginning of period
|
122,810 | 50,910 | - | |||||||||
Cash
- end of period
|
$ | 43,411 | $ | - | $ | - | ||||||
Supplemental
Cash Flow Information:
|
||||||||||||
Cash
paid for interest
|
$ | - | $ | - | $ | - | ||||||
Cash
paid for income taxes
|
$ | - | $ | - | $ | - | ||||||
Non-cash
investing and financing activities:
|
||||||||||||
Assumption
of obligation under license agreement
|
$ | - | $ | - | $ | 1,750,000 | ||||||
Value
of shares issued as consideration in acquisition of Nutra Pharma,
Inc.
|
$ | - | $ | - | $ | 112,500 | ||||||
Payments
of license fee obligation by stockholder
|
$ | - | $ | - | $ | 208,550 | ||||||
Conversion
of stockholder loan to common stock
|
$ | - | $ | - | $ | 862,012 | ||||||
Loan
advances to Bio Therapeutics, Inc. by stockholder
|
$ | - | $ | - | $ | 629,000 | ||||||
Value
of common stock issued as consideration in
acquisition of Infectech, Inc.
|
$ | - | $ | - | $ | 4,486,375 | ||||||
Liabilities
assumed in acquisition of Infectech, Inc.
|
$ | 115,586 | ||||||||||
Cancellation
of common stock
|
$ | - | $ | - | $ | 14,806 | ||||||
Value
of common stock issued by stockholder to third party in connection
with settlement
|
$ | - | $ | - | $ | 229,500 | ||||||
Value
of common stock issued by stockholder to employee for services
rendered
|
$ | - | $ | - | $ | 75,000 | ||||||
Net
deferred taxes recorded in connection with
acquisition
|
$ | - | $ | - | $ | 967,586 | ||||||
Notes
payable settled with common stock
|
$ | - | $ | - | $ | 98,000 | ||||||
Settlement
of stockholder loan in exchange for common stock of
subsidiary
|
$ | - | $ | - | $ | 1,384,931 | ||||||
Settment
of debt with common stock
|
$ | 1,200,000 | $ | - | $ | 1,406,750 | ||||||
Expenses
paid by stockhoder
|
$ | - | $ | - | $ | 119,140 | ||||||
Value
of common stock issued for the acquisition of
Receptopharm
|
$ | - | $ | - | $ | 1,050,000 |
See the
accompanying notes to the financial statements.
3
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
June 30,
2009
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, 2008 and 2007, and for the years then ended, including notes
thereto included in the Company’s Form 10-K.
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 subsidiaries, Designer Diagnostics Inc. and ReceptoPharm Inc.
(collectively, the “Company”). All intercompany balances and transactions have
been eliminated in consolidation.
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.
Use of
Estimates
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.
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 June 30, 2009, the Company had negative working
capital of $3,157,399 and an accumulated deficit of $25,104,300. In addition,
the Company has no significant 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.
4
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
June 30,
2009
2. BASIS
OF REPORTING (continued)
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. DUE TO
OFFICERS
During
the six months ended June 30, 2009, the Company borrowed an additional $319,530
from its President, Rik Deitsch, increasing the total amount owed under to Mr.
Deitsch to $1,604,448. This demand loan is unsecured and bears
interest at a rate of 4.0%. Included in the amount owed to Mr.
Deitsch is $184,264 of accrued interest.
4.
STOCKHOLDERS’ DEFICIT
From
January 1 through June 30, 2009, the Company completed private placements of
restricted shares of its common stock, whereby it sold an aggregate of 1,400,000
shares at a price per share of $0.025. The Company received proceeds of
$35,000 in connection with the sale of these shares.
The
Company also granted one (1) warrant for each share sold which gives the
investor the right to purchase one (1) additional share until December 31, 2012
at an exercise price of $0.10 per share.
5. STOCK
BASED COMPENSATION
On March
30, 2009, the Company authorized the issuance of 1,000,000 shares of its
restricted common stock to two consultants for services rendered. These shares
were valued at $0.02 per share and accordingly the Company recorded stock based
compensation of $20,000. These shares were issued on April 1,
2009.
On June
4, 2009, the Company’s Board of Directors authorized the issuance of 1,500,000
shares of its restricted common stock to a consultant in exchange for services
rendered. These shares were valued at $0.03 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 $45,000 in
connection with the issuance of these shares.
On June
4, 2009, the Company issued 5,000,000 shares of its common stock to a consultant
for services rendered. These shares were issued pursuant to an
effective registration statement on Form S-8 and were not subject to a vesting
period. The fair market value of the shares on the date of grant was
$0.03 and accordingly the Company recorded stock based compensation of
$150,000.
6. STOCK
OPTIONS
A summary
of stock options and warrants is as follows:
|
Number
of
shares
|
Weighted
average
exercise
price
|
Weighted
average
fair
value
|
|||||||||
Balance
December 31, 2008
|
21,440,000
|
$
|
0.12
|
$
|
0.00
|
|||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Issued
|
1,400,000
|
0.10
|
0.00
|
|||||||||
Forfeited
|
-
|
-
|
-
|
|||||||||
Balance
June 30, 2009
|
22,840,000
|
$
|
0.12
|
$
|
0.00
|
5
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
June 30,
2009
6. STOCK
OPTIONS (continued)
The
following table summarizes information about fixed-price stock options and
warrants:
Exercise
Price
|
Weighted
Average
Number
Outstanding
|
Weighted
Average
Contractual
Life
|
Weighted
Average
Exercise
Price
|
||||||
$0.10
|
19,840,000
|
4.35
years
|
$
|
.10
|
|||||
$0.20
|
1,000,000
|
1.50
years
|
.20
|
||||||
$0.27
|
2,000,000
|
1.75
years
|
$
|
.27
|
|||||
22,840,000
|
All
options are vested and exercisable.
7.
CONTINGENCIES
On August
18, 2006, ReceptoPharm, our wholly owned subsidiary as of April 2008, was named
as a defendant in Patricia Meding, et. al. v.
ReceptoPharm, Inc. f/k/a Receptogen, Inc., Index No.: 18247/06 (New York
Supreme Court, Queens County). The original proceeding claimed that ReceptoPharm
owed the Plaintiffs, including Patricia Meding, a former ReceptoPharm officer
and shareholder and several corporations that she claims to own, the sum of
$118,928.15 plus interest and counsel fees on a series promissory notes that
were allegedly executed in 2001 and 2002. On August 23, 2007, the Queens County
New York Supreme Court issued a decision denying Plaintiff’s motion for summary
judgment in lieu of a complaint, concluding that there were issues of fact
concerning the enforceability of the promissory notes. On May 23, 2008, the
Plaintiffs filed an amended complaint in which they reasserted their original
claims and asserted new claims. The Plaintiffs amended complaint seeks damages
of no less than $768,506 on their claims, and now alleges that in or about June
2004 ReceptoPharm breached its fiduciary duty to the Plaintiffs as shareholders
of ReceptoPharm by wrongfully canceling certain of their purported ReceptoPharm
share certificates. ReceptoPharm has filed an answer denying the material
allegations of the amended complaint and has asserted a series of counterclaims
against the Plaintiffs alleging claims for declaratory judgment, fraud, breach
of fiduciary duty, conversion and unjust enrichment as a result of the
promissory notes. Discovery in this matter has just started. We
intend to vigorously contest this matter.
8.
SUBSEQUENT EVENTS
On July
30, 2009, the Company completed a private placement of restricted shares of its
common stock, whereby it sold 2,720,000 shares at a price per share of
$0.025. The Company received proceeds of $68,000 in connection with
the sale of these shares. The Company also granted one (1) warrant
for each share sold which gives the investor the right to purchase one (1)
additional share until December 31, 2012 at an exercise price of $0.10 per
share.
On July
14, 2009, the Company’s president Rik Deitsch loaned an additional $227,000 to
the Company for working capital purposes. As a result of this
additional loan and accrued interest, the Company owed Mr. Deitsch $1,837,512 as
of July 31, 2009.
6
Item
1A. Risk Factors
As a
Smaller Reporting Company, we are not required to provide the information
required by this item; however, our disclosure under Forward Looking Statements
above on page 1 of this report contains various risks that we are subject
to.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of
Operations/Plan of Operations
This
section must be read in conjunction with our unaudited Financial Statements and
accompanying notes included in Item 1 above.
Management’s
Discussion
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, 2008.
Our financial statements for the period ending June 30, 2009 are presented on a
going concern basis, which contemplates the realization of assets and
satisfaction of liabilities in the normal course of our business. We
have experienced recurring net losses and at June 30, 2009, we had an
accumulated deficit of $25,104,300 and negative working capital of
$3,157,399. Additionally, our operations have been largely
reliant upon receiving loans from our Chief Executive Officer, Rik
Deitsch. During the six months ended June 30, 2009, we borrowed an
additional $319,530 from Mr. Deitsch, increasing the total amount owed to him to
$1,604,448. Additionally, on July 14, 2009 (after this
financial quarter ending June 30, 2009), we borrowed an additional $227,000 from
Mr. Deitsch for working capital purposes and as of July 31, 2009 we owe Mr.
Deitsch $1,837,512.
We have
no significant revenue generating operations. Our ability to continue as a going
concern is contingent upon our ability to secure additional financing, increase
ownership equity, and attain profitable operations. Additionally, 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. Should we fail to secure adequate
financing or establish a sufficient revenue base to sustain our operations, we
may deplete our available funds and be unable to pay our
obligations.
7
We have
estimated expenses of $2,575,000 pertaining to our twelve month Plan of
Operations or $214,583 of monthly expenditures. Based on our current cash
position, we have insufficient funds to accomplish our operational
objectives for even one month. 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 and revenue
obtained from ReceptoPharm’s clinical research services; however, if our
revenues fail to achieve adequate levels to provide for our operations, we will
have to raise additional capital through a 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 accomplishing any such
financing. .
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:
|
·
|
Sell or dispose of our assets, if
any;
|
|
·
|
Pay our liabilities in order of
priority, if we have available cash to pay such
liabilities;
|
|
·
|
If any cash remains after we
satisfy amounts due to our creditors, distribute any remaining cash to our
shareholders in an amount equal to the net market value of our net
assets;
|
|
·
|
File a Certificate of Dissolution
with the State of California to dissolve our corporation and close our
business;
|
|
·
|
Make the appropriate filings with
the Securities and Exchange Commission so that we will no longer be
required to file periodic and other required reports with the Securities
and Exchange Commission, if, in fact, we are a reporting company at that
time; and
|
|
·
|
Make the appropriate filings with
the Financial Industry Regulatory Authority (FINRA) to effect a delisting
of our common stock, if, in fact, our common stock is trading on the
Over-the-Counter Bulletin Board at that
time.
|
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 –
Comparison of Three Month Periods Ending June 30, 2008 and June 30,
2009
Revenue
for the three months ended June 30, 2009 was $8,398. We did not have
any revenue in the three month period ended June 30, 2008. Our
revenues are generated from the provision of clinical research services to
independent third parties. These clinical research services are
performed by our wholly owned subsidiary, ReceptoPharm.
8
General
and administrative expenses decreased $47,770 or 14% from $342,233 for the
quarter ended June 30, 2008 to $294,463 for the quarter ended June 30,
2009. This decrease is due primarily to a reduction in our consulting
expenses as well as that of our wholly owned subsidiary,
ReceptoPharm.
We
incurred a net loss of $512,185 during the three month period ending June 30,
2009 compared to a net loss of $356,535 for the comparable 2008
period. This $155,650 or 30% increase in net loss is primarily
attributable to an increase in non-cash stock based compensation from $0 in the
three month period ended June 30, 2008 to $195,000 in the three month
period ended June 30, 2009.
Results of Operations –
Comparison of Six Month Periods Ending June 30, 2008 and June 30,
2009
Revenue
for the six months ended June 30, 2009 was $26,628. We did not have
any revenue in the six month period ended June 30, 2008. Our revenues
are generated from the provision of clinical research services to independent
third parties. These clinical research services are performed by our
wholly owned subsidiary, ReceptoPharm.
General
and administrative expenses increased $52,288 or 10% from $519,517 for the six
months ended June 30, 2008 to $571,805 for the six months ended June 30,
2009. This increase is due primarily to our consolidated results of
operations for the six months ended June 30, 2008 only including ReceptoPharm’s
expenses from April 10, 2008 through June 30, 2008.
We
incurred a net loss of $833,098 during the six month period ending June 30, 2009
compared to a net loss of $974,508 for the comparable 2008
period. This $141,410 or 15% decrease in net loss is primarily
attributable to a decrease in non-cash stock based compensation from $425,000
during the six months ended June 30, 2008 to $215,000 during the six months
ended June 30, 2009. In addition, our net loss for the six months
ended June 30, 2008 only includes the net loss attributable to ReceptoPharm from
April 10, 2008 to June 30, 2008.
Uncertainties and
Trends
Our
operations and possible revenues are dependent now and in the future upon the
following factors:
|
·
|
Whether we successfully develop
and commercialize products from our research and development
activities.
|
|
·
|
If we fail to compete effectively
in the intensely competitive biotechnology area, our operations and market
position will be negatively
impacted.
|
|
·
|
If we fail to successfully
execute our planned partnering and out-licensing of products or
technologies, our future performance will be adversely
affected.
|
|
·
|
The recent economic downturn and
related credit and financial market crisis may adversely affect our
ability to obtain financing, conduct our operations and realize
opportunities to successfully bring our technologies to
market.
|
|
·
|
Biotechnology industry related
litigation is substantial and may continue to rise, leading to
greater costs and possible unpredictable
litigation.
|
|
·
|
If we fail to comply with
extensive legal/regulatory requirements affecting the healthcare industry,
we will face increased costs, and possibly penalties and business
losses.
|
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:
·
|
an obligation under a guarantee
contract;
|
9
·
|
a retained or contingent interest
in assets transferred to the unconsolidated entity or similar arrangement
that serves as credit, liquidity or market risk support to such entity for
such assets;
|
·
|
any obligation, including a
contingent obligation, under a contract that would be accounted for as a
derivative instrument, or;
|
·
|
any obligation, including a
contingent obligation, arising out of a variable interest in an
unconsolidated entity that is held by us and material to us where such
entity provides financing, liquidity, market risk or credit risk support
to, or engages in leasing, hedging or research and development services
with us.
|
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.
PLAN
OF OPERATIONS
Pending
adequate financing, we plan on spending total estimated expenses of $2,575,000
for the next 12 months, which will include: (a) $380,000 pertaining directly to
our operations; (b) $120,000 pertaining to the operations of our subsidiary,
Designer Diagnostics and (c) $2,075,000 pertaining to the operations of our
subsidiary, ReceptoPharm. 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 pertaining to research
and due diligence
|
40,000
|
3,333
|
||||||
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 RECEPTOPHARM, INC.
Type of Expenditure
|
|
Total
Expenditure
|
|
|
Monthly
Expenditure
|
|
||
Salaries
|
$
|
350,000
|
$
|
29,167
|
||||
Clinical
Trial expenses
|
1,045,000
|
87,083
|
||||||
R
& D Expenses
|
394,000
|
32,833
|
||||||
Cost
of raw materials and production
|
236,000
|
19,667
|
||||||
Operating
Expenses (Rent, Supplies, Utilities, etc..)
|
50,000
|
4,167
|
||||||
Total
|
$
|
2,075,000
|
$
|
172,917
|
10
FUNDING
OF DESIGNER DIAGNOSTICS, INC.
Type of Expenditure
|
|
Total
Expenditure
|
|
Monthly
Expenditure
|
|
|||
Operating Expenses (Rent, supplies, utilities)
|
$
|
50,000
|
$
|
4,167
|
||||
Salaries (President)
|
70,000
|
5,833
|
||||||
Total:
|
$
|
120,000
|
$
|
10,000
|
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 Sclerosis (MS)
and HIV drugs, which consist of (a) and (b)
below:
|
•
|
MS Drug under Development
(RPI-78M) - ReceptoPharm conducted microarray and histoculture studies and
related analysis of the cells of Multiple Sclerosis patients to ascertain
how RPI-78M affected the cells of these patients. Microarray analysis is
the study of the gene expression of cells. Histoculture is the study of
the entire cellular environment. We measured the effect of RPI-78M on gene
expression using cDNA microarray technology to identify any potentially
unique changes in gene expression that may be caused by RPI-78M. After
statistical evaluation of the data, the researchers found more than sixty
genes with significant changes in expression as compared to the control.
In analyzing the affected genes, at least thirty of them may have a
specific role in the progression of the disease and symptoms of MS;
and
|
•
|
HIV Drug under Development
(RPI-MN) - Viral isolates are common mutations of HIV. ReceptoPharm,
through an agreement with the University of California, San Diego,
conducted research to study the effect of ReceptoPharm’s drug under
development on different viral isolates to determine the drug’s efficacy
in mutated forms of the HIV virus. The ability of the HIV virus to
establish resistance to therapeutic drugs through genetic mutation is a
major concern in the treatment of HIV/AIDS. HIV does not always make
perfect copies of itself. With billions of viruses being made every day,
lots of small, random differences can occur. The differences are called
mutations and these mutations can prevent drugs from working effectively.
When a drug no longer works against HIV, this is called drug resistance
and the virus with the mutation is considered to be ‘resistant’ to the
drug. With the increasing number of drug-resistant patients, it is of
great importance in the development of new HIV/AIDS therapeutics that they
will be effective against HIV of known resistance characteristics. The
inhibition of multi-resistant HIV-1 strains by RPI-MN preparations was
investigated at the La Jolla Institute of Molecular Medicine. The results
from these trials indicate that the drug is effective against
drug-resistant strains of
HIV.
|
•
|
On January 24, 2006, we obtained
NanoLogix’s intellectual property pertaining to the manufacture of test
kits for the rapid isolation, detection and antibiotic sensitivity testing
of certain microbacteria, which includes reassignment to us of 11 key
patents protecting the diagnostics test kit technology and NanoLogix
licensing to us, and the remaining 18 patents that protect the diagnostics
test kit technology.
|
•
|
In February 2006, we completed
the initial funding of ReceptoPharm in the amount of
$2,000,000.
|
•
|
In January 2006, we established
Designer Diagnostics to sell NonTuberculois Mycobacterium test
kits.
|
•
|
Designer Diagnostics held a
Continuing Medical Education Seminar at the Mahatma Gandhi Institute in
India on March 24, 2006 during the World Stop TB Day. At that meeting,
Designer Diagnostics officially began marketing their test kits for the
rapid isolation, detection and antibiotic-sensitivity testing of
microbacteria. In March 2006, we made our first sales of Designer
Diagnostics’ test kits.
|
11
•
|
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.
|
12
•
|
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 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.
|
13
•
|
During July 2008, ReceptoPharm
successfully completed the Phase IIb/IIIIa clinical trial or its drug
candidate for neurological and autoimmune disorders, RPI-78M as a
treatment for AMN.
|
•
|
During August 2008, ReceptoPharm
renewed its collaborative agreement with the Centers for Disease Control
and Prevention to study RPI-78M and RPI-MN for a possible therapy for
Rabies.
|
•
|
During August 2008, ReceptoPharm
reported initial positive safety data from its Phase IIb/IIIIa clinical
study of RPI-78M for treating
AMN.
|
•
|
During November 2008, we
announced that ReceptoPharm will provide RPI-78M under compassionate
release to patients previously enrolled in the Phase IIb/IIIa clinical
study of AMN.
|
•
|
During December 2008, we
announced that ReceptoPharm has received an agreement from an Ireland
based biotechnology firm, Celtic Biotech, Ltd, to provide GMP certified
drug production of CB-24 for Celtic Biotech’s upcoming European trial for
the treatment of cancer
|
•
|
In February 2009, ReceptoPharm
filed a patent application with the United States Patent and Trademark
Office for the use of RPI-78 as a novel method for treating arthritis in
humans.
|
•
|
In February 2009, ReceptoPharm,
in collaboration with Soochow University in China published positive data
from its recent animal studies on the use of RPI-78 (Cobratoxin) as a
method for treating
arthritis.
|
•
|
In March 2009, ReceptoPharm’s
clean room manufacturing and laboratory facility achieved ISO class 5
certification from Biotec, a UK-based firm specializing in European
clinical drug import and
distribution.
|
•
|
During the quarter ending March
31, 2009, we began generating revenue from ReceptoPharm’s clinical
research services.
|
•
|
A
ReceptoPharm study published in Toxicon, which is the journal of the
International Society of Toxinology, showed that ReceptoPharm’s leading
drug treatment for the treatment of pain, RPI-78, had pain reducing
effects that lasted four times as long as morphine without the negative
side effects associated with opioid-based pain
relievers.
|
•
|
In August 2009, ReceptoPharm
filed a patent application with the United States Patent and Trademark
Office for a new method of oral formulation of cobra venom aimed at
treating pain.
|
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:
·
|
Hospitals;
|
·
|
Pharmaceutical
companies;
|
·
|
Biotechnology
companies;
|
·
|
Medical device
distributors;
|
·
|
Governmental
organizations;
|
14
·
|
Environmental testing facilities;
and
|
·
|
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 with limited sales throughout
2007 and 2008. Our sales efforts during 2007, 2008 and thus far in 2009 have
been inhibited by the necessity for FDA validation prior to active marketing in
United States based markets. These markets include the CDC (Centers for Disease
Control and Prevention) and the WHO (World Health Organization). Researchers at
National Jewish Hospital in Denver, Colorado who are currently validating
Designer Diagnostics’ TB and NTM Test Kits. This research has been protracted
due to budget restrictions at the hospital as well as our own limited
funding. We currently anticipate the completion of this research and
regulatory filing by the fourth quarter of 2009.
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. 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.
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:
·
|
Recruitment of 20 patients with
AMN;
|
·
|
Administering ReceptoPharm’s AMN
drug under development; and
|
·
|
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.
We have
estimated expenses of $2,575,000 pertaining to our twelve month Plan of
Operations or $214,583 of monthly expenditures. Based on our current cash
position, we do not have enough funds to accomplish our operational plan. 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.
15
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.
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 June 30, 2009, 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 August
18, 2006, ReceptoPharm, our wholly owned subsidiary as of April 2008, was named
as a defendant in Patricia Meding, et. al. v.
ReceptoPharm, Inc. f/k/a Receptogen, Inc., Index No.: 18247/06 (New York
Supreme Court, Queens County). The original proceeding claimed that ReceptoPharm
owed the Plaintiffs, including Patricia Meding, a former ReceptoPharm officer
and shareholder and several corporations that she claims to own, the sum of
$118,928.15 plus interest and counsel fees on a series promissory notes that
were allegedly executed in 2001 and 2002. On August 23, 2007, the Queens County
New York Supreme Court issued a decision denying Plaintiff’s motion for summary
judgment in lieu of a complaint, concluding that there were issues of fact
concerning the enforceability of the promissory notes. On May 23, 2008, the
Plaintiffs filed an amended complaint in which they reasserted their original
claims and asserted new claims. The Plaintiffs amended complaint seeks damages
of no less than $768,506 on their claims, and now alleges that in or about June
2004 ReceptoPharm breached its fiduciary duty to the Plaintiffs as shareholders
of ReceptoPharm by wrongfully canceling certain of their purported ReceptoPharm
share certificates. ReceptoPharm has filed an answer denying the material
allegations of the amended complaint and has asserted a series of counterclaims
against the Plaintiffs alleging claims for declaratory judgment, fraud, breach
of fiduciary duty, conversion and unjust enrichment as a result of the
promissory notes. Discovery in this matter has just started. We intend to
vigorously contest this matter.
There are
no other legal proceedings that occurred during our Fiscal Quarter ending June
30, 2009 that are reportable.
16
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
On June
4, 2009, we issued 1,500,000 shares of our restricted common stock to a
consultant in exchange for services rendered. These shares were valued at
$0.03 per share, which is the fair market value of our common stock on June
4, 2009. The aggregate value of this stock based compensation is
$45,000.
We relied
upon Sections 4(2) and 4(6) of the Securities Act of 1933, as amended ("the
Act") in connection with the above issuances of the securities. We believed
Sections 4(2) and 4(6) were available because:
|
·
|
We are not and were not a blank
check company at the time of the offer or
sale;
|
|
·
|
The investors had business
experience and were accredited investors as defined by Rule 501 of
Regulation D of the Act;
|
|
·
|
All offers and sales of the
investment were made privately and no party engaged in any general
solicitation or advertising of the proposed
investment;
|
|
·
|
Each investor had a preexisting
social, personal or business relationship with us and members of our
management;
|
|
·
|
The investors were provided with
all information sufficient to allow them to make an informed investment
decision;
|
|
·
|
The investors had the opportunity
to inspect our books and records and to verify statements made to induce
them to invest;
|
|
·
|
The securities representing the
investment were issued with a restrictive legend indicating the securities
represented by the certificate have not been registered;
and
|
|
·
|
No party received any
transaction-based compensation such as commissions in regard to locating
any investor for the venture
|
Item
3. Defaults Upon Senior Securities
None
Item
4. Submission of Matters to a Vote of Security Holders
None
Item 5. Other Information
Departure
of Directors or Principal Officers; Election of Directors; Appointment of
Principal Officers
As we
previously reported on Form 8-K on July 29, 2009, on July 28, 2009, Stanley J.
Cherelstein, our Director since September 28, 2004, resigned as a Director of
our Board of Directors. Mr. Cherelstein was also Chairman of our
Audit and Compensation Committees from November 5, 2004 until his Director
resignation on July 28, 2009. Mr. Cherelstein’s resignation as a
Director was not regarding any matter pertaining to our operations, policies or
practices.
17
Also, as
we reported in the July 29, 2009 Form 8-K, on July 29, 2009, our Board of
Directors unanimously approved of: (a) the appointment of Garry Pottruck as a
Director of our Board of Directors: (b) the appointment of Mr. Pottruck as
Chairman of our Audit and Compensation Committees; and (c) a stock grant to Mr.
Pottruck for 2,500,000 shares of our common stock as compensation for his
service as our director.
Item 6. Exhibits
Exhibit No.
|
Title
|
|
31.1
|
Certification of
Chief Executive Officer and Chief Financial Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
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:
August 19, 2009
|
NUTRA
PHARMA CORP.
|
Registrant
|
/s/ Rik J. Deitsch
|
Rik
J. Deitsch
|
Chief
Executive Officer/Principal
Financial
Officer
|
18