Rule 424(b)(3)
File #333-160794
PROSPECTUS SUPPLEMENT
(to Prospectus dated September 15, 2009)
CEL-SCI CORPORATION
Common Stock and Warrants
By means of this prospectus CEL-SCI Corporation is offering to sell up to
22,000,000 shares of its common stock to investors exercising warrants
previously issued by CEL-SCI.
CEL-SCI will not pay any commissions with respect to the sale of any
securities offered by this prospectus.
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 7 of CEL-SCI's prospectus dated September 15, 2009.
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 NYSE AMEX under the symbol "CVM".
On September 16, 2009 the closing price of CEL-SCI's common stock was $1.32.
The date of this prospectus supplement is September 17, 2009.
PROSPECTUS SUMMARY
THIS SUMMARY IS QUALIFIED BY THE MORE DETAILED INFORMATION APPEARING ELSEWHERE
IN THIS PROSPECTUS SUPPLEMENT, AS WELL AS CEL-SCI'S PROSPECTUS DATED SEPTEMBER
15, 2009.
CEL-SCI
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CEL-SCI Corporation (CEL-SCI) was formed as a Colorado corporation in
1983. CEL-SCI's principal office is located at 8229 Boone Boulevard, Suite 802,
Vienna, VA 22182. CEL-SCI's telephone number is 703-506-9460 and its web site is
www.cel-sci.com. CEL-SCI makes its electronic filings with the Securities and
Exchange Commission (SEC), including its annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K and amendments to these
reports available on its website free of charge as soon as practicable after
they are filed or furnished to the SEC.
CEL-SCI's business consists of the following:
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1) Multikine cancer therapy;
2) New "cold fill" manufacturing service to the pharmaceutical industry;
and 3) LEAPS technology, with two products, H1N1 swine flu
vaccine/treatment and
CEL-2000, a rheumatoid arthritis vaccine.
MULTIKINE
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CEL-SCI's lead product, Multikine(R), is being developed for the treatment
of cancer. It is the first of a new class of cancer immunotherapy drugs called
Immune SIMULATORs. It simulates the activities of a healthy person's immune
system, which battles cancer every day. Multikine is multi-targeted; it is the
only cancer immunotherapy that both kills cancer cells in a targeted fashion and
activates the general immune system to destroy the cancer. We believe Multikine
is the first immunotherapeutic agent being developed as a first-line standard of
care treatment for cancer and it is cleared for a global Phase III clinical
trial in advanced primary (previously untreated) head and neck cancer patients.
Multikine is a new type of immunotherapy in that it is a comprehensive
immunotherapy, incorporating both active and passive immune activity. A
comprehensive immunotherapy most closely resembles the workings of the natural
immune system in the sense that it works on multiple fronts in the battle
against cancer. A comprehensive immunotherapy causes a direct and targeted
killing of the tumor cells and activates the immune system to produce a more
robust and sustainable anti-tumor response.
Multikine is designed to target the tumor micro-metastases that are mostly
responsible for treatment failure. The basic concept is to add Multikine to the
current cancer treatments with the goal of making the overall cancer treatment
more successful. Phase II data indicated that Multikine treatment resulted in a
substantial increase in the survival of patients. The lead indication is
advanced primary (previously untreated) head & neck cancer (about 600,000 new
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cases per annum). Since Multikine is not tumor specific, it may also be
applicable in many other solid tumors.
In January 2007, the US Food and Drug Administration (FDA) concurred with
the initiation of a global Phase III clinical trial in head and neck cancer
patients using Multikine. The Canadian regulatory agency, the Biologics and
Genetic Therapies Directorate, had previously concurred with the initiation of a
global Phase III clinical trial in head and neck cancer patients using
Multikine.
The protocol is designed to develop conclusive evidence of the efficacy of
Multikine in the treatment of advanced primary (previously untreated) squamous
cell carcinoma of the oral cavity (head and neck cancer). A successful outcome
from this trial should enable CEL-SCI to apply for a Biologics License to market
Multikine for the treatment of this patient population.
The trial will test the hypothesis that Multikine treatment administered
prior to the current standard therapy for head and neck cancer patients
(surgical resection of the tumor and involved lymph nodes followed by
radiotherapy or radiotherapy and concurrent chemotherapy) will extend the
overall survival, enhance the local/regional control of the disease and reduce
the rate of disease progression in patients with advanced oral squamous cell
carcinoma.
UNIQUE COLD FILL CONTRACT MANUFACTURING SERVICE TO BE OFFERED AT CEL-SCI'S NEW
MANUFACTURING FACILITY
In October 2008, CEL-SCI took over its new, state-of-the-art manufacturing
facility. This facility, leased from a third party, will be used to manufacture
Multikine for CEL-SCI's Phase III clinical trial. Located near Baltimore, MD, it
was designed over several years, and was built out to CEL-SCI's specifications
during the past 18 months. In addition to using this facility to manufacture
Multikine, CEL-SCI will offer the use of the facility as a service to
pharmaceutical companies and others, particularly those that need to "fill and
finish" their drugs in a cold environment (4 degrees Celsius, or approximately
39 degrees Fahrenheit). Fill and finish is the process of filling injectable
drugs in a sterile manner and is a key part of the manufacturing process for
many medicines.
The fastest area of growth in the biopharmaceutical and pharmaceutical
markets is biologics, and most recently stem cell products. Biologics are
usually very sensitive to heat and quickly lose their biological activity if
exposed to room or elevated temperature. However, these products do not
generally lose activity when kept at 4 degrees Celsius.
The FDA and other regulatory agencies require a drug developer to
demonstrate the safety, purity and potency of a drug being produced for use in
humans. When filling a product at 4 degrees Celsius, minimal to no biological
losses occur and therefore the potency of the drug is maintained throughout the
final critical step of the drug's manufacturing process. If the same temperature
sensitive drug is instead aseptically filled at room temperature, expensive and
time consuming validation studies must be conducted, first, to be able to obtain
a complete understanding of the product's potency loss during the room
temperature fill process, and second, to create solutions to the drug's potency
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losses, which require further testing and validation.
CEL-SCI's unique, cold aseptic filling suite can be operated at
temperatures between 2 degrees Celsius and room temperatures, and at various
humidity levels. CEL-SCI's aseptic filling suites are maintained at FDA and EU
ISO classifications of 5/6. CEL-SCI also has the capability to formulate,
inspect, label and package biologic products at cold temperatures.
CEL-SCI does not know of any other facility in the United States which is
able to provide cold 4 degrees Celsius finish and fill services on a contract
basis.
L.E.A.P.S.
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CEL-SCI's patented T-cell Modulation Process uses "heteroconjugates" to
direct the body to choose a specific immune response. The heteroconjugate
technology, referred to as L.E.A.P.S. (Ligand Epitope Antigen Presentation
System), is intended to selectively stimulate the human immune system to more
effectively fight bacterial, viral and parasitic infections as well as
autoimmune, allergies, transplantation rejection and cancer, when it cannot do
so on its own. Administered like vaccines, LEAPS combines T-cell binding ligands
with small, disease associated, peptide antigens and may provide a new method to
treat and prevent certain diseases.
The ability to generate a specific immune response is important because
many diseases are often not combated effectively due to the body's selection of
the "inappropriate" immune response. The capability to specifically reprogram an
immune response may offer a more effective approach than existing vaccines and
drugs in attacking an underlying disease.
Using the LEAPS technology, CEL-SCI has created a potential peptide
vaccine/treatment against H1N1 swine flu. The Company has begun pre-clinical
formulation, evaluation and testing of a new application of its H1N1 vaccine,
which will allow the targeting of "mutated" versions of H1N1 swine and other
influenza viruses. It is believed that the influenza virus may mutate and evolve
between now and the winter flu season. In conjunction with the testing, CEL-SCI
has produced several L.E.A.P.S. flu vaccines that focus on the conserved, non
changing epitopes of the different strains of Type A Influenza viruses (H1N1,
H5N1, H3N1, etc.), including "swine", "avian or bird", and "Spanish Influenza",
in order to minimize the change of viral "escape by mutations" from immune
recognition. CEL-SCI's L.E.A.P.S. flu vaccine, LEAPS-H1N1 contains epitopes
known to be associated with immune protection against influenza in animal
models.
On September 16, 2009 the U.S. Food and Drug Administration advised
CEL-SCI that it could proceed with its first clinical trial to evaluate the
effect of LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1
patients. This followed an expedited initial review of CEL-SCI's regulatory
submission for this study proposal. Following completion of manufacturing, the
initiation of this first study will be subject to review and approval by the
Institutional Review Board of any hospital participating in the study.
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To fully consider a next-stage clinical trial to evaluate LEAPS-H1N1
treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu
under an Exploratory IND, the FDA has asked CEL-SCI to submit a detailed
follow-up regulatory filing with extensive additional data. Thus, in parallel
with preparing for this first study, CEL-SCI is proceeding on an expedited basis
to complete this next submission. Recognizing that it cannot proceed with its
next-stage clinical trial without the FDA's concurrence, CEL-SCI anticipates
engaging in a detailed dialogue with the FDA regarding the proposed LEAPS-H1N1
clinical-development program following this future filing.
With its LEAPS technology CEL-SCI also discovered a second peptide named
CEL-2000, a potential rheumatoid arthritis vaccine. The data from animal studies
of rheumatoid arthritis using the CEL-2000 treatment vaccine demonstrated that
CEL-2000 is an effective treatment against arthritis with fewer administrations
than those required by other anti-rheumatoid arthritis treatments, including
Enbrel(R). CEL-2000 is also potentially a more disease type specific therapy, is
calculated to be significantly less expensive and may be useful in patients
unable to tolerate or who may not be responsive to existing anti-arthritis
therapies.
Recent Developments
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On September 16, 2009 CEL-SCI sold 14,285,715 shares of its common stock
to a group of private investors for $20,000,000 or $1.40 per share. The
investors also received Series D warrants which entitle the investors to
purchase 4,714,284 shares of CEL-SCI's common stock. The Series D warrants may
be exercised at any time prior to September 21, 2011 at a price of $1.50 per
share. The closing of the transaction is expected to close on or before
September 21, 2009.
General
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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 the date of
this prospectus 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 $(135,000,000) at June 30, 2009 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.
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THE OFFERING
Securities Offered:
Up to 22,000,000 shares of common stock are being offered to investors who
exercise warrants previously issued by CEL-SCI.
Common Stock Outstanding: As of September 15, 2009, CEL-SCI had 162,984,024
outstanding shares of common stock. 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 or shares sold on September
16, 2009 (for which the closing will not take place
until September 21, 2009). If all outstanding
warrants and convertible securities were exercised
and converted, CEL-SCI would have approximately
269,000,000 outstanding shares of common stock.
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 the
prospectus dated September 15, 2009.
NYSE Amex trading symbol: CVM
Use of Proceeds: The net proceeds from the sale of all
shares of common stock offered, after deducting the
estimated expenses of this offering, will be
approximately $12,000,000 and will be used for
CEL-SCI's general and administrative expenses and
CEL-SCI's Phase III clinical trial involving
Multikine.
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.
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PLAN OF DISTRIBUTION
CEL-SCI will offer the shares directly to holders of CEL-SCI's outstanding
warrants. CEL-SCI will not pay any commissions with respect to the sale of any
of the securities offered by this prospectus.
CEL-SCI estimates that its portion of the total expenses of this offering
will be approximately $15,000.
DESCRIPTION OF SECURITIES
Common Stock
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CEL-SCI is authorized to issue 450,000,000 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.
Warrants
See CEL-SCI's prospectus dated September 15, 2009 for information
concerning CEL-SCI's outstanding warrants.
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 100 F. Street, N.E., 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.
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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) Annual Report on Form 10-K for the fiscal year ended September 30,
2008.
(2) Proxy Statement relating to its March 3, 2008 shareholders' meeting.
(3) Report on Form 8-K filed on December 9, 2008.
(4) Report on Form 10-Q for the three months ended December 31, 2008.
(5) Report on Form 8-K filed on January 6, 2009.
(6) Report on Form 8-K filed on March 12, 2009.
(7) Report on Form 8-K filed on April 1, 2009.
(8) Report on Form 10-Q for the three months ended March 31, 2009.
(9) Report on form 8-K filed June 25, 2009.
(10) Report on Form 8-K filed June 29, 2009.
(11) Report on Form 8-K filed July 2, 2009.
(12) Report on Form 8-K filed on August 5, 2009.
(13) Report on Form10-Q for the three months ended June 30, 2009.
(14) Report on Form 8-K filed on August 21, 2009.
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
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statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of 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.
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