As filed with the Securities and Exchange Commission on July 30, 2002
Registration No. 333-31310
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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AMENDMENT NO. 5
TO
FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Nymox Pharmaceutical Corporation
(Exact name of registrant as specified in charter)
Quebec, Canada 8071 Not Applicable
(State or other jurisdiction (Primary Standard (I.R.S. Employer
of incorporation Industrial Classification Identification No.)
or organization) Code Number)
9900 Cavendish Blvd., Suite 306
St. Laurent, QC, Canada H4M 2V2
(514) 332-3222
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
CT Corporation System
111 Eighth Avenue, 13th Floor
New York, New York 10011
(212) 590-9200
(Name, address, including zip code, and
telephone number, including area code, of agent for service)
------------------------------------------------------------
Copies to:
Marc J. Marotta Jack Gemmell
Foley & Lardner Nymox Pharmaceutical Corporation
777 East Wisconsin Avenue 9900 Cavendish Blvd., Suite 306
Milwaukee, Wisconsin 53202-367 St.-Laurent, QC, Canada H4M 2V2
(414) 271-2400 (514) 332-3222
Approximate date of commencement of proposed sale to public: As soon as
practicable after registration statement becomes effective.
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, check the following box. |X|
CALCULATION OF REGISTRATION FEE
All financial information in this prospectus is in United States
dollars unless otherwise noted.
=============================== ======================= ==================== ====================== ==================
Proposed maximum Proposed maximum Amount of
Title of each class of Amount to be aggregate price aggregate offering registration
Securities to be registered registered per unit price fee(5)
------------------------------- ----------------------- -------------------- ---------------------- ------------------
Common shares Up to 4,800,000(1) (2) $12,000,000(3) $3,168
------------------------------- ----------------------- -------------------- ---------------------- ------------------
Common shares(4) Up to 200,000 $4.52 $904,000 $238.66
------------------------------- ----------------------- -------------------- ---------------------- ------------------
Total Up to 5,000,000 $12,904,000 $3,406.66
=============================== ======================= ==================== ====================== ==================
(1) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457 under the Securities Act of 1933.
(2) The price per common share will vary based on the average daily price of
Nymox's shares during the draw down periods provided for in the common
stock purchase agreement described in this registration statement. The
purchase price will be equal to 94% of the average daily price for each
trading day within such draw down pricing periods. Under the common stock
purchase agreement, Nymox may establish a minimum price for each draw down
period. Jaspas Investments Limited (Jaspas) will not be able to purchase
Nymox shares on those trading days within a draw down period where the
average daily price is below the minimum price for that period. The
agreement allows for 24 draws over a period of 30 months for amounts up to
$750,000 per draw.
(3) $12,000,000 represents the maximum total purchase price that Jaspas is
obliged to pay Nymox under the common stock purchase agreement; the maximum
net proceeds Nymox can receive is $12,000,000 less a 3% placement fee
payable to its placement agents, Ladenburg Thalman & Co. Ltd. And Paul
Revere Capital Corp., or $11,640,000.
(4) These common shares represent the shares issuable on the exercise of a
stock purchase warrant issued by Nymox to Jaspas on November 12, 1999 under
the common stock purchase agreement. Under the warrant, Jaspas may purchase
up to 100,000 shares any time between November 30, 1999 and November 30,
2004. Jaspas may purchase the remaining 100,000 shares if and only if Nymox
does not draw down $7,000,000 within eighteen months of this registration
statement becoming effective.
(5) This registration fee was previously paid by the Registrant in connection
with the initial filing of this Registration Statement.
--------------------
The Registrant hereby amends this registration statement on such date or dates
as may be necessary to delay its effective date until the Registrant shall file
a further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the registration statement shall become
effective on such date as the Securities and Exchange Commission ("Commission"),
acting pursuant to Section 8(a) may determine.
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[LOGO]
PROSPECTUS
NYMOX PHARMACEUTICAL CORPORATION
5,000,000 SHARES OF COMMON STOCK
NYMOX PHARMACEUTICAL CORPORATION Jaspas Investments Limited may use this
prospectus to resell up to 5,000,000
shares of common stock of Nymox
Pharmaceutical Corporation.
9900 Cavendish Blvd Nymox will not receive any of the
Suite 306 proceeds from the sale of the shares by
St. Laurent, Quebec, Canada Jaspas. However, we will receive the
H4M 2V2 sale price of any common stock that we
(800) 936-9669 sell to Jaspas under the common stock
purchase agreement or under the stock
purchase warrant described in this
prospectus. Nymox will pay the costs of
registering the shares under this
prospectus, including legal fees.
Nymox's common stock is listed Jaspas may offer shares of common stock
on the Nasdaq SmallCap Market of Nymox to purchasers in transactions
under the symbol "NYMX". The last on the Nasdaq SmallCap Market, in
reported sales price for Nymox's negotiated transactions, or otherwise,
common stock on the Nasdaq or by a combination of these methods.
SmallCap Market on _______, Jaspas may sell the shares through
2002 was $_____ per share. broker-dealers who may receive
compensation from Jaspas in the form of
discounts or commissions. Jaspas does
not intend to effect resales in Canada
or through any Canadian exchange. Jaspas
is an "underwriter" within the meaning
of the Securities Act of 1933 in
connection with such sales.
Investing in the common stock of Nymox involves a high degree of risk. See
"Risk Factors" beginning on Page 6.
Neither the Securities and Exchange Commission or any state securities
commission has approved or disapproved of these securities, or determined if
this Prospectus is truthful or accurate. Any representation to the contrary is a
criminal offense.
The date of this prospectus is _______, 2002.
-3-
SUMMARY
In this prospectus, the term "Nymox" refers to both Nymox Pharmaceutical
Corporation and its subsidiaries, Nymox Corporation and Serex, Inc. and, where
applicable, a predecessor private corporation, DMS Pharmaceutical Inc. This
prospectus provides financial information in United States dollars unless
otherwise noted.
The Company
Nymox is a development stage biopharmaceutical company based in Maywood,
New Jersey and Saint Laurent, Quebec, Canada. Nymox was incorporated in May,
1995 to acquire all of the common shares of DMS Pharmaceutical Inc., a private
company which, since 1989, conducted research and development on diagnostics and
drugs for brain disorders and diseases of the aged with an emphasis on
Alzheimer's disease.
We specialize in the research and development of therapeutics and
diagnostics for the aging population with an emphasis on Alzheimer's disease.
Alzheimer's disease is a progressive, terminal brain disease of the elderly
marked by an irreversible decline in mental abilities, including memory and
comprehension, and often accompanied by changes in behavior and personality. It
currently afflicts an estimated four million people in the United States and at
least fifteen million people worldwide. As the baby-boomer generation continues
to age, these figures are expected to rise sharply.
AlzheimAlert(TM), an Aid for the Diagnosis of Alzheimer's Disease
We market a proprietary diagnostic test for Alzheimer's disease, known as
AlzheimAlert(TM), through our clinical reference laboratory in Maywood, New
Jersey. AlzheimAlert(TM) is an improved version of our AD7C(TM) test, which has
been on the market since 1997. It measures the level in urine of a brain protein
called neural thread protein which is elevated early in Alzheimer's disease. The
test helps physicians make an early diagnosis of the disease.
The early diagnosis of Alzheimer's disease is important to physicians,
patients and their families. It enables them to make informed and early social,
legal and medical decisions about treatment and care. It permits patients to
take advantage of new improvements in drug treatment and care. Even a modest
delay in institutionalization can mean substantial social and financial savings.
There is a widely recognized need for a simple, accurate and convenient
test that can help physicians diagnose Alzheimer's disease. Chapter 5 of the
Surgeon General's Report on Mental Health is indicative of this recognition. In
this Report, the Surgeon General described the diagnosis of Alzheimer's disease
as "challenging" and its early detection as "difficult." As a result,
Alzheimer's disease and other dementias, the Surgeon General's report states,
are "currently underrecognized, especially in primary care settings, where most
older patients seek care."
AlzheimAlert(TM) is one of a variety of diagnostic testing methodologies,
technologies and products that have been recently developed to aid physicians in
the diagnosis of Alzheimer's disease. It is the only commercially available
urine test for this purpose and tests for a unique, proprietary marker, neural
thread protein.
Two Principal Programs to Develop Treatments for Alzheimer's Disease
We have two principal programs to develop treatments of Alzheimer's
disease. The first program targets neural thread protein, the brain protein
detected by AlzheimAlert(TM), and its role in the extensive brain cell loss
associated with Alzheimer's disease. The second program is based on spherons.
Nymox researchers believe spherons are a source of senile plaques, the
characteristic abnormality found in abundance in the brains of patients with
Alzheimer's disease and widely believed to play a major role in the cause and
course of the illness.
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These programs are in the early development stage. We cannot assure you
that these programs will produce effective and marketable treatments for
Alzheimer's disease. The research may fail or the compounds may not receive
necessary regulatory approval. As a development stage company, we may partner
with a major pharmaceutical company in the conduct of necessary human clinical
trials, to finish product development, to obtain regulatory approval, and
ultimately to market any product. There is no guarantee we will be able to enter
into such an arrangement on satisfactory terms.
Neural Thread Protein Based Drugs
There is a body of scientific and medical evidence showing that neural
thread protein, the brain protein detected by our AlzheimAlert(TM) test, may
play a key role in Alzheimer's disease. We are developing compounds that can
impede the effects of neural thread protein and thus potentially slow or halt
the progression of Alzheimer's disease. We licensed the basic technology to
develop such compounds including patent rights in 1997 from the Massachusetts
General Hospital as part of a sponsored research and licensing agreement and
have a similar licensing arrangement with the Rhode Island Hospital.
Drugs Targeting Spherons
We are a world leader in research and development into drugs for the
treatment of Alzheimer's disease that target spherons. Spherons are tiny balls
of densely packed protein found in brain cells scattered throughout the brains
of all humans from age one. They were first discovered, characterized and
isolated by Nymox researchers. We believe that spherons are a cause of senile
plaques and that stopping or inhibiting the transformation of spherons into
senile plaques will help stop or slow the progression of Alzheimer's disease.
You should be aware that there is no consensus among researchers about the
causes or possible treatments of Alzheimer's disease and not all researchers
share this belief that spherons are a causative factor in Alzheimer's disease or
are a target for the development of treatments for the disease.
We developed and patented novel, proprietary drug screening methods based
on spherons and now have several drug candidates which have shown promise in
animal and other preclinical studies and for which we plan to seek regulatory
approval to being clinical studies for humans. We hold global patent rights
covering both methods for using spherons as targets for developing drugs and for
the actual drug candidates discovered.
New Antibacterial Agents Against Infections and Food Contamination
We are developing new antibacterial agents. One agent has proven effective
against the E. coli 0157:H7 bacteria, which can cause serious contamination in
meat and other food and drink products. We are developing treatments for E. coli
0157:H7 contamination of meat. We also have a series of collaboration agreements
with universities and research institutions and a biotechnology company,
Biophage Inc. We have also developed other new antibacterial agents that can
potentially treat human disease such as difficult chronic and persistent urinary
tract infections and streptococcal or staphylococcal infections. We hold patents
rights in this area in the United States and Australia and are pursuing further
patent rights both in the United States and in other countries.
The NicAlert(TM) and NicoMeter(TM) Tests for Tobacco Product Use
We also market NicAlert(TM) and NicoMeter(TM), inexpensive, simple-to-use
test strips that use urine or saliva (NicAlert(TM) only) to determine whether a
person is using tobacco products. NicAlert(TM) and NicoMeter(TM) detect levels
of cotinine, a byproduct of the body's breakdown of nicotine and generally
regarded as the best indicator of tobacco exposure for smokers and nonsmokers.
Our subsidiary, Serex, Inc., manufactures NicAlert(TM) and NicoMeter(TM).
NicAlert(TM) and NicoMeter(TM) are currently being used in research programs
into tobacco use and exposure and are being marketed in the United States and
Japan as tests to determine whether a person, such as a teenager, student
athlete or insurance applicant, is using a tobacco product. NicAlert(TM) and
NicoMeter(TM) employ Serex, Inc.'s patented technology.
-5-
RISK FACTORS
An investment in shares of common stock of Nymox involves a high degree of
risk. You should carefully consider each of the risks and uncertainties
described below along with all of the other information in this prospectus
before deciding to invest in these shares.
It is Uncertain When, if Ever, We Will Make a Profit
We first began operations in 1995 and are only in the early stages of
commercial marketing of our products, AlzheimAlert(TM), NicAlert(TM) and
Nicometer(TM). We have never made a profit. We incurred a net loss of $4.8
million in 1998, $3.3 million in 1999, $4.0 million in 2000, and $3.0 million in
2001. As of December 31, 2001, Nymox's accumulated deficit was $23.2 million.
We cannot say when, if ever, Nymox will become profitable. Profitability
will depend on our uncertain ability to generate revenues from the sale of our
products and the licensing of our technology that will offset the significant
expenditures required for us to advance our research, protect and extend our
intellectual property and develop, manufacture, license, market, distribute and
sell our technology and products successfully. Similar types of expenditures in
the past have helped produce the net losses reported above.
We May Not Be Able to Raise Enough Capital to Develop and Market Our Products
Nymox has funded its operations primarily by selling shares of its common
stock. Since late 1998, a small portion of the funds came from sales. However,
sales have not been, and may not be in the foreseeable future, sufficient to
meet our anticipated financial requirements.
We will continue to need to raise substantial amounts of capital for our
business activities including our research and development programs, the conduct
of clinical trials needed to obtain regulatory approvals and the marketing and
sales of our products. We anticipate being able to fund our current total annual
budgeted expenditures of approximately $3 million per year through our current
cash position and additional financing including draw downs through our Common
Stock Purchase Agreement. Clinical trials will substantially increase cash
requirements. We anticipate being able to meet those requirements as they arise.
Any necessary clinical trials for regulatory approval following successful
initial clinical trials will require considerably more capital. We plan to raise
such capital either through a new round of financing and/or through partnering
with a major pharmaceutical company. Additional financing may not be available
when needed, or, if available, may not be available on acceptable terms. If
adequate funds on acceptable terms are not available, we may have to curtail or
eliminate expenditures for research and development, testing, clinical trials,
promotion and marketing for some or all of our products.
We Face Challenges in Developing and Improving Our Products
Our success depends on our ability to develop or acquire rights to new
products or to improve our existing products. We are still developing many of
our products and have not yet brought them to market. We cannot assure you that
we will be able to develop or acquire rights to such products and to market them
successfully.
Developing a treatment for Alzheimer's disease is particularly challenging.
Many pharmaceutical companies, institutions and researchers are working on many
different approaches and treatments. There is no consensus among researchers
about the cause of this fatal illness and no guarantee that our drug development
programs in this area are targeting significant factors in its cause,
progression or symptoms. It is difficult to design drug candidates that can
cross from the bloodstream into the brain, where the damage from Alzheimer's
disease is occurring. Clinical trials to establish efficacy for drugs that slow
down the progression of Alzheimer's disease over a period of months or years
often require that a large number of subjects be tracked over many months or
years, making them very expensive to conduct. The potentially long period from
discovery and patenting through development and regulatory approval to the
market can significantly reduce
-6-
the patent life of an Alzheimer's disease treatment. Any marketed treatment in
this area may well eventually face competition from "me-too" drugs developed by
other pharmaceutical companies based on our research. We will be under constant
competitive pressure to improve our products and to develop new treatments in
order to protect our position in the field.
Developing and improving our diagnostic products is also challenging. The
science and technology of the detection and measurement of very small amounts of
biochemicals in bodily fluids and tissue is evolving rapidly. We may need to
make significant expenditures in research and development costs and licensing
fees in order to take advantage of new technologies. If any major changes to our
testing technologies used in our AlzheimAlert(TM), NicAlert(TM) and
NicoMeter(TM) tests are made, further validation studies will be required.
Developing new diagnostic products is more challenging, requiring identification
and validation of the biochemical marker being detected by the new product in
the clinical context and the development and validation of the product designed
to detect the marker.
We Face Significant and Growing Competition
The modern pharmaceutical and biotechnology industries are intensely
competitive, particularly in the field of Alzheimer's disease where there is a
large unmet need for an effective treatment. Currently there are four drugs with
the same mechanism of action approved for sale in the United States (Aricept(R),
Cognex(R), Exelon(R) and Reminyl(R)). These drugs offer some relatively
short-term symptomatic relief, but do not treat the underlying causes of the
illness. Over the past decade, there has been an intense research effort both in
the non-profit sectors such as universities, government agencies and research
institutes and in the pharmaceutical and biotechnology industry to develop new
treatments for Alzheimer's disease. Treatment candidates under development
include:
o vaccines for Alzheimer's disease;
o enzyme-blocking therapies intended to block the production of the
protein found in the senile plaques characteristic of Alzheimer's
disease. A number of pharmaceutical and biotechnology companies
including Amgen and Bristol-Myers Squibb are working on such therapies
and hope to soon be in clinical trials on humans.
o implantation of genetically modified cells that produce human nerve
growth factor into the brains of people with Alzheimer's disease.
Preliminary human testing began this year at the University of
California at San Diego in conjunction with the Salk Institute for
Biological Studies.
There is also ongoing research into possible methods of preventing
Alzheimer's disease such as taking certain cholesterol-lowering drugs called
statins, estrogen replacement therapies, anti-oxidants such as vitamin E and
ginkgo biloba or anti-inflammatory drugs such as ibuprofen (e.g., Advil or
Motrin). The successful development of a treatment or method of preventing
Alzheimer's disease could significantly impact on our ability to develop or
market a competing treatment for Alzheimer's disease.
The diagnostic testing industry is also highly competitive. In the area of
Alzheimer's disease, Elan PLC is marketing diagnostic tests for different
biochemical indicators found in blood and spinal fluid and for genetic
predispositions for the illness. Other companies are attempting to develop and
market other diagnostic products in this area. The introduction of other
diagnostics products for Alzheimer's disease or tobacco product use that are
cheaper, easier to perform, more accurate or otherwise more attractive to the
physicians, health care payers or other potential customers would have a
significant impact on the sales of our AlzheimAlert(TM), NicAlert(TM) or
NicoMeter(TM) products.
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We May Not Be Able to Successfully Market Our Products
To increase our marketing, distribution and sales capabilities both in the
United States and around the world, we will need to enter into licensing
arrangements, contract sales agreements and co-marketing deals. We cannot assure
you that we will be able to enter into agreements with other companies on terms
acceptable to us, that any licensing arrangement will generate any revenue for
the company or that the costs of engaging and retaining the services of a
contract sales organization will not exceed the revenues generated.
Our Products and Services May Not Receive Necessary Regulatory Approvals
Our products, AlzheimAlert(TM), NicAlert(TM) and NicoMeter(TM), and our
products in development, are subject to a wide range of government regulation
governing laboratory standards, product safety and efficacy. The actual
regulatory schemes in place vary from country to country and regulatory
compliance can take several years and involve substantial expenditures.
We cannot be sure that we can obtain necessary regulatory approvals on a
timely basis, if at all, for our products in development and all of the
following could have a material adverse effect on our business:
o failure to obtain or significant delays in obtaining requisite
approvals;
o loss of or changes to previously obtained approvals; and
o failure to comply with existing or future regulatory requirements.
We currently market AlzheimAlert(TM) as a clinical reference laboratory
service provided by our government-inspected clinical reference laboratory in
New Jersey. Physicians send us urine samples from their patients to our
laboratory where the AlzheimAlert(TM) test is performed and the results reported
back to the physicians. A clinical laboratory test like AlzheimAlert(TM) does
not require approval from the United States Food and Drug Administration (FDA).
Our laboratory is regulated by the Centers for Medicare & Medicaid Services
(CMS) under the Clinical Laboratory Improvement Amendments and is subject to
inspection and certification. In addition, individual states like New York and
Florida have their own requirements for reference laboratories like ours that
offer diagnostic services. In addition, the FDA has its own regulations
governing in vitro diagnostic products, including some of the reagents used in
clinical reference laboratories. Any changes in CMS or state law requirements or
in the FDA regulations could have a detrimental impact on our ability to offer
or market any reference laboratory services and/or on our ability to obtain
reimbursement from the Medicare and Medicaid programs and providers.
We may develop a diagnostic kit based on AlzheimAlert(TM) for sale to third
parties. If so, we will require prior approval from the FDA before we can
market, distribute or sell such a product in the United States. We have not
submitted any such product to the FDA for approval. Similar requirements exist
in many other countries. In general, such approval requires clinical testing as
to the safety and efficacy of the device and preparation of an approval
application with extensive supporting documentation. If approved, the device
would then be subject to postmarketing record and reporting obligations and
manufacturing requirements. Obtaining these approvals and complying with the
subsequent regulatory requirements can be both time-consuming and expensive.
We currently sell NicAlert(TM) and NicoMeter(TM) as tests for tobacco
product use and for research use. In May 2002, we filed a 510(k) application
with the FDA for NicAlert(TM) and have not received any decision on the
application.
In the United States, our drugs in development will require FDA approval,
which comes only at the end of a lengthy, expensive and often arduous process.
We have not submitted any drugs for FDA approval. We cannot predict with any
certainty the amount of time the FDA will take to approve one of our drugs or
even whether any such approval will be forthcoming. Similar requirements exist
in many other countries.
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Protecting Our Patents and Proprietary Information is Costly and Difficult
We believe that patent and trade secret protection is important to our
business, and that our success will depend, in part, on our ability to obtain
strong patents, to maintain trade secret protection and to operate without
infringing the proprietary rights of others.
Obtaining and maintaining our patent position is costly. We pay for the
filing, prosecution and fees of over 200 patents and patent applications in
countries around the world, including the United States, Europe, Japan, Canada,
Australia, New Zealand and South Korea. In the United States alone, Nymox has
ten patents issued or allowed and at least fifteen patent applications pending
relating to its technology. Its subsidiary, Serex Inc. has seven patents issued
or allowed. Through its licensing agreement with the Massachusetts General
Hospital, Nymox has licensed and paid for the prosecution of four issued patents
relating to neural thread proteins.
We believe that we have strong patent protection for the products we sell
and for our product development programs and are in the process of extending
that patent protection to cover more countries or new discoveries or products.
We cannot assure you that additional patents covering new products or
improvements will be issued or that any new or existing patents will be of
commercial benefit or be valid and enforceable if challenged.
We are not currently involved in patent litigation. In the pharmaceutical
and biotechnology industry patent disputes are frequent and can preclude the
commercialization of products. Patent litigation is costly and the outcome often
difficult to predict. It can expose us to significant liabilities to third
parties and may require us to obtain third-party licenses at a material cost or
cease using the technology or product in dispute.
We Face Changing Market Conditions
The healthcare industry is in transition with a number of changes that
affect the market for therapeutic and diagnostic test products. The U.S. Federal
and various state governments have under consideration a number of proposals
that may have the effect of directly or indirectly limiting drug prices in the
U.S. markets. Such changes may adversely affect the prices we may charge for any
therapeutic drug we develop. Funding changes and budgetary considerations can
lead major health care payers and providers to make changes in reimbursement
policies for our AlzheimAlert(TM) product. These changes can seriously impact
the potential for growth for the market for AlzheimAlert(TM), either favorably
when the decision is to offer broad coverage for our test at a reasonable price
or negatively when the decision is to deny coverage altogether. Changes in the
healthcare delivery system have resulted in major consolidation among reference
laboratories and in the formation of multi-hospital alliances, reducing the
number of institutional customers for therapeutic and diagnostic test products.
There can be no assurance that Nymox will be able to enter into and/or sustain
contractual or other marketing or distribution arrangements on a satisfactory
commercial basis with these institutional customers.
Health Care Plans May Not Cover or Adequately Pay for our Products and Services
Throughout the developed world, both public and private health care plans
are under considerable financial and political pressure to contain their costs.
The two principal methods of restricting expenditures on drugs and diagnostic
products and services are to deny coverage or, if coverage is granted, to limit
reimbursement. For single-payer government health care systems, a decision to
deny coverage or to severely restrict reimbursement for one of our products can
have an adverse effect on our business and revenues.
In the United States, where, to a significant degree, the patient
population for our products is elderly, Medicare and Medicaid are sources of
reimbursement. In general, any restriction on reimbursement, coverage or
eligibility under either program could adversely affect reimbursement to Nymox
for products and services provided to beneficiaries of the Medicare and/or
Medicaid programs. Many elderly people are covered by a variety of private
health care organizations either operating private health care plans or Medicare
or Medicaid programs
-9-
subject to government regulation. These organizations are also under
considerable financial constraints and we may not be able to secure coverage or
adequate reimbursement from these organizations. Without coverage, we will have
to look to the patients themselves who may be unwilling or unable to pay for the
product; in turn, doctors may be reluctant to order or prescribe our products in
the absence of coverage of the product for the patient. The Future Sale of
Eligible Shares may Dilute Nymox's Stock Price
The issuance of further shares and the eligibility of issued shares for
sale will dilute our common stock and may lower its share price. There are
22,567,531 common shares of Nymox currently issued and outstanding as of May 31,
2002, including the 508,309 shares issued to date under the common stock
purchase agreement covered by this prospectus. All of these shares are eligible
for sale under Rule 144 or are otherwise freely tradable. There are 711,860
warrants issued, which expire in 1 to 3 years. Finally, 1,638,500 share options
are outstanding, of which 1,373,000 are currently vested. The great majority of
these options expire in 6 to 10 years. These options have been granted to
employees, officers, directors and consultants of the company. Moreover, Nymox
may use its shares as currency in acquisitions.
We Face Potential Losses Due to Foreign Currency Exchange Risks
Nymox incurs certain expenses, principally relating to salaries and
operating expenses at its Canadian head office, in Canadian dollars. All other
expenses are derived in U.S. dollars. As a result, we are exposed to the risk of
losses due to fluctuations in the exchange rates between the U.S. dollar and the
Canadian dollar. We protect ourselves against this risk by maintaining cash
balances in both currencies. We do not currently engage in hedging activities.
We cannot say with any assurance that the Company will not suffer losses as a
result of unfavorable fluctuations in the exchange rates between the United
States dollar and Canadian dollar.
We Have Never Paid a Dividend and are Unlikely to do so in the Foreseeable
Future
Nymox has never paid any dividends and does not expect to do so in the
foreseeable future. We expect to retain any earnings or positive cash flow in
order to finance and develop Nymox's business.
Cautionary Statement Regarding Forward-Looking Statements
You should be aware that this prospectus contains forward-looking
statements about, among other things, the anticipated operations, product
development, financial condition and operating results of Nymox, proposed
clinical trials and proposed transactions, including collaboration agreements.
By forward-looking statements, we mean any statements that are not
statements of historical fact, including (but are not limited to) statements
preceded by or that include the words, "believes", "expects", "anticipates",
"hopes", "targets" or similar expressions.
In connection with the "safe harbor" provisions in the Private Securities
Litigation Reform Act of 1995, we are including this cautionary statement to
identify some of the important factors that could cause Nymox's actual results
or plans to differ materially from those projected in forward-looking statements
made by, or on behalf of, Nymox. These factors, many of which are beyond the
control of Nymox, include Nymox's ability to:
o identify and capitalize on possible collaboration, strategic
partnering or divestiture opportunities,
o obtain suitable financing to support its operations and clinical
trials,
o manage its growth and the commercialization of its products,
-10-
o achieve operating efficiencies as it progresses from a
development-stage to a later-stage biotechnology company,
o successfully compete in its markets,
o realize the results it anticipates from the clinical trials of its
products,
o succeed in finding and retaining joint venture and collaboration
partners to assist it in the successful marketing, distribution and
commercialization of its products,
o achieve regulatory clearances for its products,
o obtain on commercially reasonable terms adequate product liability
insurance for its commercialized products,
o adequately protect its proprietary information and technology from
competitors and avoid infringement of proprietary information and
technology of its competitors,
o assure that its products, if successfully developed and commercialized
following regulatory approval, are not rendered obsolete by products
or technologies of competitors and
o not encounter problems with third parties, including key personnel,
upon whom it is dependent.
Although Nymox believes that the forward-looking statements contained in
this registration statement are reasonable, it cannot ensure that its
expectations will be met. These statements involve risks and uncertainties.
Actual results may differ materially from those expressed or implied in these
statements. Factors that could cause such differences include, but are not
limited to, those discussed under "Risk Factors."
TRADING MARKET FOR COMMON SHARES
Nymox's common shares trade on the Nasdaq Stock Market. Nymox's common
shares traded on the Nasdaq National Market from December 1, 1997 until
September 16, 1999 when they began trading on the Nasdaq SmallCap Market.
Nymox's common shares also traded on the Montreal Exchange from December 18,
1995 until November 19, 1999.
The following tables set out the high and low reported trading prices of
the common shares on the Nasdaq Stock Market during the periods indicated.
Annual High and Low Market Prices - Past Five Years
YEAR ANNUAL HIGH ANNUAL LOW
---- ----------- ----------
1997 $10.750 $6.250
1998 $13.625 $2.500
1999 $5.875 $2.500
2000 $10.563 $1.063
2001 $4.910 $1.750
2002 (through June 30) $5.000 $2.810
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Quarterly High and Low Market Prices - Past Two Years
YEAR QUARTERLY PERIOD HIGH SALES PRICE LOW SALES PRICE
---- ---------------- ---------------- ---------------
2000 1st Quarter $10.563 $2.625
2nd Quarter $5.875 $2.625
3rd Quarter $6.063 $2.906
4th Quarter $3.875 $1.063
2001 1st Quarter $3.000 $1.750
2nd Quarter $3.100 $1.760
3rd Quarter $4.910 $2.310
4th Quarter $5.000 $3.650
2002 1st Quarter $4.410 $3.500
2nd Quarter $4.750 $2.810
Monthly High and Low Market Prices - Most Recent Six Months
DATE MONTHLY HIGH MONTHLY LOW
---- ------------ -----------
January, 2002 $4.220 $3.560
February, 2002 $4.110 $3.500
March, 2002 $4.410 $3.740
April, 2002 $4.040 $2.810
May, 2002 $4.120 $3.540
June, 2002 $4.750 $3.820
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SELECTED CONSOLIDATED FINANCIAL DATA
The following table sets forth selected consolidated financial data for
Nymox for the periods indicated, derived from financial statements prepared in
accordance with generally accepted accounting principles ("GAAP"). We prepare
our basic financial statements in accordance with Canadian GAAP and include, as
a note to the statements, a reconciliation of material differences to United
States GAAP. The financial statements have been audited by KPMG, LLP, Montreal,
Canada as at and for the years ended December 31, 1997, 1998, 1999, 2000 and
2001. The data set forth below should be read in conjunction with the Company's
consolidated financial statements and notes thereto.
NYMOX PHARMACEUTICAL CORPORATION
Selected Consolidated Financial Data
(In U.S. dollars(3))
Dec. 31, Dec. 31, Dec. 31, Dec. 31, Dec. 31,
-------- -------- -------- -------- --------
2001 2000 1999 1998 1997
---- ---- ---- ---- ----
CANADIAN GAAP
Current Assets $714,522 $749,510 $776,824 $2,708,543 $1,750,388
Capital Assets 3,371,524 3,412,694 1,168,316 1,279,692 983,484
Total Assets 4,192,241 4,384,716 2,140,491 3,988,235 2,733,872
Total Liabilities 747,493 323,774 833,344 301,004 202,543
Share Capital & Other 25,798,195 23,243,941 16,912,963 15,943,710 9,597,888
Shareholder's Equity 2,644,748 3,260,942 1,307,147 3,687,231 2,531,329
Total Revenues 380,609 225,867 190,203 273,565 70,055
Sales, license fees and 362,691 157,688 153,252 104,804 17,033
research contracts
Research & Development
Expenditures(1) 1,479,602 2,073,775 1,132,941 2,087,742 1,671,412
Net Loss 3,049,504 4,023,979 3,314,296 4,783,213 3,463,905
Loss per Share $0.14 $0.19 $0.17 $0.25 $0.19
Weighted Avg. No. of Common
Shares 21,873,966 20,890,735 19,886,430 19,304,435 18,370,873
U.S. GAAP(2)
Net Loss 3,095,133 $4,272,308 $3,409,166 $4,979,562 $3,755,409
Loss per Share 0.14 0.20 0.17 0.26 0.20
Shareholder's Equity $2,496,104 $3,102,887 $1,139,731 $3,304,352 $2,428,052
(1) We earn investment tax credits by making qualifying research and development expenditures. These amounts shown are
net of investment tax credits.
(2) Reference is made to Note 10 of Nymox's audited financial statements as at and for the year ended December 31, 2001
for a reconciliation of differences between Canadian and U.S. GAAP.
(3) Effective January 1, 2000, the Corporation adopted the United States dollar as its measurement currency as a result
of the increasing proportion of operating, financing and investing transactions in the Canadian operations that are
denominated in U.S. dollars. For Canadian GAAP purposes, the financial information for all periods presented up to
December 31, 1999 has been translated into U.S. dollars at the December 31, 1999 exchange rate, which was 1.4433
Canadian dollars to the U.S. dollar. For U.S. GAAP purposes, assets and liabilities for all years presented have
been translated into U.S. dollars at the ending exchange rate for the respective year and the statement of earnings
at the average rate for the respective year. Reference is made to notes 2(a) and 10 of the consolidated financial
statements.
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For the most recent unaudited quarterly financial data for Nymox, please see
Appendix A to this Prospectus.
INFORMATION ABOUT THE COMPANY
History of the Company
Nymox was incorporated in May, 1995 to acquire all of the common shares of
DMS Pharmaceutical Inc., a private company which had been carrying on research
and development since 1989 on diagnostics and drugs for brain disorders and
diseases of the aged with an emphasis on Alzheimer's disease. Nymox has two
subsidiaries: one wholly owned subsidiary named Nymox Corporation and the other
a majority owned subsidiary named Serex, Inc, purchased in March, 2000. Both
subsidiaries are based in the same building in Maywood, New Jersey, but each
have separate facilities within the building. Nymox Corporation operates our
certified clinical reference laboratory where our AlzheimAlert(TM) test is
performed, and conducts some research and development, while Serex conducts
research and development and some of the manufacturing of NicAlert(TM) and
NicoMeter(TM).
Nymox's principal executive offices are located at:
Nymox Pharmaceutical Corporation
9900 Cavendish Boulevard, Suite 306
St. Laurent, Quebec, Canada, H4M 2V2
Phone: (800) 936-9669
Fax: (514) 332-2227
Nymox's two subsidiaries are located at:
Nymox Corporation
230 West Passaic St.
Maywood, NJ, USA 07607
Serex, Inc.
230 West Passaic St.
Maywood, NJ, USA 07607
We specialize in the research and development of therapeutics and
diagnostics for the aging population with an emphasis on Alzheimer's disease.
Alzheimer's disease is a progressive, terminal brain disease of the elderly
marked by an irreversible decline in mental abilities, including memory and
comprehension, and often accompanied by changes in behavior and personality. It
currently afflicts an estimated four million people in the United States and at
least fifteen million people worldwide. As the baby-boomer generation continues
to age, these figures are expected to rise sharply.
Acquisition of a Majority Interest in Serex, Inc.
On March 2, 2000, we closed our acquisition of a controlling interest in
Serex, Inc., a privately held diagnostic company based in Maywood, New Jersey.
We have subsequently acquired more shares of the common stock of Serex, Inc.
from other shareholders and now own approximately 98% of its common stock.
Serex's NicAlert(TM) and NicoMeter(TM) strips can reliably detect one of
the metabolic products of nicotine in human urine and saliva (NicAlert(TM)
only), in order to determine whether a person, such as a teenager or insurance
applicant, is using a tobacco product. NicAlert(TM) and NicoMeter(TM) are
currently being
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distributed in Japan by Mizuho Medy Co. Ltd. of Japan and
outside of Japan by Nymox and Jant Pharmacal Corporation.
Serex developed and patented its particle valence technology, a unique,
highly sensitive, new method to detect very small amounts of biochemical
indicators in body fluids such as blood, urine and saliva. This technology can
be adapted to detect a wide range of biochemical indicators for diseases,
conditions and drug use.
Serex also assisted in the development of our AlzheimAlert(TM) test.
Diagnostic Products for Alzheimer's Disease
Alzheimer's disease is the most common cause of dementia in persons 65
years of age and older and is the fourth leading cause of death among the
elderly. Despite the need for an accurate clinical test, the definitive
diagnosis of the disease is possible only after the death of the patient by
expert, pathologic examination of brain tissue.
The Surgeon General's Report on Mental Health, released on December 13,
1999, identified the importance and the need for the early detection and
diagnosis of Alzheimer's disease. The report described the current approach to
Alzheimer's disease diagnosis, clinical examination and the exclusion of other
common causes of its symptoms, as time- and labor-intensive, costly and largely
dependent on the expertise of the examiner. As a result, the illness is
currently underrecognized, especially in primary care settings, where most older
patients seek care. The report joined other experts writing in the field in
recognizing the need for a better, more reliable method for diagnosing the
disease in living patients and in particular, the need of a simple, accurate and
convenient test that could detect a biochemical change early in patients with
Alzheimer's disease. We believe our AlzheimAlert(TM) provides such a test.
AlzheimAlert(TM); An Aid to the Diagnosis of Alzheimer's Disease
We market a proprietary diagnostic test for Alzheimer's disease, known as
the AlzheimAlert(TM) Test, through our government-inspected clinical reference
laboratory in Maywood, New Jersey. AlzheimAlert(TM) is an improved version of
our AD7C(TM) test, which has been on the market since 1997. It is a urine test,
where the patient provides a first-morning urine sample for testing. The
patient's doctor then forwards the sample to our laboratory where our technical
staff performs the test. We then report the results to the doctor.
AlzheimAlert(TM) is the latest generation of our NTP testing technology. It
measures the level of a brain protein called neural thread protein (NTP) which
is elevated early in Alzheimer's disease as reported both in the scientific
literature and at scientific conferences. Researchers at the Massachusetts
General Hospital and Brown University led by Doctors Suzanne de la Monte and
Jack Wands first found large amounts of the protein in the brain tissue of
patients known to have died with Alzheimer's disease. Subsequent research led to
the characterization of NTP and the gene that produces it. Nymox succeeded in
developing a highly sensitive test to detect the presence of NTP in the spinal
fluid and, most recently, in the urine of patients with Alzheimer's disease. A
recent study (J. Neuropathol Exp Neurol (2001; 60: 195-207)) has provided
further evidence that increased production of NTP leads to a marked increase in
nerve cell death and shown that the cells subjected to NTP died in a programmed
fashion similar to the way the nerve cells in the brains of patients with
Alzheimer's disease die. One of the characteristic signs of Alzheimer's disease
is widespread brain cell loss.
Nymox believes that its AlzheimAlert(TM) test can assist a physician faced
with the task of diagnosing whether a patient has Alzheimer's disease. In
company funded trials of its NTP testing technology to date, involving over 500
clinical samples, the test results were positive for over 80% of the patients
with verified Alzheimer disease and negative in over 89% of subjects without the
disease (known as a low false positive rate). The low rate of positive results
for patients without the disease is important for doctors investigating patients
with subtle or marginal symptoms of mental, emotional, cognitive, or behavioral
changes. If the doctor
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can rule out Alzheimer's with more assurance, a great deal of patient and family
anguish and anxiety will be avoided. A low test score will help the doctor to be
more certain that Alzheimer's disease is not the cause of the patient's symptoms
and to target the other, often reversible causes of the patient's symptoms, such
as depression.
Many studies published in scientific publications or presented at
scientific conferences over the past decade have confirmed the accuracy of NTP
as a biochemical marker for Alzheimer's disease. Recent publications in the
peer-reviewed literature include, for example, the Journal of Clinical
Investigation (1997; 100: 3093-3104); Journal of Contemporary Neurology (1998;
art. 4a); Journal of Clinical Laboratory Analysis (1998; 12: 285-288) and (1998;
12: 223-226); Alzheimer's Reports (1999; 2: 327-332), (2000; 3: 177-184) and
(2001; 4: 61-65); Neurology (2000; 54: 1498-1504) and (2000; 55: 1068); Journal
of Alzheimer's Disease (2001; 3: 345-353); and Neurology and Clinical
Neurophysiology (2002; 1: 2-7). Reports about this Nymox technology have also
been featured in prestigious trade and lay publications such as Clinica
(Sept.25, 2000), Genetic Engineering News (Oct.1, 2000), Clinical Laboratory
News (Sept., 1999 and Oct., 2000), Modern Maturity (Dec., 2000), ADVANCE for
Administrators of the Laboratory (June, 2001), ASRT Scanner (August, 2001), RN
magazine (August, 2001), Clinical Geriatrics (Nov., 2000), LabMedica
International (June, 1998), and Clinical Laboratory International (October,
1998).
There can be no assurance that further studies will repeat the same level
of success experienced to date.
The early diagnosis of Alzheimer's disease is important to physicians,
patients and their families and enables them to make informed and early social,
legal and medical decisions about treatment and care. Early diagnosis of
Alzheimer's disease has become increasingly important with new improvements in
drug treatment and care. Even a modest delay in institutionalization can mean
substantial social and financial savings. Conversely, any testing procedure that
could rule out Alzheimer's disease would eliminate the tremendous uncertainty
and anxiety patients and their families otherwise face and would allow
physicians to focus on the other, often reversible, causes of cognitive changes.
Early diagnosis as facilitated by the AlzheimAlert(TM) test represents a
potentially large cost-savings in the form of a reduced number of office visits,
lab tests, scans and other procedures required by the traditional methods of
diagnosis.
The AlzheimAlert(TM) test is an aid to diagnosis, to be considered together
with patient history, physical examination and other relevant medical data. The
test does not replace a physician's diagnosis.
We intend to develop and sell a diagnostic kit version of the
AlzheimAlert(TM) test. Such a kit would permit the testing of patient samples
either in a general purpose medical laboratory or in a physician's office. The
development of such a kit will be subject to further laboratory and clinical
validation and to any necessary regulatory approvals. AlzheimAlert(TM) offers a
more technically advanced means to detect elevated levels of NTP in urine. It is
a completely new assay in the competitive affinity format and has significant
advantages of easy adaptability to systems and equipment present in all modern
clinical laboratories.
We expect that, if approved, a diagnostic kit version of AlzheimAlert(TM)
kit will increase the availability and acceptance of our test while lowering its
cost to the patient or health care payer.
Other Biochemical Indicators of Alzheimer's Disease
We hold exclusive patent rights to several other biochemical indicators for
Alzheimer's disease, including the brain protein, 35i9, which we believe is also
associated with Alzheimer's disease. We intend to use our extensive scientific,
medical and commercial experience and know-how in the field of Alzheimer's
disease in order to develop new diagnostic tests, methods and treatments for the
disease from these and other indicators.
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Development of Therapeutic Products for Alzheimer's Disease
At present, there is no cure for Alzheimer's disease. There are four drugs
approved by the FDA, tacrine (brand-name Cognex(R)), donepezil HCI (brand-name
Aricept(R)), rivastigmine (brand-name Exelon(R)) and galantamine hydrobromide
(brand name Reminyl(R)) for the treatment of Alzheimer's disease. However, at
most these drugs offer symptomatic relief for the loss of mental function
associated with the disease and possibly help to delay the illness- progression.
There is no consensus as to the cause of Alzheimer's disease or even whether it
is one disease or many.
There is an urgent need for an effective treatment for the illness, caused
in part by the rising health care, institutional and social costs for the
treatment and care of Alzheimer's disease sufferers. The Surgeon General's
Report on Mental Health released on December 13, 1999, put the direct health
care costs for the illness in the United States at almost $18 billion for 1996.
In a 1998 statement to the House Appropriations Subcommittee, the Director of
the National Institute on Aging, Dr. Richard J. Hodes, estimated that the cost
of care to family, caregivers and society in general was as much as $100 billion
per year.
These costs are expected to rise sharply as the baby boom generation ages
and more people become at risk for the disease. According to Dr. Hodes, the
number of Americans aged 65 or over, now some 34 million, is expected to more
than double by year 2030. Within this group, the population of persons over the
age of 85 is the fastest growing segment. As people live longer, they become
more at risk of developing Alzheimer's disease.
Nymox's research into drug treatments for Alzheimer's disease is aimed at
compounds that could arrest the progression of the disease and therefore are
targeted for long term use.
Drugs Targeting Spherons
We are a leader in research and development into drugs for the treatment of
Alzheimer's disease that target spherons. Nymox researchers believe that
spherons are a cause of senile plaques, the characteristic lesion found
abundantly in the brains of patients with Alzheimer's disease and believed by
many researchers to play a pivotal role in the fatal illness. Spherons are tiny
balls of densely packed protein found in brain cells scattered throughout the
brains of all humans from age one. Nymox researchers have found that as humans
age the spherons grow up to a hundred times larger until they become too large
for the cells that hold them. Once released from the cells, the spherons burst
which the researchers believe creates senile plaques and sets off a cascade of
cellular damage and biochemical changes pivotal to the symptoms and signs of
Alzheimer's disease.
The substantial evidence linking spherons to senile plaques and Alzheimer's
disease has been published in journals such as the Journal of Alzheimer's
Disease, Drug News & Perspectives and Alzheimer Reports. There are 20 important
criteria of validity which have been set forth correlating the disappearance of
spherons in old age with the appearance of senile plaques and implicating
spherons as a major causal in Alzheimer's disease. In 2000, Nymox researchers
published important findings in Alzheimer Reports (2000; 3: 177-184) confirming
that spherons contain key proteins that are also known to be in senile plaques
and showing that, like senile plaques, spherons contain unusually old proteins
in terms of the human body's metabolism, with an average age of 20 to 40 years.
Nymox researchers believe that stopping or inhibiting the transformation of
spherons into senile plaques will help stop or slow the progress of this
illness. You should be aware that there is no consensus among researchers about
the causes or possible treatments of Alzheimer's disease and that not all
researchers share this belief that spherons are a causative factor in
Alzheimer's disease or are a target for the development of treatments for the
disease.
Based on these research findings and this approach to the treatment of the
disease, we developed novel, proprietary drug screening methods based on
spherons and used them to discover, develop and test drug
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candidates to inhibit the formation of Alzheimer plaques from spherons. These
candidates have the potential to slow or stop the progression of the disease.
We have two distinct new drug candidates, NXD-3109 and NXD-1191, neither of
which demonstrate significant toxicity and both of which had positive animal
testing results. These candidates are at the stage of pre-clinical testing.
Such drug candidates will require regulatory approval in order to begin
clinical studies for humans. You should be aware there is no guarantee that any
of these drug candidates will ever be approved for marketing as a treatment for
Alzheimer's disease. Drug candidates that look promising in early studies in the
laboratory or with animals often prove on further testing to be unsafe,
ineffective or impractical to use with human patients. The cost of bringing a
drug candidate through the necessary clinical trial and regulatory approvals is
very high and may require us to seek substantial financing through various
sources including the issuing of more stock, the borrowing of funds secured by
financial instruments such as bonds or agreements with major pharmaceutical
companies. We risk not being able to secure such funding in the necessary
amounts or on sufficiently favorable terms.
Nymox holds global patent rights covering both methods for using spherons
as targets for developing drugs and for the actual drug candidates discovered.
Neural Thread protein Based Drugs
Nymox developed a unique drug screening system, based on the research that
led to its AlzheimAlert(TM) test, to identify other potential drug candidates
for the treatment of Alzheimer's disease. There is a substantial body of
evidence showing that NTP may play a key role in Alzheimer's disease. The
published studies include Journal of the Neurological Sciences (1996; 138:
26-35), Journal of Neuropathology and Experimental Neurology (1996; 55:
1038-50), Journal of Clinical Investigation (1997; 100: 3093-3104), Alzheimer's
Reports (1999; 2: 327-332), Journal of Alzheimer's Disease (2001; 3: 345-353)
and Cellular and Molecular Life Sciences (2001; 58: 844-849). A recent study
published in the Journal of Neuropathology and Experimental Neurology (2001; 60:
195-207) reported on how a team of researchers at Brown University led by Dr.
Suzanne de la Monte and Dr. Jack Wands implanted the gene that produces NTP in
nerve cells derived from humans. They then caused the cells to turn on the
implanted NTP gene and to begin to produce NTP in elevated quantities. This
caused a marked increase in nerve cell death. Sophisticated analysis showed that
the cells died in a programmed fashion similar to the way the nerve cells in
brains of patients with Alzheimer's disease die. Extensive loss of brain cells
and accompanying brain shrinkage is a key part of the Alzheimer's disease
process.
Nymox screened compounds for their ability to impede this process of
premature cell death and thus potentially help slow or halt the loss of brain
cells in the Alzheimer's disease brain. This screening process identified
promising drug candidates but further pre-clinical studies are necessary before
these candidates can move into formal regulatory studies.
Nymox licensed this technology in 1997 from Harvard University and the
Massachusetts General Hospital as part of a sponsored research and licensing
agreement. Under the terms of this agreement, Nymox sponsored the research of
the principal investigators, Dr. Suzanne de la Monte and Dr. Jack Wands, into
the use of neural thread protein, its antibodies or genes for diagnostic or
therapeutic purposes. Nymox also paid the patent costs for the patent
applications filed arising out of this research. In return, Nymox received an
exclusive worldwide license of the patents to sell products and to use processes
encompassed by them. Nymox is to pay the Massachusetts General Hospital a 4%
royalty of the net sales price of any product developed and sold under the
license. Nymox currently pays this royalty on its sales of AlzheimAlert(TM). The
license and the obligation to pay patent costs and royalties continues for the
life of the patents, which run until November, 2014 at the earliest. The
Massachusetts General Hospital has the right to terminate the license in any
country where, after the first commercial sale of the product in the country,
there is a continuous two year period in which no product is sold in such
country. There are four issued U.S. patents and one outstanding U.S. patent
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application under license and a correspondingly larger number of patents and
patent applications in Europe, Japan, Canada, Australia, New Zealand and South
Korea. The sponsored research portion of this agreement was transferred to Brown
University and the Rhode Island Hospital as of March, 1999, when Dr. de la Monte
and Dr. Wands moved to Brown University.
Nymox also has a similar sponsored research and licensing agreement with
Brown University and the Rhode Island Hospital where Dr. de la Monte and Dr.
Wands now carry out their research into neural thread protein. Under the terms
of this agreement, which became effective March 1, 1999, Nymox sponsors the
research of the principal investigators, Dr. Suzanne de la Monte and Dr. Jack
Wands, into the use of neural thread protein, its antibodies or genes for
diagnostic or therapeutic purposes. Nymox also pays the patent costs for any
patent applications filed arising out of this research. In return, Nymox will
receive an exclusive worldwide license of the patents to sell products and to
use processes encompassed by them. The Rhode Island Hospital has the right to
terminate the license in any country where, after the first commercial sale of
the product in the country, there is a continuous two year period in which no
product is sold in such country. Nymox is to pay the Rhode Island Hospital a 4%
royalty of the net sales price of any product developed and sold under the
license.
New Antibacterial Agents Against Infections and Food Contamination
We are developing new antibacterial agents for the treatment of urinary
tract and other bacterial infections in humans which have proved highly
resistant to conventional antibiotic treatments and for the treatment of E. coli
0157:H7 bacterial contamination in hamburger meat and other food and drink
products.
Nymox has developed four new antibacterial agents:
o NXB-4221 for the treatment of difficult chronic and persistent urinary
tract infections;
o NXB-5886 for the treatment of streptococcal infection; and
o NXT-1021 for the treatment of staphylococcal infection; and
o NXC-4720 for the treatment of E. coli contamination of meat and other
food and drink products
In the last ten years there has been a growing recognition of the
increasing problem of antibiotic-resistant infections and the need for truly
novel antibacterial drugs. See, for example, the European Commission report
dated May 28, 1999, "Opinion of the Scientific Steering Committee on
Antimicrobial Resistance" and the report from the Interagency Task Force on
Antimicrobial Resistance, co-chaired by the Centers for Disease Control and
Prevention, the U.S. Food and Drug Administration and the National Institutes of
Health, entitled A Public Health Action Plan to Combat Antimicrobial Resistance
released on January 19, 2001.
Urinary tract infections in women caused by bacteria such as E. coli are a
common and significant infection often resistant to conventional antibiotic
treatment. Some varieties of streptococcus and staphylococcus bacteria, a common
source of infection in humans, have acquired a broad immunity to antibiotic
treatments. Infections from these antibiotic resistant bacteria are difficult to
treat and can be life threatening.
Nymox's three antibacterial agents for the treatment of infectious disease
have all shown the ability to kill their bacterial targets in culture with no
signs of toxicity. Further pre-clinical testing and development is required
before we can apply for regulatory approval to begin initial testing in humans.
E. coli contamination of food and drink is a serious public health problem
worldwide and a major concern for meat processors in particular. E. coli
bacteria occur normally and usually harmlessly in the
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gastrointestinal tracts of humans, cows and other animals. However, one mutant
variety of the E. coli bacteria, E. coli 0157:H7, can cause life-threatening
illness and has been implicated in cases of severe diarrhea, intestinal bleeding
and kidney failure, leading, in some cases, to death in children and the
elderly. E. coli contamination in hamburger meat and other food products and in
drinking water affects about 70,000 people in the United States a year.
There is a well-recognized need in the beef industry to address the problem
of E. coli contamination in meat processing and in livestock. E. coli
contamination has triggered massive recalls of ground beef in the U.S.. Cattle
are a natural reservoir for the deadly strain of E. coli. Water contamination
from cattle operations have led to public health tragedies.
Nymox developed a potent new antibacterial agent, NXC-4720. Tests of
NXC-4720 show it to be highly effective against all known substrains of E. coli
0157:H7, the bacteria implicated in these severe cases of food and drink
contamination. Tests of NXC-4720 show that it destroys E. coli 0157 strains,
including H7, efficiently, rapidly and at a very low dose. In 1999, we began
further laboratory trials for this agent as a treatment for food and drink
contamination and are continuing trials with various collaborators, including
the Faculty of Veterinary Medicine at the University of Montreal, the Department
of Food Science at the University of Manitoba and BioPhage Inc.. Further
pre-clinical testing and development is required before we can apply for
regulatory approval for use of this agent on the processing of food and drink
for human consumption.
Nymox has patent rights to these and other antibacterial agents.
Development of Therapeutic Products for Enlarged Prostate
We are developing treatments for enlarged prostate (benign prostatic hyperplasia
or BPH), using compounds derived from its Alzheimer's disease research. Nymox is
currently involved in formal preclinical studies of these treatments.
Enlarged prostate or BPH affects more than half of men in their sixties and as
many as 90% of men in their seventies and eighties. Symptoms include more
frequent urination (especially at night), difficulty urinating, incomplete
emptying of the bladder and sometimes complete inability to urinate. More
serious cases may require surgical intervention to reduce the size of the
prostate and to remove it entirely. There is a need for a simple, effective
treatment for BPH, particularly in cases where existing drug treatments have
proven to be ineffective and where more intrusive procedures such as surgical
cutting away of prostate tissue may be undesirable to the patient or bring
unacceptable risks.
The NicAlert(TM) and NicoMeter(TM) Tests for Tobacco Product Use
We also market NicAlert(TM) and NicoMeter(TM), inexpensive, simple-to-use
test strips that use urine or saliva (NicAlert(TM) only) to determine whether a
person is using tobacco products. NicAlert(TM) and NicoMeter(TM) detect levels
of cotinine, a byproduct of the body's breakdown of nicotine and generally
regarded as the best indicator of tobacco exposure for smokers and nonsmokers.
Smoking and other tobacco product use is a serious public health problem.
Smoking kills. According to the Centers for Disease Control and Prevention,
cigarette smoking is responsible for more than 430,000 deaths per year in the
United States alone. Smoking can cause cancer of the lung, mouth, bladder,
larynx and esophagus among others, heart disease and stroke and chronic lung
disease. Every year, exposure to second-hand smoke (environmental tobacco smoke
or ETS) causes an estimated 3,000 nonsmoking Americans to die of lung cancer and
up to 300,000 American infants and small children to suffer from lower
respiratory tract infections.
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NicAlert(TM) and NicoMeter(TM) employ Serex, Inc.'s patented technology and
is manufactured by Serex, Inc. with Mizuho USA, which provides final assembly
and packaging services. Both NicAlert(TM) and NicoMeter(TM) are currently being
used in research programs into tobacco use and exposure and are being marketed
in the United States and Japan as tests to determine whether a person, such as a
teenager, student athlete or insurance applicant, is using a tobacco product.
Property, Plant And Equipment
Nymox and Serex laboratory facilities in Maywood, New Jersey comprise 4,687
square feet of leased space. That lease agreement expires February 28, 2005.
Nymox office and research facilities in St. Laurent, Quebec, Canada comprise
6,923 square feet of leased space. The lease agreement expires on August 31,
2005. Nymox Pharmaceutical Corp. and its two US subsidiaries Nymox Corp. and
Serex, Inc. own a full complement of equipment used in all aspects of their
research and development work and the Nymox reference laboratory. Nymox believes
that its facilities are adequate for its current needs and that additional
space, if required, would be available on commercially reasonable terms.
Governmental Regulation
Our AlzheimAlert(TM) test, which we provide as a service through our
clinical reference laboratory in Maywood, New Jersey is subject to extensive
government regulation in the United States. Our clinical reference laboratory
and its performance of the AlzheimAlert(TM) must be certified by the Centers for
Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement
Amendments (CLIA), which establishes quality standards for the laboratory tests
being performed to ensure the accuracy, reliability and timeliness of patient
test results. In addition, some individual states such as New York, Florida and
New Jersey have their own requirements for the inspection and certification of
reference laboratories, which offer diagnostic services for patients within the
state. Finally, the FDA has its own regulations governing in vitro diagnostic
products, including analyte-specific reagents used in clinical reference
laboratories. Any changes in our current certification status, CMS or state law
requirements or in the FDA regulations could have an impact on our future
ability to offer or market any reference laboratory services and/or on our
ability to obtain reimbursement from the Medicare and Medicaid programs and
providers.
We intend to develop and sell a diagnostic kit version of the
AlzheimAlert(TM) test. We will need to successfully complete clinical and
laboratory validation studies and obtain FDA approval before we can market or
sell such a diagnostic kit version outside of the clinical reference laboratory
setting in the United States. Such approval for this type of commercial
development is necessary for all in vitro diagnostic kits.
The regulatory process leading to such approval can be time-consuming and
expensive and can result in an outright denial or a very limited approval only.
Our product will be subject to subject to premarketing and postmarketing
requirements applicable to such devices, including those governing:
o clinical testing;
o design control procedures;
o prior FDA approval of a 510(k) application, where the FDA has
determined that our diagnostic device is substantial equivalent to a
marketed device, or a premarket approval application, where the FDA
has been satisfied with clinical studies demonstrating the safety and
efficacy of our device;
o postmarketing record and reporting obligations; and
o good manufacturing practices.
-21-
The requirements for a premarket approval application are analogous to
those for the approval of a new drug and include four categories of information:
indications for use, device description and manufacturing methods, alternative
practices and procedures for the diagnosis of the disease and clinical and
nonclinical studies. The requirements for a 510(k) application are generally
less onerous but still include indications for use, safety and effectiveness
data as well as manufacturing and quality assurance data and information. There
can be no assurance that the AlzheimAlert(TM) test or any other medical device
that we may develop in the future will obtain the necessary approvals within a
specified time framework, if ever. In addition, the FDA may impose certain
postmarketing requirements that may significantly increase the regulatory costs
associated with our product. The FDA has recourse to a wide range of
administrative sanctions and civil and criminal penalties in order to enforce
the applicable laws, rules and regulations.
Our therapeutic products under development by Nymox would also have to
receive regulatory approval. This is a costly, lengthy and risky process. In the
United States, in order for a product to be marketed, it must go through four
distinct development and evaluation stages:
Product Evaluation
We must conduct preliminary studies of potential drug candidates using
various screening methods to evaluate them for further testing, development and
marketing.
Optimization of Product Formulation
The activities in this stage of development involve consultations between
us and investigators and scientific personnel. Preliminary selection of
screening candidates to become product candidates for further development and
further evaluation of drug efficacy is based on a panel of research based
biochemical measurements. Extensive formulation work and in vitro testing are
conducted for each of various selected screening candidates and/or product
candidates.
Clinical Screening and Evaluation
During this phase of development, portions of which may overlap with
product evaluation and optimization of product formulation, initial clinical
screening of product candidates is undertaken and full scale clinical trials
commence. The FDA must approve any clinical testing on healthy subjects (Phase
1) and on patients (Phase 2 and 3).
Final Product Development
The activities to be undertaken in final product development include
performing final clinical evaluations, conducting large-scale experiments to
confirm the reproducibility of clinical responses, making clinical lots for any
additional extensive clinical testing that may be required, performing any
further safety studies required by the FDA, carrying out process development
work to allow pilot scale production of the product, completing production
demonstration runs for each potential product, filing new drug applications,
product license applications, investigational device exemptions (and any
necessary supplements or amendments) and undergoing comprehensive regulatory
approval programs and processes.
We cannot assure you that we will successfully complete the development and
commercialization of any therapeutic products.
In the United States, obtaining the necessary FDA approval for any drug is
a lengthy, expensive and often arduous process. We cannot predict with any
certainty the amount of time the FDA will take to approve one of our drugs or
even whether any such approval will be forthcoming. Similar requirements exist
in many other countries.
-22-
In the United States, the FDA approval procedure is a two-step process. We
must file an investigational new drug application for each product with the FDA
before beginning the initial (Phase I) clinical testing of the new drug in
healthy subjects. If the FDA has not commented on or questioned the application
within 30 days of its filing, initial clinical studies may begin. If, however,
the FDA has comments or questions, the questions must be answered to the
satisfaction of the FDA before initial clinical testing can begin. In some
instances, this process could result in substantial delay and expense. Phase I
studies are intended to demonstrate the functional characteristics and safety of
a product.
After Phase I testing, we must conduct extensive clinical trials with
patients in order to establish the efficacy and safety of our drug. Once we
complete the required clinical testing, we expect to have to file a new drug
application for FDA approval in order to market most, if not all, of our new
drugs. The application is complicated and detailed and must include the results
of extensive clinical and other testing, the cost of which is substantial. The
FDA conducts an extensive and often lengthy review of such applications. The
agency is required to review applications within 180 days of their filing, but,
during the review, frequently requests that additional information be submitted.
This starts the 180-day regulatory review period anew when the requested
additional information is submitted and, as a result, can significantly extend
the review period. Until the FDA actually approves the new drug application,
there can be no assurance that the agency will consider the information
requested and submitted to justify approval. The packaging and labeling of
products are also subject to FDA regulation. Accordingly, it is impossible to
anticipate when the FDA will approve a new drug application.
We must also obtain approval for our drugs or diagnostic devices from the
comparable regulatory authority in other countries before we can begin marketing
our product in that country. The approval procedure varies from country to
country and can involve additional testing. The time required may differ from
that required for FDA approval. Although there are some procedures for unified
filings for certain European countries, in general each country has its own
procedures and requirements, many of which are time-consuming and expensive.
Thus, there can be substantial delays in obtaining required approvals from both
the FDA and foreign regulatory authorities after the relevant applications are
filed.
After such approvals are obtained, further delays may be encountered before
the products become commercially available. If, subsequent to approval, new
information becomes available concerning the safety or effectiveness of any
approved product, the regulatory authority may require the labeling for the
affected product to be revised or the product to be withdrawn. Our manufacturing
of any approved drug must conform with the FDA's good manufacturing practice
regulations which govern the production of pharmaceutical products and be
subject to inspections and compliance orders.
Government regulation also affects our ability to receive an appropriate
level of reimbursement for our products. Throughout the developed world, both
public and private health care plans are under considerable financial and
political pressure to contain their costs. The two principal methods of
restricting expenditures on drugs and diagnostic products and services are to
deny coverage or, if coverage is granted, to limit reimbursement. For
single-payer government health care systems, a decision to deny coverage or to
severely restrict reimbursement for one of our products can have an adverse
effect on our business and revenues.
In the United States, where, to a significant degree, the patient
population for our products is elderly, Medicare and Medicaid are sources of
reimbursement. In general, any restriction on reimbursement, coverage or
eligibility under either program could adversely affect reimbursement to Nymox
for products and services provided to beneficiaries of the Medicare and/or
Medicaid programs. Many elderly people are covered by a variety of private
health care organizations either operating private health care plans or Medicare
or Medicaid programs subject to government regulation. These organizations are
also under considerable financial constraints and we may not be able to secure
coverage or adequate reimbursement from these organizations. Without coverage,
we will have to look to the patients themselves who may be unwilling or unable
to pay for the product; in turn, doctors may be reluctant to order or prescribe
our products in the absence of coverage of the product for the patient.
-23-
In response to rising health care costs, the U.S. Congress implemented
sweeping changes to the U.S. Medicare and Medicaid systems in the Balanced
Budget Act of 1997 and is currently considering a number of other proposals that
could significantly impact on the level of funding for Medicare and Medicaid
programs. Under the new Part C: Medicare + Choice programs, beneficiaries can
now opt for a variety of health delivery models, including coordinated care
plans, HMOs, preferred provider organizations and provider sponsored
organizations, private fee-for-service plans and medical savings account plans.
In addition, states now have the option to require Medicaid recipients to enroll
with managed health care plans without first obtaining a waiver, making it
substantially easier for the states to meet their Medicaid obligations through
private managed care organizations. All these health care delivery systems,
including the original Medicare and Medicaid systems, are subject to funding
formulas and spending caps and may compensate for these restrictions by limiting
coverage, eligibility and/or payments. The long-term impact of these legislative
changes in terms of their efficiency, effectiveness and financial viability in
delivering health care services to an aging population is uncertain at present.
Any legislative or regulatory actions to reduce or contain federal spending
under either the Medicare or Medicaid programs could adversely affect our
ability to participate in either program as a provider or supplier of services
or products and the amount of reimbursement under these programs potentially
available to us.
Our AlzheimAlert(TM) test, and any of the new diagnostic and therapeutic
products and services that we may develop, will be subject to coverage
determinations by health care providers and payers. Federal and state
regulations and law and internal coverage policies of health care organizations
affect our ability to obtain payments for our products and services. The
Medicare program will not pay for any expenses incurred for items or services
that are not reasonable and necessary for the diagnosis or treatment of illness
or injury or to improve the functioning of a malformed body member.
Historically, CMS interpreted this provision in order to exclude from Medicare
coverage those medical and health care services that are not demonstrated to be
safe and effective by acceptable clinical evidence. CMS recently revised both
its national coverage policies and procedures in general and specifically its
coverage of diagnostic laboratory tests and constituted a Medicare Coverage
Advisory Committee to provide advice on the effectiveness and appropriateness of
medical items and services that are eligible for coverage under Medicare. It is
unknown how these changes will affect our ability to obtain Medicare coverage
for its products and services. However, an adverse national coverage decision
with respect to one of our products or services will make it impossible to
receive reimbursement from Medicare for that product and more difficult to
convince private health care organizations to provide coverage for it. Even if
we receive a favorable coverage decision for one of our products or services,
there is no guarantee that the level of reimbursement for it will be close to
our retail price for it or commensurate with the costs of developing and
marketing it.
Patents And Proprietary Information
We believe that patent and trade secret protection is important to our
business, and that our success will depend, in part, on our ability to obtain
strong patents, to maintain trade secret protection and to operate without
infringing the proprietary rights of others.
The commercial success of products incorporating our technologies may
depend, in part, upon our ability to obtain strong patent protection. We cannot
assure you that additional patents covering new products or improvements will be
issued or that any new or existing patents will be of commercial benefit or be
valid and enforceable if challenged.
We pursue a policy of seeking patent protection for valuable patentable
subject matter of our proprietary technology and require all employees,
consultants and other persons who may have access to its proprietary technology
to sign confidentiality agreements.
Nymox has patents issued and allowed and patent applications pending in the
United States and selected countries including Canada, most European countries,
Australia and Japan. These patents and patent applications cover much of our
current product development and technologies, including:
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o new drug candidates for the treatment of Alzheimer's disease;
o proprietary screening technologies for finding drugs for Alzheimer's
disease. These screening technologies consist of biological systems
and defined conditions used to determine if a drug candidate possesses
a useful action that can predict its potential for use in humans or
animals. For example, Nymox patented screening methods that show
whether a potential drug can inhibit or arrest some of the
pathological changes of Alzheimer's disease. As a second example,
Nymox patented screening methods that show whether a potential drug
can modify in a useful way the amounts of chemical markers of
Alzheimer's disease in a subject. While no proven drugs for AD have
yet been found using these screening technologies, they are a useful
component to our drug development program.
o unique proteins which are related to Alzheimer's disease and which
may, after further research and clinical trials, prove useful in
either diagnostic or therapeutic applications;
o promising diagnostic markers for Alzheimer's disease;
o new diagnostic assay methods;
o methods of treating meat and other food products for E. coli
contamination; and
o anti-infective agents.
Nymox has ten U.S. patents issued or allowed and at least fifteen U.S.
patent applications pending and a corresponding larger number of patents and
patent applications worldwide relating to the inventions and discoveries in
those patents and patent applications. Nymox has issued patents in the main
European markets, including Great Britain, Germany, France, Italy, The
Netherlands, Sweden and Spain among others and in other countries such as Canada
and Australia. The earliest expiry date for its patents is in March, 2007; the
next is in February, 2009 and the rest range from 2010 through 2017.
Nymox also has an exclusive license to a family of patents from the
Massachusetts General Hospital covering rights to the NTP diagnostic and
therapeutic products, including AlzheimAlert(TM). The license includes four
issued U.S. patents and at least four U.S. patent application pending and a
corresponding larger number of patents and patent applications worldwide. The
earliest of these patents expires in the year 2014. Under this license, the
Massachusetts General Hospital is entitled to royalties of 4% from worldwide
sales of the AlzheimAlert(TM) test. Nymox also has a similar research and
license agreement with Rhode Island Hospital, where the principal researchers,
Dr. Suzanne de la Monte and Dr. Jack Wands, now conduct their research into NTP,
the brain protein detected by our AlzheimAlert(TM) test, covering new
developments and discoveries in this area not otherwise covered by the
Massachusetts General Hospital agreement.
Nymox's subsidiary, Serex, also actively pursues a policy of seeking patent
protection for its patentable technologies and discoveries in the United States
and in selected other countries including some European countries, Canada,
Australia and Japan. Its patents issued and allowed and patent applications
pending cover such areas of its technologies and discoveries as:
o its particle valence technology which can detect very small amounts of
biochemical indicators for diseases, conditions and drug use in body
fluids such as blood, urine and saliva;
o a test that can detect biochemical indicators of cholesterol in human
saliva and therefore provide a method of determining and monitoring
cholesterol levels; and
o a unique biochemical indicator for the loss of bone matter, which is a
sign of osteoporosis, a common human bone disorder.
-25-
Serex has eight patents issued or allowed and at least two patent
applications pending in the United States and a corresponding larger number of
patents and patent applications worldwide relating to the inventions and
discoveries in those patents and patent applications. The expiry dates for its
patents range from 2012 to 2017.
Many companies have patents covering various drugs, methods and discoveries
in the fields of diagnostics and therapeutics for Alzheimer's disease and
related conditions and of new anti-infective agents. We believe that the patents
issued to date will not preclude Nymox from developing and marketing our
products; however, it is impossible to predict the extent to which licenses from
third parties will be necessary. If Nymox were to need licenses from third
parties there can be no assurance that we could obtain such licenses on
commercially reasonable terms, if at all.
In the fields of diagnostic methods and diagnostic tests for common human
diseases and conditions, where Serex has many of its patents, there are many
patents issued covering many areas of diagnostic methods, tests and
technologies. We believe that these patents issued to date to other companies
will not preclude Serex from developing and marketing its products but you
should be aware that it is often difficult to determine the nature, breadth and
validity of competing patent claims in these fields, that there has been
significant litigation in some of these areas (not involving Serex) and that, if
and when Serex's products become more commercially successful, Serex's products
or patents may become the subject matter of litigation. If Serex were to need
licenses from third parties there can be no assurance that it could obtain such
license on commercially reasonable terms, if at all.
Neither Nymox nor Serex are currently involved in litigation over patent
and other intellectual property rights but significant litigation over these
matters in the pharmaceutical and biotechnology industry is not uncommon. The
validity and extent of patent rights can be very difficult to determine and
involve complex legal, factual and scientific questions. Important legal issues
about patent protection in the field of biotechnology have not been resolved.
Patent litigation is costly and time-consuming and can consume substantial
resources. An adverse decision can preclude the marketing of a product, expose
us to significant liabilities or require us to obtain third party licenses which
may not be available at commercially reasonable prices.
We also rely upon trade secrets, know-how, and continuing technological
advancement to develop and maintain our competitive position. We control the
disclosure and use of our know-how and confidential information through
agreements with the parties involved. In addition, we have confidentiality
agreements with our key employees, consultants, officers and directors. There
can be no assurance, however, that all confidentiality agreements will be
honored, that others will not independently develop equivalent technology, that
disputes will not arise as to the ownership of intellectual property, or that
disclosure of our trade secrets will not occur. Furthermore, there can be no
assurance that others have not obtained or will not obtain patent protection
that will exclude us from using our trade secrets and confidential information.
To the extent that consultants or research collaborators use intellectual
property owned by others in their work with us, disputes may also arise as to
the rights to related or resulting know-how or inventions.
Competition
Rapidly evolving technology and intense competition are the hallmarks of
modern pharmaceutical and biotechnology industries. Our competitors include:
o major pharmaceutical, diagnostic, chemical and biotechnology
companies, many of which have financial, technical and marketing
resources significantly greater than ours;
o biotechnology companies, either alone or in collaborations with large,
established pharmaceutical companies to support research, development
and commercialization of products that may be competitive with ours;
and
-26-
o academic institutions, government agencies and other public and
private research organizations which are conducting research into
Alzheimer's disease and which increasingly are patenting, licensing
and commercializing their products either on their own or through
joint ventures.
In the field of Alzheimer's disease diagnosis, our AlzheimAlert(TM) test
faces growing competition which could detrimentally impact on our ability to
successfully market and sell our diagnostic test. Our competitors include:
o Athena Diagnostics, Inc. which is currently marketing three tests
claimed to aid in the diagnosis of Alzheimer's disease: a genetic test
for the rare cases of familial, early-onset Alzheimer's disease; a
genetic test for a relatively common mutation of a gene said to
increase the likelihood of a person with at least one of the genes
contracting the disease; and a test for two proteins in the spinal
fluid of patients.
o Mitokor, Inc. which developed a blood test known as Mito-Load that
looks for certain mutations in mitochondrial DNA said to be associated
with Alzheimer's disease. Mitokor recently entered into a
non-exclusive licensing agreement in Japan for the marketing and sale
of its product there.
o Synapse Technologies, Inc. which developed a blood test known as p97
Diagnostic that detects a protein said to be diagnostic of Alzheimer's
disease. Synapse Technologies also licensed its technology for use in
Japan.
o NeuroLogic, Inc., which announced in September, 1999 that it acquired
an exclusive world-wide license to a cellular test for Alzheimer's
disease.
o Axonyx Inc., which announced in July, 2000 findings that two enzymes
to which it had acquired world-wide exclusive rights,
butrylcholinesterase and acetylcholinesterase, were elevated in the
cerebrospinal fluid of patients with Alzheimer's disease.
There are also a number of other proposed biochemical signs of the disease
that could potentially be developed into a commercial diagnostic test as well as
various scanning and imaging technologies which might compete some day for a
portion of the diagnostic market for Alzheimer's disease.
We also face intense competition for the development of an effective
treatment for Alzheimer's disease. The market conditions for an Alzheimer's
disease drug strongly favor the entry of other corporations into the area. The
current market for therapeutic drugs for Alzheimer's disease is an estimated $2
billion. This market is expected to grow rapidly as new drugs enter the market
and as the baby boom generation becomes more at risk for developing Alzheimer's
disease. As a result, most of the major pharmaceutical companies and many
biotechnology companies have ongoing research and development programs for drugs
and treatments for Alzheimer's disease. Many of these companies have much
greater scientific, financial and marketing resources than we have and may
succeed in developing and introducing effective treatments for Alzheimer's
disease before we can. At present, three drugs for Alzheimer's disease are being
widely marketed in the United States, Aricept by Pfizer, Exelon by Novartis and
Reminyl by Janssen. These three drugs only treat some of the symptoms of
Alzheimer's disease by enhancing memory and other mental functions and not the
underlying causes of the illness.
A similar competitive reality prevails in the field of novel
anti-infectives. Over the past ten years, there has been an increasing awareness
of the medical need and of emerging market opportunities for new treatments for
antibiotic resistant bacterial infections. Many of the major pharmaceutical
companies are developing anti-infective drugs that either modify their existing
drugs or involve new anti-bacterial properties. Many biotechnology companies are
developing new classes of anti-bacterial drugs. At least three major
pharmaceutical companies have vaccines against bacterial infections in
development. To the extent that these
-27-
companies are able to develop drugs or vaccines that offer treatment for some or
all of the indications for our anti-infectives, the market for our products may
be adversely affected.
Our treatments under development for enlarged prostate (benign prostatic
hyperplasia or BPH) face significant competition from existing products. There
are five drugs approved for treatment of BPH: finasteride (Proscar(R)),
terazozin (Hytrin(R)), doxazozin (Cardura(R)), tamsulosin (Flomax(R)) and
prazosin (Minipres(R)). There are a number of thermal treatments on the market
designed to shrink the enlarged prostate by heating its tissue with a device
inserted through the urethra (the tube leading from the bladder through the
penis through which men urinate) or through the abdomen. The devices on the
market use microwave energy (Prostatron(R), Targis Therapy(R) or TherMatrx(R)),
low level radiowaves (TUNA System(R)), lasers (Indigo LaserOptic Treatment
System(R)), direct heat or hot water to heat or burn away prostate tissue. A
variety of surgical procedures exist to surgically reduce or remove the prostate
or to widen the urethra. These include procedures to cut away prostate tissue
such as TURP (transurethral resection of the prostate) and using a resectoscope
with an electrical loop inserted through the penis to cut the prostate tissue. A
small device used to widen the constricted urethra called a prostatic stent can
also be inserted.
The problem of E. coli 0157:H7 contamination of hamburger meat and other
food products is also well-known and a number of companies and researchers have
been pursuing various potential solutions, including irradiation with x-rays,
better detection of contamination, electronic pasteurization, vaccination and
competitive exclusion of the pathogenic E. coli bacteria by harmless bacteria.
The development of alternative solutions to the problem of E. coli infection may
adversely affect the market for our treatment for E. coli 0157:H7 infection in
cattle and contamination of food products.
Marketing
We currently market our AlzheimAlert(TM) test as a clinical reference
laboratory service primarily in the United States. We are also marketing the
Serex NicAlert(TM) and NicoMeter(TM) tests, which can determine whether a person
is using tobacco products, in the United States through our own marketing arm
and through a distribution agreement with Jant Pharmacal Corporation and in
Japan with Mizuho Medy Co. Ltd. of Japan. We have not started to commercially
market or distribute any of our other products under development and most of
them will require regulatory approval in each country before being marketed
there.
At present, we have a network of over 60 independent medical
representatives and do most of our marketing ourselves. We also have a strategic
marketing alliance for AlzheimAlert(TM) with Cybear Inc., a member of Andrx
Corporation. To increase our marketing, distribution and sales capabilities both
in the United States and around the world, we will need to enter into licensing
arrangements, contract sales agreements and co-marketing deals. We cannot assure
you that we will be able to enter into agreements with other companies on terms
acceptable to us, that any licensing arrangement will generate any revenue for
the company or that the costs of engaging and retaining the services of a
contract sales organization will not exceed the revenues generated.
If successfully developed and approved, we plan to market and sell our
therapeutic and diagnostic products directly or through co-promotion
arrangements or other licensing arrangements with third parties. In cases where
we have sole or shared marketing rights, we plan to build a small, focused sales
force if and when such products approach marketing approval in some markets,
including Europe. Implementation of this strategy will depend on many factors,
including the market potential of any products we develop as well as on our
financial resources. To the extent we will enter into co-promotion or other
licensing arrangements, any revenues received by us will be dependent on the
efforts of third parties.
Legal Proceedings
Amro International, S.A., a Panamanian company, served Nymox with a
Statement of Claim filed with the Ontario Superior Court of Justice (Court File
No. 00-CV-201587), claiming to be entitled to the issuance of 388,797 shares in
accordance with repricing provisions contained in the March 2000 agreement
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between Amro and Nymox and to damages of $4 million for lost opportunity to sell
these shares. Nymox believes that Amro's interpretation of the repricing
provisions in the March 2000 agreement is incorrect and that Amro's damage
claims are without merit. Nymox has filed a Statement of Defense and intends to
defend the action vigorously and to consider its other options with respect to
this matter. It is important to note that paragraph (c) of Note 7 to the
Consolidated Financial Statements of Nymox for the years ended December 31,
2001, 2000 and 1999 states that AMRO is claiming damages of $275,000. This
number was determined at the time the Financial Statements were prepared based
on discussions and correspondence to reach settlement arrangements in September
of 2001, which considered a reduced claim of $275,000. These arrangements were
never consummated and, therefore, AMRO's original claim of $4,000,000 in damages
remains in effect.
Dr. Fitzpatrick, a former employee, has filed a demand for arbitration with
the American Arbitration Association concerning the termination of her
employment with the company. She is claiming damages of up to $498,000 based
upon alleged violations of New Jersey law and breach of an employment agreement,
plus attorneys fees and costs. The Company believes these claims are without
merit and intends to defend the matter vigorously.
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
Overview
We are a development stage biopharmaceutical company that specializes in
the research and development of therapeutics and diagnostics for the aging
population with an emphasis on Alzheimer's disease.
We have begun to market the AlzheimAlert(TM) test, which we provide in our
clinical reference laboratory, that is an aid to the diagnosis of Alzheimer's
disease.
We also have under development therapeutic agents for the treatment of
Alzheimer's disease and of certain antibiotic-resistant infections as well as
antibacterial agents for E. coli contamination of food and drink products.
We also recently acquired a majority interest in Serex, Inc., a New Jersey
company specializing in diagnostic products.
AlzheimAlert(TM) is an improved version of our AD7C(TM) test, from which we
began generating revenue from sales in 1997.
We have incurred operating losses throughout our history. Management
believes that such operating losses will continue for the next few years. The
costs relating to clinical trials for our potential therapeutic products will
increase expenditures and delay profitability, despite anticipated increases in
sales revenue in the coming years.
All figures are presented in U.S. dollars, unless otherwise stated.
Liquidity And Capital Resources
We fund our operations and projects primarily by selling shares of Nymox's
common stock. However, since 1997, a small portion of our funding came from
sales. This source of funding became more significant in late 1998, following
the launch of our urinary version of the AD7C(TM) test. Since its incorporation
in May, 1995, Nymox raised the capital necessary to fund its on-going research
and development work and its marketing and sales operations primarily through
private placements of its shares.
On December 1, 1997, the shares began trading on the Nasdaq Stock Market.
Nymox's common shares also traded on the Montreal Exchange from December 18,
1995 to November 19,1999.
-29-
Private placements completed by Nymox since December, 1995 are as follows:
o December 1995, 1,578,635 common shares at a price of CAN$2.00
(US$1.38) per share for total proceeds of CAN$3,157,270
(US$2,187,536);
o April 1996, 877,300 common shares at a price of CAN$6.00 (US$4.15) per
share for total proceeds of CAN$5,263,800 (US$3,647,059);
o May 1997, 696,491 common shares at a price of CAN$6.50 (US$4.50) and
warrants exercisable at a price of CAN$8.50 (US$5.88) per share for
total proceeds of CAN$4,527,191 (US$3,136,694). In 1998, all 696,491
of these warrants were exercised for additional proceeds to Nymox of
CAN$5,920,174 (US$4,101,832);
o May 1998, 231,630 common shares at a price of CAN$8.50 (US$5.88) for
total proceeds of CAN$1,968,855 (US$1,364,134). A total of 110,000
warrants were issued as well, exercisable at a price of CAN$8.50
(US$5.88) per share (50,000) and CAN$10.00 (US$6.93) per share
(60,000). These warrants have since expired;
o December 1998, 135,000 common shares and January 1999, 55,000 common
shares at CAN$8.50 (US$5.88) per share, for total proceeds of
CAN$1,615,000 (US$1,118,963). A total of 95,000 warrants were issued
as well, exercisable at the price of CAN$10.00 (US$6.93) per share.
These warrants have since expired;
o September 1999, 122,000 common shares at CAN$5.00 (US$3.46) per share,
for total proceeds of CAN$610,000 (US$422,642).
o March 2000, 821,637 common shares at an average price of $4.87 per
share, for total proceeds of $4,000,000. A total of 93,334 warrants
were issued as well, exercisable at a price of $9.375 per share
(66,667) and $7.8125 per share (26,667). These warrants expire on
March 6, 2004.
o March, 2001, 200,000 common shares at $2.06 per share, for total
proceeds of $412,000. A total of 100,000 warrants were issued as well,
exercisable at a price of $2.06. These warrants expire on March 6,
2003.
o August 3, 2001, 80,000 common shares at $2.50 per share for total
proceeds of $200,000.
o August 22, 2001, 140,000 common shares at $3.75 per share for total
proceeds of $525,000.
o October 3, 2001, 110,000 common shares at $3.75 per share for total
proceeds of $412,490.
o November 14, 2001, 64,100 common shares at $3.90 per share for total
proceeds of $250,000.
o January 24, 2002, 74,074 common shares at $4.05 per share for total
proceeds of $300,000.
o March 18, 2002, 195,000 common shares at $4.20 per share for total
proceeds of $819,000.
On March 14, 2000, we became entitled to draw down on the $12 million
equity line of credit with Jaspas Investments Limited, a British Virgin Islands
corporation, through a common stock purchase agreement dated November 1, 1999
for the future issuance and purchase of Nymox's common shares. We plan to seek
additional capital within the limits on financing contained in the common stock
purchase agreement in order to accelerate product development and marketing and
obtaining necessary regulatory approvals.
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In general, the draw down facility created by the Jaspas agreement operates
as follows: the investor, Jaspas, is committed to purchase up to $12 million
common shares of Nymox over a thirty month period. Once a month, Nymox may
request a draw of up to $750,000 of that money, subject to a formula based on
average stock price and average trading volume, setting the maximum amount of
any request for any given draw. At the end of a 22 day trading period following
the draw down request, the amount of money that Jaspas will provide to Nymox and
the number of shares Nymox will issue to Jaspas in return for that money is
settled based on the formula in the stock purchase agreement. Jaspas receives a
six (6%) percent discount to the market price for the 22 day period and Nymox
receives the settled amount of the draw down less a 3% placement fee payable to
its placement agents, Ladenburg Thalmann & Co. Inc. and Paul Revere Capital
Corp.
The facility is based on a "use-it-or-lose" principle. We are under no
obligation to request a draw for any month. However if we do not request a draw
for a given month, we will never be able to draw those funds again. We may make
up to a maximum of twenty-four (24) draws. At July 1, 2002, Nymox had $2.25
million of financing available under this facility.
In lieu of providing Jaspas with a minimum draw down commitment, we agreed
to issue to Jaspas a stock purchase warrant to purchase up to 200,000 shares of
our common stock with an exercise price of 110% of our share price on the
closing date of November 12, 1999 or $4.53. Jaspas may purchase under the
warrant up to 100,000 Nymox shares any time between November 30, 1999 and
November 30, 2004. Jaspas may purchase the remaining 100,000 shares if and only
if we do not draw down at least $7 million within 18 months of March 14, 2000.
Since March 14, 2001, the following drawings have been made under this
common stock purchase agreement, for total proceeds of $1,327,273:
o August 16, 2000, 152,616 common shares at a volume weighted average
price of $3.2924 per share;
o October 12, 2000, 137,889 common shares at a volume weighted average
price of $3.6261 per share; and
o February 7, 2001, 161,696 common shares at a volume weighted average
price of $2.0240 per share.
o May 31, 2001, 56,108 common shares at a volume weighted average price
of $1.9466 per share.
Also, the Company has received total proceeds of $669,144 from the exercise
of 256,900 options since 1995 as follows:
o $355,536 for 158,900 shares at a per share price of $2.25.
o $258,858 for 83,000 shares at a per share price of $3.12.
o $16,000 for 5,000 shares at a per share price of $3.20.
o $38,750 for 10,000 shares at a per share price of $3.875.
Pursuant to the share purchase agreement entered into to acquire a
controlling interest of Serex, Inc., a total of 256,675 additional shares and
157,952 warrants were issued in exchange for the shares of Serex (see Note 4
"Business Acquisition" in the financial statements).
In total, Nymox has raised over $26 million, since its incorporation in May
1995.
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We have no financial obligations of significance other than long-term lease
commitments for our premises in the United States and Canada of $14,414 per
month in 2002 and ongoing research funding payments to a U.S. medical facility
totaling $292,000 for 2002. Total commitments beyond 2002 are summarized in note
7 to the consolidated financial statements.
Results Of Operations
Year Ended December 31, 2001 Compared To Year Ended December 31, 2000
Overview
Since inception, the Company has focused its activities on developing certain
pharmaceutical technologies and obtaining outside funding to support the
continued development of its technologies. The Company has incurred losses since
inception of operations. Future profitability will depend on the Company's
ability to generate revenues from the sale of products and the licensing of
technology sufficient to offset the expenditures required to further the
Company's research and development program and ongoing operations. See
"Information About The Company" for a description of the projects in the Company
pipeline.
Effective January 1, 2000, the Company adopted the US dollar as its measurement
currency. See note 2(a) to the consolidated financial statements. All amounts
presented are in US dollars.
In 2000, the Company acquired a majority interest in Serex, Inc. for a
consideration comprising common shares, warrants and options having a value of
approximately $1.3 million. See note 4 to the consolidated financial statements.
Critical Accounting Policies
In December 2001, the Securities and Exchange Commission ("SEC") released
"Cautionary Advice Regarding Disclosure About Critical Accounting Policies".
According to the SEC release, accounting policies are among the "most critical"
if they are, in management's view, most important to the portrayal of the
company's financial condition and most demanding on their calls for judgement.
Our accounting policies are described in note 2 to our consolidated financial
statements. We consider the following policies to be the most critical in
understanding the judgements that are involved in preparing our financial
statements and the matters that could impact our results of operations,
financial condition and cash flows.
REVENUE RECOGNITION
The Corporation applies guidance from SAB 101 (Staff Accounting Bulletin 101)
issued by the Securities and Exchange Commission in the recognition of revenue.
The Company derives its revenue from product sales, research contracts, license
fees and interest. Revenue from product sales is recognized when the product or
service has been delivered or obligations as defined in the agreement are
performed. Revenue from research contracts is recognized at the time research
activities are performed under the agreement. Revenue from license fees,
royalties and milestone payments is recognized upon the fulfillment of all
obligations under the terms of the related agreement. These agreements may
include upfront payments to be received by the Corporation. Upfront payments are
recognized as revenue on a systematic basis over the period that the related
services or obligations as defined in the agreement are performed. Interest is
recognized on an accrual basis.
Deferred revenue presented in the balance sheet as at December 31, 2001
represents amounts billed to and received from customers in advance of revenue
recognition.
The Company currently markets AlzheimAlert(TM) as a service provided by our CLIA
certified reference laboratory in New Jersey. Physicians send urine samples
taken from their patients to our laboratory where the AlzheimAlert(TM) test is
performed. The results are then reported back to the physicians. We recognize
the revenues when the test has been performed. The Company sometimes enters into
bulk sales of its diagnostic products to customers under
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which it has a continuing obligation to perform related testing services at its
laboratory. Although the Company receives non-refundable upfront payments under
these agreements, revenue is recognized in the period that the Company fulfils
its obligation or over the term of the arrangement. For research contracts and
licensing revenues, the Company usually enters into an agreement specifying the
terms and obligations of the parties. Revenues from these sources are only
recognized when there are no longer any obligations to be performed by the
Company under the terms of the agreement.
VALUATION OF CAPITAL ASSETS
The Company reviews the unamortized balance of intellectual property rights and
patents on an annual basis and recognizes any impairment in carrying value when
it is identified. Factors we consider important, which could trigger an
impairment review include:
o Significant changes in the manner of our use of the acquired assets or the
strategy for our overall business; and
o Significant negative industry or economic trends.
No impairment losses were recognized for the years ended December 31, 2001, 2000
and 1999.
VALUATION OF FUTURE INCOME TAX ASSETS
Management judgement is required in determining the valuation allowance recorded
against net future tax assets. We have recorded a valuation allowance of $6.4
million as of December 31, 2001, due to uncertainties related to our ability to
utilize some of our future tax assets, primarily consisting of net operating
losses carried forward, before they expire. In assessing the realizability of
future tax assets, management considers whether it is more likely than not that
some portion or all of the future tax assets will not be realized. The ultimate
realization of future tax assets is dependent upon the generation of future
taxable income and tax planning strategies. Since the Company is a development
stage enterprise, the generation of future taxable income is dependent on the
successful commercialization of its products and technologies.
Revenues
Revenues from sales amounted to $235,288 for the year ended December 31, 2001,
compared with $157,688 for the year ended December 31, 2000. The increase is
attributable to higher sales volumes for both AlzheimAlert(TM) ($113,132) and
NicAlert(TM) ($122,156) in 2001 compared to 2000 (AlzheimAlert(TM) $58,540 -
NicAlert(TM) $99,148). The Company also earned revenues from research and
licensing contracts ($127,403). Research contract revenue ($30,000) was funded
by the Foundation for Nutritional Advancement. A director and officer of the
Foundation is also a director of the Company. License fees ($97,403) include the
sale of certain rights to a third party in 2001 for which the Company has no
continuing obligations. Interest revenue was $17,918 in 2001 compared to $68,179
in 2000, due to lower average cash balances. In 2001, one customer accounted for
approximately 26% of revenues and, in total, 5 customers accounted for 54% of
revenues in 2001. In 2000 and 1999, no single customer accounted for more than
10% of revenues.
Expenses
Research and development expenditures were $1,499,654 for the year ended
December 31, 2001, compared with $2,084,232 for the year ended December 31,
2000. Management reduced its salary expenses in R&D by reducing staff, while
advancing its development of the products in the Company's pipeline. In 2001,
research tax credits amounted to $20,052 compared to $10,457 in 2000.
Marketing expenditures remained relatively constant at $343,244 for the year
ended December 31, 2001, in comparison to the expenditures of $363,142 for the
year ended December 31, 2000.
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General and administrative expenses amounted to $1,087,326 for the year ended
December 31, 2001, compared with $1,335,500 in the year ended December 31, 2000.
The decrease is principally due to reductions in professional fees.
Foreign Exchange
The Company incurs expenses in the local currency of the countries in which it
operates, which include the United States and Canada. Approximately 75% of 2001
expenses (75% in 2000) were in U.S. dollars. Foreign exchange fluctuations had
no meaningful impact on the Company's results in 2001 or 2000.
Results of Operations
Net losses for the period ended December 31, 2001 were $3,049,504, or $0.14 per
share, compared to $4,023,979, or $0.19 per share, for the same period in 2000.
The weighted, fully diluted, average number of common shares outstanding for the
period ending December 31, 2001 were 21,995,694 compared to 21,130,286 for the
same period in 2000.
Financial Position
Liquidity and Capital Resources
As of December 31, 2001, cash totaled $488,987 and receivables totaled $152,968.
In November 1999, the Company signed a common share purchase agreement whereby
the investor is committed to purchase up to $12 million of the Company's common
shares over a thirty-month period commencing March 2000, when our F-1
registration statement was declared effective. As at December 31, 2001, four
drawings have been made under this share purchase agreement, for total proceeds
of $1,436,364. Specifically, on August 16, 2000, 152,616 common shares were
issued at a volume weighted average price of $3.2924 per share; on October 12,
2000, 137,889 common shares were issued at a volume weighted average price of
$3.6261 per share, on February 7, 2001, 161,696 common shares were issued at a
volume weighted average price of $2.0240 and on May 31, 2001, 56,108 common
shares were issued at a volume weighted average price of $1.9466. The Company
intends to access financing under this agreement when appropriate to fund its
research and development.
In 2001, the Company completed private placements for 594,100 common shares and
received aggregate proceeds of $1,799,490. On March 6, 2001, 200,000 shares were
issued at a price of $2.06 in a private placement for total proceeds of
$412,000. The private placement included 100,000 warrants, which expire on March
6, 2003, exercisable at a price of $2.06. On August 3, 2001, 80,000 shares were
issued at a price of $2.50 in a private placement for total proceeds of
$200,000. On August 22, 2001, 140,000 shares were issued at a price of $3.75 in
a private placement for total proceeds of $525,000. On October 3, 2001, 110,000
shares were issued at a price of $3.75 in a private placement for total proceeds
of $412,490. On November 14, 2001, 64,100 shares were issued at a price of $3.90
in a private placement for total proceeds of $250,000. A total of $318,055 was
also raised through stock option exercises at prices ranging from $2.25 to
$3.875. The Company intends to raise additional capital in 2002 in order to
pursue its development. To March 31, 2002, the Company completed two private
placements and issued 269,074 common shares for total proceeds of $1,119,000.
The Company believes that funds from operations as well as from existing equity
facilities will be sufficient to meet the Company's cash requirements for the
next twelve months.
The Company invested $340,662 in additional capital assets in the year ended
December 31, 2001, consisting mostly of patent costs, compared to $381,568 in
the same period in 2000.
The Company intends to raise additional capital in 2002 in order to pursue its
development. However, the Company believes that funds from operations as well as
from existing equity facilities will be sufficient to meet the Company's cash
requirements for the next twelve months.
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Year Ended December 31, 2000 Compared To Year Ended December 31, 1999
Revenue
Revenues from sales amounted to $157,688 for the year ended December 31, 2000,
compared with $153,252 for the year ended December 31, 1999. Sales for fiscal
2000 include the revenues from sales of the NicAlert(TM) test of $99,148 and for
the diagnostic test AlzheimAlert(TM) and its predecessor AD7C(TM) of $58,540.
The price for AlzheimAlert(TM) was reduced in 2000, resulting in a drop in
revenue but not in sales volume for this product. Interest revenue was $68,179
in 2000, compared to $36,951 in 1999, derived from interest earned on the
Company's cash balances. The AlzheimAlert(TM) test is an improved version of
this diagnostic product and we anticipate an increase in sales volume and
revenue for this product in the coming years.
Expenses
Research and development expenditures were $2,084,232 for the year ended
December 31, 2000, compared with $1,137,122 for the year ended December 31,
1999, reflecting a net increase in expenditures in the development of the
products in the Company's existing pipeline of $860,380, as well as development
of the potential products acquired with the acquisition of Serex Inc. of
$86,730. In 2000, research tax credits amounted to $10,457 compared to $4,181 in
1999.
Management reduced its marketing activities resulting in a decrease in
expenditures to $363,142 for the year ended December 31, 2000 compared to
$942,205 for the year ended December 31, 1999.
General and administrative expenses amounted to $1,335,500 for the year ended
December 31, 2000, compared with $1,229,894 in the year ended December 31, 1999.
The increase was principally due to the acquisition of Serex Inc. in 2000.
Results of Operations
Net losses for the period ended December 31, 2000 were $4,023,979, or $0.19 per
share, compared to $3,314,296, or $0.17 per share, for the same period in 1999.
The weighted average number of common shares outstanding for the period ending
December 31, 2000 were 20,890,735 compared to 19,886,430 for the same period in
1999.
The Company invested $381,568 in additional capital assets in the year
ended December 31, 2000, consisting mostly of patent costs, compared to $164,783
in the same period in 1999.
Year Ended December 31, 1999 Compared To Year Ended December 31, 1998
Revenue
Revenues on sales for the AD7C(TM) test amounted to $153,252 for the year ended
December 31, 1999, compared with $104,804 for the year ended December 31, 1998,
reflecting an increase in sales volume for this test. All of the sales revenue
was derived from our AD7C(TM) urine test service offered in our clinical
reference laboratory. Interest revenue was $36,951 in 1999 compared to $168,761
in 1998, derived from interest earned on the cash and short-term investments
received from the private placements referred to previously.
Expenses
Research and development activities were reorganized resulting in a decrease in
expenditures to $1,137,122 for the year ended December 31, 1999, compared with
$2,091,745 for the year ended December 31, 1998. In 1999, research tax credits
amounted to $4,181 compared to $4,003 in 1997.
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Management reduced its marketing activities resulting in a decrease in
expenditures to $942,205 for the year ended December 31, 1999 compared to
$2,245,023 for the year ended December 31, 1998.
General and administrative expenses amounted to $1,229,894 for the year ended
December 31, 1999, compared with $550,269 in the year ended December 31, 1998.
This rise is attributable to net increases in professional fees of $195,242,
shareholder relations of $256,063, and in administrative personnel of $101,943.
Results of Operations
Net losses for the period ended December 31, 1999 were $3,314,296, or $0.17 per
share, compared to $4,783,213, or $0.25 per share, for the same period in 1998.
Inflation
We do not believe that inflation has had a significant impact on the
results of our operations.
ACQUISITION OF A CONTROLLING INTEREST IN SEREX, INC.
On January 8, 2000, we entered into an agreement to acquire a controlling
interest in Serex, Inc. under a share purchase agreement with Dr. Judith
Fitzpatrick, the Chief Executive Officer and majority shareholder of Serex. On
March 2, 2000, we closed this acquisition. We have subsequently acquired more
shares of the common stock of Serex, Inc. from other shareholders and now own
approximately 98% of its common stock.
Under the share purchase agreement with Dr. Fitzpatrick, we purchased
1,008,250 shares of Serex or 72.3% of the common stock of Serex from her in
exchange for 187,951 shares of Nymox and warrants to purchase 115,662 shares of
Nymox at a price of $3.70. The acquisition price was based on the closing market
price for Nymox shares as of Nov. 16, 1999, which was $3.3438.
The Nymox shares we issued to Dr. Fitzpatrick now may be sold or
transferred in accordance with an exemption under United States securities laws,
rules and regulations and are no longer restricted under the stock purchase
agreement.
Dr. Fitzpatrick has also agreed that she may only exercise her warrants to
purchase 115,662 Nymox shares according to the following timetable:
o 30,000 warrants, to be exercisable on or after January 8, 2001;
o 30,000 warrants, to be exercisable on or after January 8, 2002;
o 30,000 warrants, to be exercisable on or after January 8, 2003; and
o 25,662 warrants, to be exercisable on or after January 8, 2004.
The warrants have a five-year term beginning on January 8, 2000.
Serex has issued convertible preferred shares, 10,137 to Bristol-Meyers
Squibb Company, a major pharmaceutical company, and 10,137 to Hologic Inc., a
diagnostic company, under a series of licensing and development agreements. The
holders of these preferred shares have the right to convert their preferred
shares to common shares according to a formula set out in Serex's amended
articles of incorporation. At present, one preferred share would convert to ten
common shares. If converted to common stock, the preferred shares would
represent 14.5% of the outstanding common stock of Serex.
The preferred shareholders have a right to vote with the holders of the
common stock of Serex as if they had converted their preferred shares to common
stock.
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The preferred shareholders also have a right to redeem up to 50% of their
shares in certain circumstances after March 31, 2000 for a payment of $39.46 per
preferred share redeemed. Thus, if the full 50% of preferred shares were
redeemed, the redemption price would be $400,000.
The preferred shares also have preferential rights ahead of the common
shares, to any dividends and to the assets of the corporation on liquidation,
dissolution or winding up of the affairs of Serex. On merger or consolidation of
Serex, the preferred shareholders may, in certain circumstances, elect to treat
the merger or consolidation as a liquidation and to receive the redemption price
for their shares; otherwise the preferred shares would be converted into common
shares based on the conversion formula and treated like the other common shares.
About Serex
Serex is a privately held diagnostic company that was founded in 1983 and
is based in Maywood, New Jersey.
Serex assisted in the development of Nymox's AlzheimAlert(TM) test and the
patenting of some of the technology relating to AlzheimAlert(TM).
Serex also developed and patented its particle valence technology, a
unique, highly sensitive, new method to detect very small amounts of biochemical
indicators in body fluids such as blood, urine and saliva. Serex incorporated
this technology in its LabTab(TM) assay, which enables the easy and rapid
testing of samples by general-purpose medical laboratories or in doctors'
offices.
Serex licensed the Japanese rights to two of its principal patents to
Mizuho Medy Co. Ltd. of Japan.
Serex's diagnostic technology can be adapted to detect a wide range of
biochemical indicators for diseases, conditions and drug use. Preliminary work
at Serex has identified a wide range of potential applications for its patented
technology from detecting an early indicator of pregnancy, to detecting a brain
protein implicated in certain brain diseases, from detecting indicators for
heart disease, determining blood sugar levels in a type of diabetes and to
monitoring therapeutic drug levels.
Serex developed NicoMeter(TM) and NicAlert(TM), which can reliably detect
one of the metabolic products of nicotine in human urine and saliva
(NicAlert(TM) only), enabling it to determine whether a person, such as a
teenager or insurance applicant, is using a tobacco product. NicAlert(TM) and
NicoMeter(TM) are currently being distributed in Japan by Mizuho Medy Co. Ltd.
of Japan and outside of Japan by Nymox and Jant Pharmacal Corporation.
In November, 1999, Serex was granted a United States patent for an antibody
and for the use of the antibody in its technology in order to detect one of the
biochemical indicators for the loss of bone matter, which is a sign of
osteoporosis, a common bone disease in humans. Osteoporosis results from the
progressive loss of bone material and can cause disabling and potentially
life-threatening bone fractures in particular of the spine and the hips. It is
most common in the elderly and in post-menopausal women.
Serex has under development a test that can potentially detect biochemical
indicators of cholesterol in human saliva and therefore provide an inexpensive,
convenient and reliable method of determining and monitoring cholesterol levels.
Since 1996, Serex has collaborated with at least three major pharmaceutical
companies and two diagnostic companies under licensing and development
agreements concerning the development of some of these products. These
agreements contain confidentiality provisions that prohibit the disclosure of
their terms.
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USE OF PROCEEDS
We will not realize any proceeds from the sale of the common shares by
Jaspas; rather, Jaspas will receive those proceeds directly. However, we will
receive cash infusions of capital if and when Jaspas purchases our common shares
in accordance with the stock purchase agreement with Jaspas or with the stock
purchase warrant. We intend to use the proceeds from the sale of common shares
to Jaspas to fund our continuing research, our product development programs and
necessary clinical trials, as well as for marketing, working capital and other
general corporate purposes.
THE COMMON STOCK PURCHASE AGREEMENT
Summary
Nymox and Jaspas Investments Limited, a British Virgin Islands corporation,
signed a common stock purchase agreement dated November 1, 1999 for the future
issuance and purchase of Nymox's common shares. The transaction closed on
November 12, 1999.
The stock purchase agreement establishes what is sometimes termed an equity
line of credit or an equity draw down facility.
In general, the draw down facility operates like this: the investor,
Jaspas, committed up to $12 million to purchase Nymox's common shares of Nymox
over a thirty month period. Once a month, Nymox may request a draw of up to
$750,000 of that money, subject to a formula based on average stock price and
average trading volume, setting the maximum amount of any request for any given
draw. At the end of a 22 day trading period following the draw down request, the
amount of money that Jaspas will provide to Nymox and the number of shares Nymox
will issue to Jaspas in return for that money is settled based on the formula in
the stock purchase agreement. Jaspas receives a six (6%) percent discount to the
market price for the 22 day period and Nymox receives the settled amount of the
draw down less a 3% placement fee payable to the placement agent, Ladenburg
Thalmann & Co. Inc., which introduced Jaspas to Nymox. Ladenburg Thalmann is not
obligated to purchase any Nymox shares.
The facility is based on a "use-it-or-lose" principle. We are under no
obligation to request a draw for any month. However if we do not request a draw
for a given month, we may never to be able to draw those funds again. We may
make up to a maximum of twenty-four (24) draws; however, the aggregate total of
all draws cannot exceed $12 million.
In lieu of providing Jaspas with a minimum draw down commitment, we agreed
to issue to Jaspas a stock purchase warrant to purchase up to 200,000 shares of
our common stock with an exercise price of 110% of our share price on the
closing date of November 12, 1999 or $4.53. Jaspas may purchase under the
warrant up to 100,000 Nymox shares any time between November 30, 1999 and
November 30, 2004. Jaspas may purchase the remaining 100,000 shares if and only
if we do not draw down at least $7 million within 18 months of March 14, 2000.
The draw down procedure and the stock purchases. We may make up to
twenty-four draw downs during the term of the stock purchase agreement.
We may request a draw down by faxing a draw down notice to Jaspas, setting
out the amount of the draw down we wish to exercise and the minimum threshold
price, if any, at which we are willing to sell the shares.
The minimum draw down amount is $150,000. The maximum is $750,000 subject
to the following limiting formulas:
o For draw downs up to $500,000
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Maximum amount of draw down = 20% of average stock price multiplied by
average trading volume multiplied by 22
where
Average Stock Price = Average of the daily price of Nymox's shares
for the 22 trading days prior to the draw
down period
Average Trading Volume = Average
daily trading volume for the
45 trading days prior to the
draw down period.
o For draw downs greater than $500,000 and up to $750,000
If, during the 30 Trading Days prior to the draw down notice, the average
daily trading volume is at least 60,000 shares and the average of the average
daily price is at least $4.50 per share, then we may draw up to $750,000.
The next 22 trading days immediately following the draw down notice are
used to determine the actual amount of money Jaspas will provide and the number
of shares Nymox will issue in return. The 23rd trading day is the draw down
exercise date when the amount of the draw and the number of shares to be issued
is calculated based on the following formula:
number of common shares = Sum over each of the 22 trading days
of 1/22 of the draw down amount divided
by 94% of the daily price for Nymox shares
on each trading day.
If the daily price for any given trading day during the draw down period is
below the threshold price set by Nymox in the draw down notice, then that day is
not included in the calculation of the number of shares to be issued and the
draw down amount that Jaspas is to pay to Nymox is correspondingly reduced by
1/22 for that day. Thus, if the daily price for that day is below the threshold
price Nymox will not issue any shares and Jaspas will not purchase any shares
for that day.
The following is an example of the calculation of the draw down amount and
the number of shares to be issued to Jaspas in connection with that draw down
based on certain assumptions.
Sample draw down amount calculation.
o Nymox provides a draw down notice to Jaspas that it wishes to draw
down $400,000.
o The average of daily volume weighted average price of Nymox's common
shares for 22 trading days prior to the draw down notice is $3.50.
o The average daily trading volume for the 45 trading days prior to the
draw down notice is 25,000 shares.
o The maximum dollar amount that can be drawn down is:
20% of $3.50 multiplied by 25,000 multiplied by 22 or $385,000.
On these assumed facts, Nymox could draw $385,000 out of the $400,000 requested
in the draw down notice.
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Sample calculation of number of shares
Assume that the maximum draw down amount for the draw down period is
$385,000 and assume that the daily volume weighted average price for Nymox's
shares is as set out in the table below. The number of shares to be issued based
on any trading day during the draw down period is calculated from the formula:
(1/22 of the draw down amount) divided by (94% of the daily price).
For the first trading day in the example in the table below, the calculation is
as follows:
(1/22 of $385,000) divided by (94% of $3.50 per share) or 5,319 shares.
The number of shares to be issued for the draw down period in the example is
calculated as follows:
o for each trading day in the 22 day period, the number of shares to be
issued is based on the daily price of Nymox's shares for that day and
calculated using the formula above; and
o the number of shares to be issued for each of the 22 trading days is
then totaled to arrive at the number of shares to be issued to Jaspas
at the end of the draw down period for the purchase price of $385,000,
the draw down amount.
Number of Shares to
1/22 of Draw Down be issued based on
Trading Day Daily Stock Price Amount of $385,000 that trading day
----------------------- ---------------------------- ---------------------------- ----------------------------------
1 $3.50 $17,500 5,319
2 $3.625 $17,500 5,136
3 $3.50 $17,500 5,319
4 $3.375 $17,500 5,516
5 $3.50 $17,500 5,319
6 $3.75 $17,500 4,965
7 $3.875 $17,500 4,804
8 $4.00 $17,500 4,654
9 $4.25 $17,500 4,380
10 $3.75 $17,500 4,965
11 $3.50 $17,500 5,319
12 $3.25 $17,500 5,728
13 $3.00 $17,500 6,206
14 $3.25 $17,500 5,728
15 $3.375 $17,500 5,516
16 $3.50 $17,500 5,319
17 $3.625 $17,500 5,136
18 $3.75 $17,500 4,965
19 $3.875 $17,500 4,804
20 $4.00 $17,500 4,654
21 $3.75 $17,500 4,965
22 $3.50 $17,500 5,319
TOTAL $385,000 114,037 shares to be issued for
the draw down period
In this fictitious example, Nymox would issue 114,037 shares for this draw
down period. It would receive $385,000 less the 3% fee to the placement agent or
$373,450.
-40-
The delivery of the requisite number of shares and payment of the draw is
effected through an escrow agent. The escrow agent pays 97% of the draw to Nymox
and 3% to Ladenburg Thalmann & Co. Inc., our placement agent, in satisfaction of
placement agent fees.
Only one draw down can occur during this 22 day draw down period and Nymox
must wait a minimum of five trading days from the end of one draw down period
before issuing the next draw down notice and beginning the process again.
Necessary Conditions Before Jaspas is Obliged to Purchase Nymox's Shares
The following conditions must be satisfied before Jaspas is obligated to
purchase the common shares that Nymox wishes to sell:
o A registration statement for the shares Nymox will be issuing must be
declared effective by the Securities and Exchange Commission and must
remain effective and available as of the draw down settlement date for
making resales of the common shares purchased by Jaspas.
o There can be no material adverse change in Nymox's business,
operations, properties, prospects or financial condition not publicly
reported since the most recent prior draw down exercise date.
o No statute, rule, regulation, executive order, decree, ruling or
injunction may be in effect which prohibits consummation of the
transactions contemplated by the stock purchase agreement.
o No litigation or proceeding adverse to Nymox, Jaspas or their
affiliates, can be pending, nor any investigation by any governmental
authority threatened against them seeking to restrain, prevent or
change the transactions contemplated by the stock purchase agreement
or seeking damages in connection with such transactions.
o Trading in Nymox's common shares must not have been suspended by the
Securities and Exchange Commission or the Nasdaq SmallCap Market, nor
shall minimum prices have been established on securities whose trades
are reported by the Nasdaq SmallCap Market.
On each draw down settlement date for the sale of common shares, Nymox must
deliver an opinion from its counsel about these matters.
A further condition is that Jaspas may not purchase more than 19.9% of
Nymox's common shares issued and outstanding on November 12, 1999, the closing
date under the stock purchase agreement, without obtaining approval from Nymox
shareholders for such excess issuance.
Restrictions on Future Financings for Nymox
The stock purchase agreement limits Nymox's ability to raise money by
selling its securities for cash at a discount to the current market price for at
least eighteen months. Specifically, Nymox may not sell its securities for cash
at a discount to current market price until the earlier of
o eighteen months from March 14, 2000, the effective date of the
registration statement of which this prospectus is a part, or, if
later, the date that Nymox has drawn down at least $8,000,000 or
o sixty days after Jaspas has purchased the maximum $12 million of
common shares from Nymox.
-41-
There are important exceptions to this limitation. Nymox can sell its
shares for cash at a discount to the current market price:
o in a registered public offering of its securities underwritten by one
or more established investment banks;
o in one or more private placements where the purchasers do not have
registration rights;
o under any employee benefit plan approved by the shareholders of Nymox;
o under any compensatory plan for a full-time employee or key
consultant;
o in connection with a strategic partnership or other business
transaction, the principal purpose of which is not simply to raise
money; or
o for which Jaspas has given its written approval.
The Warrants Issued to Jaspas
Under the stock purchase agreement, we granted Jaspas a warrant to purchase
200,000 shares of Nymox's common shares, exercisable for a period of five (5)
years from November 30, 1999, at an exercise price equal to 110% of the average
daily price of the common shares on the closing date of November 12, 1999. The
average daily price of Nymox's shares for that day was $4.1097; thus the
exercise price for the warrant is $4.53.
The warrant permits Jaspas to purchase up to 100,000 shares at any time
after November 30, 1999 and before the close of business on November 30, 2004.
Jaspas may purchase the remaining 100,000 shares in the warrant if and only
if Nymox has not draw down at least $7,000,000 within eighteen months from the
effective date of the registration statement.
Costs of Closing the Transaction
At the closing of the transaction on November 12, 1999, we delivered the
warrant for the 200,000 common shares and the requisite opinion of counsel to
Jaspas and paid the escrow agent, Epstein Becker & Green P.C. $35,000 for
Jaspas's legal, administrative and escrow costs and for the ordinary services of
the escrow agent for each closing of a draw down. We also paid a placement fee
of $100,000 to Ladenburg Thalmann & Co. Inc. and an additional $35,000 for its
expenses. Ladenburg Thalmann & Co. Inc. will also receive warrants for a total
of 160,000 common shares of Nymox with a strike price of 100% of the closing bid
for Nymox shares on November 12, 1999 or $4 1/16. Ladenburg Thalmann is not
obligated to purchase any Nymox shares.
Termination of the stock purchase agreement
Jaspas may terminate the equity draw down facility under the stock purchase
agreement if any of the following events occur:
o Nymox suffers a material adverse change in its business operations,
properties, prospects or financial condition;
o the common shares of Nymox are delisted from the Nasdaq SmallCap
Market unless such is in connection with the listing of such shares on
a comparable stock exchange in the United States;
-42-
o Nymox files for protection from creditors, or;
o Nymox completes any of the financing transactions prohibited under the
stock purchase agreement.
Indemnification of Jaspas
Jaspas is entitled to customary indemnification from Nymox for any losses
or liabilities suffered by it based upon material misstatements or omissions
from the registration statement and the prospectus, except as they relate to
information supplied by Jaspas to Nymox for inclusion in such registration
statement and prospectus.
Jaspas's resale of the common shares
Jaspas has agreed that its trading and distribution activities with respect
to the common shares will be in compliance with all applicable United States
state and federal securities laws, rules and regulations; all Canadian
securities laws, rules and regulations; and the rules and regulations of the
Nasdaq SmallCap Market. Jaspas has further acknowledged that the common shares
may not be traded in a Canadian province until the expiration of the period
during which a purchaser resident in such province, purchasing under similar
circumstances, would be required to hold the common shares, except as otherwise
permitted by the laws, rules and regulations of such province. All sales by
Jaspas must be made in compliance with Regulation M under the Securities and
Exchange Act of 1934.
To permit Jaspas to resell the common shares issued to it under the stock
purchase agreement or under the warrant, Nymox agreed to register those shares
and to maintain that registration. To that end, Nymox will prepare and file such
amendments and supplements to the registration statement and the prospectus as
may be necessary in accordance with the Securities Act and the rules and
regulations promulgated thereunder, in order to keep it effective until the
earlier of any of the following dates:
o the date that none of the common shares covered by the registration
statement of which this prospectus is a part are or may become issued
and outstanding;
o the date that all of the common shares covered by the registration
statement of which this prospectus is a part have been sold pursuant
to such registration statement;
o the date the holders of the common shares receive an opinion of
counsel to Nymox, such counsel to be reasonably acceptable to Jaspas,
that such common shares may be sold under the provisions of Rule 144
under the Securities Act of 1933 without limitation as to volume;
o the date that all of the common shares have been otherwise transferred
to persons who may trade such shares without restriction under the
Securities Act of 1933 and Nymox has delivered new certificates or
other evidences of ownership of such common shares without any
restrictive legend; or
o the date that all of such common shares may be sold without any time,
volume or manner limitations under Rule 144(k) or similar provision
then in effect under the Securities Act of 1933 in the opinion of
counsel to Nymox, such counsel to be reasonably acceptable to Jaspas.
The Number of Shares Nymox Will Issue to Jaspas
The number of common shares that Nymox will issue to Jaspas depends on four
key factors:
o the number of draw downs Nymox exercises;
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o the average trading volumes for its stock for the 45 trading days
prior to each draw down period;
o the average stock price for its stock for the 22 trading days prior to
each draw down periods; and
o the average daily prices for its stock on each of the 22 days during a
draw down period.
The fewer the number of draw down Nymox exercises, the fewer the shares we
will issue to Jaspas. The stock purchase agreement provides for 24 draw downs in
a 30 month period with each draw down period consisting of 22 trading days with
at least 5 trading days between each draw down period. Thus, any decision by
Nymox to delay or forego any draw down opportunity may result in Nymox's being
unable to exercise all 24 draw downs available in the 30 month period.
The average stock price and the average trading volume prior to a draw down
period determine the maximum amount of the draw down for that period. A decline
in the trading volume or price of our stock may result in a reduction in the
amount of money Nymox is able to draw down and a corresponding reduction in the
number of shares Nymox must issue for that period.
The average daily price for each of the 22 trading days within a draw
period and the draw down amount determine the number of shares Nymox will issue
to Jaspas at the end of that period. Jaspas will purchase those shares at a 6%
discount to the average daily price.
For any given draw period, the lower the average daily price, the more
common shares Jaspas will receive for the draw down amount. The table on page 23
above in the section of this prospectus entitled "The Common Stock Purchase
Agreement" and under the headings "The Draw Down Procedure and the Stock
Purchases" and "Sample Calculation of Number of Shares" illustrates how a change
in the daily stock price can affect the number of shares issued for a constant
amount of draw down. This table uses a constant draw down amount of $17,500 for
each day. When the stock price goes down, the number of shares issued goes up.
Conversely, when the stock price goes up, the number of shares issued goes down.
However, lower average daily prices through the term of the stock purchase
agreement may not necessarily have the effect of substantially increasing the
number of shares issued. Lower stock prices during one draw period will reduce
the average stock price for the next draw down period. Assuming relatively
constant trading volumes, this reduction may limit the draw down amount and the
number of shares Nymox can issue for that next period.
Based on a review of its trading volume and stock price history and a
consideration of the factors above, Nymox is registering 4,800,000 common shares
for possible issuance under the stock purchase agreement and 200,000 shares
underlying the warrant for common shares already delivered to Jaspas.
In order to comply with the listing requirements of the Nasdaq SmallCap
Market, Nymox may not issue more than 3,980,757 shares to Jaspas, which is 19.9%
of the issued and outstanding common shares of Nymox on November 12, 1999, the
date of the closing of the stock purchase agreement, without the approval of its
shareholders. In the event that Nymox wishes to draw amounts under the stock
purchase agreement which would cause an issuance of more than 19.9% of its
issued and outstanding shares, Nymox must receive shareholder approval prior to
any such draw down.
SELLING SECURITY HOLDER
Jaspas is engaged in the business of investing in publicly-traded equity
securities for its own account. Jaspas's principal offices are located in the
British Virgin Islands, c/o Beacon Capitol Management, Harbour House, 2nd Floor,
Waterfront Drive, Road Town, Tortals, British Virgin Islands. Investment
decisions for
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Jaspas are made by its Board of Directors, consisting of Mr. Hans Gassner, Dr.
Kurt Alig and Dr. Alex Weiderkehr.
Jaspas has purchased 508,309 common shares of Nymox as of May 31, 2002, for
a total proceeds of $1,436,365, and other than its obligations to purchase
common shares under the stock purchase agreement and the warrant for 200,000
shares issued to it on November 12, 1999, it has no other commitments or
arrangements to purchase or sell any securities of Nymox.
There are no business relationships between Jaspas and Nymox other than the
stock purchase agreement.
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DIRECTORS AND OFFICERS OF NYMOX
Directors And Senior Management
Dr. Paul Averback, M.D., D.A.B.P., 51, President and Director since
September 1995 and Chairman since June of 2001, is the founder of Nymox and the
inventor of much of its initial technology. Prior to founding Nymox, Dr.
Averback served as President of Nymox's predecessor, DMS Pharmaceuticals Inc. He
received his M.D. in 1975 and taught pathology at universities, including
Cambridge University, England (1977-1980), during which time he initiated his
research on Alzheimer's disease. He has practiced medicine in numerous Canadian
institutions as well as in private practice. Dr. Averback has published
extensively in the scientific and medical literature.
Dr. Hans Black, MD, 48, Director since May 13, 1999, has a doctorate in
medicine from McGill University, and has been Chairman and Chief Investment
Officer of Interinvest Consulting Corporation, a Montreal-based global money
management firm with offices in Toronto and Boston and affiliates in Bermuda and
Zurich, for over twenty five years. Dr. Black appears regularly on the PBS
network show, Nightly Business Report, and has been a guest lecturer at Harvard,
Temple and McGill Universities. Dr. Black is a member of the boards of Fonds de
Recherche de l'Institut de Cardiologie de Montreal and L'Opera de Montreal, a
member of the Advisory Council of The Paul H. Nitze School of Advanced
International Studies of Johns Hopkins University, and is a member of the board
of the NASDAQ-listed Nymox Corporation. In addition, Dr. Black serves as
chairman of the board of the Quebec-based food company, Les Aliments SoYummi
Inc.
Jack Gemmell, 50, has been a Director since June, 2001 and is Nymox's
General Counsel and Chief Information Officer. He graduated from the Faculty of
Law at the University of Toronto in 1977 and was called to the bar in 1979. He
practiced in private practice primarily in the area of litigation for over 19
years with before joining Nymox in July, 1998.
Michael R. Sonnenreich, 64, Director since April 18, 2000, is a graduate of
Harvard University Law School, and has been Senior Partner of Michael
Sonenreich, P.C. since 1973, Chairman and CEO of Kikaku America International
for the past fifteen years, and President and CEO of Glocal Communications Corp.
Ltd. of London for the past five years. He is also Vice Chairman of PharMa
International Corporation of Tokyo, Director of Asset Advisory Services of
Zurich, Member of the Board of Advisors of John Hopkins University School of
Advanced International Studies and Member of the Board of Overseers of Tufts
University Medical School. Mr. Sonnenreich has in the past been a Board Member
or a Trustee of numerous important companies and universities, and has long-term
involvements with many non-profit institutions, and served as President of the
National Coordinating Council on Drug Education.
Professor Walter P. von Wartburg, 63, Director since April 18, 2000, is a
partner in the private law practice of Law & Life Sciences in Basel,
Switzerland, specializing in biotech and drug regulatory affairs. Prior to
joining Law & Life Sciences, Professor von Wartburg spent 32 years in the
pharmaceutical industry. Most recently, from 1996 to 1999, he was Chief
Information Officer of Novartis and from 1990-1996, he was Chief of Staff of
Ciba-Geigy (which merged with Sandor in 1996 to form Novartis). From 1980 to
1990, he was a member of the Executive Committee of Ciba-Geigy. He is a graduate
of the Universities of Basel, Paris, Princeton, Stanford and Harvard Law School;
Member of the Basel Bar Association and Professor on public health policy at the
Saint Gall Graduate School of Economics, Business and Public Administration. He
is author of various books and articles on drug abuse, pharmaceutical
legislation, biotechnology, issues management, communications and business
administration. He is also the Founder-President of the Swiss Foundation for the
Mentally Handicapped "PRO MENTE SANA;" Member of the National Advisory Board of
the Bioethics Institute of the Johns Hopkins University and past Chairman of the
Board of the University Hospital of Basel.
-46-
Michael Munzar, M.D., 48, Medical Director since June 1, 1996, received an
M.D. from the Faculty of Medicine, McGill University, in 1979. He practiced
medicine for over 15 years in a variety of institutional and private practice
settings. He has a diverse medical background that includes most aspects of
medical care, including geriatrics and psychiatry. He also has extensive
business experience with the establishment, operation and management of medical
facilities.
Mr. Roy M. Wolvin, 47, Secretary-Treasurer and Chief Financial Officer
since September 1995. Prior to September 1995, Mr. Wolvin was Account Manager,
private business, for a Canadian chartered bank. Mr. Wolvin holds a degree in
Economics from the University of Western Ontario.
Compensation
The table below provides compensation information for the fiscal year ended
December 31, 2001 for each executive officer of Nymox and for the directors and
executive officers as a group.
Summary Compensation Table
Fiscal Year ending Fiscal Year ending
Dec. 31, 2001 Dec. 31, 2000
NAME AND OTHER CASH OTHER CASH
PRINCIPAL POSITION SALARY COMPENSATION SALARY COMPENSATION
Dr. Paul Averback CAN$50,000 -- CAN$137,500 --
President and C.E.O. (US$31,391) (US$86,326)
Mr. Roy Wolvin CAN$70,000 -- CAN$84,375 --
Secretary-Treasurer (US$43,948) (US$52,973)
Mr. Jack Gemmell CAN$96,000 -- CAN$118,161 --
General Counsel (US$60,271) (US$74,184)
Dr. Michael Munzar CAN$138,000 -- CAN$171,000 --
Medical Director (US$86,640) (US$107,358)
All directors and senior CAN$354,000 CAN$511,036 --
management as a group (US$222,250) (US$320,841)
Nymox does not have written employment contracts with any of the senior
management.
Directors of Nymox, with the exception of the President and our General
Counsel, are paid a fee of $1,000 for each board meeting attendance and are
reimbursed for expenses incurred in connection with their office.
The Company does not have any pension plans or other type of plans
providing retirement or similar benefits for senior management.
Board Practices
Directors are elected at each annual meeting for a term of office until the
next annual meeting. Executive officers are appointed by the board of directors
and serve at the pleasure of the board. Other than Dr. Averback, no other
officer or director previously was affiliated with DMS Pharmaceuticals Inc.
There are no family relationships between any director or executive officer
and any other director or executive officer.
-47-
Nymox does not have written contracts with any of the directors named
above. The Company does not have any pension plans or other type of plans
providing retirement or similar benefits for directors, nor any benefits upon
termination of service as a director.
Nymox's Audit Committee recommends to the Board of Directors the firm to be
appointed each year as independent auditors of the company's financial
statements and to perform services related to the completion of such audit and
the compensation to be paid to the firm. The Audit Committee also has
responsibility for:
o reviewing the scope and results of the audit with the independent
auditors;
o reviewing with management and the independent auditors the company's
interim and year-end financial condition and results of operations;
o considering the adequacy of the internal accounting, bookkeeping and
control procedures of the company; and
o reviewing any non-audit services and special engagements to be
performed by the independent auditors and considering the effect of
such performance on the auditors' independence.
The Audit Committee also reviews at least once each year the terms of all
material transactions and arrangements between the company and its affiliates.
The Chairman of the Audit Committee is Hans Black, M.D. and the other members
are Michael Sonnenreich and Walter von Wartburg.
Nymox's Human Resources and Compensation Committee establishes and reviews
overall policy and structure with respect to compensation matters, including the
determination of compensation arrangements for directors, executive officers and
key employees of the company. The Committee is also responsible for the
administration and award of options to purchase shares pursuant to the company's
option and share purchase plans. The Chairman of the Human Resources and
Compensation Committee is Professor Walter von Wartburg and the other members
are Dr. Hans Black, Michael Sonnenreich and Paul Averback, M.D. (ex officio).
Employees
In addition to the employees in its Maywood and St.-Laurent laboratories
and offices, Nymox carries out its work with the assistance of an extensive
group of research collaborators, out-sourced manufacturing teams, research
suppliers, research institutions, service providers and research consultants. To
help carrying out its marketing, Nymox has over 60 independent medical
representatives detailing its products.
In its Maywood and St.-Laurent laboratories and offices, for the year 2001,
the company employed on the average twenty-one persons with fifteen in research
and development and six in administration and marketing; for the year 2000
twenty-three persons (eighteen in research and development and five in
administration and marketing); and for the year 1999, twenty-nine persons
(sixteen in research and development and thirteen in administration and
marketing).
Share Ownership
As of May 31, 2002, the numbers of common shares owned by and options
granted to directors and senior officers of the Corporation were as follows:
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Options Options Expiry Date
Name Common Shares Owned Vested Not Vested Exercise Price M/D/Y
Paul Averback, M.D. 12,650,895
Hans Black, M.D. 10,000 25,000 $3.12 05/13/09
(C$4.50)
25,000 $3.875 05/01/10
20,000 30,000 $6.93 05/01/10
(C$10.00)
10,000 $4.70 06/15/10
25,000 50,000 $4.33 11/13/11
Michael Sonnenreich 35,000 100,000 $3.875 05/01/10
25,000 50,000 $4.33 11/13/11
Walter von Wartburg 42,000 100,000 $3.875 05/01/10
25,000 50,000 $4.33 11/13/11
Jack Gemmell 10,525 50,000 $6.93 01/22/09
(C$10.00)
25,000 $3.875 05/01/10
25,000 $1.93 04/22/11
Roy Wolvin 5,000 10,000 $2.25 01/17/06
(C$3.25)
10,000 $9.53 01/17/06
(C$13.75)
10,000 $6.79 01/17/06
(C$9.80)
20,000 $6.93 01/17/06
(C$10.00)
20,000 $3.12 05/13/09
(C$4.50)
5,000 $1.93 04/22/11
Michael Munzar 33,925 50,000 $7.97 04/30/06
(C$11.50)
5,000 $6.24 10/31/07
(C$9.00)
30,000 $6.93 10/31/07
(C$10.00)
10,000 $6.93 10/31/07
(C$10.00)
20,000 $3.12 05/13/09
(C$4.50)
50,000 $3.90 08/25/10
35,000 $1.93 04/22/11
Options
Nymox has created a stock option plan for its key employees, its officers
and directors and certain consultants. The board of directors of Nymox
administers the plan. The board may grant options to purchase a
-49-
specified number of common shares of Nymox to a designated individual. The total
number of common shares to be optioned to any one individual cannot exceed 5% of
the total number of issued and outstanding shares and the maximum number of
common shares which may be optioned under the plan cannot exceed 2,500,000
shares without shareholder approval.
The board fixes the option price per share for common shares that are the
subject of any option, when it grants any such option. The option price cannot
involve a discount to the market price when the option is granted. The period
during which an option is exercisable shall not exceed 10 years from the date
when the option is granted. The options may not be assigned, transferred or
pledged and expire within three months of the termination of employment or
office with the Company and six months of the death of an individual.
-50-
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
Major Shareholders
The following table sets out as of May 31, 2002 the number of common
shares owned by Dr. Paul Averback, the President and CEO of Nymox and a member
of the Nymox board of directors, and by all directors and officers as a group.
Number of Common Shares owned by Percent of Class of
Name of Shareholder Shareholder Common Shares
------------------------------------------------- ----------------------------------- -------------------------
Dr. Paul Averback 12,650,895 56.1%
All directors and officers as a group 12,787,345 56.7%
In addition, as of May 31, 2002, Dr. Averback's wife owned 848,172 common
shares (3.8%) and 9022-1433 Canada Inc., a company owned by Dr. Averback and his
wife, owns 500,000 common shares (2.3%).
The above shareholders have the same voting rights as all other
shareholders. There has been no significant change in ownership for any of the
persons listed above over the past three years.
Based on a public filing, Generic Trading of Philadelphia LLC reported that
as of October 15, 2001 it beneficially owned 1,209,590 common shares or
approximately 5.4% of Nymox's shares. Nymox does not know of any other
shareholders who beneficially own more than 5% of Nymox's shares.
According to information furnished to Nymox by the transfer agent for the
common shares, as of May 31, 2002, total shares outstanding were 22,567,531.
There were 907 holders of record of the common shares and 4,688 beneficial
shareholders in total. Of these, 124 were holders of record of the common shares
and 2,613 were beneficial shareholders with addresses in the United States and
such holders owned an aggregate of 3,484,470 shares, representing 15.6% of the
outstanding shares of common stock.
Warrants Outstanding
Description Warrants Issued Exercise Price Expiry Date
----------- --------------- -------------- -----------
Series K 100,000 $2.06 Mar. 6, 2003
Series H 66,667 $9.375 Mar. 6, 2004
Series I 26,667 $7.8125 Mar. 6, 2004
Series E 200,000 $4.5315 Nov. 30, 2004
Series F 160,000 $4.0625 Nov. 30, 2004
Series G 109,879 $3.70 Jan. 8, 2005
Series G 5,783 $3.70 Jan. 8, 2005
Series J 42,864 $3.70 Jul. 31, 2005
The total number of shares subject to options at May 31, 2002 is 1,638,500,
of which options representing 1,373,000 are currently exercisable. Of those, the
total number of shares subject to options held by directors and officers of
Nymox is 910,000 of which options representing 720,000 shares are currently
exercisable.
There are no rights, warrants or options presently outstanding under which
Nymox could issue additional common shares, with the exception of options
enabling certain directors, employees and consultants of Nymox to acquire common
shares under Nymox's stock option plan and of warrants entitling the holders to
acquire up to 711,860 common shares of Nymox as outlined in the above table.
-51-
Related Party Transactions
In the year ended December 31, 2001, the Company derived $30,000 of
research contract revenue from the Foundation for Nutritional Advancement.
Michael Sonnenreich, a director of the Company is also a director and officer of
the Foundation for Nutritional Advancement.
PLAN OF DISTRIBUTION
Jaspas is offering the common shares for its account as statutory
underwriter, and not for the account of Nymox. Nymox will not receive any
proceeds from the sale of common shares by Jaspas.
Jaspas may be offering for sale up to 5,000,000 common shares acquired by
it either upon exercise of the warrant for common shares or pursuant to the
terms of the stock purchase agreement more fully described under the section
above entitled "The Common Stock Purchase Agreement."
Jaspas has agreed to be named as a statutory underwriter within the meaning
ofthe Securities Act of 1933 in connection with such sales of common shares and
will be acting as an underwriter in its resales of the common shares under this
prospectus.
Jaspas has, prior to any sales, agreed not to effect any offers or sales of
the common shares in any manner other than as specified in the prospectus and
not to purchase or induce others to purchase common shares in violation of
Regulation M under the Exchange Act.
The common shares may be sold from time to time by Jaspas or by pledgees,
donees, transferees or other successors in interest. Such sales may be made on
the Nasdaq SmallCap Market, on the over-the-counter market or otherwise at
prices and at terms then prevailing or at prices related to the then current
market price, or in negotiated private transactions, or in a combination of
these methods.
The common shares may be sold in one or more of the following manners:
o a block trade in which the broker or dealer so engaged will attempt to
sell the shares as agent, but may position and resell a portion of the
block as principal to facilitate the transaction;
o purchases by a broker or dealer for its account under this prospectus;
or
o ordinary brokerage transactions and transactions in which the broker
solicits purchases.
In effecting sales, brokers or dealers engaged by Jaspas may arrange for
other brokers or dealers to participate. Except as disclosed in a supplement to
this prospectus, no broker-dealer will be paid more than a customary brokerage
commission in connection with any sale of the common shares by Jaspas. Brokers
or dealers may receive commissions, discounts or other concessions from Jaspas
in amounts to be negotiated immediately prior to the sale. The compensation to a
particular broker-dealer may be in excess of customary commissions. Profits on
any resale of the common shares as a principal by such broker-dealers and any
commissions received by such broker-dealers may be deemed to be underwriting
discounts and commissions under the Securities Act of 1933. Any broker-dealer
participating in such transactions as agent may receive commissions from Jaspas
(and, if they act as agent for the purchaser of such common shares, from such
purchaser). Broker-dealers may agree with Jaspas to sell a specified number of
common shares at a stipulated price per share, and, to the extent such a broker
dealer is unable to do so acting as agent for Jaspas, to purchase as principal
any unsold common shares at price required to fulfill the broker-dealer
commitment to Jaspas. Broker-dealers who acquire common shares as principal may
thereafter resell such common shares from time to time in transactions (which
may involve crosses and block transactions and which may involve sales to and
through other broker-dealers, including transactions of the nature described
above) in the over-the counter market, in negotiated transactions or otherwise
at market prices prevailing at the time of sale or at negotiated prices, and in
connection with such resales may pay to or receive from the purchasers of such
common shares
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commissions computed as described above. Such brokers or dealers and any other
participating brokers or dealers may be deemed to be underwriters in connection
with such sales.
In addition, any common shares covered by this prospectus which qualify for
sale pursuant to Rule 144 may be sold under Rule 144 rather than pursuant to
this prospectus.
Nymox will not receive any of the proceeds from the sale of these common
shares, although it has paid the expenses of preparing this prospectus and the
related registration statement of which it is a part, and has reimbursed Jaspas
$35,000 for its legal, administrative and escrow costs.
Jaspas is subject to the applicable provisions of the Exchange Act,
including without limitation, Rules 10b-5 and Regulation M thereunder. Under
applicable rules and regulations under the Exchange Act, any person engaged in a
distribution of the common shares may not simultaneously engage in market making
activities with respect to such securities for a period beginning when such
person becomes a distribution participant and ending upon such person's
completion of participation in a distribution, including stabilization
activities in the common shares to effect covering transactions, to impose
penalty bids or to effect passive market making bids.
In addition, in connection with the transactions in the common shares,
Nymox and Jaspas will be subject to applicable provisions of the Exchange Act
and the rules and regulations under that Act, including, without limitation, the
Rules set forth above, and in so far as Nymox and Jaspas are distribution
participants, Regulation M. These restrictions may affect the marketability of
the common shares.
Jaspas will pay all commissions and certain other expenses associated with
the sale of the common shares.
Nymox will use its best efforts to file, during any period in which offers
or sales are being made, one or more post effective amendments to the
registration statement of which this prospectus is a part to describe any
material information with respect to the plan of distribution not previously
disclosed in this prospectus or any material change to such information in this
prospectus. This obligation may include, to the extent required under the
Securities Act of 1933, that a supplemental prospectus be filed, disclosing
o the name of any such broker-dealers;
o the number of common shares involved;
o the price at which the common shares are to be sold;
o the commissions paid or discounts or concessions allowed to such
broker-dealers, where applicable;
o that such broker-dealers did not conduct any investigation to verify
the information set out or incorporated by reference in this
prospectus, as supplemented; and
o any other facts material to the transaction.
The price at which Nymox will issue the common shares to Jaspas under
the stock purchase agreement will be 94% of current market price, measured as
the average daily price of the common shares as traded on the Nasdaq SmallCap
Market, for each day in the pricing period with respect to each draw down
request, all as further defined in the stock purchase agreement. Assuming an
average daily price of $3.00, assuming Nymox uses the remaining $2.25 million of
financing available under the stock purchase agreement, and assuming that Nymox
does not issue any more than the shares registered under the registration
statement of which this prospectus is a part, underwriting compensation for
Jaspas based on the discounted purchase price will be $221,182.
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LIMITED GRANT OF REGISTRATION RIGHTS
Nymox granted the registration rights to Jaspas described under the section
entitled "The Common Stock Purchase Agreement".
In connection with any such registration, Nymox will have no obligation:
o to assist or cooperate with Jaspas in the offering or disposition of
such shares;
o to indemnify or hold harmless the holders of any such shares (other
than Jaspas) or any underwriter designated by such holders;
o to obtain a commitment from an underwriter relative to the sale of any
such shares; or
o to include such shares within an underwriting offering of Nymox.
Nymox will assume no obligation or responsibility whatsoever to determine a
method of disposition for such shares or to otherwise include such shares within
the confines of any registered offering other than the registration statement of
which this prospectus is a part.
Nymox will use its best efforts to file, during any period during which it
is required to do so under its registration rights agreement with Jaspas, one or
more post-effective amendments to the registration statement of which this
prospectus is a part to describe any material information with respect to the
plan of distribution not previously disclosed in this prospectus or any material
change to such information in this prospectus. See the section above entitled
"The Common Stock Purchase Agreement."
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ADDITIONAL INFORMATION
Capitalization
The following table sets forth our capitalization as of December 31, 2001.
This table should be read in conjunction with the financial statements and
related notes, and the "Management's Discussion and Analysis of Financial
Condition and Results of Operations" included elsewhere in this prospectus.
Long term debt and capital lease obligations $0
----------------
Shareholder's Equity:
Share Capital:
Common stock, no par value $1.30; 22,297,525
shares issued and outstanding actual.
Shares authorized for issue: unlimited $25,376,557
Warrants 421,638
Accumulated deficit ($23,153,447)
----------------
Total shareholder's equity $2,644,748
================
Total capitalization $2,644,748
================
Dividends
We have never paid dividends on our Common Stock and our Board does not
anticipate paying any cash dividends on our Common Stock for the foreseeable
future.
Memorandum and Articles of Association
Bylaws And Articles Of Incorporation
The company's Articles of Incorporation as amended, which we refer to as
our articles of incorporation, are on file with the Corporations Directorate of
Industry Canada under Corporation Number 315235-9. Our articles of incorporation
do not include a stated purpose and do not place any restrictions on the
business that the company may carry on.
Directors
A director of our company need not be a shareholder. In accordance with our
bylaws and the Canada Business Corporations Act, at least 25% of our directors
must be residents of Canada. In order to serve as a director, a person must be a
natural person at least 18 years of age, of sound mind and not bankrupt. Neither
our articles of incorporation or by-laws, nor the Canada Business Corporations
Act, impose any mandatory retirement requirements for directors.
A director who is a party to, or who is a director or officer of or has a
material interest in any person who is a party to, a material contract or
transaction or proposed material contract or transaction with our company must
disclose to the company the nature and extent of his or her interest at the time
and in the manner provided by the Canada Business Corporations Act. The Canada
Business Corporations Act prohibits such a director from voting on any
resolution to approve the contract or transaction unless the contract or
transaction:
o Is an arrangement by way of security for money lent to or obligations
undertaken by the director for the benefit of the company or an
affiliate;
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o relates primarily to his or her remuneration as a director, officer,
employee or agent of the company or an affiliate;
o is for indemnity or insurance for director's liability as permitted by
the Act; or
o is with an affiliate.
Our board of directors may, on behalf of the company and without authorization
of our shareholders:
o borrow money upon the credit of the company;
o issue, reissue, sell or pledge debt obligations of the company;
o give a guarantee on behalf of the company to secure performance of an
obligation of any person; and
o mortgage, hypothecate, pledge or otherwise create a security interest
in all or any property of the company, owned or subsequently acquired,
to secure any obligation of the company.
The Canada Business Corporations Act prohibits the giving of a guarantee to
any shareholder, director, officer or employee of the company or of an
affiliated corporation or to an associate of any such person for any purpose or
to any person for the purpose of or in connection with a purchase of a share
issued or to be issued by the company or its affiliates, where there are
reasonable grounds for believing that the company is or, after giving the
guarantee, would be unable to pay its liabilities as they become due, or the
realizable value of the company's assets in the form of assets pledged or
encumbered to secure a guarantee, after giving the guarantee, would be less than
the aggregate of the company's liabilities and stated capital of all classes.
These borrowing powers may be varied by the company's bylaws or its
articles of incorporation. However, our bylaws and articles of incorporation do
not contain any restrictions on or variations of these borrowing powers.
Common Shares
Our articles of incorporation authorize the issuance of an unlimited number
of common shares. They do not authorize the issuance of any other class of
shares.
The holders of the common shares of our Company are entitled to receive
notice of and to attend all meetings of the shareholders of our Company and have
one vote for each common share held at all meetings of the shareholders of our
Company. Our directors are elected at each annual meeting of shareholders and do
not stand for reelection at staggered intervals.
The holders of common shares are entitled to receive dividends and our
company will pay dividends, as and when declared by our board of directors, out
of moneys properly applicable to the payment of dividends, in such amount and in
such form as our board of directors may from time to time determine, and all
dividends which our board of directors may declare on the common shares shall be
declared and paid in equal amounts per share on all common shares at the time
outstanding.
In the event of the dissolution, liquidation or winding-up of the company,
whether voluntary or involuntary, or any other distribution of assets of the
company among its shareholders for the purpose of winding up its affairs, the
holders of the common shares will be entitled to receive the remaining property
and assets of the company.
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Action Necessary To Change Rights Of Shareholders
In order to change the rights of our shareholders, we would need to amend
our articles of incorporation to effect the change. Such an amendment would
require the approval of holders of two-thirds of the shares cast at a duly
called special meeting. For certain amendments such as those creating of a class
of preferred shares, a shareholder is entitled to dissent in respect of such a
resolution amending our articles and, if the resolution is adopted and the
company implements such changes, demand payment of the fair value of its shares.
Meetings Of Shareholders
An annual meeting of shareholders is held each year for the purpose of
considering the financial statements and reports, electing directors, appointing
auditors and for the transaction of other business as may be brought before the
meeting. The board of directors has the power to call a special meeting of
shareholders at any time.
Notice of the time and place of each meeting of shareholders must be given
not less than 21 days, nor more than 50 days, before the date of each meeting to
each director, to the auditor and to each shareholder who at the close of
business on the record date for notice is entered in the securities register as
the holder of one or more shares carrying the right to vote at the meeting.
Notice of meeting of shareholders called for any other purpose other than
consideration of the minutes of an earlier meeting, financial statements and
auditor's report, election of directors and reappointment of the incumbent
auditor, must state the nature of the business in sufficient detail to permit
the shareholder to form a reasoned judgment on and must state the text of any
special resolution or by-law to be submitted to the meeting.
The only persons entitled to be present at a meeting of shareholders are
those entitled to vote, the directors of the company and the auditor of the
company. Any other person may be admitted only on the invitation of the chairman
of the meeting or with the consent of the meeting. In circumstances where a
court orders a meeting of shareholders, the court may direct how the meeting may
be held, including who may attend the meeting.
Limitations On Right To Own Securities
Neither Canadian law nor our articles or by-laws limit the right of a
nonresident to hold or vote our shares, other than as provided in the Investment
Canada Act (the "Investment Act"), as amended by the World Trade Organization
Agreement Implementation Act. The Investment Act generally prohibits
implementation of a direct reviewable investment by an individual, government or
agency thereof, corporation, partnership, trust or joint venture that is not a
"Canadian," as defined in the Investment Act (a "non-Canadian"), unless, after
review, the minister responsible for the Investment Act is satisfied that the
investment is likely to be of net benefit to Canada. An investment in our shares
by a non-Canadian (other than a "WTO Investor," as defined below) would be
reviewable under the Investment Act if it were an investment to acquire direct
control of our company, and the value of the assets of our company were CDN$5.0
million or more (provided that immediately prior to the implementation of the
investment our company was not controlled by WTO Investors). An investment in
our shares by a WTO Investor (or by a non-Canadian other than a WTO Investor if,
immediately prior to the implementation of the investment our company was
controlled by WTO Investors) would be reviewable under the Investment Act if it
were an investment to acquire direct control of our company (in 2001) and the
value of the assets of our company equaled or exceeded CDN$209.0 million. A
non-Canadian, whether a WTO Investor or otherwise, would be deemed to acquire
control of our company for purposes of the Investment Act if he or she acquired
a majority of the our shares. The acquisition of less than a majority, but at
least one-third of our shares, would be presumed to be an acquisition of control
of our company, unless it could be established that we were not controlled in
fact by the acquirer through the ownership of our shares. In general, an
individual is a WTO Investor if he or she is a "national" of a country (other
than Canada) that is a member of the World Trade Organization ("WTO Member") or
has a right of permanent residence in a WTO Member. A corporation or other
entity will be a "WTO Investor" if it is a
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"WTO investor-controlled entity," pursuant to detailed rules set out in the
Investment Act. The United States is a WTO Member. Certain transactions
involving our shares would be exempt from the Investment Act, including:
(a) an acquisition of our shares if the acquisition were made in the
ordinary course of that person's business as a trader or dealer in securities;
(b) an acquisition of control of our company in connection with the of a
security interest granted for a loan or other assistance and not for any purpose
related to the provisions the Investment Act; and
(c) an acquisition of control of our company by reason of an amalgamation,
consolidation or corporate reorganization, following which the direct or
indirect control in fact of our company, through ownership of voting interests,
remains unchanged.
Change Of Control
There are no provisions of our bylaws or articles of incorporation that
would have an effect of delaying, deferring or preventing a change in control of
the company and that would operate only with respect to a merger, acquisition or
corporate restructuring involving the company. Our bylaws do not contain a
provision governing the ownership threshold above which shareholder ownership
must be disclosed.
Material Contracts
The following is a summary of our company's material contracts, entered
into since January 1, 1999.
1. The Common Stock Purchase Agreement and Registration Rights Agreement
between Nymox Pharmaceutical Corporation and Jaspas Investments Limited November
1, 1999. (incorporated by reference to Exhibit 2.0 to the form F-1 registration
statement filed with the Commission on February 29, 2000.) These agreements
established a $12 million equity line of credit which, on March 14, 2000, we
became entitled to draw down on. The and conditions of the equity line of credit
are further described in "Liquidity and Capital Resources" section in Item 5
above and in more in our F-1 Registration Statement filed with the SEC on
November 9, and declared effective on December 4, 2001.
2. The Research and License Agreement between Rhode Island Hospital and
Nymox Corporation dated May 20, 1999. Under this agreement, sponsors the
research of two principal investigators, Dr. Suzanne de Monte and Dr. Jack
Wands, pertaining to the use of neural thread protein diagnostic or therapeutic
purposes in return for licensing rights to and patents arising out of this
research. The sponsorship was recently extended to March 1, 2005.
3. The Share Purchase Agreement between Nymox Pharmaceutical Corporation
and Judith Fitzpatrick dated January 8, 2000. Under this agreement which on
March 2, 2000, we acquired 1,008,250 shares of the common stock Serex, Inc.
which represented a majority interest of that company in for the issuance of
187,951 of our shares and warrants (Series G) to 115,662 of our shares at a
strike price of $3.70.
4. The Employment Agreement between Nymox Pharmaceutical Corporation and
Dr. Fitzpatrick dated January 8, 2000.
5. The Common Stock and Warrants Purchase Agreement dated March 6, 2000
between Nymox Pharmaceutical Corporation and Amro International, S.A. ("Amro").
Under this Agreement, Amro purchased 666,667 shares of Nymox and a warrant to
purchase up to 66,667 shares of Nymox at a strike price of 9.375 for $4 million.
The Agreement provided Amro with two opportunities to reprice a portion of the
666,667 shares it initially purchased. Pursuant these two repricing obligations,
Nymox issued Amro a further 154,970 common shares.
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Exchange Controls
Canada has no system of exchange controls. There are no exchange
restrictions on borrowing from foreign countries or on the remittance of
dividends, interest, royalties and similar payments, management fees, loan
repayments, settlement of trade debts or the repatriation of capital.
There are no limitations on the rights of non-Canadians to exercise
voting rights on their shares of Nymox.
TAXATION
U.S. Federal Income Tax Considerations for U.S. Persons
This section contains a summary of certain U.S. federal income tax
considerations for U.S. Persons (as defined below) who hold common shares of
Nymox. This summary is based upon the Internal Revenue Code of 1986, as amended
(the "Code"), Treasury regulations, rulings of the Internal Revenue Service (the
"IRS"), and judicial decisions in existence on the date hereof, all of which are
subject to change. Any such change could apply retroactively and could have
adverse consequences to Nymox and its shareholders. This summary is necessarily
general and does not attempt to summarize all aspects of the federal tax laws
(and does not attempt to summarize any state or local laws) that may affect an
investor's acquisition of an interest in Nymox. No ruling from the IRS will be
requested and no assurance can be given that the IRS will agree with the tax
consequences described in this summary.
For purposes of this discussion, the term "U.S. Person" means (a) an
individual who is a citizen of the United States or who is resident in the
United States for United States federal income tax purposes, (b) a corporation
or a partnership that is organized under the laws of the United States or any
state thereof, (c) an estate the income of which is subject to United States
federal income taxation regardless of its source, or (d) a trust (i) that is
subject to the supervision of a court within the United States and is subject to
the control of one or more United States persons as described in section
7701(a)(30) of the Code, or (ii) that has a valid election in effect under
applicable Treasury regulations to be treated as a United States person. The
term "U.S. Holder" means a shareholder of Nymox who is a U.S. Person. The term
"foreign corporation" means an entity that is classified as a corporation for
U.S. federal income tax purposes and that is not organized under the laws of the
United States or any state thereof.
This summary does not discuss all United States federal income tax
considerations that may be relevant to U.S. Holders in light of their particular
circumstances or to certain holders that may be subject to special treatment
under United States federal income tax law (for example, insurance companies,
tax-exempt organizations, financial institutions, dealers in securities, persons
who hold shares as part of a straddle, hedging, constructive sale, or conversion
transaction, U.S. Holders whose functional currency is not the U.S. dollar, and
U.S. Holders who acquired shares through exercise of employee stock options or
otherwise as compensation for services). Furthermore, this summary does not
address any aspects of state or local taxation.
The tax consequences of an investment in Nymox are complex and based on
tax provisions that are subject to change. Prospective investors are urged to
consult with, and must depend upon, their own tax advisors with specific
reference to their own tax situations as to the income and other tax
consequences of an investment in Nymox.
Dividends and gains on sale. Except as described below with respect to
the "passive foreign investment company" rules, distributions by Nymox to a U.S.
Holder will be treated as ordinary dividend income to the extent of Nymox's
current and accumulated earnings and profits. Such dividends will not be
eligible for the dividend-received deduction generally allowed under the Code to
dividend recipients that are U.S. corporations. The amount of any distribution
in excess of Nymox's current and accumulated earnings and profits will first be
applied to reduce the U.S. Holder's tax basis in its Nymox common shares, and
any amount in excess of tax basis will be treated as gain from the sale or
exchange of the common shares. Except
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as described below with respect to the "passive foreign investment company"
rules, any gain recognized by a U.S. Holder on a sale or exchange of Nymox
common shares (or on a distribution treated as a sale or exchange) generally
will be treated as capital gain. Capital gains of corporations are taxable at
the same rate as ordinary income. With respect to non-corporate taxpayers, the
excess of net long-term capital gain over net short term capital loss may be
taxed at a substantially lower rate than is ordinary income. A capital gain or
loss is long-term if the asset has been held for more than one year and
short-term if held for one year or less. In addition, the distinction between
capital gain or loss and ordinary income or loss is relevant for purposes of
limitations on the deductibility of capital losses.
A U.S. Holder generally may claim a credit against its U.S. federal
income tax liability for Canadian income tax withheld from dividends received on
Nymox common shares. The amount of this credit is subject to several limitations
under the Code.
Controlled foreign corporation rules. A foreign corporation generally is
classified as a "controlled foreign corporation" (a "CFC") if more than 50% of
the corporation's shares (by vote or value) are owned, directly or indirectly,
by "10% U.S. Shareholders". For this purpose, a "10% U.S. Shareholder" is a U.S.
Person that owns, directly or indirectly, shares possessing 10% or more of the
voting power in the foreign corporation. Nymox believes that it is not a CFC at
the present time. If Nymox were a CFC, each 10% U.S. Shareholder that owns,
directly or indirectly through foreign entities, an interest in Nymox generally
would be required to include in its gross income for U.S. federal income tax
purposes a pro-rata share of any "Subpart F" income earned by Nymox, whether or
not such income is distributed by Nymox. Subpart F income generally includes
interest, dividends, royalties, and gain on the sale of stock or securities.
Foreign personal holding company rules. In general, a foreign corporation
is a "foreign personal holding company" (a "FPHC") during a taxable year if (i)
at any time during the taxable year, more than 50% of the shares (by vote or
value) of the corporation are owned, directly or indirectly, by five or fewer
individuals who are U.S. Persons, and (ii) at least 50% of the gross income of
the corporation for the taxable year consists of "foreign personal holding
company income" (such as dividends, interest, royalties, and gains on the sale
of stock or securities).
Nymox believes that it is not a FPHC at the present time. If Nymox were a
FPHC, each U.S. Person that owns, directly or indirectly through foreign
entities, an interest in Nymox generally would be required to recognize, as a
dividend, the U.S. Person's share of the undistributed annual income of Nymox.
Passive foreign investment company rules. In general, a foreign
corporation is a "passive foreign investment company" (a "PFIC") during a
taxable year if 75% or more of its gross income for the taxable year constitutes
"passive income" or if 50% or more of its assets (by average fair market value)
held during the taxable year produce, or are held for the production of, passive
income. In general, any U.S. Person that owns, directly or indirectly, an
interest in a foreign corporation will be subject to an interest charge (in
addition to regular U.S. federal income tax) upon the disposition by the U.S.
Person of, or receipt by the U.S. Person of "excess distributions" with respect
to, any shares of the foreign corporation if: (i) the foreign corporation is a
PFIC during the taxable year in which such income is realized by the U.S.
Person; or (ii) the foreign corporation was a PFIC during any prior taxable year
that is included in whole or in part in the U.S. Person's "holding period"
(within the meaning of Section 1223 of the Code) with respect to its interest in
the shares of the foreign corporation. Furthermore, the U.S. Person's share of
such gain or "excess distribution" will be taxable as ordinary income. There
exist several other adverse tax consequences that may apply to any U.S. Person
that owns, directly or indirectly, an interest in a PFIC.
A U.S. Person that owns, directly or indirectly, an interest in a PFIC
can elect to treat such PFIC as a "qualified electing fund" (a "QEF") with
respect to the U.S. Person. In general, the effect of a QEF election with
respect to a PFIC is that, beginning with the first taxable year to which the
election applies and in all succeeding taxable years during which the foreign
corporation is a PFIC, the U.S. Person is required to include in its income its
share of the ordinary earnings and net capital gains of the PFIC. The U.S.
Person is not taxable with respect to any distribution by the PFIC from earnings
that have been included previously in the
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U.S. Person's income under the QEF provisions. If the QEF election is made with
respect to the first taxable year in which a U.S. Person owns, directly or
indirectly, an interest in the particular PFIC, the adverse tax consequences
described in the immediately preceding paragraph (including the interest charge
and the treatment of gains as ordinary income) would not apply to the U.S.
Person's interest in that PFIC. In order to make a QEF election, a U.S. Person
is required to provide to the IRS certain information furnished by the PFIC.
Nymox believes that it has not been a PFIC during any taxable year ending
on or before December 31, 2001. It is not possible to express an opinion as to
whether or not Nymox is or will be a PFIC during its current taxable year or
future taxable years. Nymox intends to notify its U.S. Holders within 45 days
after the end of the taxable year for which Nymox believes it might be a PFIC.
Nymox has further undertaken (i) to provide its U.S. Holders with timely and
accurate information as to its status as a PFIC and the manner in which the QEF
election can be made and (ii) to comply with all record-keeping, reporting and
other requirements so that the U.S. Holders, at their option, may make a QEF
election.
Each U.S. Person who owns, directly or indirectly, common shares of Nymox
is urged to consult its own tax advisor with respect to the advantages and
disadvantages of making a QEF election with respect to Nymox.
Backup withholding. Information reporting to the IRS may be required with
respect to payments of dividends on the Nymox common shares to U.S. Holders, and
with respect to proceeds received by U.S. Holders on the sale of Nymox common
shares. A U.S. Holder may be subject to backup withholding at a 30% rate with
respect to dividends received with respect to Nymox common shares, or proceeds
received on the sale of Nymox common shares through a broker, unless the U.S.
Holder (i) demonstrates that it qualifies for an applicable exemption (such as
the exemption for holders that are corporations), or (ii) provides a taxpayer
identification number and complies with certain other requirements. Any amount
withheld from payment to a U.S. Holder under the backup withholding rules
generally will be allowed as credit against the U.S. Holder's U.S. federal
income tax liability, if any, and may entitle the U.S. Holder to a refund,
provided that the required information is furnished to the IRS.
Canadian Federal Income Taxation
The following is, as of the date of this prospectus, a summary of the
principal Canadian federal income tax considerations generally applicable to
shareholders who receive a dividend from Nymox and who, at all relevant times,
for purposes of the Income Tax Act (Canada) the ("Tax Act"), hold and will hold
Nymox common shares as capital property and deal with Nymox at arm's length.
Nymox's common shares will generally constitute capital property to a
holder unless the holder holds such shares in the course of carrying on a
business or the holder has acquired such shares in a transaction or transactions
considered to be an adventure in the nature of trade. This summary is based on
the current provisions of the Tax Act, the regulations under that act, counsel's
understanding of current administrative and assessing policies of the Canada
Customs and Revenue Agency and all specific proposals to amend the Tax Act
publicly announced or released by or on behalf of the Minister of Finance
(Canada) before the date of this prospectus ("Tax Proposals").
The Tax Act contains certain provisions relating to securities held by
certain financial institutions (the "Mark-to-Market Rules"). This summary does
not take into account these Mark-to-Market Rules or any amendments to them
contained in the Tax Proposals and taxpayers that are "financial institutions"
for purposes of those rules should consult their own tax advisors.
This summary is not exhaustive of all possible Canadian federal income
tax considerations and, except for the Tax Proposals, does not take into account
or anticipate any changes in law, whether by legislative, governmental or
judicial action, nor does it take into account tax legislation of any province,
territory or
-61-
foreign jurisdiction. This summary is of a general nature only and is not
intended to be, nor should it be construed as, legal or tax advice to any
particular holder of Nymox common shares. Canadian Residents
The following summary is relevant to a holder of Nymox common shares who,
for purposes of the Tax Act and any applicable tax treaty or convention, is
resident in Canada at all relevant times.
Tax Treatment of Capital Gains and Capital Losses for Canadian Residents
On a disposition or deemed disposition of a Nymox common share, the
holder will realize a capital gain (or capital loss) equal to the amount by
which the proceeds of disposition for the Nymox common share exceed (or are less
than) the aggregate of any costs of disposition and the adjusted cost base to
the holder of the Nymox common share immediately before the disposition.
Pursuant to the Tax Proposals and subject to certain transitional rules
which apply in certain circumstances, a holder of Nymox common shares will be
required to include in income one-half of the amount of any capital gain (a
"Taxable capital gain") and may deduct one-half of the amount of any capital
loss (an "Allowable capital loss") against Taxable capital gains realized by the
holder in the year of the disposition. Allowable capital losses in excess of
Taxable capital gains may be carried back and deducted in any of the three
preceding years or carried forward and deducted in any following year against
taxable capital gains realized in such years to the extent and under the
circumstances described in the Tax Act and the Tax Proposals.
A Canadian-controlled private corporation will also be subject to a
refundable tax of 6 2/3% on certain investment income, including taxable capital
gains realized on the disposition of Nymox common shares, that will be refunded
when the corporation pays taxable dividends (at a rate of $1.00 for every $3.00
of taxable dividend paid).
A capital loss realized by a holder of Nymox common shares that is a
corporation, a partnership of which a corporation is a member or a trust of
which a corporation is a beneficiary may be reduced by the amount of dividends
received in certain circumstances. Capital gains realized by an individual may
give rise to a liability for alternative minimum tax.
Tax Treatment of Dividends Received by Canadian Residents
In the case of a holder of Nymox common shares who is an individual, any
dividends received on the common shares will be included in computing his income
and will be subject to the gross-up and dividend tax credit rules normally
applicable to taxable dividends paid by taxable Canadian corporations. A holder
that is a corporation may be liable to pay refundable tax under Part IV of the
Tax Act. However, a public corporation which is not controlled, whether because
of a beneficial interest in one or more trusts or otherwise, by or for the
benefit of an individual (other than a trust) or a related group of individuals
(other than trusts) will not be liable to pay refundable tax under Part IV of
the Tax Act.
In the case of a holder of Nymox common shares that is a corporation, the
amount of any capital loss otherwise determined resulting from the disposition
of a Nymox common share may be reduced by the amount of dividends previously
received or deemed to have been received thereon. Any such restriction will not
occur where the corporate holder owned the Nymox common share for 365 days or
longer and such holder (together with any persons with whom it did not deal at
arm's length) did not own more than 5% of the shares of any class or series of
Nymox at the time the relevant dividends were received or deemed to have been
received. Analogous rules apply where a corporation is a member of a partnership
or a beneficiary of a trust, which owns Nymox common shares.
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Shareholders Who Are Not Residents Of Canada
The following summary is relevant to a holder of Nymox common shares, who,
at all relevant times, for purposes of the Tax Act and any applicable tax treaty
or convention, is a non-resident or is deemed to be a non-resident of Canada and
does not use and is not deemed to use or hold Nymox common shares in the course
of carrying on a business in Canada. Special rules, which are not discussed
below, may apply to a non-resident that is an insurer which carries on business
in Canada and elsewhere.
Dividends Paid To Non-Residents of Canada
Under the Tax Act, dividends paid or credited to a non-resident are
subject to withholding tax at the rate of 25% of the gross amount of the
dividends. This withholding tax may be reduced or eliminated pursuant to the
terms of an applicable tax treaty between Canada and the country of residence of
the non-resident. For example, for persons who are resident in the United States
for purposes of the Canada-United States Income Tax Convention, (the
"Convention") the rate of withholding tax on dividends is reduced to 15%
generally and 5% when the United States resident is a company that beneficially
owns at least 10% of the voting stock of the company paying the dividends.
Under the Convention, dividends paid to certain religious, scientific,
charitable and other similar tax-exempt organizations and certain organizations
that are resident in, and exempt from tax in, the United States are exempt from
Canadian non-resident withholding tax. Provided that certain administrative
procedures designed to establish with the Canadian tax authorities the right of
such entities to benefit from this withholding tax exemption are complied with
by the tax-exempt entities prior to the Distribution, Nymox would not be
required to withhold such tax on such payment. Alternatively, the
above-described tax-exempt entities may claim a refund of Canadian withholding
tax otherwise withheld by Nymox on the distribution of dividends.
Tax Treatment of Capital Gains of Non-Residents of Canada
On a disposition or deemed disposition of a Nymox common share, a
non-resident holder will realize a capital gain (or capital loss) equal to the
amount by which the proceeds of disposition for the Nymox common share exceed
(or are less than) the aggregate of any costs of disposition and the adjusted
cost base to the non-resident holder of the Nymox common share immediately
before the disposition.
A non-resident of Canada is liable for Canadian income tax on a capital
gain realized on the disposition of property only where that property
constitutes "taxable Canadian property". Pursuant to the Tax Proposals and
subject to certain transitional rules which apply in certain circumstances,
one-half of any capital gain from the disposition of taxable Canadian property
is subject to Canadian tax.
Under the Tax Act, shares of Nymox will not constitute taxable Canadian
property unless, at any time, in the five years immediately preceding the
disposition, the non-resident holder, persons with whom the non-resident holder
did not deal at arms length, or the non-resident holder together with all such
persons owned (or had a right to acquire) 25% or more of the shares of any class
of Nymox. Even in circumstances where shares of Nymox are taxable Canadian
property to a non-resident holder, the non-resident holder may be entitled to
relief from Canadian tax on any capital gain realized on the disposition thereof
pursuant to the terms of an applicable tax treaty between Canada and the country
of residence of the non-resident. For example, the Convention provides that
gains realized by a resident of the United States on the disposition or deemed
disposition of shares of a company will generally not be subject to tax under
the Tax Act, provided that the value of the shares is not derived principally
from real property situated in Canada. Nymox believes that the value of its
shares is not currently derived principally from real property situated in
Canada and it does not expect this to change in the foreseeable future.
Provided that the Nymox common shares remain listed on a prescribed stock
exchange, which includes the Nasdaq SmallCap Market System, a non-resident
holder who disposes of Nymox common shares
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will not be required to comply with the Canadian notification procedures
generally applicable to dispositions of taxable Canadian property.
CERTAIN LEGAL MATTERS
The validity of the common shares offered hereby will be passed upon for
Nymox by Jack Gemmell, General Counsel of Nymox.
EXPERTS
The financial statements of Nymox as at December 31, 2001, 2000 and 1999,
for each of the years in the three year period ended December 31, 2001, included
in this prospectus and in the registration statement have been audited by KPMG
LLP, independent auditors, and are included in this prospectus and in this
registration statement in reliance upon such report, and upon the authority of
KPMG LLP as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION ABOUT NYMOX
Nymox files periodic reports and other information with the SEC. You may
read and copy any document that Nymox files at the SEC's public reference room
at 450 Fifth Street, N.W., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the public reference room.
Nymox's common shares are listed on the Nasdaq SmallCap Market. You can
consult reports and other information about Nymox that it filed pursuant to the
rules of the Nasdaq Stock Market.
The SEC allows us to incorporate by reference the information we file
with them. This means that we can disclose important information to you by
referring to documents. The information that we incorporate by reference is an
important part of this prospectus. We incorporate by reference the following
documents and any future filings that we make with the SEC under Section 13(a),
13(c) and 15(d) of the Securities Exchange Act of 1934, as amended, until we
complete the offerings using this prospectus:
o Our Annual Report on Form 20-F for the fiscal year ended December 31,
2001; and
o Our reports on Form 6-K furnished to the SEC since the end of the
fiscal year covered by the Annual Report on Form 20-F referred to
above.
o All subsequent annual reports filed by Nymox on Form 20-F, all
subsequent filings by Nymox on Form 6-K (but only to the extent that
Nymox identifies in Form 6-K that it is being incorporated by
reference into this prospectus), and all subsequent filings made under
Sections 12, 13, 14 of 15(d) of the Securities Exchange Act dated
after the date of this prospectus and before the termination of the
offering are deemed incorporated by reference into, and to be a part
of, this prospectus from the date such documents are filed.
o All other reports filed by Nymox under Sections 13(a) or 15(d) of the
Securities Exchange Act since the end of the fiscal year covered by
the Annual Report on Form 20-F referred to above.
Information that we file with the SEC will automatically update and
supercede information in documents filed with the SEC at earlier dates. All
information appearing in this prospectus is qualified in its entirety by the
information and financial statements, including the notes, contained in the
documents that we incorporate by reference in this prospectus.
-64-
You may request a copy of these filings, at no cost, by writing or
telephoning Nymox at the following address:
Nymox Pharmaceutical Corporation
9900 Cavendish Blvd., Suite 306
St. Laurent, QC, Canada H4M 2V2
(514) 332-3222
You should rely only on the information that we incorporate by reference
or provide in this prospectus. We have not authorized anyone to provide you with
different information. We are not making an offer of these securities in any
jurisdiction where the offer is not permitted. You should not assume that the
information in this prospectus is accurate as of any date other than the date on
the front of this prospectus.
ENFORCEABILITY OF CERTAIN CIVIL LIABILITIES AND
AUTHORIZED REPRESENTATIVE IN THE UNITED STATES
Many of Nymox's directors, officers and certain experts named in this
prospectus are residents of Canada. Consequently, it may be difficult for United
States investors to effect service within the United States upon Nymox's
directors, officers or certain experts named in this prospectus, or to realize
in the United States upon judgments of courts of the United States predicated
upon civil liabilities under the Securities Act. A judgment of a court of the
United States predicated solely upon such civil liabilities would probably be
enforceable in Canada by the Canadian court if the United States court in which
the judgment was obtained had jurisdiction, as determined by the Canadian court,
in the matter. There is substantial doubt whether an original action could be
brought successfully in Canada against any of such persons or Nymox predicated
solely upon such civil liabilities.
The authorized agent to receive service of process in the United States
is C.T. Corporation System, 111 Eighth Ave., 13th Floor, New York, NY, 10011,
telephone (212) 590-9200.
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FINANCIAL INFORMATION
kpmg
Consolidated Financial Statements of
NYMOX PHARMACEUTICAL
CORPORATION
Years ended December 31, 2001, 2000 and 1999
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AUDITORS' REPORT TO THE SHAREHOLDERS
We have audited the consolidated balance sheets of Nymox Pharmaceutical
Corporation as at December 31, 2001 and 2000 and the consolidated statements of
operations, deficit and cash flows for the years ended December 31, 2001, 2000
and 1999. These financial statements are the responsibility of the Corporation's
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
With respect to the consolidated financial statements for the years ended
December 31, 2001 and 2000, we conducted our audits in accordance with United
States generally accepted auditing standards and Canadian generally accepted
auditing standards. With respect to the consolidated financial statements for
the year ended December 31, 1999, we conducted our audit in accordance with
Canadian generally accepted auditing standards. Those standards require that we
plan and perform an audit to obtain reasonable assurance 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.
In our opinion, these consolidated financial statements present fairly, in all
material respects, the financial position of the Corporation as at December 31,
2001 and 2000 and the results of its operations and its cash flows for the years
ended December 31, 2001, 2000 and 1999 in accordance with Canadian generally
accepted accounting principles.
Chartered Accountants
Montreal, Canada
February 22, 2002 (except as to note 13,
which is as of March 18, 2002)
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NYMOX PHARMACEUTICAL CORPORATION
Consolidated Financial Statements
Years ended December 31, 2001, 2000 and 1999
Financial Statements
Consolidated Balance Sheets........................................... 69
Consolidated Statements of Operations................................. 70
Consolidated Statements of Deficit.................................... 71
Consolidated Statements of Cash Flows................................. 72
Notes to Consolidated Financial Statements............................ 73
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NYMOX PHARMACEUTICAL CORPORATION
Consolidated Balance Sheets
December 31, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
2001 2000
--------------------------------------------------------------------------------
Assets
Current assets:
Cash $ 488,987 $ 565,711
Accounts and other receivables 122,459 101,517
Research tax credits receivable 30,509 10,457
Inventory 17,567 4,325
Prepaid expenses and deposits 55,000 67,500
--------------------------------------------------------------------------------
714,522 749,510
Capital assets (note 3):
Property and equipment 217,083 268,679
Patents and intellectual property 3,154,441 3,144,015
--------------------------------------------------------------------------------
3,371,524 3,412,694
Deferred share issuance costs (note 6 (c)) 106,195 222,512
--------------------------------------------------------------------------------
$ 4,192,241 $ 4,384,716
--------------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 295,393 $ 323,774
Notes payable (note 5) 396,775 -
Deferred revenue 55,325 -
--------------------------------------------------------------------------------
747,493 323,774
Non-controlling interest (note 4) 800,000 800,000
Shareholders' equity:
Share capital and other (note 6) 25,798,195 23,243,941
Deficit (23,153,447) (19,982,999)
--------------------------------------------------------------------------------
2,644,748 3,260,942
Commitments and contingency (note 7)
Subsequent events (note 13)
--------------------------------------------------------------------------------
$ 4,192,241 $ 4,384,716
--------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements.
On behalf of the Board:
_______________________ Director
_______________________ Director
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NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Operations
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
-------------------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------------------
Revenues:
Sales $ 235,288 $ 157,688 $ 153,252
License fees 97,403 - -
Research contracts 30,000 - -
Interest 17,918 68,179 36,951
-------------------------------------------------------------------------------------------------------------------
380,609 225,867 190,203
Expenses:
Research and development 1,499,654 2,084,232 1,137,122
Less research tax credits (20,052) (10,457) (4,181)
-------------------------------------------------------------------------------------------------------------------
1,479,602 2,073,775 1,132,941
General and administrative 1,087,326 1,335,500 1,229,894
Marketing 343,244 363,142 942,205
Cost of sales 131,904 87,450 103,340
Depreciation and amortization 381,582 375,810 136,947
Interest and bank charges 6,455 14,169 5,856
-------------------------------------------------------------------------------------------------------------------
3,430,113 4,249,846 3,551,183
Gain on disposal of capital assets - - (46,684)
-------------------------------------------------------------------------------------------------------------------
3,430,113 4,249,846 3,504,499
-------------------------------------------------------------------------------------------------------------------
Net loss $ (3,049,504) $ (4,023,979) $ (3,314,296)
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
Basic and diluted loss per share $ (0.14) $ (0.19) $ (0.17)
-------------------------------------------------------------------------------------------------------------------
Weighted average number of common shares:
Basic 21,873,966 20,890,735 19,886,430
Effect of dilutive options and warrants 121,728 239,551 244,930
-------------------------------------------------------------------------------------------------------------------
Diluted 21,995,694 21,130,286 20,131,360
-------------------------------------------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements.
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NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Deficit
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
-------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------
Deficit, beginning of year $ (19,982,999) $ (15,605,816) $ (12,256,479)
Net loss (3,049,504) (4,023,979) (3,314,296)
Share issue costs (120,944) (353,204) (35,041)
-------------------------------------------------------------------------------------------------------
Deficit, end of year $ (23,153,447) $ (19,982,999) $ (15,605,816)
-------------------------------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements.
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NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Cash Flows
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
-------------------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------------------
Cash flows from operating activities:
Net loss $ (3,049,504) $ (4,023,979) $ (3,314,296)
Adjustments for:
Depreciation and amortization 381,582 375,810 136,947
Loss (gain) on disposal of capital assets 250 - (46,684)
Foreign exchange - - (13,453)
Write-off of note receivable - 108,280 -
Write-down of deferred share issuance costs 87,263 - -
Changes in operating assets and liabilities:
Accounts and other receivables (20,942) 16,730 36,316
Interest receivable - - 31,928
Receivable from a financial institution - - 441,696
Research tax credits receivable (20,052) (7,277) 824
Inventory (13,242) (4,325) -
Prepaid expenses and deposits 12,500 56,000 (102,945)
Accounts payable and accrued liabilities (28,381) (380,511) 188,872
Deferred revenue 55,325 - -
-------------------------------------------------------------------------------------------------------------------
(2,595,201) (3,859,272) (2,640,795)
Cash flows from financing activities:
Proceeds from issuance of share capital 2,554,254 5,010,981 969,253
Proceeds from notes payable 396,775 201,993 346,428
Repayment of notes payable - (548,421) -
Share issue costs (91,890) (380,365) (230,392)
-------------------------------------------------------------------------------------------------------------------
2,859,139 4,284,188 1,085,289
Cash flows from investing activities:
Additions to capital assets (340,662) (381,568) (164,783)
Proceeds from disposal of capital assets - - 185,896
Proceeds from collection of
notes receivable - 73,000 -
Net proceeds on maturity of short-term
investments - - 1,464,635
-------------------------------------------------------------------------------------------------------------------
(340,662) (308,568) 1,485,748
Effect of foreign exchange rate changes on cash - - 24,215
-------------------------------------------------------------------------------------------------------------------
Net (decrease) increase in cash (76,724) 116,348 (45,543)
Cash, beginning of year 565,711 449,363 494,906
-------------------------------------------------------------------------------------------------------------------
Cash, end of year $ 488,987 $ 565,711 $ 449,363
-------------------------------------------------------------------------------------------------------------------
Supplemental disclosure to statements of cash flows:
(a) Interest paid $ 6,455 $ 14,169 $ 5,856
(b) Non-cash transactions:
Acquisition of Serex Inc. by issuance
of common shares and other securities - 1,319,997 -
Amortization of deferred share
issue costs charged to deficit 29,054 20,220 -
-------------------------------------------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements.
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NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
1. Business activities:
Nymox Pharmaceutical Corporation (the "Corporation"), incorporated under
the Canada Business Corporations Act, including its subsidiaries, Nymox
Corporation, a Delaware Corporation, and Serex Inc. of New Jersey, is a
biopharmaceutical corporation which specializes in the research and
development of products for the diagnosis and treatment of Alzheimer's
disease. The Corporation is currently marketing AlzheimAlertTM, a urinary
test that aids physicians in the diagnosis of Alzheimer's disease. The
Corporation also markets NicAlertTM and NicoMeterTM, tests that use urine
or saliva to detect use of tobacco products. The Corporation is also
developing therapeutics for the treatment of Alzheimer's disease, new
treatments for benign prostate hyperplasia, and new anti-bacterial agents
for the treatment of urinary tract and other bacterial infections in
humans, including a treatment for E-coli 0157:H7 bacterial contamination in
meat and other food and drink products.
Since 1989, the Corporation's activities and resources have been primarily
focused on developing certain pharmaceutical technologies. The Corporation
is subject to a number of risks, including the successful development and
marketing of its technologies. In order to achieve its business plan and
the realization of its assets and liabilities in the normal course of
operations, the Corporation anticipates the need to raise additional
capital and/or achieve sales and other revenue generating activities.
Management believes that funds from operations as well as existing
financing facilities will be sufficient to meet the Corporation's
requirements for the next year.
The Corporation is listed on the NASDAQ Stock Market.
2. Significant accounting policies:
(a) Consolidation and change in measurement currency:
The consolidated financial statements of the Corporation have been
prepared under Canadian generally accepted accounting principles
("GAAP") and include the accounts of its US subsidiaries, Nymox
Corporation and Serex Inc. Intercompany balances and transactions have
been eliminated on consolidation.
Consolidated financial statements prepared under US GAAP would differ
in some respects from those prepared in Canada. A reconciliation of
earnings and shareholders' equity reported in accordance with Canadian
GAAP and with US GAAP is presented in note 10.
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NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
2. Significant accounting policies (continued):
(a) Consolidation and change in measurement currency (continued):
Effective January 1, 2000, the Corporation adopted the United States
dollar as its measurement currency as a result of the significance of
business activities conducted in the United States and the increasing
proportion of operating, financing and investing transactions in the
Canadian operations that are denominated in U.S. dollars. In accordance
with Canadian GAAP, the consolidated financial statements for the
figures as at and for the year ended December 31, 1999 have been
presented in US dollars using the convenience translation method
whereby all Canadian dollar amounts were converted into US dollars at
the closing exchange rate at December 31, 1999, which was $1.4433
Canadian dollar per US dollar.
(b) Inventory:
Inventory consists of finished goods and is carried at the lower of
cost and net realizable value. The cost of finished goods is determined
using the full cost accounting method.
(c) Capital assets:
Capital assets are recorded at cost. Depreciation and amortization are
provided using the following method and annual rates:
-----------------------------------------------------------------------
Asset Method Rate
-----------------------------------------------------------------------
Laboratory equipment Straight-line 20%
Computer equipment Straight-line 20%
Office equipment and fixtures Straight-line 20%
Intellectual property rights Straight-line 10%
-----------------------------------------------------------------------
Direct costs incurred in connection with securing the patents are
capitalized. Patents are being amortized using the straight-line method
over their economic useful lives or their legal terms of existence
ranging from 17 to 20 years commencing in the year of commercial
production of the developed products.
Management reviews the unamortized balance of intellectual property
rights and patents on an annual basis and recognizes any impairment in
carrying value when it is identified. An impairment loss would be
recognized when estimates of non-discounted future cash flows expected
to result from the use of an asset and its eventual disposition are
less than the carrying amount. No impairment losses were identified by
the Corporation for the years ended December 31, 2001, 2000 and 1999.
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NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
2. Significant accounting policies (continued):
(d) Revenue recognition:
The Corporation applies guidance from SAB 101 (Staff Accounting
Bulletin 101) issued by the Securities and Exchange Commission in the
recognition of revenue.
Revenue from product sales is recognized when the product or service
has been delivered or obligations as defined in the agreement are
performed. Revenue from research contracts is recognized at the time
research activities are performed under the agreement. Revenue from
license fees, royalties and milestone payments is recognized upon the
fulfillment of all obligations under the terms of the related
agreement. These agreements may include upfront payments to be received
by the Corporation. Upfront payments are recognized as revenue on a
systematic basis over the period that the related services or
obligations as defined in the agreement are performed. Interest is
recognized on an accrual basis.
Deferred revenue as at December 31, 2001 represents amounts billed to
and received from customers in advance of revenue recognition.
(e) Research and development expenditures:
Research expenditures, net of research tax credits, are expensed as
incurred. Development expenditures, net of tax credits, are expensed as
incurred, except if they meet the criteria for deferral in accordance
with generally accepted accounting principles.
(f) Foreign exchange:
The Corporation's measurement currency is the United States dollar.
Monetary assets and liabilities of the Canadian and foreign operations
denominated in currencies other than the United States dollar are
translated at the rates of exchange prevailing at the balance sheet
dates. Other assets and liabilities denominated in currencies other
than the United States dollar are translated at the exchange rates
prevailing when the assets were acquired or the liabilities incurred.
Revenues and expenses denominated in currencies other than the United
States dollar are translated at the average exchange rate prevailing
during the year, except for depreciation and amortization which are
translated at the same rates as those used in the translation of the
corresponding assets. Foreign exchange gains and losses resulting from
the translation are included in the determination of net earnings.
(g) Stock-based compensation plan:
No compensation expense is recognized under the Corporation's
stock-based compensation plan when stock options are issued to
employees or non-employees. Any consideration paid on exercise of stock
options is credited to share capital.
-75-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
2. Significant accounting policies (continued):
(h) Income taxes:
The Corporation accounts for income taxes with the asset and liability
method of accounting for income taxes. Under this method, future income
tax assets and liabilities are determined based on "temporary
differences" (differences between the accounting basis and the tax
basis of the assets and liabilities), and are measured using the
currently enacted, or substantively enacted, tax rates and laws
expected to apply when these differences reverse. A valuation allowance
is recorded against any future income tax asset if it is more likely
than not that the asset will not be realized. Income tax expense or
benefit is the sum of the Company's provision for current income taxes
and the difference between the opening and ending balances of the
future income tax assets and liabilities.
(i) Earnings per share:
Basic earnings per share are determined using the weighted average
number of common shares outstanding during the period.
In 2001, the Company adopted the recommendations of the Canadian
Institute of Chartered Accountants with respect to the calculation of
diluted earnings per share. These new recommendations substantially
eliminate the differences between Canadian and U.S. generally accepted
accounting principles in this area. The standard requires that the
treasury stock method be used for calculating diluted earnings per
share. Diluted earnings per share are computed in a manner consistent
with basic earnings per share except that the weighted average shares
outstanding are increased to include additional shares from the assumed
exercise of options and warrants, if dilutive. The number of additional
shares is calculated by assuming that outstanding options and warrants
were exercised and that the proceeds from such exercises were used to
acquire shares of common stock at the average market price during the
reporting period.
Previously, fully diluted earnings per share were calculated on the
assumption that common stock options and warrants which were dilutive
are exercised at the beginning of the year or the date granted, if
later, and the funds derived therefrom are invested at the Company's
annual after tax cost of short-term financing. Under this method, the
net earnings available to shareholders would be adjusted for this
imputed interest.
The adoption of the new standard did not affect previously reported
earnings per share.
(j) 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 revenues
and expenses during the reporting periods. Actual results could differ
from those estimates.
-76-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
3. Capital assets:
-------------------------------------------------------------------------------------------------------------------
2001
-------------------------------------------------------------------------------------------------------------------
Accumulated
depreciation Net book
Cost and amortization value
-------------------------------------------------------------------------------------------------------------------
Property and equipment:
Laboratory equipment $ 615,656 $ 444,049 $ 171,607
Computer equipment 73,044 41,497 31,547
Office equipment and fixtures 88,949 75,020 13,929
-------------------------------------------------------------------------------------------------------------------
777,649 560,566 217,083
Intangible assets:
Patents 1,660,475 269,781 1,390,694
Intellectual property rights acquired 2,219,564 455,817 1,763,747
-------------------------------------------------------------------------------------------------------------------
3,880,039 725,598 3,154,441
-------------------------------------------------------------------------------------------------------------------
$ 4,657,688 $ 1,286,164 $ 3,371,524
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
2000
-------------------------------------------------------------------------------------------------------------------
Accumulated
depreciation Net book
Cost and amortization value
-------------------------------------------------------------------------------------------------------------------
Property and equipment:
Laboratory equipment $ 613,219 $ 401,389 $ 211,830
Computer equipment 73,049 33,611 39,438
Office equipment and fixtures 88,949 71,538 17,411
-------------------------------------------------------------------------------------------------------------------
775,217 506,538 268,679
Intangible assets:
Patents 1,322,496 162,696 1,159,800
Intellectual property rights acquired 2,219,564 235,349 1,984,215
-------------------------------------------------------------------------------------------------------------------
3,542,060 398,045 3,144,015
-------------------------------------------------------------------------------------------------------------------
$ 4,317,277 $ 904,583 $ 3,412,694
-------------------------------------------------------------------------------------------------------------------
-77-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
4. Business acquisition:
In 2000, the Corporation entered into a share purchase agreement to acquire
a controlling interest in Serex, Inc. ("Serex"), a privately-held
development stage corporation based in New Jersey. When the agreement
closed on March 2, 2000, the Corporation acquired 72.3% of the issued and
outstanding common stock of Serex in exchange for 187,951 common shares of
the Corporation having a value of approximately $657,825, and a warrant to
purchase 115,662 of the Corporation's common shares at a price of $3.70 per
share exercisable on the following dates: (i) January 8, 2001 - 35,783
shares (ii) January 8, 2002 - 30,000 shares (iii) January 8, 2003 - 30,000
shares, (iv) January 8, 2004 - 19,879 shares. In connection with this
acquisition, the Corporation also issued 40,000 options to the selling
shareholder to purchase the Corporation's shares. The options are
exercisable at a price of $3.70/share over a four-year period.
On August 1, 2000, the Corporation acquired an additional 293,138 shares of
Serex for a consideration consisting of 54,646 common shares of the
Corporation having a value of $191,261 and warrants to purchase 33,627 of
the Corporation's common shares at a price of $3.70 per share. On October
25, 2000, the Corporation acquired an additional 75,520 shares of Serex for
a consideration of 14,078 common shares of the Corporation having a value
of $49,273 and warrants to purchase 8,663 of the Corporation's common
shares at a price of $3.70 per share. After the above transactions, the
Corporation had approximately 98% of the outstanding shares of Serex.
The acquisition has been accounted for using the purchase method and,
accordingly, these consolidated financial statements include the results of
operations of Serex since the date of acquisition. Details of the
acquisition are as follows:
-------------------------------------------------------------------------------
Assets acquired:
Current assets $ 98,746
Capital assets 19,056
Current liabilities (217,369)
Non-controlling interest (i) (800,000)
-------------------------------------------------------------------------------
(899,567)
Patents, technological platform and
know-how acquired ("Intellectual
property rights") 2,219,564
-------------------------------------------------------------------------------
Value of assets acquired $ 1,319,997
-------------------------------------------------------------------------------
Consideration:
Common shares $ 898,359
Warrants and options (ii) 421,638
-------------------------------------------------------------------------------
$ 1,319,997
-------------------------------------------------------------------------------
-78-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
4. Business acquisition (continued):
(i) Non-controlling interest includes redeemable, convertible preferred
shares of Serex held by third parties in the amount of $800,000. Up to
50% of preferred shares are redeemable at any time at the option of the
preferred shareholders for their issue price. The preferred shares are
convertible into common shares of Serex at a price of $3.946 per share.
(ii)The Corporation determined that the warrants and options issued in
connection with the acquisition of Serex had a value of $421,638, which
was determined using the methodology described in note 10 (d) (2).
5. Notes payable:
-------------------------------------------------------------------------------------------------------------------
2001 2000
-------------------------------------------------------------------------------------------------------------------
Note payable, bearing interest at the prime rate
plus 2%, due May 2002 $ 96,775 $ -
Note payable, bearing interest at the prime rate
plus 2%, due June 2002 300,000 -
-------------------------------------------------------------------------------------------------------------------
$ 396,775 $ -
-------------------------------------------------------------------------------------------------------------------
6. Share capital and other:
-------------------------------------------------------------------------------------------------------------------
2001 2000
-------------------------------------------------------------------------------------------------------------------
Authorized:
An unlimited number of common shares
Issued and outstanding:
22,297,525 common shares (2000 - 21,377,621) $ 25,376,557 $ 22,822,303
Warrants and options (see note 4 (ii)) 421,638 421,638
-------------------------------------------------------------------------------------------------------------------
$ 25,798,195 $ 23,243,941
-------------------------------------------------------------------------------------------------------------------
-79-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
6. Share capital and other (continued):
(a) Changes in the Corporation's outstanding common shares are presented
below:
-------------------------------------------------------------------------------------------------------------------
Shares Dollars
-------------------------------------------------------------------------------------------------------------------
Issued and outstanding, December 31, 1999 20,003,804 $ 16,912,963
Issue of common shares for cash under private
placements and common stock purchase
agreement (b) (c) 1,112,142 5,000,000
Issue of common shares in connection
with Serex acquisition 256,675 898,359
Issue of common shares pursuant to exercise
of stock options (e) 5,000 10,981
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 2000 21,377,621 22,822,303
Issue of common shares for cash under private
placements and common stock purchase
agreement (b) (c) 811,904 2,236,199
Issue of common shares pursuant to exercise
of stock options (e) 108,000 318,055
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 2001 22,297,525 $ 25,376,557
-------------------------------------------------------------------------------------------------------------------
(b) Private placements:
In 2001, the Corporation completed private placements for 594,100
common shares and received aggregate proceeds of $1,799,490. In 2000,
the Corporation completed a private placement for 821,637 common shares
for total aggregate proceeds of $4,000,000. The share issue costs
related to these private placements have been charged against the
deficit.
-80-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
6. Share capital and other (continued):
(c) Common Stock Purchase Agreement:
In November 1999, the Corporation and Jaspas Investments Limited
("Jaspas"), a corporation based in the British Virgin Islands, signed a
common stock purchase agreement (the "Agreement") that establishes the
terms and conditions for the future issuance and purchase of the
Corporation's common shares by Jaspas. In general terms, Jaspas is
committed to purchase up to $12 million of the Corporation's common
shares over a thirty-month period. However, Jaspas may not purchase
more than 19.9% of the Corporation's common shares issued and
outstanding as of November 12, 1999, the closing date under the
Agreement, without obtaining shareholder approval.
The Agreement establishes what is referred to by the parties as an
equity drawdown facility. On a monthly basis, the Corporation may
request a drawdown on the facility subject to a formula, based on the
average stock price and average trading volume, that sets the maximum
amount for any given draw. At the end of a 22-day trading period
following the drawdown request, the amount of money that Jaspas will
provide to the Corporation and the number of shares that the
Corporation will issue is settled based on the formula using the
average daily share price for each of the 22 trading days. Jaspas
receives a 6% discount on the market price determined for the 22-day
trading period, and the Corporation will receive the settled amount
less a 3% placement fee payable to the placement agents.
The Corporation may make up to 24 drawdowns to a maximum of
$750,000/drawdown and $12,000,000 in total. There are certain
conditions that must be satisfied before Jaspas is obligated to
purchase the Corporation's common shares. In 2001, the Corporation
issued 217,804 common shares (290,505 in 2000) and raised $436,709
under this facility (2000 - $1,000,000).
The Corporation has also issued a warrant to Jaspas to purchase 200,000
common shares (see note 6 (d)).
The gross fees related to this transaction amounted to $242,732. These
costs were initially accounted for as deferred share issuance costs to
be amortized over the thirty-month drawdown period. Amortization is
calculated for each drawdown based on the percentage of the actual
drawdown over the total facility. In 2001, the Corporation amortized
$29,054 (2000 - $20,220) of deferred share issuance costs to the
deficit related to drawdowns in the year. In addition, the Corporation
wrote off against earnings deferred share issuance costs in the amount
of $87,263 for the portion of the facility that can no longer be
utilized by the Corporation. The facility expires in September 2002.
-81-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
6. Share capital and other (continued):
(d) Warrants:
The Corporation has issued the following warrants to purchase common
shares:
-------------------------------------------------------------------------------------------------------------------
Exercise Outstanding at
price per Exercised December 31,
Warrants share Issued to date Expired 2001 Expiry
-------------------------------------------------------------------------------------------------------------------
Series E $ 4.53 200,000 (i) - - 200,000 November 30, 2004
Series F $ 4.06 160,000 (ii) - - 160,000 November 30, 2004
Series G $ 3.70 115,662(iii) - - 115,662 January 8, 2005
Series H $ 9.38 66,667 (iv) - - 66,667 March 6, 2004
Series I $ 7.81 26,667 (iv) - - 26,667 March 6, 2004
Series J $ 3.70 42,290(iii) - - 42,290 July 31, 2005
Series K $ 2.06 100,000 (iv) - - 100,000 March 6, 2003
-------------------------------------------------------------------------------------------------------------------
(i) Warrant issued to Jaspas in connection with the common stock
purchase agreement referred to in note 6 (c). The warrant entitles
Jaspas to purchase 200,000 common shares at an exercise price of
US$4.5315.
(ii) Warrants issued to placement agents in connection with the common
stock purchase agreement. The warrants are exercisable at a price
of US$4.0625.
(iii) Warrants issued in connection with the Serex acquisition (see
note 4).
(iv) Warrants issued in connection with certain private placements (see
note 6 (b)).
(e) Stock options:
The Corporation has established a stock option plan (the "Plan") for
its key employees, its officers and directors, and certain consultants.
The Plan is administered by the Board of Directors of the Corporation.
The Board may from time to time designate individuals to whom options
to purchase common shares of the Corporation may be granted, the number
of shares to be optioned to each, and the option price per share. The
option price per share cannot involve a discount to the market price at
the time the option is granted. The total number of shares to be
optioned to any one individual cannot exceed 5% of the total issued and
outstanding shares and the maximum number of shares which may be
optioned under the Plan cannot exceed 2,500,000 common shares without
shareholder approval.
-82-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
6. Share capital and other (continued):
(e) Stock options (continued):
Changes in outstanding options were as follows for the last two fiscal
periods:
-------------------------------------------------------------------------------------------------------------------
Weighted average
Number exercise price
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1998 1,926,000 $ 3.97
Granted 351,500 3.72
Exercised (98,900) 2.25
Expired (55,000) 6.63
Cancelled (993,100) 2.30
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1999 1,130,500 4.76
Granted 549,000 4.06
Exercised (5,000) 2.20
Expired (10,000) 4.26
Cancelled (25,000) 3.12
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 2000 1,639,500 4.54
Granted 413,500 3.78
Exercised (108,000) 2.95
Expired (265,000) 4.04
Cancelled (40,000) 3.70
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 2001 1,640,000 $ 4.51
-------------------------------------------------------------------------------------------------------------------
-83-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
6. Share capital and other (continued):
(e) Stock options (continued):
At December 31, 2001, options outstanding and exercisable were as
follows:
-------------------------------------------------------------------------------------------------------------------
Options outstanding Options exercisable Exercise price per share Expiry date
-------------------------------------------------------------------------------------------------------------------
1,500 1,500 $ 1.93 February 6, 2002
20,000 20,000 6.93 September 12, 2002
10,000 10,000 2.25 April 13, 2004
5,000 5,000 9.53 April 13, 2004
5,000 5,000 6.79 April 13, 2004
40,000 35,000 6.93 April 13, 2004
5,000 5,000 6.24 April 13, 2004
210,000 210,000 2.25 January 17, 2006
10,000 10,000 9.53 January 17, 2006
10,000 10,000 6.79 January 17, 2006
20,000 20,000 6.93 January 17, 2006
100,000 100,000 7.97 April 30, 2006
10,000 10,000 11.60 August 13, 2006
10,000 10,000 6.24 August 13, 2006
30,000 30,000 6.93 August 13, 2006
5,000 5,000 6.24 October 31, 2007
40,000 40,000 6.93 October 31, 2007
9,000 9,000 6.41 December 19, 2007
100,000 100,000 4.85 November 9, 2008
50,000 50,000 6.93 January 22, 2009
2,000 2,000 6.41 March 23, 2009
67,000 67,000 3.12 May 13, 2009
75,000 75,000 3.12 June 1, 2009
255,000 255,000 3.88 May 1, 2010
50,000 10,000 6.93 May 1, 2010
10,000 10,000 4.70 June 15, 2010
10,000 10,000 3.50 July 13, 2010
2,000 2,000 4.00 July 13, 2010
11,500 11,500 3.20 August 14, 2010
5,000 5,000 3.15 August 16, 2010
50,000 50,000 3.90 August 25, 2010
10,000 10,000 2.21 January 16, 2011
70,500 70,500 1.93 April 23, 2011
2,000 2,000 3.75 October 1, 2011
100,000 20,000 4.00 November 1, 2011
4,500 4,500 4.20 November 9, 2011
225,000 75,000 4.33 November 13, 2011
-------------------------------------------------------------------------------------------------------------------
1,640,000 1,365,000 $ 4.51
-------------------------------------------------------------------------------------------------------------------
-84-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
7. Commitments and contingency:
(a) Operating leases:
Minimum lease payments under operating leases for the Corporation's
premises for the next four years are as follows:
-----------------------------------------------------------------------------
2002 $ 172,958
2003 172,958
2004 172,958
2005 67,084
-----------------------------------------------------------------------------
$ 585,958
-----------------------------------------------------------------------------
(b) Research funding agreement:
The Corporation is committed to make research grants to an unrelated
medical facility in the U.S. in the aggregate amount of approximately
$770,750 in the next three years as follows:
-----------------------------------------------------------------------------
2002 $ 292,000
2003 249,000
2004 229,750
-----------------------------------------------------------------------------
$ 770,750
-----------------------------------------------------------------------------
Under this agreement, the medical facility benefits from research
funding and collaboration from the Corporation and is entitled to
royalties based on a percentage of sales of any commercialized product
derived from this research.
(c) Contingency:
A shareholder has served the Corporation with a Statement of Claim
filed with the Ontario Superior Court of Justice claiming to be
entitled to the issuance of 388,797 additional shares in accordance
with repricing provisions contained in the March 2000 private
placement agreement referred to in note 6 (b) and to damages of
$275,000 for lost opportunity to sell these shares. The Corporation
believes that the shareholder's interpretation of the repricing
provisions in the March 2000 agreement is incorrect and intends to
defend the action vigorously. Accordingly, no provision related to
this matter has been recorded in these financial statements.
-85-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
8. Income taxes:
Details of the components of income taxes are as follows:
-------------------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------------------
Loss before income taxes:
Canadian operations $ (2,257,157) $ (2,558,476) $ (2,631,662)
U.S. operations (792,347) (1,465,503) (682,634)
-------------------------------------------------------------------------------------------------------------------
(3,049,504) (4,023,979) (3,314,296)
Basic income tax rate 37.0% 38.0% 38.0%
-------------------------------------------------------------------------------------------------------------------
Income tax recovery at statutory rates 1,128,000 1,529,000 1,260,000
Adjustments in income taxes resulting from:
Non-recognition of losses and other
unclaimed deductions (1,128,000) (1,529,000) (1,260,000)
-------------------------------------------------------------------------------------------------------------------
Income taxes $ - $ - $ -
-------------------------------------------------------------------------------------------------------------------
The income tax effect of temporary differences that give rise to the net
future tax asset is presented below:
-------------------------------------------------------------------------------------------------------------------
2001 2000
-------------------------------------------------------------------------------------------------------------------
Non-capital losses $ 6,200,000 $ 5,695,000
Scientific research and experimental development
expenditures 600,000 544,000
Investment tax credits 250,000 230,000
Share issue costs 135,000 200,000
Intellectual property rights (500,000) (590,000)
Foreign exchange gains (240,000) (135,000)
Less valuation allowance (6,445,000) (5,944,000)
-------------------------------------------------------------------------------------------------------------------
Net future tax asset $ - $ -
-------------------------------------------------------------------------------------------------------------------
-86-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
8. Income taxes (continued):
In assessing the realizability of future tax assets, management considers
whether it is more likely than not that some portion or all of the future
tax assets will not be realized. The ultimate realization of future tax
assets is dependent upon the generation of future taxable income and tax
planning strategies. Since the Corporation is a development stage
enterprise, the generation of future taxable income is dependent on the
successful commercialization of its products and technologies.
The Corporation has non-capital losses carried forward and accumulated
scientific research and development expenditures which are available to
reduce future years' taxable income. These expire as follows:
-------------------------------------------------------------------------------------------------------------------
Federal Provincial
-------------------------------------------------------------------------------------------------------------------
Non-capital losses:
2002 $ 575,000 $ -
2003 1,250,000 800,000
2004 1,375,000 685,000
2005 1,950,000 1,950,000
2006 2,214,000 2,214,000
2007 2,578,000 2,578,000
2008 1,509,000 1,509,000
Scientific research and development expenditures:
(Indefinitely) 1,448,000 2,974,000
-------------------------------------------------------------------------------------------------------------------
The Corporation also has investment tax credits available in the amount of
approximately $400,000 to reduce future years' federal taxes payable. These
credits expire as follows:
-------------------------------------------------------------------------------------------------------------------
2005 $ 25,000
2006 184,000
2007 98,000
2008 3,000
2009 8,000
2010 32,000
2011 50,000
-------------------------------------------------------------------------------------------------------------------
-87-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
8. Income taxes (continued):
In addition, the Corporation's US subsidiaries have losses carried forward
of approximately $8,013,000 which expire as follows:
--------------------------------------------------------------------------------
2010 $ 50,000
2011 1,035,000
2012 1,933,000
2018 2,782,000
2019 1,005,000
2020 750,000
2021 458,000
--------------------------------------------------------------------------------
9. Financial instruments:
(a) Foreign currency risk management:
As indicated in note 2 (a), the Corporation adopted the US dollar as
its measurement currency effective January 1, 2000 because a
substantial portion of revenues, expenses, assets and liabilities of
its Canadian and US operations are denominated in US dollars. The
Canadian operation also has transactions denominated in Canadian
dollars, principally relating to salaries and rent. Fluctuations in the
currency used for the payment of the Corporation's expenses denominated
in currencies other than the US dollar could cause unanticipated
fluctuations in the Corporation's operating results. The Corporation
does not engage in the use of derivative financial instruments to
manage its currency exposures.
(b) Fair value disclosure:
Fair value estimates are made as of a specific point in time using
available information about the financial instrument. These estimates
are subjective in nature and often cannot be determined with precision.
The Corporation has determined that the carrying value of its
short-term financial assets and liabilities approximates fair value due
to the immediate or short-term maturity of these financial instruments.
-88-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
9. Financial instruments (continued):
(c) Credit risk:
Credit risk results from the possibility that a loss may occur from the
failure of another party to perform according to the terms of the
contract. Financial instruments that potentially subject the Company to
concentrations of credit risk consist primarily of cash and accounts
receivable. Cash is maintained with a high-credit quality financial
institution. For accounts receivable, the Company performs periodic
credit evaluations and typically does not require collateral.
Allowances are maintained for potential credit losses consistent with
the credit risk, historical trends, general economic conditions and
other information.
(d) Interest rate risk:
The Company's exposure to interest rate risk is as follows:
--------------------------------------------------------------------------------
Cash Fixed interest rate
Notes payable Floating interest rate
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences:
(a) Consolidated statements of earnings:
The reconciliation of earnings reported in accordance with Canadian
GAAP and with U.S. GAAP is as follows:
-------------------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------------------
Net loss, Canadian GAAP $ (3,049,504) $ (4,023,979) $ (3,314,296)
Adjustments:
Amortization of patents (i) 9,411 9,361 9,142
Stock-based compensation - options
granted to non-employees (ii) (55,040) (257,690) (198,815)
Change in reporting currency (iii) - - 94,803
-------------------------------------------------------------------------------------------------------------------
Net loss, U.S. GAAP $ (3,095,133) $ (4,272,308) $ (3,409,166)
-------------------------------------------------------------------------------------------------------------------
Loss per share, U.S. GAAP $ (0.14) $ (0.20) $ (0.17)
-------------------------------------------------------------------------------------------------------------------
-89-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(b) Consolidated shareholders' equity:
The reconciliation of shareholders' equity reported in accordance with
Canadian GAAP and with U.S. GAAP is as follows:
-------------------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------------------
Shareholders' equity, Canadian GAAP $ 2,644,748 $ 3,260,942 $ 1,307,147
Adjustments:
Amortization of patents (i) (138,535) (147,946) (157,307)
Stock-based compensation - options
granted to non-employees (ii):
Cumulative compensation expense (1,260,583) (1,205,543) (947,853)
Additional paid-in capital 1,313,146 1,258,106 1,000,416
Change in reporting currency (iii) (62,672) (62,672) (62,672)
-------------------------------------------------------------------------------------------------------------------
(148,644) (158,055) (167,416)
-------------------------------------------------------------------------------------------------------------------
Shareholders' equity, U.S. GAAP $ 2,496,104 $ 3,102,887 $ 1,139,731
-------------------------------------------------------------------------------------------------------------------
(i) In accordance with APB Opinion 17, Intangible Assets, the
patents are amortized using the straight-line method over the
legal life of the patents from the date the patent was secured.
For Canadian GAAP purposes, patents are amortized commencing in
the year of commercial production of the developed products.
(ii) In accordance with FAS 123, Accounting for Stock-Based
Compensation, compensation related to the stock options granted
to non-employees has been recorded in the accounts based on the
fair value of the stock options at the grant date. The fair
value of the stock options was estimated as described in note 10
(d) (2).
(iii) Change in reporting currency:
As explained in note 2 (a), the Company has adopted the US
dollar as its reporting currency effective January 1, 2000. For
Canadian GAAP purposes, the financial information for 1999 has
been translated into US dollars at the December 31, 1999
exchange rate. For United States GAAP reporting purposes, assets
and liabilities for all years presented have been translated
into US dollars at the ending exchange rate for the respective
year and the statement of earnings at the average exchange rate
for the respective year.
-90-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(c) Consolidated comprehensive income:
-------------------------------------------------------------------------------------------------------------------
2001 2000 1999
-------------------------------------------------------------------------------------------------------------------
Net loss, US GAAP $ (3,095,133) $ (4,272,308) $ (3,409,166)
Other comprehensive income (loss):
Foreign currency translation
adjustment - - 111,518
-------------------------------------------------------------------------------------------------------------------
Comprehensive loss $ (3,095,133) $ (4,272,308) $ (3,297,648)
-------------------------------------------------------------------------------------------------------------------
FAS 130, Reporting Comprehensive Income, requires the Corporation to
report and display certain information related to comprehensive income
for the Corporation. Comprehensive income includes net earnings and
certain foreign currency translation adjustments.
The accumulated comprehensive loss only comprises foreign currency
translation adjustments and is included in the amount of shareholders'
equity presented for US GAAP purposes in note 10 (b).
-91-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(d) Other disclosures required by United States GAAP:
(1) Development stage company:
The Corporation is in the process of developing unique patented
products which are subject to approval by the regulatory
authorities. It has had limited revenues to date on the sale of
its products under development. Accordingly, the Corporation is a
development stage company as defined in Statement of Financial
Accounting Standards No. 7 and the following additional
disclosures are provided:
-----------------------------------------------------------------------------------------------------------
Cumulative Cumulative
since the date of since the date of
inception of inception of
the Corporation the Corporation
to December 31, to December 31,
2001 2000
-----------------------------------------------------------------------------------------------------------
Revenues:
Interest revenue $ 502,068 $ 484,150
Sales 668,064 432,776
License revenue 97,403 -
Research contract 30,000 -
Expenses:
Gross research and development expenditures 11,044,704 9,545,050
Other expenses 13,395,963 11,445,452
Cash inflows (outflows):
Operating activities (21,588,838) (18,918,110)
Investing activities (778,198) (513,063)
Financing activities 24,296,442 21,437,303
-----------------------------------------------------------------------------------------------------------
-92-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(d) Other disclosures required by United States GAAP (continued):
(1) Development stage company (continued):
The statement of shareholders' equity since date of inception is
presented below:
-------------------------------------------------------------------------------------------------------------------
Additional
Number of Consi- paid-in Accumulated
shares deration capital deficit Total
-------------------------------------------------------------------------------------------------------------------
Year ended July 31, 1990:
Common shares issued 2,500,000 $ 172,414 $ -- $ -- $ 172,414
Net loss -- -- -- (109,241) (109,241)
-------------------------------------------------------------------------------------------------------------------
Balance, July 31, 1990 2,500,000 172,414 -- (109,241) 63,173
Year ended July 31, 1991:
Net loss -- -- -- (21,588) (21,588)
Cumulative translation adjustment -- 1,499 -- (950) 549
-------------------------------------------------------------------------------------------------------------------
Balance, July 31, 1991 2,500,000 173,913 -- (131,779) 42,134
Year ended July 31, 1992:
Common shares issued 9,375 31,468 -- -- 31,468
Net loss -- -- -- (45,555) (45,555)
Cumulative translation adjustment -- (6,086) -- 5,598 (488)
-------------------------------------------------------------------------------------------------------------------
Balance, July 31, 1992 2,509,375 199,295 -- (171,736) 27,559
Year ended July 31, 1993:
Common shares issued 201,250 159,944 -- -- 159,944
Common shares cancelled (500,000) -- -- -- --
Net loss -- -- -- (38,894) (38,894)
Cumulative translation adjustment -- (13,994) -- 12,830 (1,164)
-------------------------------------------------------------------------------------------------------------------
Balance, July 31, 1993 2,210,625 345,245 -- (197,800) 147,445
Year ended July 31, 1994:
Common shares issued 2,500 7,233 -- -- 7,233
Net loss -- -- -- (53,225) (53,225)
Cumulative translation adjustment -- (25,173) -- 15,808 (9,365)
-------------------------------------------------------------------------------------------------------------------
Balance, July 31, 1994 2,213,125 327,305 -- (235,217) 92,088
Year ended July 31, 1995:
Common shares issued 78,078 303,380 -- -- 303,380
Net loss -- -- -- (285,910) (285,910)
Cumulative translation adjustment -- 5,196 -- (7,221) (2,025)
-------------------------------------------------------------------------------------------------------------------
Balance, July 31, 1995 2,291,203 635,881 -- (528,348) 107,533
Period ended December 31, 1995:
Adjustment necessary to
increase the number of
common shares 12,708,797 -- -- -- --
-------------------------------------------------------------------------------------------------------------------
Adjusted number of
common shares 15,000,000 635,881 -- (528,348) 107,533
Common shares issued 2,047,082 2,997,284 -- -- 2,997,284
Net loss -- -- -- (1,194,226) (1,194,226)
Share issue costs -- (153,810) -- -- (153,810)
Cumulative translation adjustment -- 2,858 -- (6,328) (3,470)
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1995
carried forward 17,047,082 3,482,213 -- (1,728,902) 1,753,311
-93-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(d) Other disclosures required by United States GAAP (continued):
(1) Development stage company (continued):
The statement of shareholders' equity since date of inception is
presented below (continued):
-------------------------------------------------------------------------------------------------------------------
Additional
Number of Consi- paid-in Accumulated
shares deration capital deficit Total
-------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1995
brought forward 17,047,082 $ 3,482,213 $ -- $ (1,728,902) $ 1,753,311
Year ended December 31, 1996:
Common shares issued 882,300 3,852,364 -- -- 3,852,364
Net loss -- -- -- (3,175,587) (3,175,587)
Share issue costs -- (170,699) -- -- (170,699)
Stock-based compensation -- -- 434,145 -- 434,145
Cumulative translation adjustment -- (16,769) (2,217) 24,544 5,558
--------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1996 17,929,382 7,147,109 431,928 (4,879,945) 2,699,092
Year ended December 31, 1997:
Common shares issued 703,491 3,180,666 -- -- 3,180,666
Net loss -- -- (3,755,409) (3,755,409)
Share issue costs -- (161,482) -- -- (161,482)
Capital stock subscription -- 352,324 -- -- 352,324
Stock-based compensation -- -- 108,350 -- 108,350
Cumulative translation adjustment -- (299,275) (21,578) 325,364 4,511
--------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1997 18,632,873 10,219,342 518,700 (8,309,990) 2,428,052
Year ended December 31, 1998:
Common shares issued 1,095,031 5,644,638 -- -- 5,644,638
Net loss -- -- -- (4,979,562) (4,979,562)
Share issue costs -- (54,131) -- -- (54,131)
Stock-based compensation -- -- 274,088 -- 274,088
Cumulative translation adjustment -- (685,156) (43,750) 720,173 (8,733)
--------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1998 19,727,904 15,124,693 749,038 (12,569,379) 3,304,352
Year ended December 31, 1999:
Common shares issued 275,900 969,253 -- -- 969,253
Net loss -- -- -- (3,409,166) (3,409,166)
Share issue costs -- (35,041) -- -- (35,041)
Stock-based compensation -- -- 198,815 -- 198,815
Cumulative translation adjustment -- 943,133 52,563 (884,178) 111,518
--------------------------------------------------------------------------------------------------------------------
Balance, December 31, 1999 20,003,804 17,002,038 1,000,416 (16,862,723) 1,139,731
Year ended December 31, 2000:
Common shares issued 1,373,817 5,909,340 -- -- 5,909,340
Warrants and options -- 421,638 -- -- 421,638
Net loss -- -- -- (4,272,308) (4,272,308)
Share issue costs -- (353,204) -- -- (353,204)
Stock-based compensation -- -- 257,690 -- 257,690
--------------------------------------------------------------------------------------------------------------------
Balance, December 31, 2000
carried forward 21,377,621 22,979,812 1,258,106 (21,135,031) 3,102,887
-94-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(d) Other disclosures required by United States GAAP (continued):
(1) Development stage company (continued):
The statement of shareholders' equity since date of inception is
presented below (continued):
----------------------------------------------------------------------------------------------------------
Additional
Number of Consi- paid-in Accumulated
shares deration capital deficit Total
----------------------------------------------------------------------------------------------------------
Balance, December 31, 2000
brought forward 21,377,621 $ 22,979,812 $ 1,258,106 $(21,135,031) $ 3,102,887
Year ended December 31, 2001:
Common shares 919,904 2,554,254 -- -- 2,554,254
Net loss -- -- -- (3,095,133) (3,095,133)
Share issue costs -- (120,944) -- -- (120,944)
Stock-based compensation -- -- 55,040 -- 55,040
-----------------------------------------------------------------------------------------------------------
Balance, December 22,297,525 $ 25,413,122 $ 1,313,146 $(24,230,164) $ 2,496,104
-----------------------------------------------------------------------------------------------------------
(2) Stock-based compensation:
For US GAAP purposes, the Corporation applies APB Opinion 25,
Accounting for Stock Issued to Employees, in accounting for its
stock option plan, and, accordingly, no compensation cost has been
recognized for stock options granted to employees in these
financial statements. As explained in note 10 (b), compensation
cost has been recognized for stock options granted to
non-employees. Had compensation cost been determined for stock
options granted to employees based on the fair value at the grant
dates for awards under the plan consistent with the method of FASB
Statement 123, Accounting for Stock-Based Compensation, the
Corporation's net earnings and loss per share would have been
adjusted to the pro-forma amounts indicated below for US GAAP:
-----------------------------------------------------------------------------------------------------
2001 2000 1999
-----------------------------------------------------------------------------------------------------
Net loss As reported (US GAAP) $ (3,095,133) $ (4,272,308) $ (3,409,166)
Pro-forma (3,347,102) (5,884,919) (3,990,187)
Loss per share As reported (US GAAP) (0.14) (0.20) (0.17)
Pro-forma (0.15) (0.28) (0.20)
-----------------------------------------------------------------------------------------------------
-95-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
10. Canadian/U.S. Reporting Differences (continued):
(d) Other disclosures required by United States GAAP (continued):
(2) Stock-based compensation (continued):
The fair value of each option grant was estimated on the date of
grant using the Black-Scholes option-pricing model with the
following weighted average assumptions: risk-free interest rate of
2.20% (2000 - 5.49%; 1999 - 5.50%), dividend yield of 0%, expected
volatility of 59% (2000 - 163%; 1999 - 80%), and expected life of
5 years.
(e) Recent accounting pronouncements:
In July 2001, FASB issued SFAS 141, "Business Combinations" and SFAS
142 "Goodwill and Other Intangible Assets". SFAS 141, which replaces
APB Opinion No. 16, revises the accounting standards for business
combinations and is effective for acquisitions initiated after June 30,
2001. SFAS 142, which replaces APB Opinion No. 17, revises the
standards in accounting for goodwill and other intangibles and is
effective for fiscal years beginning after December 15, 2001. Similar
standards have been adopted by the Canadian Institute of Chartered
Accountants. Effective for the Company's fiscal year beginning January
1, 2002, the statement changes the accounting for goodwill from an
amortization method to an impairment-only approach. In addition, this
statement requires acquired intangible assets to be separately
recognized if the benefit of the intangible assets is obtained through
contractual or other legal right, or if the intangible assets can be
sold, transferred, licensed, rented or exchanged. The Company does not
expect SFAS No. 142 to have a material impact on its financial
statements.
In August 2001, FASB issued SFAS No. 143, "Accounting for Asset
Retirement Obligations". SFAS No. 143 requires the Company to record
the fair value of an asset retirement obligation as a liability in the
period in which it incurs a legal obligation associated with the
retirement of tangible long-lived assets. This statement is effective
for the Company's fiscal year beginning January 1, 2003. The Company
does not expect SFAS No. 143 to have a material impact on its financial
statements.
In October 2001, FASB issued SFAS No. 144, "Accounting for the
Impairment or Disposal of Long-lived Assets". SFAS No. 144 provides
accounting guidance for long-lived assets to be disposed of other than
by sale, and to be disposed of by sale. This statement is effective for
the Company's fiscal year beginning January 1, 2002. The Company does
not expect SFAS No. 144 to have an initial material impact on its
financial statements upon adoption.
-96-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
11. Segment disclosures:
The Corporation operates in one reporting segment - the research and
development of products for the treatment of Alzheimer's and other
diseases. Geographic segment information is as follows:
--------------------------------------------------------------------------------
United
Canada States
--------------------------------------------------------------------------------
Revenues:
2001 $ 145,501 $ 235,108
2000 68,179 157,688
1999 40,963 149,240
Net loss:
2001 (2,257,157) (792,347)
2000 (2,558,476) (1,465,503)
1999 (2,631,662) (682,634)
Capital assets:
2001 3,086,869 284,655
2000 3,191,042 221,652
Total assets:
2001 3,629,455 562,786
2000 4,110,466 408,172
--------------------------------------------------------------------------------
In 2001, one customer accounted for approximately 26% of revenues and, in
total, 5 customers accounted for 54% of revenues in 2001. In 2000 and 1999,
no single customer accounted for more than 10% of revenues.
12. Comparative figures:
Certain of the comparative figures have been reclassified to conform to the
presentation adopted in the current year.
13. Subsequent events:
(a) Private placements:
In February 2002, the Corporation completed a private placement and
issued 74,074 common shares for gross proceeds of $300,000. On March
18, 2002, the Corporation completed a private placement and issued
195,000 common shares for gross proceeds of $819,000.
-97-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
Years ended December 31, 2001, 2000 and 1999
(in US dollars)
--------------------------------------------------------------------------------
13. Subsequent events (continued):
(b) Demand for arbitration:
In March 2002, a former employee filed a demand for arbitration with
the American Arbitration Association concerning the termination of her
employment with the Corporation. The employee is claiming damages of up
to $498,000 plus attorney's fees and costs, based upon alleged
violations of New Jersey law and breach of an employment agreement. The
Corporation believes these claims are without merit and intends to
defend the matter vigorously.
-98-
APPENDIX A
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
The Securities Exchange Act of 1934
For the quarter ended March 31, 2002
Nymox Pharmaceutical Corporation
9900 Cavendish Blvd., St. Laurent, QC, Canada, H4M 2V2
(Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20F or Form 40F)
Form 20 F [X] Form 40 F [ ]
(Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934)
Yes [ ] No [X]
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
NYMOX PHARMACEUTICAL CORPORATION
---------------------------------
(Registrant)
Date: May 15, 2002
By: /s/ Paul Averback
------------------------------
Paul Averback MD
President
-99-
[NYMOX LOGO OMITTED]
CORPORATE PROFILE
-----------------
Nymox Pharmaceutical Corporation is a biotechnology company with three unique
proprietary products on the market, and a significant R&D pipeline of products
in development. Nymox is a leader in the research and development of products
for the diagnosis and treatment of Alzheimer's disease, an affliction of more
than 15 million people around the world. Nymox developed and is currently
offering its AlzheimAlert(TM) test, a urinary test that is the world's only
accurate, non-invasive aid in the diagnosis of Alzheimer's disease. Nymox also
developed and markets NicAlert(TM) and NicoMeter(TM), tests that use urine or
saliva to detect use of tobacco products. Nymox also is developing treatments
aimed at the causes of Alzheimer's disease. One program targets spherons, which
Nymox researchers believe are a source of the senile plaques found in the brains
of patients with Alzheimer's disease. Another distinct program targets the brain
protein (neural thread protein) detected by its AlzheimAlert(TM) test and
implicated in widespread brain cell death seen in Alzheimer's disease. Nymox is
developing new antibacterial agents for the treatment of urinary tract and other
bacterial infections in humans and for the treatment of E. coli 0157:H7
contamination in meat and other food and drink products. Nymox is developing a
novel treatment for benign prostatic hyperplasia. Nymox also has several other
drug candidates and diagnostic technologies in development.
Message to Shareholders
-----------------------
Nymox is pleased to present its results for the first quarter of 2002.
Nymox offers a proprietary product called AlzheimAlert(TM), which is a state of
the art urine test designed to aid physicians in the diagnosis of Alzheimer's
disease. AlzheimAlert(TM) is Nymox's unique patented urinary test for neural
thread protein, a key protein involved in the Alzheimer's disease process. We
are in the early stages of making the tests available to doctors throughout the
U.S. through a medical field force of over 60 medical representatives. The test
costs $295 and is performed by the company's clinical reference laboratory in
New Jersey.
On January 30, Scientists at Nymox announced that a significant new study had
underlined the importance of the Company's emerging diagnostic technology for
Alzheimer's disease. The independent study involved 150 patients and over 100
physicians from across the U.S. Each patient received an AlzheimAlert(TM) test,
and their clinical evolution was subsequently followed by their physician. The
AlzheimAlert(TM) test results were independently documented and compared with
the diagnosis after up to a year's follow-up. The results demonstrated a high
accuracy and usefulness for the AlzheimAlert(TM) test as an aid to physicians.
On March 14, Nymox announced that the Company's AlzheimAlert(TM) urine test will
be used in a study on nutrition, cognitive functioning, dementia and Alzheimer's
disease being conducted by researchers at the Jean Mayer USDA Human Nutrition
Research Center on Aging at Tufts University. Under the initial research
agreement between Nymox and Tufts, AlzheimAlert(TM) will be part of the
evaluation of the study participants. Tufts researchers from the Jean Mayer
Center were co-authors of the important new study recently published in the New
England Journal of Medicine (February 14, 2002, No. 7; 346: 476-483) reporting
that elderly people with elevated blood levels of homocysteine, an amino acid
affected by poor nutrition and related vitamin B deficiencies, have nearly twice
the risk of developing dementia and Alzheimer's disease. Earlier Tufts research
had already shown a relationship between elevated blood levels of homocysteine
and lower cognitive functioning in the elderly.
Nymox also markets two other proprietary products; NicAlert(TM) and
NicoMeter(TM), which are inexpensive, simple-to-use test strips used to
determine whether a person is using tobacco products. NicAlert(TM) and
-100-
NicoMeter(TM) can be applied to many situations such as athletic and school
testing, insurance testing, workplace environment testing, research studies and
smoking cessation. NicoMeter(TM) is used with urine and the new NicAlert(TM) is
used for urine and saliva detection. Nymox provides NicAlert(TM) at $8 per test.
The Company is currently negotiating a number of new marketing initiatives for
NicAlert(TM). NicAlert(TM) and NicoMeter(TM) are currently being used in
research programs into tobacco use and exposure across the U.S., and in Japan.
The tests are a new improvement of a product, which has been used for many years
by experts in the field at institutions such as the University of Texas, Brown
University, and MD Anderson and by reference laboratories such as Smith Kline
Beecham. NicAlert(TM) and NicoMeter(TM) have the distinct advantage of being the
only point-of-care quantitative smoking and tobacco product exposure tests
available in the world.
On March 7, Nymox announced results from a highly successful study of its
NicAlert(TM) product in children exposed to environmental tobacco smoke (ETS)
("second hand smoke"). ETS is a major health problem associated with lung
cancer, respiratory and cardiovascular disease. Exposure to ETS may occur in the
home, in the workplace, in social settings and in public places. As a public
health measure, NicAlert(TM) is useful for all children to detect important risk
such as e.g. wheezing, coughing, asthma, allergy, and airway obstruction in
association with repeated school absence, and increased physician visits and
infections. It is the only quantitative single step test available for ETS
exposure. In the study, NicAlert(TM) readings were compared in smokers,
non-smokers, adults exposed to second hand smoke, and children with smoking or
non-smoking adults in the household. The study found that NicAlert(TM) testing
of urine could detect smoke exposure in children with smokers in their homes and
distinguish these individuals from those with a smoke-free environment.
On February 5, Nymox announced new online marketing initiatives for the
Company's emerging line of products. The Company added a new web site for its
NicAlert(TM) and NicoMeter(TM) saliva and urine tests for tobacco exposure
(www.nicalert.com). Nymox recently entered into a strategic marketing alliance
with Cybear Inc., a member of Andrx Corporation (NASDAQ: ADRX). Under the terms
of the agreement, Nymox will utilize Cybear's Web portals, including Physicians'
Online, as a primary marketing channel for Nymox's AlzheimAlert(TM) test
product.
During the year, we continued to make progress in our several major drug
development programs. Nymox's R&D activities have been increasingly productive
in the past year in generating patentable products and company patent
applications. In the past eighteen months, the company and its affiliates have
drafted, filed and prosecuted over fourteen U.S. patent applications, as well as
a substantially larger number of foreign patent applications.
On January 22, Nymox announced that it had entered into a new sponsored research
and licensing agreement with the Rhode Island Hospital Corporation and Brown
University. The agreement concerns research in the laboratories of Dr. Suzanne
de la Monte and Dr. Jack Wands into the role of neural thread protein (NTP) in
the Alzheimer's disease process. One of Nymox's ongoing programs to develop
treatments for Alzheimer's disease targets NTP and its role in the extensive
brain cell loss associated with Alzheimer's disease.
On March 5, Nymox announced that one of its leading new Alzheimer drug
candidates had been highly effective in recent preclinical laboratory studies.
The Company's NXD 9062 works in animals by stopping cell damage. The drug
candidate has been extensively tested by Nymox scientists in animal models of
cell loss where it has been safely tolerated and has been shown to significantly
limit the damage. Nymox plans to target the compound for human testing.
On March 21, Nymox announced that its candidate drug for the treatment of benign
prostatic hyperplasia (BPH), NX1207, had shown further progress in pre-clinical
studies. NX1207 has shown significant efficacy in experimental animals without
any significant toxicity or side effects in animals. The new results follow on
from data on NX1207 showing early promising results in animals, which were
presented at the Third Manhattan Alzheimer's Disease Conference in New York in
November 2001. The Company is presently
-101-
testing NX1207 for other possible indications, in addition to preparations for
human testing of NX1207 for BPH.
We wish to thank our over 4,000 shareholders for their valuable continued
support. Nymox welcomes the challenges ahead and is confident that it will
continue to meet or surpass its important milestones.
/s/ Paul Averback
Paul Averback MD - C.E.O. & President
May 15, 2002
-102-
MANAGEMENT'S DISCUSSION AND ANALYSIS
(in US dollars)
The following discussion should be read in conjunction with the consolidated
financial statements of the Company.
Overview
The business activities of the Company since inception have been devoted
principally to research and development. Accordingly, the Company has had
limited revenues from service fees and has not been profitable to date. We refer
to the Corporate Overview on page 1 of this financial report for a discussion of
the Company's research and development projects and its product pipeline.
Critical Accounting Policies
In December 2001, the Securities and Exchange Commission ("SEC") released
"Cautionary Advice Regarding Disclosure About Critical Accounting Policies".
According to the SEC release, accounting policies are among the "most critical"
if they are, in management's view, most important to the portrayal of the
company's financial condition and most demanding on their calls for judgement.
Our accounting policies are described in note 2 to our consolidated financial
statements. We consider the following policies to be the most critical in
understanding the judgements that are involved in preparing our financial
statements and the matters that could impact our results of operations,
financial condition and cash flows.
Revenue Recognition
-------------------
The Corporation applies guidance from SAB 101 (Staff Accounting Bulletin 101)
issued by the Securities and Exchange Commission in the recognition of revenue.
The Company derives its revenue from product sales, research contracts, license
fees and interest. Revenue from product sales is recognized when the product or
service has been delivered or obligations as defined in the agreement are
performed. Revenue from research contracts is recognized at the time research
activities are performed under the agreement. Revenue from license fees,
royalties and milestone payments is recognized upon the fulfillment of all
obligations under the terms of the related agreement. These agreements may
include upfront payments to be received by the Corporation. Upfront payments are
recognized as revenue on a systematic basis over the period that the related
services or obligations as defined in the agreement are performed. Interest is
recognized on an accrual basis.
The Company currently markets AlzheimAlert(TM) as a service provided by our CLIA
certified reference laboratory in New Jersey. Physicians send urine samples
taken from their patients to our laboratory where the AlzheimAlert(TM) test is
performed. The results are then reported back to the physicians. We recognize
the revenues when the test has been performed. The Company sometimes enters into
bulk sales of its diagnostic products to customers under which it has a
continuing obligation to perform related testing services at its laboratory.
Although the Company receives non-refundable upfront payments under these
agreements, revenue is recognized in the period that the Company fulfils its
obligation or over the term of the arrangement. For research contracts and
licensing revenues, the Company usually enters into an agreement specifying the
terms and obligations of the parties. Revenues from these sources are only
recognized when there are no longer any obligations to be performed by the
Company under the terms of the agreement.
Valuation of Capital Assets
---------------------------
The Company reviews the unamortized balance of intellectual property rights and
patents on an annual basis and recognizes any impairment in carrying value when
it is identified. Factors we consider important, which could trigger an
impairment review include:
-103-
o Significant changes in the manner of our use of the acquired assets or the
strategy for our overall business; and
o Significant negative industry or economic trends.
No impairment losses were recognized for the years ended December 31, 2001, 2000
and 1999.
Valuation of Future Income Tax Assets
-------------------------------------
Management judgement is required in determining the valuation allowance recorded
against net future tax assets. We have recorded a valuation allowance of $6.4
million as of December 31, 2001, due to uncertainties related to our ability to
utilize some of our future tax assets, primarily consisting of net operating
losses carried forward, before they expire. In assessing the realizability of
future tax assets, management considers whether it is more likely than not that
some portion or all of the future tax assets will not be realized. The ultimate
realization of future tax assets is dependent upon the generation of future
taxable income and tax planning strategies. Since the Company is a development
stage enterprise, the generation of future taxable income is dependent on the
successful commercialization of its products and technologies.
Revenues
Revenues from sales amounted to $62,305 for the three months ended March 31,
2002, compared with $61,297 for the same period in 2001. In addition, there is
$145,983 of deferred revenue, which will be recognized in the next two quarters.
Interest revenue was $2,632 in the first quarter of 2002 compared to $6,743 for
the same period in 2001, due to lower average cash balances.
Research and Development
Research and development expenditures were $534,890 for the first quarter of
2002, compared with $323,784 for the same period in 2001. The increase is
attributable to higher spending in the development of the therapeutic products
in the Company's pipeline. During the first three months of 2002, research tax
credits amounted to $5,881 compared to $1,360 for the same period in 2001.
Marketing Expenses
Marketing expenditures remained relatively constant at $84,482 for the three
months ended March 31, 2002, in comparison to expenditures of $77,978 for the
same period in 2001.
Administrative Expenses
General and administrative expenses amounted to $196,248 for the quarter ended
March 31, 2002, compared with $152,134 for the same period in 2001, due to an
adjustment to Deferred Share Issuance Costs
Foreign Exchange
The Company incurs expenses in the local currency of the countries in which it
operates, which include the United States and Canada. Approximately 75% of 2001
expenses (75% in 2000) were in U.S. dollars. Foreign exchange fluctuations had
no meaningful impact on the Company's results in 2001 or 2000.
Inflation
The Company does not believe that inflation has had a significant impact on its
results of operations.
Long-Term Commitments
Nymox has no financial obligations of significance other than long-term lease
commitments for its premises in the United States and Canada of $14,414 per
month and ongoing research funding payments to a U.S. medical facility totaling
$770,750 over the next three years.
-104-
Results of Operations
Net losses for the three month period ended March 31, 2002 were $883,017, or
$0.04 per share, compared to $604,266, or $0.03 per share, for the same period
in 2001. The weighted, fully diluted, average number of common shares
outstanding for the period ending March 31, 2002 were 22,406,572 compared to
21,526,601 for the same period in 2001.
Financial Position
Liquidity and Capital Resources
As of March 31, 2002, cash totaled $943,550 and receivables totaled $281,949. In
November 1999, the Corporation signed a common stock purchase agreement whereby
the investor is committed to purchase up to $12 million of the Corporation's
common shares over a thirty-month period commencing March 2000, when our F-1
registration statement was declared effective. As at December 31, 2001, four
drawings have been made under this Share Purchase Agreement, for total proceeds
of $1,436,364. Specifically, on August 16, 2000, 152,616 common shares were
issued at a volume weighted average price of $3.2924 per share; on October 12,
2000, 137,889 common shares were issued at a volume weighted average price of
$3.6261 per share, on February 7, 2001, 161,696 common shares were issued at a
volume weighted average price of $2.0240 and on May 31, 2001, 56,108 common
shares were issued at a volume weighted average price of $1.9466. The Company
intends to access financing under this agreement when appropriate to fund its
research and development.
The Company intends to raise additional capital in 2002 in order to pursue its
development. To March 31, 2002, the Company completed two private placements and
issued 269,074 common shares for total proceeds of $1,119,000. On January 24,
74,074 shares were issued at a price of $4.05 in a private placement for total
proceeds of $300,000. On March 18, 195,000 shares were issued at a price of
$4.20 in a private placement for total proceeds of $819,000. The Company
believes that funds from operations as well as from existing equity facilities
will be sufficient to meet the Company's cash requirements for the next twelve
months.
This message contains certain "forward-looking statements" as defined
in the United States Private Securities Litigation Reform Act of 1995
that involve a number of risks and uncertainties. There can be no
assurance that such statements will prove to be accurate and the
actual results and future events could differ materially from
management's current expectations. Such factors are detailed from time
to time in Nymox's filings with the Securities and Exchange Commission
and other regulatory authorities.
-105-
kpmg
Consolidated Financial Statements of
(Unaudited)
NYMOX PHARMACEUTICAL
CORPORATION
Three-month periods ended March 31, 2002, 2001 and 2000
-106-
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Financial Statements
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
Financial Statements
Consolidated Balance Sheets.............................................108
Consolidated Statements of Operations...................................109
Consolidated Statements of Deficit......................................110
Consolidated Statements of Cash Flows...................................111
Notes to Consolidated Financial Statements..............................112
-107-
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Balance Sheets
(Unaudited)
March 31, 2002, with comparative figures as at December 31, 2001
(in US dollars)
--------------------------------------------------------------------------------
March 31, December 31,
2002 2001
--------------------------------------------------------------------------------
(Unaudited) (Audited)
Assets
Current assets:
Cash $ 943,550 $ 488,987
Accounts and other receivable 245,559 122,459
Research tax credits receivable 36,390 30,509
Inventory 30,725 17,567
Prepaid expenses and deposits 42,500 55,000
-------------------------------------------------------------------------------
1,298,724 714,522
Capital assets:
Property and equipment 218,826 217,083
Patents and intellectual property 3,159,418 3,154,441
-------------------------------------------------------------------------------
3,378,244 3,371,524
Deferred share issuance costs 70,797 106,195
-------------------------------------------------------------------------------
$ 4,747,765 $ 4,192,241
-------------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 536,178 $ 295,393
Notes payable 396,775 396,775
Deferred revenue 145,983 55,325
-------------------------------------------------------------------------------
1,078,936 747,493
Non-controlling interest 800,000 800,000
Shareholders' equity:
Share capital and other:
Share capital (note 2) 26,498,655 25,376,557
Warrants and options 421,638 421,638
Deficit (24,051,464) (23,153,447)
-------------------------------------------------------------------------------
2,868,829 2,644,748
-------------------------------------------------------------------------------
$ 4,747,765 $ 4,192,241
-------------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
-108-
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Operations
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
2002 2001 2000
--------------------------------------------------------------------------------
Revenue:
Sales $ 62,305 $ 61,297 $ 38,261
Interest 2,632 6,743 2,073
-------------------------------------------------------------------------------
64,937 68,040 40,334
Expenses:
Research and development 534,890 323,784 434,062
Less investment tax credits (5,881) (1,360) (3,538)
-------------------------------------------------------------------------------
529,009 322,424 430,524
General and administrative 196,248 152,134 308,385
Marketing 84,482 77,978 64,316
Cost of sales 19,601 23,353 21,863
Depreciation and amortization 94,414 94,882 48,434
Interest and bank charges 24,200 1,535 1,832
-------------------------------------------------------------------------------
947,954 672,306 875,354
-------------------------------------------------------------------------------
Net loss $ (883,017) $ (604,266) $ (835,020)
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Loss per share (basic and
diluted) $ (0.04) $ (0.03) $ (0.04)
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Weighted average number of
common shares outstanding 22,406,572 21,526,601 20,307,099
-------------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
-109-
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Deficit
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
2002 2001 2000
--------------------------------------------------------------------------------
Deficit, beginning of period $(23,153,447) $(19,982,999) $(15,605,816)
Net loss (883,017) (604,266) (835,020)
Share issue costs (15,000) (52,094) (302,984)
-------------------------------------------------------------------------------
Deficit, end of period $(24,051,464) $(20,639,359) $(16,743,820)
-------------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
-110-
NYMOX PHARMACEUTICAL CORPORATION
Consolidated Statements of Cash Flows
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
2002 2001 2000
--------------------------------------------------------------------------------
Cash flows from operating activities:
Net loss $ (883,017) $ (604,266) $ (835,020)
Adjustments for:
Depreciation and
amortization 94,414 94,882 48,434
Write-down of deferred
share issue costs 35,398 - -
Change in operating assets
and liabilities 201,804 (148,421) (108,168)
-------------------------------------------------------------------------------
(551,401) (657,805) (894,754)
Cash flows from financing activities:
Proceeds from issuance of
share capital 1,119,000 739,273 4,000,000
Share issue costs (15,000) (42,991) (340,027)
Repayment of note payable - - (346,428)
-------------------------------------------------------------------------------
1,104,000 696,282 3,313,545
Cash flows from investing activities:
Additions to capital assets (98,036) (54,692) (57,113)
Disposal of capital assets - 250 -
-------------------------------------------------------------------------------
(98,036) (54,442) (57,113)
-------------------------------------------------------------------------------
Increase (decrease) in cash 454,563 (15,965) 2,361,678
Cash, beginning of period 488,987 565,711 449,363
-------------------------------------------------------------------------------
Cash, end of period $ 943,550 $ 549,746 $ 2,811,041
-------------------------------------------------------------------------------
Supplemental disclosure to
statements of cash flows:
(a) Interest paid $ 2,278 $ 1,535 $ 1,832
(b) Non-cash transaction:
Acquisition of Serex,
Inc. by issuance of
common shares and
other securities 3,098 - 1,319,997
-------------------------------------------------------------------------------
See accompanying notes to unaudited consolidated financial statements.
-111-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
Nymox Pharmaceutical Corporation (the "Corporation"), incorporated under
the Canada Business Corporations Act, including its subsidiaries, Nymox
Corporation, a Delaware Corporation, and Serex Inc. of New Jersey, is a
biopharmaceutical corporation which specializes in the research and
development of products for the diagnosis and treatment of Alzheimer's
disease. The Corporation is currently marketing AlzheimAlertTM, a urinary
test that aids physicians in the diagnosis of Alzheimer's disease. The
Corporation also markets NicAlertTM and NicoMeterTM, tests that use urine
or saliva to detect use of tobacco products. The Corporation is also
developing therapeutics for the treatment of Alzheimer's disease, new
treatments for benign prostate hyperplasia, and new anti-bacterial agents
for the treatment of urinary tract and other bacterial infections in
humans, including a treatment for E-coli 0157:H7 bacterial contamination in
meat and other food and drink products.
Since 1989, the Corporation's activities and resources have been primarily
focused on developing certain pharmaceutical technologies. The Corporation
is subject to a number of risks, including the successful development and
marketing of its technologies. In order to achieve its business plan and
the realization of its assets and liabilities in the normal course of
operations, the Corporation anticipates the need to raise additional
capital and/or achieve sales and other revenue generating activities.
Management believes that funds from operations as well as existing
financing facilities will be sufficient to meet the Corporation's
requirements for the next year.
The Corporation is listed on the NASDAQ Stock Market.
1. Basis of presentation:
(a) Interim financial statements:
The consolidated financial statements of the Corporation have been
prepared under Canadian generally accepted accounting principles. The
unaudited consolidated balance sheet as at March 31, 2002 and the
unaudited consolidated statements of earnings, deficit and cash flows
for the three-month periods ended March 31, 2002, 2001 and 2000
reflect all adjustments which are, in the opinion of management,
necessary to a fair statement of the results of the interim periods
presented. The Corporation's revenues and expenses are subject to
seasonal variations. Consequently, the results for any quarter are not
traditionally indicative of the results for the full year. The interim
consolidated financial statements follow the same accounting policies
and methods of their application as described in note 2 of the annual
consolidated financial statements for the year ended December 31,
2001. The interim consolidated financial statements do not include all
disclosures required for annual financial statements and should be
read in conjunction with the most recent annual consolidated financial
statements of the Company as at and for the year ended December 31,
2001.
-112-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
1. Basis of presentation (continued):
(b) New accounting standards:
(i) Stock-based compensation:
Effective January 1, 2002, the Corporation adopted the new
recommendations of the Canadian Institute of Chartered
Accountants ("CICA"), Handbook Section 3870, with respect to the
accounting for stock-based compensation and other stock-based
payments. The new recommendations require that all stock-based
payments to non-employees, and employee awards that are direct
awards of stock, call for settlement in cash or other assets, or
are stock appreciation rights that call for settlement by the
issuance of equity instruments, granted on or after January 1,
2002, be accounted for using the fair value method. For all other
stock-based employee compensation awards, the CICA has not
prescribed specific methods, and therefore the Corporation has
chosen to continue to follow its existing policy of using the
settlement method of accounting as permitted under the new
standard. Under this method, no compensation expense is
recognized when stock options are issued to employees. Any
consideration received from the plan participants upon exercise
of stock options is credited to share capital.
The new standard requires that the Corporation disclose the pro
forma effect of accounting for all stock-based awards granted
during the three-month period ended March 31, 2002 under the fair
value-based method. As no options were granted during the
quarter, no such disclosure was required.
There is no impact on the Corporation's consolidated financial
position, results of operations and cash flows as a result of
adopting these recommendations.
(ii) Goodwill and other intangible assets:
Effective January 1, 2002, the Corporation adopted the new
recommendations of the CICA, Handbook Section 3062, with respect
to the accounting for goodwill and other intangible assets. The
standard changes the accounting for goodwill from an amortization
method to an impairment-only approach. In addition, the standard
requires acquired intangible assets to be separately recognized
if the benefit of the intangible assets is obtained through
contractual or other legal right, or if the intangible assets can
be sold, transferred, licensed, rented or exchanged.
-113-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
1. Basis of presentation (continued):
(b) New accounting standards (continued):
(ii) Goodwill and other intangible assets (continued):
There was no impact on the Corporation's consolidated financial
position, results of operations and cash flows as a result of
adopting these recommendations. In addition, there has been no
change in the estimated useful life of the other intangible
assets which continue to be amortized using the straight-line
method at the following annual rates:
---------------------------------------------------------------
Intellectual property rights 10%
Patents 17 - 20 years
---------------------------------------------------------------
2. Share capital:
Share capital transactions during the period were as follows:
-------------------------------------------------------------------------
Number Dollars
-------------------------------------------------------------------------
Balance, December 31, 2001 22,297,525 $ 25,376,557
Issued for cash pursuant to private
placements 269,074 1,119,000
Issued to acquire additional shares
of Serex, Inc. (i) 932 3,098
-------------------------------------------------------------------------
Balance, March 31, 2002 22,567,531 $ 26,498,655
-------------------------------------------------------------------------
(i) During the period, the Corporation issued 932 common shares and 574
Series J warrants to purchase an additional 5,000 shares of Serex,
Inc. that it did not previously own. The Corporation owns
approximately 98% of Serex, Inc. The warrants are exercisable at $3.70
per share and expire on July 31, 2005.
-114-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
3. Canadian/US Reporting Differences:
(a) Consolidated statements of earnings:
The reconciliation of earnings reported in accordance with Canadian
GAAP with U.S. GAAP is as follows:
--------------------------------------------------------------------------------
2002 2001 2000
--------------------------------------------------------------------------------
Net loss, Canadian GAAP $(883,017) $(604,266) $(835,020)
Adjustments:
Amortization of patents (i) 2,353 2,353 2,049
Stock-based compensation
- options granted to non-
employees (ii) (10,285) (15,310) -
-------------------------------------------------------------------------------
(7,932) (12,957) 2,049
-------------------------------------------------------------------------------
Net loss, U.S. GAAP $(890,949) $(617,223) $(832,971)
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
Loss per share, U.S. GAAP $ (0.04) $ (0.03) $ (0.04)
-------------------------------------------------------------------------------
(b) Consolidated shareholders' equity:
The reconciliation of shareholders' equity reported in accordance with
Canadian GAAP with U.S. GAAP is as follows:
--------------------------------------------------------------------------------
2002 2001 2000
--------------------------------------------------------------------------------
Shareholders' equity, Canadian GAAP $ 2,868,829 $ 3,343,855 $4,826,969
Adjustments:
Amortization of patents (i) (136,182) (145,593) (155,259)
Stock-based compensation - options
granted to non-employees (ii):
Cumulative compensation expense (1,270,868) (1,220,853) (947,853)
Additional paid-in capital 1,323,431 1,273,416 1,000,416
Change in reporting currency (iii) (62,672) (62,672) (62,672)
-------------------------------------------------------------------------------
(146,291) (155,702) (165,368)
-------------------------------------------------------------------------------
Shareholders' equity, U.S. GAAP $ 2,722,538 $ 3,188,153 $4,661,601
-------------------------------------------------------------------------------
-115-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
3. Canadian/US Reporting Differences (continued):
(i) In accordance with APB Opinion 17, Intangible Assets, the patents are
amortized using the straight-line method over the legal life of the
patents from the date the patent was secured. For Canadian GAAP
purposes, the patents are amortized commencing in the year of
commercial production of the developed products.
(ii) In accordance with FAS 123, Accounting for Stock-Based Compensation,
compensation related to the stock options granted to non-employees
prior to January 1, 2002 has been recorded in the accounts based on
the fair value of the stock options at the grant date.
(iii) The Company adopted the US dollar as its reporting currency effective
January 1, 2000. For Canadian GAAP purposes, the financial
information for prior periods has been translated into US dollars at
the December 31, 1999 exchange rate. For United States GAAP reporting
purposes, assets and liabilities for all periods presented have been
translated into US dollars at the ending exchange rate for the
respective period and the statement of earnings at the average
exchange rate for the respective period.
4. Segment disclosures:
Geographic segment information is as follows:
-------------------------------------------------------------------------
United
Canada States
-------------------------------------------------------------------------
Revenues:
2002 $ 2,632 $ 62,305
2001 6,923 61,117
2000 2,073 38,261
Net loss:
2002 (662,960) (220,057)
2001 (447,364) (156,902)
2000 (590,217) (244,803)
Capital assets:
March 31, 2002 3,085,126 293,118
December 31, 2001 (audited) 3,086,869 284,655
Identifiable assets:
March 31, 2002 4,098,614 649,151
December 31, 2001 (audited) 3,629,455 562,786
-------------------------------------------------------------------------
-116-
NYMOX PHARMACEUTICAL CORPORATION
Notes to Consolidated Financial Statements, Continued
(Unaudited)
Three-month periods ended March 31, 2002, 2001 and 2000
(in US dollars)
--------------------------------------------------------------------------------
5. Demand for arbitration:
In March 2002, a former employee filed a demand for arbitration with the
American Arbitration Association concerning the termination of her
employment with the Corporation. The employee is claiming damages of up to
$498,000 plus attorney's fees and costs, based upon alleged violations of
New Jersey law and breach of an employment agreement. The Corporation
believes these claims are without merit and intends to defend the matter
vigorously.
-117-
============================================ =================================
No dealer, salesperson or other person
has been authorized in connection with
this offering to give any information or
to make any representations other than
those contained in this prospectus. This
prospectus does not constitute an offer
or a solicitation in any jurisdiction to
any person to whom it is unlawful to
make such an offer or solicitation.
Neither the delivery of this prospectus 5,000,000 Common Shares
nor any sale made hereunder shall, under offered by
any circumstances, create an implication Jaspas Investments Ltd.
that there has been no change in the
circumstances of Nymox or the facts
herein set forth since the date hereof.
TABLE OF CONTENTS
The Company...............................4
Risk Factors..............................6
Trading Market for Common Shares.........11 NYMOX
Selected Consolidated Financial Data.....13 PHARMACEUTICAL
Information about the Company............14 CORPORATION
Management's Discussion and Analysis
of Results of Operations and
Financial Condition.....................29
Acquisition of a Controlling
Interest in Serex.......................36
Use of Proceeds..........................38
The Common Stock Purchase Agreement......38
Selling Security Holder..................44
Directors and Officers of Nymox..........46
Major Shareholders and Related
Party Transactions......................51
Plan of Distribution.....................52 P R O S P E C T U S
Limited Grant of Registration Rights.....54
Additional Information...................55
Taxation.................................59 _______, 2002
Certain Legal Matters....................64
Experts..................................64
Where You Can Find More Information......64
Enforceability of Certain Civil
Liabilities and Authorized
Representative in the United States.....65
Financial Information....................66
Appendix A - Most Recent Form 6-K........99
============================================ =================================
PART II INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13: OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following is a list of the estimated expenses that were incurred by
the Registrant in connection with the preparation and filing of this
registration statement.
SEC Registration Fee $3,406
Legal Fees and Expenses $30,000
Accountants Fees $5,000
------
TOTAL $38,406
The estimated expenses reflected herein do not include the reimbursement
of $35,000 by Nymox to Jaspas, primarily related to legal fees in preparation of
the stock purchase agreement and associated escrow costs.
Item 14: INDEMNIFICATION OF DIRECTORS AND OFFICERS
Nymox maintains Directors' and Officers' Liability Insurance (the
"Policy") for its own benefit and for the benefit of its subsidiaries and their
respective directors and officers. Subject to the limitations therein set forth,
the Policy extends coverage to directors and officers for any loss (as defined
in the Policy) incurred in connection with the performance of their duties and
to Nymox and its subsidiaries for any loss for which they have indemnified their
respective directors or officers as permitted by law.
Section 124 of the Canada Business Corporations Act ("CBCA") provides, in
pertinent part:
Indemnification
124. (1) A corporation may indemnify a director or officer of the
corporation, a former director or officer of the corporation or another
individual who acts or acted at the corporation's request as a director
or officer, or an individual acting in a similar capacity, of another
entity, against all costs, charges and expenses, including an amount paid
to settle an action or satisfy a judgment, reasonably incurred by the
individual in respect of any civil, criminal, administrative,
investigative or other proceeding in which the individual is involved
because of that association with the corporation or other entity.
Advance of costs
(2) A corporation may advance moneys to a director, officer or other
individual for the costs, charges and expenses of a proceeding referred
to in subsection (1). The individual shall repay the moneys if the
individual does not fulfil the conditions of subsection (3).
Limitation
(3) A corporation may not indemnify an individual under subsection (1)
unless the individual
(a) acted honestly and in good faith with a view to the best
interests of the corporation, or, as the case may be, to the best
interests of the other entity for which the individual acted as
director or officer or in a similar capacity at the corporation's
request; and
(b) in the case of a criminal or administrative action or
proceeding that is enforced by a monetary penalty, the individual
had reasonable grounds for believing that the individual's conduct
was lawful.
Indemnification in derivative actions
(4) A corporation may with the approval of a court, indemnify an
individual referred to in subsection (1), or advance moneys under
subsection (2), in respect of an action by or on behalf of the
corporation or other entity to procure a judgment in its favour, to which
the individual is made a party because of the individual's association
with the corporation or other entity as described in subsection (1)
against all costs, charges and expenses reasonably incurred by the
individual in connection with such action, if the individual fulfils the
conditions set out in subsection (3).
Right to indemnity
(5) Despite subsection (1), an individual referred to in that subsection
is entitled to indemnity from the corporation in respect of all costs,
charges and expenses reasonably incurred by the individual in connection
with the defence of any civil, criminal, administrative, investigative or
other proceeding to which the individual is subject because of the
individual's association with the corporation or other entity as
described in subsection (1), if the individual seeking indemnity
(a) was not judged by the court or other competent authority to
have committed any fault or omitted to do anything that the
individual ought to have done; and
(b) fulfils the conditions set out in subsection (3).
Insurance
(6) A corporation may purchase and maintain insurance for the benefit of
an individual referred to in subsection (1) against any liability
incurred by the individual
(a) in the individual's capacity as a director or officer of the
corporation; or
(b) in the individual's capacity as a director or officer, or
similar capacity, of another entity, if the individual acts or
acted in that capacity at the corporation's request.
Application to court
(7) A corporation, an individual or an entity referred to in subsection
(1) may apply to a court for an order approving an indemnity under this
section and the court may so order and make any further order that it
sees fit.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers or persons controlling the
Registrant pursuant to the foregoing provisions, the Registrant has been
informed that in the opinion of the United States Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act
and is therefore unenforceable.
Item 15. RECENT SALES OF UNREGISTERED SECURITIES
All recent sales of unregistered shares were pursuant to exemptions from
registration under applicable Canadian and Quebec securities laws and were not
made to persons resident in the United States.
2
o April 1996, 877,300 common shares at a per share price of CAN$6.00
for aggregate net proceeds of CAN$5,263,800 with Prampton Company
Ltd. (200,000 shares), Murray Lester Investments (120,000 shares),
Gestion 3B+M Inc. (100,000 shares) and a group of individual
Canadian and overseas investors (457,300 shares);
o May 1997, 696,491 common shares at a price of CAN$6.50 and
warrants exercisable at a price of CAN$8.50 per share for a total
consideration of CAN$4,527,191 with the Caisse de Depot et
Placement du Quebec (307,692 shares), Abrar Corp. (85,538 shares)
and a group of individual Canadian and overseas investors (303,261
shares). In 1998, all 696,491 of these warrants were exercised for
additional proceeds to Nymox of CAN$5,920,174;
o May 1998, 231,630 common shares at a price of CAN$8.50 for total
proceeds of CAN$1,968,855 with Dr. Stephan Eschmann (76,500
shares) and a group of individual Canadian and overseas investors
(155,130 shares). A total of 110,000 warrants were issued as well,
exercisable at prices of CAN$8.50 per share (50,000) and CAN$10.00
per share (60,000). These warrants have since expired;
o December 1998, 135,000 common shares and January 1999, 55,000
common shares at CAN$8.50(US$5.88) per share, for total proceeds
of CAN$1,615,000 with Sparks Inc. (75,000 shares), Dr. Stephan
Eschmann (70,000 shares), and a group of individual Canadian and
overseas investors (45,000 shares). A total of 95,000 warrants
were issued as well, exercisable at the price of CAN$10.00 per
share. These warrants have since expired; and
o September, 1999, 122,000 common shares at CAN$5.00 per share, for
total proceeds of CAN$610,000 with Dr. Stephan Eschmann (82,000
shares) and Mr. Michael Braeuel (40,000 shares).
o March 2000, 821,637 common shares at an average price of $4.87 per
share, for total proceeds of $4,000,000 with AMRO International. A
total of 93,334 warrants were issued as well, exercisable at a
price of $9.375 per share (66,667) and $7.8125 per share (26,667).
These warrants expire on March 6, 2004.
o August, 2000, 152,616 common shares at a volume weighted average
price of US$3.2924 per share with Jaspas Investments.
o October, 2000, 137,889 common shares at a volume weighted average
price of US$3.6261 per share with Jaspas Investments.
o February, 2001, 161,696 common shares at a volume weighted average
price of US$2.0240 per share with Jaspas Investments.
o March, 2001, 200,000 common shares at $2.06 per share, for total
proceeds of $412,000 with Dr. Stephan Eschmann. A total of 100,000
warrants were issued as well, exercisable at a price of $2.06.
These warrants expire on March 6, 2003.
o May, 2002, 56,108 common shares at a volume weighted average
price of $1.9466 per share.
o August 3, 2001, 80,000 common shares at $2.50 per share for total
proceeds of $200,000.
o August 22, 2001, 140,000 common shares at $3.75 per share for
total proceeds of $525,000.
o October 3, 2001, 110,000 common shares at $3.75 per share for
total proceeds of $412,490.
3
o November 14, 2001, 64,100 common shares at $3.90 per share for
total proceeds of $250,000.
o January 24, 2002, 74,074 common shares at $4.05 per share for
total proceeds of $300,000.
o March 18, 2002, 195,000 common shares at $4.20 per share for total
proceeds of $819,000.
Item 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
EXHIBIT NO. DESCRIPTION
2.0 Common Stock Purchase Agreement between Nymox Pharmaceutical
Corporation and Jaspas Investments Limited dated November 1, 1999*
2.1 Registration Rights Agreement between Nymox Pharmaceutical
Corporation and Jaspas Investments Limited dated November 1, 1999*
2.2 Escrow Agreement among Nymox Pharmaceutical Corporation, Jaspas
Investments Limited and Epstein, Becker & Green, P.C. dated
November 1, 1999*
2.3 Stock Purchase Warrant to purchase common shares issued to Jaspas
Previously Filed Investments Limited dated November 1, 1999*
3.0 Articles of Incorporation of Nymox Pharmaceutical Corporation*
3.1 Bylaws of Nymox Pharmaceutical Corporation*
5.1 Opinion of Foley & Lardner*
5.2 Opinion of Stikeman, Elliott*
10.1 Employment Agreement between Nymox Pharmaceutical Corporation and
Dr. Judith Fitzpatrick*
10.2 Memorandum of Agreement between Paul Averback and the Company
(incorporated by reference to Exhibit 10.1 to the Company's Form
20-F filed with the Commission December 9, 1996 (Commission File
Number 001-12033)).*
10.3 Share Option Plan of the Company (incorporated by reference to
Exhibit 10.2 to the Company" Form 20-F filed with the Commission
December 9, 1996 (Commission File Number 001-12033)).*
10.4 Research and License Agreement between the Massachusetts General
Hospital Corporation and the Company (incorporated by reference to
Exhibit 10.3 to the Company's Form 20-F filed with the Commission
December 9, 1996 (Commission File Number 001-12033)).*
10.5 Research and License Amendment between the Massachusetts General
Hospital Corporation and the Company (incorporated by reference to
Exhibit 10.5 to the Company's Form 20-F filed with the Commission
December 9, 1996 (Commission File Number 001-12033)).*
10.6 Research and License Agreement between the Rhode Island Hospital
Corporation and the Company dated May 14, 1999 (incorporated by
reference to Exhibit 10.10 to the Company's Form 20-F filed with
the Commission May 15, 2000 (Commission File Number 001-12033)).*
4
EXHIBIT NO. DESCRIPTION
10.7 Research and License Amendment between the Rhode Island Hospital
Corporation and the Company dated Nov. 19, 2001
23.1 Consent of KPMG
23.2 Consent of Foley & Lardner*
23.3 Consent of Stikeman, Elliott*
24.0 Powers of Attorney*
99.0 Press release by Nymox Pharmaceutical Corporation dated November
12, 1999 announcing the transaction with Jaspas Investments
Limited*
---------------
* Previously filed.
Item 17. UNDERTAKINGS
The undersigned Registrant hereby undertakes:
1. To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement;
(i) To include any prospectus required by section l0(a)(3) of
the Securities Act of 1933, as amended ("Securities Act").
(ii) To reflect in the prospectus included in this registration
statement any facts or events arising after the effective
date of this registration statement (or the most recent
post-effective amendment thereof) which, individually or in
the aggregate, represent a fundamental change in the
information set forth in this registration statement.
Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was
registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in
the form of prospectus filed with the Securities and
Exchange Commission ("SEC") pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no
more than a 20% change in the maximum aggregate offering
price set forth in the "Calculation of Registration Fee"
table in the effective registration statement; and
(iii) To include any material information with respect to the
plan of distribution not previously disclosed in the
registration statement or any material change to such
information in this registration statement.
2. To remove from registration by means of a post-effective amendment
any of the securities being registered, which remain unsold at the
termination of the offering.
3. To file a post-effective amendment to this registration statement
to include any financial statements required by Rule 3-19 of
Regulation S-X under the Securities Exchange Act of 1934
throughout the offering.
5
4. For the purpose of determining any liability under the Securities
Act of 1933, each post-effective amendment that contains a form of
prospectus shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
5. Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and
controlling persons of the Registrant pursuant to the provisions
described under item 14 above, or otherwise, the Registrant has
been advised that in the opinion of the SEC such indemnification
is against public policy as expressed in the Securities Act and
is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment
by the Registrant of expenses incurred or paid by a director,
officer or controlling person of the Registrant in the successful
defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the
securities being registered, the Registrant will, unless in the
opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the
question of whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by
the final adjudication of such issue.
6
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant has duly caused this Amendment to the Registration Statement to be
signed on its behalf by the undersigned, thereunto duly authorized, in the City
of Montreal, Country of Canada, on this 24th day of July, 2002.
NYMOX PHARMACEUTICAL CORPORATION
By: /s/ Paul Averback
---------------------------------
Paul Averback, M.D.
President and Chief Executive
Officer
Pursuant to the requirements of the Securities Act of 1933, this
Amendment to the Registration Statement has been signed below as of July 24,
2002 by the following persons in the capacities indicated.
/s/ Jack Gemmell /s/ Paul Averback
---------------------------- -------------------------------
Jack Gemmel Paul Averback, M.D.
Director President and Chief Executive
Officer and Director
(Principal Executive Officer)
* *
---------------------------- -------------------------------
Walter von Wartburg Hans Black, M.D.
Director Director
/s/ Roy Wolvin
------------------------------
Roy Wolvin
Chief Financial Officer and
Secretary-Treasurer
(Principal Financial and
Accounting Officer)
*
------------------------------
Michael R. Sonnenreich
Director
NYMOX CORPORATION
(Authorized Representative
in the United States)
By: /s/ Roy Wolvin
Roy Wolvin
Secretary-Treasurer
*By: /s/ Roy Wolvin
Roy Wolvin
Attorney-in-Fact
7
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
2.0 Common Stock Purchase Agreement between Nymox Pharmaceutical
Corporation and Jaspas Investments Limited dated November 1, 1999*
2.1 Registration Rights Agreement between Nymox Pharmaceutical
Corporation and Jaspas Investments Limited dated November 1, 1999*
2.2 Escrow Agreement among Nymox Pharmaceutical Corporation, Jaspas
Investments Limited and Epstein, Becker & Green, P.C. dated
November 1, 1999*
2.3 Stock Purchase Warrant to purchase common shares issued to Jaspas
Previously Filed Investments Limited dated November 1, 1999*
3.0 Articles of Incorporation of Nymox Pharmaceutical Corporation*
3.1 Bylaws of Nymox Pharmaceutical Corporation*
5.1 Opinion of Foley & Lardner*
5.2 Opinion of Stikeman, Elliott*
10.1 Employment Agreement between Nymox Pharmaceutical Corporation and
Dr. Judith Fitzpatrick*
10.2 Memorandum of Agreement between Paul Averback and the Company
(incorporated by reference to Exhibit 10.1 to the Company's Form
20-F filed with the Commission December 9, 1996 (Commission File
Number 001-12033)).*
10.3 Share Option Plan of the Company (incorporated by reference to
Exhibit 10.2 to the Company" Form 20-F filed with the Commission
December 9, 1996 (Commission File Number 001-12033)).*
10.4 Research and License Agreement between the Massachusetts General
Hospital Corporation and the Company (incorporated by reference to
Exhibit 10.3 to the Company's Form 20-F filed with the Commission
December 9, 1996 (Commission File Number 001-12033)).*
10.5 Research and License Amendment between the Massachusetts General
Hospital Corporation and the Company (incorporated by reference to
Exhibit 10.5 to the Company's Form 20-F filed with the Commission
December 9, 1996 (Commission File Number 001-12033)).*
10.6 Research and License Agreement between the Rhode Island Hospital
Corporation and the Company dated May 14, 1999
8
(incorporated by reference to Exhibit 10.10 to the Company's Form
20-F filed with the Commission May 15, 2000 (Commission File
Number 001-12033)).*
10.7 Research and License Amendment between the Rhode Island Hospital
Corporation and the Company dated Nov.11, 2001
23.1 Consent of KPMG
23.2 Consent of Foley & Lardner*
23.3 Consent of Stikeman, Elliott*
24.0 Powers of Attorney*
99.0 Press release by Nymox Pharmaceutical Corporation dated November
12, 1999 announcing the transaction with Jaspas Investments
Limited*
---------------
* Previously filed.
9