424(b)(3)
File No. 333-111357
PROSPECTUS
CEL-SCI CORPORATION
Common Stock
CEL-SCI Corporation may offer from time to time shares of common stock at
an initial offering price not to exceed $50,000,000, at prices and on terms to
be determined at or prior to the time of sale in light of market conditions at
the time of sale.
Specific terms pertaining to the shares of common stock offered by this
prospectus will be set forth in one or more accompanying prospectus supplements,
together with the terms of the offering and the initial price and the net
proceeds to CEL-SCI from the sale. The prospectus supplement will set forth,
without limitation, the number of shares of common stock and the terms of the
offering and sale of such shares.
CEL-SCI may sell the shares of common stock offered by this prospectus
directly, through agents designated from time to time, or through underwriters
or dealers. If any agents of CEL-SCI or any underwriters or dealers are involved
in the sale of the securities, the names of the agents, underwriters or dealers,
any applicable commissions and discounts, and the net proceeds to the Company
will be set forth in the applicable prospectus supplement.
CEL-SCI may not use this prospectus to complete sales of its common stock
unless this prospectus is accompanied by a prospectus supplement.
The securities offered by this prospectus are speculative and involve a
high degree of risk and should be purchased only by persons who can afford to
lose their entire investment. For a description of certain important factors
that should be considered by prospective investors, see "Risk Factors" beginning
on page 5 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or has passed upon
the accuracy or adequacy of this prospectus. Any representation to the contrary
is a criminal offense.
CEL-SCI's common stock is traded on the American Stock Exchange under the
symbol "CVM".
The date of this prospectus is May 3, 2004
PROSPECTUS SUMMARY
THIS SUMMARY IS QUALIFIED BY THE MORE DETAILED INFORMATION APPEARING ELSEWHERE
IN THIS PROSPECTUS.
CEL-SCI
--------
CEL-SCI Corporation was formed as a Colorado corporation in 1983. CEL-SCI
is involved in the research and development of certain drugs and vaccines.
MULTIKINE(R), CEL-SCI's first and main product, uses CEL-SCI's proprietary cell
culture technologies. CEL-SCI is testing MULTIKINE to determine if it is
effective in creating an anti-cancer immune response in head and neck cancer
patients, and in HIV-infected women with Human Papilloma Virus induced cervical
dysplasia, the precursor stage before the development of cervical cancer.
CEL-SCI believes that MULTIKINE has been shown to induce both an anti-cancer
immune response and to significantly increase the susceptibility of tumor cells
to radiation therapy.
LEAPS, another technology of CEL-SCI, is being tested by CEL-SCI to
determine if it is effective in developing potential treatments and/or vaccines
against various diseases. Present target diseases are herpes simplex, malaria
and autoimmune myocarditis.
Using the LEAPS technology, CEL-SCI discovered a peptide, named CEL-1000,
which is currently being tested in animals for the prevention/treatment of
herpes simplex, malaria, viral encephalitis, smallpox, vaccinia and a number of
other indications. CEL-1000 is also being tested as a bio-terrorism agent by the
National Institute of Allergy and Infectious Diseases and by the U.S. Army
Research Institute of Infectious Diseases.
Before human testing can begin with respect to a drug or biological
product, preclinical studies are conducted in laboratory animals to evaluate the
potential efficacy and the safety of a product. Human clinical studies generally
involve a three-phase process for marketing approval and a possible fourth phase
of post-approval studies. The initial clinical evaluation, Phase I, consists of
administering the product and testing for safe and tolerable dosage levels.
Phase II trials continue the evaluation of safety and determine the appropriate
dosage for the product, identify possible side effects and risks in a larger
group of subjects, and provide preliminary indications of efficacy. Phase III
trials consist of testing for actual clinical efficacy within an expanded group
of patients at geographically dispersed test sites. Phase IV clinical trials are
performed if the FDA requires or a company wishes to pursue them. Phase IV
studies generally confirm the effectiveness or safety information about the
product.
CEL-SCI has completed Phase II clinical trials with MULTIKINE and believes
that it has compiled sufficient data and clinical information to justify one or
more Phase III clinical trials for head and neck cancer. CEL-SCI plans to meet
with FDA in 2004 to discuss such trials. Depending on the FDA's review of
CEL-SCI's data, the FDA may require additional Phase II trials or may concur
with CEL-SCI's plans to begin a Phase III clinical trial. CEL-SCI's LEAPS
technology is in the pre-clinical stage.
CEL-SCI has funded the costs associated with the clinical trials relating
to CEL-SCI's technologies, research expenditures and CEL-SCI's administrative
expenses with the public and private sales of CEL-SCI's securities and
borrowings from third parties, including affiliates of CEL-SCI.
All of CEL-SCI's products are in the development stage. As of December 31,
2003, CEL-SCI was not receiving any revenues from the sale of MULTIKINE or any
other products which CEL-SCI was developing.
CEL-SCI does not expect to develop commercial products for several years,
if at all. CEL-SCI has had operating losses since its inception, had an
accumulated deficit of approximately $(86,600,000) at September 30, 2003 and
expects to incur substantial losses for the foreseeable future.
CEL-SCI's executive offices are located at 8229 Boone Blvd., #802, Vienna,
Virginia 22182, and its telephone number is (703) 506-9460.
THE OFFERING
Securities Offered:
CEL-SCI may offer from time to time shares of common stock at an initial
offering price not to exceed $50,000,000, at prices and on terms to be
determined at or prior to the time of sale in light of market conditions at the
time of sale. CEL-SCI may not use this prospectus to complete sales of its
common stock unless this prospectus is accompanied by a prospectus supplement.
See the "Plan of Distribution" section of this prospectus for additional
information concerning the manner in which CEL-SCI's shares may be offered.
Common Stock Outstanding: As of February 27, 2004 CEL-SCI
had 65,397,019 shares of common stock issued and
outstanding. The number of outstanding shares does
not give effect to shares which may be issued upon
the exercise and/or conversion of options, warrants
or other convertible securities held by the selling
shareholders or other persons. If all outstanding
warrants and convertible securities were exercised
and converted, CEL-SCI would have 80,432,447
outstanding shares of common stock. See "Comparative
Share Data".
Risk Factors: The purchase of the securities offered by
this prospectus involves a high degree of risk. Risk
factors include the lack of revenues and history of
loss, need for additional capital and need for FDA
approval. See the "Risk Factors" section of this
prospectus for additional Risk Factors.
AMEX Symbol: CVM
Summary Financial Data
Results of Operations: Years Ended
September 30, Three Months Ended
------------------- December 31, 2003
2003 2002 -------------------
---- ----
Grant Revenue and Other: $318,204 $ 384,939 $ 73,235
-------- ---------- ---------
Expenses:
Research and Development 1,915,501 4,699,909 368,348
Depreciation and Amortization 199,117 226,514 47,927
General and Administrative 2,287,019 1,754,332 647,440
Interest Income (52,502) (85,322) (11,227)
Interest Expense 2,340,667 2,131,750 126,840
------------ ------------ ---------
Net Loss $(6,371,498) $(8,342,244) $(1,106,093)
Net Loss Attributable to
Common Stockholders $(6,480,319) $(9,989,988) $(1,106,093)
============ ============ ===========
Net loss per common share
(basic and diluted) $ (0.13) $ (0.35) $ (0.02)
=========== ============ ============
Weighted average common shares
outstanding 50,961,457 28,746,341 62,848,255
=========== =========== ===========
Balance Sheet Data:
September 30,
2003 2002 December 31, 2003
---- ---- -----------------
Working Capital $531,742 $690,804 $2,472,948
Total Assets 2,915,206 3,771,258 3,514,472
Convertible Debt * 32,882 639,288 --
Note Payable - Covance * 184,330 -- --
Note Payable - Cambrex* 656,076 1,135,017 --
Total Liabilities 1,690,100 2,709,087 358,670
Stockholders' Equity 1,225,106 1,062,171 3,155,802
* Included in Total Liabilities.
Forward Looking Statements
This prospectus contains various forward-looking statements that are based
on CEL-SCI's beliefs as well as assumptions made by and information currently
available to CEL-SCI. When used in this prospectus, the words "believe",
"expect", "anticipate", "estimate" and similar expressions are intended to
identify forward-looking statements. Such statements may include statements
regarding seeking business opportunities, payment of operating expenses, and the
like, and are subject to certain risks, uncertainties and assumptions which
could cause actual results to differ materially from projections or estimates.
Factors which could cause actual results to differ materially are discussed at
length under the heading "Risk Factors". Should one or more of the enumerated
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, estimated
or projected. Investors should not place undue reliance on forward-looking
statements, all of which speak only as of the date made.
RISK FACTORS
Investors should be aware that this offering involves the risks described
below, which could adversely affect the price of CEL-SCI's common stock. In
addition to the other information contained in this prospectus, the following
factors should be considered carefully in evaluating an investment in the shares
offered by this prospectus.
RISKS RELATED TO CEL-SCI
------------------------
Since CEL-SCI Has Earned Only Limited Revenues and Has a History of Net Losses,
CEL-SCI Will Require Additional Capital to Remain in Operation.
CEL-SCI has had only limited revenues since it was formed in 1983. Since
the date of its formation and through December 31, 2003 CEL-SCI incurred net
losses of approximately $(87,700,000). During the years ended September 30,
2001, 2002 and 2003 CEL-SCI suffered losses of $(10,733,679), $(8,342,244) and
$(6,371,498) respectively. During the three months ended December 31, 2003
CEL-SCI lost $(1,106,093). CEL-SCI has not derived any revenue from the sale of
its products. CEL-SCI has relied principally upon the proceeds of public and
private sales of securities and convertible notes to finance its activities to
date. All of CEL-SCI's potential products are in the early stages of
development, and any commercial sale of these products will be many years away.
Accordingly, CEL-SCI expects to incur substantial losses for the foreseeable
future. There can be no assurance CEL-SCI will be profitable.
Since CEL-SCI does not intend to pay dividends on its common stock, any return
to investors will come only from potential increases in the price of CEL-SCI's
common stock.
At the present time, CEL-SCI intends to use available funds to finance
CEL-SCI's operations. Accordingly, while payment of dividends rests within the
discretion of the Board of Directors, no common stock dividends have been
declared or paid by CEL-SCI and CEL-SCI has no intention of paying any common
stock dividends.
If Cel-Sci cannot obtain additional capital, Cel-Sci may have to postpone
development and research expenditures which will delay Cel-Sci's ability to
produce a competitive product. Delays of this nature may depress the price of
CEL-SCI's common stock.
Clinical and other studies necessary to obtain approval of a new drug can
be time consuming and costly, especially in the United States, but also in
foreign countries. CEL-SCI's estimates of the costs associated with future
clinical trials and research may be substantially lower than the actual costs of
these activities. The different steps necessary to obtain regulatory approval,
especially that of the Food and Drug Administration, involve significant costs
and may require several years to complete. CEL-SCI expects that it will need
substantial additional financing over an extended period of time in order to
fund the costs of future clinical trials, related research, and general and
administrative expenses. Although CEL-SCI's equity line of credit agreement is
expected to be a source of funding, the amounts which CEL-SCI is able to draw
from the equity line during each drawdown period are limited and may not satisfy
CEL-SCI's capital needs.
The extent of CEL-SCI's clinical trials and research programs are
primarily based upon the amount of capital available to CEL-SCI and the extent
to which CEL-SCI has received regulatory approvals for clinical trials. CEL-SCI
is unable to estimate the future costs of clinical trials since CEL-SCI has not
yet met with the FDA to discuss the design of future clinical trials; and until
the scope of future clinical trials is known, CEL-SCI will not be able to price
any trials with clinical trial organizations.
Over the past three years CEL-SCI's research and development expenditures
have decreased, due in part to the capital available to CEL-SCI. The inability
of CEL-SCI to conduct clinical trials or research, whether due to a lack of
capital or regulatory approval, will prevent CEL-SCI from completing the studies
and research required to obtain regulatory approval for any products which
CEL-SCI is developing.
To raise additional capital CEL-SCI will most likely sell shares of its
common stock or securities convertible into common stock at prices that may be
below the prevailing market price of CEL-SCI's common stock at the time of sale.
The issuance of additional shares will have a dilutive impact on other
stockholders and could have a negative effect on the market price of CEL-SCI's
common stock. Since April 2001 CEL-SCI has sold approximately 28,000,000 shares
of its common stock to private investors at prices that were between 7% and 30%
below the market price of CEL-SCI's common stock at the time of sale.
Any failure to obtain or any delay in obtaining required regulatory approvals
may adversely affect the ability of CEL-SCI or potential licensees to
successfully market any products they may develop.
MULTIKINE is made from components of human blood which involves inherent risks
that may lead to product destruction or patient injury which could materially
harm CEL-SCI's financial results, reputation and stock price.
MULTIKINE is made, in part, from components of human blood. There are
inherent risks associated with products that involve human blood such as
possible contamination with viruses, including Hepatitis or HIV. Any possible
contamination could require CEL-SCI to destroy batches of MULTIKINE or cause
injuries to patients who receive the product thereby subjecting CEL-SCI to
possible financial losses and harm to its business.
Although CEL-SCI has product liability insurance for MULTIKINE, the successful
prosecution of a product liability case against CEL-SCI could have a materially
adverse effect upon its business if the amount of any judgment exceeds CEL-SCI's
insurance coverage.
Although no claims have been brought to date, participants in CEL-SCI's
clinical trials could bring civil actions against CEL-SCI for any unanticipated
harmful effects arising from the use of MULTIKINE or any drug or product that
CEL-SCI may try to develop. Although CEL-SCI believes its insurance coverage of
$2,000,000 per claim is adequate, the defense or settlement of any product
liability claim could adversely affect CEL-SCI even if the defense and
settlement costs did not exceed CEL-SCI's insurance coverage.
CEL-SCI's directors are allowed to issue shares of preferred stock with
provisions that could be detrimental to the interests of the holders of
CEL-SCI's common stock.
The provisions in CEL-SCI's Articles of Incorporation relating to
CEL-SCI's Preferred Stock would allow CEL-SCI's directors to issue Preferred
Stock with rights to multiple votes per share and dividend rights which would
have priority over any dividends paid with respect to CEL-SCI's Common Stock.
The issuance of Preferred Stock with such rights may make more difficult the
removal of management even if such removal would be considered beneficial to
shareholders generally, and will have the effect of limiting shareholder
participation in certain transactions such as mergers or tender offers if such
transactions are not favored by incumbent management.
RISKS RELATED TO GOVERNMENT APPROVALS
-------------------------------------
CEL-SCI's product candidates must undergo rigorous preclinical and clinical
testing and regulatory approvals, which could be costly and time-consuming and
subject CEL-SCI to unanticipated delays or prevent CEL-SCI from marketing any
products.
Therapeutic agents, drugs and diagnostic products are subject to approval,
prior to general marketing, by the FDA in the United States and by comparable
agencies in most foreign countries. Before obtaining marketing approval,
CEL-SCI's product candidates must undergo rigorous preclinical and clinical
testing which is costly and time consuming and subject to unanticipated delays.
There can be no assurance that such approvals will be granted.
CEL-SCI cannot be certain when or under what conditions it will undertake
further clinical trials, including a Phase III program for MULTIKINE. The
clinical trials of CEL-SCI's product candidates may not be completed on
schedule, and the FDA or foreign regulatory agencies may order CEL-SCI to stop
or modify its research or these agencies may not ultimately approve any of
CEL-SCI's product candidates for commercial sale. Varying interpretations of the
data obtained from pre-clinical and clinical testing could delay, limit or
prevent regulatory approval of CEL-SCI's product candidates. The data collected
from CEL-SCI's clinical trials may not be sufficient to support regulatory
approval of its various product candidates, including MULTIKINE. For example,
MULTIKINE is now being made by a process that was different from the process
tested in many of CEL-SCI's clinical studies to date. It is possible that the
FDA will require CEL-SCI to conduct additional studies to demonstrate that the
MULTIKINE that it plans to use for its Phase III program is the same as the
product previously tested in CEL-SCI's phase II studies. Even if CEL-SCI
believes the data collected from its clinical trials are sufficient, the FDA has
substantial discretion in the approval process and may disagree with CEL-SCI's
interpretation of the data. In this regard, the FDA is aware of Phase II
clinical study results from US and Canadian studies, but not results from
foreign trials. The foreign data comprises approximately 75% of the subjects
participating in CEL-SCI's Phase II program. CEL-SCI can make no assurances that
the FDA will accept the data from its foreign studies or that the agency would
not require CEL-SCI to conduct more Phase II studies before beginning Phase III
trials. CEL-SCI's failure to adequately demonstrate the safety and efficacy of
any of its product candidates would delay or prevent regulatory approval of its
product candidates, which could prevent CEL-SCI from achieving profitability.
The requirements governing the conduct of clinical trials, manufacturing,
and marketing of CEL-SCI's product candidates, including MULTIKINE, outside the
United States vary widely from country to country. Foreign approvals may take
longer to obtain than FDA approvals and can require, among other things,
additional testing and different trial designs. Foreign regulatory approval
processes include all of the risks associated with the FDA approval processes.
Some of those agencies also must approve prices for products. Approval of a
product by the FDA does not ensure approval of the same product by the health
authorities of other countries. In addition, changes in regulatory policy in the
US or in foreign countries for product approval during the period of product
development and regulatory agency review of each submitted new application may
cause delays or rejections.
In addition to conducting further clinical studies of MULTIKINE and
CEL-SCI's other product candidates, CEL-SCI also must undertake the development
of its manufacturing process and optimize its product formulations. CEL-SCI is
continuing, for example, to develop MULTIKINE to decrease or further
characterize the amount of DNA in MULTIKINE and to develop ways of better
measuring the amount of DNA in the product. CEL-SCI can make no assurances that
it will succeed in decreasing the amount of DNA in MULTIKINE to a level that is
acceptable for product approval or that it can develop a method of measuring the
amount of DNA that the FDA accepts as suitable for approving the marketing of
the product.
CEL-SCI has only limited experience in filing and pursuing applications
necessary to gain regulatory approvals, which may impede its ability to obtain
timely approvals from the FDA or foreign regulatory agencies, if at all. CEL-SCI
will not be able to commercialize MULTIKINE and other product candidates until
it has obtained regulatory approval, and any delay in obtaining, or inability to
obtain, regulatory approval could harm its business. In addition, regulatory
authorities may also limit the types of patients to which CEL-SCI or others may
market MULTIKINE or CEL-SCI's other products.
Even if CEL-SCI obtains regulatory approval for its product candidates, CEL-SCI
will be subject to stringent, ongoing government regulation.
Even if CEL-SCI's products receive regulatory approval, either in the
United States or internationally, it will continue to be subject to extensive
regulatory requirements. These regulations are wide-ranging and govern, among
other things:
o product design, development, manufacture and testing;
o adverse drug experience and other reporting regulations;
o product advertising and promotion;
o product manufacturing, including good manufacturing practice requirements;
o record keeping requirements;
o registration of CEL-SCI's establishments with the FDA and certain state
agencies
o product storage and shipping;
o drug sampling and distribution requirements;
o electronic record and signature requirements; and
o labeling changes or modifications.
CEL-SCI and any third-party manufacturers or suppliers must continually
adhere to federal regulations setting forth requirements, known as current Good
Manufacturing Practices, or cGMPs, and their foreign equivalents, which are
enforced by the FDA and other national regulatory bodies through their
facilities inspection programs. If CEL-SCI's facilities, or the facilities of
its manufacturers or suppliers, cannot pass a pre-approval plant inspection, the
FDA will not approve the marketing application of CEL-SCI's product candidates.
In complying with cGMP and foreign regulatory requirements, CEL-SCI and any of
its potential third-party manufacturers or suppliers will be obligated to expend
time, money and effort in production, record-keeping and quality control to
ensure that its products meet applicable specifications and other requirements.
State regulatory agencies and the regulatory agencies of other countries have
similar requirements.
CEL-SCI entered into an agreement with Cambrex Bio Science, Inc. whereby
Cambrex agreed to provide CEL-SCI with a facility for the periodic manufacturing
of MULTIKINE in accordance with the cGMPs established by FDA regulations. This
agreement expires on December 31, 2006. If the Cambrex facility were not
available for the production of MULTIKINE, CEL-SCI estimates that it would take
approximately six to ten months to find or build an alternative manufacturing
facility for MULTIKINE. CEL-SCI does not know what cost it would incur to obtain
an alternative source of MULTIKINE.
If CEL-SCI does not comply with regulatory requirements at any stage,
whether before or after marketing approval is obtained, it may be subject to
criminal prosecution, seizure, injuction, fines, or be forced to remove a
product from the market or experience other adverse consequences, including
restrictions or delays in obtaining regulatory marketing approval, which could
materially harm CEL-SCI's financial results, reputation and stock price.
Additionally, CEL-SCI may not be able to obtain the labeling claims necessary or
desirable for product promotion. CEL-SCI may also be required to undertake
post-marketing trials. In addition, if CEL-SCI or other parties identify adverse
effects after any of CEL-SCI's products are on the market, or if manufacturing
problems occur, regulatory approval may be withdrawn and CEL-SCI may be required
to reformulate its products, conduct additional clinical trials, make changes in
its product's labeling or indications of use, or submit additional marketing
applications to support these changes. If CEL-SCI encounters any of the
foregoing problems, its business and results of operations will be harmed and
the market price of our common stock may decline.
Also, the extent of adverse government regulations which might arise from
future legislative or administrative action cannot be predicted. Without
government approval, CEL-SCI will be unable to sell any of its products.
RISKS RELATED TO INTELLECTUAL PROPERTY
--------------------------------------
CEL-SCI may not be able to achieve or maintain a competitive position and other
technological developments may result in CEL-SCI's proprietary technologies
becoming uneconomical or obsolete.
The biomedical field in which CEL-SCI is involved is undergoing rapid and
significant technological change. The successful development of therapeutic
agents from CEL-SCI's compounds, compositions and processes through
CEL-SCI-financed research, or as a result of possible licensing arrangements
with pharmaceutical or other companies, will depend on its ability to be in the
technological forefront of this field.
Many pharmaceutical and biotechnology companies are developing products
for the prevention or treatment of cancer and infectious diseases including
Introgen Therapeutics, Inc. and ImClone Systems, Inc. which are currently
developing drugs for head and neck cancer. Both Introgen and ImClone, as well as
many other companies working on drugs designed to prevent, cure or treat cancer,
have substantial financial, research and development, and marketing resources
and are capable of providing significant long-term competition either by
establishing in-house research groups or by forming collaborative ventures with
other entities. In addition, smaller companies and non-profit institutions are
active in research relating to cancer and infectious diseases and are expected
to become more active in the future.
CEL-SCI's patents might not protect CEL-SCI's technology from competitors, in
which case CEL-SCI may not have any advantage over competitors in selling any
products which it may develop.
Certain aspects of CEL-SCI's technologies are covered by U.S. and foreign
patents. In addition, CEL-SCI has a number of patent applications pending. There
is no assurance that the applications still pending or which may be filed in the
future will result in the issuance of any patents. Furthermore, there is no
assurance as to the breadth and degree of protection any issued patents might
afford CEL-SCI. Disputes may arise between CEL-SCI and others as to the scope
and validity of these or other patents. Any defense of the patents could prove
costly and time consuming and there can be no assurance that CEL-SCI will be in
a position, or will deem it advisable, to carry on such a defense. Other private
and public concerns, including universities, may have filed applications for, or
may have been issued, patents and are expected to obtain additional patents and
other proprietary rights to technology potentially useful or necessary to
CEL-SCI. The scope and validity of such patents, if any, the extent to which
CEL-SCI may wish or need to acquire the rights to such patents, and the cost and
availability of such rights are presently unknown. Also, as far as CEL-SCI
relies upon unpatented proprietary technology, there is no assurance that others
may not acquire or independently develop the same or similar technology.
CEL-SCI's first MULTIKINE patent expired in 2000. Since CEL-SCI does not know if
it will ever be able to sell MULTIKINE on a commercial basis, CEL-SCI cannot
predict what effect the expiration of this patent will have on CEL-SCI.
Notwithstanding the above, CEL-SCI believes that trade secrets and later issued
patents will protect the technology associated with MULTIKINE.
RISKS RELATED TO THIS OFFERING
------------------------------
Since the market price for CEL-SCI's common stock is volatile, investors in this
offering may not be able to sell any of CEL-SCI's shares at a profit.
The market price of CEL-SCI's common stock, as well as the securities of
other biopharmaceutical and biotechnology companies, have historically been
highly volatile, and the market has from time to time experienced significant
price and volume fluctuations that are unrelated to the operating performance of
particular companies. During the twelve months ended December 31, 2003 CEL-SCI's
stock price has ranged from a low of $0.15 per share to a high of $1.75 per
share. Factors such as fluctuations in CEL-SCI's operating results,
announcements of technological innovations or new therapeutic products by
CEL-SCI or its competitors, governmental regulation, developments in patent or
other proprietary rights, public concern as to the safety of products developed
by CEL-SCI or other biotechnology and pharmaceutical companies, and general
market conditions may have a significant effect on the future market price of
CEL-SCI's common stock.
Shares issuable upon the exercise of options and warrants, or as a result of
sales made in connection with the equity line of credit may substantially
increase the number of shares available for sale in the public market and may
depress the price of CEL-SCI's common stock.
CEL-SCI has outstanding options and warrants which allow the holders to
acquire up to 15,112,095 additional shares of CEL-SCI's common stock Until the
options and warrants expire, the holders will have an opportunity to profit from
any increase in the market price of CEL-SCI's common stock without assuming the
risks of ownership. Holders of the options and warrants may exercise or convert
these securities at a time when CEL-SCI could obtain additional capital on terms
more favorable than those provided by the options. The exercise of the options
and warrants will dilute the voting interest of the owners of presently
outstanding shares of CEL-SCI's common stock. The sale of the shares of common
stock issuable upon the exercise of the options and warrants could adversely
affect the market price of CEL-SCI's stock.
In addition, an unknown number of shares of common stock are issuable
under a equity line of credit arrangement to Rubicon Group Ltd. As CEL-SCI sells
shares of its common stock to Rubicon Group under the equity line of credit, and
Rubicon Group sells the common stock to third parties, the price of CEL-SCI's
common stock may decrease due to the additional shares in the market. If CEL-SCI
decides to draw down on the equity line of credit as the price of its common
stock decreases, CEL-SCI will be required to issue more shares of its common
stock for any given dollar amount invested by Rubicon Group, subject to the
minimum selling price specified by CEL-SCI. The more shares that are issued
under the equity line of credit, the more CEL-SCI's then outstanding shares will
be diluted and the more CEL-SCI's stock price may decrease. Any decline in the
price of CEL-SCI's common stock may encourage short sales, which could place
further downward pressure on the price of CEL-SCI's common stock. Short selling
is a practice of selling shares which are not owned by a seller with the
expectation that the market price of the shares will decline in value after the
sale.
See the "Comparative Share Data" section of this prospectus for more
information concerning CEL-SCI's outstanding options, warrants and other
convertible notes as well as the equity line and warrants which were granted to
Rubicon Group as consideration for extending the equity line of credit.
The sale of shares of common stock which have been registered by CEL-SCI, or the
perception that sales could occur, could adversely affect the market price of
CEL-SCI's common stock.
On December 1, 2003 CEL-SCI sold 2,999,964 shares of its common stock to a
group of private institutional investors for approximately $2,550,000, or $0.85
per share. CEL-SCI has filed registration statements with the Securities and
Exchange Commission so that the 2,995,000 shares sold in December 2003, as well
as 14,912,095 shares of common stock which are issuable upon the exercise of
outstanding options and warrants, are available for public sale. In addition, an
unknown number of shares of common stock may be sold under an equity line of
credit arrangement to Rubicon Group Ltd. by means of a separate registration
statement filed with the Securities and Exchange Commission.
The sale of these shares could place downward pressure on the price of
CEL-SCI's common stock.
COMPARATIVE SHARE DATA
Number of
Shares
Shares outstanding as of February 27, 2004 65,397,019
Shares to be sold in this offering: Unknown
The number of shares outstanding as of February 27, 2004 excludes shares
which may be issued upon the exercise of options or warrants described below.
Other Shares Which May Be Issued:
The following table lists additional shares of CEL-SCI's common stock
which may be issued pursuant to the equity line of credit agreement and as the
result of the exercise of outstanding options or warrants issued by CEL-SCI:
Number of Note
Shares Reference
Shares issuable upon exercise of warrants 3,886,188 A
held by private investors
Shares issuable pursuant to equity line of credit Unknown B
Shares issuable upon exercise of equity line
warrants 395,726 B
Shares issuable upon exercise of options and 10,553,514 C
warrants granted to CEL-SCI's officers,
directors, employees, consultants, and
third parties
Shares issuable upon exercise of options 200,000 D
granted to investor relations consultants
A. In April 2001, CEL-SCI entered into an equity line of credit agreement with
Paul Revere Capital Partners. During the term the equity line of credit, which
expired in June 2003, CEL-SCI received net proceeds of $2,074,692 from the sale
of 5,430,960 shares of common stock pursuant to the terms of the equity line. As
consideration for extending the equity line of credit, CEL-SCI granted Paul
Revere Capital Partners warrants to purchase 200,800 shares of common stock at a
price of $1.64 per share at any time prior to April 11, 2004.
In August 2001, three private investors exchanged their warrants for
CEL-SCI's Series E warrants. As of February 27, 2004 the Series E warrants
collectively allowed the holders to purchase up to 570,627 additional shares of
CEL-SCI's common stock at a price of $1.19 per share at any time prior to August
16, 2004. In August 2003, in accordance with the terms of the Series E preferred
stock, CEL-SCI issued warrants which permit the holders to purchase 23,758
shares of CEL-SCI's common stock at a price of $0.77 per share at any time prior
to August 17, 2006.
In July and September 2002, CEL-SCI sold Series G convertible notes, plus
Series G warrants, to a group of private investors for $1,300,000. As of June
30, 2003 all of the Series G notes had been converted into 8,390,746 shares of
CEL-SCI's common stock. As of February 27, 2004 the Series G warrants allowed
the holders to purchase up to 450,000 shares of CEL-SCI's common stock at a
price of $0.145 per share at any time prior to July 12, 2009.
In January and July 2003, CEL-SCI sold Series H convertible notes, plus
Series H warrants, to a group of private investors for $1,350,000. As of
December 31, 2003 all of the Series H notes had been converted into 3,233,229
shares of CEL-SCI's common stock. As of February 27, 2004 the Series H warrants
allowed the holders to purchase up to 550,000 shares of CEL-SCI's common stock
at a price of $0.25 per share at any time prior to January 7, 2010.
In May 2003 CEL-SCI sold shares of its common stock plus Series I warrants
to a strategic partner. As of February 27, 2004 the Series I warrants allowed
the holder to purchase 1,100,000 shares of CEL-SCI's common stock at a price of
$0.47 per share at any time prior to May 30, 2008.
On December 1, 2003, CEL-SCI sold 2,999,964 shares of its common stock to
a group of private institutional investors for approximately $2,550,000, or
$0.85 per share. As part of this transaction, the investors and the sales agent
for a number of the investors received Series J warrants which, as of February
27, 2004, allowed the investors to purchase 991,003 shares of CEL-SCI's common
stock at a price of $1.32 per share at any time prior to December 1, 2006.
The warrant exercise price, and the number of shares issuable upon the
exercise of the Series G and H warrants are subject to adjustment under those
conditions explained in the section of the prospectus entitled "Description of
Securities".
B. An unknown number of shares of common stock are issuable under the equity
line of credit agreement between CEL-SCI and Rubicon Group, Ltd. As
consideration for extending the equity line of credit, CEL-SCI granted Rubicon
Group warrants to purchase 395,726 shares of common stock at a price of $0.83
per share at any time prior to September 16, 2008.
Under the equity line of credit agreement, Rubicon Group has agreed to
provide CEL-SCI with up to $10,000,000 of funding over a two year period ending
on the date that the registration statement relating to the shares to be sold
pursuant to the equity line of credit is declared effective by the Securities
and Exchange Commission. During this period, CEL-SCI may request a drawdown
under the equity line of credit by selling shares of its common stock to Rubicon
Group and Rubicon Group will be obligated to purchase the shares. CEL-SCI may
request a drawdown once every 22 trading days, although CEL-SCI is under no
obligation to request any drawdowns under the equity line of credit.
During the 22 trading days following a drawdown request, CEL-SCI will
calculate the amount of shares it will sell to Rubicon Group and the purchase
price per share. The purchase price per share of common stock will be based on
the daily volume weighted average price of CEL-SCI's common stock during each of
the 22 trading days immediately following the drawdown date, less a discount of
11%.
The minimum amount CEL-SCI can draw down at any one time is $100,000. The
maximum amount CEL-SCI can draw down at any one time is the lesser of $2,000,000
or the amount equal to:
o 4.5% of the weighted average price of CEL-SCI's common stock for the ninety
calendar day period prior to the date of the drawdown request
o multiplied by the total trading volume of CEL-SCI's common stock for the
ninety calendar day period prior to the date of the drawdown request.
Using the formula described above, if CEL-SCI had requested a drawdown on
February 27, 2004, the maximum amount CEL-SCI could draw down during the
subsequent 22 trading days would be approximately $1,580,000.
CEL-SCI may request a drawdown by faxing a drawdown notice to Rubicon
Group, stating the amount of the drawdown and the lowest daily volume weighted
average price, if any, at which CEL-SCI is willing to sell the shares. The
lowest volume weighted average price will be set by CEL-SCI's Chief Executive
Officer in his sole and absolute discretion.
If CEL-SCI sets a minimum price which is too high and CEL-SCI's stock
price does not consistently meet that level during the 22 trading days after its
drawdown request, the amount CEL-SCI can draw and the number of shares CEL-SCI
will sell to Rubicon Group will be reduced. On the other hand, if CEL-SCI sets a
minimum price which is too low and its stock price falls significantly but stays
above the minimum price, CEL-SCI will have to issue a greater number of shares
to Rubicon Group based on the reduced market price.
The following summarizes the drawdowns requested by CEL-SCI under the
equity line of credit as of February 27, 2004.
Date of Shares Average Sale Net Proceeds
Sale Sold Price Per Share to CEL-SCI
------ ----- --------------- -----------
01/27/04 101,308 $1.09 $109,000
02/11/04 92,722 $1.19 $109,000
The net proceeds to CEL-SCI are net of a $1,000 fee paid to an escrow
agent.
C. The options are exercisable at prices ranging from $0.16 to $11.00 per share
with a weighted average exercise price of $0.75 per share. CEL-SCI may also
grant options to purchase additional shares under its Incentive Stock Option and
Non-Qualified Stock Option Plans.
D. CEL-SCI has granted options for the purchase of 200,000 shares of common
stock to Investor Relations Group and Jonathan Gelles in consideration for
services provided to CEL-SCI. The services provided to CEL-SCI involved the
introduction of CEL-SCI to brokers and fund managers and distribution of
CEL-SCI's press releases and other information regarding CEL-SCI. The options
are exercisable at prices ranging between $1.63 and $2.50 per share with a
weighted average exercise price of $1.85 per share and expire between February
2004 and June 2006.
The shares referred to in Notes A, B and C are being, or will be, offered
for sale by means of separate registration statements which have been filed with
the Securities and Exchange Commission.
GOVERNMENT REGULATION OF CEL-SCI'S PRODUCTS
New drug development and approval process
Regulation by governmental authorities in the United States and other
countries is a significant factor in the manufacture and marketing of biological
and other drug products and in ongoing research and product development
activities. CEL-SCI's products will require regulatory approval by governmental
agencies prior to commercialization. In particular, these products are subject
to rigorous preclinical and clinical testing and other premarket approval
requirements by the FDA and regulatory authorities in other countries. In the
United States, various statutes and regulations also govern or influence the
manufacturing, safety, labeling, storage, record keeping and marketing of
pharmaceutical and biological drug products. The lengthy process of seeking
these approvals, and the subsequent compliance with applicable statutes and
regulations, require the expenditure of substantial resources. CEL-SCI believes
that it is currently in compliance with applicable statutes and regulations that
are relevant to its operations. CEL-SCI has no control, however, over compliance
by its manufacturing and other partners.
The FDA's statutes, regulations, or policies may change and additional
statutes or government regulations may be enacted which could prevent or delay
regulatory approvals of biological or other drug products. CEL-SCI cannot
predict the likelihood, nature or extent of adverse governmental regulation that
might arise from future legislative or administrative action, either in the U.S.
or abroad.
Regulatory approval, when and if obtained, may be limited in scope. In
particular, regulatory approvals will restrict the marketing of a product to
specific uses. Further, approved biological and other drugs, as well as their
manufacturers, are subject to ongoing review. Discovery of previously unknown
problems with these products may result in restrictions on their manufacture,
sale or use or in their withdrawal from the market. Failure to comply with
regulatory requirements may result in criminal prosecution, civil penalties,
recall or seizure of products, total or partial suspension of production or
injunction, as well as other actions affecting CEL-SCI. Any failure by CEL-SCI
or its manufacturing and other partners to obtain and maintain, or any delay in
obtaining, regulatory approvals could materially adversely affect CEL-SCI's
business.
The process for new drug approval has many steps, including:
Preclinical testing
Once a biological or other drug candidate is identified for development,
the drug candidate enters the preclinical testing stage. During preclinical
studies, laboratory and animal studies are conducted to show biological activity
of the drug candidate in animals, both healthy and with the targeted disease.
Also, preclinical tests evaluate the safety of drug candidates. These tests
typically take approximately two years to complete. Preclinical tests must be
conducted in compliance with good laboratory practice regulations. In some
cases, long term preclinical studies are conducted while clinical studies are
ongoing.
Investigational new drug application
When the preclinical testing is considered adequate by the sponsor to
demonstrate the safety and the scientific rationale for initial human studies,
an investigational new drug application (IND) is filed with the FDA to seek
authorization to begin human testing of the biological or other drug candidate.
The IND becomes effective if not rejected by the FDA within 30 days after
filing. The IND must provide data on previous experiments, how, where and by
whom the new studies will be conducted, the chemical structure of the compound,
the method by which it is believed to work in the human body, any toxic effects
of the compound found in the animal studies and how the compound is
manufactured. All clinical trials must be conducted under the supervision of a
qualified investigator in accordance with good clinical practice regulations.
These regulations include the requirement that all subjects provide informed
consent. In addition, an institutional review board (IRB), comprised primarily
of physicians and other qualified experts at the hospital or clinic where the
proposed studies will be conducted, must review and approve each human study.
The IRB also continues to monitor the study and must be kept aware of the
study's progress, particularly as to adverse events and changes in the research.
Progress reports detailing the results of the clinical trials must be submitted
at least annually to the FDA and more frequently if adverse events occur. In
addition, the FDA may, at any time during the 30-day period after filing an IND
or at any future time, impose a clinical hold on proposed or ongoing clinical
trials. If the FDA imposes a clinical hold, clinical trials cannot commence or
recommence without FDA authorization, and then only under terms authorized by
the FDA. In some instances, the IND process can result in substantial delay and
expense.
Some limited human clinical testing may also be done under a physician's
IND that allows a single individual to receive the drug, particularly where the
individual has not responded to other available therapies. A physician's IND
does not replace the more formal IND process, but can provide a preliminary
indication as to whether further clinical trials are warranted, and can, on
occasion, facilitate the more formal IND process.
Clinical trials are typically conducted in three sequential phases, but
the phases may overlap.
Phase I clinical trials
Phase I human clinical trials usually involve between 20 and 80 healthy
volunteers or patients and typically take one to two years to complete. The
tests study a biological or other drug's safety profile, and may seek to
establish the safe dosage range. The Phase I clinical trials also determine how
a drug candidate is absorbed, distributed, metabolized and excreted by the body,
and the duration of its action.
Phase II clinical trials
In Phase II clinical trials, controlled studies are conducted on an
expanded population of patients with the targeted disease. The primary purpose
of these tests is to evaluate the effectiveness of the drug candidate on the
volunteer patients as well as to determine if there are any side effects or
other risks associated with the drug. These studies generally take approximately
two years, and may be conducted concurrently with Phase I clinical trials. In
addition, Phase I/II clinical trials may be conducted to evaluate not only the
efficacy of the drug candidate on the patient population, but also its safety.
Phase III clinical trials
This phase typically lasts two to three years and involves an even larger
patient population, often with several hundred or even several thousand patients
depending on the use for which the drug is being studied. Phase III trials are
intended to establish the overall risk-benefit ratio of the drug and provide, if
appropriate, an adequate basis for product labeling. During the Phase III
clinical trials, physicians monitor the patients to determine efficacy and to
observe and report any reactions or other safety risks that may result from use
of the drug candidate.
Chemical and formulation development
Concurrent with clinical trials and preclinical studies, companies also
must develop information about the chemistry and physical characteristics of the
drug and finalize a process for manufacturing the product in accordance with
current good manufacturing practice requirements (cGMPs). The manufacturing
process must be capable of consistently producing quality batches of the product
and the manufacturer must develop methods for testing the quality, purity, and
potency of the final drugs. Additionally, appropriate packaging must be selected
and tested and chemistry stability studies must be conducted to demonstrate that
the product does not undergo unacceptable deterioration over its shelf-life.
New drug application or biological license application
After the completion of the clinical trial phases of development, if the
sponsor concludes that there is substantial evidence that the biological or
other drug candidate is effective and that the drug is safe for its intended
use, a new drug application (NDA) or biologics license application (BLA) may be
submitted to the FDA. The application must contain all of the information on the
biological or other drug candidate gathered to that date, including data from
the clinical trials. Under the Pediatric Research Equity Act of 2003, a company
is also required to include an assessment, generally based on clinical study
data, on the safety and efficacy of the drug candidate for all relevant
pediatric populations before submitting an application. The statute provides for
waivers or deferrals in certain situations but no assurance can be made that
such situations will apply to a particular product.
The FDA reviews all NDAs and BLAs submitted before it accepts them for
filing. It may request additional information rather than accepting an
application for filing. In this event, the application must be resubmitted with
the additional information. The resubmitted application is also subject to
review before the FDA accepts it for filing. Once the submission is accepted for
filing, the FDA begins an in-depth review of the application. The FDA may refer
the application to an appropriate advisory committee, typically a panel of
clinicians, for review, evaluation and a recommendation. The FDA is not bound by
the recommendation of an advisory committee. If FDA evaluations of the NDA or
BLA and the manufacturing facilities are favorable, the FDA may issue an
approval letter authorizing commercial marketing of the drug or biological
candidate for specified indications. The FDA could also issue an approvable
letter, which usually contains a number of conditions that must be met in order
to secure final approval of the NDA or BLA. When and if those conditions have
been met to the FDA's satisfaction, the FDA will issue an approval letter. On
the other hand, if the FDA's evaluation of the NDA or BLA or manufacturing
facilities is not favorable, the FDA may refuse to approve the application or
issue a non-approvable letter.
Among the conditions for NDA or BLA approval is the requirement that each
prospective manufacturer's quality control and manufacturing procedures conform
to current good manufacturing practice standards and requirements(cGMPs).
Manufacturing establishments are subject to periodic inspections by the FDA and
by other federal, state or local agencies.
Marketing approval
If the FDA approves the NDA or BLA, the drug or biological becomes
available for physicians to prescribe. Periodic reports must be submitted to the
FDA, including descriptions of any adverse reactions reported. The FDA may
require post-marketing studies, also known as Phase IV studies, as a condition
of approval. In addition, the FDA may require distribution to patients of a
medication guide for prescription drug products that the FDA determines pose a
serious and significant health concern in order to provide information necessary
to patients' safe and effective use of such products.
Phase IV clinical trials and post-marketing studies
In addition to studies required by the FDA after approval, a manufacturer
often conducts Phase IV studies to explore new indications. The purpose of these
trials and studies and related publications is to develop data to support
additional indications for the drug and to increase its acceptance in the
medical community. In addition, some post-market studies are done at the request
of the FDA to develop additional information regarding the safety of a product.
Postmarketing Obligations -
Any products manufactured and/or distributed pursuant to FDA approvals are
subject to continuing regulation by the FDA, including record-keeping
requirements, reporting of adverse experiences with the drug, drug sampling and
distribution requirements, notifying the FDA and gaining its approval of certain
manufacturing or labeling changes, complying with certain electronic records and
signature requirements, and complying with FDA promotion and advertising
requirements. Drug manufacturers and their subcontractors are required to
register their establishments with the FDA and certain state agencies, and are
subject to periodic unannounced inspections by the FDA and certain state
agencies for compliance with good manufacturing practices. Also, newly
discovered or developed safety or efficacy data may require changes to a
product's approved labeling, including the addition of new warnings and
contraindications, or even in some instances revocation or withdrawal of the
approval. In addition, approved biological drug products may be subject to
lot-by-lot release testing by the FDA before these products can be commercially
distributed.
MARKET FOR CEL-SCI'S COMMON STOCK
As of February 27, 2004 there were approximately 2,600 record holders of
CEL-SCI's common stock. CEL-SCI's common stock is traded on the American Stock
Exchange under the symbol "CVM". Set forth below are the range of high and low
quotations for CEL-SCI's common stock for the periods indicated as reported on
the American Stock Exchange. The market quotations reflect inter-dealer prices,
without retail mark-up, mark-down or commissions and may not necessarily
represent actual transactions.
Quarter Ending High Low
------------- ---- ----
12/31/00 $2.54 $1.00
3/31/01 $3.30 $1.30
6/30/01 $1.85 $1.16
9/30/01 $1.94 $1.02
12/31/01 $1.80 $0.72
3/31/02 $1.28 $0.52
6/30/02 $0.56 $0.27
9/30/02 $0.52 $0.16
12/31/02 $0.32 $0.19
3/31/03 $0.27 $0.15
6/30/03 $1.35 $0.20
9/30/03 $1.08 $0.61
12/31/03 $1.75 $0.98
Holders of common stock are entitled to receive such dividends as may be
declared by the Board of Directors out of funds legally available therefore and,
in the event of liquidation, to share pro rata in any distribution of CEL-SCI's
assets after payment of liabilities. The Board of Directors is not obligated to
declare a dividend. CEL-SCI has not paid any dividends on its common stock and
CEL-SCI does not have any current plans to pay any common stock dividends.
PLAN OF DISTRIBUTION
CEL-SCI may sell shares of its common stock in and/or outside the United
States: (i) through underwriters or dealers; (ii) directly to a limited number
of purchasers or to a single purchaser; or (iii) through agents. The applicable
prospectus supplement with respect to the offered securities will set forth the
name or names of any underwriters or agents, if any, the purchase price of the
offered securities and the proceeds to CEL-SCI from such sale, any delayed
delivery arrangements, any underwriting discounts and other items constituting
underwriters' compensation, any initial public offering price and any discounts
or concessions allowed or reallowed or paid to dealers and any compensation paid
to a placement agent. Any initial public offering price and any discounts or
concessions allowed or reallowed or paid to dealers may be changed from time to
time.
CEL-SCI's common stock may be sold:
o At a fixed price,
o As the result of the exercise of warrants or the conversion of preferred
shares, and at fixed or varying prices, as determined by the terms of the
warrants,
or convertible securities
o At varying prices in at the market offerings.
o In privately negotiated transactions, at fixed prices which may be changed,
at market prices prevailing at the time of sale, at prices related to such
prevailing market prices or at negotiated prices.
If underwriters are used in the sale, the offered securities will be
acquired by the underwriters for their own account and may be resold from time
to time in one or more transactions, including negotiated transactions, at a
fixed public offering price or at varying prices determined at the time of sale.
The securities may be offered to the public either through underwriting
syndicates represented by one or more managing underwriters or directly by one
or more firms acting as underwriters. The underwriter or underwriters with
respect to a particular underwritten offering of securities to be named in the
prospectus supplement relating to such offering and, if an underwriting
syndicate is used, the managing underwriter or underwriters will be set forth on
the cover of such prospectus supplement. Unless otherwise set forth in the
prospectus supplement, the obligations of the underwriters to purchase the
offered securities will be subject to conditions precedent and the underwriters
will be obligated to purchase all the offered securities if any are purchased.
If dealers are utilized in the sale of offered securities in respect of
which this prospectus is delivered, CEL-SCI will sell the offered securities to
the dealers as principals. The dealers may then resell the offered securities to
the public at varying prices to be determined by the dealers at the time of
resale. The names of the dealers and the terms of the transaction will be set
forth in the prospectus supplement relating to the securities sold to the
dealers.
If an agent is used in an offering of offered securities, the agent will
be named, and the terms of the agency will be set forth, in the prospectus
supplement. Unless otherwise indicated in the prospectus supplement, an agent
will act on a best efforts basis for the period of its appointment.
The securities may be sold directly by CEL-SCI to institutional investors
or others, who may be deemed to be underwriters within the meaning of the
Securities Act with respect to any resale of the securities purchased by the
institutional investors. The terms of any of the sales, including the terms of
any bidding or auction process, will be described in the applicable prospectus
supplement.
CEL-SCI may permit agents or underwriters to solicit offers to purchase
its securities at the public offering price set forth in a prospectus supplement
pursuant to a delayed delivery arrangement providing for payment and delivery on
the date stated in the prospectus supplement. Any delayed delivery contract,
when issued, will contain definite fixed price and quantity terms. The
obligations of any purchaser pursuant to a delayed delivery contract will not be
subject to any market outs or other conditions other than the condition that the
delayed delivery contract will not violate applicable law. In the event the
securities underlying the delayed delivery contract are sold to underwriters at
the time of performance of the delayed delivery contract, those securities will
be sold to those underwriters. Each delayed delivery contract shall be subject
to CEL-SCI's approval. CEL-SCI will pay the commission indicated in the
prospectus supplement to underwriters or agents soliciting purchases of
securities pursuant to delayed delivery arrangements accepted by CEL-SCI.
Shares sold in an at the market offering will be limited to 10% of the
aggregate market value of CEL-SCI's outstanding voting stock held by
non-affiliates of CEL-SCI and will be sold through an underwriter or
underwriters, acting as principals or as agents for CEL-SCI. The underwriter of
any at the market offering will be named in a prospectus supplement pertaining
to the offering.
Notwithstanding the above, while prospectus supplements may provide
specific offering terms, or add to or update information contained in this
prospectus, any fundamental changes to the offering terms will be made by means
of a post-effective amendment.
Agents, dealers and underwriters may be entitled under agreements entered
into with CEL-SCI to indemnification from CEL-SCI against certain civil
liabilities, including liabilities under the Securities Act, or to contribution
with respect to payments made by such agents, dealers or underwriters.
DESCRIPTION OF SECURITIES
Common Stock
CEL-SCI is authorized to issue 100,000,000 shares of common stock, (the
"common stock"). Holders of common stock are each entitled to cast one vote for
each share held of record on all matters presented to shareholders. Cumulative
voting is not allowed; hence, the holders of a majority of the outstanding
common stock can elect all directors.
Holders of common stock are entitled to receive such dividends as may be
declared by the Board of Directors out of funds legally available therefor and,
in the event of liquidation, to share pro rata in any distribution of CEL-SCI's
assets after payment of liabilities. The board is not obligated to declare a
dividend. It is not anticipated that dividends will be paid in the foreseeable
future.
Holders of common stock do not have preemptive rights to subscribe to
additional shares if issued by CEL-SCI. There are no conversion, redemption,
sinking fund or similar provisions regarding the common stock. All of the
outstanding shares of common stock are fully paid and non-assessable and all of
the shares of common stock offered as a component of the Units will be, upon
issuance, fully paid and non-assessable.
Preferred Stock
CEL-SCI is authorized to issue up to 200,000 shares of preferred stock.
CEL-SCI's Articles of Incorporation provide that the Board of Directors has the
authority to divide the preferred stock into series and, within the limitations
provided by Colorado statute, to fix by resolution the voting power,
designations, preferences, and relative participation, special rights, and the
qualifications, limitations or restrictions of the shares of any series so
established. As the Board of Directors has authority to establish the terms of,
and to issue, the preferred stock without shareholder approval, the preferred
stock could be issued to defend against any attempted takeover of CEL-SCI. As of
February 27, 2004 no shares of preferred stock were outstanding.
Warrants Held by Private Investors
In April 2001, CEL-SCI entered into an equity line of credit agreement
with Paul Revere Capital Partners. As consideration for extending the equity
line of credit, which expired in June 2003, CEL-SCI granted Paul Revere Capital
Partners warrants to purchase 200,800 shares of common stock at a price of $1.64
per share at any time prior to April 11, 2004.
In August 2001, three private investors exchanged their warrants for
CEL-SCI's Series E warrants. As of February 27, 2004 the Series E warrants
collectively allowed the holders to purchase up to 570,627 additional shares of
CEL-SCI's common stock at a price of $1.19 per share at any time prior to August
16, 2004. In August 2003, in accordance with the terms of the Series E preferred
stock, CEL-SCI issued warrants which permit the holders to purchase an
additional 23,758 shares of CEL-SCI's common stock at a price of $0.77 per share
at any time prior to August 17, 2006.
In July and September 2002, CEL-SCI sold Series G convertible notes, plus
Series G warrants, to a group of private investors for $1,300,000. All of the
Series G convertible notes have since been converted into shares of CEL-SCI's
common stock. As of February 27, 2004 the Series G warrants collectively allowed
the holders to purchase up to 450,000 shares of CEL-SCI's common stock at a
price of $0.145 per share at any time prior to July 12, 2009. Every three months
after December 9, 2003, the exercise price of the Series G warrants will be
adjusted to an amount equal to 84% of the average of the 3 lowest daily trading
prices of CEL-SCI's common stock on the American Stock Exchange during the 20
trading days immediately prior to the three month adjustment date, provided that
the adjusted price is lower than the warrant exercise price on that date.
In January and July 2003, CEL-SCI sold Series H convertible notes, plus
Series H warrants, to a group of private investors for $1,350,000. All of the
Series H Convertible notes have since been converted into shares of CEL-SCI's
common stock. As of February 27, 2004 the Series H warrants collectively allowed
the holders to purchase up to 550,000 shares of CEL-SCI's common stock at a
price of $0.25 per share at any time prior to January 7, 2010. Every three
months after December 26, 2003 the exercise price of the Series H warrants will
be adjusted to an amount equal to 84% of the average of the 3 lowest daily
trading prices of CEL-SCI's common stock on the American Stock Exchange during
the 15 trading days immediately prior to the three month adjustment date,
provided that the adjusted price is lower than the warrant exercise price on
that date.
If CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price below the then applicable exercise
price of the Series G or H warrants, the warrant exercise price will be lowered
to the price at which the shares were sold or the lowest price at which the
securities are convertible, as the case may be. If the warrant exercise price is
adjusted, the number of shares of common stock issuable upon the exercise of the
warrant will be increased by the product of the number of shares of common stock
issuable upon the exercise of the warrant immediately prior to the sale
multiplied by the percentage by which the warrant exercise price is reduced.
If CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price below the market price of CEL-SCI's
common stock, the exercise price of the Series G or H warrants will be lowered
by a percentage equal to the price at which the shares were sold or the lowest
price at which the securities are convertible, as the case may be, divided by
the then prevailing market price of CEL-SCI's common stock. If the warrant
exercise price is adjusted, the number of shares of common stock issuable upon
the exercise of the warrant will be increased by the product of the number of
shares of common stock issuable upon the exercise of the warrant immediately
prior to the sale multiplied by the percentage determined by dividing the price
at which the shares were sold by the market price of CEL-SCI's common stock on
the date of sale.
However, neither the exercise price of the Series G or H warrants nor the
shares issuable upon the exercise of the Series G or H warrants will be adjusted
as the result of shares issued in connection with a Permitted Financing. A
Permitted Financing involves shares of common stock issued or sold:
o in connection with a merger or acquisition or a strategic partnership;
o upon the exercise of options or the issuance of common stock to CEL-SCI's
employees, officers, directors, consultants and vendors in accordance with
CEL-SCI's equity incentive policies;
o pursuant to the conversion or exercise of securities which were outstanding
prior to July 12, 2002 in the case of the Series G warrants and January 7,
2003 in the case of the Series H warrants;
o to key officers of CEL-SCI in lieu of their respective salaries.
In May 2003, CEL-SCI sold shares of its common stock plus Series I warrants
to a strategic partner, at prices equal to or above the then current price of
CEL-SCI's common stock. As of December 31, 2003 the Series I warrants allowed
the holder to purchase 1,100,000 shares of CEL-SCI's common stock at a price of
$0.47 per share at any time prior to May 30, 2008.
In September 2003, CEL-SCI entered into an equity line of credit agreement
with Rubicon Group Ltd. in order to establish a possible source of funding for
the development of CEL-SCI's technologies. As consideration for extending the
equity line of credit, CEL-SCI granted Rubicon Group warrants to purchase
395,726 shares of common stock at a price of $0.83 per share at any time prior
to September 16, 2008.
On December 1, 2003, CEL-SCI sold 2,999,964 shares of its common stock to
a group of private institutional investors for approximately $2,550,000, or
$0.85 per share. As part of this transaction, the investors and the sales agent
for a number of the investors received Series J warrants which, as of February
27, 2004, allowed the investors to purchase 991,003 shares of CEL-SCI's common
stock at a price of $1.32 per share at any time prior to December 1, 2006.
All of the private investors referred to above were accredited investors.
Transfer Agent
Computershare Trust Company, Inc., of Denver, Colorado, is the transfer
agent for CEL-SCI's common stock.
EXPERTS
The financial statements incorporated in this prospectus by reference from
the Company's Annual Report on Form 10-K for the year ended September 30, 2003
have been audited by Deloitte & Touche LLP, independent auditors, as stated in
their report, which is incorporated herein by reference, and have been so
incorporated in reliance upon the report of such firm given upon their authority
as experts in accounting and auditing.
INDEMNIFICATION
CEL-SCI's Bylaws authorize indemnification of a director, officer,
employee or agent of CEL-SCI against expenses incurred by him in connection with
any action, suit, or proceeding to which he is named a party by reason of his
having acted or served in such capacity, except for liabilities arising from his
own misconduct or negligence in performance of his duty. In addition, even a
director, officer, employee, or agent of CEL-SCI who was found liable for
misconduct or negligence in the performance of his duty may obtain such
indemnification if, in view of all the circumstances in the case, a court of
competent jurisdiction determines such person is fairly and reasonably entitled
to indemnification. Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers, or persons
controlling CEL-SCI pursuant to the foregoing provisions, CEL-SCI has been
informed that in the opinion of the Securities and Exchange Commission, such
indemnification is against public policy as expressed in the Act and is
therefore unenforceable.
ADDITIONAL INFORMATION
CEL-SCI is subject to the requirements of the Securities Exchange Act of
l934 and is required to file reports, proxy statements and other information
with the Securities and Exchange Commission. Copies of any such reports, proxy
statements and other information filed by CEL-SCI can be read and copied at the
Commission's Public Reference Room at 450 Fifth Street, N.W., Washington, D.C.,
20549. The public may obtain information on the operation of the Public
Reference Room by calling the Commission at 1-800-SEC-0330. The Commission
maintains an Internet site that contains reports, proxy and information
statements, and other information regarding CEL-SCI. The address of that site is
http://www.sec.gov.
CEL-SCI will provide, without charge, to each person to whom a copy of
this prospectus is delivered, including any beneficial owner, upon the written
or oral request of such person, a copy of any or all of the documents
incorporated by reference below (other than exhibits to these documents, unless
the exhibits are specifically incorporated by reference into this prospectus).
Requests should be directed to:
CEL-SCI Corporation
8229 Boone Blvd., #802
Vienna, Virginia 22182
(703) 506-9460
The following documents filed with the Commission by CEL-SCI (Commission
File No. 0-11503) are incorporated by reference into this prospectus:
(1) CEL-SCI's Annual Report on Form 10-K for the fiscal year ended September
30, 2003.
(2) CEL-SCI's Annual Report on Form 10-K/A for the fiscal year ended September
30, 2003.
(3) CEL-SCI's Proxy Statement relating to its March 31, 2003 shareholders'
meeting.
(4) CEL-SCI's report on Form 8-K filed on December 3, 2003.
(5) CEL-SCI's report on Form 10-Q for the three months ended December 31,
2003.
All documents filed with the Commission by CEL-SCI pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to the date of this
prospectus and prior to the termination of this offering shall be deemed to be
incorporated by reference into this prospectus and to be a part of this
prospectus from the date of the filing of such documents. Any statement
contained in a document incorporated or deemed to be incorporated by reference
shall be deemed to be modified or superseded for the purposes of this prospectus
to the extent that a statement contained in this prospectus or in any
subsequently filed document which also is or is deemed to be incorporated by
reference in this prospectus modifies or supersedes such statement. Such
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this prospectus.
Investors are entitled to rely upon information in this prospectus or
incorporated by reference at the time it is used by CEL-SCI to offer and sell
securities, even though that information may be superseded or modified by
information subsequently incorporated by reference into this prospectus.
CEL-SCI has filed with the Securities and Exchange Commission a
Registration Statement under the Securities Act of l933, as amended, with
respect to the securities offered by this prospectus. This prospectus does not
contain all of the information set forth in the Registration Statement. For
further information with respect to CEL-SCI and such securities, reference is
made to the Registration Statement and to the exhibits filed with the
Registration Statement. Statements contained in this prospectus as to the
contents of any contract or other documents are summaries which are not
necessarily complete, and in each instance reference is made to the copy of such
contract or other document filed as an exhibit to the Registration Statement,
each such statement being qualified in all respects by such reference. The
Registration Statement and related exhibits may also be examined at the
Commission's internet site.
No dealer salesman or other person has been authorized to give any information
or to make any representations, other than those contained in this prospectus.
Any information or representation not contained in this prospectus must not be
relied upon as having been authorized by CEL-SCI. This prospectus does not
constitute an offer to sell, or a solicitation of an offer to buy, the
securities offered hereby in any state or other jurisdiction to any person to
whom it is unlawful to make such offer or solicitation. Neither the delivery of
this prospectus nor any sale made hereunder shall, under any circumstances,
create an implication that there has been no change in the affairs of CEL-SCI
since the date of this prospectus.
TABLE OF CONTENTS
Page
Prospectus Summary...................................................
Risk Factors.........................................................
Comparative Share Data...............................................
Plan of Distribution.................................................
Description of Securities............................................
Experts..............................................................
Indemnification......................................................
Additional Information...............................................
Common Stock
CEL-SCI CORPORATION
PROSPECTUS