UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
------------------------
Form 10-KSB
(Mark One)
[X] Annual Report Under SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT
OF 1934 For the fiscal year ended December 31, 2003
[ ] TRANSITIONAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 For the transition period from _____to______
Commission file number 0-26775
Samaritan Pharmaceuticals Inc.
(Name of small business issuer in its charter)
Nevada 88-0431538
(State or other jurisdiction of (I.R.S.Employer
Incorporation or organization) identification No.)
101 Convention Center Drive, Suite 310, Las Vegas, Nevada 89109
(Address of Principal Executive Offices) (Zip Code)
(702) 735-7001
Issuer's telephone number
Securities to be registered Pursuant to Section 12(b) of the Act: None
Securities Registered Pursuant to Section 12(g) of the Exchange Act:
Common Stock, $.001 par value per share
(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 during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes [X] No [ ]
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. [ ]
The registrant had $250,000 in revenues in the fiscal year ended December 31,
2003. The aggregate market value of the issued voting and non-voting common
equity held by non-affiliates computed by reference to the average bid and asked
price of such common stock, as of March 8, 2004, was approximately $43,610,098
based upon, as a reasonable assumption, that the issuer's shareholders list,
standing alone, supplies an accurate presentation of those shareholders who are
non affiliates, determined by the issuer to be those persons who are not
officers, Directors or owners of 10% or more of the common stock. The Company
had 111,459,790 common shares issued and outstanding as of March 8, 2004.
Transitional Small Business Disclosure Format (Check one): Yes[ ] No [X]
DOCUMENTS INCORPORATED BY REFERENCE
The registrant is incorporating by reference into Part III of this Form
10-KSB, certain information contained in the registrant's proxy statement for
its 2004 annual meeting of stockholders.
SAMARITAN PHARMACEUTICALS, INC.
FORM 10-KSB
For the Year Ended December 31, 2003
Table of Contents
Part I
Item 1. Description of Business...........................................3
Item 2. Description of Property..........................................13
Item 3. Legal Proceedings................................................13
Item 4. Submission of Matters to a Vote of Security Holders..............13
Part II
Item 5. Market For Common Equity and Related Stockholder Matters.........13
Item 6. Management's Discussion and Analysis or Plan of Operation........14
Item 7. Financial Statements.............................................18
Item 8. Changes in and Disagreements with Accountants on Accounting
and Financial Disclosures........................................19
Item 8a. Controls and Procedures..........................................19
Part III
Item 9. Directors, Executive Officers, Promoters and Control Persons.....19
Item 10. Executive Compensation...........................................19
Item 11. Security Ownership of Certain Beneficial Owners and Management...19
Item 12. Certain Relationships and Related Transactions...................19
Item 13. Exhibits and Reports on Form 8-K.................................19
Item 14. Principal accounting Fees and Services..........................19
Signatures
2
PART I
Item 1. Description of Business.
Overview
Samaritan Pharmaceuticals, Inc. is a development stage biotechnology Company
engaged in the research and development of novel therapeutic and diagnostic
products to treat chronic debilitating diseases such as Alzheimer's, Cancer,
central nervous system ("CNS") disorders, cardiovascular disease, and HIV.
Samaritan was formed in September 1994 and became public in October 1997. Our
principal executive offices are located at 101 Convention Center Drive, Suite
310, Las Vegas, NV 89109, and our telephone number is (702) 735-7001.
Current Research Programs
On June 18, 2001, Georgetown University granted Samaritan an Exclusive Worldwide
License to Georgetown's patent application for "Early Detection of Alzheimer's".
Georgetown's research efforts toward this patent application accumulated over a
seven-year period. The patent application, entitled, "Neurosteroids as Markers
for Alzheimer's Disease", naming inventors Vassilios Papadopoulos, Rachel C.
Brown and Caterina Cascio, is believed to detect early damage resulting from
Alzheimer's. Their findings, that brain levels of DHEA, are increased in
Alzheimer's pathology; have significant relevance, given the fact that many
companies are currently advocating increasing DHEA with supplements as a means
to prevent the development of Alzheimer's disease and, therefore, may put
prospective Alzheimer's patients at risk.
On July 25, 2001, Georgetown University granted Samaritan an Exclusive Worldwide
License to Georgetown's patent application for a breast cancer diagnostic test
that can be used as a tool to improve the detection, diagnosis, prognosis,
prevention, and possibly the treatment of breast cancer. The patent application,
entitled, "Peripheral-type Benzodiazepine Receptor: A Tool for Detection,
Diagnosis, Prognosis, and Treatment of Human Breast Cancer," naming as
inventors, Vassilios Papadopoulos and Martine Culty, identifies a protein named
Peripheral-type Benzodiazepine receptor (PBR) to be responsible for part of the
changes in cellular and molecular functions in the development and progression
of breast cancer. Although today there are methods for the detection of breast
tumors, such as a mammogram, little is known about the early prognosis of a
tumor to metastasize. Georgetown's scientists have identified a correlation
between high levels of PBR and the aggressiveness of a tumor. Biopsies,
considered to be safe procedures, would be used for PBR measurements and if the
levels are high, scientists believe it could serve as a marker for the
aggressiveness of a tumor with early detection, diagnosis, and prognosis.
Georgetown's research efforts toward this patent application have accumulated
over an 8-year period and, in addition, Samaritan plans to explore research
seeking possible prevention technology and drugs to inhibit, block, or arrest
the production of this protein PBR identified as a marker for breast cancer.
On September 11, 2001, Georgetown University granted Samaritan an Exclusive
Worldwide License to Georgetown's patent application for "Cholesterol
Recognition Amino Acid Sequence." The invention has identified a "cholesterol
fingerprint" present in proteins known to interact with and bind cholesterol.
This chemically synthesized peptide, containing the "cholesterol fingerprint"
amino acid sequence, binds cholesterol and could be used as a drug to remove
cholesterol from other proteins, cells, and tissues.
On December 13, 2001, Georgetown University granted Samaritan an Exclusive
Worldwide License to Georgetown's patent application for "Peripheral-type
Benzodiazepine Receptor Associated Proteins: cloning, expression and methods of
use", naming as inventors, Vassilios Papadopoulos and Hua Li. This technology
identifies proteins that are associated and regulate the function of the
Peripheral-Type Benzodiazepine Receptor in health and disease. The role of this
receptor is in cholesterol compartmentalization, steroid formation, cell death,
tumor growth, and metastasis such as, in Alzheimer's disease pathology, as well
as in other brain pathologies. It is hoped the discovery of these proteins,
might provide new tools to use for understanding the cause of diseases and
develop new methods of treatment.
3
On Oct. 7, 2003, Samaritan expanded its scope of research with Georgetown
University to include a series of preclinical studies to develop a simple
diagnostic blood test for breast cancer. The diagnostic blood test would
potentially measure whether a breast cancer tumor is aggressive in nature, that
is, the likelihood of a cancerous tumor to metastasize and spread cancer
throughout the body. Samaritan, through its collaboration with Georgetown
University, currently has the exclusive license for a breast cancer diagnostic
that measures the aggressive behavior of breast cancer cells in breast biopsies.
Government Regulation. Governmental authorities in the United States and other
countries extensively regulate the preclinical and clinical testing,
manufacturing, labeling, storage, record-keeping, advertising, promotion,
export, marketing and distribution, among other things, of our therapeutic
products. In the United States, the FDA under the Federal Food, Drug and
Cosmetic Act, the Public Health Service Act and other federal statutes and
regulations subjects pharmaceutical products to rigorous review. If we do not
comply with applicable requirements, we may be fined, our products may be
recalled or seized, our production may be totally or partially suspended, the
government may refuse to approve our marketing applications or allow us to
distribute our products, and we may be criminally prosecuted. The FDA also has
the authority to revoke previously granted marketing authorizations. In order to
obtain approval of a new product from the FDA, we must, among other
requirements, submit proof of safety and efficacy as well as detailed
information on the manufacture and composition of the product. In most cases,
this proof entails extensive laboratory tests, and preclinical and clinical
trials. This testing, the preparation of necessary applications and processing
of those applications by the FDA are expensive and typically take several years
to complete. The FDA may not act quickly or favorably in reviewing these
applications, and we may encounter significant difficulties or costs in our
efforts to obtain FDA approvals that could delay or preclude us from marketing
any products we may develop. The FDA may also require post-marketing testing and
surveillance to monitor the effects of approved products or place conditions on
any approvals that could restrict the commercial applications of these products.
Regulatory authorities may withdraw product approvals if we fail to comply with
regulatory standards or if we encounter problems following initial marketing.
With respect to patented products or technologies, delays imposed by the
governmental approval process may materially reduce the period during which we
will have the exclusive right to exploit the products or technologies.
Food and Drug Administration Clinical Phases. After an Investigational New Drug
(IND) Application becomes effective, a sponsor may commence human clinical
trials. The sponsor typically conducts human clinical trials in three sequential
phases, but the phases may overlap. In Phase I clinical trials, the product is
tested in a small number of patients or healthy volunteers, primarily for safety
at one or more doses. In Phase II, the sponsor continues to evaluate safety, but
primarily evaluates the efficacy of the product in a patient population. Phase
III Clinical trials typically involve additional testing for safety and clinical
efficacy in an expanded population at geographically dispersed test sites. The
sponsor must submit a clinical plan to the FDA, or "protocol", accompanied by
the approval of the institution participating in the trials, prior to
commencement of each clinical trial. The FDA may order the temporary or
permanent discontinuation of a clinical trial at any time.
The sponsor must submit to the FDA the results of the preclinical and clinical
trials, together with, among other things, detailed information on the
manufacture and composition of the product, in the form of a new drug
application or, in the case of a biologic, a biologics license application. In a
process which generally takes several years, the FDA reviews this application
and, when and if it decides that adequate data is available to show that the new
compound is both safe and effective and that other applicable requirements have
been met, approves the drug or biologic for marketing.
The amount of time taken for this approval process is a function of a number of
variables, including the quality of the submission and studies presented the
potential contribution that the compound will make in improving the treatment of
the disease in question, and the workload at the FDA. It is possible that our
products will not successfully proceed through this approval process or that the
FDA will not approve them in any specific period of time, or at all.
4
FDA Fast Track. Congress enacted the Food and Drug Administration Modernization
Act of 1997, in part, to ensure the availability of safe and effective drugs,
biologics and medical devices by expediting the FDA review process for new
products. The Modernization Act establishes a statutory program for the approval
of fast track products, including biologics. A fast track product is defined as
a new drug or biologic intended for the treatment of a serious or
life-threatening condition that demonstrates the potential to address unmet
medical needs for this condition. Under the fast track program, the sponsor of a
new drug or biologic may request the FDA to designate the drug or biologic as a
fast track product at anytime during the clinical development of the product.
The Modernization Act specifies that the FDA must determine if the product
qualifies for fast track designation within 60 days of receipt of the sponsor's
request. The FDA can base approval of a marketing application for a fast track
product on an effect, on a clinical endpoint or on another endpoint that is
reasonably likely to predict clinical benefit. The FDA may subject approval of
an application for a fast track product to post-approval studies to validate the
surrogate endpoint or confirm the effect on the clinical endpoint and prior
review of all promotional materials. In addition, the FDA may withdraw its
approval of a fast track product on a number of grounds, including the sponsor's
failure to conduct any required post-approval study with due diligence. If a
preliminary review of clinical data suggests that a fast track product may be
effective, the FDA may initiate review of sections of a marketing application
for a fast track product before the sponsor completes the application. This
rolling review is available if the applicant provides a schedule for submission
of remaining information and pays applicable user fees. However, the time
periods specified under the Prescription Drug User Fee Act concerning timing
goals to which the FDA has committed in reviewing an application do not begin
until the sponsor submits the entire application.
We cannot predict whether the FDA will grant these designations, nor can we
predict the ultimate impact, if any, of the fast track process on the timing or
likelihood of FDA approval of our therapeutics. The FDA may, during its review
of a new drug application or biologics license application, ask for additional
test data. If the FDA does ultimately approve the product, it may require
post-marketing testing, including potentially expensive Phase IV studies, and
surveillance to monitor the safety and effectiveness of the drug. In addition,
the FDA may in some circumstances impose restrictions on the use of the drug,
which may be difficult and expensive to administer, and may require prior
approval of promotional materials.
Manufacturing. Before approving a new drug application or biologics license
application, the FDA will also inspect the facilities at which the product is
manufactured and will not approve the product unless the manufacturing
facilities comply with current Good Manufacturing Practices ("cGMPs"). In
addition, the manufacturing, holding, and distribution of a product must comply
with cGMPs. Manufacturers must continue to expend time, money, and effort in the
areas of production, quality control, record keeping and reporting to ensure
full compliance with those requirements. The labeling, advertising, promotion,
marketing, and distribution of a drug or biologic product must comply with FDA
regulatory requirements. Failure to comply with applicable requirements can lead
to the FDA demanding that production and shipment cease, and, in some cases,
that the manufacturer recall products, or to FDA enforcement actions that can
include seizures, injunctions and criminal prosecution. These failures can also
lead to FDA withdrawal of approval to market the product.
Samaritan's FDA Status. We have not received approval in the U.S. or any foreign
states or foreign jurisdictions for the commercial sale of any of our potential
therapeutics products. However, the FDA has accepted our IND for the clinical
examination of our SP001 and the Company completed its PIb/PIIa clinical human
trials for HIV. Completion of testing, studies and trials may take several
years, and the length of time varies substantially with the type, complexity,
novelty, and intended use of the product. There can be no assurance that any of
our development programs will be successfully completed, that any IND will
become effective or that additional clinical trials will be allowed by the FDA
or other regulatory authorities or that we will successfully develop any
marketable pharmaceutical product.
Pharmaceuticals Sales. Sales of pharmaceutical products outside the United
States are subject to foreign regulatory requirements that vary widely from
country to country. Whether or not we have obtained FDA approval, we must obtain
approval of a product by comparable regulatory authorities of foreign countries
prior to the commencement of marketing the product in those countries. The time
required to obtain this approval may be longer or shorter than that required for
FDA approval. The foreign regulatory approval process includes all the risks
associated with FDA regulation set forth above, as well as country specific
regulations.
5
Environmental Matters. We currently rely primarily on third party independent
contractors and the research efforts of Georgetown University and the University
of Iowa to conduct research and development on and manufacture clinical supplies
of our proposed drugs. However, to the extent that any of our current and future
research and development activities involve the use of hazardous materials and
chemicals, or produce waste products, we will be subject to federal, state, and
local laws and regulations governing the use, manufacture, storage, handling,
and disposal of these materials. Although we would expect that our safety
procedures for handling and disposing of these materials would comply with the
standards prescribed by such laws and regulations, we may be required to incur
significant costs to comply with environmental and health and safety regulations
in the future. In addition, the risk of accidental contamination or injury from
hazardous and radioactive materials cannot be completely eliminated. The
potential liability for damages stemming from accidents involving these
materials may exceed our $2,000,000 commercial general liability insurance
coverage or available resources.
Product and Clinical Studies Liability. Administration of any drug to humans
involves the risk of allergic or other adverse reactions in certain individuals.
Accordingly, it is possible that claims might be successfully asserted against
us for liability with respect to injuries that may arise from the administration
or use of our products during clinical trials or following commercialization.
Since we are not currently conducting human clinical trials, we presently do not
carry clinical studies and product liability insurance. Although we carry a
$2,000,000 commercial general liability insurance policy, there can be no
assurance that the coverage the commercial general liability insurance policy
provides will be adequate to satisfy all claims that may arise. Regardless of
merit or eventual outcome, such claims may result in decreased demand for a
product, injury to our reputation, withdrawal of clinical trial volunteers and
loss of revenues. Thus, a clinical trial or product liability claim may result
in losses that could be material.
Employees. As of the date, hereof we had ten employees that work directly for
Samaritan Pharmaceuticals and ten scientists that work under our collaboration
agreement with Georgetown University. In addition, we make extensive use of
specialized expert consultants.
Investment Considerations
An investment in our common stock is highly speculative, involves a high degree
of risk, and should be made only by investors who can afford a complete loss.
You should carefully consider the following risk factors, together with the
other information in this prospectus, including our financial statements and the
related notes, before you decide to buy our common stock. Our most significant
risks and uncertainties are described below; however, they are not the only
risks we face. These risks may cause our business, financial condition, or
results of operations to be materially adversely affected and the trading price
of our common stock to decline. This may result in you losing all or part of
your investment. As used in this prospectus, the terms "we," "us," "our"", the
Company" and "Samaritan" means Samaritan Pharmaceuticals, Inc. a Nevada
corporation, unless the context indicates a different meaning.
Risks Related To Our Financial Condition
We Have A Limited Operating History With Significant Losses And Expect Losses To
Continue For The Foreseeable Future.
We are a Biopharmaceutical Company in a research and development stage. We have
been unprofitable since our inception and have incurred significant losses. Our
net losses since inception on September 5, 1994 to December 31, 2003 were $23.8
million. We had net losses of $4 million in year ended December 31, 2002 and net
losses of $5.5 million in year ended December 31, 2003. These losses have
resulted principally from costs incurred in our research and development
programs and from our general and administrative costs. We expect to continue to
incur losses and we may never be profitable. We have derived no significant
revenues from product sales or royalties. We do not expect to achieve
significant product sales or royalty revenue in the near future and are not able
to predict when we might do so. Furthermore, we may never do so. We expect to
continue to incur substantial additional operating losses in the future. These
losses may increase significantly, as we expand development and clinical trial
efforts although we prioritize our capital to technologies closest to
commercialization.
6
Even With Our Financing Arrangement With Fusion Capital, We May Require
Additional Financing To Sustain Our Operations.
Currently, we have a $10.0 million dollar common stock purchase agreement with
Fusion Capital. We will require substantial funds to sustain operations and to
grow our business. The amount of which will depend, among other things, on the
rate of progress and the cost of our research and product development programs
and clinical trial activities, the cost of preparing, filing, prosecuting,
maintaining and enforcing patent claims and other intellectual property rights,
and the cost of developing manufacturing and marketing capabilities, if we
decide to undertake those activities. The clinical development of a therapeutic
product is a very expensive and lengthy process and may be expected to utilize
$5 to $20 million over a three to six year development cycle. We currently do
not have available the financial resources to complete the clinical development
of any of our therapeutic products without a strategic partner. Although we
believe we could license the manufacturing and marketing rights to our products
in return for up-front licensing and other fees and royalties on any sales,
there can be no assurance that we will be able to do so in the event we seek to
do so. We need to obtain additional funds to develop our therapeutics products
and our future access to capital is uncertain. The allocation of limited
resources is an ongoing issue for us as we move from research activities into
the more costly clinical investigations required to bring therapeutic products
to market.
We have the right to receive $20,000 per trading day under the agreement with
Fusion Capital unless our stock price equals or exceeds $0.45, in which case the
daily amount may be increased at our option. Generally, Fusion Capital shall not
be obligated to purchase any shares of our common stock on any trading days that
the market price of our common stock is less than $0.10. Since we initially
registered 15,000,000 shares for sale by Fusion Capital, the selling price of
our common stock to Fusion Capital will have to average at least $0.67 per share
for us to receive the maximum proceeds of $10.0 million without registering
additional shares of common stock. Assuming a purchase price of $0.70 per share
(the closing sale price of the common stock on April 13, 2004) and the purchase
by Fusion Capital of the remaining 4,619,555 shares under the common stock
purchase agreement, proceeds to us would be $3,233,688.
The extent we rely on Fusion Capital as a source of funding will depend on a
number of factors including, the prevailing market price of our common stock and
the extent to which we are able to secure working capital from other sources. If
obtaining sufficient financing from Fusion Capital were to prove prohibitively
expensive, we will need to secure another source of funding in order to satisfy
our working capital needs. Even if we are able to access the full $10.0 million
under the common stock purchase agreement with Fusion Capital, we may still need
additional capital to implement our business, operating and development plans.
Other than the agreement with Fusion Capital and the subsequent event to
December 31, 2003, in which the Company received gross proceeds of $4,817,873
under its Continuous Secondary Offering with Fusion Capital and from Private
Placements in exchange for $13,652,561 shares of the Company's common stock, we
do not have any commitments or arrangements to obtain any such funds and there
can be no assurance that any additional funds, whether through exercise of
warrants and stock options, additional sales of securities or collaborative or
other arrangements with corporate partners or from other sources, will be
available to us upon terms acceptable to us or at all. If we are unable to
obtain additional financing we might be required to delay, scale back or
eliminate certain of our research and product development programs or clinical
trials, or be required to license third parties to commercialize products or
technologies that we would otherwise undertake ourselves, or cease certain
operations all together, any of which might have a material adverse effect upon
us. If we raise additional funds by issuing equity securities, dilution to
stockholders may result, and new investors could have rights superior toexisting
holders of shares. Should the financing we require to sustain our working
capital needs be unavailable or prohibitively expensive when we require it, the
consequences would be a material adverse effect on our business, operating
results, financial condition, and prospects.
7
Risks Related To Our Business
We Are In The Development Stage And None Of Our Products Have Completed Clinical
Trials, And May Never Demonstrate Sufficient Safety And Efficacy In Order To Do
So.
All of our products are in the development stage and most of our products are in
the preclinical or research stage. We have only one product SP001 currently in
the FDA clinical trial process, which has recently completed a phase II clinical
trial. In order to achieve profitable operation we must successfully develop,
manufacture, introduce, and market our products. The time frame necessary to
achieve market success for any individual product is long and uncertain. The
products currently under development by us will require significant additional
research and development and extensive pre-clinical and clinical testing prior
to application for commercial use. A number of companies in the biotechnology
and pharmaceutical industries have suffered significant setbacks in clinical
trials, even after showing promising results in early or later stage studies or
clinical trials. Although we have obtained some favorable results to date in
pre-clinical studies and clinical trials of, such results may not be indicative
of results, that will ultimately be obtained in, or throughout clinical trials,
and clinical trials may not show any of our products to be safe or capable of
producing a desired result. Additionally, we may encounter problems in our
clinical trials that will cause us to delay, suspend, or terminate those
clinical trials.
We Are Subject To Extensive Regulation Which Can Be Costly and Time Consuming
And Subject Us To Unanticipated Delays.
All of our potential products and manufacturing activities are subject to
comprehensive regulation by the Food and Drug Administration (FDA) in the United
States and by comparable authorities in other countries. The process of
obtaining FDA and other required regulatory approvals, including foreign
approvals, is expensive and often takes many years and can vary substantially
based upon the type, complexity, and novelty of the products involved.
Preclinical studies involve laboratory evaluation of product characteristics and
often animal studies to assess the efficacy and safety of the product. The FDA
regulates preclinical studies under a series of regulations called the current
Good Laboratory Practices regulations. If the sponsor violates these
regulations, the FDA, in some cases, may invalidate the studies and require that
the sponsor replicate them. Certain of our potential products may be novel, and
regulatory agencies may lack experience with them, which may lengthen the
regulatory review process, increase our development costs and delay or prevent
their commercialization. There is limited successful commercialization of
products based on technology such as ours. In addition, we have had only limited
experience in filing and pursuing applications necessary to gain regulatory
approvals, which may impede our ability to obtain timely FDA approvals, if at
all. We will not be able to commercialize any of our potential therapeutic
products until we obtain FDA approval, and so any delay in obtaining, or
inability to obtain, FDA approval could harm our business. We have not yet
sought FDA approval for any of our therapeutic products.
We Are Dependent on Georgetown University To Conduct Research And Development
And To Conduct Preclinical Studies, Which If Unavailable Would Impair Our
Ability To Commercialize Our Products.
We have a thirteen-year, research and development, collaboration with Georgetown
University. Therefore, our potential therapeutic products are not the result of
our own internal basic research but rather arise from our ability to license
technologies from Georgetown University. Currently, we are dependent upon
Georgetown University for all discovery and most preclinical studies. Although
we are contractually committed, there can be no assurance that we will be able
to obtain these services from Georgetown University, or other third parties, on
commercially reasonably terms or at all, or that any or all of the contemplated
benefits from such collaborative arrangements will be realized. Failure to
obtain such arrangements would result in delays in the development of our
proposed products.
Technology With Respect To Therapeutics and Other Biopharmaceutical Fields Is
Rapidly Evolving, And There Can Be No Assurance Of Our Ability To Respond
Adequately.
8
We are engaged in biopharmaceutical fields characterized by extensive research
efforts, rapidly evolving technology, and intense competition from numerous
organizations, including pharmaceutical companies, biotechnology firms, academic
institutions, and others. New developments are expected to continue at a rapid
pace in both industry and academia. We cannot assure you that research and
discoveries by others will not render any of our potential products obsolete,
uneconomical or otherwise unmarketable or unprofitable. In order to compete
successfully, we will need to complete the development of and obtain regulatory
approval of one or more of our products that keep pace with technological
developments on a timely basis. Any failure by us to anticipate or respond
adequately to technological developments will have a material adverse effect
upon our prospects and financial condition.
Competition in Our Industry Is Intense and Many of Our Competitors Have
Substantially Greater Managerial Resources Than We Have
Competition in our fields of research is intense and is accentuated by the rapid
pace of technological development. We do not have access to information
regarding the product development efforts of our competitors or the diseases
that such efforts target. It is likely that other companies are researching and
developing drugs to treat the same diseases or conditions that we are targeting.
These competitors may be using similar or different biological or metabolic
processes or delivery systems. Many of our competitors have substantially
greater research and development capabilities and manufacturing, marketing,
financial and managerial resources than we do. Research and discoveries by
others may result in breakthroughs that may render our products obsolete even
before they generate any revenue. There are products currently under development
by others that could compete with the products that we are developing.
Competitors also may succeed in developing and marketing products that are more
effective than or marketed before our products. Our competitors may develop
safer or more effective therapeutic products, reach the market more rapidly and
thereby reduce the potential sales of our products, or establish superior
proprietary positions. We also anticipate that we will face increased
competition in the future as new companies enter our markets and as scientific
developments continue to accelerate. If any of our products receive marketing
approval, the inability of our products to compete effectively in the
marketplace will materially and adversely affect our business operations.
We Are Dependent On Key Members of Management
Our success is dependent upon the continued services and performance of Dr.
Janet Greeson, our chief executive officer, president and chairman; and Dr.
Vassilios Papadopoulos, our chief scientific officer. We do not maintain key man
insurance on either officer. We have a 5-year employment agreement with Dr.
Greeson that expires in 2006. The loss of their services could delay our product
development programs and our research and development efforts at Georgetown
University. In addition, the loss of Dr. Janet Greeson is grounds for
termination of the collaboration with Georgetown University. In addition,
competition for qualified employees among companies in the biotechnology and
biopharmaceutical industry is intense and we cannot assure you that we would be
able to recruit qualified personnel on acceptable terms to replace them.
We May Not Be Able To Adequately Protect Our Intellectual Proprietary Rights
Our patent strategy is to pursue patent protection in the U.S. and in major
developed countries for our technologies. As of the date hereof, we own or
license one issued U.S. patent for SP001 and had eleven pending patent
applications from Georgetown University in the U.S. to protect our proprietary
methods and processes. We have also filed corresponding foreign patent
applications for certain of these U.S. patent applications. As of the date
hereof, our patent portfolio outside the U.S. comprised of no issued patents and
over eleven pending patent applications. The issued U.S. patent and pending
patent application relate to Alzheimer's, Cancer, Cardiovascular, and HIV
indications and is based on balancing and modulating the stress hormone
cortisol, counteracting cortisol's neurodegenerative and immunosuppressive
properties. Our goal is to obtain broad patent protection for our technologies
and their related medical indications. The patent on procaine issued on
September 1990, expires in September 2008 but patent term extensions under the
Hatch-Waxman Act may be available to Samaritan for the lost opportunity to
market and sell the invention during the regulatory review process.
9
Our success will depend in significant part on our ability to obtain and
maintain elements of business protection practices, including but not limited to
U.S. patent protection for our licensed technologies, preservation and defense
of our trade secrets and proprietary rights, and operations that do not infringe
upon the proprietary rights of third parties. Because of the length of time and
expense associated with bringing new products through development and regulatory
approval to the marketplace, the pharmaceutical industry has traditionally
placed considerable importance on obtaining patent and trade secret protection
for significant new technologies, products, and processes. We cannot assure you
that patents will be issued from the patent applications we own, or have
licensed or that the patent issued to us will provide us with significant
protection against competitive applications or otherwise be commercially
valuable. In addition, patent law relating to certain of our fields of interest,
particularly as to the scope of claims in issued patents, is still evolving.
Patent positions may not be as strong as in other, better-established fields,
and it is unclear how this uncertainty will affect our patent rights.
Litigation, which could be costly and time consuming, may be necessary to
enforce any patents issued in the future to us or our licensors or to determine
the scope and validity of the proprietary rights of third parties. The issuance
of a patent is not conclusive as to its validity or enforceability and it is
uncertain how much protection, if any, will be given to our patents if we
attempt to enforce them and they are challenged in court or in other
proceedings, such as oppositions, which may be brought in foreign jurisdictions
to challenge the validity of a patent. A third party may challenge the validity
or enforceability of a patent after its issuance by the U.S. Patent and
Trademark Office. It is possible that a competitor may successfully challenge
our patents or that a challenge will result in limiting their coverage.
Moreover, the cost of litigation to uphold the validity of patents and to
prevent infringement can be substantial. If the outcome of litigation is adverse
to us, third parties may be able to use our patented invention without payment
to us. Moreover, it is possible that competitors will infringe our patents or
avoid them through design innovation. To stop these activities we may need to
file a lawsuit. These lawsuits are expensive and would consume time and other
resources, even if we were successful in stopping the violation of our patent
rights. In addition, there is a risk that a court would decide that our patents
are not valid and that we do not have the right to stop the other party from
using the inventions. There is also the risk that, even if the validity of our
patents were upheld, a court would refuse to stop the other party on the ground
that its activities are not covered by, that is, do not infringe, our patents.
Our competitive position is also dependent upon unpatented technology and trade
secrets, which may be difficult to protect. We cannot assure you that others
will not independently develop substantially equivalent proprietary information
and techniques, which would legally circumvent our intellectual property rights,
that our trade secrets will not be disclosed or that we can effectively protect
our rights to unpatented trade secrets. As the biotechnology industry expands
and more patents are issued, the risk increases that our potential products may
give rise to claims that they infringe upon the patents of others. Any such
infringement litigation would be costly and time consuming to us. As of the date
hereof, Samaritan has no pending threats of litigation or negotiations regarding
patent issues, court challenges, or legal action.
We Are Exposed To Potential Liability Claims, and Our Insurance against These
Claims May Not Be Sufficient To Protect Us
Our business exposes us to potential clinical trial failures and may in the
future expose us to product liability risks, which are inherent in the testing,
manufacturing, marketing, and sale of pharmaceutical products. Although we carry
a $2,000,000 commercial general liability insurance policy, the Company
currently has no specific clinical trial liability or product liability
insurance. There can be no assurance that the coverage the commercial general
liability insurance policy provides will be adequate to satisfy all claims that
may arise. Regardless of merit or eventual outcome, such claims may result in
decreased demand for a product, injury to our reputation, withdrawal of clinical
trial volunteers and loss of revenues. Thus, a clinical trial or product
liability claim may result in losses that could be material.
10
We Currently Outsource for our Supply and Manufacturing of Clinical Drugs.
We currently outsource our supply and manufacturing of clinical drugs and there
would be a material adverse effect on our business and prospects if we were
unable to obtain adequate supplies. Our supplier manufactures the material in a
facility, which adheres to current Good Manufacturing Practices, or cGMP,
regulations enforced by the FDA through its facilities inspection program. If
our supplier was unable to produce and provide us with clinical drugs,
especially of cGMP grade, we will be forced to identify an alternative supplier
or produce the product ourselves. We are continuously seeking alternative
suppliers capable of meeting our needs and if we were unable to identify an
alternative supplier, we might experience delays in replacing or transitioning
our supplier. We would be required to design, in addition, if the suppliers
produce an inadequate supply, or fail to produce or deliver the product on a
timely basis; our clinical testing may be delayed, thereby delaying the
submission of products for regulatory approval or the market introduction and
subsequent sales of our products. Any such delay may lower our revenues and
potential profitability and otherwise have a material adverse effect on us.
Risks Related to our Common Stock
We are authorized to issue additional shares of our common stock without
stockholder approval, which could have an adverse affect upon the rights of our
stockholders and the market price of our common stock. We have a substantial
number of shares of common stock un-issued and not reserved for specific
issuances, of which we could issue an amount equal to 20% of our outstanding
shares of common stock, without any action or approval by our stockholders in
accordance with Samaritan Pharmaceuticals, Inc. 2001 Stock Incentive Plan (the
"2001 Plan"), thus substantially diluting the percentage ownership of Samaritan
Pharmaceuticals held by purchasers of the securities offered hereby and
potentially adversely affecting the market price of our common stock.
Market volatility may affect our stock price and the value of your investment
may be subject to sudden decreases. The trading price for our common stock has
been, and we expect it to continue to be, volatile. The price at which our
common stock trades depends upon a number of factors, including our historical
and anticipated operating results, general market, and economic conditions,
which are beyond our control. Factors such as fluctuations in our financial and
operating results, the results of preclinical and clinical trials, announcements
of technological innovations or new commercial products by us or our
competitors, developments concerning proprietary rights and publicity regarding
actual or potential performance of products under development by us or our
competitors could also cause the market price of our common stock to fluctuate
substantially. In addition, the stock market has, from time to time, experienced
extreme price and volume fluctuations. These broad market fluctuations may lower
the market price of our common stock. Moreover, during periods of stock market
price volatility, share prices of many biotechnology companies have often
fluctuated in a manner not necessarily related to their operating performance.
Accordingly, our common stock may be subject to greater price volatility than
the stock market as a whole.
The Sale Of Our Common Stock To Fusion Capital May Cause Dilution And The Sale
Of The Shares Of Common Stock Acquired By Fusion Capital Could Cause The Price
Of Our Common Stock To Decline
The purchase price for the common stock to be issued to Fusion Capital pursuant
to the common stock purchase agreement will fluctuate based on the price of our
common stock. Fusion Capital may sell none, some, or all of the shares of common
stock purchased from us at any time. Depending upon market liquidity at the
time, a sale of shares at any given time could cause the trading price of our
common stock to decline and to be highly volatile. Fusion Capital may ultimately
purchase all of the shares of common stock issuable under the common stock
purchase agreement, and it may sell some, none, or all of the shares of common
stock it acquires upon purchase. Therefore, the purchases under the common stock
purchase agreement may result in substantial dilution to the interests of other
holders of our common stock. The sale of a substantial number of shares of our
common stock by Fusion Capital or anticipation of such sales, could make it more
difficult for us to sell equity or equity-related securities in the future, at a
time and at a price, that we might otherwise wish to effect sales.
11
Future Sales of Common Stock Could Depress the Price of Our Common Stock
Future sales of substantial amounts of common stock pursuant to Rule 144 under
the Securities Act of 1933 or otherwise by certain shareholders could have a
material adverse impact on the market price for the common stock at the time.
There are presently approximately 73,239,594 outstanding shares of our common
stock held by shareholders, which are deemed "restricted securities" as defined
by Rule 144 under the Securities Act. Under certain circumstances, these shares
may be sold without registration pursuant to the provisions of rule 144. In
general, under rule 144, a person (or persons whose shares are aggregated) who
has satisfied a one-year holding period may, under certain circumstances, sell
within any three-month period a number of restricted securities which does not
exceed the greater of one (1%) percent of the shares outstanding or the average
weekly trading volume during the four calendar weeks preceding the notice of
sale required by rule 144. In addition, rule 144 permits, under certain
circumstances, the sale of restricted securities without any quantity
limitations by a person who is not an affiliate of ours and has satisfied a
two-year holding period. Any sales of shares by shareholders pursuant to rule
144 may have a depressive effect on the price of our common stock.
The Market Price of Our Common Stock Is Very Volatile and the Value of Your
Investment May Be Subject To Sudden Decreases
The trading price for our common stock has been, and we expect it to continue to
be, volatile. For example, the closing bid price of our stock has fluctuated
between $0.12 and $0.75 per share during the preceding year. The price at which
our common stock trades depends upon a number of factors, including our
historical and anticipated operating results, general market, and economic
conditions, which are beyond our control. Factors such as fluctuations in our
financial and operating results, the results of preclinical and clinical trials,
announcements of technological innovations or new commercial products by us or
our competitors, developments concerning proprietary rights and publicity
regarding actual or potential performance of products under development by us or
our competitors could also cause the market price of our common stock to
fluctuate substantially. In addition, the stock market has, from time to time,
experienced extreme price and volume fluctuations. These broad market
fluctuations may lower the market price of our common stock. Moreover, during
periods of stock market price volatility, share prices of many biotechnology
companies have often fluctuated in a manner not necessarily related to their
operating performance. Accordingly, our common stock may be subject to greater
price volatility than the stock market as a whole.
Our Common Stock Is Traded Over the Counter, Which May Deprive Stockholders of
the Full Value of Their Shares
Our common stock is quoted via the Over the Counter Bulletin Board (OTCBB)
sponsored by the National Association of Securities Dealers. As such, our common
stock may have fewer market makers; lower trading volumes and larger spreads
between bid and asked prices than securities listed on an exchange such as the
New York Stock Exchange, American Stock Exchange or NASDAQ. These factors may
result in higher price volatility and less market liquidity for the common
stock.
A Low Market Price May Severely Limit The Potential Market For Our Common Stock.
Our common stock is currently trading at a price substantially below $5.00 per
share, subjecting trading in the stock to certain SEC rules requiring additional
disclosures by broker-dealers. These rules generally apply to any non-NASDAQ
equity security that has a market price of less than $5.00 per share, subject to
certain exceptions (a "penny stock"). Such rules require the delivery, prior to
any penny stock transaction, of a disclosure schedule explaining the penny stock
market and the risks associated therewith and impose various sales practice
requirements on broker-dealers who sell penny stocks to persons other than
established customers and institutional or wealthy investors. For these types of
transactions, the broker-dealer must make a special suitability determination
for the purchaser and have received the purchaser's written consent to the
transaction prior to the sale. The broker-dealer also must disclose the
commissions payable to the broker-dealer, current bid, and offer quotations for
the penny stock and, if the broker-dealer is the sole market maker, the
broker-dealer must disclose this fact and the broker-dealer's presumed control
over the market. Such information must be provided to the customer orally or in
writing before or with the written confirmation of trade sent to the customer.
Monthly statements must be sent disclosing recent price information for the
penny stock held in the account and information on the limited market in penny
stocks. The additional burdens imposed upon broker-dealers by such requirements
could discourage broker-dealers from effecting transactions in our common stock.
12
Because We Will Not Pay Dividends, Stockholders Will Only Benefit From Owning
Common Stock If It Appreciates
We have never paid dividends on our common stock and do not intend to do so in
the foreseeable future. We intend to retain any future earnings to finance our
growth. Accordingly, any potential investor who anticipates the need for current
dividends from his investment should not purchase our common stock.
Item 2. Description of Property
The Company's executive offices are currently located at 101 Convention Center
Drive, Suite 310, Las Vegas, Nevada 89109. The 1,100 square foot office space is
rented at a base rent of $2,620 per month. In addition, under the Research
Collaboration agreement between Georgetown University and Samaritan
Pharmaceuticals, Georgetown provides space, which is located at Samaritan
Research Laboratories, Georgetown University Medical Center, Medical Dental
Building, Suite SE 111, 3900 Reservoir Road, NW, Washington, DC 20007.
Item 3. Legal Proceedings
We are, from time to time, involved in various legal proceedings in the ordinary
course of our business. While it is impossible to predict accurately or to
determine the eventual outcome of these matters, the Company believes that the
outcome of these proceedings will not have a material adverse effect on the
annual financial statements of the Company.
Item 4. Submission of Matters to a Vote of Security Holders
None
Part II
Item 5. Market for Common Equity and Related Stockholder Matters
Market Information. The Company's Common Stock is traded on the NASDAQ
over-the-counter ("OTC") Bulletin Board under the symbol "SPHC.OB" and the name
of Samaritan Pharmaceuticals, Inc. The following table sets forth the range of
high and low bid closing quotations for our common stock on the over-the-counter
market for each quarter within the last two fiscal years. The over-the-counter
quotes reflect inter-dealer prices without retail mark-up markdown or commission
and may not represent actual transactions. The quotations may be rounded for
presentation.
Low High
Year Ended December 31, 2003
Fourth Quarter 0.32 0.63
Third Quarter 0.20 0.75
Second Quarter 0.15 0.24
First Quarter 0.12 0.18
Year Ended December 31, 2002
Fourth Quarter 0.15 0.24
Third Quarter 0.15 0.30
Second Quarter 0.13 0.20
First Quarter 0.14 0.30
Holders. As of December 31, 2003, there were approximately seven hundred
forty-three (743) holders of record excluding beneficial holders of stock held
in street name.
13
Dividends. We have never paid cash or declared dividends on our common stock. We
do not anticipate that we will declare or pay cash dividends on our common stock
in the foreseeable future.
Recent sales of unregistered securities; use of proceeds from registered
securities. Securities, unregistered, were sold by the Company under an
exemption from registration. The title of these securities was the Common Stock
of the Company. They were sold for cash unless otherwise noted in this section.
They were sold in private transactions to persons believed to be of a class of
private investors acting on their own comprised of "accredited investors" (as
such term is defined in Regulation D of the U.S. Securities and Exchange
Commission or "SEC") and a limited number of non-accredited investors. All
investors, to the best knowledge of the Company, not affiliated with the
Company, purchased the shares with apparent investment intent. The Company
relied upon, among other possible exemptions, Section 4(2) of the Securities Act
of 1933, as amended. It's reliance on said exemption was based upon the fact
that no public solicitation was used by the Company in the offer or sale, and
that the securities were legended shares, along with a notation at the
respective transfer agent, restricting the shares from sale or transfer as is
customary with reference to Rule 144 of the SEC.
Management notes that the Company issues stock as compensation for services and
supplies, valuing such issues premised upon the fair market value of the stock
or the services, whichever is more clearly determinable.
During the year ended December 31, 2002, the Company issued an aggregate of
3,840,525 shares of common stock in consideration of services rendered or to be
rendered to the Company. Such shares were valued at an aggregate of $1,048,026
ranging from $.17-$.25 per share, representing the fair value of the shares
issued. The issuances were recorded as non-cash compensation expense. During the
year ended December 31, 2002 the Company exchanged 4,265,184 shares of the
Company's common stock in settlement of accounts payable.
During the year ended December 31, 2003, the Company issued an aggregate of
937,833 shares of common stock in consideration of services rendered or to be
rendered to the Company. Such shares were valued at an aggregate of $553,842
ranging from $.16-$.71 per share, representing the fair value of the shares
issued. The issuances were recorded as non-cash compensation expense. During the
year ended December 31, 2003 the Company exchanged 12,740,870 shares of the
Company's common stock in settlement of accounts payable and accrued salaries
for officers totaling $1,152,703. To the extent that the market value of shares
issued as payment of accrued salaries exceeded the recorded amount of accrued
salaries, such amount was recognized as additional compensation. The amount of
additional compensations recorded at December 31, 2003 was $2,305,863.
The Company also issued 3,125,000 shares in connection with the common stock
purchase agreement with Fusion Capital. Such amount was recorded at par value
with a corresponding charge against Additional Paid-in Capital.
During the year 2003, through various private placements, the Company sold
17,493,664 shares for $2,409,790. During the year ended 2002, through various
private placements, the Company sold 18,657,500 shares for $2,096,299.
Subsequent to December 31, 2003, the Company received gross proceeds of
$4,817,873 under its Continuous Secondary Offering with Fusion Capital and from
Private Placements in exchange for $13,652,561 shares of the Company's common
stock. As of April 13, 2004, the Company had cash and cash equivalents balance
of $4,371,085.
Item 6. Management's Discussion and Analysis or Plan of Operation
Samaritan Pharmaceuticals is a Biopharmaceutical Company engaged in the research
and development of novel therapeutics and diagnostic products to treat chronic
debilitating diseases such as Alzheimer's, Cancer, central nervous system
("CNS") disorders, cardiovascular disease, and HIV.
14
Samaritan has a series of therapeutic compounds either in "discovery research",
"preclinical trials", product development" or "clinical development"; and we
utilize these formal stages of product progression to track progress,
performance and competition. Our research programs are aimed at satisfying
defined medical needs in the areas of Alzheimer's, Cancer, Cardiovascular,
Infectious Diseases, and Neurology and are based on an intellectual property
position that, we believe, is both broad and strong. Several of our development
programs involve ex vivo technologies in which patients' tissues are manipulated
outside the body and, as such, may be less costly to investigate and quicker to
develop than in vivo agents. We expect to apply to the U.S. FDA for and receive
IND status (Investigational New Drug) for certain technologies to initiate human
trials that may commence in the future.
A key currency in the biotechnology and pharmaceutical market is patents,
intellectual property. Our central intellectual property activity has been, and
continues to be, the acquisition of patents, development, and patent
maintenance, directly in support of our product development. We continue to
expend significant funds and efforts on licensed technology and patent
protection. In addition, we are continually examining our intellectual property
positions in relation to competitive activities and our ability to operate and
defend our patent positions in relation to products. We believe that this is a
key value element for our continued development.
Samaritan Pharmaceuticals Product Pipeline
xxx = Completed x = In Progress
Drug Candidates Patent Pre -Clinical IND Phase I Phase II Phase III
---------------------------------------------------------------------------------------------------------
HIV.Procaine HCl (SP-01) xxx xxx xxx xxx xxx
HIV, Alzheimer's(AD),
Dementia.(SP-10) x x
HIV, AD.(SP-02 to 25) x x
HIV, AD.(SP-26 to 50) x x
Alzheimer's.(SP-222) x x
Alzheimer's.(SP-233) x x
Alzheimer's.(SP234-250) x x
Nerve Gas Inhibitor.(SP-04) x
Stem Cell Therapy.(SP-sc2) x x
Stem Cell Therapy.(SP-sc7) x x
Cancer.(SP-222c) x x
Cancer.(SP-234c-250c) x x
Cancer Diagnostic
and Drug. (SP-5000) x x
Pharmacologic AD Rat Model In Vitro Testing In Vivo Testing
Alzheimer's Rat Model.(New Drug Test) xxx xxx
Diagnostics In Vitro Human Human
Testing Test Small Test Large
--------------------------------------------------------------------------------
Breast Cancer.(BC Tumor Agress-Analysis) xxx xxx x
Alzheimer's.(AD Blood Test Diagnostic) xxx xxx x
Alzheimer's Generation II xxx xxx
Alzheimer's Generation III xxx
15
Current Research Agreement. Samaritan Pharmaceuticals has a research
collaboration agreement with Georgetown University with the objectives: (1) to
develop "one molecule" drugs and extend clinical studies to in vivo experiments
in animal models simulating Alzheimer's disease, (2) to develop an accurate,
reliable diagnostic for nuero-degeneration (Alzheimer's), and (3) to focus on
new drug development in Oncology and Neurology with the ability to protect the
brain from neuronal damage and tumor growth. Starting with the quarter beginning
April 1, 2004, the research collaboration between Georgetown University and
Samaritan budget has been increase to further develop Samaritan's pipeline.
Under the collaboration agreement, Samaritan pays Georgetown $1,000,000 per
year, which is used by Georgetown to fund its efforts in the collaboration in
respect of research, which is based on balancing and modulating the stress
hormone cortisol, counteracting cortisol's neurodegenerative, and
immunosuppressive properties. The $1,000,000 is paid quarterly, is unallocated,
and covers the general research and development effort. In addition, we have
incurred direct research and development expenses of approximately $350,000 for
each of the last two fiscal years related primarily to clinical trials and the
retention of consultants to assist in the FDA process.
Under the agreement, Samaritan receives worldwide exclusive rights to any novel
therapeutic agents or diagnostic technologies that may result from the research
collaboration directed by Dr. Vassilios Papadopoulos and Dr. Janet Greeson with
their team of seven research professionals (including five Ph.D. level research
scientists) who have expertise in the fields of endocrinology, pharmacology,
cell biology, organic and steroid chemistry and computer modeling. The term of
the license agreement is for the term of any associate patents. We are not
obligated to pay Georgetown any milestone payments. Georgetown is entitled to
receive royalties based on our revenue from product sales and sublicenses, if
any. Samaritan has, at its own expense, responsibility for the process of
seeking any regulatory approvals for and conducting clinical trials with respect
to any licensed product or application of the licensed technology. Samaritan
controls and has the financial responsibilities for the prosecution and
maintenance in respect to any patent rights related to the licensed technology.
Samaritan has the right to terminate the license upon written notice to
Georgetown for any reason or for no reason. In the event that Samaritan fails to
make any payment due to Georgetown under the license, Georgetown has the right
to terminate the license upon sixty (60) days prior written notice if Samaritan
fails to pay to Georgetown such amount within such 60-day period.
Our Financial Position and Our Need to Raise Additional Capital
We are a Biopharmaceutical Company in a research and development stage. Since
our inception, we have primarily focused our resources on research and
development. To date, none of our proprietary products has reached a commercial
stage, and hence, we do not have, nor do we anticipate revenue in the near
future. We have been unprofitable since our inception and have incurred
significant losses. Our net losses since inception on September 5, 1994 to
December 31, 2003 was $23 million. We had net losses of $4 million and 5.5
million in the last two years ended December 31, 2003. We will continue to have
significant general and administrative expenses, including expenses related to
clinical studies, our collaboration with Georgetown University, and patent
prosecution. We have funded our operations through a series of private
placements and through our agreement with Fusion Capital dated April 22, 2003,
described below, which we believe will assist the Company in meetings its cash
needs, but there is no guarantee. Except for an agreement to sell shares to
Fusion Capital, discussed below, no commitment exists for continued investments,
or for any underwriting.
We have the right to receive $20,000 per trading day under the agreement with
Fusion Capital unless our stock price equals or exceeds $0.45, in which case the
daily amount may be increased at our option. Generally, Fusion Capital shall not
be obligated to purchase any shares of our common stock on any trading days that
the market price of our common stock is less than $0.10. Since we initially
registered 15,000,000 shares for sale by Fusion Capital, the selling price of
our common stock to Fusion Capital will have to average at least $0.67 per share
for us to receive the maximum proceeds of $10.0 million without registering
additional shares of common stock. Assuming a purchase price of $0.70 per share
(the closing sale price of the common stock on April 13, 2004) and the purchase
by Fusion Capital of the remaining 4,619,555 shares under the common stock
purchase agreement, proceeds to us would be $3,233,688.
16
Even with our financing arrangement with Fusion Capital, we may require
substantial additional funds to sustain our operations and to grow our business.
The amount of which will depend, among other things, on the rate of progress and
the cost of our research and product development programs and clinical trial
activities, the cost of preparing, filing, prosecuting, maintaining and
enforcing patent claims and other intellectual property rights, and the cost of
developing manufacturing and marketing capabilities, if we decide to undertake
those activities. The clinical development of a therapeutic product is a very
expensive and lengthy process and may be expected to utilize $5 to $20 million
over a three to six year development cycle. We currently do not have available
the financial resources to complete the clinical development of any of our
therapeutic products without a strategic partner. Although we believe we could
license the manufacturing and marketing rights to our products in return for
up-front licensing and other fees and royalties on any sales, there can be no
assurance that we will be able to do so in the event we seek to do so. We need
to obtain additional funds to develop our therapeutics products and our future
access to capital is uncertain. The allocation of limited resources is an
ongoing issue for us as we move from research activities into the more costly
clinical investigations required to bring therapeutic products to market.
The extent we rely on Fusion Capital as a source of funding will depend on a
number of factors including, the prevailing market price of our common stock and
the extent to which we are able to secure working capital from other sources. If
obtaining sufficient financing from Fusion Capital were to prove prohibitively
expensive, we will need to secure another source of funding in order to satisfy
our working capital needs. Even if we are able to access the full $10.0 million
under the common stock purchase agreement with Fusion Capital, we may still need
additional capital to fully implement our business, operating and development
plans. Other than the agreement with Fusion Capital and the subsequent event to
December 31, 2003, in which the Company received gross proceeds of $4,817,873
under its Continuous Secondary Offering with Fusion Capital and from Private
Placements in exchange for $13,652,561 shares of the Company's common stock, we
do not have any commitments or arrangements to obtain any such funds and there
can be no assurance that any additional funds, whether through exercise of
warrants and stock options, additional sales of securities or collaborative or
other arrangements with corporate partners or from other sources, will be
available to us upon terms acceptable to us or at all. If we are unable to
obtain additional financing we might be required to delay, scale back or
eliminate certain of our research and product development programs or clinical
trials, or be required to license third parties to commercialize products or
technologies that we would otherwise undertake ourselves, or cease certain
operations all together, any of which might have a material adverse effect upon
us. If we raise additional funds by issuing equity securities, dilution to
stockholders may result, and new investors could have rights superior to
existingholders of shares. Should the financing we require to sustain our
working capital needs be unavailable or prohibitively expensive when we
require it, the consequences would be a material adverse effect on our business,
operating results, financial condition, and prospects.
We have been able to substantially meet our cash needs during the past 12
months. We believe we will be able to continue to find avenues to obtain the
capital needed for our operations through private placements and by sale of our
shares to Fusion Capital.
Forward-Looking Statements. This report and other oral and written statements
made by us to the public contain forward-looking statements within the meaning
of the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. Such statements are based upon management's current expectations that
are subject to a number of factors and uncertainties that could cause actual
results to differ materially from those described in our forward-looking
statements. Such statements address the following subjects: our need for and
ability to obtain additional capital, including from the sale of equity and/or
from federal or other grant sources; our expected future losses; the sufficiency
of cash and cash equivalents; our ability to generate revenues; our ability to
develop commercially successful products, including our ability to obtain FDA
approval to initiate further studies of our potential products and our
technologies; the high cost and uncertainty of the research and development of
pharmaceutical products; the unpredictability of the duration and results of the
U.S. Food and Drug Administration's review of new drug applications; the
possible impairment of our existing, and the inability to obtain new,
intellectual property rights and the cost of protecting such rights as well as
the cost of obtaining rights from third parties when needed on acceptable terms;
our ability to enter into successful partnering relationships with respect to
the development and/or commercialization of our product candidates; our
dependence on third parties to research, develop, manufacture and commercialize
and sell any products developed; our ability to improve awareness and
understanding of our Company, our technology and our business objectives;
whether our predictions about market size and market acceptability of our
products will prove true; and our understandings and predictions regarding the
utility of our potential products and our technology.
17
Statements in this report expressing our expectations and beliefs regarding our
future results or performance are forward-looking statements that involve a
number of substantial risks and uncertainties. When used in this Form 10-KSB,
the words "anticipate," "believe," "estimate," "expect," "intend," may be,"
"seek," "plan," "focus," and "potential" and similar expressions as they relate
to the Company or its management are intended to identify such forward-looking
statements. Our actual future results may differ significantly from those stated
in any forward-looking statements.
As a result of the foregoing and other factors, we may experience material
fluctuations in future operating results on a quarterly or annual basis, which
could materially and adversely affect our business, financial condition,
operating results and stock price. We are not under any duty to update any of
the forward-looking statements in this report to conform these statements to
actual results, unless required by law. For further information, refer to the
more specific risks and uncertainties discussed above and throughout this
report.
Item. 7. Financial Statements.
The information required under Item 310(a) of Regulation S-B is included in this
report as set forth in the "Index to Financial Statements." See F-1 for Index to
Consolidated Financial Statements.
18
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
INDEX
Page Number
INDEPENDENT AUDITORS' REPORT F - 2
CONSOLIDATED FINANCIAL STATEMENTS:
Balance Sheet F - 3
Statements of Operations F - 4
Statements of Shareholders' Deficit F - 5
Statements of Cash Flows F - 6
Notes to Financial Statements F-7 - F-14
INDEPENDENT AUDITORS' REPORT
Board of Directors and Stockholders
Samaritan Pharmaceuticals, Inc.
We have audited the accompanying consolidated balance sheet of
Samaritan Pharmaceuticals, Inc. (a development stage company) as of December 31,
2003 and the related consolidated statements of operations, shareholders'
deficit and cash flows for the years ended December 31, 2003 and 2002. These
financial statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audit.
We conducted our audit in accordance with auditing standards generally
accepted in the United States of America. 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, the consolidated financial position of Samaritan Pharmaceuticals, Inc.
(a development stage company) as of December 31, 2003 and the consolidated
results of its operations and its cash flows for the years ended December 31,
2003 and 2002 in conformity with accounting principles generally accepted in the
United States of America.
The accompanying cumulative statements of operations, shareholders'
deficit and cash flows regarding the period from inception (September 5, 1994)
through December 31, 2003, include activity prior to our engagement as auditors
upon which we or the predecessor auditor have not performed procedures.
Therefore, we do not express an opinion on them.
/s/ Sherb & Co., LLP
---------------------------------
Sherb & Co., LLP
Certified Public Accountants
New York, New York March 31, 2004, except for Note 9, as to which the date is
April 13, 2004
F-2
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEET
December 31, 2003
ASSETS
CURRENT ASSETS:
Cash $ 370,585
Prepaid expenses 21,257
------------------
TOTAL CURRENT ASSETS 391,842
------------------
PROPERTY AND EQUIPMENT 36,227
------------------
OTHER ASSETS:
Patent registration costs 202,198
Purchased technology rights 41,775
Deposits 2,779
------------------
TOTAL OTHER ASSETS 246,752
------------------
$ 674,821
==================
LIABILITIES AND SHAREHOLDERS' DEFICIT
CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 388,310
Common stock to be issued 12,500
------------------
TOTAL CURRENT LIABILITIES 400,810
------------------
SHAREHOLDERS' DEFICIT:
Common stock, 200,000,000 shares authorized at $.001
par value, 106,214,833 issued and outstanding 106,214
Additional paid-in capital 24,852,369
Stock subscriptions receivable (1,119,848)
Treasury stock (250,248)
Deficit accumulated during development stage (23,314,476)
------------------
TOTAL SHAREHOLDERS' DEFICIT 274,011
------------------
$ 674,821
==================
See accompanying notes to the consolidated financial statements.
F-3
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
FROM INCEPTION (SEPTEMBER 5, 1994) TO DECEMBER 31, 2003
AND FOR THE YEARS ENDED DECEMBER 31, 2003 AND 2002
From
Inception
(September 5, 1994) Year ended December 31,
To ------------------------------------
December 31, 2003 2003 2002
--------------------- ---------------- -----------------
(Unaudited)
REVENUES: $ 300,000 $ 250,000 $ -
--------------------- ---------------- -----------------
EXPENSES:
Research and development 4,739,549 838,208 1,097,248
Interest, net 50,006 6,334 20,307
General and administrative 17,842,085 4,902,213 2,419,215
Depreciation and amortization 1,120,616 23,776 520,383
Forgiveness of debt (137,780) - -
--------------------- ---------------- -----------------
23,614,476 5,770,531 4,057,153
--------------------- ---------------- -----------------
NET LOSS $ (23,314,476) $ (5,520,531) $ (4,057,153)
===================== ================ =================
Loss per share, basic
and diluted $ (1.01) $ (0.07) $ (0.08)
===================== ================ =================
Weighted average number of
shares outstanding:
Basic and diluted 23,122,020 79,767,085 50,788,659
===================== ================ =================
See accompanying notes to the consolidated financial statements
F-4
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STATE COMPANY)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' DEFICIT
FROM INCEPTION (SEPTEMBER 5, 1994) TO DECEMBER 31, 2003
Shares
Number Par Value Reserved Additional
of Common for Paid in
Shares Stock Conversion Capital Warrants
------------- ---------- ---------- ------------ -----------
Inception at September 5, 1994 - $ - $ - - $ -
Shares issued for cash, net of
offering costs 6,085,386 609 - 635,481 -
Warrants issued for cash - - - - 5,000
Shares issued as compensation
for services 714,500 71 - 1,428,929 -
Net loss - - - - -
------------- ---------- ---------- ------------ -----------
December 31, 1996 6,799,886 680 - 2,064,410 5,000
Issuance of stock, prior to
acquisition 206,350 21 - 371,134 -
Acquisition of subsidiary for
stock 1,503,000 150 - 46,545 -
Shares of parent redeemed, par
value $.0001 (8,509,236) (851) - 851 -
Shares of public subsidiary
issued, par value $.001 7,689,690 7,690 820 (8,510) -
Net loss - - - - -
------------- ---------- ---------- ------------ -----------
December 31, 1997 7,689,690 7,690 820 2,474,430 5,000
Conversion of parent's shares 696,022 696 (696) - -
Shares issued for cash, net of
offering costs 693,500 694 - 605,185 -
Shares issued in cancellation
of debt 525,000 525 - 524,475 -
Shares issued as compensation 400,000 400 - 349,600 -
Net loss - - - - -
------------- ---------- ---------- ------------ -----------
December 31, 1998 10,004,212 10,005 124 3,953,690 5,000
Conversion of parent's shares 13,000 13 (13) - -
Shares issued in cancellation
of debt 30,000 30 - 29,970 -
Shares issued for cash, net of
offering costs 45,000 45 - 41,367 -
Shares issued as compensation 3,569,250 3,569 - 462,113 -
Detachable warrants issued - - - - 152,125
Detachable warrants exercised 100,000 100 - 148,900 (149,000)
Debentures converted to stock 1,682,447 1,682 - 640,438 -
Net loss - - - - -
------------- ---------- ---------- ------------ -----------
December 31, 1999 15,443,909 15,444 111 5,276,478 8,125
Conversion of parent's shares 128,954 129 (111) (18) -
Shares issued for cash, net of
offering costs 1,575,192 1,575 - 858,460 -
Shares issued in cancellation
of debt 875,000 875 - 660,919 -
Shares issued in cancellation
of accounts payable 100,000 100 - 31,165 -
Shares issued as compensation 3,372,945 3,373 - 2,555,094 -
Warrants exercised 38,807 39 - 3,086 (3,125)
Warrants expired - - - 5,000 (5,000)
Net loss - - - - -
------------ --------- ---------- ------------ -----------
December 31, 2000 21,534,807 21,535 - 9,390,184 -
See accompanying notes to the consolidated financial statements.
F-5
Shares issued for cash, net of
offering cost 6,497,088 6,497 - 1,257,758 -
Shares issued as compensation 9,162,197 9,162 - 1,558,599 -
Shares issued for previously
purchased shares 342,607 342 - 188,208 -
Shares issued in cancellation
of accounts payable 200,000 200 - 68,880 -
Amortization of deferred
compensation - - - - -
Stock options issued for
services - - - 439,544 -
Net loss - - - - -
------------ ---------- ---------- ------------ -----------
December 31, 2001 37,736,699 37,736 - 12,903,173 -
Shares issued for cash, net of
offering costs 18,657,500 18,658 - 2,077,641 -
Shares issued as compensation 3,840,525 3,841 - 1,044,185 -
Shares issued for previously
purchased shares 50,000 50 - 4,950 -
Shares issued in cancellation
of accounts payable 4,265,184 4,265 - 539,291 -
Amortization of deferred
compensation - - - -
Shares issued in cancellation
of notes payable - - - - -
Stock options issued for
services - - - 225,000 -
Net loss - - - - -
------------ ---------- ---------- ------------ -----------
December 31, 2002 64,549,908 64,550 16,794,240
Shares issued for cash, net of
offering costs 17,493,664 17,493 - 2,392,296 -
Shares issued as compensation 4,062,833 4,063 - 549,779 -
Shares issued for previously
purchased shares 1,160,714 1,161 - 161,339 -
Shares issued in cancellation
of accounts payable and
accrued compensation 9,615,870 9,616 - 3,448,950 -
Shares issued in connection
with equity financing 3,125,000 3,125 (3,125) -
Exercise of stock options 7,770,892 7,771 - 1,112,077 -
Shares reacquired in settlement
of judgement (1,564,048) (1,564) - 251,812 -
Stock options issued for
services - - - 145,000 -
Net loss - - - -
------------ ---------- ---------- ------------ -----------
December 31, 2003 106,214,833 $ 106,214 $ - $24,852,369 $ -
============ ========== ========== ============ ===========
See accompanying notes to the consolidated financial statements.
F-5
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STATE COMPANY)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' DEFICIT
FROM INCEPTION (SEPTEMBER 5, 1994) TO DECEMBER 31, 2003
Stock Total
Deferred Subscriptions Treasury Accumulated Shareholders'
Compensation Receivable Shares Deficit Deficit
------------- ------------ ----------- ------------- ---------------
Inception at September 5, 1994 $ - $ - $ - $ - $ -
Shares issued for cash, net of
offering costs - - - - 636,090
Warrants issued for cash - - - - 5,000
Shares issued as compensation
for services - - - - 1,429,000
Net loss - - - (2,152,843) (2,152,843)
------------ ------------ ----------- ------------- ---------------
December 31, 1996 - - - (2,152,843) (82,753)
Issuance of stock, prior to
acquisition - - - - 371,155
Acquisition of subsidiary
for stock - - - - 46,695
Shares of parent redeemed,
par value $.0001 - - - - -
Shares of public subsidiary
issued, par value $.001 - - - - -
Net loss - - - (979,635) (979,635)
------------ ------------ ----------- ------------- ---------------
December 31, 1997 - - - (3,132,478) (644,538)
Conversion of parent's shares - - - - -
Shares issued for cash, net
of offering costs - - - - 605,879
Shares issued in cancellation
of debt - - - - 525,000
Shares issued as compensation - - - - 350,000
Net loss - - - (1,009,945) (1,009,945)
------------ ------------ ----------- ------------- ---------------
December 31, 1998 - - - (4,142,423) (173,604)
Conversion of parent's shares - - - - -
Shares issued in cancellation
of debt - - - - 30,000
Shares issued for cash, net of
offering costs - - - - 41,412
Shares issued as compensation - - - - 465,682
Detachable warrants issued - - - - 152,125
Detachable warrants exercised - - - - -
Debentures converted to stock - - - - 642,120
Net loss - - - (1,671,255) (1,671,255)
------------ ------------ ----------- ------------- ---------------
December 31, 1999 - - - (5,813,678) (513,520)
Conversion of parent's shares - - - - -
Shares issued for cash, net of
offering costs - - - - 860,035
Shares issued in cancellation
of debt - - - - 661,794
Shares issued in cancellation
of accounts payable - - - - 31,265
Shares issued as compensation (759,560) - - - 1,798,907
Warrants exercised - - - - -
Warrants expired - - - - -
Net loss - - - (3,843,308) (3,843,308)
------------ ------------ ----------- ------------- ---------------
December 31, 2000 (759,560) - - (9,656,986) (1,004,827)
See accompanying notes to the consolidated financial statements.
F-5
Shares issued for cash, net
of offering costs - - - - 1,264,255
Shares issued as compensation (230,512) - - - 1,337,249
Shares issued for previously
purchased shares - - - - 188,550
Shares issued in cancellation
of accounts payable - - - - 69,080
Amortization of deferred
compensation 495,036 - - - 495,036
Stock options issued for
services - - - - 439,544
Net loss - - - (4,079,806) (4,079,806)
----------- ------------ ----------- ------------- ---------------
December 31, 2001 (495,036) - - (13,736,792) (1,290,919)
Shares issued for cash, net
of offering costs - - - - 2,096,299
Shares issued as compensation - - - - 1,048,026
Shares issued for previously
purchased shares - - - - 5,000
Shares issued in cancellation
of accounts payable - - - - 543,556
Amortization of deferred
compensation 495,036 - - - 495,036
Shares issued in cancellation
of notes payable - - - - -
Stock options issued for
services - - - - 225,000
Net loss - - - (4,057,153) (4,057,153)
----------- ------------ ----------- ------------- ---------------
December 31, 2002 (17,793,945) (935,155)
Shares issued for cash, net of
offering costs - - - - 2,409,789
Shares issued as compensation - - - - 553,842
Shares issued for previously
purchased shares - - - - 162,500
Shares issued in cancellation
of accounts payable and
accrued compensation - - - - 3,458,566
Shares issued in connection
with equity financing - - - - -
Exercise of stock options - (1,119,848) - - -
Shares reacquired in settlement
of judgement - - (250,248) - -
Stock options issued for
services - - - - 145,000
Net loss - - - (5,520,531) (5,520,531)
----------- ------------ ----------- ------------- ---------------
December 31, 2003 $ - $(1,119,848) $ (250,248) $(23,314,476) $ 274,011
=========== ============ =========== ============= ===============
See accompanying notes to the consolidated financial statements.
F-5
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
FROM INCEPTION (SEPTEMBER 5, 1994) AND FOR THE YEARS
ENDED DECEMBER 31, 2003 AND 2002
From For the Years
Inception Ended
(September 5, 1994) December 31,
To ---------------------------------
CASH FLOWS FROM OPERATING ACTIVITIES: December 31, 2003 2003 2002
---------------------- --------------- ---------------
Net loss $ (23,314,476) $ (5,520,531) $ (4,057,153)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 129,615 23,776 25,347
Stock based compensation 9,335,069 2,859,705 1,048,026
Stock options issued for services 809,544 145,000 225,000
Amortization of deferred compensation 990,072 - 495,036
(Increase) decrease in assets:
Accounts receivable and prepaids (34,497) (18,256) 17,284
Deposits 12,941 12,941 -
Increase (decrease) in liabilities:
Deferred revenue - (250,000) -
Accounts payable and accrued expenses 2,249,124 513,524 221,440
---------------------- --------------- ---------------
NET CASH USED IN OPERATING ACTIVITIES (9,822,608) (2,233,841) (2,025,020)
---------------------- --------------- ---------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of technology (108,969) - -
Purchase of furniture and equipment (98,647) (13,902) (19,676)
Patent registration costs (211,617) (4,832) (1,700)
---------------------- --------------- ---------------
NET CASH USED IN INVESTING ACTIVITIES (419,233) (18,734) (21,376)
---------------------- --------------- ---------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from warrants 157,125 - -
Proceeds from debentures 642,120 - -
Proceeds from stock issued for cash 8,282,631 2,409,789 2,096,300
Common stock to be issued 206,050 12,500 -
Short-term loan repayments (288,422) (156,955) (131,467)
Short-term loan proceeds 1,612,922 - 135,022
---------------------- --------------- ---------------
NET CASH PROVIDED BY FINANCING ACTIVITIES 10,612,426 2,265,334 2,099,855
---------------------- --------------- ---------------
CHANGE IN CASH 370,585 12,759 53,459
CASH AT BEGINNING OF PERIOD - 357,826 304,367
---------------------- --------------- ---------------
CASH AT END OF PERIOD $ 370,585 $ 370,585 $ 357,826
====================== =============== ===============
NON-CASH FINANCING & INVESTING ACTIVITIES:
Purchase of net, non-cash assets of subsidiary
for stock $ 195 $ - $ -
====================== =============== ===============
Short-term debt retired through issuance
of stock $ 1,890,179 $ - $ 543,566
====================== =============== ===============
Issuance of common stock, previously subscribed $ - $ 162,500 $ 5,000
====================== =============== ===============
Treasury stock acquired through settlement
of judgement $ - $ 250,248 $ -
====================== =============== ===============
Stock subscriptions receivable $ - $ 1,119,848 $ -
====================== =============== ===============
Stock issued in cancellation of accounts payable
and accrued salaries $ - $ 1,815,203 $ -
====================== =============== ===============
See accompanying notes to the consolidated financial statements
F-6
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS ENDED DECEMBER 31, 2003 AND 2002
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. Samaritan Pharmaceuticals, Inc. the "Company" or "Samaritan") was formed in
September 1994 and became public in October 1997. It was named Samaritan
Pharmaceuticals in April 2001 to reflect a change in the charter and strategic
focus of its business.
Samaritan Pharmaceuticals is an emerging product-driven biopharmaceuticals
company. Samaritan is dedicated to saving lives by focusing on the development
of unique therapeutic products for Alzheimer's, Aging Related Disorders, Cancer,
Cholesterol Reduction, HIV, and Parkinson's disease. Samaritan has an emerging
pipeline, with one drug candidate Anticort completing Phase II, two Predictive
Medicine Diagnostics and several preclinical drug candidates. Samaritan's
collaboration with Georgetown University is designed to accelerate discovery and
the development of new products through the "proof of concept" phase and expand
Samaritan's intellectual property coverage for proven drug candidates.
B. Basis of Consolidation
The accompanying financial statements include the accounts of the Company and
its wholly owned subsidiary. All intercompany balances and transactions have
been eliminated in consolidation.
C. Cash Equivalents
The Company considers all highly liquid temporary cash investments with an
original maturity of three months or less to be cash equivalents.
D. Property and Equipment
Property and equipment are recorded at cost. Depreciation is provided using the
straight line method over the estimated useful lives of the assets.
E. Intangibles
1) Legal fees associated with filing patents are recorded at cost. Amortization,
once the patent is approved, will be calculated using the straight-line method,
over the estimated useful lives of the patents.
Because the patents were not approved at December 31, 2003, no amortization was
recorded for 2003 and 2002. The Company has 1 issued U.S. patent and had 11
pending patent applications in the U.S. to protect its proprietary methods and
processes. The Company also filed corresponding foreign patent applications for
certain of these U.S. patent applications. As of December 31, 2003, its patent
portfolio outside the U.S. comprised no issued patents and over 10 pending
patent applications. The issued U.S. patent and pending patent application
relate to Alzheimer's, Cancer, Cardiovascular, and HIV indications and is based
on balancing and modulating the stress hormone cortisol, counteracting
cortisol's neurodegenerative and immunosuppressive properties. Certain U.S.
patents may be eligible for patent term extensions under the Hatch-Waxman Act
may be available to Samaritan for the lost opportunity to market and sell the
invention during the regulatory review process.
F-7
The Company reviews patent costs for impairment by comparing the carrying value
of the patents with the fair value. Fair value is estimated using the present
value of expected future cash flows. The Company believes it will recover the
full amount of the patent costs based on forecasts of sales of the products
related to the patents.
2) Purchased technology rights are recorded at cost and are being amortized
using the straight line method over the estimated useful life of the technology.
Amortization was approximately $10,896 and $10,896 for the years ended December
31, 2003 and 2002. Accumulated amortization at December 31, 2003 was $67,194.
F. Earnings (loss) per share
The Company reports loss per common share in accordance with Statement of
Financial Accounting Standards ("SFAS") no. 128, "Earnings Per Share." The per
share effects of potential common shares such as warrants, options, convertible
debt and convertible preferred stock have not been included, as the effect would
be antidilutive.
G. Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenue and expenses during the reporting period. Actual
results could differ from those estimates.
H. Income Taxes
Pursuant to Statement of Financial Accounting Standards No. 109 ("SFAS 109")
"Accounting for Income Taxes", the Company accounts for income taxes under the
liability method. Under the liability method, a deferred tax asset or liability
is determined based upon the tax effect of the differences between the financial
statement and tax basis of assets and liabilities as measured by the enacted
rates, which will be in effect when these differences reverse.
I. Research and Development Costs
Research and development costs are expensed when incurred.
J. Impairment of Long-Lived Assets
The Company reviews long-lived assets and certain identifiable assets related to
those on a quarterly basis for impairment whenever circumstances and situations
change such that there is an indication that the carrying amounts may not be
recovered. At December 31, 2003, the Company does not believe that any
impairment has occurred.
K. Fair Value of Financial Instruments
Statement of Financial Accounting Standard No. 107 "Disclosures about Fair Value
of Financial Instruments" (SFAS 107) requires the disclosure of fair value
information about financial instruments whether or not recognized on the balance
sheet, for which it is practicable to estimate the value. Where quoted market
prices are not readily available, fair values are based on quoted market prices
of comparable instruments. The carrying amount of cash, accounts payable and
accrued expenses approximates fair value because of the short maturity of those
instruments.
F-8
L. Stock Based Compensation
Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based
Compensation," ("SFAS 123"), encourages, but does not require, companies to
record compensation cost for stock-based employee compensation plans at fair
value. The Company has chosen to account for stock-based compensation using the
intrinsic value method prescribed in Accounting Principles Board Opinion No. 25,
"Accounting for Stock Issued to Employees", and related Interpretations.
Accordingly, compensation cost for the Company's stock at the date of the grant
over the amount of an employee must pay to acquire the stock. The Company has
adopted the "disclosure only" alternative described in SFAS 123 and SFAS 148,
which require pro forma disclosures of net income and earnings per share as if
the fair value method of accounting had been applied.
M. New Accounting Pronouncements
In April 2003, the FASB issued Statement of Financial Accounting Standards No.
149 ("SFAS 149"), "Amendment of Statement 133 on Derivative Instruments and
Hedging Activities". This statement amends SFAS 133 to provide clarification on
the financial accounting and reporting of derivative instruments and hedging
activities and requires contracts with similar characteristics to be accounted
for on a comparable basis. The Company is in the process of assessing the effect
of SFAS 149 and does not expect the adoption of this statement, which will be
effective for contracts entered into or modified after June 30, 2003, to have a
material effect on its financial position or results of operations.
In May 2003, the FASB issued Statement of Financial Accounting Standards No. 150
("SFAS 150"), "Accounting for Certain Financial Instruments and Characteristics
of both Liabilities and Equity". SFAS 150 establishes standards on the
classification and measurement of financial instruments with characteristics of
both liabilities and equity. SFAS 150 became effective for financial instruments
entered into or modified after May 31, 2003. The adoption of SFAS 150 is not
expected to have a material effect on the Company's financial position or
results of operations.
Management does not believe that any recently issued but not yet effective
accounting pronouncements if currently adopted would have a material effect on
the accompanying financial statements.
2. PROPERTY AND EQUIPMENT
Property and equipment, at cost, consist of the following as of December 31,
2003:
Estimated Useful Life
(Years)
-----------------------
Furniture and Fixtures 5-7 $ 92,648
Software 3 6,000
Accumulated depreciation (62,421)
-------------
$ 36,227
=============
Depreciation expense for the years ended December 31, 2003 and 2002 was $12,880
and $14,451 respectively.
F-9
3. SHAREHOLDERS' DEFICIT
On June 27, 2003, the Company amended its articles of incorporation to increase
the authorized number of shares to 200 million and on April 24, 2001, a class of
5 million shares of preferred stock.
A. Stock Option Plan
The Company has a stock option plan (Samaritan Pharmaceuticals 2001 Stock Option
Plan). There were 4,925,748 options granted and 7,898,011 options remaining
pursuant to the plan as of December 31, 2003.
The following table summarizes the Company's stock options outstanding at
December 31, 2003:
Weighted average
Shares exercise price
----------- -----------------
Outstanding and exercisable
at December 31, 2001 5,418,615 $ .55
Granted 5,317,841 .20
Expired (1,742,248) (1.05)
----------- -----------------
Outstanding and exercisable
at December 31, 2002 8,994,208 .25
Granted 14,758,942 .22
Exercised (7,770,892) (.14)
Expired (20,000) (.10)
----------- -----------------
Outstanding and exercisable
at December 31, 2003 15,962,258 $ .34
=========== =================
The Company applies APB No. 25, "Accounting for Stock Issued to Employees," and
related interpretations in accounting for its stock options. As a result no
compensation expense has been recognized for employee and director stock
options. Had the Company determined compensation cost based on the fair value at
the grant date for its stock options under SFAS No. 123, "Accounting for
Stock-Based Compensation," the Company's net loss would have been reported as
follows:
December 31,
2003 2002
------------- -------------
Net Loss:
As reported $ (5,520,531) $ (4,057,153)
Pro Forma $ (7,796,531) $ (4,924,153)
Basic and diluted loss per common share:
As reported $ (0.07) $ (0.08)
Pro Forma $ (0.10) $ (0.10)
F-10
The Company utilizes the Black-Scholes option-pricing model to calculate the
fair value of each individual issuance of options with the following assumptions
used for grants during the year ended December 31, 2003 and 2002. The per-share
weighted average fair value of stock options granted during 2003 and 2002 was
$0.19 and $0.14, respectively, on the date of grant using the Black Scholes
pricing model and the following assumptions for the year ended December 31, 2003
and 2002:
2003 2002
Expected dividend yield 0% 0%
Risk-free interest rate 5.0% 5.0%
Annualized volatility 122% 150%
At December 31, 2003 the range of exercise price for all of the Company's
outstanding stock options was $.10-$1.00, with an average remaining life of five
years and an average exercise price of $.34.
C. Stock as compensation and settlement of debt
The Company issues stock as compensation for services and supplies, valuing such
issues premised upon the fair market value of the stock or the services,
whichever is more clearly determinable.
During the year ended December 31, 2002, the Company issued an aggregate of
3,840,525 shares of common stock in consideration of services rendered or to be
rendered to the Company. Such shares were valued at an aggregate of $1,048,026
ranging from $.17-$.25 per share, representing the fair value of the shares
issued. The issuances were recorded as non-cash compensation expense. During the
year ended December 31, 2002 the Company exchanged 4,265,184 shares of the
Company's common stock in settlement of accounts payable.
During the year ended December 31, 2003, the Company issued an aggregate of
937,833 shares of common stock in consideration of services rendered or to be
rendered to the Company. Such shares were valued at an aggregate of $553,842
ranging from $.16-$.71 per share, representing the fair value of the shares
issued. The issuances were recorded as non-cash compensation expense. During the
year ended December 31, 2003 the Company exchanged 12,740,870 shares of the
Company's common stock in settlement of accounts payable and accrued salaries
for officers totaling $1,152,703. To the extent that the market value of shares
issued as payment of accrued salaries exceeded the recorded amount of accrued
salaries, such amount was recognized as additional compensation. The amount of
additional compensation recorded at December 31, 2003 was $2,305,863.
The Company also issued 3,125,000 shares in connection with the common stock
purchase agreement with Fusion Capital (Note 7). Such amount was recorded at par
value with a corresponding change against Additional Paid-in Capital.
D. Private Placement
During the year 2003, through various private placements, the Company sold
17,493,664 shares for $2,409,790. During the year ended 2002, through various
private placements, the Company sold 18,657,500 shares for $2,096,299.
Subsequent to December 31, 2003, the Company received gross proceeds of
$4,817,873 under its Continuous Secondary Offering with Fusion Capital and from
Private Placements in exchange for $13,652,561 shares of the Company's common
stock.
F-11
4. INCOME TAXES
The Company has net operating losses at December 31, 2003 of approximately
$12,100,000 expiring through 2023. Utilization of these losses may be limited by
the "change of ownership" rules as set forth in section 382 of the Internal
Revenue Code.
Deferred income tax assets as of December 31, 2003 of $4,235,000 as a result of
net operating losses, have been fully offset by valuation allowances. The
valuation allowances have been established equal to the full amounts of the
deferred tax assets, as the Company is not assured that it is more likely than
not that these benefits will be realized.
A reconciliation of the statutory U.S. Federal rate (35%) and effective rates is
as follows:
Years Ended December 31,
--------------------------------------
2003 2002
--------------- --------------
Expected income tax benefit at
Federal statutory rate $ 1,932,000 $ 1,420,000
Permanent differences (1,052,000) (619,000)
Benefit not recognized (880,000) (801,000)
--------------- --------------
$ -0- $ -0-
=============== ==============
5. COMMITMENTS AND CONTINGENCIES
A. The Company leases various facilities under operating lease agreements
expiring through April 2005. Rental expense for the years ended December 31,
2003 and 2002 was $40,006 and $38,769, respectively. Future minimum annual lease
payments under the facilities lease agreements for agreements lasting more than
one year are as follows:
2004 $33,040
2005 $11,120
B. On March 8, 2001 the Company signed a seven year research collaboration and
licensing agreement with Georgetown University ("Georgetown"), which terminates
on June 30, 2013. As consideration for Georgetown's performance under this
Agreement the Company shall pay Georgetown $1,000,000 per year in quarterly
installments commencing with the quarter ended March 31, 2004. As of December
31, 2003 the Company has incurred costs of $1,640,322 which has been recorded as
research and development expense in the Company's financial statements.
C. The Company has entered into employment agreements with two officers. These
agreements started January 1, 2001 and are for five years with annual
compensation for both at $780,000, with an annual increase not less than 5% per
year. Each officer at their option can receive payment in Company common stock
calculated at the lowest closing price of the stock quoted for the period for
which the salary has been earned, divided by the current discount rate for
restricted stock offered by the Company.
Each officer is entitled to a bonus payable in ten year warrants based on a
calculation of the Company's market capitalization. In addition each officer is
guaranteed annual incentive stock options of the greater of $250,000 or a
percentage of the issued and outstanding shares on the anniversary date of the
agreement. The percentage ranges from 1% to 4%. Such options vest 25% each
quarter and are priced at the lowest closing price of the Company's common stock
in the quarter preceding the grant. The options terminate after ten years.
F-12
6. LITIGATION
Samaritan, from time to time, is involved in various legal proceedings in the
ordinary course of its business.
7. FUSION TRANSACTION
On April 22, 2003, Samaritan entered into a common stock purchase agreement with
Fusion Capital Fund II, LLC pursuant to which Fusion Capital agreed to purchase
on each trading day during the term of the agreement, $20,000 of our common
stock or an aggregate of $10.0 million. The $10.0 million of common stock is to
be purchased over a 25-month period, subject to a 6-month extension or earlier
termination at the Company's discretion. The purchase price of the shares of
common stock will be equal to a price based upon the future market price of the
common stock without any fixed discount to the market price. Fusion Capital does
not have the right or the obligation to purchase shares of the Company's common
stock in the event that the price of the Company's common stock is less than
$0.10.
Samaritan has authorized the sale and issuance of 18,125,000 shares of the
company's common stock to Fusion Capital under the common stock purchase
agreement. Samaritan estimates that the maximum number of shares Samaritan will
sell to Fusion Capital under the common stock purchase agreement will be
15,000,000 shares (exclusive of the 3,125,000 shares issued to Fusion Capital as
the commitment fee) assuming Fusion Capital purchases all $10.0 million of
common stock.
Fusion Capital may not purchase shares of the Company's common stock under the
common stock purchase agreement if Fusion Capital, together with its affiliates,
would beneficially own more than 9.9% of the Company's common stock outstanding
at the time of the purchase by Fusion Capital. However, even though Fusion
Capital may not receive additional shares of the Company's common stock in the
event that the 9.9% limitation is ever reached, Fusion Capital is still
obligated to pay to the Company $20,000 on each trading day, unless the common
stock purchase agreement is suspended, an event of default occurs or the
agreement is terminated. Absent these circumstances, Fusion Capital would have
the right to acquire additional shares in the future should its ownership
subsequently become less than the 9.9%. Fusion Capital has the right at any time
to sell any shares purchased under the common stock purchase agreement that
would allow it to avoid the 9.9% limitation. Therefore, Samaritan does not
believe that Fusion Capital will ever reach the 9.9% limitation.
Fusion Capital may terminate the common stock purchase agreement without any
liability or payment to the Company if:
- the registration statement is no longer effective,
- the trading of the Company's common stock is suspended for three
consecutive days or is de-listed from its principal market,
- the Company's transfer agent fails to deliver stock that Fusion
entitled to for five trading days,
- the Company's material breach of the common stock purchase agreement,
- the Company's default on the payment of $1.0 million or more, or
- upon the filing of a bankruptcy or insolvency proceeding.
F-13
8. RISKS AND UNCERTAINTIES
Marketability of the product is dependent, among other things, upon securing
additional capital to successfully complete the clinical testing of the product,
securing FDA approval, and procurement of viable patents.
9. SUBSEQUENT EVENT
Subsequent to December 31, 2003, the Company received gross proceeds of
$4,817,873 under its Continuous Secondary Offering with Fusion Capital and from
Private Placements in exchange for $13,652,561 shares of the Company's common
stock. As of April 13, 2004, the Company had a cash and cash equivalents balance
of $4,371,085.
F-14
Item 8. Changes In and Disagreements with Accountants on Accounting and
Financial Disclosures.
The Company had a change in registrant's certifying accountant filed as an 8-K,
on September 27, 2002 and incorporated herein by reference.
Item 8A. Control and Procedures.
Based on their evaluation, as of a date within 90 days of the filing date of
this Form 10-K, the Company's Chief Executive Officer and Chief Financial
Officer have concluded that the Company's disclosure controls and procedures (as
defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of
1934, as amended) are effective. There have been no significant changes in
internal controls or in other factors that could significantly affect these
controls subsequent to the date of their evaluation, including any corrective
actions with regard to significant deficiencies and material weaknesses.
Part III
Item 9 to 12 Inclusive.
These items have been omitted in accordance with the general instructions to
Form 10-KSB. Prior to April 29, 2004, we will file a definitive proxy statement
that will involve the election of directors. The information required by these
items will be included in said proxy statement and are incorporated by reference
in this annual report.
Item 13. Exhibits and Reports on Form 8-K.
(a) Reports on Form 8-K. None.
(b) Exhibits
Listed below are all exhibits filed as part of this report. Some exhibits are
filed by the Registrant with the Securities and Exchange Commission pursuant to
Rule 12b-32 under the Securities Exchange Act of 1934, as amended.
Exhibits
No. Description
----------------------------------------------------------------------
2.1.....Agreement and Plan of Reorganization (1)
3.1.....Articles of Incorporation, as amended and restated (6)
3.2.....By-laws (3)
4.1.....Form of common stock certificate (1)
19
4.2.....2001 Stock Option Plan (4)
10.1....Assignment between Linda Johnson and the Company dated September 6,
2000. (5)
10.2....Assignment between Linda Johnson and Spectrum Pharmaceuticals
Corporation dated May 14, 1999. (5)
10.3....Agreement containing the assignment of U.S. Patent Application
07/233,247 with improvements dated May 22, 1990. (5)
10.4....Common Stock Purchase Agreement between Company and Fusion Capital
Fund II, LLC, dated April 22, 2003 (2)
10.5....Registration Rights Agreement between Company and Fusion Capital Fund
II, LLC dated April 22, 2003. (2)
10.6 ...Agreement between Samaritan Pharmaceuticals, Inc. and Doug Bessert (5)
10.7....Agreement between Samaritan Pharmaceuticals, Inc. and Eugene Boyle (5)
10.8....Agreement between Samaritan Pharmaceuticals, Inc and Janet Greeson (5)
10.9....Research Collaboration and Licensing Agreement between Georgetown
University and Samaritan Pharmaceuticals, Inc., dated June 8, 2001 (6)
10.9....Research Collaboration and Licensing Agreement between Georgetown
University and Samaritan Pharmaceuticals, Inc., dated June 8, 2001 (6)
14.1....Code of Ethics (8)
16.1....Letter on change in certifying accountant (7)
21.1....List of Subsidiaries (1)
31.1....Certification of Chief Executive Officer
31.2....Certification of Chief Financial Officer
32.1....Certification re: Section 906
------------------------------------------
(1).....Filed as an exhibit to Samaritan Pharmaceutical's Form 10-SB, filed on
July 21, 1999, and incorporated herein by reference. (2)......Filed as
an exhibit to Samaritan Pharmaceutical's Report on Form 8-K filed on
April 25, 2003, and incorporated herein by reference.
(3).....Filed as an exhibit to Samaritan Pharmaceutical's Annual Report on Form
10K- SB, filed on April 3, 2001, and incorporated herein by reference.
(4).....Filed as an exhibit to Samaritan Pharmaceutical's Schedule 14A filed on
April 3, 2001, and incorporated herein by reference (5)......Filed as
an exhibit to Samaritan Pharmaceutical's Quarterly Report on Form
10-QSB filed on August 14, 2002, and incorporated herein by reference.
(6).....Filed as an exhibit to Samaritan Pharmaceutical's Registration
Statement on Form SB-2 (SEC file number 333-105818) an incorporated
herein by reference.
(7).....Filed as an exhibit to Form 8-K, on September 27, 2002 and incorporated
herein by reference.
(8).....Filed as an exhibit to Form 10-KSB on April 15, 2003 and incorporated
herein by reference.
Item 14. Principal Accountant Fees and Services.
Audit Fees - The aggregate fees billed for each of the last two fiscal years for
professional services rendered by the principal accountant for the audit of the
registrant's annual financial statements and review of financial statements
included in the review of financial statements included in the registrant's Form
10-QSB or services that are normally provided by the accountant in connection
with statutory and regulatory filings or engagement were $27,000 plus out of
pocket cost for each year.
Audit-Related Fees. The aggregate fees billed in each of the last two fiscal
years for assurance and related services by the principal accountant that are
reasonably related to the performance of the audit or review of the Company's
financial statements and not reported under the caption "Audit Fee".
Tax Fees. No fees were billed in each of the last two fiscal years for
professional services rendered by the principal accountant for tax compliance,
tax advice and tax planning services. All Other Fees. Other than the services
described above, the aggregate fees billed for services rendered by the
principal accountant was $0 and $0, respectively, for the fiscal years ended
December 31,2003 and 2002. These fees related to the review of the Company's
Registration Statement.
Audit Committee Policies and Procedures. The Audit Committee must pre-approve
all auditing services and permitted non-audit services (including the fees and
terms thereof) to be performed for Samaritan by its independent auditors,
subject to the de minimus exceptions for non-audit services described in Section
10A(i)(1)(B) of the Securities Exchange Act of 1934, which should be nonetheless
be approved by the Audit Committee prior to the completion of the audit. Each
year the independent auditor's retention to audit our financial statements,
including the associated fee, is approved by the committee before the filing of
the previous year's annual report on Form 10-KSB. At the beginning of the fiscal
year, the Audit Committee will evaluate other known potential engagements of the
independent auditor, including the scope of work proposed to be performed and
proposed fees, and approve or reject each service, taking into account whether
the services are permissible under applicable law and the possible impact of
each non-audit service on the independent auditor's independence from
management. At each such subsequent meeting, the auditor and management may
present subsequent services for approval. Typically, these would be services
such as due diligence for an acquisition, that would not have been known at the
beginning of the year.
Since May 6, 2003, the effective date of the Securities and Exchange Commission
rules stating that an auditor is not independent of an audit client if the
services it provides to the cline are not appropriately approved, each new
engagement of Sherb & Co., LLP, had been approved in advance by the Board of
Directors, and none of those engagements made use of the de minimus exception to
the pre-approval contained in Section 10A(i)(1)(B) for the Securities Exchange
Act of 1934.
20
SIGNATURES
In accordance with Section 13 OR 15 (d) of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
SAMARITAN PHARMACEUTICAL, INC
Dated: March 31, 2004 By: /s/ Janet Greeson, Ph.D.
------------------------
Janet Greeson, Ph.D.
President, Chief Executive Officer,
Chairman
Dated: March 31, 2004 By: /s/ Eugene Boyle
----------------
Eugene Boyle,
Chief Financial Officer, Director
Dated: March 31, 2004 By: /s/ Doug Bessert
----------------
Doug Bessert
Director
Dated: March 31, 2004 By: /s/ Vassilios Papadopoulos, Ph.D.
---------------------------------
Vassilios Papadopoulos, Ph.D.
Chief Scientific Officer, Director
Dated: March31, 2004 By: /s/ H. Thomas Winn
------------------
H. Thomas Winn
Director