This prospectus relates to the sale of up to 272,000,000 shares of our common stock by the selling
stockholders. The selling stockholders currently hold a total of 272,000,000 shares of our common
stock. There is no minimum total number of shares which must be sold in this offering, no minimum
price per share and no arrangements to place any of the proceeds of this offering in escrow. The
offering will terminate upon the earlier of (i) the second anniversary of the date of this
prospectus, (ii) the date on which all 272,000,000 shares have been sold, or (iii) the date on
which the Company elects to terminate this offering. The shares will not be offered through an
underwriter.
We will not receive any proceeds from the sale of our shares by the selling stockholders.
There is currently no trading market for Immunosyn’s securities.
INVESTING IN THE COMPANY’S COMMON STOCK INVOLVES SUBSTANTIAL RISKS, AND INVESTORS SHOULD NOT BUY
THESE SHARES UNLESS THEY CAN AFFORD TO LOSE THEIR ENTIRE INVESTMENT. SEE “RISK FACTORS” BEGINNING
ON PAGE 3.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR
DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
Price to the
Proceeds to Selling
public
Selling Commissions
Stockholders
Per Share
$.05
$-0-
$.05
Total Amount
(272,000,000
Shares)
$13,600,000
$-0-
$13,600,000
The shares offered hereby will be marketed directly through the selling stockholders, and no
sales commissions or underwriting fees will be paid.
The Company is paying the expenses of the offering.
This summary does not contain all of the information that you should consider before investing
in our common stock. You should carefully read the entire prospectus, including the section
entitled “Risk Factors” beginning on page 3 and the financial statements in this prospectus, prior
to making an investment decision.
About Immunosyn Corporation
Immunosyn Corporation (“Immunosyn” or the “Company”) is a Delaware corporation headquartered
in La Jolla, California that owns an exclusive worldwide license to market, distribute and sell a
biopharmaceutical drug product, currently referred to as SF-1019, for treatment of Chronic
Inflammatory Demyelinating Polyneuropathy (“CIDP”), diabetic neuropathy and diabetic ulcers,
subject to receipt of appropriate regulatory approval in each jurisdiction where SF-1019 will be
marketed. Under the terms of its exclusive license, the Company also holds a right of first offer
to extend its license to include variants of SF-1019 that may be approved by various regulatory
authorities for treatment of other diseases and pathologies.
The exclusive license and right of first offer have been granted to Immunosyn by Argyll
Biotechnologies, LLC (“Argyll Biotech”). Argyll Biotech is a closely-held Delaware limited
liability company, headquartered in La Jolla, California, that owns and controls worldwide rights
to SF-1019. SF-1019 has not been approved for human use in any jurisdiction. Argyll Biotech is
preparing to conduct clinical trials, develop manufacturing protocols and, if possible, apply for
regulatory approval of SF-1019’s use. Through a series of private investments, Argyll Biotech and
its affiliates and other persons have provided the funding to bring SF-1019 from its inception to
preliminary experimental research. Argyll Biotech intends to continue to manage and fund the
process for research, product development, clinical testing and regulatory approval of SF-1019,
including refinement for additional uses. SF-1019 is the first such product that Argyll Biotech
hopes to bring into the marketplace through these efforts. Argyll Biotech received 147,000,000
shares of Common Stock of the Company for its license fee and it intends to sell such shares in
this Offering.
Immunosyn’s primary asset is its exclusive license from Argyll Biotech to market, distribute
and sell SF-1019 for treatment of CIDP, diabetic neuropathy and diabetic ulcers. In addition to
SF-1019, Argyll Biotech has licensed certain intellectual property developed by Professor Kenneth
Willeford, Professor of Biochemistry and Molecular Biology, Mississippi State University. Argyll
Biotech has also retained Professors Jonathan Heeney, Chairman, Department of Virology,
BPRC, and Angus Dalgleish, Chair of Oncology, Gastroenterology and Endocrinology, St.
George’s Hospital Medical School, who are both well known anti-viral researchers and
immuno-pathology specialists, as its scientific advisors. We believe that the combined experience
of all of Argyll Biotech’s scientific advisory board members should provide substantial guidance
toward achieving approval of SF-1019 for marketing, distribution and sale to the target market.
SF-1019 is an experimental extract from caprine (goat) serum containing a number of unique
lipopeptide molecules. Argyll Biotech’s consultants first identified the precursor to SF-1019 in
the mid-1990’s, which they believed to be an effective booster and modulator of an individual’s
immune system. Subsequent research by such consultants revealed that the precursor to SF-1019 had
potential efficacy in the regulation and normalization of an individual’s immune system response to
multiple viral pathologies, including human immunodeficiency virus (“HIV”). Argyll Biotech intends
to develop SF-1019 for treatment of diabetes and CIDP first and then other diseases, and Immunosyn
will be responsible for commercializing SF-1019 when and as approval for such treatment is
procured.
Argyll Biotech is responsible for all research and product development, clinical testing,
regulatory approvals, production and product support.
Immunosyn’s
exclusive license agreement with Argyll Biotech shall remain in full force and
effect for as long as any patent coverage remains in place for SF-1019 in any country, which in
most jurisdictions is generally for twenty (20) years from the date of filing. Either party may
terminate the agreement only on account of an uncured material breach by the other party.
Immunosyn may terminate the agreement if a non-rebuttable regulatory or patient safety issue is
raised. Any fees paid prior to termination are non-refundable.
Immunosyn is a development stage company that was incorporated in August 2006 in order to work
as Argyll Biotech’s sales, marketing and distribution channel for SF-1019. Although Immunosyn
cannot guarantee that Argyll Biotech will successfully conclude development of SF-1019, Immunosyn
is hopeful that its initial product offering based on SF-1019 will be an effective and affordable
treatment for the maintenance and enhancement of the quality of life for patients suffering from
CIDP, diabetic neuropathy and diabetic ulcers.
As a sales, marketing, and distribution channel for Argyll Biotech’s treatment for CIDP,
diabetic neuropathy and diabetic ulcer treatments, Immunosyn’s primary business strategy is to
build a sales and marketing force and related resources so that if and when SF-1019 is approved for
human use it can be sold; and secondly, to increase awareness and acceptance of SF-1019 in the CIDP
and diabetes treatment communities.
As of the date of this prospectus, we have no revenue or operations. Our ability to obtain
additional funding will determine our ability to continue as a going concern. We have one principal
asset, our exclusive license from Argyll Biotech, and two part-time employees. We do not expect to
commence full scale operations or generate revenues 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, nor have we been involved in any mergers, acquisitions or
consolidations.
Summary of the Offering
Immunosyn is currently authorized to issue 450,000,000 million shares, of which 425,000,000
shares are common stock, par value $0.0001 per share (“Common Stock”), and 25,000,000 shares are
preferred stock, par value $0.0001 per share (“Preferred
Stock”). As of December 15, 2006,
272,000,000 shares of Common Stock are issued and outstanding and no shares of Preferred Stock are
issued and outstanding.
Pursuant to the offering described in this prospectus, the selling stockholders intend to sell
up to 272,000,000 shares of Common Stock to investors (the “Offering”).
The Company will not receive any proceeds from the Offering.
Investing in our securities involves a high degree of risk. Before making an investment
decision, you should carefully consider the risk factors set forth in this prospectus, as well as
other information we include in this prospectus. Although every effort has been made to anticipate
possible risks, unforeseen conditions and unexpected events may arise, and this list may not be
all-inclusive.
Our independent auditor has issued a going concern opinion which raises doubts about our ability to
continue as a going concern.
Our independent auditor has expressed doubt about our ability to continue as a going concern.
Note 2 to our financial statements includes an explanatory paragraph expressing doubt about our
ability to continue as a going concern. Our ability to continue as a going concern is dependent on
our ability to implement our business plan, raise capital and generate revenues.
Immunosyn or Argyll Biotech may not be able to secure financing, which in turn could affect
Immunosyn’s and Argyll Biotech’s respective abilities to operate as a going concern.
As of September 30, 2006, Argyll Biotech had an accumulated deficit of approximately
$2,550,000 and a working capital deficit of approximately $805,000. Argyll Biotech does not
anticipate any revenues in the foreseeable future but continues to incur significant losses from
operations. This raises substantial doubt about Argyll Biotech’s ability to continue as a going
concern. Argyll will require substantial additional financing to bring SF-1019 to market. If
adequate financing is not available to Argyll Biotech, it may be required to delay, scale back or
eliminate some of its research and development programs or the proposed clinical trials of SF-1019,
to relinquish rights to certain technologies or products or to license third parties to
commercialize technologies and products that Immunosyn might otherwise seek to license. Argyll
Biotech’s inability to obtain financing, if required, would have a material adverse effect on the
value of Immunosyn’s exclusive license and Immunosyn’s ability to develop its operations and implement its
business plan.
Argyll Biotech and Immunosyn have no operating history, which makes it impossible to evaluate their
business and to predict any future operating results.
To date, Immunosyn’s founders and Argyll Biotech have been primarily engaged in organizational
activities, including obtaining various consulting agreements for the development of products and
technologies and developing and testing products. Immunosyn has not generated any revenues to date
and does not anticipate generating any revenues until such time as SF-1019 is approved for
distribution by applicable regulatory authorities. Accordingly, neither Argyll Biotech nor the
Company has any operating history upon which an evaluation of their performance and prospects can
be made.
Immunosyn expects to incur substantial losses for the foreseeable future and may never achieve
profitability.
Immunosyn anticipates that it will continue to incur significant operating losses for the
foreseeable future. We may never generate revenues or achieve profitability and, if we ever
achieve profitability, we may not be able to maintain profitability.
Immunosyn and Argyll Biotech have no experience in completing development, obtaining regulatory
approval or marketing a novel biopharmaceutical product and, to be successful, both organizations
will need qualified personnel to complete development, successfully complete trials and launch
SF-1019 in the marketplace.
Both Argyll Biotech and Immunosyn are recently formed entities and, consequently, lack the
requisite personnel, facilities, equipment or experience to execute their product development,
testing, regulatory approval and marketing objectives. Argyll Biotech will be required to hire
additional qualified scientific and technical personnel as well as personnel with expertise in
clinical testing and government regulation, to expand various research and development programs and
to pursue product development, regulatory approval and marketing plans. Immunosyn will also have
to hire marketing and administrative personnel to promote its presence in the portion of the
medical community that treats maladies associated with CIDP and diabetes. There is intense
competition for qualified personnel in the areas of Argyll Biotech’s and the Company’s respective
activities, and there can be no assurances that Argyll Biotech or the Company will be able to
attract and retain the qualified personnel necessary for the development of its and their
respective businesses.
The Company and Argyll Biotech face competition for qualified individuals from numerous
pharmaceutical and biotechnology companies, universities and research institutions. The failure to
attract and retain key scientific, marketing and technical personnel would have a material adverse
effect on the development of the Company’s and Argyll Biotech’s respective businesses and our and
their abilities to develop, market and sell products.
The
Company and its affiliates, including Argyll Biotech, are recipients of several subpoenas issued by
the U.S. Securities and Exchange Commission to investigate their business practices and the
offering of investments in the Company’s predecessor.
Pursuant to a subpoena dated January 20, 2006 issued by the Securities and Exchange Commission
(“SEC”) 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 two subpoenas
issued by the SEC to affiliates of Argyll Biotech on March 30, 2006 in a proceeding captioned In
The Matter of The Argyll Group, LLC, the Company and its affiliates have been asked to produce all
documents concerning a wide variety of topics including many related directly to a prior licensee,
Nurovysn Merger Corporation. Pursuant to a third subpoena, dated
December 15, 2006, issued by the SEC to the Company, the Company has
been asked to produce documents concerning private placements of the
Company’s stock and other matters disclosed in this prospectus.
The Company and its affiliates are actively cooperating with the SEC and
have produced or are producing documents responsive to these
subpoenas. Although Immunosyn’s affiliates believe
they have complied and the Company intends to comply with the SEC’s subpoenas, there can be no assurance that the Company
and its affiliates will not be found liable for one or more violations of law which could expose the
Company and its affiliates, including Argyll Biotech, to liability for fines and penalties, as well as
injunctive or other sanctions that might prohibit or restrict the
Company’s or Argyll Biotech’s ability to proceed
with financing its operations. Even if the Company and its affiliates are fully in compliance with all
of their legal obligations, the existence of these proceedings may delay or otherwise negatively
impact their ability to conduct their operations, including any future registration of their or the
Company’s securities for an indefinite period of time. Furthermore, the existence of these
proceedings may discourage future investors from acquiring the securities of the Company or Argyll
Biotech.
SF-1019 has not been approved for any human use nor for treatment of any particular disease, and
such approval may never be obtained.
The Company is entirely dependent upon Argyll Biotech’s sole experimental drug, SF-1019, which
has not been tested in any clinical trials. Argyll Biotech has no patent on SF-1019 and has not
yet applied for regulatory approval of its use. Argyll Biotech and the Company cannot guarantee
that SF-
1019 will ever receive regulatory approval for the uses for which it may be licensed to
Immunosyn, namely, treatment of CIDP, diabetic neuropathy and diabetic ulcers. No clinical trials
have been conducted anywhere and following commencement of any clinical trials, completion and
evaluation of those trials may not occur or a substantial period of time may elapse before
Immunosyn has a product that may be sold and distributed for human use.
Even if a new drug product is well along the path of a clinical trial and the trial is close
to completion, regulatory authorities have the ability to shut down any trials due to safety,
efficacy or other concerns; to request additional trials or data to verify results; or to force any
portion or all of a trial to be repeated for any number of reasons. Any such action by the
regulatory authorities or any delay of a clinical trial could materially and adversely affect the
Company’s exclusive license from Argyll Biotech. Even if Argyll Biotech is successful in bringing
SF-1019 into a clinical trial for treatment of CIDP, diabetic neuropathy or diabetic ulcers, there
can be no assurances that those trials will successfully demonstrate that SF-1019 is efficacious
against CIDP, diabetic neuropathy or diabetic ulcers. Unless and until the appropriate regulatory
authority provides a final approval for the use of SF-1019 for treating CIDP, diabetic neuropathy
or diabetic ulcers, the licensed rights will be of no value.
Immunosyn has been informed that Argyll Biotech is implementing controls to prevent unregulated use
of SF-1019 and if Argyll Biotech is unable to do so or the FDA takes any action to prevent the
export or experimental use of unapproved drugs such as SF-1019, the Company’s licensed rights will
be of diminished or no value.
Prior to Argyll Biotech’s development of SF-1019, caprine serum had been the subject of
unregulated use by parties unrelated to Argyll Biotech and the Company. More recently, the Company
has learned that research samples of SF-1019 have been used by several individuals in the United
States and Mexico, and such uses have been publicized as “testimonials” on a shareholder’s web
site. To the extent unapproved research samples of SF-1019 have been exported from the United
States or used in the United States, the FDA may issue cease and desist letters and take other
action to prevent any further export, use or promotion within the United States. Such actions by
the FDA, if any, may delay or affect Argyll Biotech’s ability to obtain FDA approval for SF-1019
and will have a material adverse effect on the Company’s exclusive license from Argyll Biotech.
The Company has been informed that Argyll Biotech has taken
steps to prevent distribution or export of SF-1019 for unapproved human use in any country,
including the United States. In addition, the Company has informed all of its shareholders to
discontinue all further promotion of SF-1019 that does not comply with FDA regulations. The
Company’s Board of Directors has assumed responsibility for coordinating these controls with Argyll
Biotech and monitoring their implementation.
The Company depends on Argyll Biotech’s patent and proprietary rights to develop and protect
technologies and products, which rights may not offer sufficient protection from infringement by
third parties.
Argyll Biotech has represented to Immunosyn that it has obtained from Mississippi State
University (“MSU”) an exclusive license to U.S. patent application serial No. 10/825,603
(“Prophylactic and therapeutic benefits of a new class of immune stimulating peptides” or the “603
Application”) and pending foreign equivalents derived from the same application family. However,
no patents have yet been issued to Argyll Biotech and there can be no assurances that any of these
applications will ever be issued as a patent or patents. In addition, although it is the Company’s
belief that the 603 Application, if issued as a patent, encompasses certain therapeutically active
components which are included in SF-1019,
it is unlikely that claims in the 603 Application, even
if allowed, will provide any protection for the entire body of components contained within SF-1019.
Argyll Biotech’s inability to protect its intellectual property through sufficient patent
protection will adversely affect that Company’s ability to preserve exclusive rights to SF-1019 and
other products, and other companies may be able to develop substantially similar technologies in
competition with Argyll Biotech. If those other companies enter the marketplace with their own
similar products, the value of Immunosyn’s exclusive license from Argyll Biotech will be
substantially diminished.
The pharmaceutical industry places considerable importance on obtaining patent and trade
secret protection for new technologies, products and processes. The Company’s success will depend
on Argyll Biotech’s ability to obtain and enforce protection under United States and foreign patent
laws and other intellectual property laws for the products that the Company intends to market and
distribute, to develop and preserve the confidentiality of trade secrets and to operate without
infringing the proprietary rights of third parties.
Neither Immunosyn nor Argyll Biotech can guarantee that any applications for additional
patents will ever be filed or that, if filed, they will result in issued patents or that such
patents, if issued, will provide adequate protection against competitors. Patents may not be
issued from these applications and any rights granted thereunder may not provide Immunosyn or
Argyll Biotech with competitive advantages. Immunosyn cannot guarantee that any patents that may
be issued would survive an attack on their validity or that they will provide a competitive
advantage over Argyll Biotech’s or Immunosyn’s competitors.
Immunosyn’s exclusive license from Argyll Biotech is the Company’s primary asset and the exclusive
license agreement, including, without limitation, the fee established in that agreement, is between
related entities and does not bear any relationship to established or traditional methods of
valuing such fees and, as such, may be unfair to the Company.
Pursuant to our exclusive license agreement with Argyll Biotech, the Company issued
147,000,000 shares of Common Stock to Argyll Biotech at par value of $0.0001 per share in payment
of the exclusive world-wide license rights to SF-1019 for a term that will last until expiration of
the last patent covering SF-1019, if any, which in most jurisdictions is twenty years from the date
of filing. To the extent the proceeds from Argyll Biotech’s sale of the Company stock in this
Offering are insufficient to fund completion of product development and regulatory approval of
SF-1019, the Company is obligated to pay Argyll Biotech a license fee equal to 3 1/2% of the
Company’s net sales of SF-1019, in addition to the cost of product purchases from Argyll. The
exclusive license agreement, including, without limitation, the fee established in that agreement,
is between related entities, was not negotiated in an arms-length transaction, and does not bear
any relationship to established or traditional methods of valuing
such fees. Instead, the license rights were recorded at Argyll
Biotech’s cost basis of the underlying patents licensed to
Immunosyn.
Immunosyn’s inability or failure to pay any license fees when due will adversely affect the
Company’s licensed rights, which will cause the Company to lose substantially all of its value.
The Company’s inability or failure to pay any license fees when due will adversely affect the
Company’s licensed rights. As those rights will be the Company’s primary asset, if the Company is
unable to maintain those rights, the Company will lose substantially all of its value.
Argyll Biotech may use the proceeds from this Offering of its shares for purposes other than the
development and regulatory approval of SF-1019; the terms of Immunosyn’s exclusive license
agreement do not provide the Company with any oversight or right to control Argyll Biotech’s use of
such license fees.
Argyll Biotech reserves the right to use the cash and other proceeds it receives from the sale
of the Company’s stock received as payment of its license fee for purposes other than development
and regulatory approval of SF-1019, including corporate purposes of its other affiliates.
Furthermore, under the terms of the exclusive license agreement between Argyll Biotech and
Immunosyn, the license fee was deemed earned by Argyll Biotech when Immunosyn issued its shares of
Common Stock and non-refundable, regardless of the true cost of completing development and
obtaining regulatory approval of SF-1019. The Company will have no right to control the proceeds
received by Argyll Biotech from its sale of the Company’s stock, and the Company has no audit or
other rights to require that all of these proceeds be applied solely to the development and
regulatory approval of SF-1019. If the amount required to achieve these goals is less than the
amount of the proceeds received from Argyll Biotech’s sale of the Company’s stock, the Company will
not be entitled to any refund. In the event Argyll Biotech is unsuccessful in completing product
development or obtaining regulatory approval, the Company has no right to make any claim with
respect to Argyll Biotech’s use of the proceeds.
Argyll Biotech will be our sole supplier of SF-1019; the exclusive license agreement does not fix
the purchase price the Company will pay to Argyll Biotech for manufacturing and supplying SF-1019
and Immunosyn may be unable to negotiate rights to distribute SF-1019 for uses other than CIDP,
diabetic neuropathy and diabetic ulcers.
In the event Argyll Biotech succeeds in obtaining regulatory approval for distribution and
sale of SF-1019, Argyll Biotech will be the sole supplier of SF-1019 to the Company. In the event
of any disruption in the manufacturing process of Argyll Biotech and its contractors, the Company
will have no other source for purchasing SF-1019 and satisfying its customer commitments. Argyll
Biotech will determine the purchase price for SF-1019 in its reasonable discretion based on its
manufacturing costs, development expenses, overhead and customary industry mark-up. Furthermore,
under the terms of the exclusive license agreement, the Company’s rights to distribute SF-1019 are
limited to treatments for CIDP, diabetic neuropathy and diabetic ulcers. In the event Argyll
Biotech develops additional applications for SF-1019, the Company will be entitled to a right of
first offer to license those additional variations or uses of SF-1019 from Argyll Biotech.
However, there is no assurance that the Company will be successful in negotiating an extension of
its exclusive license to include any such variations or additional uses of SF-1019.
The safety and efficacy profiles for SF-1019 that emerge from controlled clinical trials may be
substantially less favorable than in prior uncontrolled observations of SF-1019’s precursors which
may materially and adversely affect our business.
Argyll Biotech’s only data regarding the safety and efficacy of SF-1019 is based on
uncontrolled observations of a precursor to SF-1019 among a small group of individuals, not SF-1019
itself. If and when formal and controlled clinical trials are conducted using SF-1019 over broad
populations and geographic areas, it is possible that heretofore unknown adverse safety and
unfavorable efficacy effects may be observed, in which case the Company’s ability to market SF-1019
for its intended use may be materially and substantially affected or eliminated. Moreover, formal
clinical trials are expensive and Argyll Biotech may have severely underestimated the cost of
conducting and concluding such trials. If the Company is unable to commence the marketing,
distribution and sale of SF-1019 because formal clinical trials reveal adverse safety or lack of
efficacy information, or if the clinical trials last longer or
sustain substantially higher costs
than are currently projected, the Company’s business will be severely and adversely diminished.
A decrease in the projected prices that Immunosyn may charge for SF-1019 and the level of third
party reimbursement that Immunosyn may receive from third party payors may adversely impact our
business.
To the extent that SF-1019 becomes approved for distribution in the United States or in any
foreign markets, Immunosyn’s ability to commercialize SF-1019 successfully will depend in part on
the price Immunosyn may charge for that product and on the extent to which reimbursement for the
cost of that product will be available from government health administration authorities, private
health insurance and other third-party payers. Government officials and private health insurers are
increasingly challenging the price of medical products and services. Significant uncertainty
exists as to the pricing flexibility which distributors will have with respect to newly approved
health care products as well as their reimbursement. There can be no assurance that the Company’s
assumptions concerning product pricing will be achieved.
Third-party payers may attempt to control costs further by selecting exclusive providers of
their pharmaceuticals products. If third-party payers were to make this type of arrangement with
one or more of Immunosyn’s competitors, those payers would not reimburse patients for purchasing
SF-1019.
Argyll Biotech may not apply for or be successful in receiving orphan/special drug status on any
products.
Under the Orphan Drug Act, the United States Food and Drug Administration (“FDA”) may grant
orphan drug designation to drugs intended to treat a rare disease or condition. A disease or
condition that affects populations of fewer than 200,000 people in the United States generally
constitutes a rare disease or condition. Argyll Biotech may seek orphan drug approval for certain
aspects or treatment modalities of SF-1019 in an attempt to get SF-1019 into the marketplace more
quickly. There can be no assurances that SF-1019 is entitled to orphan drug status, that Argyll
Biotech will proceed with this strategy or that, if it does proceed, any orphan drug designation
will be approved or authorized.
If Argyll Biotech fails to keep up with rapid technological change and evolving therapies, the
proprietary technologies that form the substance of SF-1019 could become less competitive or
obsolete.
The pharmaceutical industry is characterized by rapid and significant technological change.
Immunosyn expects that pharmaceutical technology will continue to develop rapidly and the Company’s
future success will depend on Argyll Biotech’s ability to develop and maintain a competitive
position. Technological development by others may result in products developed by Argyll Biotech
or the Company, both branded or generic, becoming obsolete before they are marketed or before
Immunosyn or Argyll Biotech recover any portion of their expenses incurred with respect to such
product. Alternative therapies or new medical treatments could alter existing treatment regimes,
and thereby reduce the need for one or more of the products developed by Argyll Biotech, which
would adversely affect Immunosyn’s business.
Many of Immunosyn’s competitors have substantially greater capabilities and resources and may be
able to market products more effectively, which would limit Immunosyn’s ability to generate revenue
and cash flow.
Competition in Immunosyn’s industry is intense. Potential competitors in the United States
and Europe are numerous and include pharmaceutical, chemical and biotechnology companies, most of
which have substantially greater capital resources, marketing experience, research and development
staffs and facilities than does Immunosyn. Among others, Eli Lilly & Company and Wyeth
Pharmaceuticals, Inc. market antidepressants, and Pfizer, Inc. markets anticonvulsants that are
prescribed for treating diabetic neuropathy. In addition, Daval International Limited, a UK
company, is also testing a caprine serum product, called Aimspro, for treating multiple sclerosis
and other neurological disorders
Argyll Biotech intends to seek to limit potential sources of competition by developing
products that are eligible for orphan drug designation and New Drug Application (“NDA”) approval or
other forms of protection, but Argyll Biotech’s and Immunosyn’s competitors may develop similar
technologies and products more rapidly or may market them more effectively. Competing technologies
or products may be more effective than any of those that are being or will be developed by Argyll
Biotech.
Immunosyn will depend on Argyll Biotech and other third parties for clinical testing of SF-1019. Any
disruption in such third party relationship could delay the Company’s ability to distribute and
market products on a timely basis or at all.
Neither Immunosyn nor Argyll Biotech currently has any internal product testing capabilities.
Argyll Biotech’s inability to retain third parties for the clinical testing of products on
acceptable terms, or at all, would adversely affect their ability to develop, distribute and market
products. It will be Argyll Biotech’s responsibility to arrange for and supervise clinical
testing. Any failures by third parties to adequately perform their responsibilities may delay the
submission of products for regulatory approval, impair Immunosyn’s ability to deliver products on a
timely basis or otherwise impair Immunosyn’s competitive position. The Company’s dependence on
third parties for the development of products may adversely affect its potential profit margins and
its ability to deliver products on a timely basis.
Argyll Biotech and Immunosyn will depend on others to manufacture their products and any disruption in
manufacturing could have a material adverse effect on our business.
Argyll Biotech and Immunosyn have never manufactured any products and SF-1019 may not be
suitable for commercial manufacturing in a cost-effective manner. Manufacturers of products
developed by Argyll Biotech will be subject to current good manufacturing practices prescribed by
the FDA and other rules and regulations prescribed by applicable regulatory authorities. Argyll
Biotech may not be able to enter into or maintain relationships either domestically or abroad with
manufacturers whose facilities and procedures comply or will continue to comply with current good
manufacturing practices or applicable foreign requirements. Failure by a manufacturer to comply
with current good manufacturing practices or applicable foreign requirements could result in
significant time delays or Immunosyn’s inability to commercialize or continue to market a product
and could have a material adverse effect on Immunosyn’s sales of products and, therefore, its cash
flow.
In the United States, failure to comply with current good manufacturing practices or other
applicable legal requirements can lead to federal seizure of violating products, injunctive actions
brought by the federal government and potential criminal and civil liability on part of a company
and its officers
and employees. Argyll Biotech’s or Immunosyn’s failure to satisfy any of these
legal requirements prior to attempting to market or distribute any products will place the Company
and its resources and assets at substantial risk.
Immunosyn has limited sales and marketing capability and may not be successful in selling or
marketing any products.
Immunosyn currently has no sales and marketing capability. The creation of infrastructure to
commercialize medical products is a difficult, expensive and time-consuming process. Immunosyn may
not be able to establish direct or indirect sales and distribution capabilities anywhere in the
world or be successful in gaining market acceptance for any products, including SF-1019.
Some of the concepts that are inherent in Argyll Biotech’s technologies have been known, in various
forms, for several years, and at least one other party is developing similar drug products based on
those concepts which, if approved for human use, may adversely affect Immunosyn’s exclusive license
from Argyll Biotech.
Some of the basic biochemistry behind SF-1019, specifically the concept of using extracts from
caprine serum, is in the public domain. Because the basic biochemistry may be in the public
domain, third parties may be developing similar technologies and techniques which would compete
with SF-1019. Argyll Biotech is aware of at least one potential competitor, Daval International
Limited, which is developing and/or marketing a product extracted from caprine serum in the United
Kingdom. Neither Argyll Biotech nor Immunosyn can determine whether any other entities have made
similar progress with this biochemistry or if another competitor is currently poised to enter the
market with a competing product. In the event that this does occur, the value of Immunosyn’s
exclusive license from Argyll Biotech may be severely diminished.
Third parties may assert claims against Argyll Biotech and the Company for infringement of patents
and other intellectual property rights, which could harm our business.
Parties not affiliated with either Immunosyn or Argyll Biotech have obtained or may obtain
United States or foreign patents or possess or may possess proprietary rights relating to products
being developed or to be developed by Immunosyn or Argyll Biotech. Patents now in existence or
hereafter issued to others may adversely affect the development or commercialization of products
developed or to be developed by Immunosyn or Argyll Biotech. Further, Immunosyn’s or Argyll
Biotech’s activities may infringe patents owned by others. Under its exclusive license agreement,
Argyll Biotech is obligated to defend Immunosyn against charges of infringement that refer, relate
or pertain to Immunosyn’s marketing, sale and distribution of SF-1019. Immunosyn and Argyll Biotech
could incur substantial costs in defending infringement suits brought against them or in asserting
any infringement claims against others, which they may not have the funds or insurance to cover.
The concept of using extracts from caprine serum to treat Acquired Immune Deficiency Syndrome
(AIDS), as well as other diseases, was pioneered by Dr. Gary R. Davis. A number of applications
and provisional applications for patents have been filed on his behalf, including at least two
provisional applications whose status as of the date of this prospectus is undetermined. Dr. Davis
has executed a Technology Assignment Agreement in favor of Argyll Biotech that purportedly
transfers all of his rights in his intellectual property related to the development of treatments
for AIDS. However, Argyll Biotech is also aware of previous assignments by Dr. Davis to third
parties covering his intellectual property, and Argyll Biotech has not determined to what extent
those assignments conflict with or render Dr. Davis’ agreement with Argyll Biotech invalid.
Argyll Biotech is aware of the existence of several pending patent applications by a
prospective competitor based on work previously conducted by some of Argyll Biotech’s scientific
consultants. It is the Company’s belief that the invention disclosed in the 603 Application
licensed by Argyll Biotech is different from what is described in these disclosures, regardless of
whether these disclosures describe patentable inventions. As of the date of this prospectus,
Argyll Biotech has not received an opinion of non-infringement with respect to these patent claims
nor has any analysis been conducted to determine whether any of these disclosures, or the prior
work by Dr. Davis, cover Argyll Biotech’s development, manufacture or sale of SF-1019.
On or about July 27, 2006, Daval International Limited, a UK corporation (“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 trade secrets. Argyll Biotech is investigating 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. Immunosyn is not involved in this litigation.
Immunosyn could incur substantial costs in connection with any suits relating to matters for
which it may agree to indemnify Argyll Biotech. An adverse outcome in any litigation could have a
material adverse effect on Immunosyn’s ability to market and distribute products or on Argyll
Biotech to utilize relevant patents in the future. In addition, Argyll Biotech or Immunosyn could
be required to obtain licenses under patents or other proprietary rights of third parties. These
licenses may not be made available on terms acceptable to Argyll Biotech and Immunosyn, or at all.
If Argyll Biotech or Immunosyn is required to, and does not obtain any required licenses, Argyll
Biotech or Immunosyn could be prevented from, or encounter delays in, developing, manufacturing or
marketing SF-1019 or other products.
SF-1019 and other products which may be marketed and distributed by the Company may be subject to
recall which would likely harm our business.
If SF-1019 is approved for distribution and Immunosyn is successful in marketing SF-1019,
product recalls may be issued at Immunosyn’s or Argyll Biotech’s discretion or by the FDA, the
Federal Trade Commission or other government agencies having regulatory authority over distribution
and sales of pharmaceutical products. The Company’s products may need to be recalled due to
disputed labeling claims, manufacturing issues, quality defects, or other reasons. Under its
exclusive license agreement, Argyll Biotech is responsible for costs and activities relating to any
recall of SF-1019, and must defend, indemnify and hold Immunosyn harmless for, from and against
damages associated with those recalls. Product recalls, if any in the future, may harm Argyll
Biotech and Immunosyn’s reputations and cause Argyll Biotech and Immunosyn to lose opportunities or
customers, or force Argyll Biotech and Immunosyn to pay refunds. Immunosyn does not carry any
insurance to cover the risk of potential product recall. Any product recall will have a material
adverse affect on Argyll Biotech and Immunosyn, their prospects, financial condition and results of
operations.
Argyll Biotech and Immunosyn may face exposure from product liability claims and product liability
insurance may not be available or may not be sufficient to cover the costs of liability claims
related to their technologies or products.
If Immunosyn has a product in distribution, Argyll Biotech and Immunosyn will face exposure to
product liability claims if the use of SF-1019 is alleged to have resulted in adverse effects to
users of such products related to those technologies. Product liability claims may also be brought
by clinical trial participants, although to date, no such claims have been brought against Argyll
Biotech and neither Argyll Biotech nor Immunosyn have any knowledge of any such pending claims. If
any such claims were brought against Immunosyn or Argyll Biotech, the cost of defending such claims
may adversely affect Immunosyn’s or Argyll Biotech’s business.
Regulatory approval for commercial sale of SF-1019 or any other products that the Company
intends to market and distribute does not mitigate product liability risks. Any precautions that
Argyll Biotech or Immunosyn takes may not be sufficient to avoid significant product liability
exposure. Although Argyll Biotech anticipates obtaining product liability and clinical trials
insurance on their technologies and products at levels with which their management deems
reasonable, no assurance can be given that this insurance will cover any particular claim or that
Argyll Biotech has or will have obtained an appropriate level of liability insurance coverage for
development activities.
If SF-1019 is brought to market, Argyll Biotech and Immunosyn intend to seek up to $3 million
per year, claims-made product liability insurance coverage. However, such coverage may not be
adequate. In the future, adequate insurance coverage or indemnification by collaborative partners
may not be available in sufficient amounts, or at acceptable costs, if at all.
To the extent that product liability insurance, if available, does not cover potential claims,
Argyll Biotech and Immunosyn will be required to self-insure the risks associated with those
claims. The successful assertion of an uninsured product liability or other claim against Argyll
Biotech or Immunosyn could limit their ability to market and distribute any products or could cause
monetary damages. In addition, future product labeling may include disclosure of additional
adverse effects, precautions and contra indications, which may adversely impact product sales.
If Argyll Biotech loses key management or scientific staff, or if Immunosyn or Argyll Biotech are
unable to protect their respective rights in their trade secrets, the Company’s business will
suffer.
Immunosyn is entirely dependent on Argyll Biotech’s scientific consultants for continuation
and completion of all testing and development of SF-1019. Argyll Biotech’s scientific consultants
and advisory staff members have accepted profit and incentive packages and formal consulting
arrangements have been either accepted or are under negotiation. Such persons maintain positions
of management and are responsible for all drug development activities relating to SF-1019 and have
been instrumental in the development and maintenance of key relationships within the scientific
research and medical communities as well as with inventors, co-development partners and others.
Nonetheless, Immunosyn has no management or other control over those persons or any of their
activities, and their failure to accomplish any goals established for Argyll Biotech or Immunosyn
will substantially and adversely affect Immunosyn’s business prospects.
Immunosyn and Argyll Biotech also rely upon the maintenance of trade secret protection for
confidential and proprietary information. Others may independently develop substantially
equivalent proprietary information and techniques or gain access to both our trade secrets or
disclose Argyll Biotech’s proprietary technology. Immunosyn and Argyll Biotech may not be able to
meaningfully
protect their trade secrets, which could limit Immunosyn’s ability to benefit from its
exclusive license to market and distribute SF-1019 for its intended uses.
Immunosyn requires, and has been informed that Argyll Biotech requires, their respective
employees, consultants, members of the scientific advisory board and parties to collaborative
agreements to execute confidentiality agreements upon the commencement of employment or consulting
relationships. These agreements may not provide meaningful protection of relevant trade secrets or
adequate remedies in the event of unauthorized use or disclosures of confidential and proprietary
information.
The Company’s management and internal systems might be inadequate to handle its potential growth.
The Company’s success will depend in significant part on the development of its operations and
the effective management of growth. Any growth will place a significant strain on the Company’s
systems and resources. To manage future growth, the Company’s management must build operational
and financial systems and expand, train, retain and manage its employee base. The Company’s
management may not be able to manage its growth effectively if its systems, procedures, controls
and resources are inadequate to support operations. In such case, the Company’s expansion would be
halted or delayed and the Company may lose its opportunity to gain significant market share or the
timing with which it would otherwise gain significant market share. Any inability to manage growth
effectively may harm the Company’s ability to institute its current or any subsequent business
plans. The strain on the Company’s systems, procedures, controls and resources is further
heightened by the fact that its executive office and the operational development facilities of
Argyll Biotech are located in separate time zones, namely, San Diego, California, Hardwick,
Massachusetts, and London, England.
To the extent that Argyll Biotech and the Company have international operations, it will be subject
to risks associated with conducting business in foreign countries.
The Company expects to have rights to market, distribute and sell SF-1019 in territories
outside of the United States to the extent that SF-1019 will be approved by local regulatory
authorities for distribution in such territories. To the extent that it develops these
international operations, the Company and Argyll Biotech will be subject to the risks of conducting
business in foreign countries including:
•
difficulty in establishing or managing distribution relationships;
•
different standards for the development, use, packaging, pricing and marketing of
products and technologies;
•
inability to locate qualified local employees, partners, distributors and suppliers;
•
the potential burden of complying with a variety of foreign laws, trade standards
and regulatory requirements, including the regulations of pharmaceutical products and
treatment and foreign intellectual property laws and regulations; and
•
general geopolitical risks, such a political and economic instability, changes in
diplomatic and trade relations, and foreign currency risks.
The Company does not expect to engage in forward currency transactions, which means that the
Company may be susceptible to fluctuations in the U.S. dollar against foreign currencies.
Clinical trials for SF-1019 will be expensive and time consuming, and their outcome is uncertain.
Any delay or other factor which negatively affects Argyll Biotech’s ability to fund clinical trials
will adversely affect the Company’s operations and revenues.
Before obtaining regulatory approval for the commercial sale of a product, Argyll Biotech must
demonstrate through pre-clinical testing and clinical trials that SF-1019 is safe and effective for
use in humans. Conducting clinical trials is a lengthy, time-consuming and expensive process. The
proceeds received by Argyll Biotech from sale of the Common Stock issued by Immunosyn in payment
for the exclusive license are anticipated to pay only a minor part of these expenses, and it is
almost certain that those proceeds will not be adequate to cover the entire amount of testing and
trials that will be required. In addition, we cannot assure that such license fees will be
utilized to pay for clinical trials for SF-1019. In addition, regulatory authorities may require
additional clinical trials, which could result in increased costs and significant development
delays.
Completion of clinical trials for any product, including SF-1019, will generally take several
years or more. The length of time varies substantially according to the type, complexity, novelty
and intended use of the product candidate. Argyll Biotech’s commencement and rate of completion of
clinical trials may be delayed or affected by many factors, including:
•
inability of vendors to manufacture sufficient quantities of materials for use in
clinical trials;
•
slower than expected rate of patient recruitment of variability in the number and
types of patients in a study;
•
inability to adequately follow patients after treatment;
•
safety issues, side effects or other adverse effects;
•
lack of efficacy during the clinical trials; and
•
government or regulatory delays.
Any delay in the commencement or completion of testing and trials will result in additional
delays in Immunosyn’s ability to market and distribute SF-1019, which will adversely affect
Immunosyn’s ability to generate any revenues.
SF-1019 or its variants may never be successfully commercialized.
SF-1019 or its variants are not expected to be available for sale for at least two years, if
at all. Potential products that appear to be promising at early stages of development may not
reach the market for a number of reasons, including:
•
discovery during pre-clinical testing or clinical trials that the products are
ineffective or cause harmful side effects;
•
failure to receive necessary regulatory approvals;
•
inability to manufacture on a large or economically feasible scale;
preclusion from commercialization due to proprietary rights of third parties.
Any products and technologies, including SF-1019, developed by Argyll Biotech will require
extensive additional development, including pre-clinical testing and clinical trials, as well as
regulatory approvals, prior to commercialization. Argyll Biotech’s product development efforts may
not be successful; may fail to receive required regulatory approvals from U.S. or foreign
authorities for any indication; and any products, if introduced, may not be capable of being
produced in commercial quantities at reasonable costs or being successfully marketed. The failure
of Argyll Biotech’s research and development activities to result in any commercially viable
products or technologies would materially adversely affect Immunosyn’s future prospects, as those
prospects are linked entirely to Argyll Biotech’s success through the exclusive license between the
two companies.
The industry in which we operate is subject to extensive government regulation and SF-1019 require
regulatory approvals, which makes it more expensive for us and Argyll Biotech to operate our
businesses.
Virtually all aspects of Immunosyn’s and Argyll Biotech’s business are regulated by federal
and state statutes and governmental agencies in the United States and other countries. Failure to
comply with applicable statutes and government regulations could have a material adverse affect on
Immunosyn’s and Argyll Biotech’s ability to develop and sell SF-1019, which will have a negative
impact on Immunosyn’s cash flow. The development, testing, manufacturing, processing, quality,
safety, efficacy, packaging, labeling, record-keeping, distribution, storage and advertising of
pharmaceutical products, and disposal of waste products arising from these activities, are subject
to regulation by one or more federal agencies. These activities are also regulated by similar
state and local agencies and equivalent foreign authorities. Even if regulatory approval is
obtained, a marketed product, its manufacturer and its manufacturing facilities are subject to
continual review and periodic inspections. Subsequent discovery of previously unknown problems
with a product, manufacturer or facility may result in restrictions on the product or manufacturer,
including withdrawal of the product from the market.
The regulatory requirements applicable to any product may be modified in the future.
Immunosyn cannot determine what effect changes in regulations or statutes or legal interpretations
may have on its or Argyll Biotech’s business in the future. Regulatory changes could require
modifications to manufacturing methods, expanded or different labeling, the recall, replacement or
discontinuation of certain products, additional record keeping and expanded documentation of the
properties of certain products and scientific substantiation. Any changes or new legislation could
have a material adverse effect on Argyll Biotech’s or Immunosyn’s ability to develop and sell
SF-1019 and therefore, generate revenue and cash flow.
Even after Argyll Biotech expends substantial resources on research, clinical development and
the preparation and processing of regulatory applications, it may not be able to obtain regulatory
approval for any of the products that Immunosyn intends to license from it. Moreover, regulatory
approval for marketing a proposed pharmaceutical product in any jurisdiction may not result in
similar approval in other jurisdictions. The failure to obtain and maintain regulatory approvals
for SF-1019 would have a material adverse effect on Immunosyn’s ability to distribute and sell
products and, therefore, generate revenue and cash flow.
Risks Related to the Offering
The offering price and other terms of this Offering have been arbitrarily determined.
The estimated offering price of the Common Stock in this Offering was arbitrarily determined. Such
offering price otherwise has no relationship to the Company’s assets, its book value or any other
established criterion of value, and may not be indicative of the fair market value of the Company’s
Common Stock. In the event the Company creates a market for publicly trading its shares, the
ultimate trading price of the Company’s Common Stock may be substantially higher or lower than the
price that an investor will pay in this Offering.
The offering price of the Common Stock may not be indicative of future market prices, to the extent
that such a public market ever develops.
To the extent that a public market ever develops for our Common Stock, such market may not
perceive the offering price as being representative of the fair value of the Company’s Common
Stock, in which case investors may not be able to sell their Common Stock at or above the offering
price, which will result in a loss of a portion or all of the investor’s investment. The Company
anticipates that the market price, if a market ever develops, of its shares will fluctuate
significantly in response to numerous factors, many of which are beyond the control of the Company,
including, without limitation:
•
the announcement of new products or product enhancements by the Company’s
competitors;
•
intellectual property developments and regulatory approvals;
•
quarterly variations in the Company’s and its competitors’ results of operation;
•
changes in earnings estimates or recommendations by securities analysts;
•
developments in the medical community for treatment of CIDP, diabetic neuropathy
and/or diabetic ulcers; and
•
general market conditions and other factors, including factors wholly unrelated to
the Company’s own operations or performance.
To the extent that the Company does create a market for publicly trading its Common Stock, the
Company anticipates that, at least initially, its Common Stock may be quoted on the OTC Bulletin
Board or the “Pink Sheets,” and the stock market and the securities of companies that are traded in
this manner are prone to extreme price fluctuations, which could further substantially depress the
value of the Common Stock. The price volatility of the Common Stock and the downward pressure on
its price may be intensified to the extent that the trading volume of the Common Stock will be low.
There is not now nor may there ever be an active market for the Company’s Common Stock.
There is currently no market at all for the Company’s Common Stock. Further, although the
Company anticipates that its Common Stock will be quoted on the OTC Bulletin Board, or the “Pink
Sheets,”the Company expects that trading on either of those exchanges will be light or sporadic at
best. At any given time, several days or weeks may elapse with no trading whatsoever of the Common
Stock. The Company is providing no assurances of any kind or nature whatsoever that an active
market for its Common Stock will ever develop. Investors who purchase shares in this Offering
should understand that there may be no alternative exit strategy for them to recover or liquidate
their investments in the Common Stock. Accordingly, investors must be prepared to bear the entire
economic risk of an investment in the Common Stock for an indefinite period of time.
Additional uncertainty will be experienced with respect to the price of the Common Stock
because the Company is a biotechnology entity and the market price of the securities of
biotechnology companies is especially volatile.
If the Company’s operations do not develop and its revenues do not grow or grow more slowly
than the Company anticipates, if operating or capital expenditures exceed the Company’s
expectations and cannot be adjusted accordingly or if some other event adversely affects the
Company, the market price of its Common Stock will decline.
Upon completion of this Offering, the Company will become subject to the reporting requirements of
the United States securities laws, which will require additional expenditure of capital and other
resources.
Upon completion of this Offering, the Company will become a public reporting company and will
be subject to the information and reporting requirements of the Securities Exchange Act of 1934 and
other federal securities laws, including the Sarbanes-Oxley Act (“Sarbanes”). The costs of
preparing and filing annual and quarterly reports, proxy statements and other information with the
SEC and furnishing audited reports to stockholders will cause the Company’s expenses to be
substantially higher than they would otherwise be if the Company were privately-held or otherwise
retained its status as a non-reporting public company. It will be costly and time-consuming for
the Company to develop and implement internal controls and reporting procedures required by
Sarbanes, and the Company will require additional staff and third-party assistance to develop and
implement appropriate internal controls and procedures. If the Company fails to or is unable to
comply with Sarbanes, it may not be able to obtain independent accountant certifications concerning
internal controls at the time it is required by Sarbanes.
Even
if the Company were to become an OTC Bulletin Board or “Pink Sheets” Company, it may not be
able to attract the attention of major brokerage firms or securities analysts.
Security analysts and major brokerage houses may not provide coverage of the Company, given
that its anticipated OTC Bulletin Board or “Pink Sheets” status would provide little or no incentive
to recommend the purchase of its Common Stock. The Company may also not be able to attract any
brokerage houses to conduct secondary offerings and other capital raising transactions with respect
to its securities. The Company’s business and ability to continue as a going concern would be
adversely affected if it is unable to raise funds.
Immunosyn is making no representations and is providing no assurances that its Common Stock will
become listed on the American Stock Exchange, NASDAQ or any other securities exchange.
The Company anticipates that it may in the future seek to list its Common Stock on the
American Stock Exchange or Nasdaq Capital Market. The Company is making no representations nor providing any
assurances that it will be able to meet the initial listing standards of either of those or any
other stock exchange. Prior to the listing of the Company’s stock on any stock exchange, the
Company expects that its non-restricted free trading Common Stock will be eligible to trade on the
OTC Bulletin Board or on the “Pink Sheets”. The investors may find it difficult to dispose of
shares or to obtain accurate quotations as to the market value of the Common Stock when it is
trading there. In addition, the Company will be subject to an SEC rule (Rule 15c2-11) (the
so-called penny stock rules) that imposes various requirements on broker-dealers who sell
securities governed by the rule to persons other than established customers and accredited
investors. The requirement that broker-dealers comply with this rule will deter broker-dealers
from recommending or selling the Company’s Common Stock, thus further adversely affecting the
liquidity and share price of the Common Stock, as well as the Company’s ability to raise additional
capital.
Immunosyn has never paid dividends and has no plans to pay dividends at any time in the near or
distant future.
Immunosyn has never paid dividends on its capital stock, and the Company does not anticipate
paying any dividends for the foreseeable or distant future. The Company’s present business plan
does not include, for the foreseeable future and beyond, any payments of dividends to stockholders.
Stockholders’ sole strategy for any return on their investments will be the potential for the
increase in the value of their stock and the possibility of liquidating their stock positions.
You will experience immediate and substantial dilution if the Company obtains additional financing.
If the Company obtains additional financing, that financing will have a dilutive effect on the
holders of the Company’s securities.
The Company has adopted an employee stock option plan, an incentive cash, stock and stock
option plan under which the Company’s officers, directors, consultants, and employees will be
eligible to receive, in relevant part, either securities or stock options exercisable for the
Company’s securities at exercise prices that may be equal to or lower than the offering price in
this offering. The Company has reserved five million (5,000,000) shares of Common Stock for
issuance under these plans. Stock and stock option grants under such plans will further dilute the
value of the Company’s securities and the investors’ equity position in the Company.
Immunosyn and Argyll Biotech will need to raise additional capital in order to achieve their
long-term goals, but as yet they have not identified any sources for such capital.
Under the exclusive license agreement, the Company has issued 147,000,000 shares of Common
Stock to Argyll Biotech, which Argyll Biotech intends to sell in this Offering. Argyll Biotech has
informed us that it intends to use the proceeds it receives from the sale of the Company’s Stock
for its corporate purposes and those of its affiliates, including development and regulatory
approval of SF-1019. Immunosyn has no control over how Argyll Biotech will manage or allocate
those funds, and Argyll Biotech’s management and allocation decisions may not make the most
efficient use of those funds.
In the event Argyll Biotech fails to raise sufficient funds from the sale of the Company’s
Stock, Argyll Biotech will need to raise additional funds to complete its development and obtain
regulatory approval of SF-1019. Argyll Biotech has not identified sources for additional
financing, and Argyll Biotech may be unable to raise sufficient funds on terms that are acceptable
to Argyll Biotech, or at all. If those funds are not raised by Argyll Biotech on a timely basis,
the development of SF-1019 will be delayed, and the scope of the Company’s operations will be
substantially curtailed or completely eliminated.
The Company is not selling any Common Stock in this Offering and will not receive any of the
proceeds. Consequently, the Company will need to conduct public or private offerings at appropriate
times in the future to raise money for its operations as Argyll Biotech approaches completion of
regulatory approval to commence marketing of SF-1019.
Our corporate charter contains authorized, unissued “blank check” preferred stock which can be
issued without stockholder approval with the effect of diluting then current stockholder interests
and discouraging, delaying or preventing a change in control of the Company.
Our certificate of incorporation authorizes the issuance of up to 25,000,000 shares of “blank
check” preferred stock with designations, rights and preferences as may be determined from time to
time by our board of directors. Accordingly, our board of directors is empowered, without
stockholder approval, to issue one or more series of preferred stock with dividend, liquidation,
conversion, voting or other rights which could dilute the interest of, or impair the voting power
of, our common stockholders. Furthermore, the issuance of a series of preferred stock could be
used as a method of discouraging, delaying or preventing a change in control.
Any of the above-identified risks, even if borne out only partially and not fully, will adversely
affect Immunosyn’s business, its financial condition and its operating results. If any of the
events we have identified occur, in whole or in part, the value of our Common Stock will likely
decline, and an investor will lose all or part of the funds paid to acquire the Common Stock
described in this prospectus with no opportunity to regain any portion of those funds in return.
This prospectus includes forward-looking statements. You can identify these forward-looking
statements when you see us using words such as “expect,”“anticipate,”“estimate,”“believe,”“intend,”“may,”“predict,” and other similar expressions. These forward looking statements cover,
among other items:
•
our future capital needs;
•
our expectations about Argyll Biotech’s ability to complete development of SF-1019;
•
our expectations about the FDA and other regulatory approval processes that will be
required for SF-1019;
•
our expectations about reimbursement of our products by third party payors;
•
our expectations about the future performance of the products that Argyll Biotech is
developing;
•
our expectations about acceptance in the market of the products Argyll Biotech is
developing;
•
our expectations about the ability of SF-1019 to compete in the market;
•
our marketing and sales plans; and
•
our expectations about our financial performance.
We have based these forward-looking statements largely on our current expectations. However,
forward-looking statements are subject to a number of risks and uncertainties, certain of which are
beyond our control. Actual results could differ materially from those anticipated as a result of
the factors described under “Risk Factors” including, among others:
•
problems that Argyll Biotech may face in successfully completing SF-1019;
•
our inability to raise additional capital when needed;
•
uncertainty of acceptance of SF-1019 in the market;
•
reluctance or unwillingness of laboratories and physicians to accept SF-1019;
•
refusal of insurance companies and other third party payors to reimburse patients,
clinicians and laboratories for SF-1019;
•
problems that we may face in marketing and selling SF-1019;
•
the possibility that we may not be able to compete with established companies;
•
the lack of experienced management including development, clinical, marketing and
other personnel;
delays in obtaining, or Argyll Biotech’s inability to obtain, approval by the FDA or
foreign regulatory authorities for SF-1019;
•
problems for Argyll Biotech in acquiring and protecting intellectual property
important to our business through patents, licenses and other agreements;
•
our and Argyll Biotech’s ability to successfully defend claims that SF-1019 may
infringe the intellectual property rights of others;
•
problems that we and Argyll Biotech may face in obtaining product liability
insurance or defending product liability claims;
•
problems that Argyll Biotech may face in manufacturing SF-1019 and we may face
distributing SF-1019; and
•
the risks we face in potential international markets.
We do not undertake any obligation to publicly update or revise any forward-looking statements
contained in this prospectus or incorporated by reference, whether as a result of new information,
future events or otherwise. Because of these risks and uncertainties, the forward-looking
statements and circumstances discussed in this prospectus might not transpire.
Immunosyn is a development stage company that was incorporated in August 2006 and its primary
objective is to market and distribute SF-1019 throughout the world for treatment of medical
conditions related to CIDP, diabetic neuropathy and diabetic ulcers. Immunosyn’s core strategy
will be to increase market awareness and acceptance of SF-1019 as the preferred treatment for these
diseases, building efficient sales and distribution channels for the product’s delivery and
diligent post sales support.
Argyll Biotech is the owner of SF-1019 and the party responsible for its development and
clinical testing, obtaining regulatory approval for its sale and distribution and the sole source
for its supply to Immunosyn. Argyll Biotech was formed after several years of investment in
experimentation and studies of SF-1019 to evaluate its viability for treatment of diabetes related
conditions.
CIDP is a neurological disorder characterized by slowly progressive weakness and a loss of
sensation in the legs and arms. CIDP is more common in young adults, and it affects men more than
women. Symptoms include tingling or numbness (beginning in the toes and fingers); weakness of the
arms and legs; aching pain in the muscles; loss of deep tendon reflexes; fatigue; and abnormal
sensation. CIDP is similar to Guillain-Barré-Strohl-Landry syndrome, which appears suddenly and
generally improves spontaneously. Although CIDP was once called “chronic Guillain-Barré syndrome,”
it is now regarded as a related, but distinct condition. The course of CIDP varies widely among
individuals. Some may have a bout of CIDP followed by spontaneous recovery, while others may have
many bouts with partial recovery in between relapses.
Diabetes mellitus refers to a family of diseases featuring high glucose levels caused by the
body’s inability to produce and/or utilize insulin. According to the U.S. National Diabetes
Information Clearinghouse, the 2005 estimate of prevalence or total number of cases of diabetes in
adults is 20.8 million, with 14.6 million diagnosed cases and an additional 6.2 million undiagnosed
cases (http://www.ndep.nih.gov/diabetes/pubs/FS_GenSnapshot.pdf). According to the same source,
the 2005 incidence, or number of new cases, is 1.5 million.
One of the most severe complications of diabetes is lower-limb amputation, which is caused by
diabetic ulcers. These ulcers form as a result of diabetic neuropathy, or peripheral neuropathy, a
nervous system disease evident in 60% of diabetic patients (Caring For Diabetes Educational Forum;
http://www.caringfordiabetes.com/T&P/MicroComplications/T_P_Neuropathy.cfm). According to the
National Diabetes Education Program, diabetic neuropathy causes micro-vascular damage that can
result in loss of protective sensation in the feet, poor circulation and foot ulcers.
We believe that SF-1019 is a new category of drug that may be characterized as an
“Immunomodulator.” Many disease pathologies that affect individuals are the result of an
over-active immune system. Specifically, when a viral agent begins to adversely affect an
individual’s cells, the immune system frequently becomes overactive, which destroys the viral agent
but also injures surrounding healthy cell structures. Other disease pathologies suppress an
individual’s immune system, which allows other diseases and agents to kill healthy cells. We
believe that SF-1019 regulates an individual’s immune system to prevent it from both over-reacting
and under-reacting to a viral invasion of an individual’s body systems.
We believe that SF-1019 contains a number of unique lipopeptide molecules which
neutralize viral pathogens and their inhibitory properties by activation of a cytokine system.
This, in turn,
enhances an individual’s cell mediated immunity and augments the individual’s
humoral immune system by eliminating negative inhibitory cytokine factors and eliminates pathogenic
free-floating organisms, while simultaneously sparing normal and healthy cells.
Argyll Biotech’s core objective is the continued development of SF-1019 and its cognates and
variants for treatment of multiple medical conditions. Rather than detract from its core
proficiency, Argyll Biotech’s founders and its scientific and advisory team elected to license the
marketing, distribution and sale of SF-1019 and other products to another entity, whose strategy
would be to target key markets and demographics for treatment with SF-1019 and its cognates and
variants. The exclusive license agreement between Argyll Biotech, as the licensor, and Immunosyn,
as the licensee, is a result of that decision.
The Argyll Biotech License Agreement
The Company is in the development stage and has only engaged in organizational activities to
date. Its principal asset is the exclusive license with Argyll Biotech. The Company intends to
develop its operations so that it is in a position to market, distribute and sell SF-1019 as soon
as appropriate regulatory approvals are received by Argyll Biotech for SF-1019. The key terms of
the exclusive license agreement with Argyll Biotech are as follows:
Grant of Rights
Argyll Biotech has granted Immunosyn the exclusive worldwide right to market, distribute, sell
and promote SF-1019 for treatment of CIDP, diabetic neuropathy and diabetic ulcers. Argyll Biotech
has also licensed its trademarks to Immunosyn, and granted Immunosyn a right of first offer to
enter into additional license agreements for other uses of SF-1019 and its variants and cognates.
Finally, during the first five years of the term of the exclusive license agreement, Immunosyn has
a right to enter into partnering arrangements with Argyll Biotech for development of other novel
drug treatment products.
Development and Regulatory Matters
Argyll
Biotech anticipates that it will commence clinical trials and studies of SF-1019 and prepare and submit all
filings required for regulatory approval of that product for treatment of CIDP, diabetic neuropathy
and diabetic ulcers, both in the United States and in other countries that are targeted for
distribution and sale of the product. Argyll Biotech will also submit periodic written reports to
Immunosyn to document its efforts toward procuring such regulatory approval, as well as clinical
budgets and plans for each year during which development efforts are conducted. Argyll Biotech
will retain full responsibility for preparation and implementation of all trial protocols and
regulatory activities and for all costs associated with those activities.
Distribution and Promotion
Immunosyn will assume full responsibility to promote and sell SF-1019 for its approved uses.
To accomplish this, Immunosyn has agreed to develop a sales force, and an order processing and
distribution network for each country in which regulatory approval of SF-1019 is granted.
Immunosyn has also agreed to develop full marketing plans for each such country, although Argyll
Biotech will retain a right to participate in all marketing and promotion activities. Each party
is responsible for its own costs associated with these activities.
Immunosyn has issued 147,000,000 shares of its Common Stock to Argyll Biotech which Argyll
Biotech expects to sell in this Offering to raise funds for product development and regulatory
approval for SF-1019. However, in the event the proceeds it receives from this Offering are
insufficient for Argyll Biotech to complete development and regulatory approval in both the United
States and the United Kingdom, Immunosyn is obligated to pay a royalty to Argyll Biotech equal to
31/2%
of Immunosyn’s gross sales of SF-1019 until Argyll Biotech has received enough funds to complete its
development in those jurisdictions. The license fee is deemed earned when paid and there are no
restrictions on the release or use of the proceeds received by Argyll Biotech from the sale of
Immunosyn’s shares, and these proceeds may be used at Argyll Biotech’s sole discretion for any
purpose. No refund will be owed by Argyll Biotech in the event the cost of development and
regulatory approval is substantially less than the fee, nor are there any penalties owed by Argyll
Biotech if it fails to complete product development or obtain regulatory approval for its
distribution.
Payments and Reports
Argyll Biotech is not obligated to provide any accounting for its use of proceeds, nor does
Immunosyn have any audit rights to inspect Argyll Biotech’s use of the license proceeds. In the
event Immunosyn is obligated to pay the 31/2% royalty to Argyll Biotech to complete its development
and regulatory approval for SF-1019, Immunosyn will be obligated to provide Argyll Biotech with
monthly royalty reports to account for its gross sales and calculation of the royalty paid to
Argyll Biotech.
Manufacture and Supply
Argyll Biotech retains responsibility for manufacturing and supplying all of Immunosyn’s
requirements of SF-1019. Argyll Biotech will sell quantities of the product to Immunosyn at a
price per dose that is below the anticipated market or reimbursement price per dose of the product.
The exact product price is not specified in the exclusive license agreement, and will be the
subject of future negotiations once Argyll Biotech’s cost of production is determined. Argyll
Biotech shall also confirm through testing and other programs that the commercial quantities of
SF-1019 that it manufactures are fully compliant with all manufacturing and laboratory standards
applicable to drug products which are intended for use in humans.
Intellectual Property Ownership
Argyll Biotech will retain full ownership of its intellectual property, including intellectual
property that is jointly-developed by the parties. Argyll Biotech must take reasonable steps to
protect its intellectual property from third-party infringement, and to defend Immunosyn against
charges of infringement that refer, relate or pertain to Immunosyn’s marketing, sale and
distribution of SF-1019.
Publication and Confidentiality
Argyll Biotech and Immunosyn must collaborate on all publications of scientific or medical
reports relating to either company’s business, operations, research and development or clinical
trial results.
Argyll Biotech has agreed to retain full responsibility for costs and activities relating to
any recall of SF-1019, and must defend, indemnify and hold Immunosyn harmless for, from and against
damages associated with those recalls.
Term and Termination
The exclusive license agreement shall remain in full force and effect for as long as any
patent coverage remains in place for SF-1019 in any country, which in most jurisdictions is
generally for twenty (20) years from the date of filing. Either party may terminate the agreement
only on account of an uncured material breach by the other party. Immunosyn may terminate the
agreement if a non-rebuttable regulatory or patient safety issue is
raised, in which event all remaining license fee obligations will
immediately be cancelled. Any fees paid prior to
termination are non-refundable.
Discussion of Applicable Government Regulations
The FDA and comparable regulatory agencies in foreign countries, as well as drug regulators in
state and local jurisdictions, impose substantial requirements upon clinical development,
manufacture and marketing of pharmaceutical products. These agencies and other federal, state and
local entities regulate research and development activities and the human testing, manufacture,
quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising
and promotion of Argyll Biotech’s SF-1019, as well as any other products that either Argyll Biotech
or Immunosyn may independently develop or may otherwise license for marketing and distribution.
The process required by the FDA under the drug provisions of the United States Food, Drug, and
Cosmetic Act before any initial products may be marketed in the United States generally involves
the following:
•
Preclinical laboratory and animal tests;
•
Submission of an Investigational New Drug Application (“IND”), which must become
effective before human clinical trials may begin;
•
Adequate and well-controlled human clinical trials to establish the safety and
efficacy of the product candidate for its intended use;
•
Submission to the FDA of a New Drug Application (“NDA”); and
•
FDA approval and review of a NDA.
The testing and approval process requires substantial time. Preclinical tests include
laboratory evaluation of the product candidate, its chemistry, formulation and stability, as well
as animal studies to assess the potential safety and efficacy of the product candidate. Certain
preclinical tests must be conducted in compliance with good laboratory practice regulations.
Violations of these regulations can, in some cases, lead to an invalidation of the studies,
requiring such studies to be replicated. In some cases, long-term preclinical studies are
conducted while clinical studies are ongoing.
Argyll Biotech must submit the results of preclinical tests, together with manufacturing
information and analytical data, to the FDA as part of an IND, which must become effective before
any human clinical trials begin in the U.S. Analogous requirements are in place in the countries
of the
European Union and in the United Kingdom, where Argyll Biotech is preparing to conduct
preclinical and clinical trials. If the FDA or its foreign equivalent raises questions about an
IND within a certain period of time after its submission, that regulatory body may impose a
clinical hold. In such a case, the IND sponsor and the regulatory authority must resolve any
outstanding concerns before clinical trials can begin. All clinical trials must be conducted under
the supervision of a qualified investigator in accordance with good clinical practice regulations.
These regulations include the requirement that all subjects provide informed consent. Further, an
independent Institutional Review Board (“IRB”) at each medical center proposing to conduct clinical
trials must review and approve any clinical study. The IRB also continues to monitor the study and
must be kept aware of the study’s progress, particularly as to adverse events and changes in any
research. Progress reports detailing the results of the clinical trials must be submitted at least
annually to the FDA or its foreign equivalent and more frequently if adverse events occur.
Human clinical trials are typically conducted in three sequential phases that may overlap:
•
Phase I: The drug is initially introduced into healthy human subjects or patients
and tested for safety, dosage tolerance, absorption, metabolism, distribution and
excretion.
•
Phase II: The drug is studied in a limited patient population to identify possible
adverse effects and safety risks, to determine the efficacy of the product for specific
targeted diseases and to determine dosage tolerance and optimal dosage.
•
Phase III: When Phase II evaluations demonstrate that a dosage range of the drug is
effective and has an acceptable safety profile, Phase III trials are undertaken to
further evaluate dosage and clinical efficacy and to further test for safety in an
expanded patient population, often at geographically dispersed clinical study sites.
Concurrent with preclinical studies and clinical trials, Argyll Biotech must develop
information about the chemistry and physical characteristics of SF-1019 and must finalize a process
for manufacturing this product in accordance with good manufacturing practice (“GMP”) requirements.
The manufacturing process must be capable of consistently producing quality batches of SF-1019 and
Argyll Biotech must develop methods for testing the quality, purity and potency of the drug
candidate. Additionally, appropriate packaging must be selected and tested and chemistry stability
studies must be conducted to demonstrate that the SF-1019 product does not undergo unacceptable
deterioration over its shelf life.
We understand that Argyll Biotech intends to submit the results of SF-1019 product
development, pre-clinical studies and clinical studies to the FDA or its foreign equivalent as part
of an NDA for approval of the marketing and commercial shipment of the product. The appropriate
regulatory authority will review each NDA submitted and may request additional information, rather
than accept the NDA for filing. In this event, the application must be resubmitted with additional
information. The resubmitted application is also subject to review before the regulatory body
accepts it for filing. Once the NDA is accepted, the regulatory agency begins an in-depth review
of the NDA. Regulatory agencies have substantial discretion in the approval process and may
disagree with Argyll Biotech’s interpretation of the data submitted in the NDA. The review process
may be significantly extended by the regulatory agency’s requests for additional information or
clarification regarding information already provided. Also, as part of the review, the regulatory
agency may refer the application to an appropriate advisory committee, typically a panel of
clinicians, for review, evaluation and a recommendation. Manufacturing establishments also are
often subject to inspections prior to NDA approval to assure compliance with GMPs and with
manufacturing commitments made in relevant marketing applications.
In the United States, under the Prescription Drug User Fee Act (“PDUFA”), submission of an NDA
with clinical data requires payment of a user fee. For fiscal year
2006, that fee was $767,400.
Similar fees and requirements are in place in foreign jurisdictions. In return, the relevant
regulatory agencies assign time goals for reviewing NDAs prior to issuing a “complete response” in
which an NDA may be approved, or denied if the regulatory agency’s criteria are not satisfied, or
require additional clinical data. Even if these data are submitted, the regulatory agency may
ultimately decide that the NDA does not satisfy the criteria for approval. If the regulatory
agency approves the NDA, the product becomes available for physicians to prescribe, but even after
approval, a regulatory agency may later decide to withdraw product approval if compliance with
regulatory standards is not maintained or if safety problems occur after the product reaches the
market. A regulatory agency may also require post-marketing studies, known as Phase IV studies, as
a condition to approval to develop additional information regarding the safety of a product. In
addition, a regulatory agency can require surveillance programs to monitor approved products that
have been commercialized, and such agencies have the power to require changes in labeling or to
prevent further marketing of a product based on the results of these post-marketing programs.
Regulatory agencies also regulate drug labeling and promotion activities. As marketing and
distribution will be the primary and substantial business function of Immunosyn, the Company
anticipates that it will experience a significant burden as a result of these regulatory
activities. Regulatory agencies actively enforce regulations prohibiting the marketing of products
for unapproved or “off-label” uses. Further regulations on certain pharmaceutical marketing
practices are imposed in the United States by the U.S. Federal Trade Commission and Office of the
Inspector General of the U.S. Department of Health and Human Services. Reimbursement practices and
HHS coverage of medicine will be important to the success of procurement and utilization of Argyll
Biotech’s SF-1019 and other products and product candidates, if they are ever approved for
marketing.
European Regulations
The initial preclinical trials and clinical studies of SF-1019 are expected to be conducted by
Argyll Biotech under European auspices and jurisdiction. Prior regulatory approval in order to
initiate Phase I (healthy human volunteer) studies is required in many of the European Union member
states. Following successful completion of Phase I studies, data must be submitted in a summarized
format to the applicable regulatory authority in the member state in respect of applications for
the conduct of later Phase II proposed studies. E.U. regulatory authorities typically are required
to raise objections within one to three months after receipt of a proposal for a study, but they
often have a right to extend this review period at their discretion. In addition, one or more
independent ethics committees, which typically operate similarly to an Institutional Review Board
in the United States, will review the ethics of conducting the proposed research.
In order to gain marketing approval in the E.U., Argyll Biotech must submit a dossier to the
relevant authority for review, which, in the E.U., is known as a Marketing Authorization
Application (“MAA”). The format of the MAA is specific and is laid out by each applicable
regulatory authority, although in general it will contain information on the quality of the
chemistry, manufacturing and pharmaceutical aspects of the product as well as non-clinical and
clinical data.
For many products, the E.U. provides a choice of a centralized or decentralized authorization
route. Under the centralized route, one marketing authorization is granted for the entire E.U.,
while under the decentralized route, a series of national marketing authorizations are granted. In
the centralized system, an application will be reviewed by the members of the Committee for
Proprietary Medicinal Products (“CPMP”), on behalf of the European Medicines Agency (“EMEA”). The
EMEA will, based
upon the review of the CPMP, provide an opinion to the European Commission on the
safety, quality and efficacy of the product. The decision to grant or refuse an authorization is
made by the European Commission. In circumstances where use of the
centralized route is not
mandatory, Argyll Biotech can choose to use the decentralized route, in which case an application
will be reviewed by each member state’s regulatory agency. If a regulatory agency grants
authorization, other member states’ regulatory agencies and authorities are asked to “mutually
recognize” the authorization granted by the first member state’s regulatory agency.
Failure to comply with applicable regulatory requirements after obtaining regulatory approval
can, among other things, result in the suspension of regulatory approval, as well as possible civil
and criminal sanctions. Renewals in the E.U. may require additional data, which may result in a
license being withdrawn. In the E.U., regulators have the authority to revoke, suspend or withdraw
approvals of previously-approved products, to prevent companies and individuals from participating
in the drug approval process, to request recalls, to seize violative products and to obtain
injunctions to close manufacturing plants not operating in conformity with regulatory requirements
and to stop shipments of violative products.
Pricing Controls
Before a pharmaceutical product may be marketed and sold in certain foreign countries the
proposed pricing for the product must be approved. The requirements governing product pricing vary
widely from country to country and can be implemented disparately at a national level.
The E.U. generally provides options for its member states to control the prices of medicinal
products for human use. A member state may approve a specific price for the medicinal product or
it may instead adopt a system of direct or indirect controls on the profitability of the company
placing the medicinal product on the market. For example, the regulation of prices of
pharmaceuticals in the United Kingdom is generally designed to provide controls on the overall
profits that pharmaceutical companies may derive from their sales to the U.K. National Health
Service. The U.K. system is generally based on profitability targets or limits for individual
companies which are normally assessed as a return on capital employed by the company in servicing
the National Health Service market, comparing capital employed and profits.
In comparison, Italy generally establishes prices for pharmaceuticals based on a price
monitoring system. The reference price is the European average price calculated on the basis of
the prices in four reference markets: France, Spain, Germany and the U.K. Italy generally
establishes the price of medicines belonging to the same therapeutic class on the lowest price for
a medicine belonging to that category. Spain generally establishes the selling price for new
pharmaceuticals based on the prime cost, plus a profit margin within a range established each year
by the Spanish Commission for Economic Affairs.
Third Party Reimbursements
In the U.S., E.U., and elsewhere, sales of therapeutic and other pharmaceutical products are
dependent in part on the availability and adequacy of reimbursement to the consumer or the health
care provider from third party payors, such as government and private insurance plans. Third party
payors are increasingly challenging the prices charged for medical products and services and new
products that are
more expensive than existing treatments may have difficulty finding ready
acceptance unless there is a clear therapeutic benefit.
Patent Restoration and Marketing Activity
The Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman
Amendments (“Hatch-Waxman”), permits the FDA to approve an abbreviated NDA for generic versions of
innovator drugs, as well as NDAs with less original clinical data. Hatch-Waxman also provides
certain patent restoration and exclusivity protections to innovator drug manufacturers.
The abbreviated NDA process permits competitor companies to obtain marketing approval for a
drug with the same active ingredient for the same uses as an innovator drug but does not require
the conduct and submission of clinical studies demonstrating safety and efficacy for that product.
Instead of safety and efficacy data, a competitor could make a copy of any of Argyll Biotech’s
drugs and only submit data demonstrating that the copy is a bioequivalent to the SF-1019 product,
which may allow the competitor to obtain marketing approval from the FDA.
Hatch-Waxman also provides competitors with the ability to market copies of innovator products
with the submission of significantly less clinical data outside of the abbreviated NDA context.
Such applications are known as “505(b)(2) NDAs”, or “paper NDAs”. They may rely on clinical
investigations not conducted by or for that applicant and for which the applicant has not obtained
a right of reference or use. Such products are subject to the same patent notification procedures
as for abbreviated NDAs.
Hatch-Waxman also provides for the restoration of a portion of a product’s United States
patent term that is lost during a drug’s clinical development and NDA review by the FDA, and
further provides for the statutory protection, known as exclusivity, against the FDA’s approval or
acceptance of certain competitor applications. Patent term restoration can return up to five years
of a patent term for a patent that covers a new product or its use to compensate for time lost
during product development and the regulatory review process. This period is generally one-half
the time between the effective date of an IND and the submission date of an NDA, plus the time
between the submission date of the NDA and the approval of that application, subject to a maximum
extension of five years. No extension can extend the patent life beyond fourteen years after the
drug approval date. The application for patent term restoration is subject to approval by the
United States Patent and Trademark Office in conjunction with the FDA.
Hatch-Waxman also provides for differing periods of statutory protection for new drugs
approved under an NDA. Among the types of exclusivity are those for a new chemical entity and
those for a new formulation or a new indication for a previously-approved drug. Marketing
exclusivity in the United States for the type of product that Immunosyn intends to market and
distribute, if granted by the FDA, would prohibit that agency from approving the application of
another company that submits an abbreviated NDA or a paper NDA for five years. This marketing
exclusivity protection does not prohibit the FDA from approving a full NDA.
Competition
Competition in the biotechnology industry is intense. Potential competitors in the United
States and Europe are numerous and include pharmaceutical, chemical and biotechnology companies,
most of which have substantially greater capital resources, marketing experience, research and
development staffs and facilities than Immunosyn. Among others, Eli Lilly & Company and Wyeth
Pharmaceuticals, Inc. market antidepressants, and Pfizer, Inc. markets anticonvulsants that are
prescribed for treating diabetic
neuropathy. In addition, Daval International Limited, a UK
company, is also testing a caprine serum product, called Aimspro, for treating multiple sclerosis
and other neurological disorders.
Argyll Biotech intends to seek to limit potential sources of competition by developing
products that are eligible for orphan drug designation and approval or other forms of protection.
Specifically, Immunosyn intends to target CIDP as a potential candidate for treatment with SF-1019
due to its orphan drug for orphan drug status. CIDP is listed by the National Organization for
Rare Disorders (http://www.rarediseases.org/) as an orphan disease with less that 200,000 cases in
the U.S. The only available treatment is IVIG (intravenous gamma globulin) at a cost of $2000-$6000
per month depending on dosage. The mechanism of action of IVIG is to block release of inflammatory
cytokines directly and therefore lasts only about 1-2 weeks. However, due to their substantially
greater resources, competitors may develop similar technologies and products more rapidly or may
market them more effectively. Competing technologies or products may be more effective than any of
those that are being or will be developed by Argyll Biotech. In addition, existing competitors
enjoy the strategic advantages of existing brand recognition, marketing and distribution networks,
thus enabling them to introduce new products much more rapidly than Immunosyn.
Employees
As
of December 15, 2006, we had two executive officers, Mr. Kent Norton, President and CEO,
and Mr. Douglas McClain, Jr., our Chief Financial and Accounting Officer and Corporate Secretary, neither of which
are full-time employees. After the completion of this Offering, the Company expects to retain Mr.
Norton on a full time basis, and hire additional executive staff and employees as needed.
Property
The Company has been provided with rent-free office space for two executive offices under a
monthly oral agreement with no specific term from its affiliate and shareholder, Argyll Equities.
It is uncertain how long Argyll Equities will continue providing office space or on what terms
space will continue to be provided to the Company in the future. At present, we do not require
dedicated office space. We believe that our existing facilities are adequate for our current needs
and that additional space will be available as needed.
Legal Proceedings
Pursuant to a subpoena dated January 20, 2006 issued by the Securities and Exchange Commission
(“SEC”) 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 two subpoenas
issued by the SEC to affiliates of Argyll Biotech on March 30, 2006 in a proceeding captioned In
The Matter of The Argyll Group, LLC, the Company and its affiliates have been asked to produce all
documents concerning a wide variety of topics including many related directly to a prior licensee,
Nurovysn Merger Corporation. Pursuant to a third subpoena dated
December 15, 2006 issued by the SEC to the Company, the Company
has been asked to produce documents concerning private placements of
the Company’s stock and other matters disclosed in this
prospectus. The Company and its affiliates are actively cooperating with the SEC and
have produced or are producing documents responsive to these subpoenas. Although Immunosyn’s affiliates believe
they have complied and Immunosyn intends to comply with the
SEC’s subpoenas, there can be no assurance that the Company or
the Company’s affiliates will not be found liable for one or more violations of law which could expose the
Company or the Company’s affiliates, including Argyll Biotech, to liability for fines and penalties, as well as
injunctive or other sanctions that might prohibit or restrict the
Company’s or Argyll Biotech’s ability to proceed
with financing its operations.
On or about July 27, 2006, Daval International Limited, a UK corporation (“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, breach by such persons of their fiduciary
duties and conspiracy by Argyll Biotech to wrongfully disclose and use Daval’s trade secrets.
Argyll Biotech is investigating 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. Immunosyn is not a
party to this litigation.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Immunosyn Corporation
(a Development Stage Company)
La Jolla, California
We have audited the accompanying balance sheet of Immunosyn Corporation (a Development Stage
Company) as of September 30, 2006 and the related statements of operations, cash flows and changes
in stockholders’ equity for the period from August 3, 2006 (inception) through September 30, 2006.
These financial statements are the responsibility of Immunosyn’s management. Our responsibility is
to express an opinion on these financial statements based on our audit.
We conducted our audit in accordance with standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the financial position of Immunosyn Corporation as of September 30, 2006, and the results
of its operations and its cash flows for the period described in conformity with accounting
principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that Immunosyn will continue as a
going concern. As discussed in Note 2 to the financial statements, Immunosyn suffered recurring
losses from operations which raises substantial doubt about its ability to continue as a going
concern. Management’s plans regarding those matters also are described in Note 2. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
Immunosyn Corporation
(A Development Stage Company)
STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY
The Period from August 3, 2006 (Inception) Through September 30, 2006
Immunosyn Corporation (A Development Stage Company) Notes To Financial Statements
Note 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Background
Immunosyn Corporation is a Delaware corporation formed August 3, 2006 and headquartered in La
Jolla, California that executed an exclusive worldwide license to market, distribute and sell a
biopharmaceutical drug product, currently referred to as SF-1019, for treatment of Chronic
Inflammatory Demyelinating Polyneuropathy (“CIDP”), diabetic neuropathy and diabetic ulcers for an
affiliated company, Argyll Biotechnologies, LLC.
Cash
Immunosyn maintains cash in a checking account at a bank. The cash balance at the bank is insured
by the Federal Deposit Insurance Corporation up to $100,000.
Long-Lived Assets
Long-lived assets to be held and used are reviewed for impairment whenever events or changes in
circumstances indicate that their carrying amount may not be recoverable. The carrying amount is
not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the
use and eventual disposition of the asset. If the carrying amount is not recoverable, an
impairment loss is recognized for the amount by which the carrying amount of the asset exceeds its
fair value.
Income Taxes
Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for
deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary
differences. Temporary differences are the differences between the reported amount of assets and
liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in
the opinion of management, it is more likely than not that some portion or all of the deferred tax
assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of
changes in tax laws and rates on the date of enactment.
Stock Options
Immunosyn accounts for stock options using the fair value method. Fair value is determined at the
date of grant for employee options and at the date at which the grantee’s performance is complete
for non-employee options. Compensation cost is recognized over the vesting period based on the
fair value of the options. The fair value of the options is calculated using the Black-Scholes
option pricing model.
Basic and Diluted Net Loss per Share
Basic and diluted net loss per share calculations are presented in accordance with Financial
Accounting Standards Statement 128, and are calculated on the basis of the weighted average number
of common shares outstanding during the year. They include the dilutive effect of common stock
equivalents in years with net income. Basic and diluted loss per share are the same due to the
absence of common stock equivalents.
Estimates
The preparation of financial statements in conformity with generally accepted accounting principles
requires management to make estimates and assumptions that affect 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 revenues and expenses during the reporting period. Actual
results could differ from those estimates.
Recent Accounting Pronouncements
Immunosyn does not expect any recent accounting pronouncements to have a material effect on its
financial position or results of operations.
Note 2. GOING CONCERN UNCERTAINTY
The accompanying financial statements have been prepared assuming that Immunosyn will continue as a
going concern. Immunosyn was formed in August 2006 with an initial source of financing from
issuance of common stock and an advance from an affiliate. As shown in the financial statements,
Immunosyn had an accumulated deficit of $84,846 and a working capital deficit of $72,346 as of
September 30, 2006 which is considered insufficient to fund operations over the next 12 months.
These conditions raise substantial doubt about Immunosyn’s ability to continue as a going concern.
The financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
Note 3. LICENSE RIGHTS
Grant of Rights
Under the terms of the license agreement executed on September 28, 2006, Immunosyn was granted the
exclusive worldwide right to market, distribute, sell and promote SF-1019 for treatment of CIPD,
diabetic neuropathy and diabetic ulcers by Argyll Biotechnologies, LLC, in exchange for 147,000,000
shares of the common stock of the Company. Argyll Biotech also licensed its trademarks and granted
Immunosyn a right of first offer to enter into additional license agreements for other uses of
SF-1019 and its variants and cognates. Argyll Biotech purchased a group of patents for $5,000,000
and licensed one of those patents to Immunosyn. Also, during the first five years of the term of
the license agreement, Immunosyn has the right to enter into partnering arrangements with Argyll
Biotech for development of other novel drug treatment products.
Development and Regulatory Matters
Argyll Biotech anticipates that it will commence clinical trials and studies of SF-1019 and prepare
and submit all filings required for regulatory approval of that product for treatment of CIPD,
diabetic neuropathy and diabetic ulcers, both in the United States and in other countries that are
targeted for distribution and sale of the product. Argyll Biotech is required to submit periodic
written reports to Immunosyn to document its efforts toward procuring such regulatory approval, as
well as clinical budgets and plans for each year during which development efforts are conducted.
Argyll Biotech retains full responsibility for preparation and implementation of all trial
protocols and regulatory activities and for all costs associated with those activities.
Distribution and Promotion
Immunosyn assumes full responsibility to promote and sell SF-1019 for its approved uses. To
accomplish this, Immunosyn plans to develop a sales force, and an order processing and distribution
network for each country in which regulatory approval of SF-1019 is granted. Immunosyn plans to
develop full marketing plans for each such country, although Argyll Biotech will retain a right to
participate in all marketing and promotion activities. Each party is responsible for its own costs
associated with these activities.
License Fees
As consideration to Argyll Biotech for the rights granted to Immunosyn under the agreement,
Immunosyn issued 147,000,000 shares of common stock to Argyll Biotech. If and to the extent the
proceeds received by Argyll Biotech from the disposition of such shares of Immunosyn’s stock issued
are insufficient to fund Argyll Biotech’s budget for obtaining regulatory approval for sale of
SF-1019 in the U.S and U.K,
Immunosyn will be required to pay a royalty to Argyll Biotech equal to three and one-half per cent
(31/2%) of Immunosyn’s gross receipts from sales of SF-1019 until Argyll Biotech’s development
costs have been reimbursed in full.
Payments and Reports
Argyll Biotech is not obligated to provide any accounting for its use of proceeds, nor does
Immunosyn have any audit rights to inspect Argyll Biotech’s use of the license proceeds. Immunosyn
is required to submit periodic sales reports to Argyll Biotech, which will be utilized to determine
the amount of royalties that are payable, if any, to complete payment of the license fee.
Manufacture and Supply
Argyll Biotech retains responsibility for manufacturing and supplying all of Immunosyn’s
requirements of SF-1019. Argyll Biotech plans to sell quantities of the product to Immunosyn at a
price per dose that is below the anticipated market or reimbursement price per dose of the product.
The exact product price is not specified in the license agreement, and will be the subject of
future negotiations once Argyll Biotech’s cost of production is determined. Argyll Biotech shall
also confirm through testing and other programs that the commercial quantities of SF-1019 that it
manufactures are fully compliant with all manufacturing and laboratory standards applicable to drug
products which are intended for use in humans.
Ownership; Patents and Trademarks
Argyll Biotech retains full ownership of its intellectual property, including intellectual property
that is jointly-developed by the parties. Argyll Biotech must take reasonable steps to protect its
intellectual property from third-party infringement, and to defend Immunosyn against charges of
infringement that refer, relate or pertain to Immunosyn’s marketing, sale and distribution of
SF-1019.
Publication and Confidentiality
Argyll Biotech and Immunosyn must collaborate on all publications of scientific or medical reports
relating to either company’s business, operations, research and development or clinical trial
results.
Recall and Indemnification
Argyll Biotech retains full responsibility for costs and activities relating to any recall of
SF-1019, and is required to defend, indemnify and hold Immunosyn harmless for, from and against
damages associated with those recalls.
Term and Termination
The license agreement is in full force and effect for as long as any patent coverage remains in
place for SF-1019 in any country. Either party may terminate the agreement only on account of an
uncured material breach by the other party. Immunosyn may terminate the agreement if a
non-rebuttable regulatory or patient safety issue is raised, in which event all remaining license
fee obligations will immediately be cancelled. Any fees paid prior to termination are
non-refundable.
Valuation
The license rights are being recorded at Argyll Biotech’s cost basis of the underlying patents
licensed to Immunosyn.
Note 4. ADVANCES FROM AFFILIATES
Immunosyn was advanced $14,932 from Argyll Equities, LLC. These advances will be repaid on demand.
No interest expense was accrued.
Immunosyn has adopted a stock option plan for employees, outside consultants, and directors. There
are 5,000,000 common shares available for grant under the plan. The plan allows for incentive
options with exercise prices of at least 100% of the fair market value of Immunosyn’s common stock
and nonqualified options with exercise prices of at least 85% of the fair market value of
Immunosyn’s common stock.
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 December15, 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 are
actively cooperating with the SEC and producing documents responsive to these subpoenas.
On or about July 27, 2006, Daval International Limited filed suit in the United Kingdom, in the
High Court of Justice, Chancery Division, against Argyll Biotech and five of Argyll Biotech’s
research scientists seeking an injunction and damages based on allegations of breach by the
scientists of confidentiality agreements with Daval and conspiracy by Argyll Biotech to wrongfully
disclose and use Daval’s trade secrets. Argyll Biotech is investigating the merits of the suit and
evaluating its defenses on the basis that, among other grounds, Argyll Biotech’s product and method
of producing SF-1019 is fundamentally different than that used by Daval.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with the financial
statements and notes thereto appearing elsewhere in this prospectus.
General
The Company is a development stage company formed in August 3, 2006 in order to work as Argyll
Biotech’s sales, marketing and distribution channel for its biopharmaceutical drug product,
currently referred to as SF-1019. Since inception, the Company has been principally devoted to
raising capital and negotiating the exclusive license to SF-1019 with Argyll Biotech, an affiliated
company to market, distribute and sell SF-1019 as soon as appropriate regulatory approvals are
received by Argyll Biotech for SF-1019. On September 28, 2006, it successfully acquired the
exclusive license from Argyll Biotech.
For
the period August 3, 2006 (inception) through September 30, 2006, the Company had no revenues
and incurred an accumulated deficit of $84,846. Legal fee expense associated with the formation
and initial private placement accounted for the accumulated deficit.
Liquidity and Capital Resources
In August 2006, the Company completed an initial private placement and raised $4,100 from the
offering, in addition to $8,400 paid in capital by the initial subscribers. As of September 30, 2006,
the Company had cash and cash equivalents of $21,893 and a working
capital deficit of $72,346. The
Company expects to incur substantial operating expenses related to building its sales, marketing
and distribution channel activities over the next several years. Accordingly, the Company will be
required to immediately seek additional financing to continue its activities beyond the near term.
While the Company believes it will be successful in raising capital through future private and
public placements, there can be no assurances that it will be able to obtain any required
additional funds, in which event it may be necessary for the Company to significantly curtail its
operations.
The following plan of operation should be read in conjunction with the financial statements and
related notes thereto appearing elsewhere in this prospectus. This plan of operation contains
forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results
may differ materially from those anticipated in these forward-looking statements as a result of
certain factors, including but not limited to those set forth under “Risk Factors” and elsewhere in
this filing. See also “Forward Looking Statements.”
Overview
Immunosyn Corporation is a development stage company that was formed in August 2006 and is
headquartered in La Jolla, California. In September 2006, it executed an exclusive license
agreement with an affiliated company, Argyll Biotech, for 147,000,000 shares of its Common Stock.
Pursuant to the terms of the license agreement, the Company has an exclusive worldwide license to
market, distribute and sell a biopharmaceutical drug product, currently referred to as SF-1019, for
treatment of CIDP, diabetic neuropathy and diabetic ulcers, 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.
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 CIDP and diabetes treatment communities.
As of the date of this prospectus, we have no revenue or operations. Our ability to obtain
additional funding will determine our ability to continue as a going concern. We have one principal
asset, our exclusive license from Argyll Biotech, and two part-time employees. We do not expect to
commence full scale operations or generate revenues 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, nor have we been involved in any mergers, acquisitions or
consolidations.
Plan of Operation
At
September 30, 2006, the Company had an accumulated deficit of
$84,846 and a working capital
deficit of $72,346. Based on its current cash balance, management believes the Company cannot
attract individuals to fill permanent key management positions and cannot build its operations.
Currently, an affiliated company provides general and administrative support services to the
Company on a part-time basis, without charge. The Company believes that a public market for its
Common Stock will enable it to attract funding for its operations and offer stock-based
compensation to hire personnel to fill the key positions necessary to commence operations.
Accordingly, the Company needs additional financing to continue its operations and may raise funds
in the future privately or publicly.
The Company intends to raise working capital through one or more financings to meet the
following requirements:
•
hiring staff, including a CFO, controller and five sales and marketing personnel;
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; and
•
developing market awareness in the medical community and educating those effected
with CIDP, diabetic neuropathy and diabetic ulcers.
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 seeks regulatory
approval from the FDA and 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. 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.
Off Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements.
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
Set forth below is information regarding the Company’s current directors and executive
officers. There are no family relationships between any of our directors or executive officers.
The directors are elected annually by stockholders. The executive officers serve at the pleasure
of the Board of Directors.
Name
Age
Title
D. Kent Norton
55
President and Chief Executive Officer, Director
Douglas McClain, Jr.
32
Chief Financial and Accounting Officer, Secretary, Director
D. KENT NORTON, J.D., President and Chief Executive Officer, Director
Mr. Norton is 55 years of age and an attorney with 28 years of executive experience in various
industries. Mr. Norton is our current President and Chief Executive Officer and has also served as
a director of the Company since August 2006. Mr. Norton served as a senior manager of OK
Foundation from November 1999 until May 2006, including Chief Executive Officer from April 2003
until May 2006, and Managing Director of The Sutherland Institute, a Utah-based public policy
think-tank since October 2005. Mr. Norton attended University of Utah and graduated magna cum
laude in 1975 with a Bachelor of Science degree in Organizational Communications. He received his
Juris Doctorate from the J. Reuben Clark Law School at Brigham Young University in 1978.
DOUGLAS
MCCLAIN, JR., Chief Financial and Accounting Officer, Corporate Secretary, Director
Mr. McClain is 32 years of age and a financial executive with 10 years of experience. In
2002, Mr. McClain co-founded Argyll Equities, LLC and its affiliates, a boutique private equity
investment banking and corporate finance firm, where he serves as an executive officer and
director. In 1999, he joined International Profit Associates, a business consulting firm, as a
Senior Executive responsible for mergers and acquisitions, and corporate finance, where he was
employed until 2001. Mr. McClain graduated with a Bachelor of Business Administration in finance
from Mercer University’s Stetson School of Business and Economics in 1996.
Audit Committee Financial Expert
The Company does not have an audit committee or a compensation committee of its board of
directors. In addition, the Company’s board of directors has determined that the Company does not
have an audit committee financial expert serving on the board. When the Company develops its
operations, it will create an audit and a compensation committee and will seek an audit committee
financial expert for its board and audit committee. Until it has such committees and such an
expert, the Company will not be able to list its stock on the major securities exchanges or the
Nasdaq.
Advisors and Consultants
The following person is serving as an advisor to the Company:
FRED G. JAGER Mr. Jager is founder, president and chief executive officer of Hunter Wise
Financial Group, LLC and Hunter Wise Securities, LLC. For three decades he has represented public
and privately held companies throughout North America, and a successful advisor in middle-market
corporate finance. Formerly president of Geneva Corporate Finance, Inc., Mr. Jager also founded
Denver-based
Jager & Company, Inc., which was the largest corporate finance firm of its kind in the
Rocky Mountain region. He also was executive vice president of an investment banking firm in
Northern California, and chief operating officer of one of the largest vocational educational
companies in the world. A former intelligence officer, Mr. Jager has been a director on numerous
public and private companies, is experienced business speaker and author of numerous published
articles.
It is anticipated that the Company’s President and Chief Executive Officer, D. Kent Norton,
will receive base compensation of $300,000.00 per year beginning in 2007. In addition, it is
anticipated that the Company will provide Mr. Norton with normal and customary benefits, including
health and dental insurance, vacation, expense reimbursement, and retirement plan contributions.
There is currently no arrangement with Mr. McClain to provide compensation for his executive
services to the Company.
Non-Employee Director Compensation
The Company has no formal plan for Director compensation, but anticipates that it will
reimburse the reasonable and customary expenses of any future non-employee directors associated
with their service on the board, including travel expenses and standard fees for attending board
meetings. In addition, the Company has established the Immunosyn 2006 Stock Option Plan (the
“Plan”) for employees, directors and consultants and reserved 5,000,000 shares for issuance under
the Plan. At the date hereof, no options have been issued under this Plan.
SECURITY OWNERSHIP OF CERTAIN
BENEFICIAL OWNERS AND MANAGEMENT
The
following table lists stock ownership of our Common Stock as of
December 15, 2006. The
information includes beneficial ownership by (i) holders of more than 5% of our Common Stock, (ii)
each of our directors and executive officers and (iii) all of our directors and executive officers
as a group. Except as noted below, to our knowledge, each person named in the table has sole
voting and investment power with respect to all shares of our Common Stock beneficially owned by
them.
Name and Address
Amount and Nature of
Percentage
of Beneficial Owner
Director/Officer
Beneficial Ownership (1)
of Class
Argyll Biotechnologies LLC (2)
4225 Executive Square, Suite 260 La Jolla, CA92037
147,000,000
54.0
%
Padmore Holdings, Ltd. (3)
1100 N.W. Loop 410, Suite 207 San Antonio, TX78213
28,000,000
10.3
%
Clairsvelle Holdings, Ltd. (4)
1100 N.W. Loop 410, Suite 207 San Antonio, TX78213
20,500,000
7.5
%
Cuxhaven Holdings Ltd (5)
1100 N.W. Loop 410, Suite 207 San Antonio, TX78213
20,500,000
7.5
%
Argyll Equities LLC (6)
4225 Executive Square, Suite 260 La Jolla, CA92037
Douglas McClain, Jr. (7)
4225 Executive Square, Suite 260 La Jolla, CA92037
Chief Financial and Accounting
Officer and Secretary, Director
114,100,000
41.9
%
All directors and officers as a group (two persons)
114,600,000
42.1
%
(1)
Includes in each case shares of Common Stock that may be issued upon exercise of options or warrants that are exercisable within 60
days for the subject individual only, if any. Percentages are computed on the basis of 272,000,000 shares of Common Stock outstanding
as of December 15, 2006. All shares are directly owned unless
otherwise indicated.
A Delaware limited liability company owned 50% by James T. Miceli and 50% by Douglas McClain Jr.
(3)
A British Virgin Islands entity, with Mr. Lynn Booker having voting and dispositive control, and owned 45% by James T. Miceli, 45% by
Douglas McClain Jr., and 10% by Douglas McClain Sr.
(4)
A British Virgin Islands entity, with Mr. Lynn Booker having voting and dispositive control, and owned by Douglas McClain Jr.
(5)
A British Virgin Islands entity, with Mr. Lynn Booker having voting and dispositive control, and owned by James T. Miceli.
(6)
A Texas limited liability company owned 50% by Douglas McClain Jr. and 50% James T. Miceli.
(7)
Including Mr. McClain’s shares held by Clairsvelle Holdings, Ltd., his undivided interests in Padmore, Argyll Biotechnologies and
Argyll Equities.
Securities Authorized for Issuance Under Equity Compensation Plans
The Company has adopted an employee stock option plan, which acts as an incentive cash, stock,
and stock option plan, under which the Company’s officers, directors, consultants, and employees
will be eligible to receive, in relevant part, either securities or stock options exercisable for
the Company’s securities at exercise prices that may be equal to or lower than the offering price.
The Company has reserved five million (5,000,000) shares of Common Stock for issuance under this
plan. No options have been issued under this plan.
Except as set forth below, there have been no material transactions during the past two years
between us and any officer, director or any stockholder owning greater than 5% of our outstanding
shares, nor any of their immediate family members.
The Company has entered into an exclusive license agreement with Argyll Biotech, an affiliate
of the Company that owns approximately 50% of the Company’s issued and outstanding Common Stock as
of December 15, 2006. The exclusive license agreement, including, without limitation, the fees
established in that agreement, will be between related entities, was not negotiated in an
arms-length transaction and does not necessarily bear any relationship to established or
traditional methods of valuing such fees. No independent audit or verification of the license fee
has been made to determine its fairness to Immunosyn.
If the proceeds received by Argyll Biotech from the sale of the Company’s stock hereunder are
inadequate to complete development and regulatory approval of SF-1019, we will pay the deficiency
through a fee equal to three and one-half per cent (3-1/2%) of
Immunosyn’s gross sales of SF-1019, in
addition to the cost of product purchases from Argyll Biotech. The license fee is deemed earned
when paid and there are no restrictions on the release or use of the license fee paid to Argyll
Biotech, which may be used in Argyll Biotech’s discretion for any purpose. No refund will be owed
by Argyll Biotech in the event the cost of development and regulatory approval is substantially
less than the fee, nor are there any penalties owed by Argyll Biotech if it fails to complete
product development or obtain regulatory approval for its distribution. The Company’s inability or
failure to pay any license fees when due will adversely affect the Company’s licensed rights. As
those rights will be the Company’s sole and primary asset, if the Company is unable to maintain
those rights, the Company will lose substantially all of its value. See “Business – The Argyll
Biotech License Agreement.”
The Company has been provided with rent-free office space for two executive offices under a
monthly oral agreement with no specific term from its affiliate and shareholder, Argyll Equities.
It is uncertain how long Argyll Equities will continue providing office space or on what terms
space will continue to be provided to the Company in the future.
Between
August 3, 2006 and August 31, 2006, the Company sold a total of 125,000,000 shares of Common
Stock, at a purchase price of $0.0001 per share, to the selling stockholders, resulting in gross
proceeds to the Company of $12,500.00. Douglas McClain Sr., the beneficial owner of a 10% interest
in Padmore which owns 28,000,000 shares of Common Stock in the Company, is the father of Douglas
McClain, Jr., who is a Director, as well as the Chief Financial and
Accounting Officer and Secretary for the
Company. Including Douglas McClain Jr.’s undivided interest in Padmore, Argyll Biotech and Argyll
Equities, the McClains control a total of 116,900,000 shares of Common Stock, or approximately 43%
of the Company’s Common Stock.
Immunosyn has authorized a total of 450,000,000 shares, consisting of 425,000,000 shares of
Common Stock, par value $0.0001 per share, and 25,000,000 shares of Preferred Stock, par value
$0.0001 per share. As of December 15, 2006, the Company had 272,000,000 shares of Common Stock
issued and outstanding and no shares of Preferred Stock issued and outstanding.
Common Stock
Voting Rights
Each holder of Common Stock is entitled to one vote for each share of Common Stock held on all
matters submitted to a vote of stockholders.
Dividends
Subject to preferences that may be applicable to any then-outstanding shares of Preferred
Stock, if any, and any other restrictions, holders of Common Stock are entitled to receive ratably
those dividends, if any, as may be declared from time to time by the Company’s board of directors
out of legally available funds. The Company and its predecessors have not declared any dividends
in the past. Further, the Company does not presently contemplate that there will be any future
payment of any dividends on Common Stock.
Preferred Stock
Our board of directors has the authority to issue 25,000,000 shares of preferred stock in one
or more series and to determine all of the rights, preferences, privileges and restrictions of the
preferred stock. As of the date of this prospectus, the Company does not have any preferred stock
issued or outstanding. If we issue any preferred stock in the future, it may have the effect of
delaying or preventing a change in control without further action by our stockholders and may
adversely affect the voting, dividend and other rights of the holders of our common stock. In
addition, the issuance of preferred stock with voting and/or conversion rights may adversely affect
the voting power of the holders of our common stock, including the loss of voting control to
others.
Options
The Company has established the Immunosyn 2006 Stock Option Plan (the “Plan”) for employees,
directors and consultants and reserved 5,000,000 shares for issuance under the Plan. At the time
of this Offering, no options have been issued under this Plan.
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
There
is no public trading market for our securities. As of December 15, 2006, 425,000,000
shares of our Common Stock were authorized for issuance and 272,000,000 shares of Common Stock were
issued and outstanding. As of December 15, 2006, 25,000,000 shares of our Preferred Stock were
authorized for issuance and no shares of Preferred Stock were issued and outstanding.
The Company has not paid any dividends on its capital stock and does not expect to pay
dividends for the foreseeable future.
The following table details the name of each selling stockholder, the number of shares owned
by that selling stockholder and the number of shares that may be offered by each selling
stockholder for sale under this prospectus. The selling stockholders may sell up to 272,000,000
shares of our Common Stock from time to time in one or more offerings under this prospectus.
Because each selling stockholder may offer all, some or none of the shares it holds, and because,
based upon information provided to us, there are currently no agreements, arrangements, or
understandings with respect to the sale of any of the shares, no definitive estimate as to the
number of shares that will be held by each selling stockholder after the Offering can be provided.
The following table has been prepared on the assumption that all shares offered under this
prospectus will be sold to parties unaffiliated with the selling stockholders. Except as indicated
below, no selling stockholder nor any of their affiliates have held a position or office or had any
other material relationship with us.
Relationship to
Company or its
Total No.
% Owned
No. of Shares
Affiliates Within Past
Amount Being
Currently
Prior to
Owned After
Name
3 Years
Registered
Owned
Offering
Offering
Argyll Equities
An Affiliate
15,000,000
15,000,000
5.5
%
0
Padmore Holdings Limited*
James T. Miceli,
Douglas McClain Jr.
and Douglas McClain
Sr. are the
[beneficial owners
of Padmore Holdings
Limited
28,000,000
28,000,000
10.3
%
0
Clairsvelle
Holdings Ltd.
Douglas McClain Jr.
is the sole
beneficial owner of
Clairsvelle
Holdings
20,500,000
20,500,000
7.5
%
0
Cuxhaven Holdings Limited
James T. Miceli is
the sole beneficial
owner of Cuxhaven
Holdings Limited
20,500,000
20,500,000
7.5
%
0
David Maizels
Consultant to
Argyll Biotech
4,000,000
4,000,000
1.5
%
0
Angus Dalgleish
Consultant to
Argyll Biotech
4,000,000
4,000,000
1.5
%
0
Troustpawn Trustee
Ltd.
The principal
beneficiary is a
consultant to
Argyll Biotech
4,000,000
4,000,000
1.5
%
0
Fairwater Trustee
Ltd.
The principal
beneficiary is a
consultant to
Argyll Biotech
4,000,000
4,000,000
1.5
%
0
GRD Family Trust 2006
The principal
beneficiary is a
consultant to
Argyll Biotech
The Common Stock offered by this prospectus is being offered by the selling stockholders.
Subject to the lock-up agreements between the selling stockholders and the Company, described
below, the Common Stock may be sold or distributed from time to time by the selling stockholders
directly to one or more investors or through brokers, dealers or underwriters who may act solely as
agents at market prices prevailing at the time of sale, at prices related to the prevailing market
prices, at negotiated prices, or at fixed prices, which may be changed. The sale of the Common
Stock offered by this prospectus may be effected in one or more of the following methods:
•
ordinary brokers’ transactions,
•
through brokers, dealers, or underwriters who may act solely as agents,
•
“at the market” into an existing market for the Common Stock,
•
in other ways not involving market makers or established trading markets, including
direct sales to purchasers or sales effected through agents,
•
in privately negotiated transactions, including conversion of certain notes issued
by Argyll Biotech, as described below, and resale of the Common Stock by the former
note holders, and
•
any combination of the foregoing.
In August 2006, Argyll Biotech sold $1,055,000 principal amount of 8% convertible
notes due June 30, 2007 in a private placement to nine accredited investors (the “AB Note
Holders”). The notes are convertible at the option of the AB Note Holders, at any time between
November 1, 2006, and June 30, 2007, into Common Stock of Immunosyn at a conversion rate equal to
the lesser (i) $5.00 per share, or (ii) if Immunosyn’s Common Stock is quoted on the OTC Bulletin
Board, the average closing price per share on the ten trading days preceding the conversion date,
subject to a minimum conversion price of $3.00 per share. In addition, certain AB Note Holders’
conversion rights include, along with each share acquired by converting their note, a warrant to
purchase two additional shares of Common Stock of Immunosyn, with an exercise price of $7.50 per share and the
second at $10.00 per share. The conversion rights, if exercised, must be exercised in full. The
Plan of Distribution by Argyll Biotech includes the issuance of shares of Common Stock of the
Company owned by Argyll Biotech to the AB Note Holders upon their conversion of the convertible
notes. If all the notes were converted in full by all the AB Note Holders, it is estimated that a
maximum of 633,000 shares of Immunosyn Common Stock, including those shares transferred upon
exercise of the AB Note Holders’ warrants, would be transferred by Argyll Biotech to the AB Note
Holders and Argyll Biotech would retain 146,367,000 shares of Immunosyn Common Stock. Immunosyn
received no consideration from the issuance by Argyll Biotech of the convertible notes to the AB
Note Holders and will receive no consideration from the conversion of the convertible notes by the
AB Note Holders into shares of Immunosyn Common Stock.
Argyll Biotech and all other shareholders whose Common Stock will be registered in this
Offering, except for Argyll Equities LLC, are subject to a Lock-Up Agreement between the Company
and such selling stockholders (the “Lock-Up”) which contains certain lock-up provisions with regard
to future sales of our Common Stock for a period of 12 months after the Offering.
In order to comply with the securities laws of certain states, if applicable, the Common Stock
may be sold only through registered or licensed brokers or dealers. In addition, in certain
states, the Common
Stock may not be sold unless the shares have been registered or qualified for
sale in the state or an exemption from the registration or qualification requirement is available
and complied with.
Subject to the Lock-Up, the selling stockholders may pledge their Common Stock to their
brokers under the margin provisions of customer agreements. If a selling stockholder defaults on a
margin loan, the broker may, from time to time, offer and sell the pledged shares. Broker-dealers
engaged by a selling stockholder may arrange for other broker-dealers to participate in sales.
Broker-dealers may receive commissions or discounts from the selling stockholders (or, if any
broker-dealer acts as agent for the purchaser of Common Stock, from the purchaser) in amounts to be
negotiated.
The selling stockholders and any broker-dealers or agents that are involved in selling the
shares may be deemed to be “underwriters” within the meaning of the Securities Act of 1933, as
amended, in connection with such sales. In such event, any commissions received by such
broker-dealers or agents and any profit on the resale of the Common Stock purchased by them may be
deemed to be underwriting commissions or discounts under the Securities Act of 1933, as amended.
We will pay all of the expenses incident to the registration, offering, and sale of the Common
Stock to the public other than commissions or discounts of underwriters, broker-dealers or agents.
While
they are engaged in a distribution of the Common Stock included in this prospectus, the
selling stockholders are required to comply with Regulation M promulgated under the Securities
Exchange Act of 1934, as amended. With certain exceptions, Regulation M precludes the selling
stockholders, any affiliated purchasers and any broker-dealer or other person who participates in
the distribution, from bidding for or purchasing, or attempting to induce any person to bid for or
purchase any security which is the subject of the distribution until the entire distribution is
complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price
of a security in connection with the distribution of that security. All of the foregoing may
affect the marketability of the Common Stock offered by this prospectus.
This prospectus relates to shares of our Common Stock that may be offered and sold from time
to time by selling stockholders. The selling stockholders currently hold a total of 272,000,000
shares of our Common Stock. We will receive no proceeds from their sale of shares of Common Stock
in this Offering.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
The Company’s charter and bylaws provide that directors and officers shall be indemnified by
the Company to the fullest extent authorized by the General Corporation Law of the State of
Delaware, against all expenses and liabilities reasonably incurred in connection with services for
the Company or on its behalf.
Insofar as indemnification for liabilities arising under the Securities Act might be permitted
to directors, officers or persons controlling our Company under the provisions described above, the
Company has been informed that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act and is therefore
unenforceable.
The
audited financial statements of our Company for the period
August 3, 2006 through September30, 2006 have been audited by Malone & Bailey, P.C., independent public accountants. The report of
Malone & Bailey P.C., which appears elsewhere herein, includes an explanatory paragraph as to the
ability of our Company to continue as a going concern. The financial statements of our Company are
included in reliance upon such report and upon the authority of such firm as an expert in auditing
and accounting.
FURTHER INFORMATION
We will become subject to the reporting requirements of the Securities Exchange Act of 1934,
as amended, and file reports, proxy statements and other information with the Securities and
Exchange Commission. These reports, proxy statements and other information may be inspected and
copied at the public reference facilities maintained by the Securities and Exchange Commission at
100 F. Street, N.E., Room 1580, Washington, D.C. 20549 and at the Securities and Exchange
Commission’s regional offices. You can obtain copies of these materials from the Public Reference
Section of the Securities and Exchange Commission upon payment of fees prescribed by the Securities
and Exchange Commission. You may obtain information on the operation of the Public Reference Room
by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Securities and Exchange
Commission’s Web site contains reports, proxy and information statements and other information
regarding registrants that file electronically with the Securities and Exchange Commission. The
address of that site is http://www.sec.gov.
58
Dates Referenced Herein and Documents Incorporated by Reference