Attached files
file | filename |
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EX-31.1 - CERTIFICATION CEO - IMMUNOSYN CORP | ex31-1.htm |
EX-32.1 - CERTIFICATION CEO - IMMUNOSYN CORP | ex32-1.htm |
EX-32.2 - CERTIFICATION CFO - IMMUNOSYN CORP | ex32-2.htm |
EX-31.2 - CERTIFICATION CFO - IMMUNOSYN CORP | ex31-2.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
quarterly period ended September 30,
2009
¨ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
transition period from _____ to _____
Commission
file number 005-82677
IMMUNOSYN
CORPORATION
(Exact
Name of Registrant as Specified in its Charter)
Delaware
|
20-5322896
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer
Identification
No.)
|
10815
Rancho Bernardo Road, Suite 101, San Diego, CA
|
92127
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(888)
853-3663
(Registrant’s
Telephone Number, Including Area Code)
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last
Report)
Indicate
by check mark if the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act during the past 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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of
this chapter) during the preceding 12 months (or for such shorter period that
the Registrant was required to submit and post such files). Yes ¨ 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. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
Large
Accelerated Filer ¨
Accelerated
Filer x
Non-Accelerated
Filer ¨
Smaller reporting
Company ¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes ¨ No x
As of
December 14, 2009, the Company had 269,381,869 shares of Common Stock issued and
267,692,869 shares of Common Stock outstanding.
PART
I
Item
1.
|
Financial
Statements.
|
Immunosyn
Corporation
(A
Development Stage Company)
Balance
Sheets
(unaudited)
September
30,
2009
|
December
31,
2008
|
|||||||
ASSETS
|
||||||||
Current
Assets
|
||||||||
Cash
|
$ | 1,101 | $ | 2,052 | ||||
Prepaid
expenses
|
3,234 | 41,455 | ||||||
Total
Current Assets
|
4,335 | 43,507 | ||||||
Property
and equipment
|
6,433 | 6,433 | ||||||
Accumulated
depreciation
|
(3,431 | ) | (2,466 | ) | ||||
License
rights
|
400,000 | 400,000 | ||||||
Deposits
|
2,825 | 2,825 | ||||||
Total
Assets
|
$ | 410,162 | $ | 450,299 | ||||
LIABILITIES
AND SHAREHOLDERS’ DEFICIT
|
||||||||
Current
Liabilities
|
||||||||
Note payable
|
$ | 35,105 | $ | 35,105 | ||||
Accounts
payable
|
777,281 | 320,352 | ||||||
Accrued
expenses
|
6,060 | - | ||||||
Accrued
compensation to affiliate
|
40,500 | 14,268 | ||||||
Advances
from affiliates
|
1,029,101 | 893,663 | ||||||
Total
Liabilities
|
1,888,047 | 1,263,388 | ||||||
Shareholders’
Deficit
|
||||||||
Common
stock, $0.0001 par value, 425,000,000 shares authorized, 272,332,612
and
272,200,976
shares issued and 270,643,612 and 272,200,976 shares outstanding
at
September
30, 2009 and December 31, 2008, respectively
|
27,233 | 27,220 | ||||||
Additional
paid-in capital
|
1,164,619 | 1,094,630 | ||||||
Deficit
accumulated during the development stage
|
(2,669,568 | ) | (1,934,939 | ) | ||||
Less:
treasury stock, at cost (1,689,000 shares at $.0001)
|
(169 | ) | - | |||||
Total
Shareholders’ Deficit
|
(1,477,885 | ) | (813,089 | ) | ||||
Total
Liabilities and Shareholders’ Equity
|
$ | 410,162 | $ | 450,299 |
See
accompanying notes to unaudited financial statements.
2
Immunosyn
Corporation
(A
Development Stage Company)
Statements
of Expenses
(unaudited)
Three
Months
Ended
September
30,
2009
|
Three
Months
Ended
September
30,
2008
|
Nine
Months
Ended
September
30,
2009
|
Nine
Months
Ended
September
30,
2008
|
August
3, 2006
(inception)
Through
September
30, 2009
|
||||||||||||||||
EXPENSES
|
||||||||||||||||||||
General
& Administrative
|
$ | 162,682 | $ | 141,051 | $ | 672,370 | $ | 946,567 | $ | 2,519,926 | ||||||||||
Interest
Expense
|
27,005 | 16,034 | 62,259 | 44,724 | 149,642 | |||||||||||||||
NET
LOSS
|
$ | (189,687 | ) | $ | (157,085 | ) | $ | (734,629 | ) | $ | (991,291 | ) | $ | (2,669,568 | ) | |||||
Net
loss per common share, basic and diluted
|
(0.00 | ) | (0.00 | ) | (0.00 | ) | (0.00 | ) | ||||||||||||
Weighted
average number of common shares outstanding
|
270,619,398 | 272,164,837 | 271,037,499 | 272,033,560 | N/A |
See
accompanying notes to unaudited financial statements.
3
Immunosyn
Corporation
(A
Development Stage Company)
Statements
of Cash Flows
(unaudited)
Nine
Months
Ended
September
30,
2009
|
Nine
Months
Ended
September
30,
2008
|
August
3, 2006
(inception)
through
September
30, 2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$
|
(734,629
|
)
|
$
|
(991,291
|
)
|
$
|
(2,669,568
|
)
|
|||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
964
|
964
|
3,431
|
|||||||||
Imputed
interest on advances from affiliates
|
54,483
|
44,725
|
141,869
|
|||||||||
Services
rendered for stock
|
15,350
|
547,751
|
637,313
|
|||||||||
Changes
in:
|
-
|
|||||||||||
Prepaid
expenses
|
38,223
|
42,380
|
(3,234
|
)
|
||||||||
Other
assets
|
-
|
(1,661
|
)
|
(2,825
|
)
|
|||||||
Accounts
payable
|
456,929
|
116,317
|
812,387
|
|||||||||
Accrued
expenses
|
6,060
|
(
9,149
|
)
|
6,060
|
||||||||
Accrued
compensation to affiliate
|
26,232
|
-
|
40,500
|
|||||||||
Net
cash used in operating activities
|
(136,388
|
)
|
(249,964
|
)
|
(1,034,067
|
)
|
||||||
Cash
flows from investing activities:
|
||||||||||||
Purchase
of property and equipment
|
-
|
-
|
(6,433
|
)
|
||||||||
Net
cash used in investing activities
|
-
|
-
|
(6,433
|
)
|
||||||||
Cash
flows from financing activities:
|
||||||||||||
Net
advances from affiliates
|
135,437
|
226,158
|
1,029,101
|
|||||||||
Sale
of common stock
|
-
|
-
|
12,500
|
|||||||||
Net
cash provided by financing activities
|
135,437
|
226,158
|
1,041,601
|
|||||||||
Net
change in cash
|
(951
|
)
|
(23,806
|
)
|
1,101
|
|||||||
Cash
at beginning of period
|
2,052
|
24,115
|
-
|
|||||||||
Cash
at end of period
|
$
|
1,101
|
$
|
309
|
$
|
1,101
|
||||||
Supplemental
Disclosures
|
||||||||||||
Cash
paid for interest
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Cash
paid for income taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Non-Cash
Investing and Financing Activities
|
||||||||||||
Stock
issued for license rights
|
$
|
-
|
$
|
-
|
$
|
400,000
|
See
accompanying notes to unaudited financial statements.
Immunosyn
Corporation
Notes
To Unaudited Interim Financial Statements
Note
1 - BASIS OF PRESENTATION
The
accompanying unaudited interim financial statements of Immunosyn Corporation
(“Immunosyn” or the “Company”) have been prepared in accordance with accounting
principles generally accepted in the United States of America and the rules of
the Securities and Exchange Commission, and should be read in conjunction with
Immunosyn’s audited 2008 year end financial statements and notes thereto
contained in Immunosyn’s Annual Report on Form 10-K for the year ended December
31, 2008 filed with the Securities and Exchange Commission. In the
opinion of management, all adjustments, consisting of normal recurring
adjustments, necessary for a fair presentation of financial position and the
results of operations for the interim period have been reflected
herein. The results of operations for interim periods are, however,
not necessarily indicative of the results to be expected for the full
year. Notes to the financial statements which substantially duplicate
the disclosure contained in the audited financial statements for fiscal 2008 as
reported in the Company’s Annual Report on Form 10-K for the year ended December
31, 2008 have been omitted.
Treasury
Stock – Treasury stock is accounted for using the cost method.
Recently
Issued Accounting Pronouncements
Effective during the second quarter of
2009, the Company implemented ASC 855, Subsequent Events (“ASC
855”). This standard establishes general standards of accounting for
and disclosure of events that occur after the balance sheet date but before
financial statements are issued. The adoption of ASC 855 did not
impact the Company’s financial position or results of operations. The
Company evaluated all events or transactions that occurred after September 30,
2009 up through December 14, 2009, the date the Company issued these financial
statements. During this period, the Company did not have any material
recognizable subsequent events.
Note
2 - GOING CONCERN
During
the three and nine months ended September 30, 2009 and since inception,
Immunosyn has been unable to generate cash flows sufficient to support its
operations and has been dependent on advances from its
affiliates. Advances from affiliates have not been sufficient to
cover the Company’s expenses including the salary of its Chief Executive Officer
which the Company has been unable to pay since August 2008. In
addition to negative cash flow from operations, Immunosyn has experienced
recurring net losses, and has a negative working capital.
These
factors raise substantial doubt about Immunosyn’s ability to continue as a going
concern. The financial statements do not include any adjustments that
might be necessary if Immunosyn is unable to continue as a going
concern.
Note
3 - ADVANCES FROM AFFILIATES
As of
September 30, 2009, $1,020,542 is owed to Argyll Equities, LLC and Argyll
Biotechnologies, LLC who together own approximately 60% of Immunosyn’s common
stock. These advances are unsecured and are to be repaid on
demand. Interest expense in the amount of $54,483 was imputed using
an interest rate of 7.5% for the nine months ended September 30, 2009 and is
included in additional paid-in capital. Advances from Stephen D.
Ferrone, CEO and President of Immunosyn, in the amount of $8,559 are due and
payable on demand. These advances are unsecured and carry no interest
rate. The Company has accrued for an additional $40,500 in
compensation to Mr. Ferrone.
Note
4 – COMMON STOCK
Pursuant
to a contract entered into on October 12, 2007 for The Blaine Group (TBG)
to provide financial relations and investor relations services to Immunosyn, TBG
earned 121,636 restricted shares of Immunosyn common stock in the nine months
ended September 30, 2009 valued at $13,500.
Pursuant
to a contract entered into on September 29, 2008 for Bear Creek Advisors to
provide consulting services to Immunosyn, Bear Creek earned 10,000 restricted
share of Immunosyn common stock in the nine months ended September 30, 2009
valued at $1,850.
5
Note
5 – TREASURY STOCK
1,689,000 shares of common stock of the
Company were acquired and put into treasury stock on March 16, 2009 as part of a
settlement agreement with a shareholder. The purchase price was
zero.
Note
6 – COMMITMENTS AND CONTINGENT LIABILITIES
On
October 12, 2007, Immunosyn agreed to a 12 month contract with The Blaine Group,
Inc. (TBG) for TBG to undertake a national financial public relations and
investors relations campaign for Immunosyn. As part of this contract,
TBG agreed to handle all public relations matters, as agreed upon, for
Immunosyn. This contract continues until terminated by either party
with thirty days written notice. Immunosyn agreed to pay TBG $10,000
as a monthly retainer fee. $8,500 of this retainer is payable in cash
and $1,500 in stock to be valued at current market value on the date of
issue.
On August
25, 2009, a complaint was filed by Myron W. Wentz, a shareholder of the
Company, in the United States District Court for the Southern District of
California that names as defendants Argyll Biotech, Immunosyn and Does
1-10. The complaint alleges, among other things, that Argyll Biotech
breached its contract with the plaintiff and that Immunosyn tortiously
interfered with Argyll Biotech’s contract with the plaintiff. The
complaint seeks damages in the amount of $1,948,000 plus pre- and post-judgment
interest; consequential damages and attorneys fees in an amount to be
proven at trial against Argyll Biotech for breach of
contract; an order compelling Argyll Biotech to provide 14,984,615
shares of common stock of the Company to Dr. Wentz; and attorneys fees
in an amount to be proven at trial. The parties, including Immunosyn, have not
filed an answer to the complaint and the time to do so has officially passed.
The defendants are seeking a settlement with the plaintiff although there can be
no assurance that they will be able to successfully settle the
matter. It is possible that the plaintiff will seek to obtain a
default judgment against the defendants.
On August
24, 2009, a complaint was filed by Denise Campbell on behalf of a
putative class in the United States District Court for the Southern District of
Texas that names as defendants Immunosyn, Argyll Biotech, James T. Miceli,
Douglas A. McClain, Jr., Frank Morales, Argyll Equities, LLC, Stephen Ferrone
and Douglas A. McClain, Sr. The complaint alleges, among other
things, that the defendants have made false and/or misleading
statements concerning Immunosyn and SF-1019 in filings with the SEC in violation
of the Securities Exchange Act of 1934, as amended, including Section 10b-5
thereof, including, without limitation, that the Food & Drug Administration
had not approved SF-1019 for human injection, that SF-1019 had not received
compassionate waiver status, that SF-1019 was on clinical hold, that SF-1019 had
negative results in certain safety studies, that SF-1019 was being sold by the
defendants outside of the exclusive license held by Immunosyn and that Alan
Osmond was being paid to promote SF-1019; defendants have committed fraud in
their SEC disclosures and on their websites; defendants have engaged in civil
conspiracy; defendants have been unjustly enriched through the sale of Immunosyn
stock; and James T. Miceli, Douglas McClain, Sr. and Douglas McClain Jr. have
committed RICO violations and conspired to violate RICO. The complaint
seeks damages in an amount to be proven at trial, plus interest, costs and
attorneys fees. The parties, including Immunosyn, answered the
complaint on October 16, 2009. An initial pretrial conference is
expected to be held in December 2009 and discovery is expected to commence in
early 2010. Immunosyn intends to vigorously defend against the
allegations contained in the complaint which it believes to be untrue and
without merit.
Note
7- SUBSEQUENT EVENTS
On
December 19, 2007, a shareholder of Immunosyn, Leon S. Segen, commenced an
action in the Southern District of New York derivatively on behalf of Immunosyn
to recover alleged short-swing profits from several alleged statutory insiders
of Immunosyn, including Immunosyn officer and director Douglas A. McClain Jr.
The action included Immunosyn as a nominal defendant only and did not
allege any claims of liability against Immunosyn. On December 4,
2009, the parties entered into a settlement agreement, which was approved by the
court on December 15, 2009, pursuant to which the defendants agreed to pay
Immunosyn the sum of $475,000 consisting of a cash payment of $75,000 (for legal
fees for plaintiff’s counsel) and the forgiveness of $400,000 of indebtedness of
Immunosyn to defendant Argyll Equities and to retire 2,950,000 shares of
Immunosyn common stock held by defendant Argyll Equities to the treasury of
Immunosyn. Argyll Equities reduced the outstanding Advances from Affiliates
which Immunosyn owes to Argyll Equities by $400,000 effective as of December 4,
2009. Argyll Equities paid $75,000 on Immunosyn’s behalf for legal fees for
plaintiff’s counsel. On December 11, 2009, Argyll Equities effectively retired
2,950,000 shares of common stock held by it to Immunosyn’s
treasury.
6
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
Overview
Immunosyn
is a development stage company that was formed in August 2006 and is
headquartered in San Diego, California. In September 2006, it
executed an exclusive license agreement with an affiliated company, Argyll
Biotechnologies, LLC (“Argyll Biotech”), in exchange for 147,000,000 shares of
its Common Stock or approximately 54% of the outstanding shares of the Company’s
Common Stock. The license agreement was amended and restated in
October 2007. Pursuant to the terms of the license agreement, as
amended, the Company has an exclusive worldwide license to market, distribute
and sell a biopharmaceutical drug product, currently referred to as SF-1019, for
multiple uses including the treatment of a variety of diseases, subject to the
receipt of appropriate regulatory approval in each jurisdiction where SF-1019
will be marketed. Under the terms of its exclusive license, Immunosyn
also has a right of first offer to extend its exclusive license to include
variants of SF-1019 that may be approved by various regulatory authorities for
treatment of other diseases and pathologies. Argyll Biotech is
responsible for all research and product development, clinical testing,
regulatory approvals, production and product support. In accordance
with the amended license agreement, the parties agreed that the cost of SF-1019
to the Company will be 40% of the gross sales price of SF-1019 as sold to a
third party customer by the Company.
As a
sales, marketing, and distribution channel for SF-1019, Immunosyn’s primary
business strategy is to build a sales and marketing force and related resources
so that if SF-1019 is approved for human use it can be sold; and secondly, to
increase awareness and acceptance of SF-1019 in the medical
community.
As of the
date of this report, we have no revenue and limited operations. Those
operations have been principally funded by loans from affiliates. Our
ability to obtain additional funding will determine our ability to continue as a
going concern. From time to time, we have retained investment bankers
and other financial advisors to assist us with fundraising efforts; however,
those efforts have not been successful to date. We have one principal
asset, our exclusive license from Argyll Biotech, and one full-time and one
part-time employee. We do not expect to commence full scale
operations or generate revenue unless and until Argyll Biotech completes
development and obtains regulatory approval for SF-1019. Since
incorporation, we have not made any significant purchases or sale of assets
(other than our exclusive license from Argyll Biotech), nor have we been
involved in any mergers, acquisitions or consolidations.
Results
of Operations
To date,
the Company has had no revenue and limited operations. During the
nine months ended September 30, 2009 and since inception, Immunosyn has been
unable to generate cash flows sufficient to support its operations and has been
dependent on advances from its affiliates. In addition to negative
cash flow from operations, Immunosyn has experienced recurring net losses, and
has a negative working capital. During the nine months ended
September 30, 2009, the Company had a net loss of $734,629 and a loss of
$189,687 for the three months ended September 30, 2009, an accumulated deficit
of $2,669,568 and a working capital deficit of $1,883,712. See Note 2
of Notes to Unaudited Financial Statements for our going concern.
Currently,
an affiliated company provides general support services to the Company, without
charge. In addition, since inception, Immunosyn has borrowed
$1,020,542 from Argyll Equities, LLC and Argyll Biotech who together own
approximately 60% of Immunosyn’s Common Stock, including $135,437 which was
borrowed during the nine months ended September 30, 2009. Interest
expense in the amount of $54,483 was imputed on the aggregate advances using an
interest rate of 7.5% for the nine months ended September 30, 2009 and is
included in additional paid-in capital. These advances are unsecured
and will be repaid on demand. In October 2007, the Company hired a
Chief Executive Officer. The Company has advances from the CEO in the
amount of $8,559 as well which are due and payable on demand. These
advances are unsecured and carry no interest rate. The Company has
accrued for an additional $40,500 in compensation to Mr. Ferrone. The
Company’s funds have not been sufficient to cover its expenses resulting in a
net loss, an accumulated deficit and a working capital deficit. See
Note 3 of Notes to Unaudited Financial Statements.
The
Company needs additional financing to continue its current limited operations
and may raise funds in the future privately or publicly if it is able to do so
or will continue to look to advances from affiliates who are under no obligation
to provide funds to the Company.
In
addition, the Company intends to raise working capital through one or more
financings to meet the following requirements before it commences full scale
operations if and when Argyll Biotech completes development and obtains
regulatory approval for SF-1019:
·
|
Paying
current administrative staff;
|
·
|
hiring
staff, a full-time controller and five sales and marketing
personnel;
|
7
·
|
purchasing
capital equipment, including securing its principal offices, both
executive and sales, and distribution
facilities;
|
·
|
monitoring
the progress of the research and development effort conducted by Argyll
Biotech;
|
·
|
developing
a marketing plan for the sale and distribution of
SF-1019;
|
·
|
hiring
industry consultants to assist in developing a channel strategy for sales
and marketing of SF-1019, including direct sales, third party
distributors, and strategic
partnerships;
|
·
|
developing
market awareness in the patient and medical community and educating those
effected with various diseases including CIDP, diabetic neuropathy and
diabetic ulcers and other diseases;
and
|
·
|
selecting
and compensating board members.
|
The
Company requires substantial future sources of capital in order to meet such
anticipated expenditures and to continue its operations during the period Argyll
Biotech completes development of SF-1019 and seeks regulatory approval from US
and/or foreign regulatory authorities. The Company currently
anticipates this process to be between three and five years and the amount of
funds required to be between $14 million and $24 million.
The
Company believes that significant funding will be required to provide adequate
sources of working capital during that period. There can be no
assurance that the Company will be able to raise any or all the capital required
for its operations. See Note 2 to Unaudited Financial
Statements. Failure to obtain future financing will require the
Company to delay or substantially curtail its operations or close its business,
resulting in a material adverse effect on the Company and its
shareholders.
This
report includes “forward-looking statements” within the meaning of Section 27A
of the Securities Act, and Section 21E of the Exchange Act. All
statements other than statements of historical facts included in this
report, regarding the Company’s financial position, business
strategy, plans and objectives, are forward-looking
statements. Although the Company believes that the expectations
reflected in the forward-looking statements and the assumptions upon which such
forward-looking statements are based are reasonable, it can give no assurance
that such expectations and assumptions will prove to have been
correct.
In
addition, from time to time in the future, the Company may publish
“forward-looking statements” within the meaning of Section 27A of the Securities
Act, and Section 21E of the Exchange Act or make oral statements that constitute
forward-looking statements. These forward-looking statements may relate to such
matters as anticipated financial performance, future revenues or earnings,
business prospects, projected ventures, new products, anticipated market
performance, and similar matters.
The
Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements. In order to comply with the terms of the safe
harbor, the Company cautions readers that a variety of factors could cause the
Company’s actual results to differ materially from the anticipated results or
other expectations expressed in the Company’s forward-looking statements. These
risks and uncertainties, many of which are beyond the Company’s control,
include, but are not limited to: (i) the Company’s ability to raise financing to
fund its development and allow it to continue as a going concern; (ii) the
effects of the economy on the Company’s ability to find and maintain financing
options and liquidity; (iii) general economic conditions, both domestic and
international; (iv) Argyll Biotech’s ability to complete development of SF-1019
and other products it may acquire or develop and license to the Company; (v)
Argyll Biotech’s ability to obtain FDA and/or other regulatory approvals for
SF-1019 and other products it may acquire or develop and license to the Company;
(vi) competition from existing pharmaceutical, chemical and biotech companies
and other participants in the drug and related markets; (vii) legal developments
affecting the litigation experience of the Company including the results of any
subpoenas issued to the Company or its affiliates by the SEC and any pending
lawsuits involving the Company; (viii) the effectiveness of the Company’s
efforts to hire qualified personnel; (ix) changes in regulatory requirements
which could affect the cost and method of doing business; (x) the Company’s
ability to achieve its business plan; (xi) corporate governance issues; (xii)
credit, operations, legal and regulatory risks; (xiii) risks related to foreign
operations; and (xiv) risks related to disclosure controls and/or internal
controls or the lack thereof. There can be no assurance that the Company has
correctly or completely identified and assessed all of the factors affecting the
Company’s business. The Company does not undertake any obligation to publicly
update or revise any forward-looking statements. See also Item 1A – Risk Factors
in the Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2008.
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk.
|
We do not
presently enter into any transactions involving derivative financial instruments
for risk management or other purposes.
8
Our
available cash balances are held in our corporate bank account which is
non-interest bearing but is insured by the FDIC. We do not currently have any
cash flows that arise outside of the United States and today we are not subject
to market risk associated with changes in foreign exchange
rates.
Item
4.
|
Controls
and Procedures.
|
Controls and
Procedures
The
Company maintains disclosure controls and procedures (as defined in Rule
13a-15(e) under the Securities Exchange Act of 1934, as amended) that are
designed to ensure that information required to be disclosed by the Company in
reports it files or submits under the Securities Exchange Act of 1934, as
amended, is recorded, processed, summarized and reported within the time periods
specified in the SEC’s rules and forms and that such information is accumulated
and communicated to the Company’s management, including the Company’s Chief
Executive Officer and Chief Financial and Accounting Officer, as appropriate, to
allow timely decisions regarding required disclosures. In designing
and evaluating the disclosure controls and procedures, management recognizes
that any controls and procedures, no matter how well designed and operated, can
provide only reasonable assurance of achieving the desired control objectives,
and management necessarily is required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and
procedures.
As of the
end of the period covered by this report, and under the supervision and with the
participation of management, including its Chief Executive Officer and Chief
Financial and Accounting Officer, who are responsible for establishing and
maintaining adequate internal control over financial reporting as such term is
defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act, such persons
conducted an evaluation of the effectiveness of the design and operation of
these disclosure controls and procedures. Based on this evaluation and subject
to the foregoing, the Company’s Chief Executive Officer and Chief Financial and
Accounting Officer concluded that these controls are not effective because there
are material weaknesses in our internal control over financial
reporting.
Immunosyn
recognizes the importance of internal controls. As Immunosyn is
currently a development stage company with limited ongoing financial operations,
management is making an effort to mitigate this material weakness to the fullest
extent possible. At present this is done by having the Chief
Executive Officer review Immunosyn’s financial statements, account
reconciliations and accounts payable reports that have been prepared by Chief
Financial Officer for reasonableness. All unexpected results are
investigated. At any time, if it appears that any control can be
implemented to continue to mitigate such weakness, it will be immediately
implemented. As Immunosyn grows in size and as its finances allow,
management will hire sufficient accounting staff and implement appropriate
procedures for monitoring and review of work performed by our Chief Financial
Officer.
Changes in Internal
Controls
In our
efforts to continuously improve our internal controls, management intends to
take steps, when funding permits, to enhance controls and procedures as part of
our remediation efforts in addressing the material weaknesses described above
and in our Annual Report on Form 10-K for the year ended December 31, 2008. One
of the steps management intends to take is to increase documentation around
certain authorization and review controls.
9
PART
II
OTHER
INFORMATION
Item
1.
|
Legal
Proceedings.
|
Pursuant
to a subpoena dated January 20, 2006 issued by the Securities and Exchange
Commission to an affiliate of Argyll Biotech in proceedings captioned In the
Matter of Directors Financial Group, Ltd. and In The Matter of Prime Bank
Securities, and pursuant to subpoenas issued by the SEC to affiliates of Argyll
Biotech on March 30, 2006 and to Immunosyn on December 15, 2006 in a proceeding
captioned In The Matter of The Argyll Group, LLC, Immunosyn and its affiliates
have been asked to produce all documents concerning a wide variety of topics
including many related directly to Immunosyn. Immunosyn and Argyll Biotech’s
affiliates actively cooperated with the SEC and produced documents responsive to
these subpoenas, completing their responses in early August 2007. The
Directors Financial Group matter was resolved in June 2006 through a settlement
between the SEC and the parties to the proceeding, and, accordingly, Immunosyn
will not be required to respond further to that subpoena. Immunosyn
had had no further communication with the SEC regarding the remaining subpoenas
since January 2007 until March 2009. On or about March 17, 2009,
representatives of both Immunosyn and Argyll Biotech became aware that they had
received additional subpoenas from the SEC on or about March 6, 2009 (the “March
2009 Subpoenas”). In addition, on or about June 4, 2009, Immunosyn
directors and officers, Douglas A. McClain, Jr. and Stephen Ferrone, received
subpoenas from the SEC (the “June 2009 Subpoenas”) as did James T. Miceli, a
director and officer of Argyll Biotech, and Douglas A. McClain,
Sr. Immunosyn and Argyll Biotech subsequently learned from the SEC
that the March 2009 Subpoenas and the June 2009 Subpoenas would be treated as
voluntary requests. On or about September 11, 2009, Immunosyn
and Immunosyn directors and officers, Douglas A. McClain, Jr. and Stephen
Ferrone, received additional subpoenas from the SEC as did James T. Miceli, a
director and officer of Argyll Biotech, and Douglas A. McClain, Sr.
On August
25, 2009, a complaint was filed by Myron W. Wentz, a shareholder of the
Company, in the United States District Court for the Southern District of
California that names as defendants Argyll Biotech, Immunosyn and Does
1-10. The complaint alleges, among other things, that Argyll Biotech
breached its contract with the plaintiff and that Immunosyn tortiously
interfered with Argyll Biotech’s contract with the plaintiff. The
complaint seeks damages in the amount of $1,948,000 plus pre- and post-judgment
interest; consequential damages and attorneys fees in an amount to be
proven at trial against Argyll Biotech for breach of
contract; an order compelling Argyll Biotech to provide 14,984,615
shares of common stock of the Company to Dr. Wentz; and attorneys fees
in an amount to be proven at trial. The parties, including Immunosyn, have not
filed an answer to the complaint and the time to do so has officially passed.
The defendants are seeking a settlement with the plaintiff although there can be
no assurance that they will be able to successfully settle the
matter. It is possible that the plaintiff will seek to obtain a
default judgment against the defendants.
On August
24, 2009, a complaint was filed by Denise Campbell on behalf of a
putative class in the United States District Court for the Southern District of
Texas that names as defendants Immunosyn, Argyll Biotech, James T. Miceli,
Douglas A. McClain, Jr., Frank Morales, Argyll Equities, LLC, Stephen Ferrone
and Douglass A. McClain, Sr. The complaint alleges, among other
things, that the defendants have made false and/or misleading
statements concerning Immunosyn and SF-1019 in filings with the SEC in violation
of the Securities Exchange Act of 1934, as amended, including Section 10b-5
thereof, including, without limitation, that the Food & Drug Administration
had not approved SF-1019 for human injection, that SF-1019 had not received
compassionate waiver status, that SF-1019 was on clinical hold, that SF-1019 had
negative results in certain safety studies, that SF-1019 was being sold by the
defendants outside of the exclusive license held by Immunosyn and that Alan
Osmond was being paid to promote SF-1019; defendants have committed fraud in
their SEC disclosures and on their websites; defendants have engaged in civil
conspiracy; defendants have been unjustly enriched through the sale of Immunosyn
stock; and James T. Miceli, Douglas McClain, Sr. and Douglas McClain Jr. have
committed RICO violations and conspired to violate RICO. The complaint
seeks damages in an amount to be proven at trial, plus interest, costs and
attorneys fees. The parties, including Immunosyn, answered the complaint on
October 16, 2009. An initial pretrial conference is expected to be
held in December 2009 and discovery is expected to commence in early
2010. Immunosyn intends to vigorously defend against the allegations
contained in the complaint which it believes to be untrue and without
merit.
On
December 19, 2007, a shareholder of Immunosyn, Leon S. Segen, commenced an
action in the Southern District of New York derivatively on behalf of Immunosyn
to recover alleged short-swing profits from several alleged statutory insiders
of Immunosyn, including Immunosyn officer and director Douglas A. McClain Jr.
The action includes Immunosyn as a nominal defendant only and does not allege
any claims of liability against Immunosyn. On December 4, 2009, the
parties entered into a settlement agreement, which was approved by the court on
December 15, 2009, pursuant to which the defendants agreed to pay Immunosyn the
sum of $475,000 consisting of a cash payment of $75,000 (for legal fees for
plaintiff’s counsel) and the forgiveness of $400,000 of indebtedness of
Immunosyn to defendant Argyll Equities and to retire 2,950,000 shares of
Immunosyn common stock held by defendant Argyll Equities to the treasury of
Immunosyn. See Note 7 to unaudited financial statements.
On March
19, 2008, a shareholder of the Company, Deborah Donoghue, commenced two actions
— one in the U.S. District Court for the Southern District of California and the
other in the U.S. District Court for the Southern District of New York –
derivatively on behalf of the Company to recover alleged short-swing profits
from several alleged statutory insiders of the Company, including Company
officer and director Douglas A. McClain Jr. The actions include the
Company as a nominal defendant only and do not allege any claims of liability
against the Company. Donoghue withdrew the New York action in April
2008 and the California action was dismissed without prejudice in March 2009
subject to reopening the action nunc pro tunc to the date of dismissal upon ex
parte application or noticed motion by any party to reopen the
action.
10
On March
16, 2007, Frank Bramante and Salvatore Bramante commenced an action in the
United Stated District Court for the Southern District of California against
various defendants including Immunosyn seeking amongst other relief an
injunction to prevent the transfer and/or sale of the patents and/or proprietary
information relating to SF-1019 to third parties. The case was stayed
by Order dated January 17, 2008 pending resolution of a largely
duplicative action filed in the United Stated District Court for the
Western District of Texas, San Antonio Division, by the same plaintiffs against
the same defendants excluding Immunosyn on July 28, 2006. The Texas action
was dismissed with prejudice in September 2008 and a stipulation dismissing
the California action was filed with the Court and the entire California action
was dismissed with prejudice on or about June 3, 2009.
On or
about July 27, 2006, Daval filed suit in the High Court of Justice, Chancery
Division in London, England against Argyll Biotech and five of Argyll Biotech’s
research scientists and others, including Douglas McClain, Sr., seeking an
injunction and damages or an account of profits based on allegations of breach
by the scientists and Mr. McClain of confidentiality agreements with Daval,
breaches by such persons of their fiduciary duties and conspiracy by Argyll
Biotech and certain of its shareholders to wrongfully disclose and use Daval’s
alleged trade secrets. These proceedings do not allege infringement
of any Daval patent whether by Argyll Biotech or any of the other
defendants. Argyll Biotech has filed its defenses and continues to
investigate the merits of the suit and the basis of its defenses including,
among other grounds, that one of the active ingredients in SF-1019 disclosed in
Argyll Biotech’s 603 Application is based on independent research by Argyll
Biotech’s research scientists, and the method of producing SF-1019 is materially
different from Daval’s process. The action had been listed for trial in the UK
in January 2009 but, in December 2008, the High Court in London ordered that the
trial be rescheduled for a later date, likely to be during 2010. Immunosyn is
not involved in this litigation.
Item
1A.
|
Risk
Factors.
|
During
the nine months ended September 30, 2009, there were no material changes to the
information contained in Part I, Item 1A of the Company’s Annual Report on Form
10-K for the year ended December 31, 2008, but see “CAUTIONARY STATEMENTS
REGARDING FORWARD-LOOKING INFORMATION” in Part I, Item 2, above.
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
(A) and
(B) During the nine months ended September 30, 2009, The Blaine Group
(TBG) earned 121,636 shares of restricted common stock of the Company valued at
$13,500 (and having a per share value of approximately $0.111 on the due date)
pursuant to a contract entered into on October 12, 2007 for TBG to provide
financial relations and investor relations services to the
Company. Immunosyn agreed to pay TBG $10,000 as a monthly retainer
fee. $8,500 of this retainer is payable in cash and $1,500 in
restricted stock to be valued at the current market value on the date of
issue. See Notes 4 and 6 to Unaudited Financial
Statements.
These
shares would be issued pursuant to the exemption provided by Section 4(2) of the
Securities Act of 1933 as a transaction by an issuer not involving any public
offering.
As
previously disclosed, pursuant to a contract entered into on September 29, 2008
for Bear Creek Advisors to provide consulting services to Immunosyn, Bear Creek
earned 10,000 restricted share of Immunosyn common stock in the nine months
ended September 30, 2009 valued at $1,850. See Note 4 to Unaudited
Financial Statements.
(C) The
Company has no repurchase plans or programs. As previously disclosed,
1,689,000 shares of common stock of the Company were acquired and put into
treasury stock on March 16, 2009 as part of a settlement agreement with a
shareholder. The purchase price was zero. See Note 5 to
Unaudited Financial Statements.
Item 3.
|
Defaults
Upon Senior Securities.
|
Not
applicable.
Item
4.
|
Submission
of Matters to a Vote of Security
Holders.
|
None.
11
Item
5.
|
Other
Information.
|
As
previously reported, in November 2008, a physician submitted a
physician-sponsored Investigational New Drug (IND) application to the US Food
& Drug Administration (“FDA”) for a Phase II clinical trial for the
treatment of Multiple Sclerosis with SF-1019. In mid-September 2009, an officer
of Immunosyn learned from a third party that the FDA had previously notified the
physician-sponsor that his proposed study was on full clinical hold and could
not be initiated. The officer further learned that this full clinical
hold listed approximately nine specific clinical hold deficiencies, one of which
is related to Argyll Biotech’s need to complete full animal toxicity studies of
SF-1019 as described in FDA guidelines, and the information needed to resolve
the deficiencies.
Item
6.
|
Exhibits.
|
The
following exhibits are filed with, or incorporated by reference into, this
Report.
Exhibit
Number
|
Description
|
31.1*
|
Certification
of Stephen D. Ferrone, Chief Executive Officer, pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002.
|
Certification
of Douglas A. McClain, Jr., Chief Financial and Accounting Officer,
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
|
32.1*
|
Certification
of Stephen D. Ferrone, Chief Executive Officer, pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002.
|
32.2*
|
Certification
of Douglas A. McClain, Jr., Chief Financial and Accounting Officer,
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
____________________________
*
|
Filed
Herewith.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this Report to report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Dated: December
16, 2009
IMMUNOSYN
CORPORATION
|
|||
|
By:
|
/s/ Douglas A. McClain, Jr. | |
Douglas
A. McClain, Jr.
Chief
Financial and Accounting Officer
|
|||