UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-KSB/A
AMENDMENT NO. 2
(X) Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934
For the fiscal year ended December 31, 2003.
OR
( ) Transition Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
COMMISSION FILE NUMBER: 33-05384
IR BIOSCIENCES HOLDINGS, INC.
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(Name of Small Business Issuer in its Charter)
DELAWARE 13-3301899
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(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
8655 East Via De Ventura, Suite E-155 85258
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(Address of Principal Executive Offices) (Zip Code)
(480) 922-3926
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(Issuer's Telephone Number, including Area Code)
Securities registered under Section 12(b) of the Exchange Act:
NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(G) OF THE EXCHANGE ACT:
COMMON STOCK, $ 0.001 PAR VALUE PER SHARE
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(Title of class)
Check whether the issuer: (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act of 1934 during the past 12 months (or for such
shorter period that the Registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes No X
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Check if there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B is not contained in this form, and no disclosure will be
contained, to the best of registrant's knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-KSB
or any amendment to this Form 10-KSB. [X]
State issuer's revenues for its most recent fiscal year: $ 0
The aggregate market value of the Registrant's issued and outstanding shares of
common stock held by non-affiliates of the Registrant as of May 6, 2004 (based
on the average of the bid and asked prices as reported by the NASD OTC Bulletin
Board as of that date) was approximately $2,309,569.
The number of shares outstanding of Registrant's Common Stock, par value $0.001
as of May 3, 2004: 27,581,274.
Documents Incorporated by reference: None
Transitional Small Business Disclosure Format Yes No X
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TABLE OF CONTENTS
Page
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PART I
Item 1. Description of Business.............................................3
PART III
Item 13. Exhibits and Reports on Form 8-K...................................17
Signatures.........................................................18
3
INTRODUCTORY NOTE
THE DISCUSSIONS IN THIS FORM 10-KSB MAY CONTAIN CERTAIN FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE SECURITIES ACT OF 1933 AND
SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934. IN ADDITION, WHEN USED IN
THIS FORM 10-KSB, THE WORDS "ANTICIPATES," "IN THE OPINION," "BELIEVES,"
"EXPECTS," AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING
STATEMENTS. PLEASE NOTE THAT THE SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
UNDER THE SECURITIES ACT OF 1933 AND THE SECURITIES EXCHANGE ACT DO NOT APPLY TO
OUR COMPANY. ACTUAL FUTURE RESULTS COULD DIFFER MATERIALLY FROM THOSE DESCRIBED
IN THE FORWARD-LOOKING STATEMENTS AS A RESULT OF FACTORS DISCUSSED IN
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS SET FORTH BELOW, AS WELL AS IN "RISK FACTORS" SET FORTH HEREIN. THE
COMPANY CAUTIONS THE READER, HOWEVER, THAT THIS LIST OF RISK FACTORS MAY NOT BE
EXHAUSTIVE. THE COMPANY EXPRESSLY DISCLAIMS ANY OBLIGATION OR UNDERTAKING TO
RELEASE PUBLICLY ANY UPDATES OR CHANGES TO THESE FORWARD-LOOKING STATEMENTS THAT
MAY BE MADE TO REFLECT ANY ANTICIPATED OR UNANTICIPATED EVENTS OR CIRCUMSTANCES
AFTER THE DATE OF SUCH STATEMENTS.
PART I
ITEM 1. DESCRIPTION OF BUSINESS
Unless the context otherwise requires, references to "we," "us," the "Company"
or "ImmuneRegen" mean IR BioSciences Holdings, Inc.
BUSINESS DEVELOPMENT
Our company, IR BioSciences Holdings, Inc., is a Delaware corporation and, until
July 2001, was engaged in the business of assisting unaffiliated early-stage
development and small to mid-sized emerging growth companies with financial and
business development services, including raising capital in private and public
offerings. During 2001, we failed to meet our revenue targets. On July 27, 2001,
a majority interest in our company was acquired by a private investor, and we
installed new management and adopted a new business plan. The immediate action
taken regarding this new business plan was to discontinue our then current
operations effective July 27, 2001.
On July 2, 2003, our company and ImmuneRegen Biosciences, Inc., a privately-held
Delaware corporation ("ImmuneRegen"), entered into and consummated an Agreement
and Plan of Merger (the "Merger"). In accordance with the Merger, on July 2,
2003, we acquired ImmuneRegen in exchange for 10,531,585 shares of our common
stock. The transaction contemplated by the Agreement was intended to be a
"tax-free" reorganization pursuant to the provisions of Section 351 and
368(a)(1)(A) of the Internal Revenue Code of 1986, as amended. On August 29,
2003, the Registrant's name was changed from GPN Network, Inc. to IR BioSciences
Holdings, Inc.
CORPORATE STRUCTURE
IR BioSciences Holdings is a publicly-traded entity and has one wholly-owned
subsidiary: ImmuneRegen BioSciences, Inc. ImmuneRegen BioSciences, Inc. is a
Delaware Corporation, and was incorporated on October 30, 2002. Currently, all
of our Company's operations are conducted by ImmuneRegen BioSciences, Inc.
BUSINESS DESCRIPTION
ImmuneRegen BioSciences, Inc. is a biotechnology company engaged in the research
and development of applications utilizing modified substance P, a naturally
occurring immunomodulator. Derived from homeostatic substance P, ImmuneRegen has
named its proprietary compound "Homspera." Currently, ImmuneRegen holds two
patents and four provisional patents in the United States. Additionally,
ImmuneRegen holds a patent with the European Union and Australia and is seeking
to extend its patents into Canada and, possibly, Japan.
ImmuneRegen's initial areas of focus will be in continuing development of
several applications for use in improving pulmonary function and stimulating the
immune system. These applications have been derived from research studies and
positive results from laboratory tests conducted by management over the past
nine years.
With the assistance of our U.S. Food and Drug Administration ("FDA")
consultants, Synergos, Inc., ImmuneRegen plans to apply for Investigational New
Drug ("IND") approval from the FDA. Based on ImmuneRegen's past test results and
continuing studies, ImmuneRegen believes that its IND may be activated, allowing
it to begin its human clinical trials using the Homspera compound as a treatment
for lung injury caused by acute respiratory disease syndrome ("ARDS"), an often
fatal disease.
ImmuneRegen's goal is to enter into overseas licensing and royalty agreements
for its applications while awaiting approval by the FDA in the Unites States.
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Once approval has been obtained by the FDA, ImmuneRegen hopes to further expand
its sales efforts internationally and will attempt to begin to generate sales
domestically through the licensing and the direct sales of its products in the
United States. A goal is to strategically align itself with larger
pharmaceutical and other biotechnology and medical research companies, which
ImmuneRegen believes may enhance its ability to succeed in reaching the
objectives of bringing its applications to the marketplace. If FDA approval is
granted, ImmuneRegen intends to seek to establish license agreements and
relationships domestically that will bring Homspera to those in need of it.
Substance p
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Substance P, first isolated in 1931, is a bioactive 11-amino acid peptide
belonging to a group of neurokinins (small peptides that are broadly distributed
in the central nervous system and peripheral nervous system). Substance P has
been found to be involved in many physiological processes including pain
modulation, smooth muscle contraction, blood pressure control, kidney function
and water homeostasis. The peptide is widely distributed in numerous tissues and
body fluids including the central and peripheral nervous system,
gastrointestinal tract, visual system and circulatory system.
In the 1950s, substance P was considered to be the neurotransmitter for primary
sensory afferent fibers, or the pain transmitter. By the 1970s, the biochemical
properties of purified substance P were found to be a proteinaceous substance
composed of amino acids that, subsequently, could be synthetically derived.
Since then, substance P has been extensively studied by researchers and
scientists worldwide because of its many general physiological effects (smooth
muscle contraction, inflammation, neurotransmission, blood vessel dilation,
histamine release, and activation of the immune system) including its potential
to stimulate epithelial growth; heal ulcers and ocular wounds; and, as a new
approach to dulling anxiety and relieving depression and stress.
ImmuneRegen's patents and continued substance P research are derived from
discoveries made during research funded by the Air Force Office of Scientific
Research in the early 1990s. During this research ImmuneRegen's founders, Drs.
Witten and Harris, observed that the exposure of animals to jet fuels resulted
in pathological changes in the lung and immune systems of those exposed. It was
also observed that such exposure resulted in depletion of substance P from the
lungs of the animals. These studies further showed that the administration of
substance P may help prevent and reverse the effects of jet fuel exposure in the
lungs, as well as protect and regenerate the immune system. The immune findings
led to early research on the treatment of exposure to acute radiation and on the
possible reversal of lung damage caused by ARDS and cigarette smoke.
Research & Development
----------------------
Homspera is a proprietary compound created by modifying substance P. Based on
initial findings and ongoing research studies, ImmuneRegen intends to initially
focus on developing treatments for acute radiation syndrome ("ARS"), ARDS and
hair replacement related to loss due to traditional anti-cancer treatments.
Additionally, management believes that Homspera may be proven to provide
applications for: 1) lessening lung damage caused by cigarette smoke and other
toxicants related to air pollution; 2) the treatment of respiratory diseases
associated with chronic obstructive pulmonary disease ("COPD"); 3) the treatment
of lung and other cancers; 4) hair replacement; and, 5) the treatment of animals
through the development of similar applications for use in veterinary medicine.
In the future, ImmuneRegen believes that it may be able to increase and
strengthen its market position in the following ways: (i) working with the FDA
to obtain the approval of the Homspera and future developments; (ii)
investigating foreign markets for the use of Homspera and future products; and,
(iii) continuing its current research into developing new applications.
ImmuneRegen has established a pilot manufacturing facility at its lab
headquarters in Tucson, Arizona for the production of immune-based therapies.
ImmuneRegen expect these facilities to be adequate to supply limited clinical
trial quantities for its products under development. Additional manufacturing
capacity will be needed for commercial scale production, if these therapies are
approved for commercial sale.
For the manufacture of the applications under development, ImmuneRegen obtain
synthetic peptides from third party manufacturers. ImmuneRegen believes that
synthesized version of substance P is readily available at low cost from several
life science and technology companies that provide biochemical and organic
chemical products and kits used in scientific and genomic research,
biotechnology, pharmaceutical development and the diagnosis of disease and
chemical manufacturing. ImmuneRegen believes that the synthetic substance P and
other materials necessary to produce Homspera are readily available from various
sources, and several suppliers are capable of supplying substance P in both
clinical and commercial quantities. These suppliers also store and ship the
product as well.
ImmuneRegen expects that its products will use an inhaler (puffer) device to
deliver Homspera to the user. To develop, manufacture and test an inhaler device
ImmuneRegen hopes to partner with a drug development and chemical services
company that offers services ranging from pre-clinical and toxicology studies to
clinical trial support and manufacturing services. ImmuneRegen believes that
such a partnership may enable it to decrease the time-to-market for its products
and to increase its productivity.
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Our Products
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Based on its initial research findings, ImmuneRegen plans to initially develop
applications using Homspera for:
o The treatment for ARS;
o The treatment of ARDS; and,
o Hair loss replacement/attenuation due to its traditional anti-cancer
treatments.
While performing the necessary research studies and due diligence to gain FDA
approval of Homspera, ImmuneRegen hopes to enter into various license
agreements, joint ventures and perform additional research overseas.
In conjunction with these initial areas ImmuneRegen plans to continue research
and data collection, perform further research studies, and hopes to enter into
license agreements overseas for:
o Therapies that may lessen lung damage caused by cigarette smoke and
other toxicants related to air pollution;
o Providing a possible solution to the hair replacement industry; and,
o The treatment of animals through the possible development of similar
applications for use in veterinary medicine.
Looking ahead, based on collected preliminary research data, ImmuneRegen
believes it may be able to develop applications for:
o Reducing the risk of cancer development;
o Prevention of the spread and metastasis of cancer;
o The treatment of lung and other cancers;
o Enhancing an immune response to a viral infection; and,
o Boosting a suppressed or failing immune system, which has direct
applications in the treatment of the common cold, AIDS, food
poisoning and slowing the effects of aging.
Immuneregen's Strategy
----------------------
ImmuneRegen's strategy is to develop, test and obtain regulatory approval for
various applications using Homspera in a diverse array of applications. The
first two regulatory approvals ImmuneRegen hopes to obtain are in the United
States and Europe. ImmuneRegen is currently investigating regulatory and other
requirements in these countries, as well as others. ImmuneRegen is also
evaluating other market for distribution of Homspera and hopes to secure
potential strategic partners and licensees in these foreign markets.
ImmuneRegen's strategy is focused on the following major steps:
ESTABLISHING AND FORMALIZING STRATEGIC PARTNERING RELATIONSHIPS.
ImmuneRegen's aim is to establish relationships with industry leaders in the
pharmaceutical and medical device industries for application-specific sales and
distribution of its techniques and products, both domestic and international.
ImmuneRegen believes this may have the effect of generating revenues in under
twelve months after funding in the form of license agreements with companies in
Europe and other countries, while awaiting possible FDA approval for sales in
the United States to begin.
ACCELERATING CURRENT RESEARCH EFFORTS.
ImmuneRegen is working on capturing the full benefit of the Homspera technology
in applications relating to the aforementioned fields. Further, the research
that has produced Homspera could be applicable to other processes.
EXPANDING PRODUCTION FACILITY CAPACITY.
ImmuneRegen intends to operate a laboratory facility in Tucson, Arizona, which
is equipped with state-of-the-art culture equipment, instrumentation and storage
systems. ImmuneRegen intends to implement expansion plans if it receives its IND
from the FDA.
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EXPANDING SALES, PRODUCTION AND ADMINISTRATIVE RESOURCES.
Sales, increased research, and foreign affiliations will require more resources
by ImmuneRegen. ImmuneRegen hopes these will be supplied through third party
relationships and increases to staff as necessary.
SUPPLEMENTING AND LEVERAGING EXISTING ADVISORY RELATIONSHIPS.
Pharmaceutical, biotechnology and corporate companies are a primary channel for
introducing and distributing new products. To facilitate the marketing
strategies outlined above, ImmuneRegen intends to supplement and leverage its
existing relationships.
In the future, ImmuneRegen believes that it may be able to increase and
strengthen its market position in the following ways: (i) working with the FDA
to obtain the approval of the Homspera and future developments; (ii)
investigating foreign markets for the use of Homspera and future products; and,
(iii) continuing its current research into the science of attenuating ailments.
Manufacturing
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ImmuneRegen has established a pilot manufacturing facility at its lab
headquarters in Tucson, Arizona for the production of immune-based therapies.
ImmuneRegen expects these facilities to be adequate to supply limited clinical
trial quantities for our products under development. Additional manufacturing
capacity will be needed for commercial scale production, if these therapies are
approved for commercial sale.
For the manufacture of the applications under development, ImmuneRegen obtains
synthetic peptides from third party manufacturers. ImmuneRegen believes a
synthesized version of substance P is readily available at low cost from several
life science and technology companies that provide biochemical and organic
chemical products and kits used in scientific and genomic research,
biotechnology, pharmaceutical development and the diagnosis of disease and
chemical manufacturing. ImmuneRegen believes that the synthetic substance P and
other materials necessary to produce Homspera are readily available from various
sources, and several suppliers are capable of supplying substance P in both
clinical and commercial quantities. These suppliers also store and ship the
product as well.
ImmuneRegen's products will use an inhaler (puffer) device to deliver Homspera
to the user. To develop, manufacture and test an inhaler device, ImmuneRegen
hopes to partner with a full-service drug development and chemical services
company that offers services ranging from pre-clinical and toxicology studies to
clinical trial support and manufacturing services. ImmuneRegen believes such a
partnership may enable it to decrease the time-to-market for its products and to
increase its productivity.
Government Regulation
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Our development, manufacture and potential sale of therapeutics are subject to
extensive regulation by United States and foreign governmental authorities. In
particular, pharmaceutical products are subject to rigorous preclinical and
clinical testing and to other approval requirements by the FDA in the United
States under the Food, Drug and Cosmetic Act, and by comparable agencies in most
foreign countries.
As an initial step in the FDA regulatory approval process, preclinical studies
are typically conducted in animals to identify potential safety problems. For
certain diseases, animal models exist that are believed to be predictive of
human efficacy. For such diseases, a drug candidate is tested in an animal
model. The results of the studies are submitted to the FDA as a part of the
Investigational New Drug application (IND) that is filed to comply with FDA
regulations prior to commencement of human clinical testing in the U.S. For
diseases for which no appropriately predictive animal model exists, no such
results can be filed. As a result, no IN VIVO evidence of efficacy would be
available until such compounds progress to human clinical trials.
Clinical trials are typically conducted in three sequential phases, although the
phases may overlap. In Phase I, which frequently begins with the initial
introduction of the drug into healthy human subjects prior to introduction into
patients, the compound will be tested for safety, dosage tolerance, absorption,
bioavailability, biodistribution, metabolism, excretion, clinical pharmacology
and, if possible, for early information on effectiveness. Phase II typically
involves studies in a small sample of the intended patient population to assess
the efficacy and duration of the drug for a specific indication, to determine
dose tolerance and the optimal dose range and to gather additional information
relating to safety and potential adverse effects. Phase III trials are
undertaken to further evaluate clinical safety and efficacy in an expanded
patient population at geographically dispersed study sites, to determine the
overall risk-benefit ratio of the drug and to provide an adequate basis for
physician labeling. Each trial is conducted in accordance with certain standards
under protocols that detail the objectives of the study, the parameters to be
used to monitor safety and the efficacy criteria to be evaluated. Each protocol
must be submitted to the FDA as part of the IND. Further, each clinical study
must be evaluated by an independent Institutional Review Board at the
institution at which the study will be conducted. The Institutional Review Board
will consider, among other things, ethical factors, the safety of human subjects
and the possible liability of the institution.
Data from preclinical testing and clinical trials are submitted to the FDA in a
New Drug Application (NDA) for marketing approval. The process of completing
clinical testing and obtaining FDA approval for a new drug is likely to take a
number of years and require the expenditure of substantial resources. Preparing
an NDA involves considerable data collection, verification, analysis and
7
expense, and there can be no assurance that approval will be granted on a timely
basis, if at all. The approval process is affected by a number of factors,
including the severity of the disease, the availability of alternative
treatments and the risks and benefits demonstrated in clinical trials. The FDA
may deny an NDA if applicable regulatory criteria are not satisfied or may
require additional testing or information. Among the conditions for marketing
approval is the requirement that the prospective manufacturer's quality control
and manufacturing procedures conform to the FDA's CGMP regulations, which must
be followed at all times. In complying with standards set forth in these
regulations, manufacturers must continue to expend time, monies and effort in
the area of production and quality control to ensure full mechnical compliance.
Manufacturing establishments, both foreign and domestic, also are subject to
inspections by or under the authority of the FDA and by or under the authority
of other federal, state or local agencies.
Even after initial FDA approval has been obtained, further studies, including
post-marketing studies, may be required to provide additional data on safety and
will be required to gain approval for the use of a product as a treatment for
clinical indications other than those for which the product was initially
tested. Also, the FDA will require post-marketing reporting to monitor the side
effects of the drug. Results of post-marketing programs may limit or expand
further marketing of the drug products. Further, if there are any modifications
to the drug, including changes in indication, manufacturing process, labeling or
manufacturing facilities, an NDA supplement may be required to be submitted to
the FDA.
The Orphan Drug Act provides incentives to drug manufacturers to develop and
manufacture drugs for the treatment of diseases or conditions that affect fewer
than 200,000 individuals in the United States. Orphan drug status can also be
sought for diseases or conditions that affect more than 200,000 individuals in
the United States if the sponsor does not realistically anticipate its product
becoming profitable from sales in the United States. Under the Orphan Drug Act,
a manufacturer of a designated orphan product can seek tax benefits, and the
holder of the first FDA approval of a designated orphan product will be granted
a seven-year period of marketing exclusivity for that product for the orphan
indication. While the marketing exclusivity of an orphan drug would prevent
other sponsors from obtaining approval of the same compound for the same
indication, it would not prevent other types of drugs from being approved for
the same use. We may apply for orphan drug status for the use of Homspera for
certain indications.
Under the Drug Price Competition and Patent Term Restoration Act of 1984, a
sponsor may be granted marketing exclusivity for a period of time following FDA
approval of certain drug applications if FDA approval is received before the
expiration of the patent's original term. This marketing exclusivity would
prevent a third party from obtaining FDA approval for a similar or identical
drug through an Abbreviated New Drug Application, which is the application form
typically used by manufacturers seeking approval of a generic drug. The statute
also allows a patent owner to extend the term of the patent for a period equal
to one-half the period of time elapsed between the filing of an IND and the
filing of the corresponding NDA plus the period of time between the filing of
the NDA and FDA approval. We may seek the benefits of this statute, but there
can be no assurance that we will be able to obtain any such benefits.
Whether or not FDA approval has been obtained, approval of a drug product by
regulatory authorities in foreign countries must be obtained prior to the
commencement of commercial sales of the product in such countries. Historically,
the requirements governing the conduct of clinical trials and product approvals,
and the time required for approval, have varied widely from country to country.
In addition to the statutes and regulations described above, we are also subject
to regulation under the Occupational Safety and Health Act, the Environmental
Protection Act, the Toxic Substances Control Act, the Resource Conservation and
Recovery Act and other present and potential future federal, state and local
regulations.
FACILITIES
The Company has a lease agreement for 1,440 square feet of office space in
Scottsdale, Arizona. The lease expires August 31, 2004. Rent expense is $2,734
per month.
EMPLOYEES
As of December 31, 2003, ImmuneRegen had one full-time employee and three
contract employees. Our sole full time employee is our Chief Executive Officer,
Michael K. Wilhelm. None of its employees are covered by a collective bargaining
agreement.
RISK FACTORS
In evaluating our business, you should consider the following discussions of
risks, in addition to other information contained in this report as well as our
other public filings with the Securities and Exchange Commission. Any of the
following risks could materially adversely affect our business, financial
condition, results of operations and prospects.
WE HAVE LIMITED CASH RESOURCES, AN ACCUMULATED DEFICIT, ARE NOT CURRENTLY
PROFITABLE AND EXPECT TO INCUR SIGNIFICANT EXPENSES IN THE NEAR FUTURE.
As December 31, 2003, our working capital totaled approximately $(866,040). We
have incurred a substantial net loss for the period from our inception in
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October 2002 to December 31, 2003, and currently experiencing negative cash
flow. We expect to continue to experience negative cash flow and operating
losses through at least 2004 and possibly thereafter. As a result, we will need
to generate significant revenues to achieve profitability. If our revenues grow
more slowly than we anticipate, or if our operating expenses exceed our
expectations, we may experience reduced profitability.
WE MAY FAIL TO BECOME AND REMAIN PROFITABLE OR WE MAY BE UNABLE TO FUND OUR
CONTINUING LOSSES, IN WHICH CASE OUR BUSINESS MAY FAIL.
We are focused on product development and have not generated any revenue to
date. We have incurred operating losses since our inception. Our net loss for
the twelve months ended December 31, 2003 was $1,856,702. As of December 31,
2003, we had an accumulated deficit of $1,902,620.
We currently have no product candidates for sale in the United States, and we
cannot guarantee that we will ever have marketable products in the United
States. We must demonstrate that our product candidates satisfy rigorous
standards of safety and efficacy before the FDA and other regulatory authorities
in the United States and abroad will approve the products for commercial
marketing. We will need to conduct significant additional research, preclinical
testing and clinical testing before we can file applications with the FDA for
approval of our product candidates. In addition, to compete effectively, our
future products must be easy to use, cost-effective and economical to
manufacture on a commercial scale. We may not achieve any of these objectives.
We expect to incur losses as we research, develop and seek regulatory approvals
for our products. If our products fail in clinical trials or do not gain
regulatory approval, or if our products do not achieve market acceptance, we
will not be profitable. If we fail to become and remain profitable, or if we are
unable to fund our continuing losses, our business may fail.
OUR INDEPENDENT OUTSIDE AUDITORS HAVE RAISED SUBSTANTIAL DOUBT ABOUT OUR ABILITY
TO CONTINUE AS A GOING CONCERN.
Our independent certified public accountants have stated in their report
included in this Form 10-KSB that the Company has incurred a net loss and
negative cash flows from operations of $1,856,702 and $996,890, respectively,
for the year ended December 31, 2003, and a lack of operational history, among
other matters, that raise substantial doubt about its ability to continue as a
going concern, which contemplates, among other things, the realization of assets
and satisfaction of liabilities in the normal course of business. The effect of
this going concern would materially and adversely affect our ability to raise
capital, our relationship with potential suppliers and customers, and have other
unforeseen effects.
OUR OPERATING EXPENSES ARE UNPREDICTABLE, WHICH MAY ADVERSELY AFFECT OUR
BUSINESS, OPERATIONS AND FINANCIAL CONDITION.
As a result of our limited operating history and because of the emerging nature
of the markets in which we will compete, our financial data is of limited value
in planning future operating expenses. To the extent our operating expenses
precede or are not rapidly followed by increased revenue, our business, results
of operations and financial condition may be materially adversely affected. Our
expense levels will be based in part on our expectations concerning future
revenues. A significant portion of our revenue is anticipated to be derived from
Homspera; however the size and extent of such revenues are wholly dependent upon
the choices and demand of individuals, which are difficult to forecast
accurately. We may be unable to adjust our operations in a timely manner to
compensate for any unexpected shortfall in revenues. Further, business
development and marketing expenses may increase significantly as we expand our
operations.
IF OUR PLAN IS NOT SUCCESSFUL OR MANAGEMENT IS NOT EFFECTIVE, THE VALUE OF OUR
COMMON STOCK MAY DECLINE.
Our operating subsidiary, ImmuneRegen BioSciences, Inc., was founded in October
2002. As a result, we are a development stage company with a limited operating
history that makes it impossible to reliably predict future growth and operating
results. Our business and prospects must be considered in light of the risks and
uncertainties frequently encountered by companies in their early stages of
development. In particular, we have not demonstrated that we can:
o ensure that our products function as intended in human clinical
applications;
o obtain the regulatory approvals necessary to commercialize products
that we may develop in the future;
o manufacture, or arrange for third-parties to manufacture, future
products in a manner that will enable us to be profitable;
o establish many of the business functions necessary to operate,
including sales, marketing, administrative and financial functions,
and establish appropriate financial controls;
o make, use, and sell future products without infringing upon third
party intellectual property rights; or,
o respond effectively to competitive pressures.
9
We cannot be sure that we will be successful in meeting these challenges and
addressing these risks and uncertainties. If we are unable to do so, our
business will not be successful.
WE WILL BE REQUIRED TO RAISE ADDITIONAL CAPITAL TO FUND OUR OPERATIONS. IF WE
CANNOT RAISE NEEDED ADDITIONAL CAPITAL IN THE FUTURE, WE WILL BE REQUIRED TO
CEASE OPERATIONS.
We require substantial working capital to fund our operations. Since we do not
expect to generate significant revenues in the foreseeable future, in order to
fund operations, we will be completely dependent on additional debt and equity
financing arrangements. As of December 31, 2003, our cash and cash equivalents
totaled approximately $10,534. Based on our current plans, we believe these
financial resources, and interest earned thereon, will be sufficient to meet our
operating expenses and capital requirements for at least the next 30 days. There
is no assurance that any financing will be sufficient to fund our capital
expenditures, working capital and other cash requirements for the fiscal year
ending December 31, 2004. No assurance can be given that any such additional
funding will be available or that, if available, can be obtained on terms
favorable to us. If we are unable to raise needed funds on acceptable terms, we
will not be able to develop or enhance our products, take advantage of future
opportunities or respond to competitive pressures or unanticipated requirements.
A material shortage of capital will require us to take drastic steps such as
reducing our level of operations, disposing of selected assets or seeking an
acquisition partner. If cash is insufficient, we will not be able to continue
operations.
We expect to require substantial additional funds in order to finance our drug
discovery and development programs, fund operating expenses, pursue regulatory
clearances, develop manufacturing, marketing and sales capabilities, and
prosecute and defend our intellectual property rights. We may seek additional
funding through public or private financing or through collaborative
arrangements with strategic partners.
You should be aware that in the future:
o we may not obtain additional financial resources when necessary or
on terms favorable to us, if at all; and,
o any available additional financing may not be adequate.
If we cannot raise additional funds when needed, or on acceptable terms, we will
not be able to continue to develop our drug candidates. We require substantial
working capital to fund our operations. Since we do not expect to generate
significant revenues in the foreseeable future, in order to fund operations, we
will be completely dependent on additional debt and equity financing
arrangements. There is no assurance that any financing will be sufficient to
fund our capital expenditures, working capital and other cash requirements for
the next 12 months. Our working capital as of December 31, 2004 was $(866,040).
No assurance can be given that any such additional funding will be available or
that, if available, can be obtained on terms favorable to us. If we are unable
to raise needed funds on acceptable terms, we will not be able to develop or
enhance our products, take advantage of future opportunities or respond to
competitive pressures or unanticipated requirements. A material shortage of
capital will require us to take drastic steps such as reducing our level of
operations, disposing of selected assets or seeking an acquisition partner. If
cash is insufficient, we will not be able to continue operations.
ALL OUR APPLICATIONS ARE ALL DERIVED FROM THE USE OF HOMSPERA. IF HOMSPERA IS
FOUND TO BE UNSAFE OR INEFFECTIVE, WE WOULD HAVE NO POTENTIAL SOURCE OF REVENUES
AND MAY BE REQUIRED TO CEASE OPERATIONS.
All our potential applications are derived from the use of Homspera. In
addition, we expect to utilize Homspera in the development of any future
products we market. If these current or future Homspera-based products are found
to be unsafe or ineffective due to the use of Homspera, we may have to modify or
cease production of the products. As all of our applications utilize or will
utilize Homspera, any findings that Homspera is unsafe or ineffective would
severely harm our Homspera-based business operations, since all of our primary
revenue sources would be negatively affected by such findings. In such an event,
we may be required to cease operations.
IF WE FAIL TO SUCCESSFULLY DEVELOP AND COMMERCIALIZE PRODUCTS, WE WILL HAVE TO
CEASE OPERATIONS.
Our failure to develop and commercialize products successfully will cause us to
cease operations. Our potential therapies utilizing Homspera will require
significant additional research and development efforts and regulatory approvals
prior to potential commercialization in the future. We cannot guarantee that we,
or our corporate collaborators, if any, will ever obtain any regulatory
approvals of Homspera. We currently are focusing our core competencies on
Homspera although there may be no assurance that we will be successful in so
doing.
Our therapies and technologies utilizing Homspera is at early stages of
development and may not be shown to be safe or effective and may never receive
regulatory approval. Our technologies utilizing Homspera have not yet been
tested in humans. Regulatory authorities may not permit human testing of
potential products based on these technologies. Even if human testing is
permitted, any potential products based on Homspera may not be successfully
developed or shown to be safe or effective.
The results of our preclinical studies and clinical trials may not be indicative
or future clinical trial results. A commitment of substantial resources to
conduct time-consuming research, preclinical studies and clinical trials will be
10
required if we are to develop any products. Delays in planned patient enrollment
in our clinical trials may result in increased costs, program delays or both.
None of our potential products may prove to be safe or effective in clinical
trials. Approval of the Unites States Food and Drug Administration, the FDA, or
other regulatory approvals, including export license permissions, may not be
obtained and even if successfully developed and approved, our potential products
may not achieve market acceptance. Any products resulting from our programs may
not be successfully developed or commercially available for a number of years,
if at all.
Moreover, unacceptable toxicity or side effects could occur at any time in the
course of human clinical trials or, if any products are successfully developed
and approved for marketing, during commercial use of any of our proposed
products. The appearance of any unacceptable toxicity or side effects could
interrupt, limit, delay or abort the development of any of our proposed products
or, if previously approved, necessitate their withdrawal from the market.
THE MARKET FOR TREATING ACUTE RADIATION SYNDROME IS UNCERTAIN AND IF WE ARE
UNABLE TO SUCCESSFULLY COMMERCIALIZE RADILEX, WE WILL NOT RECOGNIZE A
SIGNIFICANT PORTION OF OUR PLANNED REVENUES.
We do not believe any drug has ever been approved and commercialized for the
treatment of severe acute radiation injury. In addition, the incidence of
large-scale exposure to nuclear or radiological events has been low.
Accordingly, even if Radilex, our lead drug candidate to treat Acute Radiation
Syndrome (ARS), is approved by the FDA, we cannot predict with any certainty the
size of this market. The potential market for Radilex is largely dependent on
the size of stockpiling orders, if any, procured by the U.S. and foreign
governments. While a number of governments have historically stockpiled drugs to
treat indications such as smallpox, anthrax exposure, plague, tularemia and
certain long-term effects of radiation exposure, we are unaware of any
significant stockpiling orders for drugs to treat ARS. While we have filed a
formal response to the U.S. Department of Health and Human Services Request for
Information (RFI) for therapeutics to treat ARS, at least one other company has
responded to this RFI, and we cannot guarantee that our response to this RFI
will result in a U.S. Department of Health and Human Services Request for
Proposal (RFP) or any stockpiling orders. A decision by the U.S. Government to
enter into a commitment to purchase Radilex prior to FDA approval is largely out
of our control. Our development plans and timelines may vary substantially
depending on whether we receive such a commitment and the size of such
commitment, if any. In addition, even if Radilex is approved by regulatory
authorities, we cannot guarantee that we will receive any stockpiling orders for
Radilex, that any such order would be profitable to us or that Radilex will
achieve market acceptance by the general public.
THE LENGTHY PRODUCT APPROVAL PROCESS AND UNCERTAINTY OF GOVERNMENT REGULATORY
REQUIREMENTS MAY DELAY OR PREVENT US FROM COMMERCIALIZING PROPOSED PRODUCTS, AND
THEREFORE ADVERSELY AFFECT THE TIMING AND LEVEL OF FUTURE REVENUES, IF ANY.
The process of obtaining FDA and other regulatory approvals is time consuming,
expensive and difficult to design and implement. Clinical trials are required
and the marketing and manufacturing of our applications are subject to rigorous
testing procedures. Significant delays in clinical trials will impede our
ability to commercialize our applications and generate revenue and could
significantly increase our development costs. The commencement and completion of
clinical trials for our Homspera-based applications or any of our applications
could be delayed or prevented by a variety of factors, including:
o delays in obtaining regulatory approvals to commence a study;
o delays in identifying and reaching agreement on acceptable terms
with prospective clinical trial sites;
o delays in the enrollment of patients;
o lack of efficacy during clinical trials; or,
o unforeseen safety issues.
Even if marketing approval from the FDA is received, the FDA may impose
post-marketing requirements, such as:
o labeling and advertising requirements, restrictions or limitations,
including the inclusion of warnings, precautions, contra-indications
or use limitations that could have a material impact on the future
profitability of our applications;
o testing and surveillance to monitor our future products and their
continued compliance with regulatory requirements;
11
o submitting products for inspection and, if any inspection reveals
that the product is not in compliance, prohibiting the sale of all
products;
o suspending manufacturing; or
o withdrawing marketing clearance.
Additionally, the FDA's policies may change and additional government
regulations may be enacted, which could prevent or delay regulatory approval of
our applications. We cannot predict the likelihood, nature or extent of adverse
government regulation that may arise from future legislation or administrative
action, either in the United States or abroad. If we are not able to maintain
regulatory compliance, we might not be permitted to market our future products
and our business could suffer.
Even if human clinical trials of Homspera are initiated and successfully
completed, the FDA may not approve Homspera for commercial sale. We may
encounter significant delays or excessive costs in our efforts to secure
necessary approvals. Regulatory requirements are evolving and uncertain. Future
United States or foreign legislative or administrative acts could also prevent
or delay regulatory approval of our products. We may not be able to obtain the
necessary approvals for clinical trials, manufacturing or marketing of any of
our products under development. Even if commercial regulatory approvals are
obtained, they may include significant limitations on the indicated uses for
which a product may be marketed.
The FDA has not designated expanded access protocols for Homspera as "treatment"
protocols. The FDA may not determine that Homspera meets all of the FDA's
criteria for use of an investigational drug for treatment use. Even if Homspera
is allowed for treatment use, third party payers may not provide reimbursement
for the costs of treatment with Homspera. The FDA also may not consider Homspera
to be an appropriate candidate for accelerated approval, expedited review or
fast track designation.
IF WE FAIL TO OBTAIN APPROVAL FROM FOREIGN REGULATORY AUTHORITIES, WE WILL NOT
BE ALLOWED TO MARKET OR SELL OUR PRODUCTS IN OTHER COUNTRIES, WHICH WOULD
ADVERSELY AFFECT OUR LEVELS OF FUTURE REVENUES, IF ANY.
Marketing any drug products outside of the United States will subject us to
numerous and varying foreign regulatory requirements governing the design and
conduct of human clinical trials and marketing approval. Additionally, our
ability to export drug candidates outside the United States on a commercial
basis will be subject to the receipt from the FDA of export permission, which
may not be available on a timely basis, if at all.
Approval procedures vary among countries and can involve additional testing, and
the time required to obtain approval may differ from that required to obtain FDA
approval. Foreign regulatory approval processes include all of the risks
associated with obtaining FDA approval set forth above, and approval by the FDA
does not ensure approval by the health authorities of any other country.
CLINICAL TRIALS MAY FAIL TO DEMONSTRATE THE SAFETY AND EFFICACY OF OUR
APPLICATIONS, WHICH COULD PREVENT OR SIGNIFICANTLY DELAY REGULATORY APPROVAL.
Prior to receiving approval to commercialize any of our applications or
therapies, we must demonstrate with substantial evidence from well-controlled
clinical trials, and to the satisfaction of the FDA and other regulatory
authorities in the United States and abroad, that our applications are both safe
and effective. We will need to demonstrate our applications' efficacy and
monitor their safety throughout the process. If any future clinical trials are
unsuccessful, our business and reputation would be harmed and our stock price
would be adversely affected.
All of our applications are prone to the risks of failure inherent in biologic
development. The results of early-stage clinical trials of our applications do
not necessarily predict the results of later-stage clinical trials. Applications
in later-stage clinical trials may fail to show desired safety and efficacy
traits despite having progressed through initial clinical testing. Even if we
believe the data collected from clinical trials of our applications is
promising, this data may not be sufficient to support approval by the FDA or any
other U.S. or foreign regulatory approval. Preclinical and clinical data can be
interpreted in different ways. Accordingly, FDA officials could interpret such
data in different ways than we do, which could delay, limit or prevent
regulatory approval. The FDA, other regulatory authorities, or we may suspend or
terminate clinical trials at any time. Any failure or significant delay in
completing clinical trials for our applications, or in receiving regulatory
approval for the sale of any products resulting from our applications, may
severely harm our business and reputation.
12
DELAYS IN THE CONDUCT OR COMPLETION OF OUR PRECLINICAL OR CLINICAL STUDIES OR
THE ANALYSIS OF THE DATA FROM OUR PRECLINICAL OR CLINICAL STUDIES MAY RESULT IN
DELAYS IN OUR PLANNED FILINGS FOR REGULATORY APPROVALS, OR ADVERSELY AFFECT OUR
ABILITY TO ENTER INTO COLLABORATIVE ARRANGEMENTS.
We may encounter problems with some or all of our completed or ongoing studies
that may cause us or regulatory authorities to delay or suspend our ongoing
studies or delay the analysis of data from our completed or ongoing studies. If
the results of our ongoing and planned studies for our drug candidates are not
available when we expect or if we encounter any delay in the analysis of the
results of our studies for our drug candidates:
o we may not have the financial resources to continue research and
development of any of our drug candidates; and,
o we may not be able to enter into collaborative arrangements relating
to any drug candidate subject to delay in regulatory filing.
Any of the following reasons, among others, could delay or suspend the
completion of our ongoing and future studies:
o delays in enrolling volunteers;
o interruptions in the manufacturing of our drug candidates or other
delays in the delivery of materials required for the conduct of our
studies;
o lower than anticipated retention rate of volunteers in a trial;
o unfavorable efficacy results;
o serious side effects experienced by study participants relating to
the drug candidate;
o new communications from regulatory agencies about how to conduct
these studies; or,
o failure to raise additional funds.
IF THE MANUFACTURERS OF OUR PRODUCTS DO NOT COMPLY WITH CURRENT GOOD
MANUFACTURING PRACTICES REGULATIONS, OR CANNOT PRODUCE THE AMOUNT OF PRODUCTS WE
NEED TO CONTINUE OUR DEVELOPMENT, WE WILL FALL BEHIND ON OUR BUSINESS
OBJECTIVES.
Manufacturers producing our drug candidates must follow current Good
Manufacturing Practices, or GMP, regulations enforced by the FDA and foreign
equivalents. If a manufacturer of our drug candidates does not conform to the
GMP regulations and cannot be brought up to such a standard, we will be required
to find alternative manufacturers that do conform. This may be a long and
difficult process, and may delay our ability to receive FDA or foreign
regulatory approval of our products.
We also rely on our manufacturers to supply us with a sufficient quantity of our
drug candidates to conduct clinical trials. If we have difficulty in the future
obtaining our required quantity and quality of supply, we could experience
significant delays in our development programs and regulatory process.
OUR LACK OF COMMERCIAL MANUFACTURING, SALES, DISTRIBUTION AND MARKETING
EXPERIENCE MAY PREVENT US FROM SUCCESSFULLY COMMERCIALIZING PRODUCTS, WHICH
WOULD ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.
The manufacturing process of our proposed products is expected to involve a
number of steps and requires compliance with stringent quality control
specifications imposed by us and by the FDA. We have no experience in the sales,
marketing and distribution of pharmaceutical or biotechnology products. We have
not manufactured any of our products in commercial quantities. We may not
successfully make the transition from manufacturing clinical trial quantities to
commercial production quantities or be able to arrange for contract
manufacturing and this could prevent us from commercializing products or limit
our profitability from our products.
WE RELY ON THIRD PARTY MANUFACTURERS FOR THE MANUFACTURE OF HOMSPERA. OUR
INABILITY TO MANUFACTURE HOMSPERA, AND OUR DEPENDENCE ON SUCH MANUFACTURERS, MAY
DELAY OR IMPAIR OUR ABILITY TO GENERATE REVENUES, OR ADVERSELY AFFECT OUR
PROFITABILITY.
We may enter into arrangements with contract manufacturing companies in order to
meet requirements for our products or to attempt to improve manufacturing
efficiency. If we choose to contract for manufacturing services, we may
encounter costs, delays and/or other difficulties in producing, packaging and
distributing our clinical trials and finished product. Further, contract
manufacturers must also operate in compliance with the GMP requirements; failure
to do so could result in, among other things, the disruption of our product
supplies. Our potential dependence upon third parties for the manufacture of our
proposed products may adversely affect our profit margins and our ability to
develop and deliver proposed products on a timely and competitive basis. For the
manufacture of the applications under development, we obtain synthetic peptides
from third party manufacturers. A synthesized version of Homspera is readily
available at low cost from several life science and technology companies that
provide biochemical and organic chemical products and kits used in scientific
and genomic research, biotechnology, pharmaceutical development and the
diagnosis of disease and chemical manufacturing. If any of these proposed
13
manufacturing operations prove inadequate, there may be no assurance that any
other arrangements may be established on a timely basis or that we could
establish other manufacturing capacity on a timely basis. Although, we believe
that the synthetic substance P and other materials necessary to produce Homspera
are readily available from various sources, and several suppliers are capable of
supplying substance P in both clinical and commercial quantities, our dependence
on such manufacturers, may delay or impair our ability to generate revenues, or
adversely affect our profitability.
ADVERSE DETERMINATIONS CONCERNING PRODUCT PRICING, REIMBURSEMENT AND RELATED
MATTERS COULD PREVENT US FROM SUCCESSFULLY COMMERCIALIZING HOMSPERA, WHICH WOULD
ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.
Our ability to earn sufficient revenue on Homspera or any other proposed
products will depend in part on the extent to which reimbursement for the costs
of such products and related treatments will be available from government health
administration authorities, private health coverage insurers, managed care
organizations and other organizations. Failure to obtain appropriate
reimbursement may prevent us from successfully commercializing Homspera or any
proposed products. Third-party payers are increasingly challenging the prices of
medical products and services. If purchasers or users of Homspera or any such
other proposed products are not able to obtain adequate reimbursement for the
cost of using such products, they may forego or reduce their use. Significant
uncertainty exists as to the reimbursement status of newly approved health care
products and whether adequate third party coverage will be available.
THE MEDICAL COMMUNITY MAY NOT ACCEPT AND UTILIZE HOMSPERA, THE EFFECT OF WHICH
WOULD PREVENT US FROM SUCCESSFULLY COMMERCIALIZING THE PRODUCT, AND ADVERSELY
AFFECT OUR LEVEL OF FUTURE REVENUE, IF ANY.
Our ability to market and commercialize Homspera depends on the acceptance and
utilization of Homspera by the medical community. We will need to develop
commercialization initiatives designed to increase awareness about us and
Homspera among targeted audiences, including public health activists and
community-based outreach groups in addition to the investment community.
Currently, we have not developed any such initiatives. Without such acceptance
of Homspera, the product upon which we expect to be substantially dependent, we
may not be able to successfully commercialize Homspera or generate revenue.
PRODUCT LIABILITY EXPOSURE MAY EXPOSE US TO SIGNIFICANT LIABILITY OR COSTS,
WHICH WOULD ADVERSELY IMPART OUR FUTURE OPERATING RESULTS AND DIVERT FUNDS FROM
THE OPERATION OF OUR BUSINESS.
We face an inherent business risk of exposure to product liability and other
claims and lawsuits in the event that the development or use of our technology
or prospective products is alleged to have resulted in adverse effects. We may
not be able to avoid significant liability exposure. We may not have sufficient
insurance coverage and we may not be able to obtain sufficient coverage at a
reasonable cost. An inability to obtain product liability insurance at
acceptable cost or to otherwise protect against potential product liability
claims could prevent or inhibit the commercialization of our products. A product
liability claim could hurt our financial performance. Even if we avoids
liability exposure, significant costs could be incurred that could hurt our
financial performance.
WE MAY FAIL TO PROTECT ADEQUATELY OUR PROPRIETARY TECHNOLOGY, WHICH WOULD ALLOW
COMPETITORS TO TAKE ADVANTAGE OF OUR RESEARCH AND DEVELOPMENT EFFORTS, THE
EFFECT OF WHICH COULD ADVERSELY AFFECT ANY COMPETITIVE ADVANTAGE WE MAY HAVE.
We own or have obtained a license to 4 issued U.S. and foreign patents and 8
pending U.S. and foreign patent applications. Our success will depend in part on
our ability to obtain additional United States and foreign patent protection for
our drug candidates and processes, preserve our trade secrets and operate
without infringing the proprietary rights of third parties. We place
considerable importance on obtaining patent protection for significant new
technologies, products and processes.
Our long-term success largely depends on our ability to market technologically
competitive processes and products. If we fail to obtain or maintain these
protections we may not be able to prevent third parties from using our
proprietary rights. Our currently pending or future patent applications may not
result in issued patents. In the United States, patent applications are
confidential until patent applications are published or the patent is issued,
and because third parties may have filed patent applications for technology
covered by our pending patent applications without us being aware of those
applications, our patent applications may not have priority over any patent
applications of others. In addition, our issued patents may not contain claims
sufficiently broad to protect us against third parties with similar technologies
or products or provide us with any competitive advantage. If a third party
initiates litigation regarding our patents, and is successful, a court could
revoke our patents or limit the scope of coverage for those patents. Legal
standards relating to the validity of patents covering pharmaceutical and
biotechnology inventions and the scope of claims made under such patents are
still developing. In some of the countries in which we intend to market our
products, pharmaceuticals are either not patentable or have only recently become
14
patentable. Past enforcement of intellectual property rights in many of these
countries has been limited or non-existent. Future enforcement of patents and
proprietary rights in many other countries may be problematic or unpredictable.
Moreover, the issuance of a patent in one country does not assure the issuance
of a similar patent in another country. Claim interpretation and infringement
laws vary by nation, so the extent of any patent protection is uncertain and may
vary in different jurisdictions.
The U.S. Patent and Trademark Office, commonly referred to as the USPTO, and the
courts have not consistently treated the breadth of claims allowed in
biotechnology patents. If the USPTO or the courts begin to allow broader claims,
the incidence and cost of patent interference proceedings and the risk of
infringement litigation will likely increase. On the other hand, if the USPTO or
the courts begin to allow narrower claims, the value of our proprietary rights
may be limited. Any changes in, or unexpected interpretations of the patent laws
may adversely affect our ability to enforce our patent position.
We also rely upon trade secrets, proprietary know-how and continuing
technological innovation to remain competitive. We protect this information with
reasonable security measures, including the use of confidentiality agreements
with our employees, consultants and corporate collaborators. It is possible that
these individuals will breach these agreements and that any remedies for a
breach will be insufficient to allow us to recover our costs. Furthermore, our
trade secrets, know-how and other technology may otherwise become known or be
independently discovered by our competitors.
OUR PATENTS AND PROPRIETARY TECHNOLOGY MAY NOT BE ENFORCEABLE AND THE PATENTS
AND PROPRIETARY TECHNOLOGY OF OTHERS MAY PREVENT US FROM COMMERCIALIZING
PRODUCTS.
Although we believe our inventions to be protected and our patents enforceable,
the failure to obtain meaningful patent protection products and processes would
greatly diminish the value of our potential products and processes.
In addition, whether or not our applications are issued, or issued with limited
coverage, others may receive patents, which contain claims applicable to our
products. Patents we are not aware of may adversely affect our ability to
develop and commercialize products.
The patent positions of biotechnology and pharmaceutical companies are often
highly uncertain and involve complex legal and factual questions. Therefore, the
breadth of claims allowed in biotechnology and pharmaceutical patents cannot be
predicted. We also rely upon non-patented trade secrets and know how, and others
may independently develop substantially equivalent trade secrets or know how. We
also rely on protecting our proprietary technology in part through
confidentiality agreements with our current and former corporate collaborators,
employees, consultants and certain contractors. These agreements may be
breached, and we may not have adequate remedies for any such breaches.
Litigation may be necessary to defend against claims of infringement, to enforce
our patents or to protect trade secrets. Litigation or other disputes regarding
patents and other proprietary rights may be expensive, cause delays in bringing
products to market and harm our ability to operate. In addition, litigation
could result in substantial costs and diversion of management efforts regardless
of the results of the litigation. An adverse result in litigation could subject
us to significant liabilities to third parties, require disputed rights to be
licensed or require us to cease using certain technologies.
Our products could infringe on the intellectual property rights of others, which
may cause us to engage in costly litigation and, if not successful, could cause
us to pay substantial damages and prohibit us from selling our products. Because
patent applications in the United States are not publicly disclosed until the
patent application is published or the patent is issued, applications may have
been filed which relate to products similar to those offered by us. We may be
subject to legal proceedings and claims from time to time in the ordinary course
of our business, including claims of alleged infringement of the trademarks and
other intellectual property rights of third parties.
If our products violate third-party proprietary rights, we cannot assure you
that we would be able to arrange licensing agreements or other satisfactory
resolutions on commercially reasonable terms, if at all. Any claims made against
us relating to the infringement of third-party propriety rights could result in
the expenditure of significant financial and managerial resources and
injunctions preventing us from developing and commercializing our products. Such
claims could severely harm our financial condition and ability to compete.
In addition, if another party claims the same subject matter or subject matter
overlapping with the subject matter that we have claimed in a United States
patent application or patent, we may decide or be required to participate in
interference proceedings in the United States Patent and Trademark Office in
order to determine the priority of invention. Loss of such an interference
proceeding would deprive us of patent protection sought or previously obtained
and could prevent us from commercializing our products. Participation in such
proceedings could result in substantial costs, whether or not the eventual
outcome is favorable. These additional costs could adversely affect our
financial results.
FAILURE TO COMPLY WITH ENVIRONMENTAL LAWS OR REGULATIONS COULD EXPOSE US TO
SIGNIFICANT LIABILITY OR COSTS WHICH WOULD ADVERSELY IMPART OUR OPERATING
RESULTS AND DIVERT FUNDS FROM THE OPERATION OF OUR BUSINESS AND HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS.
We may be required to incur significant costs to comply with current or future
environmental laws and regulations. Although we do not currently manufacture
commercial quantities of our proposed products, we do produce limited quantities
15
of these products for our clinical trials. Our research and development and
manufacturing processes involve the controlled storage, use and disposal of
hazardous materials, biological hazardous materials and radioactive compounds.
We are subject to federal, state and local laws and regulations governing the
use, manufacture, storage, handling and disposal of these materials and some
waste products. Although we believe that our safety procedures for handling and
disposing of these materials comply with the standards prescribed by these laws
and regulations, the risk of contamination or injury from these materials cannot
be completely eliminated. In the event of an incident, ImmuneRegen BioSciences,
Inc. could be held liable for any damages that result, and any liability could
exceed our resources. Current or future environmental laws or regulations may
have a material adverse effect on our operations, business and assets.
WE DEPEND ON THE CONTINUED SERVICES OF OUR EXECUTIVE OFFICERS AND THE LOSS OF A
KEY EXECUTIVE COULD SEVERELY IMPACT OUR OPERATIONS.
The execution of our present business plan depends on the continued services of
Michael K. Wilhelm, our Chief Executive Officer and President, Mark L. Witten,
Ph.D., our acting Chief Scientific Officer. We do not currently maintain key-man
insurance on their lives. While we have entered into employment agreements with
each of them, the loss of any of their services would be detrimental to us and
could have a material adverse effect on our business, financial condition and
results of operations.
OUR COMPLIANCE WITH SECURITIES LAWS, RULES AND REGULATIONS TO WHICH WE ARE
SUBJECT COULD SUBSTANTIALLY INCREASE OUR OPERATING EXPENSES AND DIVERT
MANAGEMENT'S ATTENTION FROM THE OPERATION OF OUR BUSINESS.
Because our common stock is publicly traded, we are subject to a variety of
rules and regulations of federal, state and financial market exchange entities
charged with the protection of investors and the oversight of companies whose
securities are publicly traded. These entities, including the SEC, the Public
Company Accounting Oversight Board and the NASD OTC Bulletin Board, have
recently issued new requirements and regulations and are currently developing
additional regulations and requirements in response to recent laws enacted by
Congress, most notably the Sarbanes-Oxley Act of 2002. As certain rules are not
yet finalized, we do not know the level of resources we will have to commit in
order to be in compliance. Our compliance with current and proposed rules is
likely to require the commitment of significant financial and managerial
resources. As a result, our management's attention might be diverted from other
business concerns, which could negatively affect our business.
OUR EXECUTIVE OFFICERS, DIRECTORS AND PRINCIPAL STOCKHOLDERS CONTROL OUR
BUSINESS AND MAY MAKE DECISIONS THAT ARE NOT IN OUR BEST INTERESTS.
Our officers, directors and principal stockholders, and their affiliates, in the
aggregate, own over a majority of the outstanding shares of our common stock. As
a result, such persons, acting together, have the ability to substantially
influence all matters submitted to our stockholders for approval, including the
election and removal of directors and any merger, consolidation or sale of all
or substantially all of our assets, and to control our management and affairs.
Accordingly, such concentration of ownership may have the effect of delaying,
deferring or preventing a change in discouraging a potential acquirer form
making a tender offer or otherwise attempting to obtain control of our business,
even if such a transaction would be beneficial to other stockholders.
TRADING IN OUR SECURITIES COULD BE SUBJECT TO EXTREME PRICE FLUCTUATIONS THAT
COULD ADVERSELY AFFECT YOUR INVESTMENT.
The market prices for securities of life sciences companies, particularly those
that are not profitable, have been highly volatile, especially recently.
Publicized events and announcements may have a significant impact on the market
price of our common stock. For example:
o biological or medical discoveries by competitors;
o public concern about the safety of our drug candidates;
o delays in the conduct or analysis of our preclinical or clinical
studies;
o unfavorable results from preclinical or clinical studies;
o unfavorable developments concerning patents or other proprietary
rights; or
o unfavorable domestic or foreign regulatory developments;
may have the effect of temporarily or permanently driving down the price of our
common stock. In addition, the stock market from time to time experiences
extreme price and volume fluctuations which particularly affect the market
prices for emerging and life sciences companies, such as ours, and which are
often unrelated to the operating performance of the affected companies. For
example, our stock price has ranged from $0.01 to $4.50 between January 1, 2003
and December 31, 2003.
These broad market fluctuations may adversely affect the ability of a
stockholder to dispose of his shares at a price equal to or above the price at
which the shares were purchased. In addition, in the past, following periods of
volatility in the market price of a company's securities, securities
class-action litigation has often been instituted against that company. Any
litigation against our company, including this type of litigation, could result
in substantial costs and a diversion of management's attention and resources,
which could materially adversely affect our business, financial condition and
results of operations.
16
A LIMITED PRIOR PUBLIC MARKET AND TRADING MARKET MAY CAUSE VOLATILITY IN THE
PRICE OF OUR COMMON STOCK, AND THUS ADVERSELY AFFECT THE VALUE OF YOUR
INVESTMENT.
Our common stock is currently traded on a limited basis on the OTC Bulletin
Board (the "OTCBB") under the symbol "IRBO". The OTCBB is an inter-dealer,
Over-The-Counter market that provides significantly less liquidity than the
NASDAQ Stock Market. Quotes for stocks included on the OTCBB are not listed in
the financial sections of newspapers as are those for the NASDAQ Stock Market.
Therefore, prices for securities traded solely on the OTCBB may be difficult to
obtain and holders of common stock may be unable to resell their securities at
or near their original offering price or at any price. The NASD has enacted
recent changes that limit quotations on the OTC Bulletin Board to securities of
issuers that are current in their reports filed with the Securities and Exchange
Commission. The effect on the OTC Bulletin Board of these rule changes and other
proposed changes cannot be determined at this time.
The quotation of our common stock on the OTCBB does not assure that a
meaningful, consistent and liquid trading market currently exists, and in recent
years such market has experienced extreme price and volume fluctuations that
have particularly affected the market prices of many smaller companies like us.
Our common stock is thus subject to this volatility.
SALES OR ISSUANCES OF ADDITIONAL EQUITY SECURITIES MAY ADVERSELY AFFECT THE
MARKET PRICE OF OUR COMMON STOCK AND YOUR RIGHTS IN US MAY BE REDUCED.
We expect to continue to incur product development and selling, general and
administrative costs, and in order to satisfy our funding requirements, we will
need to sell additional equity securities, which may be subject to similar
registration rights. The sale or the proposed sale of substantial amounts of our
common stock in the public markets may adversely affect the market price of our
common stock.
From time to time, certain stockholders of our company may be eligible to sell
all or some of their shares of common stock by means of ordinary brokerage
transactions in the open market pursuant to Rule 144, promulgated under the Act
("Rule 144"), subject to certain limitations. In general, pursuant to Rule 144,
a stockholder (or stockholders whose shares are aggregated) who has satisfied a
one-year holding periods may, under certain circumstances, sell within any
three-month period a number of securities which does not exceed the greater of
1% of the then outstanding shares of our common stock or the average weekly
trading volume of the class during the four calendar weeks prior to such sale.
Rule 144 also permits, under certain circumstances, the sale of securities,
without any limitations, by a non-affiliate of our company who has satisfied a
two-year holding period. Any substantial sale of our common stock pursuant to
Rule 144 or pursuant to any resale prospectus may have an adverse effect on the
market price of our securities.
Our stockholders may experience substantial dilution and a reduction in the
price that they are able to obtain upon sale of their shares. Also, any new
equity securities issued, including any new series of preferred stock authorized
by our board of directors, may have greater rights, preferences or privileges
than our existing common stock. To the extent stock is issued or options and
warrants are exercised, holders of our common stock will experience further
dilution. In addition, as in the case of the warrants, in the event that any
future financing should be in the form of, be convertible into or exchangeable
for, equity securities and upon the exercise of options and warrants, security
holders may experience additional dilution.
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PART III
ITEM 13. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a) Financial Statements, Financial Statement Schedules and Exhibits
INDEPENDENT AUDITOR'S REPORT.
CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2003.
Consolidated Statements of Operations for the twelve months ended December 31,
2003 and from the date of inception (October 30, 2002) to December 31, 2003.
Consolidated Statement of Stockholder's Equity for the period from the date of
inception (October 30, 2002) to December 31, 2003.
Consolidated Statements of Cash Flows for the twelve months ended December 31,
2003 and from the date of inception (October 30, 2002) to December 31, 2003.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
EXHIBITS
Exhibit
Number Description
------- -----------
31.1 Certification of Chief Executive Officer pursuant to Section 302
of the Sarbannes Oxley Act of 2002
31.2 Certification of Chief Financial Officer persuant to Section 302
of the Sarbannes Oxley Act of 2002
32.1 Certification Pursuant To 18 U.S.C.ss.1350, As Adopted Pursuant
To Section 906 Of The SARBANES-OXLEY ACT OF 2002
32.2 Certification Pursuant To 18 U.S.C.ss.1350, As Adopted Pursuant
To Section 906 Of The SARBANES-OXLEY ACT OF 2002
(b) Form 8K/A filed as of December 29, 2003 to amend the Company's form 8K filed
on July 7, 2003 pursuant to a change in control of the Company.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Company has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized, on November 16, 2005
IR BIOSCIENCES HOLDINGS, INC.
By: /s/ Michael K. Wilhelm
-------------------------------------
Michael K. Wilhelm
President and Chief Executive Officer
19